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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.

3289 Study Matches

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Mechanisms of Altered Ventilatory Control in Heart Failure

A Study of Mechanisms of Altered Ventilatory Control in Heart Failure

Thomas Olson
All
18 years to 90 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-113006-H01-RST
12-005318
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Inclusion Criteria Heart Failure Patients:

  • History of Heart Failure with preserved ejection fraction or with reduced ejection fraction
  • No history of dangerous arrhythmias
  • Body Mass Index less than or equal to 35 kg/m
  • Current non-smokers with less than 15 pack year history
  • Non-pregnant women
  • Individuals who are able to exercise without orthopedic limitations
  • All patients will be managed by their primary care physician or cardiologist prior to enrollment to ensure inclusion and exclusion criteria have been satisfied and participation in exercise testing is safe.

Inclusion Criteria Control Participants:

  • Will be matched for age, gender, height and weight and will have no history of cardiovascular related abnormalities.
  • Body Mass Index less than 35 kg/m
  • Current non-smokers with less than 15 pack year history
  • Non-pregnant women
  • Individuals who are able to exercise without orthopedic limitations
Drug, Other
Heart failure
Cardiovascular system, Heart failure
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Mayo Clinic — Rochester, MN

Laryngopharyngeal Reflux before and after Cricopharyngeal Myotomy

Laryngopharyngeal Reflux before and after Cricopharyngeal Myotomy

Dale Ekbom
All
18 years and over
This study is NOT accepting healthy volunteers
0000-115315-H01-RST
12-010052
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Inclusion Criteria:

  • symptoms of gastroesophageal reflux
  • presence of Zenker's diverticulum or cricopharyngeal hypertrophy
  • undergoing surgery for Zenker's diverticulum or cricopharyngeal hypertrophy with endoscopic laser cricopharyngeal myotomy
  • at least 18 years old


Exclusion Criteria:

  • pregnant women
  • children
  • prisoners
  • adults lacking capacity to consent
GERD
Digestive system, Gastroesophageal reflux disease, Heller myotomy, Laryngopharyngeal reflux, Zenker's diverticulum
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Mayo Clinic — Rochester, MN

The Role of Strain Echocardiography in Assessment of Valvular Heart Disease. A Prospective Study

A Study of Strain Echocardiography in Assessment of Valvular Heart Disease

Sorin Pislaru
All
18 years and over
This study is NOT accepting healthy volunteers
0000-115343-H01-RST
13-000009
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Inclusion Criteria:

  • Patients referred for echocardiographic assessment of severe valvular disease and who are referred for valvular surgery. 
Aortic valve regurgitation, Aortic valve stenosis, Heart valve disease, Mitral valve regurgitation, Mitral valve stenosis, Tricuspid valve regurgitation
Aortic valve repair and replacement, Cardiovascular system, Echocardiogram, Heart valve disorder, Heart valve surgery, Mitral valve repair and replacement, Tricuspid valve repair and replacement
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Mayo Clinic — Rochester, MN

Cardiovascular Effects of Energy Drinks in Healthy Adults

Cardiovascular Effects of Energy Drinks in Healthy Adults

Virend Somers
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-115515-H01-RST
13-001918
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Inclusion Criteria:

  • Adults 18 years of age and older
  • Healthy subjects without known cardiovascular disease and thyroid disease
  • Subjects who are on no medications (except oral contraceptive pill)
  • Nonsmokers
  • No prior history of caffeine sensitivity or allergy


Exclusion Criteria:

  • Subjects with known cardiovascular and/or thyroid disease
  • Subjects currently taking medications other than oral contraceptive pill
  • Smokers
  • Prior history of caffeine sensitivity or allergy
  • Pregnancy
Drug, Drug therapy
Heart disease
Cardiovascular monitoring, Cardiovascular system
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Mayo Clinic — Rochester, MN

Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

A Study of Evaluating the Use of Ultrasound Shear Wave Imaging in Patients with Liver Fibrosis

Shigao Chen
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
0000-115544-H01-RST
13-002289
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Inclusion Criteria:

  • Both male and female
    • age 18 to 80
    • Healthy volunteers
      OR
    • Patients who are scheduled for clinically indicated liver MRE for fibrosis staging


Exclusion Criteria:

  • Subjects lacking capacity to consent 
  • Subjects with unreliable ultrasound or MRE measurements.
  • Pregnant women will be excluded.
  • Women of child baring potential will be asked by our study coordinator if they are pregnant.
    • If not sure, a urine pregnancy test will be given to screen the subject at no cost to the subject.
Liver problems
Hepatic fibrosis, Ultrasound
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Mayo Clinic — Rochester, MN

A Retrospective and Prospective Study on Mayo Clinic Patients with Friedreich Ataxia

A Study on Mayo Clinic Patients with Friedreich Ataxia

Ralitza Gavrilova
All
Not specified
This study is NOT accepting healthy volunteers
0000-115564-H01-RST
13-002531
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Inclusion Criteria:

  • All ages
  • Diagnosis of
  • Seen at Mayo clinic between 1995 and 2013
Cerebellar degeneration, Friedreich's ataxia, Movement disorder, Spinocerebellar ataxia
Friedreich's ataxia, Nervous system
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Mayo Clinic — Rochester, MN

Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

Vijay Shah
All
21 years and over
This study is NOT accepting healthy volunteers
0000-115584-H01-RST
13-002715
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CASES: Heavy drinkers with alcoholic hepatitis

Inclusion criteria

  1. The diagnosis of AH will be established on published criteria this is based on:
    1. Average daily ethanol consumption of > 40 grams/day for women and > 60 grams/day for men for a minimum of 6 months and within the 6 weeks prior to study enrolment. Judgment regarding daily and yearly alcohol use will be made by the site investigator
    2. Clinical evaluation and appropriate laboratory testing as defined by total bilirubin > 2 mg/dL and AST > 50 U/L. When the diagnosis of AH remains in question, a liver biopsy (if clinically feasible and that subject has no contra-indications) will be required.
    3. Subjects with HBV, HCV and/or HIV will be eligible for enrollment

Exclusion criteria

  1. Evidence of other liver diseases such as autoimmune or drug-induced
  2. Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
  3. Abstinence of alcohol use > 6 weeks immediately preceding enrollment
  4. Hemochromatosis
  5. Wilson Disease
  6. Active intravenous drug use

CONTROLS: Heavy drinkers without alcoholic hepatitis

Inclusion criteria

  1. Average daily ethanol consumption of > 40 grams /day for women and > 60 grams/day for males for a minimum of 6 months and within the 6 weeks prior to study enrollment. In addition, heavy drinkers who have just become abstinent within prior 2 weeks are eligible to be enrolled. Judgment regarding daily and yearly alcohol use will be made by the site investigator
  2. AST and ALT ≤ 50 and total bilirubin levels within normal range. If bilirubin is increased due to a suspected Gilbert's Syndrome, patient may be enrolled if the direct bilirubin is within normal limits

Exclusion criteria

  1. Evidence of liver disease
  2. Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
  3. Abstinence of alcohol use > 2 weeks immediately preceding enrollment
  4. Hemochromatosis
  5. Wilson Disease
  6. Active intravenous drug use
  7. Prior history of known alcoholic liver disease
  8. Presence of hepatosplenomegaly from the physical examination/radiographic imaging or stigmata of liver disease
Toxic hepatitis
Alcoholic hepatitis, Digestive system
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Mayo Clinic — Rochester, MN

Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

Vijay Shah
All
21 years and over
This study is NOT accepting healthy volunteers
0000-115584-H01-ALCL
13-002715
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CASES: Heavy drinkers with alcoholic hepatitis

Inclusion criteria

  1. The diagnosis of AH will be established on published criteria this is based on:
    1. Average daily ethanol consumption of > 40 grams/day for women and > 60 grams/day for men for a minimum of 6 months and within the 6 weeks prior to study enrolment. Judgment regarding daily and yearly alcohol use will be made by the site investigator
    2. Clinical evaluation and appropriate laboratory testing as defined by total bilirubin > 2 mg/dL and AST > 50 U/L. When the diagnosis of AH remains in question, a liver biopsy (if clinically feasible and that subject has no contra-indications) will be required.
    3. Subjects with HBV, HCV and/or HIV will be eligible for enrollment

Exclusion criteria

  1. Evidence of other liver diseases such as autoimmune or drug-induced
  2. Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
  3. Abstinence of alcohol use > 6 weeks immediately preceding enrollment
  4. Hemochromatosis
  5. Wilson Disease
  6. Active intravenous drug use

CONTROLS: Heavy drinkers without alcoholic hepatitis

Inclusion criteria

  1. Average daily ethanol consumption of > 40 grams /day for women and > 60 grams/day for males for a minimum of 6 months and within the 6 weeks prior to study enrollment. In addition, heavy drinkers who have just become abstinent within prior 2 weeks are eligible to be enrolled. Judgment regarding daily and yearly alcohol use will be made by the site investigator
  2. AST and ALT ≤ 50 and total bilirubin levels within normal range. If bilirubin is increased due to a suspected Gilbert's Syndrome, patient may be enrolled if the direct bilirubin is within normal limits

Exclusion criteria

  1. Evidence of liver disease
  2. Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
  3. Abstinence of alcohol use > 2 weeks immediately preceding enrollment
  4. Hemochromatosis
  5. Wilson Disease
  6. Active intravenous drug use
  7. Prior history of known alcoholic liver disease
  8. Presence of hepatosplenomegaly from the physical examination/radiographic imaging or stigmata of liver disease
Toxic hepatitis
Alcoholic hepatitis, Digestive system
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Mayo Clinic Health System — Albert Lea, MN

Capillary Lipid Screening in Children Ages 9-11 Years

A Study of Fingerstick Lipid Screening Effectiveness Among Children Ages 9-11

Bradley Karon
All
9 years to 11 years old
This study is NOT accepting healthy volunteers
0000-115866-H01-RST
13-005616
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Inclusion Criteria:

Pediatric patients ages 9-11 years undergoing clinical lipid screening test.


Exclusion Criteria:
 

  • Patients with an acute viral illness and/or fever > 38C.Acute illness has been shown to result in transient elevation of lipid levels.

  • Patients outside the ages of 9-11.

 

 

Lipid management, Lipids abnormal
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Mayo Clinic Rochester, MN — Rochester, MN

Viscoelastic Parameters Estimation and Imaging for the Assessment of Axillary Lymph Nodes

Viscoelastic Parameters Estimation and Imaging for the Assessment of Axillary Lymph Nodes

Azra Alizad
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-115898-H01-RST
13-006035
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Inclusion Criteria:

  • Female patients who have axillary lymph nodes which may be benign or may have been diagnosed or suspicious for breast cancer will be candidates for enrollment.
  • It is anticipated that the majority of these participants will undergo an US guided lymph node biopsy (standard of care). U.S. and CUSE/SDUV data collection from each participant will take place before or 2 weeks after lymph node biopsy/aspiration.  


Exclusion Criteria:
 

  • Having any condition that does not allow proper use of our imaging devices.

 

 

 

 

 

 

Breast cancer, Cancer
Malignant tumor of breast, Medical Oncology, Ultrasound
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Mayo Clinic — Rochester, MN

Effect of Sleep Deprivation on Reflex Activation of the Sympathetic Nervous System

A Study of the Effect of Lack of Sleep on Blood Pressure

Virend Somers
All
18 years to 40 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-116169-H01-RST
13-009224
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Inclusion Criteria

  • A subset of 32 healthy subjects from those participants enrolled in studies IRB 11-002121 and IRB 11-007272
  • BMI 18.5-35 kg/m2 
  • age 18-40 years
  • non-smokers
  • free of any chronic medical or psychiatric disorders
  • on no medications other than birth control and second generation antihistamines
  • will have a history of normal sleep patterns
Other, Sleep deprivation
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Mayo Clinic — Rochester, MN

Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients

Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients

John Lieske
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
0000-116394-H01-RST
14-001766
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Inclusion Criteria:

  • Primary hyperoxaluria: Patients diagnosed with type I PH by genetic testing and part of the Rare Kidney Stone Consortium (RKSC) Primary hyperoxaluria registry
  • Enteric hyperoxaluria: Patients with Roux-en-Y-gastric-bypass
  • Idiopathic CaOx stone : History of passing or having surgically removed a calcium oxalate kidney stone within 5 years of recruitment
  • Healthy participants with no history of kidney or bowel disease


Exclusion Criteria:

  • History of kidney or liver transplant
  • History of antibiotics use within 6 months of recruitment
Kidney stone
Kidney stone, Urinary system
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Mayo Clinic — Rochester, MN

Mayo Clinic Cardiac Implantable Electronic Device (CIED) Magnetic Resonance Imaging (MRI) Registry; Determining the Risks of of MRI in the Presence of Cardiac Implantable Electronic Devices

Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

Robert Watson
All
18 years and over
This study is NOT accepting healthy volunteers
0000-116409-P01-RST
14-001925
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Inclusion Criteria:

  • Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology
  • Male or Female
  • 18 years of age or older
  • Able to provide informed consent
  • Presence of CIED


Exclusion Criteria:

  • Presence of metallic objects that represent a contraindication to MR imaging, including: MRI-unsafe intra-orbital or intra-ocular retained metal fragments, and MRI-unsafe intracranial vascular clips and coils, other MRI-unsafe devices
  • Morbid obesity (abdominal diameter greater than 60 centimeters) which results in contact wiht the magnet bore.
  • Pregnant at time of scanning Pacemaker or Implanted Cardiac Device that is labeled as MRI-Conditional (approved by the Food and Drug Administration for exposure to MRI)
  • Pacemaker dependent and either: 1) device implanted before 2005, or 2) advisory pulse generator that may lower outputs in the setting of radiofrequency currents
MRI
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Mayo Clinic — Rochester, MN

Validation of an Over-the-Counter Accelerometer as a Sleep Monitor: Comparison with Actigraph and Polysomnography

Validation of an Over-the-Counter Accelerometer as a Sleep Monitor: Comparison with Actigraph and Polysomnography

Robert Wilder
All
10 years to 18 years old
This study is NOT accepting healthy volunteers
0000-116645-H01-RST
14-004322
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Inclusion Criteria:

  • Children who are undergoing a sleep study (polysomnography) for clinical purposes


Exclusion Criteria:
 

  • Refusal to participate
Sleep apnea, Sleep disorders
Actigraphy, Nervous system, Polysomnography, Sleep disorder
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Cancer and Autoimmune Diseases Repository

A Registry for Data and Biospecimen of Cancer and Autoimmune Diseases

Sean Pittock
All
18 years and over
This study is NOT accepting healthy volunteers
0000-116785-H01-RST
14-005670
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Inclusion Criteria

  • Study Participant
    • 18 years of age or older
    • Has cancer or an autoimmune disease
  • Healthy Control
    • Does not have any autoimmune disease
    • No history of cancer
    • Non-smoker

Exlcusion Criteria

  • None
Autoimmune disease, Cancer
Autoimmune disease, Malignant neoplastic disease, Medical Oncology
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Mayo Clinic — Rochester, MN

Evaluation of the Clinical and Genetic association between Myotonic Dystrophy Type 1 and Fuchs Endothelial Corneal Dystrophy

Evaluation of the Clinical and Genetic association between Myotonic Dystrophy Type 1 and Fuchs Endothelial Corneal Dystrophy

Keith Baratz
All
18 years and over
This study is NOT accepting healthy volunteers
0000-116932-H01-RST
14-007285
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Inclusion Criteria:

  • Subjects with DM1 which is genetically proven or clinically diagnosedFamily members of subjects with DM1 who are affected or unaffected by the disease
  • Ability to understand and willingness to sign the informed consent documents
  • Age ≥18 yrs


Exclusion Criteria:
 

  • Unable or unwilling to sign or understand the informed consent documents
  • Unwilling to participate in the research
  • Unwilling to allow genetic testing
  • Unwilling to allow samples to be sent to other institutions for testing
  • Not meeting the inclusion criteria
Fuchs' dystrophy, Myotonic dystrophy
Congenital myotonic dystrophy, Fuchs' corneal dystrophy
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Mayo Clinic — Rochester, MN

Novel MRI Markers in Pediatric White Matter Disease

A Study of New MRI Markers to Detect the Earliest Phases of Pediatric Multiple Sclerosis

Jan-Mendelt Tillema
All
1 years to 18 years old
This study is NOT accepting healthy volunteers
0000-117001-H01-RST
14-008171
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Inclusion Criteria

  • Age 18 or below
  • Ability to obtain MRI without sedation
    • This in practice comes down to age > 5-6
  • Evaluation at Mayo Clinic by pediatric neurologist for groups 1-3
  • Group 1
    • Pediatric onset Multiple Sclerosis
    • Clinically isolated syndrome (single demyelinating event with abnormal MRI of the brain)
  • Group 2
    • Non-specific T2 signal change on MRI
    • Clinical history not consistent with MS
    • Acquired or inherited WM disease, e.g. low grade neoplasm, leukodystrophy
  • Group 3
    • Patients with epilepsy
  • Group 4
    • Healthy controls
    • No neurological disease

Exclusion Criteria 

  • Claustrophobia or sedation required to obtain MRI
  • Standard exclusion criteria for MRI, e.g.
    • Pacemaker
    • Implanted device
    • Etc
Small vessel white matter disease
Leukoencephalopathy, MRI
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Mayo Clinic — Rochester, MN

Pilot Study to Evaluate the Effects of Intrapleural Cryotherapy on Tumor Infiltrating Lymphocytes in Malignant Pleural Mesothelioma using Spray cryotherapy Therapy and Possibly Followed by Pleurectomy or Extrapleural Pneumonectomy

Spray cryotherapy therapy for malignant pleural mesothelioma

Shanda Blackmon
All
18 years and over
This study is NOT accepting healthy volunteers
0000-117058-H01-RST
14-008715
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Inclusion Criteria

  • Subject provides informed consent
  • Subject is >18 years of age
  • Subject is deemed competent for making medical decisions
  • Subject is scheduled to undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma
  • A negative pregnancy test is required in women of child-bearing potential, as standard of care.
  • Subject is mentally capable of understanding study procedures.

Exclusion Criteria

Study subject has any disease or condition that interferes with safe completion of the study including:

  • Platelet count < 50K, coagulopathy defined as an International Normalized Ratio (INR) > 1.5
  • Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published
  • Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians.
  • Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements.
  • Concurrent participation in another study involving investigational drugs or investigational medical devices
  • Absence of or limited access to the pleural space during medical pleuroscopy.
  • Inability to read and understand the necessary study documents.

Device
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Mayo Clinic — Rochester, MN

Prothrombin Complex Concentrate Compared to Fresh Frozen Plasma for Post-Cardiopulmonary Bypass Coagulopathy and Bleeding, a Prospective Randomized Trial at Large US Medical Center

A Study Using Prothrombin Complex Concentrate versus Fresh Frozen Plasma for Post Cardiopulmonary Bypass Surgery Clotting Problems and Bleeding

Gregory Nuttall
All
18 years and over
Phase 4
This study is NOT accepting healthy volunteers
0000-117145-H01-RST
14-009579
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Inclusion Criteria:

  • Be ≥ 18 years of age.
  • Be undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass.
  • Have an INR ≤ 1.3 if warfarin was not held for 5 days.


Exclusion Criteria:

  • Are unable to grant informed consent or comply with study procedure.
  • History of hypercoagulable condition (e.g., Factor V Leiden, AT-3 deficiency, Prothrombin gene mutation, Anti-phospholipid antibody syndrome, etc.) or previous unprovoked thromboembolic complications.
  • Coagulopathic conditions such as factor deficiencies, factor inhibitors, heparin induced thrombocytopenia, or use of intravenous anticoagulants other than heparin at the time of cardiovascular surgery.
  • Thromboembolic event with past 3 months.
  • Received oral therapy with ELIQUIS (apixaban) within 3 days prior to planned surgical procedure.
  • Received oral therapy with clopidogrel,prasugrel, rivaroxaban or dabigatran within 5 days prior to planned surgical procedure.
  • Are undergoing emergency open heart-surgery.
  • Cardiopulmonary bypass time is expected to be < 30 minutes.
  • Are pregnant.
  • Heparin allergy.
  • ECMO post op.
  • Life threatening bleeding necessitating transfusion of hemostatic products (FFP or PCC)  prior to the study intervention time point.
  • Circumstances for which the safety of the patient could be jeopardized by continued adherence to the study protocol.

 

Biologic/Vaccine, Drug therapy, Transfusion of plasma
Bleeding disorder
Blood coagulation disorder, prothrombin
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Mayo Clinic — Rochester, MN

Maximizing Anti-PD-1 Therapy By Monitoring T Cell Responses In Melanoma, Lung and Other Cancer Types

A Study to Maximize Anti-PD (Programmed Death) -1 Therapy By Monitoring T Cell Responses in Melanoma, Lung Cancer, and Other Cancer Types.

Roxana Dronca
All
18 years and over
This study is NOT accepting healthy volunteers
0000-117298-H01-RST
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Inclusion Criteria:

  • 18 years of age or older.
  • Have histologic evidence of locally or regionally advanced or stage IV malignancy.
  • Are considered appropriate for starting therapy with anti-PD-1/anti-PD-L1 monoclonal antibody by their treating physician (prior therapy with ICI is allowed).
  • Have an understanding of the protocol and its requirements, risks, and discomforts.
  • Are willing to undergo peripheral blood collection at the time points mentioned in the protocol.
  • Are able and willing to sign an informed consent.


Exclusion Criteria:

  • Inability to understand the informed consent or be compliant with the protocol.
  • Receiving any concurrent anti-cancer therapy or investigational agents (with the exception of an anti-PD-1 agent as mentioned above).
  • Are pregnant or nursing.
  • Are of childbearing potential and are unwilling to employ adequate contraception.
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Mayo Clinic — Rochester, MN

Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity

A Study of the Effect of Liraglutide on Weight Loss and Stomach Functions in Obesity

Michael Camilleri
All
18 years to 65 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-117389-H01-RST
15-001783
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Inclusion Criteria:

  • Overweight and obese adults (≥30 kg/m2 or ≥27 kg/m2 with an obesity-related co-morbidity).
  • Subjects will reside within 125 miles of Mayo Clinic in Rochester, Minnesota.
  • Healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia type 2 diabetes mellitus on metformin) disorders.
  • Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrolment and before each radiation exposure.
  • Subjects must have the ability to provide informed consent before any trial-related activities.


Exclusion Criteria:

  • Weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes).
  • Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.
  • Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat.
  • Patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia-type 2.
  • Patients with a personal history of pancreatitis (acute or chronic)
  • Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory, a self-administered alcoholism screening test (AUDIT-C), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a Hospital Anxiety Depression (HAD) score >8 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.
  • Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxin replacement therapy and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility including gastric emptying (GE) and gastric accommodation. For example, statins for hyperlipidemia, diuretics, β-adrenergic blockers,Angiotensin Converting Enzyme (ACE) inhibitors and angiotensin antagonists for hypertension, and metformin for type 2 diabetes mellitus or prediabetes are permissible. In contrast, resin sequestrants for hyperlipidemia [which may reduce GE and reduce appetite, α2-adrenergic agonists for hypertension, or other GLP-1 receptor agonists (exenatide) or amylin analogs (pramlintide) are not permissible because they significantly affect GE and/or gastric accommodation.
  • Hypersensitivity to the study medication, liraglutide.
Drug, Drug therapy
Obesity
Obesity, liraglutide
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Mayo Clinic Rochester, MN — Rochester, MN

Bone Health in Patients with Overgrowth

A Study of Bone Health in Patients with Overgrowth Syndromes

Megha Tollefson
All
5 years and over
This study is NOT accepting healthy volunteers
0000-117428-H01-RST
15-002284
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Inclusion Criteria

  • Age > 5 years such that the patient is able to cooperate with the DXA scan or Xtreme CT
  • Known clinical diagnosis of an overgrowth syndrome such as
    • Klippel-Trenaunay Syndrome
    • CLOVE syndrome
    • Proteus syndrome
    • diffuse capillary malformation with overgrowth
    • other unspecified OGS

 

Exclusion Criteria

  • Age < 5 years
  • Inability to comply with the scan
  • No or uncertain diagnosis of an OGS
  • Prior bisphosphonate use
  • Systemic steroids in the past 6 months
  • Pregnant women
Vascular malformation
Bone density below reference range, Circulatory system, Congenital anomaly of musculoskeletal system, Congenital vascular malformation
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Mayo Clinic — Rochester, MN

Combined Non-Targeted and Targeted Metabolomics in Adrenal Tumors, Implications for Novel Diagnostic Strategies of Hormonal Excess

A Study of the Characteristics of Adrenal Steroid Production and Metabolism in Patients with Adrenal Tumors, Using Comprehensive Steroid Profiling

Irina Bancos
All
18 years and over
This study is NOT accepting healthy volunteers
0000-117492-H01-RST
15-002904
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Inclusion Criteria:

  • Age 18 years old and above
  • Has adrenocortical adrenal mass with planned adrenalectomy
  • Adrenal imaging and hormonal work up is available


Exclusion Criteria:

  • Acute sickness
  • Active exogenous oral glucocorticoid therapy before surgery
  • Pheochromocytoma, adrenocortical carcinoma, adrenal metastasis or other suspected non-cortical adrenal mass, primary hyperaldosteronism
  • Pregnancy (due to the fact that steroid profile is affected by the pregnancy itself. However, testing for pregnancy will not be required in potential subjects as OGTT is a standard procedure during pregnancy not contributing to fetal risk)
Benign adrenal tumor, Cushing syndrome
Adrenal Cushing's syndrome, Endocrine system, Neoplasm of adrenal gland
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Mayo Clinic — Rochester, MN

Initial Outcomes of 2-day Pediatric Pain Rehabilitation Program

Pediatric Pain Rehabilitation Program

Cynthia Harbeck Weber
All
12 years to 25 years old
This study is NOT accepting healthy volunteers
0000-117533-H01-RST
15-003322
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Inclusion Criteria:

  • Age 12-25
  • Patients in the 2-day Pediatric Pain Rehabilitation Program


Exclusion Criteria:

  • Don’t speak English as their first language
POTS
Postural orthostatic tachycardia syndrome
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Mayo Clinic — Rochester, MN

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy

Ron Smith
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-117562-P01-MAIJ
15-003690
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Pre-Registration Eligibility Criteria:

  1. Patients ≥ 18 years of age
  2. Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition
  3. No inflammatory breast cancer
  4. No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
  5. All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy. Note: Biopsy of intramammary nodes does not fulfill eligibility criteria.
  6. Patients must have had estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 (HER2) status by immunohistochemistry [IHC] and/or fluorescence in situ hybridization [FISH] evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy. Note: If HER2 status has not been clearly determined (ie equivocal/indeterminate), then patients should not be enrolled.
  7. Patients must have completed all planned chemotherapy prior to surgery. Sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery). Patients must have completed at least 6 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes. NOTE: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 6 cycles of neoadjuvant chemotherapy is administered. More than 6 cycles of NAC may be administered at the discretion of the treating medical oncologist.
  8. Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen). Therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (IRB)-approved clinical trial.
  9. All patients must have a clinically negative axilla (no palpable lymph nodes or bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy. NOTE: An ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy. If performed, its findings do NOT impact eligibility.
  10. No neoadjuvant endocrine therapy
  11. No neoadjuvant radiation therapy
  12. No sentinel lymph node (SLN) surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy
  13. No prior history of ipsilateral breast cancer (invasive disease or ductal carcinoma in situ [DCIS]). Lobular carcinoma in situ (LCIS) and benign breast disease is allowed.
  14. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
  15. No history of prior or concurrent contralateral invasive breast cancer. Benign breast disease, LCIS or DCIS of contralateral breast is allowed.
  16. Patients must not be pregnant or nursing. A negative pregnancy test is required prior to registration for women of childbearing potential. Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential.
  17. Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1.
  18. Required Pre-Registration Laboratory Values:

    • Serum or urine beta-human chorionic gonadotropin (ß-HCG)
    • Negative in women of child-bearing potential

Intra-Operative Registration/Randomization Criteria:

  1. Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of neoadjuvant chemotherapy.
  2. A minimum of 1 sentinel node and a maximum of 6 total nodes (sentinel + non-sentinel) are identified and excised by the surgeon. Patients who do not have an identifiable sentinel lymph node will not proceed to Registration/Randomization.
  3. At least one lymph node (sentinel or non-sentinel) with a metastasis greater than 0.2 mm in greatest dimension identified on intra-operative pathologic assessment. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+). Axillary lymph node dissection [ALND] is not to be performed prior to Registration/Randomization.

Post-Operative Registration/Randomization Criteria:

1. For cases where ALND has not been performed and one of the following is true:

  • intra-operative evaluation of sentinel lymph node could not be/was not performed and final pathology identified a positive lymph node (sentinel or non-sentinel) with metastasis greater than 0.2 mm on hematoxylin and eosin stain (H & E) OR
  • lymph node (sentinel or non-sentinel) considered negative on intra-operative evaluation was found to be positive on final pathology (with metastasis greater than 0.2 mm on H & E)

    • Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of neoadjuvant chemotherapy.
    • At least one lymph node (sentinel or non-sentinel) with a metastasis greater than 0.2 mm in greatest dimension identified by H&E staining on final pathology (for cases where intra-operative evaluation was not performed, or was negative and completion dissection was not performed).
    • Among the minimum of 1 and the maximum of 6 nodes (sentinel or non-sentinel) identified and excised by the surgeon, no more than 8 lymph nodes (sentinel and non-sentinel) were found by the pathologists to have been actually excised. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+).
    • For those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration/randomization.
Procedure/Surgery, Radiation
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Mayo Clinic Health System — Mankato, MN

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease - CAPE (CAPE)

A Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease

William Faubion
All
6 years to 30 years old
This study is NOT accepting healthy volunteers
0000-117634-P01-RST
15-004413
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Inclusion Criteria

  • For the HUMIRA treatment group
    • Children between the ages of 6 and 17 years inclusive at the time of enrollment
    • Diagnosed with moderately to severely active Crohn's Disease
    • Has been prescribed Humira therapy according to the local approved Humira product label
  • For the immunosuppressant therapy treatment group
    • Children between the ages of 6 and 17 years inclusive at the time of enrollment
    • Diagnosed with moderately to severely active Crohn's Disease
    • Has been prescribed azathioprine, 6-mercaptopurine or methotrexate
  • Parent or guardian or patient (if 18 years of age or older at enrollment and rolling over from an AbbVie-sponsored investigational Pediatric Crohn's Disease investigation trial) has voluntarily signed and dated an Authorization for Use/Disclosure of Data informed consent form after the nature of the registry has been explained and there has been the opportunity to ask questions

Exclusion Criteria

  • Cannot be treated in accordance with the local Humira product label
  • Is currently being treated with any investigational agents or is receiving any investigational procedures
  • Should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA
Crohn's disease, Inflammatory bowel disease
Crohn's disease, Digestive system, adalimumab
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Mayo Clinic — Rochester, MN

Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device

A Study to Detect Minimally-Invasive Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma

Prasad Iyer
All
18 years to 90 years old
This study is NOT accepting healthy volunteers
0000-117646-H01-RST
15-004540
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Inclusion Criteria:

  • Subjects with known Barrett's Esophagus (BE):
    • Between the ages 18 - 90 years old;
    • With a BE segment ≥ 1cm in maximal extent endoscopically;
    • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia;
    • Undergoing clinically indicated endoscopy.
  • Subjects without known evidence of BE:
    • Undergoing clinically indicated diagnostic endoscopy.


Exclusion Criteria:

  • Subjects with known Barrett's Esophagus (BE):
    • Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded;
    • Patients with history of esophageal resectiobn for esophageal carcinoma.
  • Subjects with or without known evidence of BE (on history or review of medical records):
    • Pregnant or lactating females;
    • Patients who are unable to consent;
    • Patients with current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study);
    • History of eosinophilic esophagitis, achalasia;
    • Patients on oral anticoagulation including Coumadin, Warfarin;
    • Patients on antiplatelet agents including Clopidogrel, unless discontinued for at least three days prior to the sponge procedure;
    • Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for at least three days prior to the sponge procedure;
    • Patients with history of known varices or cirrhosis;
    • Patients with history of esophageal resection for esophageal carcinoma;
    • Patients with congenital or acquired bleeding diatheses;
    • Patients with a history of esophageal squamous dysplasia;
    • Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.

 

Device, Screening for disorder
Barrett's esophagus, Cancer, Esophageal cancer
Adenocarcinoma of esophagus, Barrett's esophagus, Digestive system, Medical Oncology
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Mayo Clinic — Rochester, MN

Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device

A Study to Detect Minimally-Invasive Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma

Prasad Iyer
All
18 years to 90 years old
This study is NOT accepting healthy volunteers
0000-117646-H01-AUAC
15-004540
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Inclusion Criteria:

  • Subjects with known Barrett's Esophagus (BE):
    • Between the ages 18 - 90 years old;
    • With a BE segment ≥ 1cm in maximal extent endoscopically;
    • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia;
    • Undergoing clinically indicated endoscopy.
  • Subjects without known evidence of BE:
    • Undergoing clinically indicated diagnostic endoscopy.


Exclusion Criteria:

  • Subjects with known Barrett's Esophagus (BE):
    • Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded;
    • Patients with history of esophageal resectiobn for esophageal carcinoma.
  • Subjects with or without known evidence of BE (on history or review of medical records):
    • Pregnant or lactating females;
    • Patients who are unable to consent;
    • Patients with current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study);
    • History of eosinophilic esophagitis, achalasia;
    • Patients on oral anticoagulation including Coumadin, Warfarin;
    • Patients on antiplatelet agents including Clopidogrel, unless discontinued for at least three days prior to the sponge procedure;
    • Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for at least three days prior to the sponge procedure;
    • Patients with history of known varices or cirrhosis;
    • Patients with history of esophageal resection for esophageal carcinoma;
    • Patients with congenital or acquired bleeding diatheses;
    • Patients with a history of esophageal squamous dysplasia;
    • Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.

 

Device, Screening for disorder
Barrett's esophagus, Cancer, Esophageal cancer
Adenocarcinoma of esophagus, Barrett's esophagus, Digestive system, Medical Oncology
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Mayo Clinic Health System — Austin, MN

Genetic studies in Common Variable Immunodeficiency (CVID)

Genetic studies in Common Variable Immunodeficiency (CVID)

Avni Joshi
All
up to 75 years old
This study is NOT accepting healthy volunteers
0000-117648-H01-RST
15-004573
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Inclusion Criteria:
    

  • All patients who meet the diagnostic criteria for CVID  


Exclusion Criteria:
   

  • Infants below 6 months of age
  • Subjects unable to provide a research blood sample for any medical reason             
CVID, Primary immunodeficiency
Common variable agammaglobulinemia
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Mayo Clinic Rochester, MN — Rochester, MN

A Pilot Trial of Dietary Therapy Directed by the Esophageal Sponge in the Management of Eosinophilic Esophagitis.

A Study Using the Esophageal Sponge to Gather Specimens for Management of Dietary Therapy in Eosinophilic Esophagitis

Jeffrey Alexander
All
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-117668-H01-RST
15-004741
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Inclusion Criteria

  • 18 to 80 years of age.
  • Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf.
  • Going through the six food elimination diet or have just completed elimination of the six foods: fish, nuts, eggs, soy, wheat, and milk.
  • Patients that have completed the six food elimination diet clinically and none of the foods were identified as being the food causing their EoE.

Exclusion Criteria

  • Clinical evidence of infectious process potentially contributing to dysphagia ( candidiasis, CMV, herpes).
  • Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm).
  • Esophageal minimal diameter < 13 mm on structured barium esophagram.
Device, Dietary Supplement
Eosinophilic esophagitis
Eosinophilic esophagitis, Upper endoscopy
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Mayo Clinic — Rochester, MN