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

3802 Study Matches

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Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction (MI) (i-STAT hs-TnI)

Abbott i-STAT High Sensitivity Troponin I Study (i-STAT hs-TnI)

Leslie Donato
All
18 years and over
This study is NOT accepting healthy volunteers
2023-311107-P01-RST
21-008237
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Inclusion Criteria:


- Subject is 18 years of age or older.

- Presenting to the ED with signs and symptoms suggestive of ACS: Acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure without apparent non-cardiac source; Shortness of breath, nausea, vomiting, fatigue/malaise; other equivalent discomfort suggestive of an MI (in accordance with the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines).

- ECG ordered as part of the standard of care.


Exclusion Criteria:


- Previously enrolled in the study.

- Enrolled in any interventional clinical trial (within the last 30 days).

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

Eligibility last updated 3/8/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Role of the Neurovascular System in Spontaneous Coronary Artery Dissection (SCAD) (SCAD)

A Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection

Marysia Tweet
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304867-H01-RST
21-005636
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Inclusion Criteria:

  • Having spontaneous coronary artery dissection.
  • Sex and age-matched control subjects, 18 years of age and older.


Exclusion Criteria:

  • Individuals under 18 years of age.

 

Behavioral, Diagnostic Test, Other
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Life After Pediatric Intensive Care (PICU) - A Mixed Method Study

A Mixed Method Study of Life After Pediatric Intensive Care

Yu Shi
All
4 years and over
This study is NOT accepting healthy volunteers
2022-309704-H01-RST
22-010549
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Inclusion Criteria:

  • Parents or guardians of children who were between 4 and 10 years old at the time of PICU admission at Mayo Rochester in 2022 and discharged home afterwards.


Exclusion Criteria:

  • Parents or guardians who do not speak English. This is recognized as a limitation and the need to study non-English-speaking population in the future.

Eligibility last updated 10/24/22. Questions regarding updates should be directed to the study team contact.

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Computer Aided Auscultation (CAA) of Phonoenterogram (PEG) PEG-CAAe for noninvasive diagnosis of patients with bowel diseases

Noninvasive Diagnosis of Patients With Bowel Diseases with Computer Aided Auscultation of Phonoenterogram

Shivaram Poigai Arunachalam
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310381-H01-RST
22-013060
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Inclusion Criteria:

  • Healthy male and female volunteers ≥ 18 years of age.
  • Patients diagnosed with irritable bowel syndrome (IBS) ≥ 18 years of age.
  • Patients with risk of developing POI or with clinical diagnosis ≥ 18 years of age.
  • Patients with evidence of partial bowel obstruction ≥ 18 years of age.


Exclusion Criteria:
 

  • Inability or unwillingness to participate in study.
  • Age ≤ 17 years old.

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

Eligibility last updated 12/19/22. Questions regarding updates should be directed to the study team contact.

Inflammatory bowel disease, Intestinal obstruction, Irritable bowel syndrome
Digestive system, Inflammatory bowel disease, Irritable bowel syndrome, Partial obstruction of intestine, Postoperative paralytic ileus
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A Pilot Study of the Associations Between Chemotherapy-Induced Nausea in Breast Cancer Patients and Gut Microbiome Composition Profiles

A Study to Evaluate Chemotherapy-Induced Nausea in Breast Cancer Patients

Kathryn Ruddy
Female
20 years and over
This study is NOT accepting healthy volunteers
2020-302168-P01-RST
20-009279
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Inclusion Criteria:

  • At least 20 years of age.
  • Subjects with a diagnosis of Stage I-III adenocarcinoma of the breast will be recruited at Mayo Clinic, Arizona and Mayo Clinic Florida.
  • Female gender.
  • Will receive taxotere + cyclophosphamide treatment +/- Trastuzumab.


Exclusion Criteria:

  • Metastatic disease.
  • Concurrent radiation therapy.
  • Concurrent antibiotic treatment.

Eligibility last updated 4/20/22. Questions regarding updates should be directed to the study team contact.

 

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A Phase 1 Study in Patients with Clinically Node-Positive Breast Cancer to Assess the Safety, Ultrasound Conspicuity, and Migration of an Ultrasound Twinkling Marker Observed for Sonographic Targeting (UTMost Trial) (UTMost)

Assessment of the Safety, Ultrasound Conspicuity, and Migration of Twinkling Markers in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Systemic Therapy and Surgery, UTMOST Trial

Christine Lee
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307603-P01-RST
22-002857
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Inclusion Criteria:

  • Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node.
  • Surgical management will be determined by Dr. Mara Piltin, who will decide if preoperative I-125 seed localization of the positive node is necessary or if she will retrieve the positive node with intraoperative ultrasound guidance. During surgery, the targeted node, its associated biopsy markers, I-125 seed if placed, and twinkling marker will be resected. The position of the marker in the lymph node or proximity to the node will be noted from the surgical and pathology documentation.
  • Surgery will be performed by Dr. Mara Piltin.
  • Patients must be able to understand the study procedures and comply with them for the entire length of the study.
  • No contraception is necessary or required.


Exclusion Criteria:

  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  • Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
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Qualitative Research with Bladder Cancer Patients: What are Largest Patient-Reported Barriers in Radical Cystectomy Care? (QualBC)

Patient Perspectives on Bladder Cancer Care

Timothy Lyon
All
18 years to 88 years old
This study is NOT accepting healthy volunteers
2021-303698-P01-RST
21-001279
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Inclusion Criteria:

  • Adults, age 18-88 years of age.
  • English-speaking.
  • Have undergone radical cystectomy for the treatment of bladder cancer at Mayo Clinic'c campus in Jacksonville, FL.
  • Able and willing to consent to participate in phone interview.


Exclusion Criteria:

  • Individuals < 18 years if age or ≥ 89 years of age.
  • Non-English speaking.
  • Unable or unwilling to provide informed consent.
  • Having undergone radical cystectomy for a reason other than bladder cancer.

Eligibility last updated 2/25/22. Questions regarding updates should be directed to the study team contact.

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A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over 52 Weeks in Patients With IPF

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Teng Moua
All
40 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307984-P01-RST
22-004356
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Inclusion Criteria:


1. Written Informed Consent consistent with ICH-GCP and local laws signed prior to entry
into the study (and prior to any study procedure including shipment of high-resolution
computed tomography (HRCT) to reviewer).

2. Patients (male/female) with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF), aged ≥
40 years when signing the informed consent. IPF diagnosis based on 2018
ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan
taken within 12 months of Visit 1 and if available surgical lung biopsy; AND Usual
interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical
diagnosis of IPF, as confirmed by central review prior to Visit 2.

3. Patients need to be either:

-- on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to
Visit 1 and during screening and planning to stay on this background treatment after
randomization. Combination of nintedanib plus pirfenidone is not allowed;

[*stable therapy is defined as the individually and general tolerated regimen of
either nintedanib or pirfenidone (no dose changes) for at least 12 weeks]; OR

-- not on a therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit
1 or during the screening period. (e.g. either antifibrotic (AF)-treatment naïve or
previously discontinued) and start or re-start of an antifibrotic is not planned.

4. Forced Vital Capacity (FVC) ≥ 45% of predicted normal at Visit 1.

5. Diffusing capacity for carbon monoxide (DLCO) corrected for Haemoglobin (Hb) [visit 1]
≥ 25% and <90% predicted of normal at Visit 1.

6. Female and male patients: Women of childbearing potential (WOCBP) and men able to
father a child must be ready and able to use highly effective methods of birth control
per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used
consistently and correctly. A list of contraception methods meeting these criteria and
instructions on the duration of their use is provided in the patient information.


Exclusion Criteria:


1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume (FEV)1/FVC <
0.7) at Visit 1.

2. In the opinion of the Investigator, other clinically significant pulmonary
abnormalities.

3. Acute IPF or Interstitial Lung Disease (ILD) exacerbation within 3 months prior to
screening and/or during the screening period (investigator-determined).

4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit
1 and/or during the screening period.

5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and
viral hepatitis and a confirmed infection with severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) within the 4 weeks prior to Visit 1 or during the screening
period.

A patient can be re-screened if the patient was treated and/or cured from the acute
infection.

6. Any documented active or suspected malignancy or history of malignancy within 5 years
prior to Visit 1, except appropriately treated basal cell carcinoma of the skin,
"under surveillance" prostate cancer or in situ carcinoma of uterine cervix.

7. Major surgery (major according to the investigator's assessment) performed within 3
months prior to Visit 1 or planned during the course of the trial. Being on a
transplant list is allowed.

8. Aspartate amino transferase (AST) or Alanine amino transferase (ALT) > 2.5 x upper
limit of normal (ULN) or total Bilirubin > 1.5 x ULN at Visit 1.

Additional Exclusion Criteria may apply.

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

 

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Identification of the optimal analgesic dose of intrathecal hydromorphone for pediatric patients undergoing posterior spine surgery for idiopathic scoliosis

A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

Kathryn Handlogten
All
10 years to 17 years old
Phase 4
This study is NOT accepting healthy volunteers
2022-308672-H01-RST
22-006823
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Inclusion Criteria:

  • Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.


Exclusion Criteria:

  • Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included.
  • Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included.
  • Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.

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

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The effects of acute and chronic exercise on the immune phenotype of indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia patients

The Effects of Acute and Chronic Exercise on the Immune Phenotype of Chronic Lymphocytic Leukemia Patients

Neil Kay
All
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-310156-P01-RST
22-012246
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Inclusion Criteria:

  • Individuals who are English speaking.
  • Individuals between the ages of 18-80.
  • Individuals with histologically confirmed diagnosis of indolent non-Hodgkin lymphoma (NHL) will be required to participate in Aim 2 (CLL/SLL only), aim 3 and 4 (indolent NHL) and aim 5 (indolent NHL) of this study. z
  • Individuals will not be excluded based on baseline exercise.


Exclusion Criteria:

  • Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular or pulmonary disease (e.g., heart disease, coronary artery disease, COPD, asthma, etc.) an  orthopedic or musculoskeletal limitation which would limit ability to exercise or are a current or former smoker.
  • Indolent NHL individuals receiving treatment must have least 8 weeks of planned treatment remaining and those not currently receiving treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible.
  • Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate.

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

Eligibility last updated 10/3/2023. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery, Behavioral, Other
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Genetic Information in Oocyte Donor Selection: A Qualitative Study of the Experiences of Oocyte Donation Recipients (GIODS)

A Study Evalauting Genetic Information in Oocyte Donor Selection

Laura Rust
All
18 years and over
This study is NOT accepting healthy volunteers
2020-301816-H01-RST
20-008436
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Inclusion Criteria:

  • Over 18 years of age.
  • Speak English.
  • Any gender identity.
  • Have undergone or are currently undergoing the oocyte donor selection process for use with in-vitro fertilization and/or the help of a surrogate.
  • Have had a successful pregnancy as a result of the oocyte donation if the process has been completed.


Exclusion Criteria:

  • Under 18 years of age.
  • Do not speak English.
  • Have only utilized ART with own gametes.
  • Have undergone the oocyte donor selection process but did not have a successful pregnancy, and/or are currently pregnant. 
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Exploratory Phase 2A, Double-blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety, Tolerability, PD, and PK of HU6 for the Treatment of Subjects With Obese Heart Failure With Preserved Ejection Fraction (HFpEF) (HFpEF)

Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF

Barry Borlaug
All
40 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308326-P01-RST
22-005604
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Inclusion Criteria:

  • Adult male or female, ≥ 30 years of age.
  • Competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) and must sign the form prior to the initiation of any study procedures.
  • Body mass index (BMI) ≥ 30 kg/m^2.
  • Signs and symptoms of HF in the judgement of the Investigator, and meets the following disease severity criteria:
    • KCCQ OSS ≤ 80 (by exception, Investigator judgment in consult with the Medical Monitor, subjects may be enrolled who meet all eligibility criteria but have a KCCQ OSS ≤ 82);
    • NYHA Classification Class II-III;
    • Baseline peak VO2 ≤ 20 mL/kg/min for females or ≤ 22 mL/kg/min for males;
    • Peak respiratory exchange ratio (respiratory quotient) (RER [RQ]) at baseline of >1.0;
    • Left ventricular ejection fraction (EF) ≥ 50%;
    • The Investigator has determined that the subject has the established diagnosis of chronic HFpEF based on medical history and supported by one of the following criteria (Lang 2014, Arques 2018, Ibrahim 2020, Nassif 2021):
    • Documented hospitalization with HF as primary cause, or emergency room or other urgent outpatient visit for acute HFpEF (as primary cause) at which administration of IV loop diuretic was provided as treatment (≥ 1 month prior to screening);
    • Increased left atrial size (LA): confirmed by the echo core lab and defined as: AP dimension (cm): ≥ 4.0 in men, > 3.8 in women; or LA length ≥ 5.0 cm or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2;
    • Pulmonary capillary wedge pressure (PCWP) at rest > 1 5 mmHg (or left ventricular end-diastolic pressure [LVEDP] ≥18 mmHg) or ≥ 25 mmHg (or ≥ 2.0 mmHg/L/min) with exercise;
    • Either of the following at rest by Doppler and Tissue Doppler: a) for patients in sinus rhythm: E/e’ ratio ≥ 15 at septal annulus, or E/e’ ratio 13 at lateral annulus, or average E/e’ ratio 14; for patients in atrial fibrillation E/e’ ≥ 11 at the septal annulus. v. Currently: • Local lab: BNP ≥ 35 pg/mL (≥ 75 pg/mL with chronic atrial fibrillation) or • Central lab: elevated NT-proBNP ≥125 pg/mL (≥ 250 with chronic atrial fibrillation) vi. History of BNP ≥ 75 pg/mL (≥ 100 pg/mL with chronic fibrillation) or NTproBNP ≥ 225 pg/mL (≥375 pg/mL with chronic atrial fibrillation).
  • Participants should maintain their stable level of physical activity throughout the duration of the study and must agree to not enroll in an exercise training program during the study.
  • Participants should maintain their stable diet and no plan to enter into a weight loss program prior to or during the course of the study.
  • Clinically euthyroid as assessed by a thyroid profile utilizing thyroid stimulating hormone (TSH) and free thyroxine (T4) testing at screening as assessed by the Investigator based on the medical history of the subject. Subjects with a stable history of thyroid disease and who have been on stable doses of thyroid medications for a minimum of 4 months can be enrolled. (Guidance to Investigator: Generally, TSH values greater than 1.5x upper limit of normal (ULN) or less than 1.5x lower limit of normal (LLN) would be exclusionary, but it needs interpretation in the context of T4. In subjects with TSH values within these ranges, there should be no evidence of clinically significant, insufficiently treated hyper- or hypothyroidism that could be contributing to symptoms of dyspnea, exercise intolerance, or weight changes in the opinion of the site Investigator).
  • Ambulatory (not wheelchair- or scooter-dependent) and able to perform upright exercise testing including a 6 MWT.
  • Stable doses of medications (defined as no new medication or change in existing dose of medication >50%) for approximately 30 days prior to screening, with additional specific criteria for the diuretics: a. If treated with a loop or thiazide diuretic, must be on stable regimen for approximately 3 weeks prior to enrollment.
  • The following applies for male and female subjects: a. Male subject whose sexual partner is of childbearing potential and agrees to use of reliable method of contraception as defined in Section 8.2.2); b. Female subject is of childbearing potential and agrees to use a reliable method of contraception (as defined in Section 8.2.2); c. Female subject is of non-childbearing potential, defined as surgically sterile (hysterectomy or bilateral tubal ligation) or post-menopausal (having amenorrhea for a minimum of 12 consecutive months with follicle stimulating hormone [FSH] >40 U/L).


Exclusion Criteria:

  • Life expectancy <1 year due to non-cardiovascular reasons, in the judgement of the Investigator.
  • History of malignancy within 5 years (except non-high-grade skin cancers, carcinoma-in-situ, or low-grade prostate cancer).
  • Weight change (gain or loss) of ≥ 10 pounds either by self-reporting or documented weight loss within the past 30 days.
  • Bariatric surgery prior to screening or planned bariatric surgery during the course of the study.
  • Treatment with GLP-1 receptor agonist begun within approximately 1 year of screening.
  • Treatment with SGLT2 inhibitors begun within approximately 3 months of screening.
  • Intolerance to MRI or with conditions contraindicated for MRI procedures including but not limited to: a. Having surgical clips/metallic implants/shrapnel/MRI-incompatible internal electric implants (e.g. pacemaker); b. Inability to fit into MRI scanner due to subject habitus or exceeding weight tolerance limit of the scanner (generally, 350 or 400 lbs, dependent on manufacturer); or c. Claustrophobia: history of severe claustrophobia that would lead to inability to conduct MRI. (Subjects may receive medication (for example, oral benzodiazepine) for anxiety one hour prior to the conduct of the MRI at the discretion of the Investigator as per facility’s guidelines).
  • Current acute decompensated HFpEF requiring intravenous (IV) diuretics or recent (<1 month before screening) hospitalization for HFpEF.
  • Any condition (e.g., ongoing substance, drug, or alcohol abuse) that may interfere with participation or safety of investigations, in the opinion of the Investigator.
  • Uncontrolled diabetes (HBA1c >10%) or history of recurrent ketoacidosis.
  • Wilson’s disease.
  • History of malignant hyperthermia.
  • Uncontrolled psychiatric disorder. 35. Contraindication for CPET: a. Severe hypertension or hypotension; b. Recent or untreated acute coronary syndrome; c. Heart rate < 40 bpm; d. Systolic blood pressure < 90 mmHg; e. Instability on the treadmill.
  • Laboratory Values at Screening: a. Serum ferritin, < 30 ng/mL for males and < 13 ng/mL for females; b. Anemia (hemoglobin < 9.5 g/dL); c. Serum copper or ceruloplasmin below the normal reference range; d. Serologic evidence of Hepatitis B based on hepatitis B surface antigen (HBsAG); e. Serologic evidence of Hepatitis C antibody (HCV Ab) and HCV RNA; f. Serologic evidence of human immunodeficiency virus (HIV); g. Absolute blood neutrophil count below 1500/µL; h. Female subjects with a positive urine β-human chorionic gonadotropin (β-hCG) test at screening or prior to dosing or who are breastfeeding.
  • Treatment with any investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to the beginning of screening (this includes investigational formulations of marketed products, inhaled and topical drugs), or plans to participate in an investigational drug or device study at any time during this study.
  • Known hypersensitivity to HU6, the metabolite, or formulations excipients.
  • Currently taking prohibited medications: a. Herbal preparations (except where allowed after discussion with Sponsor to avoid potential interaction with HU6 based on emerging data); b. Any over the counter drug, mail order or prescription drug for weight loss; c. Oral, intranasal or inhaled products with cannabidiol; d. Prescription or over the counter stimulants including: dextroamphetamine/Dexedrine®, dextroamphetamine/amphetamine combination product/Adderall®, or methylphenidate (Ritalin®, Concerta®); e. Systemic corticosteroids, methotrexate, tamoxifen, amiodarone, chronic use of tetracycline; 40. Planning to receive volatile anesthetics (for elective surgery) at any time from randomization until the end of study follow-up visit.

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

Eligibility last updated 8/22/23. Questions regarding updates should be directed to the study team contact.

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Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA)

Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

William Breen
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308704-P01-RST
22-006990
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of glioblastoma.
  • ECOG Performance Status (PS) ≤ 2.
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Postoperative/post-biopsy tumor plus surgical bed size 6 cm in maximum diameter.

Exclusion Criteria

  • Unable to undergo MRI scans with contrast.
  • Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson’s Disease, taking carbidopa/levodopa and/or less than 48 hours from discontinuance).
  • NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline. If a patient is on any of these drugs, list which ones on the On-Study form.
  • IDH mutation identified in the tumor on surgical pathology.

Eligibility last updated 10/25/23. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug, Procedure/Surgery, Radiation, Other
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Qualitative techniques to define meaningful within-patient change in symptoms of advanced cancer patients (QTMC)

Defining Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients

Minji Lee
All
20 years and over
This study is NOT accepting healthy volunteers
2022-309388-P01-RST
22-012283
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Inclusion Criteria:

  • Patients with a diagnosis of cancer including solid tumor and hematologic malignancy at Mayo Clinic, Rochester.
  • To ensure sampling patients likely to have experienced declines in fatigue, all patients will have had at least two in-person encounters for radiation or chemotherapy treatment within the 3 months prior to recruitment. The sampling methodology developed for the CAHPS Cancer Care survey[9] will be modified and used to identify eligible patients from Mayo Clinic’s electronic health record.
  • As interviews will be conducted either in person or by video conference (Zoom, Teams, or similar), access to internet is required for those unable or unwilling to travel to the clinic for an in-person interview.
  • Answered “Yes” to screening question: “In the past 3 months, have you experienced changes in your level of fatigue?” Yes/No.

Exclusion Criteria

  • Unwilling to be audio recorded during the interviews.
  • Answered “No” for the screening question.

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

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

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Mayo Clinic Family Medicine Resident Activity and Wellness Research Study: A Three-Month Tailored Virtual Intervention to Incorporate Workplace and Leisure-Time Physical Activity

Virtual Intervention to Incorporate Workplace and Leisure-Time Physical Activity of Mayo Clinic Family Medicine Residents

Matthew Meunier
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309756-H01-RST
22-010597
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Inclusion Criteria:

  • A Family Medicine Resident at the Mayo Clinic Health System of Eau Claire and Mayo Clinic Family Medicine Residency of Rochester in either the PGY-1 Year, PGY-2 Year, or PGY-2 Year


Exclusion Criteria:
 

  • Participant is not able to wear the devices for the assigned timeframe. Any condition the investigator considers will prevent compliance with study instructions.

Eligibility last updated 10/7/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Device
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Epidemiology of Chronic Lymphocytic Leukemia (CLL) Study

Epidemiology of Chronic Lymphocytic Leukemia

Susan Slager
All
18 years and over
This study is NOT accepting healthy volunteers
0000-117856-H01-RST
15-006439
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Inclusion Criteria:

  • Patient identified as having CLL or MBL, precursor condition to CLL and over the age of 18


Exclusion Criteria:
 

  • No diagnosis of CLL or MBL
Cancer, Chronic lymphocytic leukemia, Leukemia
Chronic lymphoid leukemia, disease, Hematopoietic system, Medical Oncology, Monoclonal B-cell lymphocytosis
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Magnetic Resonance Elastography of Myofascial Pain Syndrome

Magnetic Resonance Elastography of Myofascial Pain Syndrome

Ziying Yin
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308906-H01-RST
22-007647
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Healthy Volunteer

Inclusion Criteria:


- Absence of a history of chronic pain in the targeted anatomical location (i.e., lower back and low extremities) that had limited activities of daily living or work.

- A numerical current pain index of less than 0.5 (on a 10-point Visual Analog Scale).

- Able to understand the goal of the project and give informed consent..

Healthy Volunteer
Exclusion Criteria:


- Pregnancy or breastfeeding.

- Any contraindication to an MRI exam.

- Previous severe/acute back or low extremity injury (including fracture).

- Previous back or low extremity surgery.

- Back and lower limb deformities.

- Inability to provide consent.

Myofascial-Related Pain Patient
Inclusion Criteria:


- A history of chronic low back or leg pain (the targeted location will be determined based on the findings in Aim 1) for at least 3 months. (Measured by patient history and physical exam).

- A palpable taut band or nodule within the skeletal muscle.

- Hypersensitive tender spot within the taut band.

- Recognition of current pain complaint by pressure on the tender nodule/taut band.

- Painful limit to the full stretch range of motion.

Myofascial-Related Pain Patient
Exclusion Criteria:


- Pregnancy or breastfeeding.

- Any contraindication to an MRI exam.

- Previous therapy in the area to be treated within 6 months.

- Previous severe back or low extremity injury (including fracture) or surgery.

- Any neurological conditions or active systemic disease (e.g., diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception.

- Severe osteoarthritis.

- Skin injuries in the area to be treated.

- Inability to provide consent.

Diagnostic Test
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Mayo Clinic — Rochester, MN

Correlation of Plasma High Sensitivity Cardiac Troponin T and Cardiac Troponin Measured Using a Novel Transdermal Infrared Spectroscopic Device

Using a Novel Transdermal Infrared Spectroscopic Device Correlation of Plasma High Sensitivity Cardiac Troponin T and Cardiac Troponin

Leslie Donato
All
18 years and over
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
2022-307994-H01-RST
22-004147
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Inclusion Criteria:

  • Adult males or females that present to the emergency department and have serial plasma hs-cTnT performed as a routine part of their care.
  • Age 18 years or older.
  • Able to provide written informed consent.


Exclusion Criteria:
 

  • Acutely ill patients in need or rapid intervention/care.
  • Those unable to provide written informed consent because of lack of capacity or unconsciousness.
Device
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Mayo Clinic — Rochester, MN

A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered [15-O]-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging (RAPID-WATER FLOW)

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma (PHOX)

Geoffrey Johnson
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308236-P01-RST
22-005193
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Inclusion Criteria:


1. Male and female participants ≥18 years;

2. Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;

3. Participants who fall into any one of the following categories:

1. Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT).

2. Had an ICA with no intervention. However, if any stenosis > 40% but ≤ 70% was observed, an FFR assessment was performed.

3. Had a CCTA with normal coronaries or minimal CAD (no stenosis >20%).

The SPECT study, PET 15O-H2O study, and ICA or CCTA testing need to be completed within a 30-day window, with time 0 defined as the date of the first of these three
tests.

4. Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a urine human chorionic gonadotropin (HCG) pregnancy test (with the result known on the day of drug administration) must be negative; these participants must be practicing appropriate birth control from time of the screening visit until the end of the follow-up period. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or
hysterectomy) or are post-menopausal (cessation of menses for more than 1 year), enrollment in the study without a pregnancy test at screening is allowed.

5. Male will need to use contraceptive methods until end of the follow-up period.

6. Participants are able to comply with all study procedures as described in the protocol.


Exclusion Criteria:


1. Participants are unable to undergo (even partially) any of the imaging procedures;

2. Participants with a known history of cardiac disease including:

1. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy

2. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy

3. known left ventricular dysfunction

3. Participants in whom adenosine stress testing is contraindicated, including but not limited to:

1. Participants with severe COPD or chronic asthma.

2. Participants with second- or third-degree atrioventricular block without a pacemaker.

4. Participants with claustrophobia to an extent that would limit their ability to undergo SPECT and PET imaging (patients whose claustrophobia is known to be readily
controlled with drugs or psychological support may be enrolled).

5. Participants who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy and for whom its use cannot be terminated or suspended for ≥ 24 hours
prior to treatment of study drug.

6. Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures.

7. Participants who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial
(patients in observational studies with approved agents and participants known to be on placebo may be enrolled).

8. Participants who have previously participated in this study.

9. Participants with a close affiliation with the investigational site, defined as a close relative to the Investigator, or a dependent person such as an employee, student or intern at the investigational site.

10. Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or enrollment and 15O-H2O PET MPI (pathway 2 and 3)

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

Eligibility last updated 11/17/23. Questions regarding updates should be directed to the study team contact.

Behavioral, Procedure/Surgery, Radiation, Drug
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Mayo Clinic — Rochester, MN

Understanding the Impact of Unproven Stem Cell Corrections on Attitudes and Behavioral Intent of Patients

Patient Perceptions of the Impact of Unproven Stem Cell Corrections

Zubin Master
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310019-H01-RST
22-011654
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Inclusion Criteria:

  • Different conditions based on the top 20 diseases as determined by patients seeking stem cells (Smith et al., 2020 Regen Med) (ResearchMatch permits the selection of participants based on specific conditions).
  • Equal numbers of women and men (ResearchMatch provides sex at birth).
  • Different states and rural/urban populations (ResearchMatch provides state information).
  • Diverse racial/ethnic backgrounds including minorities (ResearchMatch permits the selection of participants based on race and ethnicity).
  • Moderate and high SCI seekers (by administering a short email survey of 8 questions determining SCI seeking intent.
  • Participation will be determined based on desire for information about SCIs, race/ethnicity, geographic location, condition, and gender (equal numbers of women and men).


Exclusion Criteria:
 

  • < 18 years of age.

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.

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Mayo Clinic — Rochester, MN

Integrating animal-assisted therapy in stroke rehabilitation: a randomized controlled trial assessing the impact on psychological state and functional recovery of patients, as well as wellbeing of therapy dogs

A Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation

Arya Mohabbat
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304374-H01-RST
21-005175
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Inclusion Criteria:

  • Patient must be 18 years of age or older.
  • Patient must be in the comprehensive in-patient stroke rehabilitation program.
  • Patient must have a stroke from any cause.
  • Patients must be able and willing to give informed consent.
  • Patients must be able to speak English as the questionnaires being used are only available in English.


Exclusion Criteria:

  • Patient who has a pacemaker.
  • Patient who is pregnant.
  • Patient who is deemed inappropriate to the study by the medical professional.
  • Patient who is unable to give informed consent.
  • Patient who is unable to speak English.

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

Eligibility last updated 5/24/23. Questions regarding updates should be directed to the study team contact.

Behavioral, Other
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Mayo Clinic — Rochester, MN

Occurrence of Shared Decision Making (SDM) in Unhurried Conversations

Characteristics of Unhurried Conversations and Shared Decision Making in Clinical Encounters

Victor Montori
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310615-H01-RST
23-000764
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Inclusion Criteria
•Patients:

  • Adults ≥ 18 years.
  • Have an appointment scheduled in primary care.

Inclusion Criteria
•Clinicians:

  • Clinicians who meet with patients in primary care.

 


Exclusion Criteria:

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

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

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

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Mayo Clinic — Rochester, MN

Senolytics as a novel treatment for Interstitial Lung Disease in Common Variable Immunodeficiency (CVID)

SenolyticsTreatment of Interstitial Lung Disease in Common Variable Immunodeficiency

Avni Joshi
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304130-H01-RST
21-003119
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Inclusion Criteria:


- Patient must have received a diagnosis of CVID according to the international consensus document (ICON) at least 30 days before enrollment.

- Physician diagnosis of possible GLILD associated with CVID.

- IgA results.

- Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile. (A negative pregnancy test for women whose
menopausal status is determined by self-reported absence of menstrual periods in the past 12 months will be required within 72 hours prior to randomization).

- Patient must be able and willing to comply with the requirements of this study protocol.


Exclusion Criteria:


- Unable or unwilling to give informed consent.

- Presence of any condition that the Investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully
completing the trial.

- Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization.

WCBP who are unwilling to abstain from sex or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration.

- Men who are unwilling to abstain from sex with WCBP or use an adequate method of contraception from the time of the first IP administration through 48 hours after the
last IP administration.

- Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.

- Patient currently hospitalized or under immediate consideration for hospitalization.

- Current use of tobacco products or as per clinical judgement.

- Current excessive caffeine intake (400 mg or more per day).

Eligibility last updated to match clinicaltrials.gov on 2/10/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Mayo Clinic — Rochester, MN

Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure (ACCLAIM)

Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)

Grant Schmit
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-307391-P01-RST
22-002816
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Inclusion Criteria:


1. Patient must be at least 18 years old.

2. Patient has signed a written informed consent for the MWA and participation in the
study.

3. Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging
(e.g., CT or MRI).

4. Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.

5. Patient may have up to 5 lesions in the lung (none larger than ≥ 2.0 cm) and/or any
lymph node ≤2.0 cm in the largest diameter

6. Ability to safely create an ablation zone (AZ) that completely covers the tumor with
minimal margin of 5.0 mm. Subcapsular (any tumor within 10 mm from the liver capsule)
or perivascular (any tumor within 10 mm from a vessel larger than 3 mm) lesions may be
included. For these tumors, the calculation of the margin will not apply to the area
abutting the capsule or the vessel.

7. The target tumor(s) is/are visible by US and/or CT in a location where MWA is
technically achievable and safe based on the proximity to adjacent structures.
Protective maneuvers such as hydrodissection for organ mobilization are allowed and
will be recorded.

8. ECOG performance status of 0-1.

9. Platelet count >50,000/mm3 (correctable allowed) within 30 days prior to study
treatment.


Exclusion Criteria:


1. Patient is unable to lie flat or has respiratory distress at rest.

2. Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.

3. Patient has a history of an allergic reaction to intravenous iodine that cannot be
pre-medicated or prevents performance of a CT with IV contrast.

4. Patient has evidence of active systemic infection.

5. Patient has a debilitating medical or psychiatric illness that would preclude giving
informed consent or receiving optimal treatment or follow up.

6. Patient is currently participating in other experimental studies that could affect the
primary endpoint.

7. Patient unable to receive general anesthesia or adequate analgesia and sedation.

8. Tumor location less than 25 mm from hilum (see diagrams with illustration of central
ducts).

9. Patient is currently pregnant or intends to become pregnant

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

Eligibility last updated 1/25/23. Questions regarding updates should be directed to the study team contact.

Device
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Mayo Clinic — Rochester, MN

A Phase 3, Open-Label, Extension Study to Assess the Long-term Safety and Efficacy of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II)

AVTX-803 in Patients with Leukocyte Adhesion Deficiency Type II

Eva Morava-Kozicz
All
6 months to 75 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-308817-P01-RST
22-007356
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Inclusion Criteria:

  • Subject must have completed protocol AVTX-803-LAD-301.
  • Subject must be between 6 months and 75 years old.
  • Subject or parent (for subjects under legal age for consent) has provided written informed consent for this study. Additionally, written informed assent has been provided, as appropriate, for minors of older age, per local institutional review board (IRB)/ethics committee (EC) policy and requirements.
  • Subject has biochemically and genetically proven LAD II (SLC35C1-CDG).
  • Subject is willing and able to comply with the protocol.
  • Women of childbearing potential (WOCBP) meeting the criteria below:
    • Non-lactating and has a negative pregnancy test at screening; AND
    • Uses an acceptable double-barrier method of contraception as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug.
  • Male subjects must agree to use an acceptable double-barrier method of contraception with their partner as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug.  


Exclusion Criteria:
 

  • Subject has severe anemia defined as hemoglobin < 8.0 g/dL (< 4.9 mmol/L).
  • Subject has impaired renal function as defined by an eGFR < 90 mL/min.
  • Subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product.
  • In the investigator’s opinion, subject has a history of failure to respond to fucose at adequate dosing.
  • In the investigator’s opinion, subject is not able or not willing to comply with the study requirements.
  • Subject is pregnant.

Eligibility last updated 7/13/22. Questions regarding updates should be directed to the study team contact.

Drug, Drug therapy
Leukocyte adhesion deficiency - type 2, fucose
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Circuit-Based Deep Brain Stimulation for Parkinson's Disease P1A2&3 Catalyst

Female
21 Years and over
This study is NOT accepting healthy volunteers
NCT05658302
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Inclusion Criteria:

• Diagnosis of idiopathic PD
• Surgery at UMN to implant DBS system with directional lead(s) and multiple independent current control IPG is planned as part of routine clinical care
• At least 21 years old
• Existing or planned 7T brain imagery
Exclusion Criteria:

• Other significant neurological disorder
• History of dementia
• Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
• Pregnant women
• Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip
Parkinson Disease
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University Of Minnesota — Minneapolis, Minnesota Michael Park, MD, PhD

Development of a patient-centered quality of life outcome measure after parotidectomy, Phase II

Development of a Patient-Centered Quality of Life Outcome Measure Following Parotidectomy

Eric Moore
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309804-H01-RST
22-012109
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Previously underwent parotidectomy at Mayo Clinic Rochester for benign and malignant tumors.


Exclusion Criteria:
 

  • Participants not residing in the United States (to avoid potential EU GDPR compliance issues).

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

Eligibility last updated 11/14/22. Questions regarding updates should be directed to the study team contact.

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A Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Phase 2, Dose-Ranging Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared with Placebo for the Treatment of Participants with Mycobacterium Avium Complex (MAC) Pulmonary Disease

Sarah Chalmers
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-309512-P01-RST
22-009850
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Inclusion Criteria:


1. Has a prior diagnosis of NTM-PD due to MAC

2. Has at least one prior lower respiratory culture (sputum or bronchoalveolar lavage [BAL]) positive for MAC in the 12 months prior to consent

3. Has an induced sputum culture at Screening positive for MAC by quantitative culture on solid agar

4. Is either treatment naïve and has not received any prior treatment for MAC, OR if previously treated for MAC and meets all of the following criteria:

1. Has a history of successful treatment with sputum culture conversion to negative

2. Has recent sputum or BAL culture evidence of recurrent or relapsed disease and

3. Has been off therapy for at least 3 months prior to consent

5. Has clinical signs and symptoms within the 6 weeks prior to consent that are consistent with NTM-PD ≥2 of the following:

1. chronic cough

2. fatigue

3. frequent throat clearing

4. shortness of breath (dyspnea)

5. coughing up of blood (hemoptysis)

6. excessive mucus (sputum) production

7. fever (temperature >38ºC or >100.4ºF)

8. night sweats

9. loss of appetite

10. unintended weight loss

11. wheezing

12. chest pain

6. Has a measured forced expiratory volume in the first second following maximal inhalation (FEV1) % predicted ≥30% within 3 months prior to consent. If prior FEV1%
predicted test result is not available, obtain FEV1% predicted at Screening to confirm eligibility


Exclusion Criteria:


1. In the opinion of the Investigator, is not a candidate for a 4-month delay in initiation of standard multidrug therapy to participate in a placebo-controlled clinical trial (e.g., participant has severe symptoms or, extensive disease burden)

2. Has disseminated or extrapulmonary NTM disease

3. Has end-stage NTM-PD or treatment-refractory NTM-PD

4. Has isolation on lower respiratory (sputum or BAL) cultures of any Mycobacterium species other than those included in MAC within the 6 months prior to consent

5. Has any other condition or prior therapy, which, in the opinion of the Investigator, would make the participant unsuitable for this study, including compliance with all
study assessments and adherence to the protocol schedule of assessment

6. Prior exposure to SPR720. Participants who are unable to comply with the requirements of the study or who in the opinion of the Investigator should not participate in the
study are not eligible

- Other inclusion and exclusion criteria as per protocol may apply.

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

Eligibility last updated 9/8/23. Questions regarding updates should be directed to the study team contact.

 

Drug, Other
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An Open-Label, Multicenter, Phase II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Subcutaneous Mosunetuzumab Monotherapy in Patients With Select B-Cell Malignancies (MorningSun)

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies (MorningSun)

Jose Villasboas Bisneto
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308342-P01-RST
22-005666
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Inclusion Criteria:


- At least one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its
longest dimension, or one bi-dimensionally measurable lesion, defined as >1.0 cm in
its longest diameter by computed tomography (CT) scan, positivie emission tomography -
computed tomography (PET- CT), or magnetic resonance imaging (MRI)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

- Adequate hematologic function

- No active infection

- Negative HIV test at screening, with the following exception: Individuals with a
positive HIV test at screening are eligible provided they are stable on antiretroviral
therapy for at least 4 weeks, have a CD4 count ≥ 200/µL, have an undetectable viral
load, and have not had a history of opportunistic infection attributable to AIDS
within the last 12 months

- For women of childbearing potential (except those in Cohort B): agreement to remain
abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and
agreement to refrain from donating eggs, as defined by the protocol

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
a condom, and agreement to refrain from donating sperm, as defined by the protocol

Inclusion Criteria Specific to Cohorts A1 and A2

- Previously untreated FL with indication to start systemic therapy

- Adequate renal function

Inclusion Criteria Specific to Cohort B

- Aged ≥ 80 years at the time of signing informed consent form (ICF), or aged 65-79
years and considered ineligible for chemoimmunotherapy (R-CHOP) with at least one of
the following: Impairment in ≥ 2 Activities of Daily Living (ADL); impairment in ≥ 2
Instrumental Activities of Daily Living (IADL); or Cumulative Illness Rating
Scale-Geriatric (CIRS-G) score of ≥ 1 comorbidity with a severity of 3-4 or a score of
2 in ≥ 8 comorbidities

- Histologically confirmed DLBCL according to WHO 2016 classification expected to
express the CD20 antigen (Swerdlow et al. 2016)

- Previously untreated DLBCL with indication to start systemic therapy and are not
eligible for curative therapy

- High-grade B-cell lymphomas, not otherwise specified (HGBL NOS) and HGBL with MYC and
B-cell lymphoma (BCL)-2 and/or BCL-6 rearrangements

- Adequate end-organ function

Inclusion Criteria Specific to Cohort C

- Histologically conformed MZL (splenic, nodal, and extra-nodal)

- Previously untreated MZL with indication to start systemic therapy

- Helicobacter pylori-positive disease that has remained stable, progressed, or relapsed
following antibiotic therapy and requires therapy, as assessed by the investigator
(for cases of gastric/MALT MZL)

- Adequate renal function

Inclusion Criteria Specific to Cohort D

- Histologically confirmed MCL

- Relapsed after or failed to respond to at least one prior treatment regimen containing
a Bruton's tyrosine kinase (BTK) inhibitor

- Adequate renal function

- Adverse events from prior anti-cancer therapy resolved to Grade </= 1

Inclusion Criteria Specific to Cohort E

- Histologically confirmed RT or tFL

- Relapsed after or failed to respond to at least one prior systemic treatment regimen
for RT or tFL

- Adequate renal function

- Absolute lymphocyte count </= 5000 uL

- Adverse events from prior anti-cancer therapy resolved to Grade </= 1


Exclusion Criteria:


- Current or past history of central nervous system (CNS) lymphoma or leptomeningeal
infiltration

- Prior treatment with mosunetuzumab

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies or known sensitivity or allergy to murine products

- History of confirmed progressive multifocal leukoencephalopathy (PML)

- Known active SARS-CoV-2 infection

- Known or suspected chronic active Epstein-Barr virus (CAEBV) infection

- Patients with history of macrophage activation syndrome (MAS)/hemophagocytic
lymphohistiocytosis (HLH)

- Positive test results for chronic hepatitis B infection (HBV), acute or chronic
hepatitis C virus (HCV) infection, or known or suspected HIV infection

- Administration of a live, attenuated vaccine within 4 weeks before first mosunetuzumab
administration or anticipation that such a live, attenuated vaccine will be required
during the study

- Prior solid organ transplantation

- Prior allogenic stem cell transplant

- Treatment with CAR-T therapy within 30 days prior to C1D1

- History of autoimmune disease, including, but not limited to myasthenia gravis,
myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid
syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple
sclerosis, vasculitis, or glomerulonephritis

- Received systemic immunosuppressive medications (including, but not limited to,
cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis
factor agents) with the exception of corticosteroid treatment </= 10 mg/day prednisone
or equivalent within 2 weeks prior to the first dose of mosunetuzumab

- Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or
neurodegenerative disease

- History of other malignancy that could affect compliance with the protocol or
interpretation of results

- Evidence of significant, uncontrolled concomitant diseases that could affect
compliance with the protocol or interpretation of results or that could increase risk
to the patient

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) at study enrollment or any major episode of
infection requiring treatment with intravenous antibiotics or hospitalization
(relating to the completion of the course of antibiotics) within 4 weeks before C1D1

- Clinically significant history of liver disease, including viral or other hepatitis,
or cirrhosis

- Recent major surgery within 4 weeks before the start of C1D1, other than superficial
lymph node biopsies for diagnosis

- Prior treatment with radiotherapy within 2 weeks prior to C1D1

- Adverse events from prior anti-cancer therapy not resolved to Grade </= 1 (with the
exception of alopecia, anorexia, nausea, vomiting, and fatigue)

- Significant cardiovascular disease (such as New York Heart Association Class III or IV
cardiac disease, congestive heart failure, myocardial infarction within the previous 6
months, unstable arrhythmias, or unstable angina) or significant pulmonary disease
(including obstructive pulmonary disease and history of bronchospasm)

- History of severe allergic or anaphylactic reaction to humanized, chimeric or murine
monoclonal antibodies (MAbs)

- Contraindication to tocilizumab

- Prior anti-lymphoma treatment with monoclonal antibodies, radioimmunoconjugates, or
antibody-drug conjugates within 4 weeks before first mosunetuzumab administration

Exclusion Criteria Specific to Cohorts D and E

- Prior anti-lymphoma treatment with any monoclonal antibody (e.g., anti-CD20),
radioimmunoconjugate, or antibody-drug conjugate therapy within 4 weeks before first
mosunetuzumab administration

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

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

Biologic/Vaccine
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IXT7:Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children (IXT7)

Full-Time Occlusion Therapy for Intermittent Exotropia in Children (IXT7)

Erick Bothun
All
3 years to 8 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-308933-P01-RST
22-007769
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Inclusion Criteria:


Children under the care of a pediatric optometrist or pediatric ophthalmologist will be eligible for the study if they meet all the following criteria:

  • Age 3 to < 9 years.
  • IXT meeting all of the following criteria:
    • Intermittent or constant XT at distance (mean distance control 2.0 or more) with at least 1 control measure of 3, 4 or 5 (i.e., indicating spontaneous tropia);
    • Either IXT, exophoria, or orthophoria at near (cannot have control score of 5 on all 3 near assessments);
    • Distance exodeviation between 15Δ and 50Δ by PACT;
    • Near exodeviation between 0Δ and 50Δ by PACT;
    • Near exodeviation does not exceed distance by more than 10Δ by PACT (convergence insufficiency-type IXT excluded).
  • Age-normal visual acuity in both eyes:
    • 3 years: 20/50 or better (≥ 63 letters);
    • 4 years: 20/40 or better (≥ 68 letters);
    • 5-6 years: 20/32 or better (≥ 73 letters);
    • 7
      •< 9 years: 20/25 or better (≥ 78 letters).
  • Interocular difference in distance VA of 2 logMAR lines or less (10 letters or less on E-ETDRS for patients ≥ 7 years old). Testing by ATS HOTV for participants 3 to < 7 years old and by E-ETDRS for participants ≥ 7 years old.
  • Cycloplegic refraction within the last 7 months.
  • Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months.
  • Participants with refractive error meeting any of the following based on a cycloplegic refraction within 6 months must be wearing spectacles for at least 2 weeks:
    • Myopia > -0.50 D spherical equivalent (SE) in either eye;
    • Anisometropia > 1.00 D SEl;
    • Astigmatism in either eye > 1.00 D.
  • Any refractive correction worn at enrollment (required or not) must meet the following guidelines based on a cycloplegic refraction within 7 months:
    • Anisometropia SE must be within 0.50 D of the full anisometropic difference correction;
    • Astigmatism must be corrected within 0.50 D;
    • Axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ± 5 degrees if cylinder power is >1.00 D;
    • For hyperopia, the spherical component can be reduced at investigator discretion provided the reduction is symmetrical and does not meet the definition of deliberate overminus (see below);
    • For myopia, the intent is to fully correct, but the spherical component can be  undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia;
    • Deliberate overminus is not allowed;
    • Deliberate overminus is defined for this protocol as any refractive correction prescribed to yield lenses that are overminused by more than -0.50D SE than cycloplegic refraction SE;
    • Less than the full cycloplegic hyperopic correction (i.e., prescribing reduced plus) is not considered the same as overminusing for this protocol (because most patients without IXT but with hyperopic SE refractions up to +2.00 D SE would not typically be prescribed a refractive correction);
    • For refractive errors with an emmetropic or myopic SE, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Prescribing a correction that yields more than 0.50 D more minus SE than the cycloplegic refraction SE is considered deliberate overminus and is not allowed.
    • Note that the refractive correction guidelines and the requirement to wear refractive correction for at least 2 weeks apply not only to participants who require refractive correction under the above criteria but also to any other participant who is wearing refractive correction.
  • Gestational age > 30 weeks.
  • Birth weight > 1500 grams.
  • Patient and/or parent understands protocol, is willing to enroll, and is willing to accept that other (i.e., nonrandomized) treatment for IXT will not be offered by the investigator for 3 months.
  • Parent has phone and is willing to be contacted by Jaeb Center staff.
  • Relocation outside of area of an active PEDIG site within 3 months not anticipated.


Exclusion Criteria:

  • Individuals meeting any of the following criteria at baseline will be excluded from study participation:
    • Prior strabismus, intraocular, or refractive surgery (including BOTOX injection);
    • Prior nonsurgical treatment for IXT (e.g., patching, vergence therapy, vision therapy/orthoptics, base-in prism, or deliberate overminus (more than 1.00 D) spectacles of > 1 week duration within the past year.
  • Previous amblyopia treatment other than refractive correction.
  • Diplopia more than 2 times per day by parental assessment.
  • Paretic or restrictive strabismus.
  • Craniofacial malformations affecting the orbits.
  • Ocular disorders which would reduce VA (except refractive error).
  • Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or ADHD are not excluded.
  • Neurological anomaly that could affect ocular motility (e.g., cerebral palsy, Down syndrome).
  • Immediate family member (child or sibling) of any investigative site personnel directly affiliated with this study.
  • Known allergy to adhesive patches.
  • Known allergy to silicone.

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

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Location Contacts
Mayo Clinic — Rochester, MN