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3802 Study Matches

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Studies of Pediatric Liver Transplantation

A Study to Learn More About Children Before and After Liver Transplant

Samar Ibrahim
All
up to 18 years old
This study is NOT accepting healthy volunteers
0000-116213-H01-RST
13-009794
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Inclusion Criteria

  • The patient must meet all of the below criteria to be eligible for enrollment in the study:
    • The participant is less than 18 years of age at the time of transplant
    • The participant received a liver-only, a combined liver-kidney, or a combined liver-pancreas transplant at a participating SPLIT Registry Center

 

Exclusion Criteria

  • The participant previously received a solid-organ transplant other than a liver-only, kidney-only, a combined liver-kidney, or a combined liver-pancreas transplant.
Liver transplant
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Mayo Clinic — Rochester, MN

Patient and Clinician Informed Labeling of AI/ML-Based Software to Enable Transparency and Trust for Cardiac Monitoring and Diagnostics

Labeling of AI/ML-Based Software

Barbara Barry
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306233-H01-RST
21-012302
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Inclusion Criteria:

  • Mayo Clinic clinicians (MD, DO, or equivalent).


Exclusion Criteria:

  • None.

Eligibility last updated 4/27/22. Questions regarding updates should be directed to the study team contact.

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The Effects of Glucagon on Hepatic Metabolism in People with Type 2 Diabetes after Caloric Restriction (The Effects of Glucagon on Hepatic Metabolism in People with Type 2 Diabetes after Caloric Restricti)

Glucagon on Hepatic Metabolism in People with Type 2 Diabetes after Caloric Restriction

Adrian Vella
All
25 years to 65 years old
This study is NOT accepting healthy volunteers
2022-306856-H01-RST
22-000233
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Inclusion Criteria:

  • Age > 25 or  < 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
  • HbA1c ≤ 8.5%.
  • BMI ≥ 28 Kg/M^2.
  • Use of insulin sulfonylureas or metformin only.
  • For female subjects: negative pregnancy test at the time of enrollment or study.
  • No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • No active systemic illness or malignancy.
  • No symptomatic macrovascular or microvascular disease.
  • Any contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit > 35%.
  • TSH > 0.4 or < 5.5.
  • Consumption of < 2 alcohol drinks per day or < 14 per week or a negative AUDIT questionnaire.


Exclusion Criteria:

  • Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
  • HbA1c ≥ 8.5%.
  • BMI ≤ 28 Kg/M^2.
  • Use of insulin or agents other than sulfonylureas or metformin.
  • For female subjects: positive pregnancy test at the time of enrollment or study.
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Contraindications to MRI (e.g. metal implants, claustrophobia).
  • Hematocrit < 35%.
  • TSH < 0.4 or > 5.5.
  • Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.

Eligibility last updated 1/10/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of GDC-6599 in Patients with Chronic Cough

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

Vivek Iyer
All
18 years to 80 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308578-P01-RST
22-006576
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Inclusion Criteria:


- Previous diagnosis of CRC, despite optimized treatment for asthma or COPD, or UCC for at least 1 year.

- Chest X-ray or computed tomography (CT) scan thorax within 5 years prior to screening visit that confirms the absence of any clinically significant abnormality contributing
to the chronic cough in the opinion of the investigator.

- Cough severity VAS score ≥ 40 at screening visit.

- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted at screening".

- Mannitol CDR ≥ 12 coughs/100 mg determined at screening visit mannitol challenge test

- For women of childbearing potential: agreement to remain abstinent or use contraception For men: agreement to remain abstinent or use a condom, and agreement to
refrain from donating sperm.

Inclusion Criteria for Patients with CRC with Atopic Asthma or Patients with CRC with Non-Atopic Asthma (Part A):

- Physician diagnosis of asthma for ≥ 12 months based upon GINA STEP 2-5.

- Stable treatment with ICS therapy (GINA STEP 2) or ICS therapy and at least one additional controller (GINA STEP 3- 5) for ≥ 3 months.

- Patients with atopic asthma (n= 20), based upon historic record of positive test for atopy (if available), or confirmed at screening by any positive test result from a panel of standard allergens including cat dander, dog dander, cockroach, dust mite, mold, and relevant local allergens, as determined through use of ImmunoCAP Specific IgE test, skin prick test, or radioallergosorbent test (RAST)

- Patients with non-atopic asthma (n=20), based upon historic record of negative test for atopy (if available), or confirmed at screening by negative test result across chosen atopy testing panel and no history or symptoms suggesting atopy

- No history of smoking or former smoker with smoking history of < 20 pack-years or equivalent history Smoking is defined as use of inhaled tobacco or cannabis products (e.g., cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes). A former smoker is defined as someone with smoking history who has not used inhaled tobacco or cannabis products within 6 months prior to screening.

Inclusion Criteria for Patients with UCC (Part A):

- Patients with UCC must meet the following criteria for study entry:

- Diagnosis of UCC 

- No history of smoking or former smoker with smoking history of < 20 pack-years or equivalent history

- Smoking is defined as use of inhaled tobacco or cannabis products (e.g., cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes).

- A former smoker is defined as someone with smoking history who has not used inhaled tobacco or cannabis products within 6 months prior to screening.

Inclusion Criteria for Patients with CRC COPD-CB or Patients with CRC COPD (Part B):

- Diagnosis of COPD GOLD I-II ± CB.

- Stable background treatment consisting of a bronchodilator medication and or stable
ICS therapy for ≥ 12 weeks prior to screening visit.

- Former smoker with ≥10 pack-years or equivalent history who has not used inhaled tobacco or cannabis products (e.g., cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes) within 6 months prior to screening

- Post-bronchodilator FEV1/ forced vital capacity (FVC) ratio ≤ 0.70 at screening.

- Chest X-ray or CT scan within 6 months prior to screening visit or during the screening period (prior to randomization [Study Visit 2]), that confirms the absence of clinically significant lung disease besides COPD.


Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study entry:

-  Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of GDC-6599 Women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test within 1 day prior to initiation of study drug.

- History of diagnosed bleeding diathesis or easy bruising or bleeding (i.e., bruising or bleeding out of proportion to the degree of trauma).

- Post-bronchodilator FEV1/FVC ratio< 0.60 at screening (patients with CRC asthma and UCC only: Part A)

- Acute exacerbations of asthma or COPD within 8 weeks prior to screening

- Use of oral or systemic corticosteroids for the treatment of respiratory diseases, including cough, within 8 weeks prior to screening

- Continued, chronic use of oral or systemic corticosteroids for non-respiratory conditions is permitted, provided patient has been receiving a stable treatment regimen for at least 8 weeks prior to screening and, in the opinion of the investigator, is likely to remain on the stable treatment regimen through completion of the study.

- Use of anticoagulant or anti-platelet therapies within 2 weeks prior to screening

- Initiation of proton-pump inhibitor (PPI) therapy within 8 weeks prior to screening

- History of significant hepatic impairment, defined as Child-Pugh Class B or C, corresponding to a Child-Turcotte-Pugh Score ≥ 7

- History of aspiration pneumonia

- Respiratory infection (including upper respiratory infection), known COVID-19 infection, persistent symptoms of known prior COVID-19 infection, and/or known positive COVID-19 test within 8 weeks prior to screening and randomization COVID-19 testing is not required for participation in the study unless required by local regulations or institutional policies.

- Positive HIV antibody test at screening

- Positive hepatitis B surface antigen (HBsAg) at screening

- Positive hepatitis C virus (HCV) antibody test followed by a positive HCV RNA test at screening

- The HCV RNA test must be performed if a patient has a positive HCV antibody test at screening to determine if the patient has an HCV infection.

- Treatment with investigational therapy within 28 days or 5 drug-elimination half-lives (if known), whichever is longer, prior to initiation of study drug

- Treatment with any strong inhibitor or inducer of CYP3A within 28 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug

- Need for ongoing treatment with strong CYP3A inhibitor or inducer during the study

- Treatment with any vaccine within 7 days prior to initiation of study drug or a scheduled vaccination during study period (through follow-up/early termination visit)

- Treatment with angiotensin-converting enzyme (ACE) inhibitor within 8 weeks prior to screening

- Treatment with opioids (including codeine), pregabalin, gabapentin, amitriptyline, or nortriptyline for the treatment of cough within 2 weeks prior to screening

- Treatment with any of these medications for indications other than chronic cough is permitted, provided the patient is receiving a stable treatment regimen for at least 2 weeks prior to screening and, in the opinion of the investigator, is likely to remain on the stable treatment regimen through completion of the study.

- Treatment with dextromethorphan, guaifenesin, benzonatate, and any other overthe-counter or prescription medication containing an anti-tussive or expectorant for the treatment of cough within 2 weeks prior to screening

- History of serious adverse reaction or serious hypersensitivity to any drug or the study drug formulation excipients

- Malabsorption syndrome or other condition that would interfere with enteral absorption

- Planned major surgical intervention that may require general anesthetic and/or hospital stay during the study

- Serious infection requiring oral or IV antibiotics within 14 days prior to screening or randomization

- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

- History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma

- Clinical laboratory value outside the reference range for the test laboratory at screening unless the value is deemed not clinically significant by the investigator. The Medical Monitor should be informed of the test result and the decision to include the patient in the study by investigator

- Any of the following clinical laboratory values at screening (even if not considered clinically significant):

– PT (INR) > upper limit of normal (ULN), PTT > ULN or platelet < lower limit of normal (LLN) – ALT or AST >ULN – Total bilirubin > ULN; patients with Gilbert syndrome may enroll provided total bilirubin ≤ 1.5× ULN and direct (conjugated) bilirubin is ≤ ULN

Eligibility last updated 12/29/23. Questions regarding updates should be directed to the study team contact.

Diagnostic Test, Drug, Other
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Mayo Clinic — Rochester, MN

An Interventional, Multi-center Investigation of the MOTUS Total Joint Replacement

MOTUS Total Joint Replacement Investigational Device Exemption Study

Ahmad Nassr
All
21 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-309028-P01-RST
22-008051
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Inclusion Criteria:

  • Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy.
  • The subject has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1 confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 1 (< 25% translation) spondylolisthesis. Symptomatic lumbar degeneration that may be associated with a co-morbid condition such as:
    • Herniated nucleus pulposus;
    • Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;
    • Facet joint degeneration/osteophyte formation;
    • Spondylosis (defined by the presence of osteophytes);
    • Disc degeneration and/or annular degeneration; and/or
    • Lumbar stenosis defined by spinal cord or nerve root compression.
  • Exhausted conservative treatment (e.g. bed rest, physical therapy, medications, TENS, manipulation, and/or spinal injections) for at least 3 months or has a neurologic emergency.
  • Preoperative Oswestry Disability Index score ≥ 40/100 at baseline.
  • Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
  • Signed informed consent.


Exclusion Criteria:
 

  • More than one vertebral level requiring treatment.
  • Previous instrumented surgery (i.e., anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level.
  • Degenerative or lytic spondylolisthesis greater than Grade 1 (< 25% translation).
  • Rotatory scoliosis at the level to be treated.
  • Congenital bony and/or spinal cord abnormalities at the level to be treated.
  • Subcaudal defect, disrupting the integrity of the pedicle.
  • Clinically compromised vertebral bodies at the involved level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, malunion or nonunion.
  • Disrupted anterior longitudinal ligament at the index level.
  • Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated.
  • Back pain of unknown etiology without leg pain.
  • Severe spondylosis at the level to be treated as characterized by any of the following:
    • Autofusion (solid arthrodesis) determined radiographically (CT);
    • Totally collapsed disc, or;
    • Vertebral body that cannot be mobilized.
  • Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E.
  • Unable to undergo an MRI scan, CT scan or other radiograph assessments.
  • Osteopenia: The SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if completed within 6 months of subject screening.
  • Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta).
  • Insulin-dependent diabetes mellitus.
  • Lactating, pregnant or interested in becoming pregnant in the next 3 years; 18. Active infection – systemic or local.
  • Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study.
  • Body Mass Index > 40.
  • Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease.
  • Systemic disease including Lupus disease, Reiter’s disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation.
  • Spinal tumor.
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
  • Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson’s disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis.
  • Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease.
  • Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
  • In the opinion of the investigator, the subject has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device.
  • Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code.
  • Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered ‘current’).
  • Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation.
  • Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results.
  • Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.

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

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

Device
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A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a) (OCEAN(a))

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

Iftikhar Kullo
All
18 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-309070-P01-RST
22-008182
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Inclusion Criteria:


- Age 18 to ≤ 85 years

- Lp(a)≥ 200 nmol/L during screening

- History of ASCVD as evidenced by history of either:

- Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or

- Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.


Exclusion Criteria:


- Severe renal dysfunction

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening

- History of hemorrhagic stroke

- History of major bleeding disorder

- Planned cardiac surgery or arterial revascularization

- Severe heart failure

- Current, recent, or planned lipoprotein apheresis

- Previously received ribonucleic acid therapy specifically targeting Lp(a)

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

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Outcomes of anterior interosseous nerve transfer to ulnar nerve motor branch in ulnar nerve injuries

Anterior Interosseous Nerve Transfer to Ulnar Nerve Motor Branch Outcomes in Ulnar Nerve Injuries

Steven Moran
All
Not specified
This study is NOT accepting healthy volunteers
2022-310254-H01-RST
22-012619
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Inclusion Criteria:

  • Ulnar nerve injuries:
    • High ulnar nerve traumatic injuries: proximal to the junction of the proximal and middle thirds of the forearm;
    • Severe compression injuries: intrinsic muscle weakness and atrophy.
  • Treated with anterior interosseous to ulnar motor branch nerve transfer performed at Mayo Clinic.
  • More than 1 year follow-up.

Exclusion Criteria

  • Nerve transfer performed at a different hospital.
  • Insufficient follow up and data.

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

Eligibility last updated 12/9/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of ABBV-383 in Subjects With Relapsed or Refractory Multiple Myeloma

A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Shaji Kumar
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2023-310799-P01-RST
23-003154
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Inclusion Criteria:


- Must have measurable disease as outlined in the protocol.

- Eastern Cooperative Oncology Group (ECOG) performance of ≤ 2.

- Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of
progression during or after the participant's last treatment regimen based on the
investigator's determination of the International Myeloma Working Group (IMWG) 2016
criteria.

- Must be naïve to treatment with ABBV-383.

- Must have received at least 3 or more lines of therapy, including a proteasome
inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal
antibody.


Exclusion Criteria:


- Received B-cell maturation antigen (BCMA)-targeted therapy.

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

Eligibility last updated 2/7/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Natural History of Von Willebrand Disease (VWD)

Von Willebrand Disease Natural History

Meera Sridharan
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308267-H01-RST
22-005304
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Inclusion Criteria:
 

  • Patients with type 1 Von Willebrand Disease (VWD).


Exclusion Criteria:
 

  • Unable to give informed consent or assent.

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

Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    Assessment of cognitive biomarkers in patients with multiple sclerosis and other progressive immune-mediated neurodegenerative disorders

    Progressive Multiple Sclerosis (MS) and Paraneoplastic CNS Disorders Gait Changes

    Sean Pittock
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2023-310831-H01-RST
    23-001587
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    Inclusion Criteria:

    Multiple Sclerosis

    • Diagnosed with multiple sclerosis according to the 2017 revised McDonald criteria.
    • Age ≥18 years.

     Physician determined disease progression

    • Patient must be able to walk without a walker for the motion tests (e.g. 25 ft walk)
    • Patient must be enrolled in IRB#08-007846 and actively participating in sample collections.
    • Patient must agree to the lumbar puncture and skin biopsy components of IRB#08-007846.

    Progressive Immune-Mediated Neurodegenerative Disorder

    • Age ≥ 18 years.
    • Physician determined disease progression
    • Gait disorder is primarily associated with a seropositive autoimmune CNS disorder.
    • Patient must be able to walk without a walker for the motion tests (e.g. 25 ft walk).
    • Patient must be enrolled in IRB#08-007846 and actively participating in sample collections.
    • Patient must agree to the lumbar puncture and skin biopsy components of IRB#08-007846.


    Exclusion Criteria:
     

    Multiple Sclerosis

    • Unable to have annual clinical MRI.

    Progressive Immune-Mediated Neurodegenerative Disorder

    • Unable to have annual clinical MRI.

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

    Eligibility last updated 11/22/23. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    Shared decision making for kidney transplant candidates to plan for an organ offer decision

    Donor Plan Donor Call Tool Evaluation to Promote Shared Decision Making

    Kasey Boehmer
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    2023-310767-P01-RST
    23-001324
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    Inclusion Criteria:

    • Candidate on the kidney transplant waiting list for more than 3 months..
    • 18 years of age or older.
    • English-speaking.


    Exclusion Criteria:

    • Non-English speaking.
    • < 18 years of age.
    • Patients who choose to opt out of research.
    • Unable to provide informed consent.

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

    Eligibility last updated 2/6/23. Questions regarding updates should be directed to the study team contact.

    Behavioral, Other
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    Mayo Clinic — Rochester, MN

    Pediatric Idiopathic Scoliosis Preference Study of Motion Sparing Spinal Growth Modulation versus Spinal Fusion & Development of Shared Decision-Making Tool – Decision Aid Construction

    Multicenter Study Protocol: Pediatric Idiopathic Scoliosis (AIS) Preference Study of Motion Sparing Spinal Growth Modulation versus Spinal Fusion – Decision Aid Construction

    Annalise Larson
    All
    10 years to 17 years old
    This study is NOT accepting healthy volunteers
    2021-305171-P01-RST
    21-006940
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    Inclusion Criteria:

    • Patients age ≥ 10 to < 22 with the diagnosis of idiopathic scoliosis being seen for scoliosis treatment (any skeletal maturity level, Risser 0-5).
    • Curves > 35 degrees, < 70 degrees.
    • Patient has consulted with a spine specialist regarding surgery of treatment of their scoliosis and surgery (fusion or non-fusion) has been considered, or the patient has undergone surgery for treatment of their scoliosis within the past three years.
    • English speaking with parent/guardian present and willing to participate.
    • Male and females.
    • Patients < 3 years postop fusion and/or tether.


    Exclusion Criteria:

    • Individuals < 10 and over 22 years of age.
    • Non-English speaking.

     

     

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    Mayo Clinic — Rochester, MN

    Efficacy and Safety of NNC6019-0001 at Two Dose Levels in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)

    A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis

    Martha Grogan
    All
    18 years to 85 years old
    Phase 2
    This study is NOT accepting healthy volunteers
    2022-308067-P01-RST
    22-004574
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    Inclusion Criteria:

    • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
    • Male or female.
    • Age ≥ 18 to < 85 years at the time of signing informed consent.
    • Have an established diagnosis of ATTR CM with either wild-type TTR or hereditary TTR genotype as per local standardsa.
    • Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the randomisation visit.
    • Known end-diastolic interventricular septal wall thickness ≥ 12 mm.
    • Presently classified as New York Heart Association (NYHA) Class II-III.
    • NT-proBNP concentration ≥ 650 pg/mL in sinus cardiac rhythm and > 1000 pg/mL in atrial fibrillation at screening.
    • Completed ≥ 150 meters to ≤ 450 meters on the 6MWT at screening.
    • Absolute neutrophil count ≥ 2.0 × 10^9 /L; platelet count ≥ 120 × 10^9 /L at screening.
    • Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 × the upper limit of normal (ULN) and total bilirubin ≤ 2 × ULN at screening.
    • Estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m^2 at screening.


    Exclusion Criteria:

    • Known or suspected hypersensitivity to study intervention(s) or related products.
    • Previous dosing in this study.
    • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. 
    • Use of another approved or non-approved investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (whichever is longer) before screening.
    • Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
    • Current diagnosis or history of amyloid light chain or other non-ATTR amyloidosis.
    • Cardiomyopathy not primarily caused by ATTR CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease.
    • A prior solid organ transplant.
    • Planned solid organ transplant during the study.
    • Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
    • Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
    • Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularisation, cardiac valve repair, or major surgery within 3 months of screening.
    • Body weight > 120 kg (264.6 lb) at screening.
    • Evidence of current or chronic hepatitis C virus or hepatitis B virus infection.
    • History of or known seropositivity for human immunodeficiency virus (HIV).
    • International normalised ratio (INR) >1.5 (unless participant is on anticoagulant therapy, in which case excluded if INR >3.5) .
    • History of contrast allergy or adverse reactions to gadolinium-containing agents. Definitions:
      • Non-invasive diagnostic pathway will be confirmed by a centralised expert review;
      • Medical history/records are accepted;
      • Vitamin K antagonists; i.e. warfarin, acenocoumarol etc.;
      • Criterion not applicable for participants on therapy with direct-acting oral anticoagulants (DOACs).

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

    Eligibility last updated 9/28/23. Questions regarding updates should be directed to the study team contact.

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    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab in Adult Subjects With H-1 Antihistamine Refractory Chronic Spontaneous Urticaria (MAVERICK)

    A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria

    Gerald Volcheck
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2022-310167-P01-RST
    22-012682
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    Key

    Inclusion Criteria:


    1. Subject is able to understand the information on the study, has the capacity to
    consent, and has provided written informed consent.

    2. Male and female subjects ≥ 18 years of age at the time of screening.

    3. CSU diagnosis for ≥ 6 months.

    4. Diagnosis of moderate-severe CSU refractory to H1-antihistamine (H1-AH) at a minimum
    of the licensed dose at the licensed frequency at the time of randomization as defined
    by the following: presence of hives and itch for ≥6 consecutive weeks prior to
    Screening Visit 1; UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥8 during
    the 7 days prior to randomization.

    5. Subjects that are omalizumab-naïve or omalizumab-exposed.

    6. Subjects must be on stable dose of H1-AH, between 1x and 4x of the licensed dose and
    at the licensed frequency, for treatment of CSU for at least 1 week prior to screening
    and willing to remain on a stable dose throughout the study.

    7. Able and compliant with completing a daily symptom eDiary for the duration of the
    study and adherent to the study visit schedules.

    Key
    Exclusion Criteria:


    1. History of hypersensitivity to the study drugs or their excipients or to drugs of
    similar chemical classes (i.e., murine, chimeric or human antibodies).

    2. Current use of biologics for any indication.

    3. Demonstrated lack of primary response to treatment with a biologic therapy (e.g.,
    omalizumab) for the treatment of CSU.

    4. Use of any of the following treatments within 4 weeks prior to the baseline visit or
    any condition that in the opinion of the Investigator is likely to require such
    treatment(s) during the first 4 weeks of study treatment: (i) immunosuppressive or
    immunomodulatory drugs, including but not limited to systemic calcineurin inhibitors
    (e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus),
    anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide,
    mycophenolate mofetil), alkylating agents (e.g., cyclophosphamide), TNF inhibitors
    (e.g., infliximab, adalimumab), and eosinophil-depleting drugs (e.g., benralizumab,
    pramipexole); (ii) routine (daily or every other day during 5 or more consecutive
    days) doses of systemic hydroxychloroquine; (iii) intravenous immunoglobulin (IVIG);
    (iv) plasmapheresis.

    5. Use of oral Janus kinase (JAK) inhibitors within 8 weeks of the baseline visit.

    6. Use of any of the following treatments within 3 weeks prior to the baseline visit: (i)
    H2 antihistamines (H2-AH); (ii) routine (daily or every other day during 5 or more
    consecutive days) doses of systemic corticosteroids; (iii) regular (daily or every
    other day) doxepin (oral); (iv) leukotriene receptor antagonists (LTRA) (e.g.,
    montelukast, zafirlukast).

    7. H1-AH use at greater than approved doses or greater than local CSU guideline
    recommended doses after Screening Visit 1.

    8. Previous treatment with biologics: (i) any cell-depleting agents including but not
    limited to rituximab within 6 months prior to the baseline visit or until lymphocyte
    count returns to normal, whichever is longer; (ii) other biologics, including
    investigational biologics (e.g., dupilumab, omalizumab, benralizumab, etc) within 5
    half-lives if known or 8 weeks prior to the baseline visit, whichever is longer.

    9. Planned or anticipated use of any prohibited medication.

    10. Subjects having causes other than CSU for their urticaria including symptomatic
    dermographism, cholinergic urticaria, or any inducible urticaria.

    11. Subjects with known or suspected urticarial vasculitis.

    12. Subjects with known or suspected hereditary angioedema.

    13. Any other skin disease associated with chronic itch, including atopic dermatitis, that
    in the Investigator's opinion might influence study outcome and subject's
    interpretation of symptoms caused by CSU.

    14. A helminth parasitic infection diagnosed within 6 months prior to the date that
    informed consent is obtained and has not been treated with or has failed to respond to
    standard-of-care therapy.

    15. Participation in a concurrent interventional study with the last intervention
    occurring within 30 days prior to study drug administration (or 90 days or 5
    half-lives, whichever is longer, for biologic products).

    16. Vaccination with live attenuated vaccines within 30 days prior to initiation of
    treatment in the study, during the treatment period, or vaccination expected within 5
    half-lives (4 months) of study drug administration. This exclusion criterion does not
    apply to all types and formulations of vaccines (including live attenuated vaccines)
    currently authorized/approved by FDA or other regulatory authority for the prevention
    of COVID-19, which may be administered before, during, or after the study. The vaccine
    should not be administered within 3 days before and within 3 days after the
    administration of lirentelimab so that any side effects caused by either of the 2
    medications can more easily be determined.

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

    Eligibility last updated 11/29/22. Questions regarding updates should be directed to the study team contact.

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    A Phase III Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (MAJIC)

    A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    Neil Kay
    All
    18 years and over
    Phase 3
    This study is NOT accepting healthy volunteers
    2023-310607-P01-RST
    23-000587
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    Inclusion Criteria:

    • Participant must be ≥ 18 years at the time of screening.
    • Documented TN CLL/SLL requiring treatment according to iwCLL guidelines 2018 (Hallek et al 2018).
    • Adequate BM function independent of growth factor or platelet transfusion support within 2 weeks of screening initiation as follows, unless cytopenia is due to CLL/SLL:
      • Absolute neutrophil count ≥ 1.0 × 10^9 /L;
      • Platelet counts ≥ 30 × 10^9 /L; in cases of thrombocytopenia clearly due to CLL/SLL (per the discretion of the investigator), platelet count should be ≥ 10 × 10^9 /L.
    • Estimated CrCL > 30 mL/min calculated according to Cockcroft-Gault (using actual body weight) or directly measured with 24-hour urine collection,.
    • Males:  CrCL = Weight (kg) × (140 Age) (mL/min) 72 × serum creatinine (mg/dL).
    • Females:  CrCL = Weight (kg) × (140 Age) × 0.85 (mL/min) 72 × serum creatinine (mg/dL).
    • Adequate liver function, as indicated by a total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3 × ULN value, unless directly attributable to the participant's CLL/SLL or to Gilbert's Syndrome (The ULN is based on institutional values).
    • Eastern Cooperative Oncology Group Performance Status performance status 0 to 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
    • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
    • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules and tablets without difficulty.


    Exclusion Criteria:

    • As judged by the investigator, any evidence of past or current diseases that, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize their safety or compliance with the protocol or would put the study at risk.
    • Clinically significant cardiovascular disease, such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction, within 6 months of screening or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
      • Note: Participants with controlled, asymptomatic atrial fibrillation can enroll in the study.
    • Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
    • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.
    • History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study intervention.
    • Child-Pugh B/C liver cirrhosis.
    • History of prior or current malignancy (including but not limited to known CNS lymphoma/leukemia or known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome) that could affect compliance with the protocol or interpretation of results. Exceptions can be made for the following based on physician discretion:
      • Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study;
      • Other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which the participant is disease-free for ≥ 3 years without further treatment.
    • An individual organ system dysfunction limiting the ability to receive the study intervention or any other life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the participants' safety or interfere with the absorption, distribution, metabolism, or excretion of the study interventions (e.g., refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, previous significant bowel resection, or impaired resorption in the gastrointestinal tract).
    • Known history of infection with HIV or any active significant infection (e.g., bacterial, viral, or fungal; including participants with positive cytomegalovirus DNA PCR).
    • History of or ongoing confirmed PML.
    • Serologic status reflecting active hepatitis B or C infection:
      • Participants who are anti-HBc positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before randomization and must be willing to undergo DNA PCR testing during the study. Those who are HbsAg-positive or hepatitis B PCR positive will be excluded;
      • Participants who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.
    • Any prior CLL/SLL-specific therapies, except prior rituximab if used for autoimmune cytopenias and not as anti-CLL/SLL treatment.
    • Corticosteroid use > 20 mg within 1 week before the first dose of study intervention, except as indicated for other medical conditions, such as autoimmune cytopenias, inhaled steroid for asthma, topical steroid use, or as premedication for administration of study intervention or contrast. Participants requiring steroids at daily doses > 20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for leukemia control or white blood cell count lowering, are excluded. Of note, patients may receive corticosteroids as doses > 20 mg as per institutional standards for obinutuzumab pre-medication prior to C1D1.
    • Prior radio- or toxin-conjugated antibody therapy.
    • Prior allogeneic stem cell or autologous transplant.
    • Known history of hypersensitivity or anaphylaxis to study intervention(s), including active product or excipient components.
    • Requires treatment with a strong cytochrome CYP3A4 inhibitor/inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited.
    • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (other anticoagulants allowed).
    • Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole).
      • Note: Participants receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
    • Vaccination with live vaccines 28 days prior to registration for study screening.
    • Major surgical procedure within 28 days of first dose of study intervention.
      • Note: If a participant had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study intervention.
    • Concurrent participation in another therapeutic clinical trial. Use of investigational agents that interfere with the study intervention(s) within 28 days or 5 half-lives (whichever is shorter) prior to registration for study screening.
    • Prothrombin time (PT)/INR or activated partial thromboplastin time, in the absence of lupus anticoagulant, > 2 × ULN.
    • Currently pregnant (confirmed with positive pregnancy test) or breast feeding.
    • Women of Childbearing Potential (WOCBP) a negative pregnancy test is required for all WOCBP within 21 days before start of study intervention, followed by immediate highly effective contraception; further pregnancy testing will be performed monthly).
    • Fertile men or WOCBP unless the following criteria are met: Willing to use 2 methods of reliable contraception, including one highly effective contraceptive method (Pearl Index < 1) and one additional effective (barrier) method during study intervention and for 2 days after last acalabrutinib dose (for WOCBP), 30 days after last venetoclax dose (fertile men and WOCBP), and 6 months after last obinutuzumab dose for fertile men and 18 months after last obinutuzumab dose for WOCBP.

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

    Eligibility last updated 1/18/23. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    A Study of the Natural History of Ado-trastuzumab emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients

    Ado-trastuzumab emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients

    Charles Loprinzi
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2022-308361-P01-RST
    22-010634
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    Inclusion Criteria:

    • Age ≥ 18 years.
    • Planning to receive three or more doses T-DM1 for HER2-positive metastatic breast cancer (any line) or for earlier-stage breast cancer. The patient may have received one dose of T-DM1, prior to study entry if it has not been longer than 14 days since that dose and that the patient will be able to complete the required baseline questionnaire within 14 days of their first dose of T-DM1.
    • Patients with previous use of neurotoxic antineoplastic agents (excluding previous use of T-DM1), pre-existing CIPN, or peripheral neuropathy secondary to other causes will be able to be enrolled in the study.
    • The patient plans to continue clinical follow-up at the same institution, where the patient entered the study.
    • Provide informed consent.
    • Ability to complete questionnaire(s) in English by themselves or with assistance.


    Exclusion Criteria:

    • Individuals < 18 years.
    • Previous use of T-DM1.
    • Concomitant use of other neurotoxic anticancer agents including cisplatin, carboplatin, oxaliplatin, docetaxel, paclitaxel, vincristine, eribulin, vinorelbine, thalidomide, lenalidomide, bortezomib, or epothilones. If the patient used any of these previously, then they must have been stopped for at least 7 days prior to study entry.
    • Current use of commonly used drugs for the treatment of peripheral neuropathy, including duloxetine, gabapentinoids (pregabalin and gabapentin), venlafaxine, nortriptyline, or amitriptyline (including use of these medications for things other than neuropathy). If the patient used any of these previously, then they must have been stopped for at least 7 days prior to study entry.

    Eligibility last updated 11/8/22. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    Understanding Rheumatoid Arthritis Pain Using Functional Neuroimaging

    Using Functional Neuroimaging to Understand Rheumatoid Arthritis Pain

    John Davis
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2022-308831-H01-RST
    22-007555
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    Inclusion Criteria:
     

    • Adult (≥ 18 years of age) patients with incident RA defined by the 1987 ACR classification criteria.


    Exclusion Criteria:

    • < 18 years old. 

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

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

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    Mayo Clinic — Rochester, MN

    Patient/Community/Stakeholder Advisory Board and Patient Needs Assessment to Inform a Forthcoming Randomized Clinical Trial of a Virtual World-Based Cardiac Rehabilitation Program

    Virtual World-Based Cardiac Rehabilitation (VWCR)

    LaPrincess Brewer
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2022-309930-P01-RST
    22-011357
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    Inclusion Criteria:

    • Patient/Community/Stakeholder-Advisory Board (PCS-AB):
      • Patients (CR alumni, CR non-completers, and CR-eligible people who did not attend), caregivers (of patient who ever participated in CR or CR-eligible), representatives from key stakeholder/advocacy groups (e.g., AACVPR, AHA, payers, information technology, etc.;
      • Age ≥ 18 years;
      • Basic Internet navigation skills;
      • Active email address.
    • Survey:
      • Patients (CR alumni, CR non-completers, and CR-eligible people who did not attend);
      • Age ≥ 18 years;
      • Access to a device to take web-based survey (i.e., smartphone, computer, laptop/tablet).


    Exclusion Criteria:

    • Visual/hearing impairment or mental disability that would preclude independent use of the VW platform.
    • Non-English-speaking patients due to logistical challenges with real time translation over a virtual platform and the English language-only survey and materials.

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

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

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    Mayo Clinic — Rochester, MN

    Concordance and Communication about Perceived Financial Hardship in Patients with Multiple Myeloma and Their Caregivers

    Perceived Financial Hardship in Patients with Multiple Myeloma and Their Caregivers

    Nandita Khera
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2022-308754-H01-RST
    22-008274
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    Inclusion Criteria:

    • Patients treated at Mayo Clinic with Multiple Myeloma and their caregivers.


    Exclusion Criteria:
     

    • < 18 years of age. 

    Eligibility last updated 8/19/22. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (HEAL-IST)

    HEAL-IST IDE Trial

    Ammar Killu
    All
    18 years to 75 years old
    Not Applicable
    This study is NOT accepting healthy volunteers
    2022-310066-P01-RST
    22-011861
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    Inclusion Criteria:

    • Age ≥ 18 years and ≤ 75 years at time of enrollment consent.
    • Subject has a diagnosis of IST:
      • Documentation of mean heart rate > 90bpm with 7-day monitor within 90 days of the Index Procedure; and
      • Documentation of a resting heart rate of > 100bpm; and
      • Documentation of presence of IST for at least 6-months; and
      • Documentation of absence of other tachycardia; and
      • Documentation of absence of secondary causes such as hormonal issues or systemic illness that might contribute to increased heart rate.
    • Documentation of refractoriness (intolerance or failure) of a drug (e.g., rate control drugs such as beta-blockers/calcium channel blockers, ivabradine), and/or AADs.
    • Subject is willing and able to provide written informed consent.


    Exclusion Criteria:

    • Subjects on whom cardiac surgery or single lung ventilation cannot be performed.
    • Subjects with indication for or existing ICDs/Pacemakers.
    • Presence of channelopathies.
    • Previous cardio-thoracic surgery.
    • Left Ventricular Ejection Fraction (LVEF) < 50%.
    • Body Mass Index (BMI) ≥ 35.
    • Presence of supraventricular or ventricular tachycardia.
    • Presence of Postural Orthostatic Sinus Tachycardia (POTS).
    • Presence of congenital heart disease.
    • History suggestive of secondary cause of tachycardia such as pheochromocytoma, anemia, thyrotoxicosis, chronic fever of unknown origin, COPD, long-term bronchodilators use, severe asthma or carcinoid syndrome.
    • Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders:
      • Allowed catheter ablations in the right atrium:
      • One previous catheter ablation > 90 days prior to the Index Procedure for AVRT or CTI;
      • One previous catheter ablation > 180 days prior to the Index Procedure for AVNRT.
    • Life expectancy < 24 months
    • Pregnant or planning to become pregnant during trial
    • Subjects with substance abuse
    • Subjects with previous weight loss surgery
    • Subject is unwilling and/or unable to return for scheduled follow-up visits
    • Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a trial that may interfere with trial results
    • Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and;
    • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation result

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

    Eligibility last updated 8/25/23. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    Reduction of fluid reservoir depth, intraocular pressure, and tear exchange in habitual scleral lens wearers

    Determining Rate of Change in Corneal Clearance of Scleral Lenses in Habitual Lens Wearer

    Cherie Nau
    All
    18 years to 99 years old
    This study is NOT accepting healthy volunteers
    2023-311232-H01-RST
    23-002966
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    Inclusion Criteria:

    • Scleral lens wear in at least one eye for at least one year with wear at least 5 days a week. 
    • No significant corneal scarring that would interfere with Pentacam measurements.
    • Patient will be asked not to wear the lens on the day of the study until after the initial Pentacam measurement is taken.


    Exclusion Criteria:
     ,

    • Dense corneal scarring (that would interfere with Scheimpflug images). Inability to tolerate measurements.

    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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    Mayo Clinic — Rochester, MN

    A multi-center open-label trial evaluating the efficacy and safety of daratumumab SC in treatment of patients with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID)

    Daratumumab for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune Deposits (PGNMID)

    Fernando Fervenza
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2022-307540-H01-RST
    22-002587
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    Inclusion Criteria:

    • Age ≥ 18 years of age.
    • Renal biopsy read at Mayo Clinic confirming the diagnosis of PGNMID.
    • Proteinuria ≥ 1000 mg over 24 hours.
    • Creatinine clearance ≥ 20 mL/min/SA.
    • Subjects able and willing to give informed consent.
    • For female subjects of reproductive childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously during the Treatment Period, during any dose interruptions, and for 3 months after the last dose of any component of the treatment regimen. Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. This birth control method must include one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings, or implants] or partner’s vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy:
      • A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing;
      • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen.
    • For male subjects of reproductive potential who are sexually active with females ofreproductive potential must always use a latex or synthetic condom during the study and for 3 months after discontinuing study treatment (even after a successful vasectomy):
      • Male subjects of reproductive potential must not donate sperm during the study or for 3 months after the last dose of study treatment;
      • Must sign an informed consent form (ICF) or their legally acceptable representative must sign indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.


    Exclusion Criteria:

    • Pregnant or planning to become pregnant.
    • Seropositive for human immunodeficiency virus (HIV).
    • Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
    • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) will also be excluded. Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR and can be included.
    • Multiple myeloma defined as >10% plasma cells on bone marrow biopsy and M-spike > 3 g/dL and presence of myeloma defining event (hypercalcemia, cast nephropathy, bone disease, or anemia), or plasma cells >60% or FLC ratio of involved to uninvolved > 100.
    • Abnormal clinical labs defined as: anemia with Hgb < 8.0 g/dL, thrombocytopenia with platelet count < 75,000, leukopenia with WBC < 3.5, or neutropenia with ANC < 1000 , AST/ALT > 2.5 X ULN, bilirubin > 2 X ULN.
    • Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is < 50% of predicted normal.
    • Moderate or severe persistent asthma withing the past 2 years or uncontrolled asthma of any classification. Note the participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.
    • Clinically significant cardiac disease including:
      • Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to cardiac dysfunction (e.g. unstable angina, congestive heart failure, New York Heart Association Class III-IV);
      • Uncontrolled arrythmia.
    • Prior or current exposure to any of the following:
      • To daratumumab or other anti-CD-38 therapies (unless a re-treatment study);
      • Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer;
      • Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma.
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
    •  Unable to provide consent.
    • Patients receiving therapy with oral prednisone or glucocorticoid equivalent in the last 4 weeks.  Patients treated with low dose oral prednisone or glucocorticoid are allowed to be included if they are taking the medication for conditions unrelated to PGNMID (e.g., asthma, gout) at a daily dose of 10mg or less.
    • Patients who had received immunosuppressive therapy with MMF, cyclosporine, tacrolimus, or azathioprine in the last 3 months.
    • Patients who have received cyclophosphamide or bortezomib will be allowed to participate as long as there is clear evidence of lack of response to cyclophosphamide or bortezomib defined as lack of achieving complete or partial remission (see section 3.3 regarding definition).
    • Patients who received rituximab previously with CD20 count of < 20 cells/microliter at the time of enrollment.
    • Have received vaccination with live attenuated vaccines within 4 weeks of first study agent administration.
    • A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease before the date of randomization. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years.

    Eligibility last updated 8/4/22. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    A Phase Ib, Open-Label, Randomized, Dose-Finding, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of GDC-8264 in Combination with Standard of Care in the Treatment of Acute Graft-Versus-Host Disease in Patients who have undergone Allogeneic Hematopoietic Stem Cell Transplantation

    A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)

    William Hogan
    All
    18 years and over
    Phase 1
    This study is NOT accepting healthy volunteers
    2022-309111-P01-RST
    22-008440
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    Inclusion Criteria:


    - Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening.

    - Evidence of engraftment post-transplant.

    - Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening.

    - Initiation of treatment with systemic corticosteroids for aGVHD at a dose of prednisone ≥ 2 milligrams per kilograms per day (mg/kg/day) by orally (PO) or methylprednisolone ≥ 2 mg/kg/day intravenously (or equivalent) in divided doses at
    diagnosis and up to 3 days prior to or on the same day as initiation of GDC-8264 (Day 1), with no taper planned prior to Day 3.


    Exclusion Criteria:


    - Evidence of relapsed, progressing, or persistent malignancy, or treatment for relapse after transplant, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse.

    - Prior receipt of more than one allogeneic HSCT.

    - Prior systemic treatment for aGVHD, except for the standard of care corticosteroid treatment initiated as part of this trial.

    - Diagnosis of chronic GVHD or overlap syndrome.

    - Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment, or persistently positive blood cultures despite treatment, or any other evidence of severe sepsis).

    - Severe organ dysfunction (e.g., acute liver failure, renal failure requiring dialysis, ventilator support, or vasopressor therapy).

    - Initiation or planned use of a marketed small molecule (excluding corticosteroids) or biologic therapy as treatment for aGVHD from the start of screening through the treatment period.

    -  of seizure or convulsions, except history of childhood febrile seizures.

    - Higher risk of seizure, as determined by the investigator (including, but not limited to, history of stroke; known Alzheimer’s disease or non-Alzheimer’s dementia; structural brain disease including arteriovenous malformations or other mass lesions; clinical diagnosis of traumatic brain injury or concussion within previous 6 months).

    Patients on concomitant medications known to increase the risk of seizure may continue taking those medications, provided they have not previously experienced a seizure at or below the dose level being administered prior to initiation of GDC-8264.

    Eligibility last updated 10/9/23. Questions regarding updates should be directed to the study team contact.

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    A Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults, With Optional Open-Label Extension

    Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults

    Elaine Wirrell
    All
    4 years to 55 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    2022-308664-P01-RST
    22-007953
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    Inclusion Criteria:

    Subject must have a documented history of Lennox-Gastaut syndrome by:

    • Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure.
    • History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern <3.0 Hz).
    • History of developmental delay.
    • Male or female subjects.
    • Subjects must be age 4-55 years at the time of consent/assent.
    • Must have been < 11 years old at the onset of LGS.
    • Subjects must have experienced at least 2 drop seizures with potential to fall (tonic, atonic, tonic-clonic) each week during the 4-week Baseline period preceding randomization. Drop seizures are defined as a seizure involving the entire body, trunk, or head that led or could have led to a fall, injury, slumping in a chair, or hitting the subject's head on a surface. For seizures that occur in clusters: if countable, an exact seizure count should be used; if uncountable, the caregiver should estimate the number of seizures.
    • Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1.
    • If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a concomitant ASM.
    • Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.
    • Parents or caregivers must be able to keep accurate seizure diaries.
    • Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study, if able.
    • Subject and/or parent(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
    • Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements.
    • History of COVID-19 vaccination is permitted.


    Exclusion Criteria:

    • Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor.
    • Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct.
    • Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline.
    • Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling.
    • Current use of felbamate with less than 18 months of continuous exposure.
    • Concomitant use of vigabatrin: subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test, if able.
    • Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline.
    • Status epilepticus within 12 weeks of Visit 1.
    • Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as determined by the Investigator.
    • Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2).
    • Subject has a history of any serious drug-induced hypersensitivity; e.g., toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) or any drug-related rash requiring hospitalization Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation for epilepsy device implanted or activated < 5 months year prior to enrollment. Stimulation parameters that have been stable for < 4 weeks, or battery life of unit not anticipated to extend for duration of trial.
    • Subject is pregnant, may be pregnant, lactating or planning to be pregnant.
    • Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 (i.e., answering "Yes" to questions 4 or 5 in the Suicidal Ideation section of the age- specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.
    • Any suicidal behavior within 2 years before Visit 2 (i.e., answering YES to any question in the Suicidal behavior section of the age-specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.
    • Evidence of significant active hepatic disease. Stable elevations of liver enzymes (alanine aminotransferase (ALT), and aspartate aminotransferase (AST)) due to concomitant medication(s) will be allowed if they are < 3 x ULN.
    • Subject with total bilirubin [TBL] > 2 x ULN (except for Gilbert's syndrome).
    • Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1).
    • History of positive antibody/antigen test for human immunodeficiency virus (HIV).
    • If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products.
    • Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study.
    • Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1).
    • Concomitant use of medications known to be strong inducers of cytochrome P450 (CYP3A) including, but not limited to: phenobarbital, phenytoin, carbamazepine, primidone, rifampin, troglitazone, St. John's Wort, efavirenz, nevirapine, glucocorticoids (other than topical usage), modafinil, pioglitazone, and rifabutin.
    • Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome.
    • Subject with a short QTc interval (<340 msec) or long QTc interval (>460 msec) as confirmed by a repeated electrocardiogram (ECG).
    • Benzodiazepine rescue administered on average more than once a week in the month before Visit 1.
    • Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.

    Eligibility last updated 6/7/23. Questions regarding updates should be directed to the study team contact.

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    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects With Biopsy Confirmed NASH

    Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects

    Manal Abdelmalek
    All
    18 years to 70 years old
    Phase 2
    This study is NOT accepting healthy volunteers
    2022-309061-P01-RST
    22-008148
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    Inclusion Criteria:


    - Adults ≥ 18 to ≤ 70 years.

    - BMI ≥ 18 kg/m^2, with stable body weight (defined as change < 5%) by history for 3
    months prior to screening or since baseline liver biopsy, whichever is earlier.

    - Subjects have a diagnosis of noncirrhotic NASH with liver fibrosis (Fibrosis stage
    F1-F3) confirmed by liver biopsy within 6 months of Day -7.

    - MRI-PDFF performed at screening with ≥ 8% steatosis.


    Exclusion Criteria:


    - Subjects with a history of active or chronic liver disease, including alcoholic liver
    disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis,
    autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin
    deficiency, human immunodeficiency virus (HIV).

    - Any history of clinically significant chronic liver disease including esophageal
    varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for
    treatment of chronic liver disease; or Model for End Stage Liver Disease > 12.

    - Recent (within 3 months of baseline biopsy) use of therapies associated with
    development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen,
    aromatase inhibitors, amiodarone, or long-term use of tetracyclines).

    - Type 1 diabetes subjects, or T2DM subjects on insulin and/or GLP-1 receptor agonist
    therapy, or other therapies not allowed for this study

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

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    A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)

    Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

    Marius Stan
    All
    18 years and over
    Phase 3
    This study is NOT accepting healthy volunteers
    2022-309590-P01-RST
    22-010235
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    Inclusion criteria:

    1. Are ≥ 18 years of age at screening.

    2. Have a clinical diagnosis of TED associated with active, moderate to severe TED with a
    CAS ≥ 4 in either eye at screening and Baseline.

    3. Have moderate to severe active TED, as defined by European Group on Graves'
    Orbitopathy (EUGOGO) guidelines.

    4. Have onset of active TED within 12 months prior to screening.

    5. Have documented evidence of detectable anti-TSHR-Ab at screening.

    6. Are not expected to require immediate surgical intervention and are not planning
    corrective surgery/irradiation or medical therapy for TED during the course of the
    study.

    7. Are euthyroid with the baseline disease under control or have mild hypo- or
    hyperthyroidism.

    Additional inclusion criteria are defined in the protocol.


    Exclusion Criteria:


    1. Have decreased best corrected visual acuity due to optic neuropathy.

    2. Have at least a 2-point decrease in CAS or ≥ 2 mm decrease in proptosis between
    screening and Baseline assessments in either eye.

    3. Have used any steroid (intravenous or oral) for the treatment of TED or other
    conditions within 4 weeks prior to screening.

    4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g
    of methylprednisolone for the treatment of TED.

    5. Have known autoimmune disease other than TED, that, in the opinion of the
    Investigator, would interfere with the course and conduct of the study.

    6. Had previous orbital irradiation or surgery for TED.

    Additional exclusion criteria are defined in the protocol.

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

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

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    A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study with Open-label Extension of BLU-5937 in Adult Participants with Refractory Chronic Cough Including Unexplained Chronic Cough (CALM-2) (CALM-2)

    A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)

    Vivek Iyer
    All
    18 years to 80 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    2022-309916-P01-RST
    22-011348
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    Inclusion Criteria:

    • Capable of giving signed informed consent.
    • Refractory chronic cough (including unexplained chronic cough) for at least one year.
    • Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose.


    Exclusion Criteria:

    • Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with > 20 pack-year smoking history.
    • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma.
    • Respiratory tract infection within 4 weeks before screening.
    • Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening.
    • History of malignancy in the last 5 years.
    • History of alcohol or drug abuse within the last 3 years.
    • Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
    • Previous participation in a BLU-5937 trial.

    Eligibility last updated 2/16/23. Questions regarding updates should be directed to the study team contact.

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    A Phase 2, Randomized, Sham-Controlled, Single-Masked, Dose-Ranging, Multi-Center Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Macula-off Rhegmatogenous Retinal Detachment

    A Phase 2 Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Mac-off Retinal Detachment

    Andrew Barkmeier
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2023-311302-P01-RST
    23-003118
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    Inclusion Criteria:

    • Adult subject, ≥ 18 years old at the time of informed consent.
    • Able and willing to give informed consent and comply with all study visits and procedures.
    • Presentation with macula-off RRD with a duration ≥ 24 hours up to 14 days from time of central visual decline to the Baseline (Visit 2) visit, inclusive (based on subject reported date of loss of central vision) in the Study Eye (SE).
    • Visual acuity with subject's current corrective lenses or pinhole of 20/100 (line scoring) on the Snellen or ETDRS chart to light perception (LP) in the SE.
    • Visual acuity with subject's current corrective lenses or pinhole of 20/200 (line scoring) or better in the fellow eye.
    • Determination by Investigator of macula-off status by clinical examination with confirmation by SD-OCT or B-scan ultrasound, if available.
    • SOC retinal reattachment surgery by means of a pars plana vitrectomy (with or without scleral buckle) is indicated.
    • In the opinion of the Investigator, can safely undergo the IVT injection procedure at Baseline (Visit 2).
    • Surgical repair scheduled or anticipated to take place >12 hours after IVT injection or sham (Visit 2) and ≤10 days from Screening (Visit 1).


    Exclusion Criteria:

    • Presence of a complex retinal detachment (RD) in the SE, identified by one or more of the following:
      • Giant retinal tear, defined as retinal break ≥ 3 clock hours in extent;
      • Proliferative vitreoretinopathy grade C1 or worse on the Retina Society Terminology Committee Classification System;
      • Presence of tractional detachments as seen in proliferative retinopathies;
      • RRD in the setting of open- or closed-globe trauma;
      • RRD following endophthalmitis or infectious retinitis;
      • Similarly complex RD as determined by the Investigator.
    • Use of silicone oil tamponade in the primary RD repair without planned removal by end of study.
    • Vitreous hemorrhage or cataract in the SE that prohibits adequate examination for other exclusion criteria, per Investigator's discretion.
    • Presence of ocular or periocular infection or intraocular inflammation in either eye.
    • Uncontrolled glaucoma, as defined by an IOP > 36 mmHg in either eye, at Screening.
    • Any other significant ocular disease in the SE that, in the opinion of the Investigator, would preclude a postoperative (post-op) visual acuity of at least 20/30.
    • History of previous ocular surgery in the SE for RD (excluding only barrier laser), endophthalmitis, glaucoma tube shunts, trabeculectomy, or ocular trauma.
    • Any systemic condition or ocular condition in either eye that, in the opinion of the Investigator, makes the subject unsuitable for treatment with an investigational agent or that would compromise the safety and tolerability of assessments in the trial.
    • History of and/or active:
      • Autoimmune disease in active flare (i.e., not well controlled on current medications) with ocular involvement that, in the opinion of the Investigator, would impact ability to participate in the trial and/or alter the outcome of retinal reattachment surgery;
      • Ocular malignancy;
      • Proliferative diabetic retinopathy or diabetic macular edema or uveitis.
    • Currently participating in other clinical trials or use of any other investigational drugs or devices within 12 weeks prior to Visit 1.
    • Females who are pregnant or lactating, and women of childbearing potential (WOCBP) or men with female partners of childbearing potential who are not using at least one adequate contraceptive precaution (e.g., intrauterine device, oral contraceptive, barrier method, or other contraception deemed adequate by the Investigator).

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

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

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    Mechanisms of gait and balance impairment in progressive supranuclear palsy

    Progressive Supranuclear Palsy Gait and Balance Impairment in Mechanisms

    Farwa Ali
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2023-311813-H01-RST
    23-004889
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    Inclusion Criteria:

    • Adults over age 18 only.
    • Normal controls will include individuals over the age of 18, who provide informed consent for gait analysis and do not have any medical condition affecting their gait and balance.
    • Patients with Progressive Supranuclear Palsy (PSP):
      • Patients over the age of 35 meeting the 2017 Movement disorders society criteria for PSP will be recruited. To be able to participate in the gait analysis patients must be able to ambulate with or without a gait aid. Patients will be identified from the neurology clinic, where the PI commonly sees this condition.


    Exclusion Criteria:
     

    • Subjects will be excluded if they do not have the symptoms necessary to fulfill inclusion criteria for PSP.
    • Individuals with PSP at very advanced disease stage who are no longer ambulatory or are wheelchair bound excluded.
    • Subjects with concurrent illnesses that could account for their gait and balance abnormality such as traumatic brain injury, encephalitis, strokes, amputation, injury or developmental syndromes will be excluded. Women that are pregnant or post-partum and breast-feeding will be excluded.

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

    Eligibility last updated 5/10/23. Questions regarding updates should be directed to the study team contact.

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    A Randomized, Double-Blind, Placebo-Controlled, Phase 2, 6-Month Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of CT1812 in Subjects with Mild to Moderate Dementia with Lewy Bodies (COG1201)

    Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies

    Bradley Boeve
    All
    50 years to 85 years old
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-306719-P01-RST
    21-013140
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    Inclusion Criteria:

    • Subjects or their Legally Authorized Representative (LAR) must provide written informed consent to the study procedures prior to any study procedures.
    • Subjects must have a caregiver/ study partner who in the opinion of the site principal investigator, has contact with the study subject for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study assessments.
    • Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with Lewy Bodies (DLB).
    • Men willing to comply with acceptable form of contraception or women of non-childbearing.
    • Willingness to undergo a lumbar puncture (LP) during the screening period and at the end of the 6-month treatment period.
    • Formal education of eight or more years.
    • Subjects living at home or in an assisted living facility.
    • Subjects shall be generally healthy with mobility, vision and hearing sufficient for compliance with testing procedures.
    • Must be able to complete all screening evaluations.


    Exclusion Criteria:

    • Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the subject's DLB, including any co-morbidities detected by clinical assessment or MRI (or CT scan due to contraindication of MRI, if approved by medical monitor).
    • History of transient ischemic attacks or stroke within 12 months of screening.
    • Parkinsonian (extrapyramidal) features with Modified Hoehn and Yahr stage 4 or higher or any diagnosis of Parkinson’s disease or parkinsonism that preceded cognitive decline by more than one year.
    • Hospitalization (except for planned procedures) or change of chronic concomitant medication within one month prior to screening.
    • Any major psychiatric diagnosis, including schizophrenia, bipolar disorder, and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition.
    • Geriatric Depression Scale score > 6. (Subjects with a GDS > 6 may be allowable if the investigator does not believe the subject is clinically depressed. Investigators should contact the medical monitor to discuss eligibility).
    • Subjects living in a continuous care nursing facility.
    • Contraindication to the MRI examination for any reason (CT scan may be substituted for an MRI if subjects are unable to tolerate an MRI or an MRI is contraindicated for medical reasons, if the proposed CT scan is discussed and approved by the medical monitor on a case-by-case basis).
    • Screening MRI (or historical MRI or CT scan due to contraindication of MRI if approved by medical monitor) or historical MRI/CT scan, if applicable. of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm3 , > 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility.
    • Clinical, laboratory findings or medical history consistent with:
      • Other primary degenerative dementia, (frontotemporal dementia, Huntington’s disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.);
      • Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.);
      • Seizure disorder;
      • Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
    • Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as:
      • Chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, alkaline phosphatase > 1.5 ULN, lactate dehydrogenase (LDH) > 1.5 x ULN);
      • Respiratory insufficiency which requires the use of supplemental oxygen;
      • Renal insufficiency eGFR < 50 mL/min based on the CKD‐EPI formula;
      • Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening);
      • Bradycardia (100 beats/min.). If heart rate is below 50 beats/min or above 100 beats/min, the heart rate assessment may be repeated to assess eligibility;
      • Poorly managed hypertension (systolic > 160 mm Hg and/or diastolic > 95 mm Hg) or hypotension (systolic 7.5% in subjects with diabetes, only those subjects with known diabetes are required to get a HbA1c at screen.
    • History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.
    • Seropositive for human immunodeficiency virus (HIV).
    • History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody).
    • Clinically significant abnormalities in screening laboratory tests, including:
      • Hematocrit less than 35% for males and less than 32% for females, absolute neutrophil cell count of 1500/uL (with the exception of a documented history of a chronic benign neutropenia, absolute lymphocyte count 1.4 or other coagulopathy, confirmed by repeat assessment of:
      • Hematocrit;
      • Neutrophil count;
      • Lymphocyte count;
      • Platelet count.
    • Disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, severe language difficulty, etc.).
    • Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents, antiepileptics, centrally active antihypertensive drugs (e.g., clonidine, l-methyl dopa, guanidine, guanfacine, etc.), sedatives, opioids, mood stabilizers (e.g., valproate, lithium); or benzodiazepines, with the following exceptions:
      • At the discretion of the investigator, lorazepam or another anxiolytic may be administered as per local standard of care prior to MRI scan or optional lumbar puncture. Note neurocognitive testing should not be done within 24 hours of administration of conscious sedation;
      • Stable use of clonazepam for at least 30 days as indicated for REM Sleep Behavioral Disorder (RBD);
      • Stable use of atypical antipsychotics (e.g., quetiapine, pimavanserin) for at least 30 days as indicated for delusions and hallucinations secondary to DLB.
    • Any disorder that could interfere with the absorption, distribution, metabolism, or excretion of drugs (e.g., small bowel disease, Crohn’s disease, celiac disease, or liver disease).
    • Nootropic drugs except stable AD meds (acetylcholinesterase inhibitors or memantine).
    • Suspected or known drug or alcohol abuse; i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day indicated by elevated MCV significantly above normal value at screening.
    • Suspected or known allergy to any components of the study treatments.
    • Enrollment in another investigational study or intake of investigational drug within the previous 30 days or five half-lives of the investigational drug, whichever is longer.
    • Intake of drugs or substances potentially involved in clinically significant induction or inhibition of CYP3A4 or P-gp mediated drug interactions with CT1812, within 4 weeks or five half-lives of the interacting drug prior to administration of CT1812 and throughout the course of the study. Grapefruit juice should be avoided in the two weeks prior to dosing and throughout the course of the study. 
    • Any prior exposure to immunomodulators, anti Aβ vaccines, or passive Aβ immunotherapies (e.g., monoclonal antibodies) and/or exposure to BACE inhibitors within the past 30 days.
    • Any condition, which in the opinion of the investigator or the sponsor makes the subject unsuitable for inclusion.
    • Any vaccination within one week of the baseline visit.

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

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    Location Contacts
    Mayo Clinic — Rochester, MN