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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.

2962 Study Matches

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Minnesota Regional SCIMS (SCIMS)

Spinal Cord Injury Model Systems for Minnesota Region (SCIMS)

Ronald Reeves
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306996-P01-RST
22-000795
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Inclusion Criteria:

  • Presence of an external traumatic event that results in a spinal cord injury, including surgical procedures, radiation, and medical complications.
  • Temporary or permanent loss of sensory and/or motor function as a result of the traumatic event.
  •  Admission to the system within one year of injury.
  • Discharge from the System Rehab as:
    • Having completed inpatient acute rehabilitation;
    • Deceased.
  • Signed informed consent and HIPAA authorization forms.
  • Reside in the geographic catchment area of the system at the time of the injury.  Patients may be injured outside of the catchment area.
  • A US citizen or non-US citizen who is expected to stay in the catchment area.


Exclusion Criteria:

  • Must not have previously been treated at another model system for the injury.
    • Ensures that patients are enrolled into the database by only one model system.
  • Must not have completed an organized rehabilitation program prior to the admission to the system.

Eligibility last updated 1/24/22. Questions regarding updates should be directed to the study team contact.

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Pushing the Envelope in Reduction of Hysterectomy Surgical Site Infection (SSI): Studying the role of an Anal Occlusive Dressing (AOD) (AOD and SSI)

Anal Occlusion and SSI Reduction

Tarek Khalife
Female
18 years to 65 years old
This study is NOT accepting healthy volunteers
2022-307005-H01-MAIJ
22-000637
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Inclusion Criteria:

  • Patients subject to a laparoscopic hysterectomy procedure necessitating uterine manipulator use,
  • Age 18-65.


Exclusion Criteria:

  • Patient known to have a vesicovaginal or rectovaginal fistula.
  • Patients who have a documented tape allergy.
  • Patients know to have an active pelvic infection.
  • Patient diagnosed or known to have fecal incontinence.
  • Patients diagnosed or known to have severe external hemorrhoids.
  • Patients with a very short perineal body with < 2cm.
  • Patients who were found to have a disruption in the occlusive dressing seal at the end of the case (blood soilage).
  • Patients necessitating a rectal exam or manipulation as part of the procedure.
  • Patient with visible skin irritation or inflammation around the anal orifice.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Mankato, MN

Assessing the Experiences of LGBTQ patients in the ICU (LGBT in ICU)

Assessing the Experiences of LGBTQ Patients in the ICU

Erin DeMartino
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307009-H01-RST
22-000846
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Inclusion Criteria:

  • Is 18 years old or older.
  • Self-identifies as a member of the LGBTQ community or self-identified as such at the time of their admission or is the spouse, partner, or family member who identifies as a member of the LGBTQ community.
  • Has been on a ventilator in the intensive care unit or is the spouse, partner, or family member of a patient on a ventilator in the intensive care unit between 1/2016 and 2/2022.


Exclusion Criteria:
 

  • Does not meet the above criteria for age, LGBTQ identity, relationship to an LGBTQ identifying individual, and past mechanical ventilation.

Eligibility last updated 3/2/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

The Development of a Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients with Resected Non-Small Cell Lung Cancer (NSCLC)

Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients with Resected Non-Small Cell Lung Cancer

Konstantinos Leventakos
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307019-P01-RST
21-013359
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Patient

Inclusion Criteria:

  • Adults ≥ 18 years with biopsy proven resected NSCLC.
  • Appointment to discuss adjuvant treatment of resected NSCLC.

Patient


Exclusion Criteria:

  • Major barriers to providing informed consent (i.e. dementia, severe hearing or visual impairment).

Clinician

Inclusion Criteria:

  • Clinicians who meet with patients to discuss adjuvant treatment of resected NSCLC.

Clinician


Exclusion Criteria:

  • None.

PAG Member

Inclusion Criteria:

  • Adults ≥ 18 years.
  • Member of the KER Unit PAG.

PAG Member


Exclusion Criteria:

  • None.

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

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Mayo Clinic — Rochester, MN

A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Spinal Cord Stimulation to Treat Chemotherapy-Induced Peripheral Neuropathy

Ryan D'Souza
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307074-P01-RST
22-001218
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Inclusion Criteria:


- Adult patients aged 18 to 70 who have been clinically diagnosed with CIPN for greater
than six months after stopping chemotherapy

- Average pain intensity >= 5 on 11-point numeric rating scale (NRS) in the lower
extremities at enrollment

- Failed conventional medication management with at least two neuropathic pain
medications

- Have electrophysiological evidence of length-dependent peripheral neuropathy

- Underwent a 10-kHz spinal cord stimulator trial for a primary indication of CIPN and
reported a successful trial of at least 75% reduction in pain intensity

- Have stable neurological status

- Be on a stable analgesic regimen

- Be an appropriate candidate for surgical procedures required in this study

- Be able to read and understand English-written questionnaires and sign an informed
consent form in English

- Be willing and capable of giving informed consent

- Be willing and able to complete study-related requirements, procedures, and visits


Exclusion Criteria:


- Patient refusal to be included in study

- Presence of lower limb mononeuropathy

- History of lower limb amputation or ulceration

- Presence of another painful condition that is unrelated to CIPN and that is not
intended to be treated in this study

- Body mass index (BMI) >= 40

- Omeprazole (OME) > 120 mg

- Progressive neurological disease (multiple sclerosis, chronic inflammatory
demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord
tumor, central deafferentation syndrome, complex regional pain syndrome, acute
herniating disc, severe spinal stenosis)

- Certain comorbidities: coagulation/bleeding disorders, diminished capacity from
cardiac/pulmonary disease

- Obtaining another interventional procedure unrelated to SCS to treat limb pain

- Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm.
Included patients must be deemed as in remission per discretion of treating oncologist

- Have a life expectancy of less than one year

- Have untreated addiction or dependency to medications, alcohol, or illicit drugs

- Have active, disruptive, and/or unstable psychological or psychiatric disorder

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

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Mayo Clinic — Rochester, MN

Normative Biomechanical Measures of Reaching in Able-Bodied Adults

Reach Normal Controls

Kristin Zhao
All
20 years to 59 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307103-H01-RST
22-000958
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Inclusion Criteria:


- 20-59 years of age at time of enrollment


Exclusion Criteria:


- Failure to give consent or follow simple commands

- Score of 7 or above on the QuickDASH Outcome Measure

- Score of 5 or above on the Oswestry Low Back Disability Questionnaire

- Score of 76 or below on the Lower Extremity Functional Scale

- Diagnosis of a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis,
fibromyalgia)

- Diagnosis of an inner ear balance disorder (e.g., benign paroxysmal positional
vertigo)

- Insufficient active range of motion of bilateral shoulders or hips that results in
inability to perform forward or lateral reaching tasks

- Any illness or condition which, based on the research team's assessment, will
compromise the patient's ability to comply with the protocol, patient safety, or the
validity of the data collected during this study

Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.

Other, Functional reach test
Finding related to ability to reach
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Autotransfusion During Intralesional Tumor Resection: Effectiveness of Leukocyte Reduction Filtration in Removing Neoplastic Cells (CSDTR)

Cell Saver During Tumor Resection

Matthew Houdek
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307110-H01-RST
22-000975
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Inclusion Criteria:

  • Any patient undergoing surgery for intralesional resection of neoplasm such as tumors of the spine/extremities or metastatic disease.


Exclusion Criteria:

  • Patients undergoing surgery with an expected blood loss of less than 135cc.
  • Provisions for inclusion of minorities: 
    • Subjects will be enrolled prospectively irrespective of their sex/gender, race, and ethnicity in order to improve generalizability.        

Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.

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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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Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)

Cadman Leggett
All
45 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307142-P01-RST
22-001278
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Inclusion Criteria:
 

  • Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥ years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
  • Between the ages of 45 and 80 years, inclusive.
  • Able and willing to provide written informed consent.


Exclusion Criteria:

  • Self-reported pregnancy.
  • Known diagnosis of Colorectal Cancer.
  • History of, or referral for, Inflammatory Bowel Disease.
  • Previous surgery involving the colon or rectum.
  • Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
  • High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
  • Referral for overt, symptomatic gastrointestinal bleeding.

Eligibility last updated 2/4/22. Questions regarding updates should be directed to the study team contact.

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Intracardiac Flow Assessment in Cardiac Amyloidosis

Intracardiac Flow Assessment in Cardiac Amyloidosis

Ian Chang
All
40 years and over
This study is NOT accepting healthy volunteers
2022-307150-H01-RST
22-001098
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Inclusion Criteria:


- Subject is clinically stable without cardio-vascular-related hospitalizations within 6
weeks prior to enrollment as assessed by the investigators.

- Subject is able to provide written informed consent and is willing and able to
complete study procedures.

- Currently in sinus rhythm by clinical assessment or documented electrocardiographic
studies.

- Subject and disease characteristics noted by medical record review:

- Healthy control volunteers must also meet the following criteria: Karnofsky
performance scale > 80%; ECOG status 0 or 1.

- ATTRwt cardiac amyloidosis based on meeting all the following criteria: Diagnosis
of amyloidosis within two years prior to study screening; Documentation of
absence of pathogenic TTR mutation; Documentation of absence of plasma cell
dyscrasia, including monoclonal gammopathy of undetermined significance (MGUS) by
laboratory studies including serum free light chain assay and serum or urine
immunofixation; Amyloid deposits in cardiac tissue with TTR protein
identification by mass spectrometry or immuno-histochemistry, OR technetium
(99mTc) pyrophosphate scintigraphy with grade 2 or 3 cardiac uptake; Evidence of
cardiac involvement by echocardiography with an end-diastolic mean wall thickness
> 12 mm, OR CMR diagnostic of amyloidosis;

- AL with cardiac involvement based on meeting all the following criteria:
Diagnosis of amyloidosis within two years prior to study screening;
Histopathologic diagnosis of amyloidosis with AL protein identification by mass
spectrometry or immuno-histochemistry; Documented clinical signs and symptoms
consistent with heart failure in the absence of an alternative explanation;
Cardiac involvement as defined by: Amyloid deposits in cardiac deposits OR
Echocardiography with an end-diastolic mean wall thickness > 12 mm in the absence
of other causes OR Elevated NT-proBNP (>332 ng/L) in the absence of renal failure
or atrial fibrillation OR CMR diagnostic of amyloidosis;

- AL without cardiac involvement based on meeting all the following criteria:
Diagnosis of amyloidosis within two years prior to study screening;
Histopathologic diagnosis of amyloidosis with AL protein identification by mass
spectrometry or immuno-histochemistry; No documented clinical signs and symptoms
consistent with heart failure from AL; Absence of cardiac involvement as defined
by: Echocardiography with an end-diastolic mean wall thickness < 13 mm if the
subject does not have other causes for increased wall thickness AND NT-proBNP
<333 ng/L if the subject does not have renal failure or atrial fibrillation AND
No CMR diagnostic of amyloidosis if CMR is available prior to screening.


Exclusion Criteria:


- Unable to consent or unable to complete all study procedures.

- Unable to ambulate for 6 minutes (confirmed at study coordinator visit).

- Unable to maintain in supine position for 30 minutes.

- Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator
visit).

- Contraindications for safe CMR scanning (e.g., claustrophobia, cochlear implant,
implanted neural stimulator).

- Presence of implantable cardiac pacemaker, defibrillator or recorder.

- History of intracardiac prosthesis, congenital heart disease, intracardiac shunt,
prior intrathoracic surgery, or procedures to the thoracic aorta or pulmonary
arteries.

- Significant artifact from prior MRI studies.

- Pregnant or breast-feeding women.

- Weight equal to or greater than 155 kg.

- Maximum body side-to-side or anterior-posterior diameter equal to or greater than 70
cm.

- Documented non-sinus rhythm within 6 months prior to screening.

- For healthy controls, the following exclusion criteria apply, confirmed per chart
review and/or patient report:

- History of cardiomyopathy or structural heart disease;

- History of valvular disease of greater than mild severity;

- History of coronary artery disease or coronary heart disease;

- History of cardiac or thoracic surgery.

- History of atrial tachyarrhythmia, ventricular tachyarrhythmia, or symptomatic
bradyarrhythmia;

- Left ventricular hypertrophy or abnormally increased myocardial thickness by
prior echocardiography, cardiac computed tomography, or CMR;

- Acute kidney injury, OR chronic renal disease with glomerular filtration rate <
60 mL/min/1.73m^2 as per medical record review.

- Uncontrolled hypertension of systolic blood pressure > 140 mmHg or diastolic
blood pressure > 90 mmHg as per medical record review;

- Taking two or more anti-hypertensive medications;

- Type 1 diabetes, OR uncontrolled type 2 diabetes mellitus of hemoglobin A1c
greater than 7, as per medical record review;

- Taking two or more diabetic medications;

- History of stroke or transient ischemic attack;

- Current cigarette smoker;

- History of peripheral artery disease of aortopathy;

- History of plasma cell dyscrasia or chronic hematologic diagnosis;

- BMI > 35 kg/m^2.

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

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

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Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System

Focal Prostate Ablation Utilizing TULSA Profound System

David Woodrum
Male
45 years to 80 years old
This study is NOT accepting healthy volunteers
2022-307169-P01-RST
22-001336
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Inclusion Criteria:

  • Male patients.
  • Age 45-80 years, with > 10 years life expectancy.
  • Biopsy-confirmed, NCCN (favorable GG2 and unfavorable GG3) intermediate-risk prostate cancer.
  • Stage ≤ T2c, N0, M0.
  • ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy (minimum 3 cores from each PI-RADS v2 category ≥ 3 lesion). Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline.
  • PSA ≤ 20 ng/mL reported within 3 months of baseline.
  • Treatment naïve.
  • Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline.  


Exclusion Criteria:

  • Inability to undergo MRI or general anaesthesia.
  • Suspected tumour > 30 mm from the prostatic urethra.
  • Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumour on low-dose pelvic CT:                
    • Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcifications. Imaging for calcification screening must be dated within 1 year of baseline visit.
  • Unresolved urinary tract infection or prostatitis.
  • History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder.
  • Artificial urinary sphincter, penile implant or intraprostatic implant.
  • Less than 10 years life expectancy.
  • Patients who are otherwise not deemed candidates for RP.
  • Inability or unwillingness to provide informed consent.
  • History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices.

Eligibility last updated 2/7/22. Questions regarding updates should be directed to the study team contact.

 

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Placental inflammation and function – in vitro analysis

Placenta Study

Sylvie Girard
Female
18 years to 50 years old
This study is NOT accepting healthy volunteers
2022-307202-H01-RST
22-000892
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Inclusion Criteria:

  • Women who will give birth at Mayo Clinic by caesarean-section at term following an uncomplicated pregnancy.


Exclusion Criteria:

  • Multiple pregnancy.
  • Known presence of clinical infections (e.g., chorioamnionitis), congenital anomalies or maternal pathologies (i.e., diabetes, hypertension, preeclampsia).
  • Intrauterine growth retardation or fetal macrosomia.
  • Maternal age under 18 or over 50.
  • Maternal body mass index (BMI) of less than 18 and more than 40.
  • Pregnancy less than 37 weeks of completed gestation.

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

 

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A Post-market Study for Continuing Evaluation and Periodic Reporting of the Safety and Effectiveness of the Spatz3 Intragastric Balloon (PAS-S)

Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

Barham Abu Dayyeh
All
22 years to 65 years old
Post Market
This study is NOT accepting healthy volunteers
2022-307203-P01-RST
22-001232
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Inclusion Criteria:

  • Age 22
    •65 years.
  • BMI ≥ 35 and < 40 kg/m^2 or BMI of 30 to 34.9 kg/m^2 with one or more major obesity-related comorbid conditions.
  • Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
  • History of obesity (BMI ≥ 30) for at least 2 years.
  • History of failure with non-surgical weight loss methods.
  • Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling.
  • Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow-up visits.
  • Ability to give informed consent.
  • Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.  Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence.  Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester
    •the timing of which will be determined via consultation with the subject’s obstetrician.


Exclusion Criteria:

  • Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery.
  • Prior open or laparoscopic bariatric surgery.
  • Prior surgery of any kind on the esophagus, stomach, duodenum or any type of hiatal hernia surgery.
  • Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett’s esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease
  • Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
  • A gastric mass.
  • A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.
  • Acid reflux symptoms to any degree that require more than one medication for symptom control.
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
  • Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device.
  • Severe coagulopathy.
  • Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
  • Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
  • Chronic abdominal pain.
  • Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
  • Hepatic insufficiency or cirrhosis.
  • Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months.
  • Alcoholism or drug addiction.
  • Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  • Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
  • Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
  • Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
  • Patients who have BOTH:
    • A previous history of a serotonin syndrome; AND
    • currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)].
  • Patients who are pregnant or breast-feeding.
  • Subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs.
  • Subjects who have tested positive for H. Pylori, and who have not yet been treated.

Eligibility last updated 2/3/22. Questions regarding updates should be directed to the study team contact.

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T-cell Clonality in Rheumatoid Arthritis (SMRA)

Somatic Mutation in Rheumatoid Arthritis

Jorg Goronzy
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307251-H01-RST
22-001428
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Inclusion Criteria:

  • Diagnosis of seropositive rheumatoid arthritis (either Rheumatoid factor or anti-CCP positive).
  • Age-matched Healthy Controls.


Exclusion Criteria:

  • Chronic active viral infection.
  • History of chemo/radiotherapy.
  • History of cancer.
  • Other autoimmune disease.
  • Pregnancy.

Eligibility last updated 3/23/22. Questions regarding updates should be directed to the study team contact.

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An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome

Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

Irina Bancos
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307253-P01-RST
22-001433
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Inclusion Criteria:
 

  • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
  • According to the Investigator's opinion, will benefit from continuing treatment with relacorilant.


Exclusion Criteria:

  • Premature discontinuation from a relacorilant parent study.
  • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
  • Has poorly controlled hypertension.
  • Has Stage ≥ 4 renal failure.

Eligibility last updated 2/8/22. Questions regarding updates should be directed to the study team contact.

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Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (Phase II) (ADI 3)

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

Bruce Johnson
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2022-307263-P01-RST
22-001477
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Inclusion Criteria:

  • Adults over the age of 18 and who are willing and able to give informed consent.
  • Willing to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device.
  • Volunteers of any race, any gender.
  • Range of physiques.


Exclusion Criteria:

  • Injury or skin disturbance in the area of the test device.
  • Pregnant.
  • Currently smokes cigarettes.
  • Has known respiratory conditions such as:
    • Flu;
    • Pneumonia/bronchitis;
    • Shortness of breath/respiratory distress;
    • Respiratory or lung surgery;
    • Emphysema, COPD, lung disease.
  • Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function.
  • Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask).
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Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)

Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

Wen Wee Ma
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307312-P01-RST
22-001698
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Inclusion Criteria:

  • Male or female and ≥ 18 years-of-age at the time of informed consent.
  • ECOG Performance status 0 or 1.
  • Locally advanced or metastatic resistant or refractory solid tumors.
  • Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible.
  • Measurable disease as per RECIST v1.1.
  • Ability to swallow and retain oral medications.
  • Acceptable hematologic and organ function at screening.
  • Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
  • Resolution of all toxicities of prior therapy or surgical procedures.
  • Life expectancy ≥ 12 weeks after the start of the treatment.


Exclusion Criteria:

  • Chemotherapy or small molecule antineoplastic agent given within 21 days or < 5 half- lives, whichever is shorter, prior to first dose of study drug.
  • History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Known sensitivity to any of the ingredients of RP-6306 or gemcitabine.
  • Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
  • Major surgery within 4 weeks prior to first dose of RP-6306 and gemcitabine.
  • Uncontrolled, symptomatic brain metastases.
  • Uncontrolled hypertension.
  • Moderate or severe hepatic impairment.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

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Per Oral Endoscopic Myotomy - A Minimally Invasive Treatment Modality for Achalasia (POEM Prospective)

Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia (POEM)

Karthik Ravi
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307348-H01-RST
22-001899
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Inclusion Criteria:

  • Patients ≥ 18 years old
  • Patients undergoing POEM for:
    • Achalasia (types I, II, and III);
    • Non-achalasia esophageal motility disorders (e.g., diffuse esophageal spasm).
  • POEM performed at Mayo Clinic by providers in the Division of Gastroenterology or the Division of Thoracic Surgery.


Exclusion Criteria:

  • Patients < 18 years old.
  • Patients with prior POEM performed outside of Mayo Clinic.
  • Prior upper gastrointestinal surgery.
  • No authorization for research participation at Mayo Clinic.
  • Inability to communicate/provide history of symptoms.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.

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(ECTx) A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in Combination With Dabrafenib for the Treatment of Advanced Solid Tumors With MAPK Pathway Mutations (JSI-1187-01)

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations

Robert McWilliams
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307388-P01-RST
22-002123
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Inclusion Criteria:

  • Males and females ≥ 18 years of age
  • Have locally advanced or metastatic solid tumor malignancy with measurable disease and be an appropriate candidate for experimental therapy.
  • Part A (JSI-1187 Monotherapy Dose Escalation):
    • Histologically or cytologically confirmed MAPK pathway mutation, including hyperactivating pathway mutations or gene fusions; e.g., BRAF (Class I, II or III), RAS (H/K/N), MEK (MAP2K1), RAS-GAP (NF1 loss, RASA1), RAS-GEF, refractory to or relapsed on prior therapy, and have received all available therapy known to confer clinical benefit.
    • Part B (JSI-1187 Plus Dabrafenib Combination Dose Escalation):
      • Histologically or cytologically confirmed BRAF V600-mutated locally advanced or metastatic solid tumor, refractory to, or relapsed on, prior therapy, and have received all available therapy known to confer clinical benefit.
  • Part C (JSI-1187 Plus Dabrafenib Expansion Cohorts): Histologically or cytologically confirmed:
    • Cohort 1: BRAF V600-mutated metastatic melanoma after two prior therapies for metastatic disease, including anti-PD1 therapy, with or without ipilimumab, and BRAF/MEK inhibitor treatment;
    • Cohort 2: BRAF V600-mutated metastatic melanoma after adjuvant therapy for Stage 3 disease followed by one prior therapy for metastatic disease, including anti-PD-1 therapy, with or without ipilimumab or BRAF/MEK inhibitor treatment;
    • Cohort 3: Either BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC), or BRAF V600-mutated metastatic solid tumor, after 1 or 2 prior therapies.
  • MAPK mutation tumor status will be established prior to entry based on previous MAPK pathway mutation reports from a CLIA qualified laboratory, or, if a report is not available, the mutation analysis will be performed at Screening on archival tissue or newly biopsied tumor tissue.
  • Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤ 1.
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2.
  • Life expectancy of ≥ 3 months -Subjects with asymptomatic stable, prior or currently treated brain metastases are allowed -Adequate hematologic parameters without ongoing transfusional support:
    • Hemoglobin (Hb) ≥ 9 g/dL -Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 cells/L;
    • Platelets ≥ 75 x 10^9 cells/L -Adequate renal and hepatic function;
    • Creatinine ≤ 1.5 times the upper limit of normal (ULN), or calculated creatinine clearance ≥ 50 mL/minute x 1.73 m^2 per the Cockcroft-Gault formula;
    • Total bilirubin ≤ 2 times the (ULN) unless due to Gilbert's disease;
    • ALT/AST ≤ 2.5 times the ULN, or < 5 times the ULN for subjects with liver metastases.
  • Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy throughout the study and for 28 days after the completion of study treatment.
  • Ability to provide written informed consent.


Exclusion Criteria:

  • Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV.
  • QT interval corrected for rate (QTc) > 480 msec on the ECG obtained at Screening using Fridericia method for QTc calculation.
  • Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.
  • Medications that are strong inhibitors of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
  • Medications that are strong inducers of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
  • Medications that are strong inhibitors of BCRP are prohibited during study and for 14 days prior to the first dose of study drugs(s).
  • Subjects on dabrafenib (Parts B and C) also are advised to avoid concurrent administration of strong inhibitors of CYP2C8 as these medications may increase the concentration of dabrafenib -History of or current evidence/risk of retinal vein occlusion or central serous retinopathy, or has medically relevant abnormalities identified on screening ophthalmologic examination -Symptomatic central nervous system malignancy or metastasis -Gastrointestinal conditions that could impair absorption of study drug(s).
  • Current hematologic malignancies -Second, active primary solid tumor malignancy that, in the judgement of the investigator or Sponsor medical monitor, may affect the interpretation of results.
  • Prior malignancies, with the exception of carcinoma in situ of any origin, non-muscle invasive bladder cancer, Gleason 3+3 prostate cancer and prior malignancies in remission whose likelihood of recurrence is very low, as judged by the Sponsor medical monitor.
  • Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment within the last week prior to study treatment.
  • Other active infection requiring IV antibiotic usage within the last week prior to study treatment.
  • Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.
  • Participation within the last 28 days in a clinical trial, or currently enrolled in a clinical trial, involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Previously completed or withdrawn from this study or any other study investigating an ERK1/2 inhibitor.
  • If female, pregnant, breast-feeding, or planning to become pregnant.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

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

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

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

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


Exclusion Criteria:

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

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

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

Artificial Intelligence Enhanced Assessment of Speech Disorders

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

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


Exclusion Criteria:

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

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

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

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

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

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


Exclusion Criteria:

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

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

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Mayo Clinic Digital Menopause Management Study

Testing of a Menopause Management Digital Health Application

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

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


Exclusion Criteria:

  • Current use of hormone therapy.

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

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

GB5121 in Adult Subjects With Relapsed/Refractory CNS Lymphoma

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

  • Subjects must have histologically/cytologically confirmed primary central nervous system lymphoma (PCNSL), primary vitreoretinal lymphoma (PVRL), or CNS-only systemic High Grade B-cell lymphoma (DLBCL/SCNSL).
  • All subjects must have relapsed/refractory disease and have received at least one prior CNS-directed therapy.
  • Subjects must be able to tolerate gadolinium-enhanced magnetic resonance imaging (MRI) scans, or contrast-enhanced computed tomography (CT).
  • Subjects with parenchymal lesions must have baseline imaging (gadolinium-enhanced MRI or if contraindicated, measurable CT, of the brain) within 28 days prior to first study drug dose. For subjects with leptomeningeal disease only, cerebrospinal fluid (CSF) cytology must document lymphoma cells and/or imaging findings consistent with CSF disease after informed consent and prior to first study dose (at the discretion of the Investigator).
  • Subjects with parenchymal lesions must have measurable disease on imaging (gadolinium-enhanced MRI or if contraindicated, measurable CT, of the brain) prior to first study dose.
  • Subjects must be able to tolerate and consent for a lumbar puncture and/or have pre-existing placement of an Ommaya reservoir, unless clinically contraindicated.
  • Subject must have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  • Demonstrate adequate bone marrow and organ function.


Exclusion Criteria:

  • Subject is concurrently using other approved or investigational antineoplastic agents.
  • Subject has an active concurrent malignancy requiring active therapy.
  • Subject is allergic to components of the study drug.
  • Subject has a known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia.
  • Subject has significant abnormalities on screening electrocardiogram (ECG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, uncontrolled hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening.
  • Subjects with the following will be excluded:
    • A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval > 480 ms [CTCAE grade 2]) using Frederica's QT correction formula;
    • A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome);
    • The use of concomitant medications that prolong the QT/QTc interval.
  • Subject is known to have a history of active or chronic infection with hepatitis C virus (HCV), hepatitis B virus (HBV), as determined by serologic tests.
  • Known history of infection with human immunodeficiency virus (HIV).
  • Subject is known to have an uncontrolled active systemic infection.
  • Subject has a history of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  • Subject has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the Investigator, could compromise the subject's safety or put the study outcomes at undue risk.
  • Women who are pregnant or nursing (lactating).
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Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps

Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps

Elizabeth Rajan
All
50 years to 75 years old
This study is NOT accepting healthy volunteers
2022-307480-P01-RST
22-002580
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Inclusion Criteria:

  • Subjects 50-75 years old
  • Able to provide a signed informed consent.
  • Willing and able to comply with the specified study requirements and can be contacted by telephone.
  • Scheduled for colonoscopy procedure no later than 60 days after C-Scan ingestion
  • Maximal abdominal circumference < 125 cm.


Exclusion Criteria:

  • Subject who is not a suitable candidate for a colonoscopy.
  • Known history of dysphagia or other swallowing disorders.
  • History of the following:
    • Colorectal polyps;
    • A personal history of CRC;
    • A family history of CRC or adenomatous polyps diagnosed in a relative before 60 years of age;
    • A history of inflammatory bowel disease of significant duration;
    • One of two (2) hereditary syndromes.
  • Known motility disorders:
    • Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months;
    • Ongoing diarrhea defined as passage of loose or watery stools at least three times within 24-hour;
    • Delayed gastric emptying;
    • Known IBD (Crohn's, Ulcerative Colitis).
  • Prior history of gastrointestinal tract surgery.
  • Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by a physician.
  • Any condition believed to have an increased risk for capsule retention, known strictures, known bowel adhesion or 'obstacles' to free passage of the capsule (such as diverticulosis, intestinal tumors, radiation enteritis) or incomplete colonoscopies as determined by a physician.
  • Significant change in diameter and frequency of stool within the last 3 months.
  • GI bleeding within the last 3 months; i.e., rectal outlet bleeding, hematochezia or melena.
  • Implanted cardiac device or any other implanted active device.
  • Known sensitivity to iodine.
  • Acute kidney failure.
  • Known condition which precludes compliance or is contraindicated with study and/or device instructions.
  • Any procedure requiring contrast agent, or which may introduce electronic interference (such as magnetic resonance imaging, DEXA scan) or an imaging procedure pre-scheduled within 14 days of C-Scan ingestion.
  • Nuclear imaging procedure within the four (4) weeks preceding the C-Scan procedure.
  • Known condition of opioid use disorder and/or alcoholism.
  • Women who are either pregnant or nursing at the time of screening (to be verified by urine or serum pregnancy test for woman of child- bearing potential who are not post-menopausal or undergone surgical sterilization).
  • Concurrent participation in another clinical trail using any investigational drug or device.

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

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

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

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

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


Exclusion Criteria:

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

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

 

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

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

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

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


Exclusion Criteria:

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

Patient Outcomes after Hepatic Artery Infusion Pump Placement

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

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


Exclusion Criteria:

  • Age < 18 years old.
  • Absence of written consent.
  • Systemic disease.
  • Pregnancy.
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Bipolar Disorder Measures in Clinical Care - Patient Preferences on Measures

Bipolar Disorder Measures in Clinical Care

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

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


Exclusion Criteria:

  • Among participants recruited from the Mayo Clinic, individuals who are not intending to return to care in that system.
  • No exclusion criteria apply to participants recruited from the Depression and Bipolar Support Alliance.
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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
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.

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