Health Studies MN

Within 


Search Results

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

3802 Study Matches

Sorting by: Relevance Distance

Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)

68GaFAPI-46 PET/CT for Pancreatic Ductal Adenocarcinoma

Ajit Goenka
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308153-P01-RST
22-004884
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Adults > 18 years (yrs.) with treatment-naive biopsy-proven PDA or with findings
diagnostic for PDA on baseline imaging (CT, MRI, or PET)

- Localized disease expected to undergo surgical resection following neoadjuvant therapy
(NAT)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Ability to provide informed consent


Exclusion Criteria:


- Hypersensitivity to any excipients in 68Ga-FAPI-46

- Require emergency surgery

- Non-PDA histology on biopsy

- Histopathologically proven metastatic PDA

- Pregnant women

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

Eligibility last updated 12/30/22. Questions regarding updates should be directed to the study team contact.

Diagnostic Test
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Developing a Cancer Distress Management Program Cancer within a Specialized Program of Research Excellence (SPORE) (SPORE)

Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE

Shawna Ehlers
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306566-H01-RST
21-012404
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients who have received care for hepatobiliary cancer at Mayo Clinic in the past 5 years.
  • Caregiver of above patient.
  • Clinician providing care for hepatobiliary cancer patients at Mayo Clinic.
  • Member of SPORE Patient Advocacy Board.


Exclusion Criteria:
 

  • Inability to complete an English language electronic survey for any reason. Non-English speaking patients will be offered translation services when available.

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Bedside Confirmation of Intrauterine Contraception Using Point-of-Care Ultrasound

Using Point-of-Care Ultrasound for Bedside Confirmation of Intrauterine Contraception

Terin Sytsma
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307819-H01-RST
22-003638
Show full eligibility criteria
Hide eligibility criteria

Eligibility last updated [date of initial abstraction or last Mod]. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Initial Evaluation of the Pulmonary Hypertension Functional Class Self Report

A Study of Functional Class Self Report in Pulmonary Hypertension

Hilary DuBrock
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307941-P01-RST
22-004268
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria

  • ≥ 18 years of age.
  • Subject must have a clinician-recorded diagnosis of  Pulmonary Hypertension (PH).
  • Subject must have either PAH (WHO Group 1), PH due to left heart disease (WHO Group 2), PH due to lung disease (WHO Group 3), PH due to blood clots in the lungs (WHO Group 4), or PH with unclear and/or multifactorial mechanisms (WHO Group 5) based on a clinician-reported diagnosis.
  • Subject is able to read and complete an English-language electronic survey.
  • Subject has access to a computer or tablet to complete the electronic survey.
  • Subject is willing and able to provide electronic informed consent.


Exclusion Criteria:
 

  • ≤ 18 years of age. 

Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.

 

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Predicting Acute Respiratory Distress Syndrome (ARDS) and Acute Respiratory Failure (ARF) after Hematopoietic Stem Cell Transplantation (HSCT)

Acute Respiratory Distress Syndrome (ARDS) and Acute Respiratory Failure (ARF) Following Hematopoietic Stem Cell Transplantation

Hemang Yadav
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308529-H01-RST
22-006326
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Adult (age 18 or greater) patients who consent for enrollment in the study.
  • Have undergone allogeneic HSCT within 100 days or autologous HSCT within 30 days.

Exclusin Criteria: 

  • Subject transferred from another institution having already been admitted there for > 24h. This proposal seeks to create a biorepository whose purpose will be to determine mechanism of ARF/ARDS development based on initial hospital course. If a substantial part of a patient’s hospital course preceeds enrollment (and is affected by care received at another institution), we may not get meaningful insights into the ARDS mechanism by enrolling them well into the disease processes that are involved in the pathogenesis of ARDS.
  • ARDS at the time of hospital admission. Since this study is looking at the mechanisms of ARDS development, we would seek to enroll patients before ARDS develops. 
  • Patient’s goals of care are such that ICU transfer (and specifically use of noninvasive or mechanical ventilation) would not be considered. As such, these patients would not be able to develop the outcome of interest (ARDS).
  • Admitted for:
    1. Admission only for chemotherapy administration.
    2. Control of symptoms related to diarrhea, vomiting, dehydration due to inability to swallow, dysphagia, pain or mucositis. 

Eligibility last updated 12/7/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Characteristics and Management of Acute Kidney Injury in Hospitalized Patients With Cirrhosis: a Multicenter Intercontinental Observational Prospective Study: The International Club of Ascites GLOBAL AKI Project (GLOBAL-AKI)

International Registry of Acute Kidney Injury in Cirrhosis: The GLOBAL AKI Project

Douglas Simonetto
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308993-P01-RST
22-007946
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

1. Patients with cirrhosis admitted to hospital for the treatment of a complication of liver disease (ascites, gastrointestinal bleeding, hepatic encephalopathy, bacterial infections, jaundice, etc.).


Exclusion Criteria:

1. Age < 18 years old.

2. Pregnancy.

3. Hepatocellular carcinoma outside Milan criteria (i.e., a single lesion < 5 cm or multiple lesions [maximum of three], the largest of which measures ≤ 3 cm).

4. Extrahepatic malignancy other than non-melanoma skin cancer within last 5 years.

5. Previously known severe extrahepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe congestive heart disease [NYHA class ≥ 3]; severe chronic obstructive pulmonary disease [GOLD class ≥ 3], psychiatric disorders).

6. Previous solid organ transplantation.

7. HIV infection with CD4 ≤ 250/µL.

8. Patients who cannot provide prior informed consent and no legal surrogate decision maker.

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

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)

All
1 Day to 17 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT05267821
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• ≥ 40 weeks corrected gestational age to < 18 years; AND
• Admission to the PICU or CICU; AND
• Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified Proulx criteria; AND
• Documented or suspected infection as the MODS inciting event.
Exclusion Criteria:

• Weight <3kg; OR
• Limitation of care order at the time of screening; OR
• Patients at high likelihood of progression to brain death in opinion of the clinical team; OR
• Moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; OR
• History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; OR
• Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR
• Peripheral white blood cell count < 1,000 cells/mm3 as the result of myeloablative therapyOR receipt of myeloablative therapy within the previous 14 days; OR
• Known allergy to anakinra, or E. coli-derived products; OR
• Known pregnancy; OR
• Lactating females; OR
• Receipt of anakinra or GM-CSF within the previous 28 days; OR
• Resolution of MODS by MODS Day 2; OR
• Previous enrollment in the TRIPS study.
I'm interested
Share via email
See this study on ClinicalTrials.gov

MC210807 Phase 1 Study to Determine the Safety and Efficacy of Onvansertib, A Novel, Oral, PLK1 Inhibitor in Patients With Proliferative Chronic Myelomonocytic Leukemia (CMML) Relapsed/Refractory or Intolerant to Available Therapies

Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia

Mrinal Patnaik
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-304390-P01-RST
22-005600
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria
•Pre-Registration:


- Age >= 18 years

- Histological confirmation of World Health Organization (WHO)-defined diagnosis of proliferative chronic myelomonocytic leukemia (CMML) (white blood cell (WBC) count >= 13,000/mm^3)

- Relapsed/refractory following treatment with hydroxyurea; or at least 4 cycles of treatment with hypomethylating agents; or who are intolerant of treatment with either
therapy. Note: Prior exposure to erythropoiesis stimulating agents is allowed.  Hydroxyurea may continue for the first 28 days on study. Continuation of hydroxyurea beyond the first cycle must be discussed with the principal investigator (PI)

- Willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy

- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

- Willingness to provide mandatory bone marrow specimens for correlative research

- ECOG performance status (PS) 0, 1 or 2

- Recovered to grade 1 or baseline or established as sequelae from all toxic effects of previous therapy except alopecia

- Platelet count >= 20,000/mm^3 (obtained =< 14 days prior to pre-registration)

- Total bilirubin =< 1.5 x upper limit of normal (ULN) (=< 3 x ULN for patients with Gilbert's syndrome) (obtained =< 14 days prior to pre-registration)

- Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (obtained =< 14 days prior to pre-registration)

- Estimated glomerular filtration rate (eGFR) >= 60 mL/min/m^2 using the Cockcroft-Gault formula (obtained =< 14 days prior to pre-registration)

- Ability to complete questionnaire(s) by themselves or with assistance

- Willingness to provide mandatory blood specimens for correlative research

Inclusion Criteria
•Registration


- For a man or a woman of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of any study drug. Adequate contraception is defined as follows:

- Complete true abstinence

- Consistent and correct use of one of the following methods of birth control:

- Male partner who is sterile prior to the female patient's entry into the study and is the sole sexual partner for that female patient

- Implants of levonorgestrel

- Injectable progestogen

- Intrauterine device (IUD) with a documented failure rate of less than 1% per year

- Oral contraceptive pill (either combined or progesterone only)

- Barrier method, for example: diaphragm with spermicide or condom with spermicide in combination with either implants of levonorgestrel or injectable progestogen

- WOCBP must have a negative serum or urine pregnancy test =< 7 days prior to registration

- NOTE: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as
amenorrhea > 12 consecutive months); or women on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an IUD or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), must be considered to be of child-bearing potential

- NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Exclusion Criteria
•Pre-Registration:


- Previous exposure to an alternative (investigational) PLK1 inhibitor

- MDS/MPN overlap syndromes other than CMML

- Prior allogeneic hematopoietic stem cell transplantation

- Active central nervous system disease

- Concurrent active malignancy, except adequately treated nonmelanoma skin cancer.  History of curatively treated in situ cancer of the cervix, curatively treated in situ cancer of the breast, or other solid tumors curatively treated is allowed as long as there is no evidence of disease for > 2 years

- New York Heart Association (NYHA) class III/IV heart failure or active angina/angina equivalents

- Anticancer chemotherapy or biologic therapy administered within 2 weeks (and at least 4 elimination half-lives for clinical trial agents) prior to pre-registration.

NOTE: Hydroxyurea is allowed for the first 28 days on study. Continuation of hydroxyurea beyond the first cycle must be discussed with the PI

- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

- Major surgery =< 6 weeks prior to pre-registration

- Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (eg, intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)

- Unable or unwilling to swallow study drug

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant nonhealing or healing wounds, clinically significant
cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements

- Known active infection with human immunodeficiency virus (HIV) with measurable viral titer, hepatitis B surface antigen positivity, or hepatitis C with measurable viral titer.

NOTE: Patients with antibody to hepatitis B core antibody are eligible if they have no measurable viral titer. Patients who have had a hepatitis B virus (HBV) immunization are eligible

- Patient is receiving any live vaccine (eg, varicella, pneumococcus) =< 28 days prior to pre-registration.

NOTE: messenger ribonucleic acid (mRNA)-based (e.g., Pfizer or Moderna) or replication-deficient virus (e.g., Oxford/AstraZeneca) COVID19 vaccines are
permitted

- Disease requiring systemic treatment with systemic immunosuppression with steroid steroids at a dose of >= 20 mg/day prednisone (or equivalent).

Exceptions:  Intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids

- Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug

- Strong CYP3A4 inhibitors/inducers as identified per institutional guidelines

- QT interval with Fridericia's correction (QTcF) > 470 milliseconds. In the case of potentially correctible causes of QT prolongation, (e.g., medications, hypokalemia), the
electrocardiogram (ECG) may be repeated once during screening and that result may be used to determine eligibility

Exclusion Criteria
•Registration:


- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown:

- Pregnant persons

- Nursing persons

- Persons of childbearing potential who are unwilling to employ adequate contraception

- Increased risk of Torsade des Pointes (TdP) defined as follows:

- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 480 msec [CTCAE Grade >= 2] using Fredericia's QT correction
formula)

- A history of additional risk factors for TdP (e.g.. heart failure, family history of long QT syndrome)

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

Eligibility last updated 12/5/23. Questions regarding updates should be directed to the study team contact.

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Determining the mechanism of aspirin action in preventing nasal polyp recurrence in AERD patients

Determining Prevention of Nasal Polyp Recurrence in AERD Patients Using Aspirin

Elina Jerschow
All
18 years to 79 years old
This study is NOT accepting healthy volunteers
2022-309158-H01-RST
22-008350
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 and < 70 years.
  • Any gender.
  • Patients with physician-diagnosed AERD (including a physician diagnosis of bilateral nasal polyposis, and at least one NSAID-induced reaction that caused respiratory symptoms).
  • Patients with nasal polyps and no AERD (with and without asthma).
  • Patients who require endoscopic sinus surgery (ESS) for treatment of chronic rhinosinusitis and sinonasal polyposis as part of their standard of care treatment.


Exclusion Criteria:

  • Patients under the age of 18 years and above 70 years.
  • Patients who are or intend to get pregnant during the course of the study or those who are breastfeeding.
  • Patients with mental or legal incapacitation.
  • Patients with acute of chronic kidney or liver disease either self-reported or physician-diagnosed.
  • Patients with anemia requiring work-up up (hemoglobin < 10 mg/dL).
  • Patients with an active peptic ulcer disease.
  • Patients with bleeding-disorder or G6PD deficiency.
  • Patients with a planned surgical procedure during the 1-year study period.

Eligibility last updated 8/16/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

The Effect of Synaquell on Objective Brain Function Measures in Youth Ice Hockey Players

The Effects of Synaquell on Brain Function of Ice Hockey Players

Michael Stuart
Male
13 years to 19 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307754-H01-RST
22-003414
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • 18 years of age or greater.
  • Fluent English speakers.
  • Medically cleared to play ice hockey.


Exclusion Criteria:

  • An allergy to the ingredients of Synaquell or Synaquell+ (Magnesium, beta hydroxybutyrate, Glutathione, N-acetyl-L-cysteine, Riboflavin, Magnesium, Leucine,
  • Isoleucine, Valine, Resveratrol, Curcumin Phytosome, Nicotinamide riboside,
  • Docosahexanoic Acid).
  • Clinically documented hearing issues.
  • In-ear hearing aid or cochlear implant.
  • Implanted pacemaker or defibrillator.
  • Metal or plastic implants in skull.
  • Lack of verbal fluency in the English language.
  • History of seizures.
  • Allergy to rubbing alcohol or EEG gel.
  • Unhealthy scalp.

Eligibility last updated 4/11/22. Questions regarding updates should be directed to the study team contact.

Dietary Supplement, Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Development of a droplet digital PCR (ddPCR) assay for the detection of mutant circulating tumor (ct)DNA in patients with uveal melanoma

Detection of Mutant Circulating Tumor (CT)Dna in Uveal Melanoma With Development of a Droplet Digital Pcr (Ddpcr) Assay

Kevin Halling
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308501-H01-RST
22-006011
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients seen in Ophthalmology including ones referred to Oncology with metastatic uveal melanoma


Exclusion Criteria:
 

  • < 18 years of age. 

Eligibility last updated 7/11/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit From Palovarotene Therapy. (PIVOINE)

A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥ 14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.

Robert Pignolo
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-308712-P01-RST
22-007027
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Participant has completed the EOS or End of Treatment Visit of Study PVO-1A-301 or
PVO-1A-202 (PVO-1A-202 Parts C and D correspond to Study PVO-1A-204 in France) and did
not previously withdraw consent from any of the parent studies to be eligible for
Study CLIN-60120-452.

- Participant must be ≥ 14 years of age (aligned with the age of treated participants in
the ongoing parent studies PVO-1A-301 and PVO-1A-202/PVO-1A-204) and qualify as 100%
skeletally mature (if < 18 years, based on assessments carried out at parent EOS Visit;
if ≥ 18 years, automatically considered 100% skeletally mature) or have reached final
adult height based on investigator's assessment, at the time the Study CLIN- 60120-452
informed consent is signed.


Exclusion Criteria:


- History of allergy or hypersensitivity to retinoids, gelatin, lactose (note that
lactose intolerance is not exclusionary) or palovarotene, or unresponsiveness to prior
treatment with palovarotene.

- Uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine,
metabolic, ophthalmologic, immunologic, psychiatric, or other significant disease.

- Intercurrent known or suspected non-healed fracture at any location;

- Any other medical condition/clinically significant abnormalities that would expose the
participant to undue risk or interfere with study assessments.

- Amylase or lipase > 2 × above the upper limit of normal (ULN) or with a history of
chronic pancreatitis.

- Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × ULN.

- Fasting triglycerides > 400 mg/dL with or without therapy.

- Suicidal ideation (type 4 or 5) or any suicidal behaviour at the Inclusion Visit as
defined by the Columbia-Suicide Severity Rating Scale (C-SSRS).

- Current use of vitamin A or beta carotene, multivitamins containing vitamin A or beta
carotene, or herbal preparations, fish oil, and unable or unwilling to discontinue use
of these products during palovarotene treatment.

- Exposure to synthetic oral retinoids other than palovarotene within 4 weeks of the
Inclusion Visit.

- Concurrent treatment with tetracycline or any tetracycline derivatives due to the
potential increased risk of pseudotumor cerebri.

- Use of concomitant medications that are strong inhibitors or inducers of cytochrome
P450 (CYP450) 3A4 activity; or kinase inhibitors such as imatinib.

- Palovarotene is commercially available in the country where the study is being
conducted.

- Any reason that, in the opinion of the investigator, would lead to the inability of
the participant and/or family to comply with the protocol.

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

Drug
Progressive myositis ossificans
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Exercise Pressor Reflex Pathophysiologic Mechanisms in Human Hypertension

Human Hypertension Exercise Pressor Reflex Pathophysiologic Mechanisms

Joshua Smith
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308879-H01-RST
22-007531
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

Healthy Adults

  • Healthy participants (≥ 18 years of age) will be recruited from the surrounding community.
  • These participants will not have a history of cardiovascular, pulmonary, neurologic, orthopedic, or other diseases affecting the neuromuscular system.
  • Additional inclusion criteria include: age, sex, and body mass index matched to the Human Hypertension (HTN) group and those who are able to engage in exercise (i.e., without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise).

Patients with Hypertension

  •  ≥ 18 years of age.
  • Patients with HTN will have a clinical diagnosis of essential HTN and receiving standard pharmacologic therapy for > 3 months.
  • In addition to their primary care physician, Dr. Borlaug, M.D. will provide oversight for all participants throughout the study duration. Patients will be tested while receiving optimized standard pharmacologic optimized therapy. All patients will be managed by their primary care physician or cardiologist with additional review by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure inclusion and exclusion criteria have been satisfied and participation in exercise testing is safe. Additional inclusion criteria include no history of cardiovascular (except for HTN), pulmonary, renal, and/or muscular related abnormalities and those who are able to engage in exercise (i.e., without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise).

Patients with Heart Failure:

  • Patients with HF with reduced ejection fraction and HF with preserved ejection fraction. Patients with HF are expected to have a history of ischemic or idiopathic dilated cardiomyopathy (stable > 6 months with a duration of > 1 year) and New York Heart Association class I-III. Although HF medications may influence multiple physiologic systems, we feel it is important, practical, and safe to study these patients under conditions of optimal care. Concurrent withdrawal of ACE-inhibitor, beta-blocker, digoxin, and/or diuretic therapies would likely be associated with moderate decompensation in a high proportion of patients. 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.


Exclusion Criteria:

  • ≥ 18 years of age.
  • History of dangerous arrhythmias.
  • Body mass index > 35 kg/m^2.
  • Current smokers and/or smoking history > 15 pack years.
  • Pregnant women (testing will be done by research team if requested).
  • Uremia, history of allergy to iodides.
  • Impaired renal function.
  • Creatinine value greater than or equal to 1.3 mg/dL (via clinical record within the past 6 months).
  • Diagnosis of liver disease; or (10) individuals who are not able to engage in exercise.
  • For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.

Eligibility last updated 7/26/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Analysis of the Dynamics of Clinical Trial Discussions in Oncology to Identify Patient Barriers and Help Develop a Patient-centered Intervention to Increase Participation in Clinical Trials

Dynamics of Clinical Trial Discussions in Oncology to Identify Patient Barriers and Help Develop a Patient-centered Intervention to Increase Participation in Clinical Trials

Konstantinos Leventakos
All
18 years and over
This study is NOT accepting healthy volunteers
2020-302545-H01-RST
20-010980
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Medical oncology patients being seen at their regularly scheduled outpatient oncology visit that are eligible for existing clinical trials and could reasonably expect to discuss clinical trials at their visit.
  • Caregivers attending medical oncology encounters with eligible patients.
  • Medical oncology clinicians (MD, NP, PA), research nurses, study coordinators that are reasonably expected to discuss clinical trials with patients as part of their jobs.


Exclusion Criteria:

  • Patients or caregivers that lack the capacity to participate fully in the trial.
  • Not fluent in English.
  • Too medically fragile or burdened by care in the opinion of the clinician.
  • Caregivers of eligible patients that choose not to participate (i.e., caregivers will not be eligible to participate independently).

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

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Exploring perceptions and experiences of fertility preservation and reproductive care in transgender and gender diverse patient populations.

Fertility Preservation and Reproductive Care in Transgender and Gender Diverse Patient Population Perceptions and Experiences

Zaraq Khan
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309064-H01-RST
22-008155
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Transgender and gender diverse (TGD) identifying patients.
  • Patients ≥ 18 years old.
  • Patients who are seeking or have sought gender-affirming care or fertility preservation.
  • Willingness to provide informed consent and allow recording of the interview.
  • Speaks and understand English language proficiently.


Exclusion Criteria:
 

  • Patients who are not transgender or gender diverse or have not received gender-affirming care or counseling.
  • Participants under 18 years old.

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

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Molecular Epidemiology of Pediatric Germ Cell Tumors

All
Not specified
This study is NOT accepting healthy volunteers
NCT05564026
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Cases will be eligible for the study if they have a primary diagnosis of GCT including germinoma (ICCC code105 9060-9065), teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071), choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain.
• The patient must be enrolled on APEC14B1 with consent to future contact or enrolled in AEPI10N1 with consent for future contact (N=827). Patients enrolled in AEPI10N1 were recruited from ACCRN07. All patients must be registered with COG by a North American member institution. Note: (history of) treatment on a COG therapeutic trial is not required.
• Patients must be diagnosed at < 20 years of age at the time of GCT diagnosis. Study participants will be followed over time in the survivorship study so there is no maximum age for participation.
• Participants must be able to complete study related documents in English or Spanish.
• All patients and/or their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.
• All institutional, FDA, and NCI requirements for human studies must be met.
Exclusion Criteria:

• Participants from AEPI10N1 who did not consent to future contact. Patients who do not meet the eligibility criteria described above or cannot complete study materials in English or Spanish
Other: Questionnaire Administration, Other: Tumor Specimen Collection, Other: Germline DNA Samples, Procedure: Blood Sample Collection
Germ Cell Tumor, Germinoma, Teratoma, Embryonal Carcinoma, Yolk Sac Tumor, Choriocarcinoma, Mixed Germ Cell Tumor, Late Effects, Pediatric Germ Cell Tumor
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Hide all locations

Location Contacts
University of Minnesota — Minneapolis, Minnesota Jenny Poynter, PhD - (poynt006@umn.edu)

DCC-3014-03-001: A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION) (MOTION)

Phase 3 Study of Vimseltinib for Tenosynovial Giant Cell Tumor

Scott Okuno
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305844-P01-RST
21-009962
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients ≥ 18 years of age.
  • TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening).
  • Symptomatic disease as defined as at least moderate pain per BPI Worst Pain or at least moderate stiffness per Worst Stiffness NRS item (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period, prior to the first dose, and documented in the medical record.
  • Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol.
  • Must have stable analgesic regimen, as judged by the investigator, for at least 2 weeks prior to first dose of study drug.
  • Must have at least 1 measurable lesion according to RECIST Version 1.1, with a minimum tumor size of 2cm.
  • Adequate organ and bone marrow function.
  • If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
  • Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
  • Willing and able to complete the patient-reported outcome (PRO) assessments on an electronic device.


Exclusion Criteria:

  • Previous use of systemic therapy targeting colony stimulating factor 1 (CSF1) or CSFR1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed.
  • Received therapy for TGCT, including investigational therapy within 14 days prior to the administration of study drug or within 28 days for therapies with a half-life longer than 3 days or an unknown half-life prior to the administration of study drug.
  • Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis).
  • QT interval corrected by Fridericia's formula (QTcF) > 450 ms in males or > 470 ms in females or history of long QT syndrome.
  • Concurrent treatment with any study-prohibited medications.
  • Major surgery within 14 days of the first dose of study drug.
  • Any clinically significant comorbidities.
  • Active liver or biliary disease including evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis.
  • Malabsorption syndrome or other illness that could affect oral absorption.
  • Known active human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or known active mycobacterium tuberculosis infection.
  • If female, the participant is pregnant or lactating.
  • Known allergy or hypersensitivity to any component of the study drug.
  • Contraindication to MRI.
Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

MARANI PRENATAL CONNECTED CARE (M•care) Safety and Effectiveness Study (M•CARE SE Study)

Marani Health M Care Study

Kyle Traynor
Female
18 years and over
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
2022-306916-P01-RST
22-000485
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Able to provide Informed Consent and follow study instructions.
  • 18 years of age or older.
  • Pregnant subjects ≥ 32 weeks’ gestation.
  • Singleton pregnancy.
  • BMI ≥ 15, pre-pregnancy.
  • BMI ≤ 45, pre-pregnancy.
  • Belly circumference ≥ 80 cm and ≤ 135 cm.
    • NOTE: Subjects admitted for induction of labor and subjects being monitored for premature rupture of membranes (PROM) or other inpatient evaluations can be enrolled in the trial.


Exclusion Criteria:

  • Known major fetal malformation or chromosome abnormality.
  • Abdominal medical skin conditions, including surgical incisions, open wounds with or without infections, edema, or irritation.
  • Subjects with implanted electronic devices (pacemakers, defibrillator, etc.).
  • Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
  • Medical or obstetric problem that in investigator's opinion would make the subject incapable of taking part in the study.
  • In the investigator’s opinion, the subject is not likely to be available for the minimum 60 minutes of the monitoring session.
  • History of skin allergies to cosmetics and lotions.
  • Known allergies to silver, nylon, or polyester.
    • NOTE: some people with sensitivity to silver jewelry are sensitive to the impurities in silver alloys and not to silver itself.

Eligibility last updated 10/26/22. Questions regarding updates should be directed to the study team contact.

Device
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared with Mepolizumab in Adults with Relapsing or Refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy (OCEAN)

OCEAN (depemOkimab effiCacy Eosinophilic grAnulomatosis with polyaNgiitis)

Ulrich Specks
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307298-P01-RST
22-001822
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Participant (male or female) must be 18 years of age or older at the time of signing
the informed consent.

- Participants who are >=40 kilogram at Screening Visit 1.

- Participants with a documented diagnosis of EGPA for at least 6 months based on the
history or presence of: asthma plus eosinophilia defined as >1.0*10^9/Liter (L) and/or
>10 percentage (%) of leucocytes plus at least 2 of the following additional features
of EGPA: a biopsy showing histopathological evidence of eosinophilic vasculitis, or
perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation,
neuropathy, mono or poly (motor deficit or nerve conduction abnormality), pulmonary
infiltrates, non-fixed, sino-nasal abnormality, cardiomyopathy (established by
echocardiography or magnetic resonance imaging), glomerulonephritis (hematuria, red
cell casts, proteinuria), alveolar hemorrhage (by bronchoalveolar lavage), palpable
purpura, anti-neutrophil cytoplasmic antibodies positive Myeloperoxidase or Proteinase
3.

- History of relapsing OR refractory disease.

- Participants must be on a stable dose of oral prednisolone or prednisone of >=7.5
mg/day (but not >50 mg/day) for at least 4 weeks prior to Baseline (Visit 2).

- If participants receiving immunosuppressive therapy (excluding cyclophosphamide) the
dosage must be stable for the 4 weeks prior to Baseline (Visit 2) and during the
study.

- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and one of the following conditions applies: Is a woman of
non-childbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP)
and using a contraceptive method that is highly effective, with a failure rate of <1%.

- Capable of giving signed informed consent


Exclusion Criteria:


- Participants diagnosed with granulomatosis with polyangiitis; previously known as
Wegener's granulomatosis or microscopic polyangiitis.

- Participants with organ-threatening EGPA as per EULAR criteria,

- Imminently life-threatening EGPA disease within 3 months prior to Screening (Visit 1).

- A current malignancy or previous history of cancer in remission for less than 12
months prior to Screening.

- Participants with alanine aminotransferase >2*upper limit of normal (ULN) or if
participant is on background methotrexate or azathioprine >3*ULN, aspartate
aminotransferase >2*ULN or if participant is on background methotrexate or
azathioprine >3*ULN, alkaline phosphatase >=2.0*ULN, total bilirubin >1.5*ULN
(isolated bilirubin >1.5*ULN is acceptable if bilirubin is fractionated and direct
bilirubin <35%), Cirrhosis or current unstable liver or biliary disease per
investigator assessment.

- Participants who have severe or clinically significant cardiovascular disease
uncontrolled with standard treatment.

- Participants who have known, pre-existing, clinically significant system abnormalities
that are not associated with EGPA and are uncontrolled with standard treatment.

- Clinically significant abnormality in the hematological, biochemical or urinalysis
screen at Visit 1.

- Chronic or ongoing active infectious disease requiring systemic treatment.

- Participants with a known, pre-existing parasitic infestation within 6 months prior to
Screening Visit 1.

- A known immunodeficiency (e.g. human immunodeficiency virus [HIV]).

- Participants that, according to the investigator's medical judgment, are likely to
have active coronavirus disease 2019 (COVID-19) infection. Participants with known
COVID-19 positive contacts within the past 14 days must be excluded for at least 14
days following the exposure during which the participant must remain symptom-free.

- Participants with a known allergy or intolerance to a monoclonal antibody or biologic
therapy or any of the excipients of the investigational products.

- Participants who have a previous documented failure with anti-Interleukin-5
/Interleukin-5 receptor therapy. Participants who have received monoclonal antibodies
(mAb) and who have not undergone the required washout periods, prior to Visit 1.

- Participants receiving any of the following: Oral corticosteroids: Participant
requires an oral corticosteroid dose of >50 mg/day prednisolone/prednisone in the
4-week period prior to Baseline (Visit 2), Intravenous (IV), intramuscular or
subcutaneous (SC) corticosteroids in the 4-week period prior to Baseline (Visit 2),
Omalizumab within 130 days prior to Screening (Visit 1), Cyclophosphamide (CYC): oral
CYC within 4 weeks prior to Baseline (Visit 2) and IV CYC within 3 weeks prior to
Baseline (Visit 2), if their total white blood cells is >=4*10^9/L (measured using the
local laboratory if necessary), Rituximab within 12 months prior to Screening (Visit
1); in addition, the Participant must have shown recovery of peripheral B-cell count
to within the normal range, Tezepelumab and Dupilumab with a washout period of 5
half-lives prior to Screening Visit 1, IV or SC immunoglobulin within 6 months prior
to Screening (Visit 1); For China and Japan only within 12 weeks prior to Screening
(Visit 1), Interferon-alpha within 6 months prior to Screening Visit 1, Anti-tumor
necrosis factor therapy within 12 weeks prior to Screening Visit 1, Anti-CD52
(alemtuzumab) within 6 months prior to Screening Visit 1.

- Participants with QT interval corrected for heart rate according to Fridericia's
formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with
Bundle Branch Block in the 12-lead ECG central over-read from at Screening Visit 1.

 

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

Eligibility last updated 3/29/23. Questions regarding updates should be directed to the study team contact.

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Stories for Change: Cancer Prevention

Cancer Prevention: Stories for Change in Hispanic Community

Irene Sia
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309050-H01-RST
22-008177
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Hispanic adults (age 18 or older).
  • Speak Spanish fluently.
  • Identify as a survivor or co-survivor of breast, cervical, or colorectal cancer.
  • Have received all the recommended COVID-19 vaccinations for their age group (we will be in close quarters during the DST workshop and want to protect any participants who may be immunocompromised after receiving cancer treatment).


Exclusion Criteria:
 

  • People younger than 18 years old.
  • Non-Hispanic individuals.
  • Hispanic individuals who do NOT speak Spanish.
  • Individuals who do NOT identify as a survivor or co-survivor of breast, cervical, or colorectal cancer.
  • Individuals who have not received a COVID-19 vaccination.

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

Behavioral
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

HLA DQ Alleles Associated with Increased Risk for Developing Anti-drug Antibodies to Infliximab or Adalimumab

Developing Antidrug Antibodies to Infliximab or Adalimumab in HLA DQ Alleles

Maria Alice Willrich
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309488-H01-RST
22-009707
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Previously received a positive result from either the antibodies to infliximab (INXAB) OR antibodies to adalimumab (ADLAB) test


Exclusion Criteria:

  • Does not meet inclusion criteria, does not provide consent to participate.

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

Eligibility last updated 9/13/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

APAL2020SC, Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study

Wendy Allen-Rhoades
All
up to 22 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-310014-P01-RST
22-011639
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Patients must be less than 22 years of age at the time of study enrollment.

- Patient must have one of the following:

- Patient has known or suspected relapsed/refractory (including primary refractory) AML;

- This includes isolated myeloid sarcoma.

- Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome.

- Patient has known or suspected relapsed ALL that meets one of the following criteria:

- Second or greater B-ALL medullary relapse, excluding KMT2Ar;

- Any first or greater B-ALL medullary relapse involving KMT2Ar;

- Any first or greater T-ALL medullary relapse with or without KMT2Ar;

- Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia;

- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment related AML.

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

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

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

Eligibility last updated 11/4/22. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery
Acute myelogenous leukemia, Cancer, Leukemia, Recurrent cancer
Acute myeloid leukemia, disease, B-cell acute lymphoblastic leukemia, Cancer treatment, Hematopoietic system, Inherited acute myeloid leukemia, Medical Oncology, Mixed phenotype acute leukemia, Myeloid leukemia co-occurrent with Down syndrome, Myeloid sarcoma, Refractory acute myeloid leukemia, T-cell acute lymphoblastic leukemia, Therapy related acute myeloid leukemia and myelodysplastic syndrome
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating

Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

Xiao Jing Wang
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308387-H01-RST
22-005844
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients who meet Rome IV criteria for functional abdominal bloating/distension.
  • Patients who meet criteria for other Rome IV Disorder of Gut Brain Interaction diagnoses (including but not limited to irritable bowel syndrome, functional constipation, or functional dyspepsia) may be included if bloating is their predominant symptom.
  • Patients will be proficient in English language for comprehension of content.
  • Patients will have reliable access to digital delivery systems for content and questionnaire access via smartphone over the course of the study and follow up period.


Exclusion Criteria:

  • Patients with known prior diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, advanced connective tissue diseases (e.g., scleroderma), and uncontrolled inflammatory bowel disease (IBD) will be excluded.
  • Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study.
  • Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual deficiencies in cognition, dementia, shall be excluded.
  • Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major depressive disorder with suicidal ideation will be excluded.
  • Patients with substance abuse disorders and drug addiction will be excluded.
  • Patients who are unlikely to comply or unlikely to benefit from psychotherapy-based interventions may be excluded at the direction of medical screening provider or principal investigator.   

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.

  

Hypnotherapy, Other
Constipation, Gas and gas pains, Irritable bowel syndrome
Digestive system, Hypnosis
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Insomnia in patients with metastatic non small cell lung cancer.

Metastatic Non-Small Cell Lung Cancer Insomnia

Konstantinos Leventakos
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309377-P01-RST
19-001466
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Have a diagnosis of metastatic non small cell lung cancer.
  • Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy.
  • Subjects will be limited to older than 18 years old at the time of diagnosis.


Exclusion Criteria:
 

  • Have advanced terminal cancer, severe depression, or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing).
  • Regular use of psychotropic medication other than hypnotics (e.g., antidepressants) per chart review.

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Change in Hertel Exophthalmometry and Quality of Life, Following Balanced Decompression and/or Treatment with Medical Therapy in Patients with Thyroid Eye Disease

Change in Hertel Exophthalmometry and Quality of Life After Balanced Decompression to Treat Thyroid Eye Disease

Janalee Stokken
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309505-H01-RST
22-009774
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients ≥ 18 years of age.
  • Diagnosis of thyroid eye disease; undergoing balanced decompression surgery at Mayo Clinic Rochester. 


Exclusion Criteria:

  • Pediatric patients; i.e., those < than age 18.
  • Pregnant women, and those with thyroid eye disease + optic neuropathy.
  • Patients unable to understand the study consent form.
  • Patients who do not plan on following up in the ENT department at Mayo Clinic for their TED.

Eligibility last updated 9/14/22. Questions regarding updates should be directed to the study team contact.

Thyroid eye disease
Endocrine system, Thyroid eye disease
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

GS-US-586-6144, A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

Study of Magrolimab Combination Therapy to Treat Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

Roberto Leon Ferre
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305726-P01-RST
21-008934
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patient has provided informed consent
  • Patient is willing and able to comply with clinic visits and procedures outlined in the study protocol
  • Male or female, at least 18 years of age
  • Patients must have an ECOG performance status of 0 or 1.
  • Laboratory measurements, blood counts:
    • Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment. Red blood cell
      (RBC) transfusions are allowed to meet hemoglobin eligibility within limits set per
      Exclusion Criterion #4 
    • Absolute neutrophil count (ANC) at least 1.5 x 10^9/L without growth factor support
      within 2 weeks of study treatment initiation
    • Platelets at least 100 x 10^9/L
  • Laboratory measurements, renal function:
    • Patients must have adequate renal function as demonstrated by a creatinine clearance of at least 30 mL/min; calculated by the Cockcroft Gault formula
  • Adequate liver function, as demonstrated by:
    • AST less than or equal to 2.5 x ULN or less than or equal to 5 x ULN in patients with liver metastases
    • ALT less than or equal to 2.5 x ULN or less than or equal to 5 x ULN in patients with liver metastases
    • Bilirubin less than or equal to 1.5 x ULN, or less than or equal to 3.0 x ULN and primarily unconjugated if patient has a documented history of Gilbert’s syndrome or genetic equivalent
  • Pretreatment blood cross-match completed (Section 7.8.1.1)
  • Male and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 5.
  • Measurable disease according to response evaluation criteria in solid tumors (RECIST),Version 1.1. Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.
  • Patients must have a life expectancy of 3 months or greater, in the opinion of the investigator.

Safety Run-in Cohort 1 and Phase 2 Cohort 1
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety
Run-in Cohort 1 and Phase 2 Cohort 1 must fulfill the following cohort-specific inclusion
criteria:

  • Patients previously untreated for unresectable locally advanced or mTNBC that is histologically or cytologically confirmed based on the most recent analyzed biopsy or other pathology specimen, defined as negative for estrogen receptor (ER), progesterone receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) according to the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guideline (Appendix 9).
  • Patients whose tumors are considered PD-L1 negative, as determined by an approved test according to local standards.
  • Prior systemic treatment for neoadjuvant and/or adjuvant therapy and/or curative intent radiation therapy is permitted if completed at least 6 months prior to enrollment.

Note: Maintenance therapies are not counted as separate lines of therapy.

Safety Run-in Cohort 2 and Phase 2 Cohort 2
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety
Run-in Cohort 2 and Phase 2 Cohort 2 must fulfill the following cohort-specific inclusion
criterion:

  • Patients with unresectable, locally advanced or mTNBC that is histologically or cytologically confirmed based on the most recent analyzed biopsy or other pathology specimen, defined as negative for ER, PR, and HER2 according to the most recent ASCO/CAP guideline (Appendix 9), who have received 1 prior line of therapy in the unresectable, locally advanced/metastatic setting. Patients must have been previously treated with a taxane in the neoadjuvant, adjuvant, or locally advanced/metastatic setting
  • Patients with tumors considered positive for PD-L1 expression (as determined by an approved test according to local standards) must have received an immune checkpoint inhibitor for 1L treatment of locally advanced/metastatic disease


Exclusion Criteria:

  • Positive serum pregnancy test.
  • Breastfeeding female.
  • Active central nervous system (CNS) disease. Patients with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
  • Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. RBC transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria.
  • History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
  • Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
  • Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha-targeting agents.
  • Current participation in another interventional clinical trial.
  • Known inherited or acquired bleeding disorders.
  • Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which patients are not on active anticancer therapies and who are in complete remission for over 2 years.
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus infection in medical history).
  • Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.
  • Uncontrolled pleural effusion.
  • Uncontrolled hypercalcemia (ionized calcium >1.5 mmol/L) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
  • Uncontrolled tumor-related pain.
  • Severe/serious systemic infection within 4 weeks of randomization.
  • Rapid deterioration during screening prior to enrollment (eg, significant change in performance status, 20% or greater decrease in serum albumin levels or uncontrolled tumorrelated pain)
  • Other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and followup
    examinations
  • Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted
  • Patients who have received a live vaccine within 30 days of randomization
     

Safety Run-in Cohort 1 and Phase 2 Cohort 1
Patients who meet the following exclusion criterion are not eligible to be enrolled into Safety
Run-in Cohort 1 or Phase 2 Cohort 1:

  • Disease progression within 6 months following neoadjuvant/adjuvant therapy or rapid visceral progression and/or symptomatic disease, where single-agent chemotherapy would not be appropriate.

NOTE: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormonereleasing
hormone agonists for breast cancer, and treatment with bisphosphonates and receptor
activator of nuclear factor kappa B ligand inhibitors are not criteria for exclusion. There is no
required minimum washout period for these therapies. Patients should be recovered from the
effects of radiation.

Safety Run-in Cohort 2 and Phase 2 Cohort 2
Patients who meet any of the following exclusion criteria are not eligible to be enrolled into
Safety Run-in Cohort 2 or Phase 2 Cohort 2:

  • Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of bowel obstruction or gastrointestinal perforation within 6 months of enrollment
  • Patients who previously received topoisomerase I inhibitors or antibody-drug conjugates containing a topoisomerase inhibitor
  • High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Cycle 1 Day 1
  • Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent
    • Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study
    • Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

NOTE: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormonereleasing hormone agonists for breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa B ligand inhibitors are not criteria for exclusion. There is no required minimum washout period for these therapies. Patients should be recovered from the effects of radiation.

Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Quantitative Contrast-free Ultrasound Microvessel Imaging for Differentiation of Ocular Tumors (qHDMI)

Ultrasound Microvessel Imaging for Differentiation of Ocular Tumors

Azra Alizad
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307344-P01-RST
22-001824
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Male and female, age 18 and older.
  • Suspected of having eye tumor.

AIM 1 - SUBSET OF LARGE CHOROIDAL NEVI:

Inclusion Criteria:

  • Lesions with thickness > 1.5 mm and minimum documented stability interval of 2 years.


Exclusion Criteria:

  • Lesions with thickness < 1.5 mm or fewer than 2 years of documented stability.

SUBSET LARGE MELANOMA:

Inclusion Criteria:

  • Choroidal, ciliary body, or ciliochoroidal melanoma in a patient who elected to have enucleation for primary tumor treatment.


Exclusion Criteria:

  • Iris melanoma or melanoma that has undergone prior treatment before enucleation.

PRESUMED CHOROIDAL MELANOMA:

Inclusion Criteria:

  •  Choroidal, ciliary body, or ciliochoroidal melanoma with thickness > 1.5 mm treated by radiation. These lesions may sometimes have biopsy for cytogenetic testing at the time of radiation treatment.


Exclusion Criteria:

  • Iris melanoma, lesions with thickness < 1.5 mm, non-melanoma tumors.

AIM 2

Inclusion Criteria:

  • Orbital mass with completed neuroimaging (typically with MRI) and clinical/MRI suspicion for lymphoma.


Exclusion Criteria:

  • Recent orbital biopsy (within the past 3 months) prior to qHDMI, clinical impression clearly compatible with a non-lymphoma tumor type.

Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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

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

Thanh Ho
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307438-P01-RST
22-002700
Show full eligibility criteria
Hide eligibility criteria

Key

Inclusion Criteria:


1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.  Molecular pathology report must be available for Part 2; if molecular pathology report
is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.

2. Documented disease progression on or intolerance to imatinib.

3. Subjects must have received the following treatment:

- Part 1a: Treatment with ≥1 prior lines of therapy for GIST;

- Part 1b: Treatment with ≥ 2 prior TKI for GISTs;

- Part 2: Prior treatment with imatinib only.

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

5. ECOG
•0 to 2.

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

Key


Exclusion Criteria:


1. Known PDGFR driving mutations or known succinate dehydrogenase deficiency.

2. Clinically significant cardiac disease.

3. Major surgeries (e.g., abdominal laparotomy) within 4 weeks of the first dose of study drug.

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

5. Any active bleeding excluding hemorrhoidal or gum bleeding.

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

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

8. Received strong CYP3A4 inhibitors or inducers.

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

Eligibility last updated 8/8/23. Questions regarding updates should be directed to the study team contact.

 

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

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

William Hogan
All
12 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307504-P01-RST
22-002478
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


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

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

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

4. Has evidence of myeloid engraftment

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

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


Exclusion Criteria:


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

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

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

4. Evidence of cGVHD or overlap syndrome

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

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

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

 

Biologic/Vaccine, Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Phase 2, Randomized, Open-label Study of Encorafenib and Cetuximab Plus Pembrolizumab Versus Pembrolizumab Alone in Participants with Previously Untreated BRAF V600E-Mutant, MSI H/DMMR Metastatic Colorectal Cancer (SEAMARK)

A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

Zhaohui Jin
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307850-P01-RST
22-003945
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Locally confirmed microsatellite instability-high/ deficient mismatch repair
(MSI-H/dMMR) stage IV colorectal carcinoma

- Locally confirmed BRAF V600E mutation in tumor tissue or blood

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

- Have not received prior systemic regimens for metastatic disease.

- Measurable disease per RECIST 1.1

- Adequate organ function


Exclusion Criteria:


- Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is
unknown

- Known active central nervous system metastases and/or carcinomatous meningitis;
leptomeningeal disease

- Immunodeficiency or active autoimmune disease requiring systemic treatment in the past
2 years

- Presence of acute or chronic pancreatitis

- Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular
accident events ≤ 12 wks prior)

- Received a live or live-attenuated vaccine within 30 days of planned start of study
medication

- Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib,
vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR)
inhibitor (eg, cetuximab, panitumumab).

- Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death
[PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another
stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).

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

Eligibility last updated 5/2/23. Questions regarding updates should be directed to the study team contact.

Drug, Biologic/Vaccine
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN