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3802 Study Matches

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Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Nicholas Bedard
All
18 years to 99 years old
Phase 4
This study is NOT accepting healthy volunteers
2022-307207-H01-RST
22-001273
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Inclusion Criteria:

  • Patient ≥ 18 years of age.
  • Patient is a candidate for elective, primary total hip arthroplasties (THA) or total knee arthroplasties (TKA).
  • Patient is considered high-risk for developing Periprosthetic joint infections (PJI) based on having at least one of the following criteria:
    • Body mass index (BMI) > 35 kg/m^2;
    • Diagnosis of diabetes mellitus;
    • Active tobacco smoker;
    • Chronic kidney disease;
    • Autoimmune disease;
    • Nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-sensitive Staphylococcus aureus (MSSA).


Exclusion Criteria:

  • < 18 years of age.
  • Inability to consume oral antibiotics.
  • Allergy to antibiotic alternatives in the protocol.
  • History of clostridium difficile colitis.
  • Revision hip or knee arthroplasty procedure.
  • Non-elective surgery.
  • Hemiarthroplasty.
  • Unicompartmental knee arthroplasty.
  • Simultaneous bilateral THA or TKA.
  • Will have subsequent THA or TKA within 12 weeks of the index study procedure.
  • Pregnant.
Drug
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Phase 2 Multiple-Dose, Multiple-Arm, Parallel Assignment Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapies in Selected Subjects With Metastatic Castration-Resistant Prostate Cancer

XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Daniel Childs
Male
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307637-P01-RST
22-003002
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Inclusion Criteria:


- Able to provide written informed consent

- Adult (age ≥ 18 years)

- Histologically confirmed diagnosis of carcinoma of the prostate

- Documented progressive mCRPC based on at least one of the following criteria:

- PSA progression, defined as at least 2 rises in PSA with a minimum of a 1 week interval (1.0 ng/mL is the minimal starting value if confirmed rise is the only indication of progression)

- Soft-tissue progression per RECIST 1.1

- Progression of bone disease (evaluable disease) or 2 or more new bone lesions by bone scan

- Progression after treatment with at least 2 prior lines of anticancer therapy approved for treatment of metastatic prostate cancer; prior treatment of subjects in Cohort D
(MSI-H, MMRD or TMB-H) must include a checkpoint inhibitor approved by FDA for that indication

- Subjects who did not have a surgical orchiectomy must be on androgen suppression treatment (e.g., luteinizing hormone-releasing hormone agonist) with castrate level of
testosterone (≤ 50 ng/dL) and be willing to continue the treatment throughout the study

- Prior targeted or whole exome sequencing panel performed by CLIA-certified laboratory documenting:

1. Cohort A (AVPCa)
•Aggressive variant prostate cancer

2. Cohort B or C (HRD)
•Homologous recombination deficient (HRD) tumor 
3. Cohort D (MSI-H/MMRD)
•Microsatellite instability-high (MSI-H) or mismatch repair deficient (MMRD) tumors (MSI-H/MMRD) or TMB-H (≥ 10 mut/Mb)

4. Cohort E (No Targetable Mutations)
•Not eligible for Cohorts A, B, C, or D

- Evaluable disease according to PCWG3 criteria

- Adequate archival metastatic tumor tissue or agree to undergo a biopsy of at least 1 metastatic site (fresh biopsy of primary prostate is only allowed if there is clear local disease and no other measurable disease site or biopsiable bone lesion)

- ECOG performance status of 0 or 1

- Able and willing to complete the study according to the study schedule


Exclusion Criteria:


Currently receiving anticancer therapies other than androgen deprivation therapy

- Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.)

- Disease progression on prior treatment with cabazitaxel plus carboplatin (applicable to subjects eligible for Cohort A

- Prior treatment with any cytotoxic T-lymphocyte-associated protein (CTLA4), PD1, PDL1, or programmed cell death ligand 2 (PDL2) directed immunotherapy, except subjects in
Cohort D, who will have had prior FDA-approved checkpoint inhibitor therapy

- Grade 4 immune-mediated adverse events related to prior immunotherapy (applicable to subjects eligible for Cohort D)

- Failure to recover from any toxicity related to previous anticancer treatment to ≤ Grade 2

- Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are
radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), are clinically stable, and are without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.

- Platelet count < 100 × 10^9/L

- Hemoglobin level ≤ 9.0 g/dL

- Absolute neutrophil count ≤ 1.7 × 10^9 for subjects who will receive cabazitaxel; < 1.0 × 10^9/L for all others

- Aspartate aminotransferase at screening > 3 × upper limit of normal (ULN) for subjects without known liver involvement by tumor or > 5 × ULN for subjects with known liver
involvement by tumor

- Alanine aminotransferase at screening > 3 × ULN for subjects without known liver involvement by tumor or > 5 × ULN for subjects with known liver involvement by tumor

- Bilirubin ≥ 1.5 × ULN (unless prior diagnosis and documentation of ongoing hemolysis or Gilbert's syndrome has been made)

- Estimated creatinine clearance < 50 mL/minute calculated by the Cockcroft Gault or Modification of Diet in Renal Disease formulas

- Active known or suspected autoimmune disease (except vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that
is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)

- Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response). Subjects who are currently taking prednisone from a previous prostate cancer therapy will be permitted to enroll in the study.

- Receipt of an organ allograft

- Known history of left ventricular ejection fraction ≤ 40%

- History or evidence of any other clinically  unstable/ uncontrolled disorder, condition, or disease other than their primary malignancy that, in the opinion of the
Investigator, would pose a risk to patient safety or inte rfere with study evaluations, procedures, or completion

- Evidence of any serious bacterial, viral, parasitic, or systemic fungal infections within the 30 days prior to the first dose of study drug

- Receipt of a live-virus vaccine within 30 days prior to the first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted)

- A human immunodeficiency virus (HIV) positive subject with CD4+ T-cell (CD4+) counts < 350 cells/µL, or an HIV viral load greater than 400 copies/mL, or a history of an AIDS
(acquired immunodeficiency syndrome)-defining opportunistic infection within the past 12 months, or who has not been on established antiretroviral therapy (ART) for at
least 4 weeks prior to initiation of study drug dosing. (Effective ART is defined as a drug, dosage, and schedule associated with reduction and control of the viral load.)

- Positive test for hepatitis C RNA (a subject who is hepatitis C virus [HCV] antibody positive but HCV RNA negative due to documented, curative prior antiviral treatment or natural resolution is eligible)

- Positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb; a subject whose HBsAg is negative and HBcAb is positive may be enrolled if a
hepatitis B virus [HBV] DNA test is negative and the subject is retested for HBsAg and HBV DNA every 2 months)

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

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

Combination Product, Biologic/Vaccine
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Mayo Clinic — Rochester, MN

A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy (SunRISe-4)

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

Paras Shah
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308046-P01-RST
22-005527
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Inclusion Criteria:


- Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 120 days of randomization date.  Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial predominance. However, the presence of small cell or neuroendocrine variants will make a participant ineligible

- Participants with no residual tumor, or intravesical tumor size of less than or equal to (<=)3 centimeter (cm) following transurethral resection of bladder tumor (TURBT)
are eligible; debulking TURBT for any residual disease is encouraged but not mandated. Participants with persistent tumors greater than (>)3 cm at screening must undergo a
second debulking, re-staging TURBT. Participants will be ineligible if any individual tumor is >3 cm after debulking TURBT

- Deemed eligible for and willing to undergo RC by the operating urologist

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

- Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant
eligibility assessment in the case of equivocal or marginal tests results

- All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2
prior to randomization


Exclusion Criteria:


- Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment

- Participants must not have evidence of cT4b, or N1-3, or M1 disease based on central radiology staging (chest, abdomen, and pelvis must be performed using computed
tomography [CT] or magnetic resonance imaging [MRI]) within 42 days prior to randomization

- Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200

- Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time

- Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment

- Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing

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

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

Drug, Biologic/Vaccine
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Mayo Clinic — Rochester, MN

Determination of novel chorionic villi DNA methylation-based biomarkers for noninvasive tampon-based detection of first trimester intrauterine pregnancies

Chorionic Villi DNA Methylation-Based Biomarkers in Patients With First Trimester Intrauterine Pregnancies

Alyssa Larish
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-309888-H01-RST
22-011176
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Inclusion Criteria
normal first trimester pregnancy tampon group

  • Viable intrauterine pregnancy on ultrasound.
  • < 15 weeks gestation.

Inclusion Criteria - surgical D&C group:

  • Confirmed non-viable missed miscarriage or incomplete miscarriage (also termed missed abortion/incomplete abortion) and planned dilation and curettage or manual vacuum aspiration procedure to remove contents.

Inclusion Criteria - ectopic/suspected ectopic with pregnancy of unknown location:

  • Clinician identification of suspicious adnexal mass OR abnormally trending hcg level with clinician suspicion for ectopic pregnancy OR surgical listing for ectopic pregnancy.

Inclusion Criteria - control hysterectomy group:

  • Age ≤ 42 years undergoing hysterectomy with salpingectomy for prolapse, dysmenorrhea, pelvic pain, non-submucosal fibroids, endometriosis, or gender dysphoria.

Inclusion Criteria - whole peripheral blood group:

  • Reproductive age (Age ≤ 42 years), female biologic sex. This group has been previously recruited, samples have been obtained, and is for comparison only.


Exclusion Criteria:
 

  • Not pregnant.
  • Submucosal myoma, current known endometrial pathology (polyp, EIN), IUD in place in preceding month, cervical dysplasia.

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

Eligibility last updated 9/6/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Realtime Diagnosis from Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation with Long Follow-Up (REGAL)

A Study of Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation

Xiaoxi Yao
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309903-H01-RST
22-011253
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Inclusion Criteria:

  • Had a 10-second 12-lead ECG done at Mayo Clinic.
  • Have a high AI-ECG risk score indicating a high likelihood of previously unrecognized atrial fibrilation (AF).
  • Men with CHA2DS2-VASc2 ≥ 2 or women with CHA2DS2-VASc ≥ 3.


Exclusion Criteria:

  • Diagnosed atrial fibrillation.
  • Diagnosed dementia.
  • Diagnosed end-stage kidney disease.
  • History of intracranial bleeding.
  • Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder.
  • Missing date of birth.
  • Residence outside of the U.S. or missing address information.

Eligibility last updated 6/28/23. Questions regarding updates should be directed to the study team contact.

Other, Device
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Tissue characteristics of early vascular aging

Early Vascular Aging in Patients With Early Coronary Artery Disease

Amir Lerman
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310817-H01-RST
22-008605
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Inclusion Criteria:

  • Routine coronary angiography.
  • Age ≥ 18 years.


Exclusion Criteria:
 

  • < 18 years of age.

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

Eligibility last updated 9/22/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

A Phase 2 Evaluation of Tonabersat for Diabetic Macular Edema (Protocol AN)

Evaluation of Tonabersat for DME

Andrew Barkmeier
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2023-311373-P01-RST
23-003383
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Inclusion Criteria:

  • Adults with type 1 or 2 diabetes mellitus.
  • At least one eye with:
    • Best corrected E-ETDRS visual acuity letter score ≥ 79 (i.e., 20/25 or better);
    • Ophthalmoscopic evidence of center-involved DME in study eye confirmed by central subfield thickness on spectral domain OCT;
    • Zeiss Cirrus: ≥ 290 µm in females, ≥ 305 µm in males;
    • Heidelberg Spectralis: ≥ 305 µm in females, ≥ 320 µm in males.
      • Recruitment will be monitored with a goal to have equal proportions in the following categories above the CI-DME thresholds: < 75 µm, 75 µm to < 175 µm, ≥ 175 µm.
  • Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT.


Exclusion Criteria:

  • Macular edema is considered to be due to a cause other than DME.
  • Major ocular surgery within prior 4 months, or anticipated after randomization.
  • History of focal/grid laser or other ocular surgical, intravitreal, or peribulbar treatment for DR or DME within prior 1 year, and no more than 4 prior anti-VEGF injections total.
  • Anticipated need to treat DME or DR during the first 6 months, or anticipated need for cataract surgery during study period.
  • Any history of vitrectomy.
  • Systemic anti-VEGF or pro-VEGF treatment within 12 months prior to randomization.
  • History of chronic renal failure requiring dialysis or kidney transplant.
  • History of moderate to severe hepatic impairment, including known liver function test .
  • (LFT) values > 3x's the upper limit of normal.

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

Drug, Other
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A Mayo-Adimune Collaborative and Programmatic Approach to Tolerization Therapy

Mayo-Adimune Collaborative and Programmatic Approach to Tolerization Therapy

Charles Howe
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2023-311398-H01-RST
23-003442
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Inclusion Criteria:

  • Stiff Person Syndrome or Ataxia or Epilepsy with elevated anti-GAD serum antibody titers > 20 nM/L or CSF antibody titer greater than 0.02 nM/L.
  • Ambulatory with or without gait aid (cane, walker).
  • Willingness to wean IVIg/IST therapy and symptomatic therapies during final 6 months prior to screening for a phase II trial.
  • Patients will be allowed to receive the ongoing non-immunosuppressive drugs used to treat SPS including diazepam, eurontin or baclofen. The dose of these drugs will remain unchanged final 6 months prior to screening for a phase II trial. Willingness and legal ability to give and sign informed study consent.
  • Patients with diabetes (Type I) will be allowed to participate because up to 40% of SPS patients have diabetes.
  • Concurrent enrollment in IRB#08-007846 with skin punch biopsy and lumbar puncture for research only.


Exclusion Criteria:

  • Wheelchair bound.
  • Candidates may not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, anti-lymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive in the final 6 month prior to screening for the phase II trial.
  • Any medical or social condition that precludes follow-up visits.
  • Any history of cardiac insufficiency, major vascular disease, or symptomatic coronary artery disease. Patients with cardiomyopathy grade III or IV by the New York Heart Classification will be excluded from this study. Systemic edema or pulmonary edema.
  • Chronic liver disease or alcoholism.
  • Any condition, including active infections, that would likely increase the risk of protocol participation or confuse the understanding of the data.
  • Pregnancy. Serum pregnancy test will be performed and must be negative in all women of childbearing potential enrolled in the study.
  • History of active psychiatric disorder that may interfere with participation in the study.

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

Eligibility last updated 8/24/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT) (ASCENT)

Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study

Andrea Cheville
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2023-311432-P01-RST
23-004139
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Inclusion Criteria:

  • A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site.
  • Age 18+.
  • NRS pain score of a 5+ out of 10.
  • Pain that developed (onset) or significantly worsened since cancer diagnosis.
  • Malignant Hematology including:
    • Lymphoma;
    • Myeloma;
    • Chronic Leukemias.


Exclusion Criteria:

  • PHQ8 score of 14 or more.
  • Life expectancy less than 12 months
  • Hospice enrollment
  • Admitted to hospital from Long Term Care/SNF
  • Acute Leukemias
  • Primary brain tumors
  • Confinement to a bed or a chair more than a third of waking hours because of health complications.

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

Eligibility last updated 10/30/23. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery, Behavioral, Other
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Mayo Clinic — Rochester, MN

Prospective Longitudinal Study of Neurological Disease Trajectory in Children Living with Late-Infantile or Juvenile Onset of GM1 or GM2 Gangliosidoses (PRONTO)

Prospective Longitudinal Study of Neurological Disease Trajectory in Children Living with Late-Infantile or Juvenile Onset of GM1 or GM2 Gangliosidoses

Marc Patterson
All
2 years and over
This study is NOT accepting healthy volunteers
2021-305779-P01-RST
21-009174
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Inclusion Criteria:

  • Genetically confirmed diagnosis of GM1 gangliosidosis or genetically confirmed diagnosis of Tay-Sachs or Sandhoff disease.
  • Onset of neurological symptoms on or after the patient’s first birthday.
  • Achieved 12-month developmental milestones at normal developmental time points as per Principal Investigator’s judgement.
  • Abnormal gait and/or speech disturbance, defined as a SARA Gait score and/or SARA Speech disturbance score of ≥ 1 at baseline (or at patient’s last examination performed during a clinical routine visit).
  • Age 2-20 years at baseline.
  • Willing and able to complete (part of the) protocol assessments.
  • Patient and/or legal guardian is able to read, understand, and sign the informed consent. Where appropriate, assent will also be sought for patients < 18 years of age.


Exclusion Criteria:

  • Patients will be excluded from participation if they have received (within 6 months before screening), are currently receiving, or are planned to receive (within the next 6 months) gene therapy, stem cell transplantation, experimental drugs, or any drug, which, in the Investigator´s opinion, may (have) interfere(d) with disease progression.

Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.

Infantile GM1 gangliosidosis, Infantile GM2 gangliosidosis, Juvenile GM1 gangliosidosis, Juvenile GM2 gangliosidosis
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Pragmatic Analysis of the Impact and Utilization of Workflow-Integrated Artificial Intelligence for RPM Enrollment

Impact and Utilization of Workflow-Integrated Artificial Intelligence for Remote Patient Monitoring Enrollment

Tufia Haddad
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309022-H01-RST
22-008014
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Inclusion Criteria:

  • The study participants will be nurses who are part of the RPM care team that cares for adult patients ≥ 18 years.
  • A patient’s data will be included in the analysis if the patient is ≥ 18 years old and receives care from a participating nurse.
  • Patient data will only be collected if permitted (based on the use of the Minnesota Research Authorization Retrieval Tool).
  • Patients who will be considered for this study will be assessed based on standard RPM program inclusion and exclusion criteria for the any of the chronic disease RPM programs (congestive heart failure, coronary artery disease, hypertension, type 2 diabetes, COPD, and general complex care).


Exclusion Criteria:
 

  • < 18 years old. 

Eligibility last updated 8/1/22. Questions regarding updates should be directed to the study team contact.

Other
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A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects with Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (Tailwind)

Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (Tailwind)

Timothy Aksamit
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-309872-P01-RST
22-011666
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Key

Inclusion Criteria:

  • Are able and willing to comply with the Protocol and provide signed informed consent prior to any study-specific procedures.
  • Are male or female ≥ 18 years old.
  • Have a body mass index of ≥ 16.5 kg/m^2.
  • Have findings consistent with bronchiectasis per computerized tomography (CT) (or high-resolution CT [HRCT]).
    • Note: A CT or HRCT that demonstrates the above criterion is required during Screening or the Screening Period unless such an examination has been performed within the last 5 years and meets the above criterion.
  • Have microbiological evidence of pulmonary P. aeruginosa infection from a sputum sample within the last 24 months. Sputum cultures may be repeated on up to 3 occasions during the Screening Period to document P. aeruginosa presence if the initial sputum culture is negative.
  • Are willing and able to provide an induced sputum sample at Screening or during the Screening Period and at designated time points during the study and are willing and able to provide a spontaneously expectorated or induced sputum at all other time points.
  • Have ≥ 104 colony-forming units of P. aeruginosa per gram of induced sputum obtained at Screening or during the Screening Period. Up to 3 specimens may be collected to meet this criterion.
  • Have forced expiratory volume (FEV1) ≥ 35% of predicted normal for age, gender, race, and height (using Global Lung Function Initiative standards) at Screening (regardless of the timing of the most recent prior administration of short-acting bronchodilator) or during the Screening Period.
  • Have, at the Baseline Visit, stable lung function, as determined by the Investigator, provided that the FEV1 at the Baseline Visit has not decreased by more than 10% compared to the FEV1 measured at Screening or during the Screening Period.
  • Have no acute infection or exacerbation of primary disease, as determined by the Investigator, prior to randomization and first dose of study drug.
  • Are able to reproducibly perform spirometry per American Thoracic Society/European Respiratory Society Standards.
  • Have past experience administering inhaled antibiotics and/or feel comfortable administering inhaled antibiotics and/or have a caregiver that is comfortable administering inhaled antibiotics to the subject.
  • For Cohort A, have not received chronic inhaled antipseudomonal antibiotic regimen for at least 3 months prior to Visit 1. For Cohort B, have received chronic inhaled antipseudomonal antibiotic regimen for at least 3 months prior to Visit 1.
  • Are able to comply with study visits and study procedures as judged by the Investigator.
  • Have a negative serum pregnancy test at Screening and a negative urine pregnancy test at the Baseline Visit, with results known prior to randomization and first dose of study drug, if a woman of childbearing potential.
  • Must agree to use a highly effective method of birth control (defined as those, alone or in combination, that result in a low failure rate [ie, less than 1% per year]) from Screening through 60 days following the last dose of study drug if female or female partner of male subjects, of childbearing potential; and
  • Must agree to use barrier contraception (ie, condoms) from Day 1 through 60 days following the last dose of study drug if male. Male subjects must refrain from donating sperm throughout the study and until 60 days after the last dose of study drug.


Exclusion Criteria:

  • Have previously received 1 or more doses of AP-PA02 in any context, including, but not limited to, prior participation in study AP-PA02-101, prior enrollment in this study, or emergency use (with or without prior authorization).
  • Have a history of lung transplantation.
  • Have a history of primary or acquired immunodeficiency syndromes, including, but not limited to, hypogammaglobulinemia and common variable immunodeficiency.
  • Have a history of cystic fibrosis.
  • Have a history of α1-antitrypsin deficiency.
  • Have a history of pulmonary malignancy (primary or metastatic) or any other malignancy requiring treatment (including, but not limited to, chemotherapy, radiation therapy, or immunotherapy) within 1 year prior to Screening or anticipated during the study period (Exceptions: Basal cell carcinoma of the skin and carcinoma in situ of the cervix surgically excised and assessed as definitely removed).
  • Have, at Screening or during the Screening Period, either of the following findings:
    • A personal history or subject-reported family history of prolonged QT syndrome; or
    • Severe cardiovascular disease such as severe uncontrolled hypertension, unstable ischemic heart disease or cardiac arrhythmia and any other cardiac conditions that would confound the evaluation of safety in the opinion of the Investigator.
  • Have a history of hemoptysis meeting either of the following criteria:
    • Within the 6 months prior to Screening, was hospitalized for management or evaluation of hemoptysis; or
    • Within the 3 months prior to Screening, had hemoptysis totaling greater than 30 mL in a single day.
  • Have, within the 3 months prior to Screening, used supplemental oxygen during the day while at rest.
  • Have, within the 3 months prior to Screening, lost more than 10% of their body weight.
  • Have, within the 2 months prior to Screening, participated in any clinical study involving an investigational drug, an investigational device, or any systemic antibiotic.
  • Note: For systemic drugs or antibiotics with a half-life > 12 days, the exclusion period is 5 half-lives.
  • Have, within the 30 days prior to Screening, received any intravenous, intramuscular, or oral antipseudomonal antibiotic (Exception: Chronic oral macrolide treatment with a stable dose is permitted).
    • Note: Inhaled antibiotic use for chronic suppression of P. aeruginosa is acceptable for subjects enrolling in Cohort B.
  • Have, within 30 days prior to Screening, had changes in either the treatment regimen or initiation of treatment with any of the following medications: oral macrolides (e.g., azithromycin, erythromycin, or clarithromycin), hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroids.
  • Have, within the 30 days prior to Screening, received a course of any systemic antibiotics (by any route) for a new active infection at any site, unless assessed as fully resolved and not clinically significant by the Investigator with concurrence of the Medical Monitor.
  • Are, at Screening or during the Screening Period, receiving treatment for active pulmonary infection due to any of the following pathogens: nontuberculous mycobacteria, Staphylococcus aureus, Burkholderia cepacia complex, Aspergillus species, or endemic mycoses.
  • Are receiving treatment for allergic bronchopulmonary aspergillosis.
  • Have, within 30 days prior to Screening, received either a systemic corticosteroid at a dose equivalent to > 20 mg/day of prednisone (including every other day dosing of > 40 mg equivalent) or any immunosuppressive medication or biologic for the treatment of inflammatory or autoimmune disease.
  • Have history of AIDS (human immunodeficiency virus positive with AIDS-defining condition and/or CD4 count 3 × ULN or total bilirubin ≥ 2 × ULN at Screening.
    • Note: Abnormal laboratory results may be repeated once and only once at the discretion of the Investigator. Subjects with values outside the normal range may be permitted if the value is not clinically significant in the opinion of the Investigator with concurrence from the study Medical Monitor and/or Sponsor designee.
  • Have, in the opinion of the Investigator, any acute or chronic medical, psychiatric, or behavioral condition or laboratory abnormality such that any of the following apply: the subject is considered not medically stable or in any other way not suitable for the study; participation in the study is not in the subject’s best interest, including, but not limited to, concern that participation in the study has the potential to put the subject at undue risk or to interfere with the results of the study or the outcome measures.

Eligibility last updated 12/20/23. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Other
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Treatment of headache with occipital nerve blocks: comparison trial of anesthetic with or without dexamethasone

Steroids in Occipital Nerve Block for Treatment of Headache

Carrie Robertson
All
18 years and over
Phase 4
This study is NOT accepting healthy volunteers
2022-308967-H01-RST
22-007855
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Treated for headache including, but not limited to, occipital neuralgia, episodic migraine, chronic migraine and/or cervicogenic headache.
  • Stable on preventative medication dosing for at least 1 month prior to occipital nerve block and no change in preventative medication regimen during the course of the study.
  • Able to understand the requirements of the study and return for treatment.
  • Able to independently provide informed consent.


Exclusion Criteria:

  • Diagnosis of cluster headache according to the International Classification of Headache Disorders 3rd edition.
  • Occipital or other cranial nerve block administered within 3 months prior to initiation of study.
  • History of adverse reaction or contraindication to any of the study ingredients (bupivacaine, lidocaine, dexamethasone), including pregnancy.
  • Infection or bleeding at site of injection.
  • Cranial bone or cervical spine defects/prior surgeries near injection site that prohibit use of landmark-based technique.

Eligibility last updated 7/27/22. Questions regarding updates should be directed to the study team contact.

Drug, Procedure/Surgery
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Mayo Clinic — Rochester, MN

Prospective Investigation of Palliative and End-of-Life ExpeRiences with ICDs (PIPER-ICD) Study (PIPER-ICD)

Palliative and End-of-Life ExpeRiences with ICDs Study

Peter Noseworthy
All
65 years and over
This study is NOT accepting healthy volunteers
2022-309026-P01-RST
22-008033
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Inclusion Criteria:
 

  • Patient with ICD (including CRT devices) for > 5 years.
  • Age ≥ 65 years.
  • Englishspeaking (instruments only available/validated in English).
  • Sufficient cognitive ability to provide consent (i.e., answer simple questions about participation, study purpose, and procedures).
  • Participation in remote monitoring (the standard of care; necessary for comprehensive data collection).
  • Has an informally or formally designated proxy (i.e., family member) who agrees to participate in study interviews if the patient becomes incapacitated (e.g., cannot participate due to mental of physical disability) or dies.


Exclusion Criteria:
 

  • < 65 years of age. 

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

Eligibility last updated 10/31/2022. Questions regarding updates should be directed to the study team contact.

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Variation in Usual Gait and its Effect on the Outcomes of Forensic Gait Analysis Utilizing the Sheffield Features of Gait Tool

Outcomes of Forensic Gait Analysis Using the Sheffield Features of Gait Tool.

Elizabeth Bondi
All
18 years to 40 years old
This study is NOT accepting healthy volunteers
2023-311050-H01-RST
23-002412
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Inclusion Criteria:

  • Healthy men and women, ability to walk 10 minutes.


Exclusion Criteria:
  

  • Current lower extremity musculoskeletal or neurological injury or condition, use of any assistive devices or braces, any impairment in gait.

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

Eligibility last updated 3/10/23. Questions regarding updates should be directed to the study team contact.

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A Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effect of Obinutuzumab versus Rituximab in PR3-Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (PRRR)

PR3-AAV Resilient Remission or PRRR

Ulrich Specks
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306135-P01-RST
21-012197
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Inclusion Criteria:


- Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis or microscopic
polyangiitis).

- Positivity for ANCA, directed against proteinase-3 (PR3)

- Severe newly-diagnosed disease or severe relapsing disease. Severe relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator
deems standard treatment for severe disease is necessary.

- Minimum BVAS/WG of 3

- Relapsing patients must have B cells detectable in the peripheral blood.

- Patients must have completed COVID-19 vaccination (per current recommended CDC guidelines) at least 4 weeks prior to enrollment. Patients who have recovered from COVID-19 prior to screening with a positive spike protein antibody test result but have not been vaccinated are also eligible.

- Female subjects of childbearing potential who are not sterile must agree to use an acceptable method of contraception for 18 months after the last dose of infusion medication. Male subjects who are not sterile whose female partners are of
childbearing potential must agree to use an acceptable method of contraception for 180 days after the last dose of infusion medication.

- Females of childbearing potential include any female who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (to be considered
postmenopausal, the patient must have had amenorrhea for >12 consecutive months).

- Acceptable methods of contraception include the use of at least two of the following: 1) intrauterine device; 2) hormonal contraceptives for at least 30 days prior to first dose infusion (oral, injectable, implant or ring); 3) barrier contraceptives (condom or diaphragm) with spermicide; or 4) abstinence.


Exclusion Criteria:


- Diagnosis with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) as defined by the Chapel Hill Consensus Conference.

- Positive serum assays for ANCA directed against myeloperoxidase (MPO-ANCA)

- Non-severe AAV, defined as disease that does not justify treatment with both B cell depletion and a four-month glucocorticoid taper.

- Any of the co-morbidities:

- Allergies: a history of severe allergic reactions to human or chimeric monoclonal antibodies or murine protein.

- Infection (systemic): an active systemic infection at screening visit

- Infection (deep space): have been diagnosed as having a deep-space infection, such as osteomyelitis, septic arthritis, or pneumonia complicated by empyema or lung abscesses, within 6 months prior to the screening visit

- Infection (blood borne): active hepatitis B or active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C

- Infection (history): History of recurrent significant infection or history of recurrent bacterial infections

- Liver disease: acute or chronic liver disease that is deemed sufficiently severe to impair their ability to participate in the trial.

- Renal disease: a history of documented anti-glomerular basement membrane disease (anti-GBM disease).

- Malignancy: Active or history of malignancy in the last 5 years. Individuals with squamous cell or basal cell skin carcinomas and individuals with cervical or ductal carcinoma in situ may be enrolled if they have received curative surgical
treatment.

- Active COVID-19 infection.

- Uncontrolled disease: evidence of glucocorticoid dependent disease (such as asthma, COPD, psoriasis or IBD, etc.) requiring consistently greater than 10 mg of prednisone for disease control which might affect endpoint assessment or,

- Other uncontrolled diseases, including any uncontrolled psychiatric disorders, drug and alcohol abuse, that could interfere with participation in the trial according to the protocol.

- Known diagnosis of human anti-chimeric antibodies (HACA) formation.

- Subjects who are premenopausal and are:

- Pregnant on the basis of a serum pregnancy test,

- Breastfeeding, or

- Do not agree to use effective method(s) of contraception

- Use of prohibited medications: They have used any of the prohibited medication listed in Section 5.9.1.

- Plasma exchange: They have been treated with plasma exchange within the 3 months preceding the screening visit.

- History of intolerance to rituximab or other chimeric monoclonal antibodies (e.g., infliximab).

- Recent vaccination: They have had a live vaccine fewer than 4 weeks (28 days) before or during randomization (vaccination with live vaccine through the end of study
participation is contraindicated).

- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs)

- Exclusion criteria related to laboratory parameters:

- Bone marrow suppression as evidenced by a total white count < 4 x10 /l, hemoglobin < 7 gm/dl or platelet count < 100,000/?l

- Aspartate aminotransferase or alanine aminotransferase or amylase > 2.5 times the upper limit of normal, unless attributed to vasculitis

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

Eligibility last updated 11/20/23. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Endocrine Therapy-Induced Alopecia Natural History Evaluation among Female Breast Cancer Survivors

Natural History Evaluation Among Female Breast Cancer Survivors with Endocrine Therapy-Induced Alopecia

Stephan Thome
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-307712-P01-MAIJ
22-004341
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Registration
•Inclusion Criteria

  • Age ≥ 18 years
  • Women with a diagnosis of breast cancer who are being treated with curative intent, with the one exception being women who are receiving CDK4/6 inhibitors (these patients being allowed to have more advanced disease).
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Filling into one of the 5 groups discussed in section 5.0 (understanding that groups will close once they complete their accrual goals of 30 patients.
  • Willingness to complete questionnaires every 3 months.
  • Ability to complete the first questionnaire within 2 weeks of therapy initiation (for the four arms that are receiving adjuvant hormonal therapy).

Registration
•Exclusion Criteria

  • Verbal baseline alopecia ≥ 2 on an 11 point scale (from none=0 to severe=10).   The question to use for this item is: Please rate your hair thinning or loss on a scale from 0 to 10, with 0 being no hair loss and 10 being complete hair loss.
  • Planned receipt of chemotherapy or another cancer-directed therapy concurrently (e.g., everolimus, etc.; note that a CDK4/6 inhibitor is allowed within cohort 3).
  • Prior use of endocrine therapy for breast cancer.
  • Receipt of chemotherapy over the previous 6 months.

Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Mankato, MN

Endocrine Therapy-Induced Alopecia Natural History Evaluation among Female Breast Cancer Survivors

Natural History Evaluation Among Female Breast Cancer Survivors with Endocrine Therapy-Induced Alopecia

Mina Hanna
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-307712-P01-ALCL
22-004341
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Registration
•Inclusion Criteria

  • Age ≥ 18 years
  • Women with a diagnosis of breast cancer who are being treated with curative intent, with the one exception being women who are receiving CDK4/6 inhibitors (these patients being allowed to have more advanced disease).
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Filling into one of the 5 groups discussed in section 5.0 (understanding that groups will close once they complete their accrual goals of 30 patients.
  • Willingness to complete questionnaires every 3 months.
  • Ability to complete the first questionnaire within 2 weeks of therapy initiation (for the four arms that are receiving adjuvant hormonal therapy).

Registration
•Exclusion Criteria

  • Verbal baseline alopecia ≥ 2 on an 11 point scale (from none=0 to severe=10).   The question to use for this item is: Please rate your hair thinning or loss on a scale from 0 to 10, with 0 being no hair loss and 10 being complete hair loss.
  • Planned receipt of chemotherapy or another cancer-directed therapy concurrently (e.g., everolimus, etc.; note that a CDK4/6 inhibitor is allowed within cohort 3).
  • Prior use of endocrine therapy for breast cancer.
  • Receipt of chemotherapy over the previous 6 months.

Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Albert Lea, MN

Childhood Onset Sjogren Disease Registry (cSD)

A Registry of Childhood Sjogren Disease

Matthew Basiaga
All
Not specified
This study is NOT accepting healthy volunteers
2022-308894-P01-RST
22-007602
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Inclusion Criteria:

  • Subject diagnosed with Sjogren Disease prior to 21 years of age. This will include patients either:
    • Fulfilling AECG or ACR/EULAR criteria; or
    • Are diagnosed by an expert.
  • Patients with a history of recurrent or persistent salivary or lacrimal gland inflammation or swelling without an underlying etiology. This can include patients with a label of recurrent juvenile parotitis.
  • Elevated SSA/Ro or SSB/La without a diagnosis of SD at study entry.
  • Subject suspected of having SD in evolution based on expert opinion.


Exclusion Criteria:

  • Symptom onset after 21 years of age.
  • Not receiving care at a study related institution.

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

Eligibility last updated 8/2/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Audiovisual Database for Voice and Voice Affected Disorders. (VVV)

Voice and Voice Affected Disorders Audiovisual Database

Diana Orbelo
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310640-P01-RST
23-000725
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Inclusion Criteria:

  • Fluent in English (does not need an interpreter).
  • Able to give consent for self.


Exclusion Criteria:
 

  • History of upper respiratory infection in the past month.
  • Vocal surgery or surgery targeted at altering vocal symptoms such as recurrent laryngeal nerve denervation renervation, Type I-IV thyroplasty, or deep brain stimulator. 
  • Botulinum toxin injection within 3 months (90days) of study enrollment.
  • Congenital or acquired hearing loss to the degree testing process is impaired. 
  • Subjects wearing hearing aids will be excluded from the speech in noise stressor task.
  • Severe comorbidities such as major depressive disorder or neurodegenerative disease will be excluded.

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

Eligibility last updated 1/27/23. Questions regarding updates should be directed to the study team contact.

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A Phase I Clinical Trial to Evaluate the Safety and Tolerability of VLP Peanut in Healthy Subjects and Subjects With Peanut Allergy and to Explore Preliminary Signals of Its Efficacy (PROTECT) (PROTECT)

Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects

Thanai Pongdee
All
18 years to 50 years old
Phase 1
This study is NOT accepting healthy volunteers
2022-307755-P01-RST
22-005524
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Part A Main

Inclusion Criteria:


1. Capable of giving signed informed consent.

2. Subject who has a signed and dated Informed Consent Form (ICF).

3. Subject must be 18 to 50 years, inclusive, at the time of signing the ICF.

4. Male or female.

5. Female subjects who are not of childbearing potential (or females of childbearing
potential who agree to comply with the contraceptive requirements of the clinical
trial protocol).

6. Good general health, as determined by the Investigator.

7. A positive SPT to histamine.

The following additional inclusion criteria are only applicable to the healthy
subjects in Group A1:

8. Healthy subjects (non-atopic) with no clinically significant co-morbidity (including
broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).

9. Subjects with no history of allergy or intolerance to peanut or any other food and who
consume peanuts with no effect.

10. Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole
peanut extract.

11. Peanut specific immunoglobulin E (IgE) < 0.1 kU/L.

12. Ara h 2 specific IgE < 0.1 kU/L.

13. Subjects with negative basophil activation test (BAT).

The following additional inclusion criteria are only applicable to the subjects with
PA in Group A2:

14. Clinical history of physician diagnosed PA.

15. Peanut allergen sensitivity confirmed by SPT and IgE.

16. Subjects who currently adhere to a strict peanut-free diet and who agree to continue
this for the duration of the clinical trial.

17. Subjects who are able to handle and correctly use an adrenaline auto-injector.

Part B Main
Inclusion Criteria:


1. Capable of giving signed informed consent.

2. Subject who has a signed and dated ICF.

3. Subjects aged 18 to 50 years of age, inclusive, at the time of signing the ICF.

4. Male or female.

5. Female subjects who are not of childbearing potential (or females of childbearing
potential who agree to comply with the contraceptive requirements of the clinical
trial protocol).

6. Clinical history of physician diagnosed PA.

7. Peanut allergen sensitivity confirmed by SPT and IgE.

8. Subjects with positive BAT.

9. Subjects who currently adhere to a strict peanut-free diet and who agree to continue
this for the duration of the clinical trial.

10. Good general health, as determined by the Investigator.

11. Subjects who are able to handle and correctly use an adrenaline auto-injector.

Main Exclusion Criteria Part A and B:

1. Pregnant or lactating subject.

2. Presence of any medical condition that may reduce the ability to survive a serious
allergic reaction.

3. Subjects with atopic dermatitis with >25% skin surface involvement.

4. For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.

5. History of severe or life-threatening anaphylactic reactions to peanut resulting in
neurological compromise or requiring mechanical ventilation.

6. Clinical history of severe systemic or life-threatening anaphylactic reactions to
other foods (apart from peanut), insect venom, exercise, drugs, etc. or idiopathic
anaphylaxis.

7. Unable to receive epinephrine therapy.

8. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could
interfere with the subject's ability to participate in the clinical trial.

9. Participation in a clinical research trial with any investigational drug/placebo
within 3 months of screening (Visit 1) or concomitantly with this clinical trial.

10. Personal, financial or other dependent relationship (e.g., employee or immediate
relative) with the clinical trial site, Sponsor, Sponsor's representative, or another
individual who has access to the clinical trial protocol.

11. Vulnerable subjects or those in judicial or governmental detention, detainment or
imprisonment in a public institution.

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

Eligibility last updated 1/19/23. Questions regarding updates should be directed to the study team contact.

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A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation

Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation

Hao Xie
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-309608-P01-RST
23-002094
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Inclusion Criteria:

  • Histologically confirmed metastatic and/or unresectable colorectal cancer (CRC).
  • Documentation of a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation in exon 2, 3, or 4 in primary tumor or metastasis, assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
  • Age ≥ 18 years.
  • Participants with tumors that have progressed on an oxaliplatin/fluoropyrimidine--based regimen with or without bevacizumab.
  • Participants must have had systemic therapy within 180 days of the screening visit.
  • Participants must have, at any time previously, received oxaliplatin-based chemotherapy with or without bevacizumab (≥ 6 weeks in duration).
  • Participants who received oxaliplatin/fluoropyrimidine-based neoadjuvant, adjuvant, and/or fluoropyrimidine maintenance or adjuvant therapy and have disease recurrence or progression > 6 months from their last dose of oxaliplatin will be required to have received oxaliplatin/fluoropyrimidine-based therapy with or without bevacizumab as first-line treatment for metastatic disease.
  • Participants who received an oxaliplatin-based regimen in the first-line setting and discontinued oxaliplatin because of toxicity or who received oxaliplatin for maintenance therapy are eligible as long as progression occurred < 6 months after the last dose of oxaliplatin therapy for advanced metastatic disease. It is recommended that these participants be re-challenged (if feasible) with oxaliplatin/fluoropyrimidine therapy and subsequently progress prior to eligibility. Participants with oxaliplatin-related neuropathy or oxaliplatin infusion-related hypersensitivity that cannot be rechallenged with oxaliplatin are eligible.
  • Participants must not have received prior treatment with irinotecan.
  • FOLFIRI therapy is appropriate for the participant as determined by the Investigator.
  • Imaging computed tomography (CT) or magnetic resonance imaging (MRI) of chest/abdomen/pelvis or other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib. Only participants with measurable disease as defined per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) are eligible for enrollment. CT is the preferred imaging modality, but MRI is also accepted. All subsequent scans must consistently use the same imaging modality for comparison with the Screening scan throughout the study.
  • Must have acceptable organ function.
  • Signed informed consent to provide blood sample(s) for specific correlative assays.


Exclusion Criteria:

  • Concomitant KRAS or NRAS and BRAF-V600 mutation or Microsatellite Instability High/Deficient Mismatch Repair (MSI-H/dMMR).
  • Anti-cancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug. The exception is a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before enrollment, provided it is not the target lesion.
  • More than 1 prior chemotherapy regimen administered in the metastatic setting.
  • Major surgery within 6 weeks prior to enrollment.
  • Untreated or symptomatic brain metastasis.
  • Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (e.g., intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection).
  • Unable or unwilling to swallow study drug.
  • Known hypersensitivity to fluoropyrimidine or leucovorin.
  • Known hypersensitivity to irinotecan.
  • Abnormal glucuronidation of bilirubin; known Gilbert's syndrome.
  • QT interval:
    • Fridericia's correction (QTcF) > 470 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate electrocardiograms (ECGs). In the case of potentially correctible causes of QT prolongation that are readily corrected (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during Screening and that result may be used to determine eligibility;
    • Planned concomitant use of medications known to prolong the QT/QTc interval according to institutional guidelines;
    • Presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia.
  • Use of strong cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19) inhibitors or strong CYP3A4 inducers. Participants currently receiving these agents who can be switched to alternate therapy are not excluded. Inhibitors should be stopped at least 1 week prior to the first dose of protocol therapy and inducers should be stopped at least 2 weeks prior to initiation of protocol therapy.
  • The following are exclusion criteria for bevacizumab:
    • History of cardiac disease: Congestive heart failure (CHF) Class II or higher according to the New York Heart Association (NYHA); active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of participants who have been receiving therapy and are deemed by the Investigator to have stable/controlled disease;
    • Current uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical management) and prior history of hypertensive crisis or hypertensive encephalopathy;
    • History of arterial thrombotic or embolic events (within 6 months prior to study entry);
    • Significant vascular disease (eg, aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease);
    • Evidence of bleeding diathesis or clinically significant coagulopathy;
    • Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within 28 days, or anticipation of the need for major surgical procedure during the study, and minor surgical procedure (excluding placement of a vascular access device) within 7 days prior to study enrollment;
    • Proteinuria at Screening as demonstrated by urinalysis with proteinuria ≥ 2+ (participants discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours to be eligible);
    • Abdominal fistula, gastrointestinal perforation, peptic ulcer, or intra-abdominal abscess within the past 6 months;
    • Ongoing serious, non-healing wound, ulcer, or bone fracture;
    • Known hypersensitivity to any component of bevacizumab;
    • History of reversible posterior leukoencephalopathy syndrome.

Eligibility last updated 3/17/23. Questions regarding updates should be directed to the study team contact.

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Analysis of aqueous humor samples in participants with or without age-related macular degeneration

Calibrating Laboratory Machinery to Handle Smaller Volumes of Aqueous Humor Samples

Brittni Scruggs
All
18 years and over
This study is NOT accepting healthy volunteers
2023-311119-H01-RST
23-002591
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Inclusion Criteria:

  • Patients consented for cataract surgery or intraocular lens surgery.


Exclusion Criteria:

  • Patient unable to understand the consent for specimen collection or unwilling to participate.
  • Patients undergoing an intraocular surgery that does not involve corneal paracentesis wound formation.
  • Patients who have ever received intravitreal injections at any prior timepoint.
  • Patients with advanced glaucoma, active uveitis, active choroidal neovascular membrane, proliferative diabetic retinopathy, optic neuropathy, any inherited retinal degeneration, or toxic maculopathy.
  • Patients younger than 18 years old.

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

Eligibility last updated 3/20/23. Questions regarding updates should be directed to the study team contact.

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ESR-21-21131_Restoring Sensitivity to Immunotherapy Post Failure to the Pacific Regimen: A Pilot Study of Combined Durvalumab (MEDI 4736) and Grid Therapy for Non Small Cell Lung Cancer

Durvalumab and Grid Therapy for the Treatment of Non-small Cell Lung Cancer in Patients Who Progressed During or After Treatment With the PACIFIC Regimen

Dawn Owen
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304813-P01-RST
21-005691
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Body weight > 30 kg.
  • Primary non small cell lung cancer treated previously on PACIFIC regimen (concurrent chemoradiation followed by durvalumab for stage III lung cancer).
  • Progression during duvalumab administration or within 6 months after completion of final durvalumab infusion.
  • Extracranial lesion > 4 cm amenable to grid therapy.
  • Patients with brain metastases are permitted to enroll.
  • Patients with polymetastatic disease are permitted to enroll.
  • Patients with local recurrence are permitted to enroll.
  • Patients who do not have rapid polymetastatic progression (at the discretion of the enrolling physician).
  • Patients who have not had SBRT within 1 month of enrolment.
  • Patients may receive conventional palliative radiation to other symptomatic metastatic disease.
  • ECOG Performance Status (Dronca, Liu, et al.) 0-2.
  • The following laboratory values obtained ≤15 days prior to registration:
    • Hemoglobin ≥ 9.0 g/dL;H
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 100,000/mm^3;
    • Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ULN if total bilirubin is > 1.5 x ULN;
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement);
    • Creatinine OR glomerular filtration rate (GFR) ≤ 1.5 x ULN; OR
    • GFR > 60 mL/min for patients with creatinine > 1.5 x ULN.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • Persons able to become pregnant OR able to father a child must be willing to use an adequate method of contraception while on treatment and for 120 days after last treatment.
  • Life expectancy ≥ 12 weeks.
  • Provide written informed consent..
  • Willingness to provide mandatory blood specimens for correlative research.
  • Willing to return to Mayo Clinic for follow-up (during the Active Monitoring Phase of the study).


Exclusion Criteria:

  • < 18 years of age.
  • 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 OR able to father a child who are unwilling to employ adequate contraception.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Active autoimmune disease requiring systemic treatment, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
  • NOTE: Exceptions are allowed for:
    • Vitiligo;
    • Resolved childhood asthma/atopy;
    • Intermittent use of bronchodilators or inhaled steroids;
    • Daily steroids at dose of ≤10mg of prednisone (or equivalent);
    • Local steroid injections;
    • Stable hypothyroidism on replacement therapy;
    • Stable diabetes mellitus on non-insulin therapy;
    • Sjögren’s syndrome.
  • Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection requiring systemic therapy;
    • Interstitial lung disease;
    • Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn’s disease or others);
    • Known active hepatitis B (i.e., known positive HBV surface antigen (HBsAg) reactive);
    • Known active hepatitis C (i.e., positive for HCV RNA detected by PCR);
    • Known active tuberculosis (TB);
    • Symptomatic congestive heart failure;
    • Unstable angina pectoris;
    • Unstable cardiac arrhythmia; or
    • Psychiatric illness/social situations that would limit compliance with study requirements (e.g., substance abuse).
  • History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Hypersensitivity to durvalumab or any of its excipients.
  • Previous adverse event attributed to durvalumab or other PD-1 or PD-L1 directed therapy that led to drug discontinuation.
  • History of Grade ≥ 3 immune-related adverse event or any grade of immune-related neurologic or ocular adverse event while receiving immunotherapy.
    • Note: Patients who had endrocrine adverse events ≤ Grade 2 are allowed to enroll if they are stable on appropriate replacement therapy and asymptomatic.
  • Other active malignancy < 6 months prior to registration.
    • EXCEPTIONS: Non-melanotic skin cancer, papillary thyroid cancer, prostate cancer, or carcinoma-in-situ of the cervix, or others curatively treated and now considered to be at less than 30% risk of relapse.

 

 

Biologic/Vaccine, Drug, Radiation
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A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia (ENHANCE-2)

Study to Evaluate the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Adults With TP53 Mutant Acute Myeloid Leukemia

Abhishek Mangaonkar
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306571-P01-RST
21-012592
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Inclusion Criteria:

  • Individuals with histological confirmation of AML by World Health Organization criteria, previously untreated for AML, and who have presence of at least 1 TP53 gene mutation that is not benign or likely benign based on evaluation by central laboratory (individuals with biallelic 17p deletions, loss of both 17p alleles, are eligible based on locally evaluated cytogenetics/karyotype/fluorescence in situ hybridization (FISH) report).
  • Individuals with white blood cell (WBC) count ≤ 20×10^3/microliter (μL) prior to randomization. If the individual's WBC is > 20×10^3/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20×10^3/μL prior to the first dose of study treatment and prior to each magrolimab dose for Cycle 1 (if the individual is randomized to the experimental arm).
    • Note: Individuals can be treated with hydroxyurea throughout the study or prior to randomization to reduce the WBC to ≤ 20×10^3/μL to enable eligibility for study drug dosing. Oral etoposide (up to 200 mg orally per day) may be given as an alternative to hydroxyurea for individuals who are intolerant to hydroxyurea or cannot achieve sufficient WBC lowering on hydroxyurea.
  • The hemoglobin must be ≥ 9.5 grams per deciliter (g/dL) prior to initial dose of study treatment for individuals with prior cardiac history (eg, ischemic heart disease, left ventricular ejection fraction (LVEF) ≤ 45%, symptomatic congestive heart failure, or other conditions that may be sensitive to demand ischemia). Transfusions are allowed to meet hemoglobin eligibility.
  • Individual has provided informed consent.
  • Individual is willing and able to comply with clinic visits and procedure outlined in the study protocol.
  • Individuals must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, except for individuals less than 75 years of age and appropriate for non-intensive treatment. For these individuals, the ECOG performance status score may be 0 to 3.
  • Individuals must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 milliliters per minute per 1.73 square meter (mL/min/1.73m^2); calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.
  • Adequate cardiac function as demonstrated by:
    • Lack of symptomatic congestive heart failure and clinically significant cardiac arrhythmias and ischemic heart disease;
    • LVEF > 50% for individuals appropriate for intensive therapy.
  • Adequate liver function as demonstrated by:
    • Aspartate aminotransferase ≤ 3.0 × upper limit of normal (ULN);
    • Alanine aminotransferase ≤ 3.0 × ULN;
    • Total bilirubin ≤ 1.5 × ULN, or primary unconjugated bilirubin ≤ 3.0 × ULN if individual has a documented history of Gilbert's syndrome or genetic equivalent.
  • Pretreatment blood cross-match completed -Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  • Individuals must be willing to consent to mandatory pretreatment and on-treatment bone marrow biopsies (aspirate and trephines).


Exclusion Criteria:

  • Positive serum pregnancy test.
  • Breastfeeding female.
  • Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
  • Prior treatment with any of the following:
    • Cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα)-targeting agents;
    • Antileukemic therapy for the treatment of AML (excluding hydroxyurea or oral etoposide), hypomethylating agent (HMA), low dose cytarabine and/or venetoclax.
    • Note: Individuals with prior myelodysplastic syndrome (MDS) who have not received prior HMAs or chemotherapeutic agents for MDS are allowed on study. Other prior MDS therapies including, but not limited to, lenalidomide, erythroid stimulating agents, or similar RBC-direct therapies, are allowed. Localized non-central nervous system (CNS) radiotherapy, erythroid and/or myeloid growth factors, hormonal therapy with luteinizing hormone-releasing hormone agonists for prostate cancer, hormonal therapy or maintenance for breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand inhibitors are also not criteria for exclusion.
  • Current participation in another interventional clinical study.
  • Known inherited or acquired bleeding disorders.
  • Individuals appropriate for non-intensive therapy, who have received treatment with strong and/or moderate cytochrome P450 enzyme 3A (CYP3A) inducers within 7 days prior to the initiation of study treatments.
  • Individuals appropriate for non-intensive therapy who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days prior to the initiation of study treatment.
  • Individuals appropriate for non-intensive therapy who have malabsorption syndrome or other conditions that preclude enteral route of administration.
  • Clinical suspicion of active CNS involvement with AML.
  • Individuals who have acute promyelocytic leukemia.
  • 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 neoplasms such as MDS/myeloproliferative disorders that can transform to AML, or treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anti-cancer therapies and have had no evidence of active malignancy for at least ≥ 1 year.
    • Note: Individuals on maintenance therapy alone who have no evidence of active malignancy for at least ≥ 1 year are eligible.
  • Known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or human immunodeficiency virus (HIV) infection in medical history.
  • Active HBV, and/or active HCV, and/or HIV following testing at screening:
    • Individuals who test positive for hepatitis B surface antigen (HBsAg);
    • Individuals who test positive for hepatitis B core antibody (anti-HBc) will require HBV deoxyribose nucleic acid (DNA) by quantitative polymerase chain reaction (PCR) for confirmation of active disease;
    • Individuals who test positive for HCV antibody. These individuals will require HCV ribose nucleic acid (RNA) quantitative PCR for confirmation of active disease -Individuals who test positive for HIV antibody;
    • Individuals not currently receiving antiviral therapy and who have an undetectable viral load in the prior 3 months may be eligible for the study.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/2/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug
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Non-invasive measurement of blood glucose, blood pressure and extrapolation of QRS complex using a wrist wearable photoplethysmography sensor

Blood Glucose and Blood Pressure Measurements Using a Wrist Wearable Sensor

Narayan Kowlgi
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309800-H01-RST
22-010799
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Inclusion Criteria:

  • Diabetic patients on insulin undergoing four times daily blood sugar checks as part of standard of care.
  • Patients undergoing continuous monitoring for heart rate and blood pressure as part of their routine care.
  • Patients undergoing catheter ablation for atrial fibrillation.


Exclusion Criteria:
 

  • Patients unable to provide informed consent.
  • Patients without arms as these are needed to wear the wrist-based sensor.

Eligibility last updated 10/11/22. Questions regarding updates should be directed to the study team contact.

Device
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Mayo Clinic — Rochester, MN

A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections (STRIVE)

Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE)

Zelalem Temesgen
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-310025-P01-RST
22-011679
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Inclusion Criteria
•STRIVE Platform:

  • Age ≥ 18 years.
  • Informed consent for trial participation.
  • Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection.

Exclusion Criteria
•STRIVE Platform:

  • The patient is expected to be discharged from the hospital within the next 24 hours.
  • Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization.
  • Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization.
  • Patient undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life.
  • Expected inability or unwillingness to participate in study procedures.
  • In the opinion of the investigator, participation in a trial is not in the best interest of the patient.

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

Eligibility last updated 11/9/22. Questions regarding updates should be directed to the study team contact.

Drug, Procedure/Surgery, Other
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Skin Local Heating Responses in Chronic Pain

Chronic Pain Reaction to Local Heating of the Skin

Sarah Baker
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
2023-310612-H01-RST
23-000608
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Inclusion Criteria:
         

  • Two groups of adults will be tracked:
    • Adults who do not have chronic pain (control group); and
    • Adults who have had fibromyalgia greater than 6 months. The groups will be matched for age, body mass index, and sex.
  • Men and women, 18-80 years of age.
  • Non-obese class III (body mass index BMI ≤ 39.9 kg/m^2).


Exclusion Criteria:
 

  • Body mass index greater or equal to 40 kg/m^2.
  • Current nicotine use (e.g., smoking, chewing tobacco, vaping, etc.).
  • Significant metabolic (e.g., diabetes), cardiovascular (including stage II hypertension) or neurologic disease.
  • Known skin allergies or disease, disorders of pigmentation, or rash; history of angioedema.
  • Renal disease, renal artery stenosis, and/or renal impairment.
  • Any current medications which could conceivably alter cardiovascular responses (e.g. antihypertension medication, diuretic, digoxin, CYP3A4 inhibitors, Lithium, etc.).
  • Taking hormone replacement therapy.
  • Women who are pregnant or breastfeeding.

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

Eligibility last updated 7/19/23. Questions regarding updates should be directed to the study team contact.

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Examining the Patient Experience of Awake Laryngoscopy Procedures

Awake Laryngoscopy Procedure Patient Experiences

Semirra Bayan
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
2023-311940-H01-RST
23-005492
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Inclusion Criteria:

  • Provide oral consent for the study.
  • Provide written consent for the procedure itself.
  • 18-99 years of age.
  • Undergoing outpatient, office-based laryngoscopy procedure


Exclusion Criteria:
 

  • Pregnancy.
  • Body weight < 50 kg or > 110 kg.

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

Eligibility last updated 5/18/23. Questions regarding updates should be directed to the study team contact.

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Perfusion imaging to identify posterior circulation candidates for thrombectomy (PRECISE) (PRECISE)

Identifying Posterior Circulation Candidates for Thrombectomy Using Perfusion Imaging

Alejandro Rabinstein
All
18 years to 89 years old
This study is NOT accepting healthy volunteers
2022-309030-P01-RST
22-008755
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Inclusion Criteria:

Clinical

  • Signs and symptoms consistent with an acute posterior circulation ischemic stroke.
  • Baseline modified Rankin Scale (mRS) score ≤ 2 prior to qualifying stroke.
  • Subjects age is 18-89 years.
  • Baseline National Institutes of Health Stroke Scale Score > 4 and remains > 4 immediately prior to thrombectomy treatment.
  • Stroke symptoms began within 48 hours of thrombectomy treatment. Stroke onset is defined as the time the patient was last known to be at his/her neurologic baseline. Wake-up strokes are eligible if they meet the above time limits.
  • Endovascular thrombectomy for PCLVO planned as standard-of-care therapy.
  • Time of arterial puncture (femoral or radial artery) occurred (or expected to occur) within 90 minutes of CT or MR imaging study completion.
  • Patient or Legally Authorized Representative has signed the study Informed Consent form.

Imaging

  • Planned to undergo standard neuroimaging evaluation by computed tomography (CT) or magnetic resonance (MR) imaging that includes CT or MR angiography or the intracranial circulation and cerebral perfusion imaging prior to thrombectomy.
  • .Vertebral artery or basilar artery occlusion on CTA or MRA. (Alternative assessment (if MRA/CTA technically inadequate or > 90 minutes old): Tmax>6s perfusion deficit consistent with a vertebral or basilar artery occlusion).


Exclusion Criteria:
 

Clinical

  • Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
  • Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional outcomes evaluation.
  • Endovascular treatment that primarily involves angioplasty or stent placementt.
  • Any condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.

Imaging

  • Acute symptomatic arterial occlusions in more than one vascular territory on CTA (ie – associated anterior circulation LVO of the internal, middle, or anterior cerebral artery.
  • Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm or arteriovenous malformation.
  • Mass effect with significant herniation above the cerebral tentorium or below the foramen magnum.
  • Intracranial stent implanted in the same vascular territory that precludes safe deployment/removal of neurothrombectomy device.

Eligibility last updated 8/1/22. Questions regarding updates should be directed to the study team contact.

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