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3705 Study Matches

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

Palliative and End-of-Life ExpeRiences with ICDs Study

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

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


Exclusion Criteria:
 

  • < 65 years of age. 

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

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

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

BalancedBack 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.

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

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

Identifying Posterior Circulation Candidates for Thrombectomy Using Perfusion Imaging

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

Clinical

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

Imaging

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


Exclusion Criteria:
 

Clinical

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

Imaging

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

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

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Mayo Clinic — Rochester, MN

A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome

Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome

Thorvardur Halfdanarson
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-309037-P01-RST
22-010163
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Inclusion Criteria:


1. Male or female subjects ≥18 years of age.

2. Documented carcinoid syndrome requiring medical therapy.

1. Not currently treated with somatostatin receptor ligands agonists for at least 12
weeks prior to screening and actively symptomatic. This can include
treatment-naïve subjects.

2. Subjects currently treated with lanreotide, octreotide long acting release, or
short acting octreotide (subcutaneous or oral) who are currently symptomatically
controlled

3. Evaluable documentation of locally advanced or metastatic histopathologically
confirmed well-differentiated neuroendocrine tumor (NET).

4. No significant disease progression as assessed by the Investigator within the last 6
months before initiation of study drug dosing.


Exclusion Criteria:


1. Diarrhea attributed to any condition(s) other than carcinoid syndrome.

2. Uncontrolled/severe diarrhea associated with significant volume contraction,
dehydration, or hypotension.

3. Requires second line treatments (eg, telotristat) for control of carcinoid syndrome
symptoms.

4. Treatment with specific NET tumor therapy <4 weeks before Screening (such as
everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor
radionuclide therapy (PRRT), and/or tumor debulking <12 weeks before Screening.

5. Any malignancy except for eligible NET, basal cell or squamous cell skin carcinoma
considered clinically cured, or in situ cervical carcinoma.

6. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry

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

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

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

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

Zaraq Khan
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309064-H01-RST
22-008155
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Inclusion Criteria:

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


Exclusion Criteria:
 

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

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

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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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Exposure to C. Albicans during Early Life Predisposes Individuals to Atopy

C. Albicans during Early Life Predisposes Individuals to Atopy

Avni Joshi
All
up to 1 years old
This study is NOT accepting healthy volunteers
2022-309078-H01-RST
22-008236
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Inclusion Criteria:

  • Infants born via vaginal delivery at Mayo Clinic Rochester.
  • Infants must be followed by the Division of Pediatrics with follow-up routine prenatal care to be completed at Baldwin Building.
  • 25 infants will be at high risk for development of atopic dermatitis. High risk for development of atopic dermatitis is determined by an immediate family history (parent or sibling) of one of the following: atopic dermatitis, asthma, allergic rhinitis, or food allergy.
  • 25 infants will be at low risk for development of atopic dermatitis. Low risk for development of atopic dermatitis is determined by an immediate family history (parent or sibling) without the presence of any of the following medical conditions: atopic dermatitis, asthma, allergic rhinitis, or food allergy.
  • No underlying medical conditions at birth including underlying congenital medical conditions.


Exclusion Criteria:

  • Infants born via cesarean section delivery.
  • Infants followed by the Division of Family Medicine with routine follow-up prenatal care to be completed outside of Baldwin Building.
  • Presence of underlying medical conditions at birth including congenital medical conditions.

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

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Validation and feasibility of patient self-sampling of HPV for cervical cancer screening

Patient Self-sampling of HPV to Screen for Cervical Cancer

Kathy MacLaughlin
Female
25 years to 65 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-309081-P01-RST
22-008247
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Inclusion Criteria:

  • Females ≥ 25 and ≤ 60 years of age.
  • Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam).
  • Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion). 


Exclusion Criteria:
 

  • Excluded if pregnant.
  • Excluded if no cervix (history of total hysterectomy).
  • Excluded if moderate to heavy vaginal bleeding on the day of the visit.
  • Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge.

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

Diagnostic Test
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Impact of CardiolRxTM on Recurrent Pericarditis An Open Label Pilot Study

Impact of CardiolRxTM on Recurrent Pericarditis

Sushil Luis
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-309084-P01-RST
22-008276
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Inclusion Criteria:


1. Male or female 18 years of age or older

2. Diagnosis of at least two episodes of recurrent pericarditis*,

3. At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS)
within prior 7 days

4. One of;

1. C-Reactive Protein** (CRP) level ≥1.0 mg/dL within prior 7 days OR

2. Evidence of pericardial inflammation assessed by delayed pericardial
hyperenhancement on cardiac magnetic resonance imaging (CMR)

5. Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine
and/or corticosteroids (in any combination) for treatment of pericarditis in stable
doses

6. Male patients with partners of childbearing potential who have had a vasectomy or are
willing to use double barrier contraception methods during the conduct of the study
and for 2 months after the last dose of study drug.

7. Women of childbearing potential willing to use an acceptable method of contraception
starting with study drug administration and for a minimum of 2 months after study
completion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal
bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥40 mIU/mL
[or ≥ 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile.

- Diagnosis of pericarditis according to the 2015 European Society of Cardiology
(ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler
et al. 2015):

At least two of:

1. Pericarditic chest pain

2. Pericardial rub

3. New widespread ST-segment elevation or PR-segment depression according to
electrocardiogram (ECG) findings

4. Pericardial effusion (new or worsening)

- Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP


Exclusion Criteria:


1. Diagnosis of pericarditis that is secondary to specific prohibited etiologies,
including tuberculosis (TB); neoplastic, purulent, or radiation etiologies;
post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis

2. Estimated glomerular filtration rate (eGFR) <30 mL/min at screening

3. Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times
the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN

4. Sepsis, defined as documented bacteremia at the time of screening or other documented
active infection

5. Prior history of sustained ventricular arrhythmia

6. History of QT interval prolongation

7. QTc interval > 500 msec

8. Current participation in any research study involving investigational drugs or device

9. Inability or unwillingness to give informed consent

10. Ongoing drug or alcohol abuse

11. On any cannabinoid during the past month

12. Women who are pregnant or breastfeeding

13. Current diagnosis of cancer, with the exception of non-melanoma skin cancer

14. Any factor, which would make it unlikely that the patient can comply with the study
procedures

15. Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS),
administered at screening

16. On digoxin and/or type 1 or 3 antiarrhythmics

17. On immunosuppressive therapy with any of the following:

1. Rilonacept

2. Anakinra

3. Canakinumab

4. Methotrexate

5. Azathioprine

6. Cyclosporine

7. Intravenous immune globulin (IVIG)

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

Eligibility last updated 3/28/23. Questions regarding updates should be directed to the study team contact.

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Extension Study to Assess the Long-Term Safety in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products

Long-term Safety Follow-up in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products

Mark Stegall
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309088-P01-RST
22-008309
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Inclusion Criteria:


1. Able and willing to fully comply with all study procedures and restrictions.

2. Able to understand and provide written, signed, and dated informed consent to
participate in the study in accordance with ICH GCP Guideline and all applicable local
regulations.

3. Have previously completed a Medeor study and received a Medeor cellular immunotherapy
product


Exclusion Criteria:


1. Has any condition or circumstance, which in the opinion of the Investigator would
significantly interfere with the subject's protocol compliance or put the subject at
increased risk.

2. Unable or unwilling to provide written, signed, and dated informed consent to
participate in the study.

3. Has undergone a second organ transplant with an organ derived from an individual other
than the donor of the transplant kidney received during a Medeor study.

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

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Mitochondrial adaptation to high-intensity interval training during cardiac rehabilitation in patients with heart failure

Cardiac Rehabilitation in Heart Failure With Mitochondrial Adaptation To High-intensity Interval Training

Thomas Olson
All
21 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309090-H01-RST
22-008320
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Inclusion Criteria:

  • Adult 21 years and older.
  • English speaking.
  • Able to provide consent.
  • Clinically diagnosed stable heart failure with NYHA Class I-III symptoms.


Exclusion Criteria:
 

  • Patients who are unable to engage in a regularly structured exercise training program.
  • History of dangerous arrhythmias.
  • BMI > 40 kg/m^2
  • Current smokers or smoking history of > 20 pack years
  • Pregnant women, implanted pacemaker and/or ICD, cochlear implants, drug infusion pump, or any other implanted metal objects.

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

Cardiac rehabilitation, High-intensity interval training, Other
Heart failure
Cardiac rehabilitation, Cardiovascular system, Heart failure
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Feasibility of Internet Delivered Parent Child Interaction Therapy (AI I-PCIT) Real-Time Monitoring of Sleep and Behavior of Children 3-7 Years-Old Receiving Remote PCIT (AI I-PCIT)

Feasibility of Internet Delivered PCIT (AI I-PCIT)

Magdalena Romanowicz
All
3 years to 99 years old
Phase 1
This study is NOT accepting healthy volunteers
2022-309093-H01-RST
22-009425
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Inclusion Criteria
•Childre:

  • Ages 3-7.
  • Outpatients.
  • Any gender, race, or ethnicity.
  • Able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent.
  • EBP Severity rated above the clinically significant range (≥120; T-score ≥ 60) (Eyberg Child Behavior Inventory- ECBI; Eyberg & Pincus, 1999).
  • Families approached for participation will be asked to commit to complete the treatment:
  • At least one primary caregiver and the identified child will have to be able to speak and understand English;
  • Must have the ability, technology, and internet access for remote therapy/research visits.   

Inclusion Criteria
•Adults:

  • Agree to wear Garmin watch.
  • Ages 18-99.
  • Any gender, race, ethnicity.
  • Able to provide informed consent.
  • Able to speak and understand English.
  • Has the ability, technology, and internet access for remote therapy/research visits.

Exclusion Criteria
•Children: 

  • Formal diagnosis of Severe Intellectual disability, Autistic Spectrum Disorder Level 3, or a psychotic disorder for the child.
  • Parents not consenting to the study.
  • Parents or child is not able to adhere to the study protocol.
  • A Child who is reasonable expected to be unable to tolerate wearing the Garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). This is based on the principal investigator’s discretion.
  • Unable to speak and understand English.
  • Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
  • Children in foster care.
  • Does not have the ability, technology, and/or internet access for remote therapy/research visits.
  • Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.

Exclusion Criteria
•Adults:

  • Unable to speak and understand English. 
  • Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.

Eligibility last updated  10/19/22. Questions regarding updates should be directed to the study team contact.

Behavioral
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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.

Eligibility last updated 2/1/23. Questions regarding updates should be directed to the study team contact.

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A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TAK-341 in Subjects With Multiple System Atrophy

Phase 2 Study of TAK-341 for Multiple System Atrophy

Phillip Low
All
40 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-309115-P01-RST
22-008452
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Inclusion Criteria
•General: 

  • The subject (or, when applicable, the subject’s legally acceptable representative) signs an informed consent form indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
  • The subject is an outpatient of either sex, at least 40 years old, at the time of consent.
  • Subjects must, in the opinion of the investigator, be able to participate in all scheduled evaluations, likely to be compliant, and likely to complete all required tests, including neuroimaging brain scans and lumbar punctures.
  • The subject has a body mass index (BMI) ≥ 18 and ≤ 35 kg/m^2 at screening.

Inclusion Criteria
•Diagnostic:

  • The subject has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria (Gilman et al. 2008).
  • The subject’s onset of first MSA symptoms (including parkinsonism, cerebellar symptoms, orthostatic or urinary symptoms) occurred ≤ 4 years before screening, as assessed by the investigator.
  • The subject’s anticipated life expectancy is ≥ 3 years, per investigator judgment.
  • The subject has an UMSARS Part I score of ≤ 21 (excluding Item #11, sexual function), and additionally has:
    • Severity score ≤ 2 on the swallowing item (#2);
    • Severity score ≤ 2 on the ambulation item (#7);
    • Severity score ≤ 2 on the falling item (#8).
  • The subject has an UMSARS Part IV disability score ≤ 3.
  • Subject has a MoCA ≥ 18. Additionally, subject has sufficiently intact cognition to complete study assessments and follow study instructions, per investigator's judgment.
  • A male subject who is nonsterilized and sexually active with a female partner of childbearing potential is eligible to participate if he agrees to use a barrier method of contraception (i.e., condom with or without spermicide) from the signing of informed consent throughout the study and for 90 days plus 5 half-lives (total of 190 days) after the last dose.
  • Female subjects are eligible to participate if:
    • they are not pregnant or nursing; and
    • they are of nonchildbearing potential or agree to use highly effective contraception from the signing of informed consent throughout the study and for 30 days plus 5 half-lives (total of 130 days) after the last dose of study drug.

Exclusion Criteria
•Medical History:

  • The subject has serious or unstable clinically significant illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic or autoimmune (e.g., multiple sclerosis), hematologic, or other major disease, which, in the judgment of the investigator, is poorly controlled or otherwise likely to deteriorate, compromises the subject’s safety or ability to complete the study, or compromises the interpretation of the study results.
  • The subject has other medical problems (neurological, visual, orthopedic, psychiatric) that, in the opinion of the investigator, may significantly interfere with completion of the study or interpretation of study endpoints.
  • The subject has a disorder that is likely to interfere with drug disposition and elimination.
  • In the opinion of the investigator, the subject has a diagnosis of depression or other psychiatric disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), AND this disorder is poorly controlled AND of sufficient severity to interfere with completion of the study or interpretation of the endpoints.
  • The subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the subject has attempted suicide within the past year before screening. Subjects who have positive answers on Item 4 or 5 on the C-SSRS (based on the past year) before randomization are excluded.
  • The subject has a history of alcohol or substance use disorder (except tobacco use disorder), as defined by the DSM-5, within 1 year before screening or between screening and randomization, or, in the opinion of the investigator, the subject’s current or past use of substances may interfere with performance on the assessments.
  • The subject has a positive finding on an alcohol or illicit drug screen. A positive result for cannabis or prescription medications does not require exclusion.
  • The subject has undergone surgery for the treatment of MSA (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation).
  • The subject has a history of epilepsy or seizures, except self-limited febrile childhood seizures.
  • The subject has any contraindication to lumbar puncture including but not limited to thrombocytopenia or other coagulation disorders (including subjects who are receiving anticoagulants and cannot safely stop them), the absence of cutaneous or soft-tissue infection overlying or adjacent to the site of lumbar puncture, previous spinal surgery that could complicate access to the subarachnoid space, or conditions associated with raised intracranial pressure such as a closed head injury within 3 months or benign intracranial hypertension, or any spinal abnormality or other aspects (e.g., tattoos in the midline lumbar area) or other clinical findings (papilledema seen with ophthalmoscopy) that may complicate or contraindicate lumbar puncture, as judged by the investigator. Subjects who are using low-dose aspirin, low molecular weight heparin, coumadin, or other anticoagulants may still participate if use of these medications can be safely suspended before lumbar puncture, per investigator judgment and local medical practices.

Exclusion Criteria
•Diagnostic Assessments:

  • Any clinically significant abnormality as determined by investigator at screening or between screening and randomization in physical examination findings, vital signs, ECGs, or clinical laboratory test results that may compromise the subject’s safety or ability to complete the study or compromise the interpretation of the study results.
  • Presence of any of the following contraindications to MRI:
    • claustrophobia that would contraindicate brain MRI or the presence of a pacemaker;
    • cardiac defibrillator; spinal cord or vagus nerve stimulator;
    • aneurysm clip;
    • artificial heart valve; recently placed (within 1 year) coronary or carotid stent; ear implant;
    • CSF shunt; other implanted medical device (e.g., insulin pump); or
    • metal fragments or foreign objects in the eyes, skin, or body.
  • Ophthalmic abnormalities. The following are considered exclusionary:
    • Ophthalmic abnormalities and conditions that, in the judgment of the investigator and/or ophthalmologist, would affect subject safety and/or impair the ability to perform a quality ophthalmological evaluation;
    • Congenital or acquired ophthalmic conditions (primary or secondary) that are considered poorly controlled within the last 12 months before screening, with or without treatment, or otherwise expected to lead to significant deterioration in visual acuity in the next 12 months after randomization;
    • Any ocular opacities that may prevent quality fundus assessment;
    • Neovascular or exudative (wet) form of age-related macular degeneration.
  • The subject has any of the following at the screening visit:
    • estimated glomerular filtration rate (determined with the Chronic Kidney Disease Epidemiology Collaboration equation) < 50 mL/min; QT interval with Fridericia correction method > 450 ms for male subjects and > 470 ms for female subjects;
    • a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 1.5 × the upper limit of normal (ULN).
  • Clinically significant vital sign abnormalities at screening, defined as:
    • Systolic blood pressure ≥ 160 mm Hg;
    • Diastolic blood pressure ≥ 90 mm Hg (blood pressure assessed with the subject at rest in the seated position; may be repeated up to 3 times), or;
    • Pulse rate 100 beats per minute (subject at rest in the seated position).
  • The subject has a positive hepatitis B surface antigen test result, known or suspected active hepatitis C infection, or known history of HIV infection:
    • Note: Subjects with positive hepatitis C virus (HCV) serology results may be enrolled if results from a quantitative polymerase chain reaction for HCV RNA is negative, to exclude active hepatitis C infection, and if the investigator agrees that the subject can safely participate in the study.
  • The subject has a brain MRI that shows clinically significant evidence of malignant, ischemic, demyelinating, structural, or degenerative brain disease (other than MSA) that may confound diagnosis or subject safety during the study, or the subject has findings that compromise the safety of lumbar puncture per investigator judgment.
  • The subject has a current blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory tests of coagulation.

Exclusion Criteria
•Other:

  • The subject has poor venous access such that IV drug delivery or PK/safety blood sampling would be difficult.
  • The subject has participated in another study investigating active or passive immunization against αSYN for PD or MSA, or has had immunoglobulin G therapy, within 6 months before screening.
  • The subject’s participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment) will compromise the interpretability of the data from the present study, per consultation with medical monitor or designee. For example, subjects who participated in a study of gene therapy and antisense oligonucleotides (or other disease-modifying treatment) and received active treatment would be excluded.
  • The subject has received any investigational compound that, in the opinion of the investigator or sponsor, may not have completely washed out before the screening visit or may affect the safety or efficacy evaluations.
  • The subject has a positive pregnancy test result at screening.
  • The subject is an immediate family member, is a study site employee, or is in a dependent relationship (e.g., as a spouse, parent, child, or sibling) with a study site employee who is involved in the conduct of this study.
  • The subject has donated 400 mL or more of his or her blood volume within 90 days before the start of the screening visit.  

Eligibility last updated 8/10/22. Questions regarding updates should be directed to the study team contact.

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Functional significance of a human OSTEOCALCIN gene variant.

Human Osteocalcin Gene Variant Functional Significance

Sundeep Khosla
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309148-H01-RST
22-008567
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Inclusion Criteria:
 

  • Individuals carrying the OSTEOCALCIN SNP gene and age, sex, and race matched controls.


Exclusion Criteria:
 

  • Participants with a known diagnosis of type 1 or type 2 diabetes mellitus or those individuals on lipid lowering drugs, as these conditions may alter FGF21 and/or apolipoprotein B levels.

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

Eligibility last updated 10/25/22. Questions regarding updates should be directed to the study team contact.

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Echocardiographic Findings Associated With Rapid Weight Loss in Collegiate Wrestlers

Echocardiographic Findings of Collegiate Wrestlers With Rapid Weight Loss

Darrell Newman
All
18 years to 25 years old
This study is NOT accepting healthy volunteers
2022-309157-H01-RST
22-008937
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Inclusion Criteria:

  • Wrestlers on roster from Rochester Community and Technical College.
  • ≥ 18 years of age. 


Exclusion Criteria:
 

  • Any athlete with a known cardiac condition will be excluded.

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

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

Determining Prevention of Nasal Polyp Recurrence in AERD Patients Using Aspirin

Elina Jerschow
All
18 years to 70 years old
This study is NOT accepting healthy volunteers
2022-309158-H01-RST
22-008350
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Inclusion Criteria:

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


Exclusion Criteria:

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

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

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SDMo – a measure of the occurrence of SDM in the care of patients with chronic conditions (SDMo)

Shared Decision Making Occurrence Between Chronic Care Patients and Clinicians

Ian Hargraves
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309173-H01-RST
22-008683
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Inclusion Criteria:

Adult Patients With Two or More Chronic Conditions

  • Members of Mayo Clinic Connect, the online community of patients facilitated by the Mayo Clinic Center for Social Media, who have received care in multiple settings and organizations.

People Living With One or More Chronic Conditions

  •  Individual with one of more chronic conditions.

International Experts in Shared Decision Making (SDM)

  • Participants will be adults that have published, peer reviewed, SDM related manuscripts.
  • Affiliated with institutions eligible to support a research collaborator status with Mayo Clinic and willing to become Mayo Clinic research collaborators for the duration of their participation in this study.

Primary and Specialty Care Clinicians

  • Clinicians included in the KER Unit database as having expressed interest in SDM, having participated in prior focus groups, or contributed to our work as clinical content experts in developing SDM tools.


Exclusion Criteria:
 

Adult Patients With Two or More Chronic Conditions

  • Minors, those with cognitive issues and/or non-English speaking.

People Living With One or More Chronic Conditions

  • Minors, those with cognitive issues and/or non-English speaking.

International Experts in Shared Decision Making (SDM)

  • No expertise in SDM or ability to enter into research collaborator status with Mayo Clinic , Minors, those with cognitive issues and/or non-English speaking.

Primary and Specialty Care Clinicians

  • Minors, those with cognitive issues and/or non-English speaking.

Eligibility last updated 8/17/22. Questions regarding updates should be directed to the study team contact.

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Impact of Dermoscopy with TADA – Triage Amalgamated Dermoscope Algorithm – Utilization within Primary Care

Dermoscopy Impact with TADA in Primary Care

Hayden Middleton
All
Not specified
This study is NOT accepting healthy volunteers
2022-309193-H01-RST
22-008747
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Inclusion Criteria:

  • Primary care clinicians in Rochester/Kasson who complete the pre/posttests, dermoscopy education and conducts skin lesion visits in their practice.  


Exclusion Criteria:

  • Patient refusal for dermoscopy skin lesion photo (skin lesion would then be excluded), dermoscopy image not captured by clinician at visit.

Eligibility last updated 8/18/22. Questions regarding updates should be directed to the study team contact.

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Urinary crystal burden as a biomarker for predicting disease progression in pediatric patients with autosomal dominant polycystic kidney disease (ADPKD)

Predicting Disease Progression in Pediatric Patients With Autosomal Dominant Polycystic Kidney Disease Using Urinary Crystal Burden as a Biomarker

Christian Hanna
All
5 years to 18 years old
This study is NOT accepting healthy volunteers
2022-309197-H01-RST
22-010623
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Inclusion Criteria:

  • Any autosomal dominant polycystic kidney disease (ADPKD) patient (ages 5-18 years) with confirmed ADPKD (via a combination of imaging, family history, and/or genetic testing), identified from existing and newly identified families for the proposed study.
  • Matched controls will be identified as unaffected siblings, unaffected family members of ADPKD subjects, or children recruited from the outpatient primary care clinics.


Exclusion Criteria:
 

  • ADPKD patients with liver and or kidney transplant.

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

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Beta Trace Protein venous blood levels in CSF-venous fistula (CVF)

CSF-venous Fistula (CVF) Beta Trace Protein Venous Blood Levels

Ian Mark
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309217-H01-RST
22-008829
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Inclusion Criteria:

  • English speaking subjects with a suspected CVF, known CVF, or healthy control subjects.


Exclusion Criteria:
 

  • Subjects who are not English speaking.

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

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Fostering Caregiver Connections via Intentional Technology Pairing for Caregivers of Patients with Alzheimer’s Disease and Other Types of Dementia—Phase 2 (C2C)

A Study to Evaluate Caregiver Connections via Technology for Patients with Alzheimer's and Other Types of Dementia

Julie Fields
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309221-P01-RST
22-008835
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Inclusion Criteria:

  • The participant must have a family member that has been diagnosed with one of the following forms of dementia:
    • Parkinson’s/Lewy body dementia;
    • Any frontotemporal lobar degeneration dementia; or
    • Alzheimer’s dementia.
  • The participant must identify as a care partner or caregiver who has contact with their loved one with dementia, in person or by phone, and provides social/emotional support and full or partial assistance with daily activities at least 3 days per week.
  • The participant must have been caring for their loved one with dementia for at least 3 months. 
  • All participants must have access to a computer and be able to use the internet.
  • All participants must be English speaking.
  • All participants must agree to participate in the 15-month study, which includes completing questionnaires, brief “virtual” interactions with the study coordinator quarterly, and actively interacting with the website and potential matches.
  • All participants must agree to follow-up contact throughout the duration of the study, which is anticipated to last 3 years.


Exclusion Criteria:
 

  • Care Partner’s loved one does not have a confirmed diagnosis of dementia.
  • Care Partner is unable to provide consent.
  • Care Partner was or has been in that role for less than 3 months.

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

Eligibility last updated 2/15/23. Questions regarding updates should be directed to the study team contact.

Other
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Impact of environmental factors on development of pheochromocytoma and/or paraganglioma.

A Survey of Pheochromocytoma and Paraganglioma Patient Environment

Irina Bancos
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309224-H01-RST
22-011614
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Inclusion Criteria:

  • ≥ 18 years of age. 
  • Patients with known genetic predisposition to pheochromocytomas and paragangliomas (PPGL) development.
  • Patients with history of (PPGL).


Exclusion Criteria:
 

  • < 18 years of age. 

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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A Phase 2, Randomized, Open-Label, 24-Week Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GLM101 Administered Intravenously to Adult Participants with PMM2-CDG

24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Adults With PMM2-CDG

Eva Morava-Kozicz
All
18 years to 65 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-309245-P01-RST
22-008910
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Inclusion Criteria:


- Is a male or female, 18 to 65 years of age, inclusive, at Screening;

- Has been diagnosed with PMM2-CDG with genetic test confirmation;

- Has antithrombin III (ATIII) levels below 80%;

- If the participant is a female of childbearing potential, she must not be pregnant (confirmed by a negative serum pregnancy test), is using a medically accepted method
of contraception (abstinence, a hormonal contraceptive in conjunction with a barrier method, double-barrier method, or use of an intrauterine device), and must agree to continue using this method for 30 days after the last infusion of GLM101;

- If the participant is a female of non-childbearing potential, she must be pre-pubertal, surgically sterile, or must have an ovarian dysfunction confirmed by a follicle stimulating hormone > 40 IU/L;

- If the participant is a sexually active male with female partners, the sexually mature, nonsterile male participant agrees to use a medically acceptable method of
contraception (abstinence, the partner taking a hormonal contraceptive in conjunction with a barrier method, double-barrier method, or use by the partner of an intrauterine
device) and agrees to continue using this method for 30 days after the last infusion of GLM101. Males are considered surgically sterile if they have undergone bilateral
orchiectomy or vasectomy at least 3 months prior to Screening;

- If the participant is male, he must agree to refrain from donating sperm during the study and 30 days after the last infusion of GLM101;

- Is willing and able to provide informed consent/assent, directly or through his/her legally authorized representative.


Exclusion Criteria:


- Diagnosis of congenital disorder of glycosylation (CDG) other than PMM2;

- Has an active infection requiring parenteral antibiotics, antivirals, or antifungals or treatment with systemic steroids within 7 days prior to Screening;

- Has confirmed active coronavirus disease-2019 (COVID-19) infection or tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening or check in to clinical site;

- Has a history of a severe allergic reaction to any drug or excipients of GLM101 (as listed in the GLM101 Investigator's Brochure);

- Has a known history of poor venous access;

- Has a history of liver transplant;

- Has a history of drug or alcohol use disorder within 12 months from Screening;

- Has had a major surgical procedure within 30 days prior to Screening;

- Has Screening or eligibility confirmation laboratory value(s) outside the laboratory reference range considered clinically significant and not related to PMM2-CDG;

- If female, has a positive serum pregnancy test during Screening;

- Has serology positive for hepatitis B surface antigen or hepatitis C antibody during Screening;

- Has history or presence, upon clinical evaluation, of any illness that might impact the safety of GLM101 infusion or evaluability of drug effect based on the Principal
Investigator's and Medical Monitor's discretion;

- Is currently participating in another interventional clinical study or has completed another clinical study with an investigational drug or device within 30 days or 5
half-lives before GLM101 infusion, except for acetazolamide. Participants may be enrolled and continue treatment with acetazolamide only if they are on a stable dose for at least 30 days prior to dosing with GLM101, and the dose remains unchanged for the duration of the study.

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

Eligibility last updated 9/15/23. Questions regarding updates should be directed to the study team contact.

Drug
Congenital disorder of glycosylation type Ia
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Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy

Treating Epilepsy With Transcranial Direct Current Stimulation

Brian Lundstrom
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309254-H01-RST
22-008944
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Inclusion Criteria

- Clinical diagnosis of focal epilepsy.

- Estimated to have at least 2 countable seizures per month.

- Has not had control with at least 2 anti-seizure medicines.

- Able to maintain a constant medication for duration of the study (rescue meds
allowed).

- Subject or legally authorized representative is able to understand consent and keep a
seizure diary in English.


Exclusion Criteria:


- A disease likely to progress over course of the study.

- Psychogenic non-epileptic seizures.

- Suicide attempt or psychiatric hospitalization past 2 years.

- A skin condition interfering with scalp electrodes or allergy to silver.

- Women will verify not pregnant, and if applicable, have a serum pregnancy test.

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

Eligibility last updated 3/15/23. Questions regarding updates should be directed to the study team contact.

Device
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Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI) (SAMURAI)

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Study

Mark Waddle
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-309256-P01-RST
22-012786
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Inclusion Criteria:


- Pathologically (histologically or cytologically) proven diagnosis of renal cell
carcinoma prior to registration

- Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following
diagnostic workup:

- History/physical examination within 45 days prior to registration

- CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days
prior to registration

- Patients must have IMDC intermediate (1-2 factors) or poor risk disease (>= 3 factors)

- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial

- Patients with measurable disease (node positive or metastatic) as defined by RECIST
version 1.1 excluding the primary renal tumor

- Patient not recommended for or refused immediate cytoreductive nephrectomy

- Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF
combination regimen

- Primary renal tumor measuring 8 cm or less in anterior to posterior dimension only on
axial imaging

- Age >= 18

- Karnofsky performance status >= 60 within 45 days prior to registration

- Hemoglobin >= 8 g/dL (transfusions are allowed) (within 45 days prior to registration)

- Platelet count >= 50,000/mm^3 (within 45 days prior to registration)

- Absolute neutrophil count (ANC) >= 1500/mm^3 (within 45 days prior to registration)

- Calculated (Calc.) creatinine clearance >= 30 mL/min (within 45 days prior to
registration)

- For African American patients specifically whose renal function is not considered
adequate by the formula above, an alternative formula that takes race into
account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula)
should be used for calculating the related estimated glomerular filtration rate
(GFR) with a correction factor for African American race creatinine clearance for
trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate

- Total bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert
Syndrome, who can have total bilirubin < 3.0 mg/dL) (within 45 days prior to
registration)

- Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =< 3 x upper
limit of normal (ULN) or < 5 x ULN if hepatic metastases present (within 45 days prior
to registration)

- Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial.
Testing is not required for entry into protocol

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated

- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. Patients with HCV infection who are currently on treatment are eligible if
they have an undetectable HCV viral load

- The patient must agree to use a highly effective contraception, including men with
vasectomies if they are having sex with a woman of childbearing potential or with a
woman who is pregnant, while on study drug and for 6 months following the last dose of
study drug. Childbearing potential is defined as any person who has experienced
menarche and who has not undergone surgical sterilization (hysterectomy or bilateral
oophorectomy) or who is not postmenopausal

- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information


Exclusion Criteria:


- Patients with planned treatment of all metastatic disease with definitive therapy
including either surgery, ablative (non-palliative) doses of radiation, or
intervention of some type (definitive interventional radiology techniques) to ALL
metastatic sites rendering the patient without extra-renal measurable disease.
Patients NOT planned for definitive treatment of all metastatic sites are eligible.
Lesions radiated palliatively are not eligible for response assessment

- Patients with untreated or unstable brain metastases or cranial epidural disease

- Note: Patients who have been adequately treated with radiotherapy, radiosurgery,
or surgery and stable for at least 4 weeks prior to registration as documented by
MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated
brain metastases are defined as having no ongoing requirement for steroids and no
evidence of progression or hemorrhage after treatment for at least 4 weeks prior
to registration as documented by MRI or CT imaging or deemed stable by clinical
investigator

- Prior radiotherapy to the kidney that would result in overlap of radiation therapy
fields treatment of the primary tumor

- Any prior systemic therapy for metastatic renal cell carcinoma (RCC) note that prior
chemotherapy for a different cancer is allowed (completed > 3 years prior to
registration)

- Severe, active comorbidity defined as follows:

- Active autoimmune disease requiring ongoing therapy including systemic treatment
with corticosteroids (> 10 mg daily prednisone equivalents) or other
immunosuppressive medications daily. Inhaled steroids and adrenal replacement
steroid doses > 10 mg daily prednisone equivalents are permitted in the absence
of active autoimmune disease

- History of severe allergic, anaphylactic or other hypersensitivity reactions to
chimeric or humanized antibodies

- Active tuberculosis (purified protein derivative [PPD] response without active
tuberculosis [TB] is allowed)

- Uncontrolled hypertension (systolic blood pressure [BP] > 190 mmHg or diastolic
BP > 110 mmHg)

- Major surgery < 45 days prior to registration.

- Any serious (requiring hospital stay or long term rehab) non-healing wound,
ulcer, or bone fracture within 45 days prior to registration

- Any arterial thrombotic (ST elevation myocardial infarction [STEMI], non-ST
elevation myocardial infarction [NSTEMI], cerebrovascular accident [CVA], etc)
events within 180 days prior to registration

- Active New York (NY) Heart Association class 3-4 heart failure symptoms

- Moderate or severe hepatic impairment (Child-Pugh B or C)

- Any history of untreated pulmonary embolism or deep venous thrombosis (DVT)
within 180 days prior to registration. (Any asymptomatic or treated pulmonary
embolism or asymptomatic treated deep venous thrombosis > 30 days prior to
registration is allowed)

- Unstable cardiac arrhythmia within 180 days prior to registration

- History of abdominal fistula, gastrointestinal perforation, intra-abdominal
abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior
to registration

- History of or active inflammatory bowel disease

- Malabsorption syndrome within 45 days prior to registration

- Pregnancy and individuals unwilling to discontinue nursing. For women of child bearing
potential must have a negative pregnancy test =< 45 days prior to registration

Biologic/Vaccine, Drug
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Mayo Clinic — Rochester, MN

Risks, safety, and outcomes of temperature-sensitive endobiliary radiofrequency ablation in patients with malignant biliary obstructions (Endobiliary ELRA)

Impact of Temperature-sensitive Radiofrequency Ablation in Patients with Malignant Biliary Obstructions Undergoing Biliary Stenting

Vinay Chandrasekhara
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309268-H01-RST
22-005206
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Inclusion Criteria:


- Malignant biliary stricture

- Biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to
undergo radiofrequency ablation with placement of biliary stents

- Patients with life expectancy greater than 3 months


Exclusion Criteria:


- Patients who are pregnant, have cirrhosis, or significant liver metastasis >30% on
radiologic imaging suggestive of poor liver function that will not improve despite
endoscopic drainage.

- Patients who have undergone prior biliary decompression stents or percutaneous
drainage that cannot be removed at time of ERCP and thus preclude effective
radiofrequency ablation

- Patients with altered anatomy unable to undergo conventional ERCP

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

Eligibility last updated 5/4/23. Questions regarding updates should be directed to the study team contact.

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Longitudinal investigation of cross-variant memory B cell and T cell responses after a booster of COVID-19 mRNA vaccine

Cross-Variant Memory B Cell and T Cell Responses After COVID-19 mRNA Vaccine Booster

Richard Kennedy
All
21 years and over
This study is NOT accepting healthy volunteers
2022-309280-H01-RST
22-009024
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Inclusion Criteria:

  • Male or female adults ages 21 and older at the time of enrollment.
  • Received at least one COVID-19 vaccination (Johnson &Johnson, Pfizer, Moderna, Novavax; subjects with any number of prior vaccine doses are eligible) and would like to receive an mRNA booster vaccine.
  • No immunosuppression or immunodeficiency.
  • Determined by medical history and clinical judgment to be eligible for the study, by being generally healthy, with no autoimmune or immunosuppressive conditions and having stable current medical conditions (subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the booster vaccine, will be eligible. A change in dose or therapy within a category (e.g., change from one nonsteroidal anti-inflammatory drug to another) is allowed. A change to a new therapy category (e.g., surgery or addition of a new pharmacological class) is only allowed if it is not caused by worsening disease. A change to a new therapy category caused by worsening disease is considered significant and therefore ineligible for enrollment.
  • Patients with diabetes mellitus are eligible for inclusion if they have had a hemoglobin A1c measurement of < 8.0 within the past 6 months prior to enrollment. These hemoglobin A1c measurements are recommended at least twice yearly by the American Diabetes Association (ADA), and the target levels here are representative of the goals of the ADA. These hemoglobin A1c levels will ensure that these participants have good glycemic control. (American Diabetes Association. American Diabetes Association Position Statement: Standards of Medical Care in Diabetes— 2015. Diabetes Care 2015;38(Suppl. 1): S1–S94).
  • Able to follow study procedures in the opinion of the investigator.
  • Expected to be available for the duration of the study.
  • Weighs > 110 lbs.


Exclusion Criteria:
 

  • Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents (e.g., for cancer, HIV, or autoimmune disease).
  • Subjects on corticosteroids will be excluded if ≥ 20mg of Prednisone (or equivalent drug) has been (or will be) administered daily for 2 weeks or more. Subjects will be eligible if corticosteroid therapy has been discontinued for at least 30 days.
  • Serious chronic medical conditions including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator’s opinion, precludes the subject from participating in the study. Diabetic patients will be excluded if they do not have a hemoglobin A1c measurement within the past 6 months or if they had a hemoglobin A1c measurement of an A1c  > 8.0.
  • Receipt of any blood products, including immunoglobulin, within 6 months of study enrollment.
  • Current anticoagulant therapy or a history of bleeding diathesis that would contraindicate intramuscular (IM) injection:
    • Note: antiplatelet drugs such as aspirin and clopidogrel are permitted.
  • Receipt of any COVID-19-specific monoclonal antibodies within the past 90 days prior to enrollment.
  • Any acute illness within the last 30 days.
  • Blood donation within the last 56 days prior to study enrollment and within 56 days following the last study visit.
  • Pregnancy, Nursing or trying to conceive at the time of the study or for 28 days following the baseline visit.
  • Currently taking antibiotics to treat a serious infection. Preventative use of antibiotics (i.e. oral surgery) is not an exclusion criterion.
  • Diagnosis of a cognitive disorder (e.g., Alzheimer’s, Dementia).
  • Anemia.
  • Any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.

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

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

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A Phase 1b Study of Serabelisib in Combination with an Insulin Suppressing Diet (Study ISD) and with or without nab-paclitaxel in Adult Subjects with Advanced Solid Tumors with PIK3CA Mutations with or without PTEN loss

Combination of Serabelisib and Insulin Suppressing Diet in Subjects With Advanced Solid Tumors with PIK3CA Mutations

Andrea Wahner Hendrickson
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-309284-P01-RST
22-009034
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Inclusion Criteria:


1. Able to provide written informed consent.

2. Age ≥18 at Visit -1 (screening).

3. Histologically or cytologically confirmed recurrent solid tumors.

1. Cohort 1a: any extracranial solid tumor (may include EC, ovarian clear cell, or
ovarian endometrioid carcinoma if subject is not eligible for nab-paclitaxel in
Cohort

1b)

2. Cohort 1b: either recurrent or persistent endometrial adenocarcinoma (EC) with
the following histologic epithelial cell types: endometrioid adenocarcinoma,
serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma,
mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.),
mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma,
and carcinosarcoma or; ovarian cancer (OC) with the primary tumor having ≥ 50%
clear cell histomorphology or ovarian clear cell or ovarian endometrioid
carcinoma.

3. Cohort 2: adenocarcinoma of the colon or rectum.

4. Cohort 3: recurrent or persistent endometrial adenocarcinoma with the following
histologic epithelial cell types as described for Cohort 1b

5. Cohort 4: OC primary tumor carcinomas as described for Cohort 1b

4. Tumor must harbor an activating mutation in the PIK3CA gene with or without PTEN loss,
either previously documented or determined during screening.

5. Fresh or archival tumor biopsy with sufficient material to be sent to the designated
laboratory for PD analyses. For subjects who consent to future research, an additional
5 slides from a surgical specimen or biopsy is required.

6. Cohort 1a
•Dose Modification (subjects with any solid tumor): failed, were intolerant
of, or ineligible for no more than three prior lines of therapy (LOT) for
advanced/metastatic disease or refused SOC therapy.

7. For all cohorts, in the unlikely scenario that a subject refused all available SOC
they may proceed with trial. These subjects would be regarded as having 0 prior LOT.

8. Cohorts 1b, 2, 3, and 4
•failed, were intolerant of, ineligible for, or have refused
SOC therapy for advanced/metastatic disease (AJCC stage III and IV) and:

1. Cohort 2 (subjects with colorectal cancer): Have failed no more than two prior
LOT for metastatic CRC.

2. Cohort 1b, and Cohort 3 (subjects with EC): Have no more than three prior
chemotherapeutic regimens for management of endometrial carcinoma (neo-adjuvant
and/or adjuvant chemotherapy will be counted as one prior LOT). Prior hormonal
therapy will not count as a systemic regimen.

3. Cohort 1b, and Cohort 4 (subjects with clear cell or endometrioid OC): Subjects
must have had no more than three prior chemotherapeutic regimens for management
of ovarian carcinoma. Prior hormonal therapy will not count as a systemic
regimen.

9. Life expectancy of at least 3 months.

10. At least one measurable lesion (as defined by Response Evaluation Criteria in Solid
Tumors [RECIST] 1.1).

11. ECOG PS of 0 to 1.

12. Adequate organ function

1. Absolute neutrophil count (ANC) ≥1.0 × 10^9/L or ≥1.5 x 10^9/L if planned to be
treated with nab-paclitaxel, platelet count ≥75 × 10^9/L, and hemoglobin ≥8.5
gm/dL (may be transfused to reach this hemoglobin level unless due to blood
loss).

2. Liver transaminases (AST and ALT) ≤2.5 × upper limit of normal (ULN) (<5 × ULN if
liver metastases are present), and total bilirubin ≤1.5 × ULN (<3 x ULN if
subject has Gilbert Syndrome).

3. INR ≤1.5 x ULN unless subject is on anticoagulants that would affect the INR,
then INR must be in the desired therapeutic range as judged by the Investigator.

4. Albumin level ≥3.0 mg/dL or ≥ the lower limit of normal.

5. Renal: Serum creatinine ≤2 x ULN

13. Ability to take PO medication, be willing to adhere to study procedures and Study
Intervention administration, and receive, consume, and comply with Study ISD.

14. For women of child-bearing potential, a negative serum pregnancy test collected at
screening (Visit-1) and negative urine pregnancy test collected at baseline (Visit-1)
and use of physician-approved method of birth control from the time of the pregnancy
test performed at screening to 90 days following the last administration of Study Drug
or, if applicable, 6 months following the last administration of nab-paclitaxel.

15. Male subjects must be surgically sterile or must agree to use physician-approved
contraception during the study and for 90 days following the last administration of
Study Drug.


Exclusion Criteria:


1. Diagnosis of primary malignant brain tumor.

2. Has had serabelisib, alpelisib, or other PI3K inhibitor.

3. Leptomeningeal disease and symptomatic or untreated brain metastases.

4. Diagnosis of, or requiring treatment for, another malignancy within the past 2 years
(excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin
cancer, or superficial bladder cancer that has been adequately treated, or stage 1
prostate cancer that does not require treatment or requires only treatment with
luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 90
days prior to the first dose of Study Drug).

5. Is less than 21 days from therapeutic radiation or chemotherapy prior to the first day
of dosing with Study Drug and has not recovered to Grade ≤ 1 from all clinically
significant toxicities related to prior therapies.

6. For subjects receiving nitrosoureas or mitomycin C, the subject is < 6 weeks from last
dose. For monoclonal antibody therapy, the subject is < 1 half-life or <4 weeks from
the last dose.

7. Chronic, systemically administered glucocorticoids in doses equivalent to >5 mg
prednisone daily. Replacement corticosteroids for adrenal insufficiency are permitted.

8. Diabetes mellitus requiring insulin or insulin secretagogue therapy.

9. Poorly controlled diabetes mellitus defined as glycosylated hemoglobin A1c (HbA1c)
>7.5% or fasting blood sugar >160 mg/ dL.

10. Known impaired cardiac function or clinically significant cardiac disease.

11. QTcF interval >470 msec found at screening.

12. Myocardial infarction, cardiac stent placement, or unstable angina within 6 months
before the first administration of Study Drug.

13. Have clinically significant peripheral vascular disease.

14. Manifestations of malabsorption

15. Other clinically significant comorbidities.

16. Pregnant (positive serum pregnancy test), planning to become pregnant during the
study, or breastfeeding/planning to breastfeed during the study.

17. Have taken strong CYP3A4 inducers/inhibitors within 7 days before the first
administration of serabelisib or have conditions that require the concomitant use of
CYP3A4 inducers/inhibitors.

18. Untreated or poorly controlled, gastro-esophageal reflux disease.

19. Have taken histamine-H2 receptor antagonists within 12 hours before the first
administration of serabelisib.

20. Have taken PPI within 7 days or 5 half-lives (whichever is the shorter duration)
before the first administration of serabelisib or are anticipated to need PPI during
the study.

21. Have taken neutralizing antacids within 4 hours before the first administration of
serabelisib or are anticipated to need frequent antacid use during the study.

22. Subjects with poorly controlled human immunodeficiency virus, hepatitis B virus,
and/or hepatitis C virus infections.

23. Known allergies to nab-paclitaxel or excipients, serabelisib or excipients or the ISD

24. Severe, uncontrolled gout.

25. A BMI <18.5 kg/m2, or serious or refractive cachexia or anorexia that, in the
Investigator's opinion, realistically prohibits subjects from having energy or
appetite sufficient to reliably engage in a strict ISD regimen for an extended time.

26. Any condition that renders the subject unable to satisfactorily chew, swallow, digest,
or tolerate (i.e., persistent diarrhea) the majority of foods and liquids of the Study
ISD.

27. History of severe nephrolithiasis requiring urologic intervention.

28. Participation in a diet or weight loss plan within 10 days prior to the first
administration of Study Drug.

29. Severe constipation or condition where exacerbation of constipation is not advisable
(eg, small bowel obstruction history).

30. History of anaphylaxis from food allergy or other disease state requiring avoidance of
a particular food, such as celiac disease.

31. Diagnosed eating disorder in the past 10 years.

32. Unwilling to take a non-vegan or non-vegetarian diet.

33. Peripheral neuropathy ≥ CTC Grade 2

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

Eligibility last updated 6/13/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
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