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3802 Study Matches

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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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A Phase 2, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet

Joseph Murray
All
18 years to 75 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-308231-P01-RST
22-005185
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Inclusion Criteria:

  • Has an adequate comprehension of a GFD assessed by completion of a knowledge test after viewing of educational materials.
  • Has at least 1 CeD-related GI symptom of moderate or greater severity, as measured by the CDSD, on at least 3 days out of any consecutive 7-day period during the screening period (Week -8 visit until Week -4 visit), felt by the investigator to be related to gluten exposure. The CeD-related symptom(s) may vary day by day as long as the severity of at least 1 symptom is moderate or greater. The participants must meet symptom criteria to undergo esophagogastroduodenoscopy (EGD)/video capsule endoscopy (VCE).
  • Has been attempting to maintain a GFD for at least 12 months as self-reported by the participant.
  • Has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd <2.5 at Week -4.
  • The participant is human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8 positive.
  • The participant is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator.
  • Have a body mass index (BMI) between 16 and 40 kilogram per meter square (kg/m^2), inclusive.
  • The participant is willing and able to continue any current dietary and/or medical regimens (including gastric acid suppression) in effect at the first visit (Visit 1).
  • There should be no changes to diet, medications (prescription or over-the-counter) or supplements during study participation.


    Exclusion Criteria:

  • Has the presence of other inflammatory GI disorders or systemic autoimmune diseases (including but not limited to the following: inflammatory bowel disease, eosinophilic esophagitis, gastroenteritis or colitis, microscopic colitis diagnosed at screening or requiring treatment in the 6 months before screening, scleroderma, psoriatic or rheumatoid arthritis, lupus) other than those noted below:

    • Thyroid disease that has been well-controlled for at least 6 months.
    • Well-controlled type 1 diabetes (glycosylated hemoglobin <8% and no hospitalization or emergency room visit in the last 12 months for hyperglycemia or hypoglycemia).
  • Has ongoing systemic immunosuppressant, systemic corticosteroid treatment excluding medication given for the endoscopies, or treatment with systemic immunosuppressants or systemic corticosteroids in the 12 weeks before Screening.

    • The participant is receiving immunosuppressive doses of corticosteroids: 3 mg per day or more of budesonide for more than 3 consecutive days within 3 months before Screening, more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months before the first dose, any dose of oral or intravenous (IV) corticosteroids within 30 days of the first dose, or high-dose inhaled corticosteroids (>960 micrograms per day [μg/day] of beclomethasone dipropionate or equivalent), or other systemic immunosuppressive agents.

  • Has ongoing use of over-the-counter digestive enzymes or digestive supplements, other than lactase, including those for gluten digestion. Probiotics are allowable if they were started before Screening and not discontinued or changed in dose or type during the study.
  • Has completed the CDSD on ≤75% of the days during Week -8 until randomization.
  • Has active microscopic colitis requiring treatment in the 6 months before Screening.

    • Microscopic colitis detected at screening if sigmoidoscopy is performed would exclude the participant.

  • Has known or suspected type 2 refractory CeD or ulcerative jejunitis.
  • Has ongoing chronic use (defined as >7 days continuous use) of a nonsteroidal anti-inflammatory drug aside from <100 mg aspirin, daily, for prophylactic use.
  • Has ongoing use, or use in the 3 months before screening, of medications known to cause villous abnormalities (e.g., mycophenolate mofetil, angiotensin receptor blockers, colchicine).
  • Has used treatments for GI symptoms including antiemetics, antidiarrheals, antispasmodics, medical marijuana, and constipation agents other than fiber, within 2 weeks of Screening.
  • Has a known or suspected severe enteric infection (viral, bacterial, or parasitic) within 6 months before randomization. Severe enteric infection is defined as requiring emergency room visit or hospitalization or treatment with antibiotics or anti-infectives due to infection. Non enteric viral infections, either resolved or well-controlled are not exclusionary.
  • Has a contraindication to endoscopy with duodenal biopsy.

    --Contraindication to VCE (strictures, anastomoses, etc) is not an exclusion if the participant is able to complete the other aspects of the study.

  • Has additional food allergies (tapioca syrup, oats, almonds, rice crisp, chocolate, almond, butter, wheat gluten, cocoa butter, oat flour, glycerin, sunflower lecithin, salt, and natural flavors) to nongluten ingredients in the SIGE bar study food or significant symptoms upon ingestion of the gluten-free SIGE bar during screening.
  • Has a history of intolerance, hypersensitivity, or idiosyncratic reaction to an aminoglycoside.
  • Has a known human immunodeficiency virus (HIV) infection or positive tests for hepatitis B or C. The participant has a known clinically significant chronically active hepatopathy of any origin, including cirrhosis, and participants with persistent positive hepatitis B virus surface antigen and quantitative hepatitis B virus polymerase chain reaction (PCR), or positive serology for hepatitis C virus (HCV) and quantitative HCV PCR within 6 months before the screening visit.
  • Has known or suspected coronavirus disease 2019 (COVID-19) as determined by the investigator within the past month or COVID-19-related symptoms that have not resolved (direct viral or serologic testing may be performed according to site procedures at the discretion of the investigator).
  • Has a known hypersensitivity reaction and/or allergy, including anaphylaxis, to wheat and/or gluten.
  • Has known history of hypersensitivity, idiosyncratic reaction, or intolerance to any ingredients or excipients in TAK-062 and/or placebo.

    Region-specific


    Exclusion Criteria:

  • Participant enrolling in a study in France is not affiliated to a social security scheme or a beneficiary of such a scheme.
  • Participant enrolling in a study in France is deprived of their liberty by a judicial or administrative decision.

Eligibility last updated 6/21/23. Questions regarding updates should be directed to the study team contact.

Dietary Supplement, Drug, Other
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Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction (EF) Heart Failure (Protocol #2201) (RESPONDER-HF)

RESPONDER-HF Trial

Barry Borlaug
All
40 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308856-P01-RST
22-007452
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Inclusion Criteria:

  • Chronic symptomatic heart failure (HF) documented by the following:
    • Symptoms of HF requiring current treatment with diuretics if tolerated for ≥ 30 days; AND
    • New York Heart Association (NYHA) class II with prior history of > class II; OR
    • NYHA class III, or ambulatory NYHA class IV symptoms; AND
    • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) diuretics; or intensification of oral diuresis within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg/ml in normal sinus rhythm, > 450 pg/ml in atrial fibrillation, or a BNP value > 50 pg/ml in normal sinus rhythm, > 150 pg/ml in atrial fibrillation within the past 6 months.
  • 2. Ongoing stable guideline-directed medical therapy (GDMT) HF management and management of comorbidities according to the 2022 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Heart Failure. Stable management includes a minimum period of 4 weeks post-hospitalization for any cause, including treatment with IV diuretics


3. Site determined echocardiographic LV ejection fraction ≥ 40% within the past 6 months, without documented ejection fraction < 30% in the 5 years prior.

4. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:

1. Left Atrial (LA) diameter > 4 cm; or

2. Diastolic LA volume > 50 or LA volume index > 28 ml/m2 or

3. Lateral e' < 10 cm/s; or

4. e' < 8 cm/s; or

5. Site determined elevated pulmonary capillary wedge pressure (PCWP) with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during
supine ergometer exercise ≥ 25 millimeters of mercury (mm Hg), and greater than RAP by ≥ 5 mm Hg.

6. Resting RAP ≤ 14 mmHg

7. Site determined hemodynamic evidence of peak exercise pulmonary vascular resistance (PVR) < 1.75 Wood units

8. Age ≥ 40 years old

9. Participant has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the Institutional Review Board (IRB) or Ethics Committee (EC)

10. Participant is willing to comply with clinical investigation  procedures and agrees toreturn for all required follow-up visits, tests, and exams

11. Transseptal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator.


Exclusion Criteria:


1. Advanced heart failure defined as one or more of the below:

1. ACC/AHA/European Society of Cardiology (ESC) Stage D heart failure, non-ambulatory NYHA Class IV HF

2. Cardiac index < 2.0 L/min/m^2

3. Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months

4. Patient is on the cardiac transplant waiting list.

2. Inability to perform 6-minute walk test (distance < 50 meters), OR 6-minute walk test > 600m

3. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle (and not by
shortness of breath and/or fatigue and/or chest pain)

4. Right ventricular dysfunction, assessed by the site cardiologist and defined as one or more of the following:

1. More than mild right ventricular (RV) dysfunction as estimated by transthoracic echocardiogram (TTE); OR

2. TAPSE < 1.4 cm; OR

3. Right ventricular (RV) size ≥ left ventricular (LV) size as estimated by TTE; OR

4. Ultrasound or clinical evidence of congestive hepatopathy; OR

5. Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%.

5. Any implanted cardiac rhythm device

6. Structural heart repair aortic valve replacement (AVR) or mitral valve replacement (MVR) (surgical or percutaneous) within the past 12 months; planned valve intervention
in the next 3 months, or presence of hemodynamically significant valve disease as assessed by the site cardiologist and defined as:

1. Mitral valve disease grade ≥ 3+ mitral regurgitation (MR) or > mild Mitral Stenosis (MS); OR

2. Tricuspid valve (TR) regurgitation grade ≥ 2+ TR; OR

3. Aortic valve disease ≥ 2+ aortic regurgitation (AR) or > moderate aortic stenosis (AS)

7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation

8. Participants with existing or surgically closed (with a patch) atrial septal defects. Participants with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded

9. Myocardial Infarction (MI) and/or percutaneous cardiac intervention within past 3 months; Coronary Artery Bypass Graft (CABG) surgery in past 3 months or any planned
cardiac interventions in the 3 months following enrollment.

10. Known clinically significant un-revascularized coronary artery disease, defined as:  coronary artery stenosis with angina or other evidence of ongoing active coronary
ischemia

11. Known clinically significant untreated carotid artery stenosis likely to require intervention

12. Atrial fibrillation with resting heart rate (HR) > 100 beats-per-minute (BPM)

13. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)

14. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months

15. Participant is contraindicated to receive either dual antiplatelet therapy, or an oral anticoagulant; or has a documented coagulopathy

16. Anemia with Hemoglobin < 10 g/dl

17. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as forced expiratory volume (FEV)1 <1Liter

18. Resting arterial oxygen saturation < 95% on room air, < 93% when residing at high altitude

19. Currently requiring dialysis; or estimated glomerular filtration rate eGFR < 25ml/min/1.73 m^2 by chronic kidney disease (CKD) CKD-Epi equation

20. Systolic blood pressure > 170 mm Hg at screening

21. Significant hepatic impairment defined as 3 times upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase

22. Participants on significant immunosuppressive treatment or on systemic steroid treatment

23. Life expectancy less than 12 months for known non-cardiovascular reasons

24. Known hypersensitivity to nickel or titanium

25. Women of childbearing potential

26. Severe obstructive sleep apnea not treated with continuous positive airway pressure (CPAP) or other measures

27. Body Mass Index (BMI) > 45; BMI 40
•45 is also excluded unless in the opinion of the investigator, vascular access can be obtained safely

28. Severe depression and/or anxiety

29. Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study.

Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational

30. In the opinion of the investigator, the Participant is not an appropriate candidate for the study.

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

Eligibility last updated 7/13/23. Questions regarding updates should be directed to the study team contact.

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Safety and Efficacy of the Rivet Pulmonary-to-Venous Shunt (PVS) Therapy in Patients With Group 2 Pulmonary Hypertension (PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Rivet PVS Therapy in Group 2C

Trevor Simard
All
18 years and over
Not Applicable, Early Feasibility
This study is NOT accepting healthy volunteers
2022-309784-P01-RST
22-010691
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Inclusion Criteria:


- Age ≥ 18 years.

- Prior diagnosis of Group 2 PH due to HFpEF, with the following resting hemodynamic criteria confirmed in the past year by right heart catheterization.

a. mPAP ≥ 25 mmHg at rest or mPAP/CO slope > 3 mmHg/L/min during incremental exercise.

- Confirmation of the following hemodynamic criteria during supine exercise.

a. PCWP ≥ 25 mmHg, or PCWP/CO slope > 2 mmHg/L/min.

- Chronic symptomatic heart failure documented by the following:

1. NYHA HF Class II with history > II, or Class III or ambulatory Class IV.

2. ≥ 1 HF hospitalization, or healthcare facility with IV diuretics or intensification of oral diuresis for HF within 12 months, or NT-pro BNP value > 400 pg/mL in normal sinus rhythm or > 750 pg/mL in atrial fibrillation in past 6
months.

- Ongoing stable guideline directed medical therapy (GDMT) for HF and medically optimized per treating HF physician according to current ACCF/AHA guidelines that is
expected to be maintained without change for 6 months (excluding diuretic dosage changes for HF optimization within 90 days of the Index Procedure).

- 6MWD ≥ 150 m.

Select
Exclusion Criteria:


- Any therapeutic intracardiac intervention within the last 30 days.

- PH Group 1, 3, 4 or 5.

- Mean RAP >12 mmHg by RHC at rest on room air.

- Right ventricular dysfunction, defined as one or more of the following.

1. Greater than moderate RV dysfunction as assessed by TTE and/or MRI.

2. RV FAC < 35%.

3. TAPSE < 14 mm via TTE.

4. RV size severely enlarged compared to LV size as estimated by TTE and/or MRI.

- Severe tricuspid valve regurgitation.

- Peak systolic pulmonary arterial pressure > 80 mmHg by RHC at rest while awake.

- Mean pulmonary arterial pressure > 50 mmHg by RHC at rest while awake.

- PVR > 6 Wood units at rest while awake on room air or exercise PVR > 2 Wood Units.

- Left ventricular ejection fraction < 50%.

- Severe heart failure, defined as one or more of the following:.

1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF.

2. If BMI < 30, Cardiac Index < 2.0 L/min/m^2.

3. If BMI ≥ 30, Cardiac Index < 1.8 L/min/m^2.

4. Requires continuous intravenous inotropic infusion.

5. Requires mechanical circulatory support.

6. Currently on the cardiac transplant waiting list.

- Chronic renal dysfunction defined as one or more of the following:

1. Currently requiring dialysis; OR

2. eGFR < 35 mL/min/1.73 m2 by the CKD-Epi equation.

- Chronic pulmonary disease defined as one or more of the following:

1. Requires continuous home oxygen therapy;

2. Recent hospitalization for exacerbation within 12 months prior to screening;

3. FEV1 < 50% predicted.

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

Eligibility last updated 11/17/22. Questions regarding updates should be directed to the study team contact.

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Role Of Lisinopril In Preventing The Progression Of Non-Alcoholic Fatty Liver Disease (NAFLD): RELIEF-NAFLD

Non-Alcoholic Fatty Liver Disease Progression Prevention Using Lisinopril

Manal Abdelmalek
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-309796-P01-RST
22-010751
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Inclusion Criteria:


- Male and female subjects ≥ 18 years of age.

- Clinical diagnosis of nonalcoholic steatohepatitis (NASH) assessed by the presence of
body imaging criteria (ultrasound, computed tomography [CT], or magnetic resonance
imaging [MRI]), or liver biopsy up to six months prior to enrollment without
suspicious nodules or cancer.

- Screening transient elastography (Fibroscan) liver stiffness ≥ 12 kPa (which
correlates with F3 fibrosis and more) and < 25 kPa. Historic transient elastography
(Fibroscan) within 0-4 weeks prior to the date of the screening visit is acceptable.

- Controlled attenuation parameter score of ≥ 270 dB/m or historic liver biopsy within
0-6 months prior to the date of the screening visit consistent with NASH (defined as
the presence of steatosis, inflammation, and ballooning), with stage 3-4 fibrosis
according to the NASH Clinical Research Network classification (or equivalent).

- Leukocytes ≥ 3,000/microliter.

- Absolute neutrophil count ≥ 1,500/microliter.

- Platelets ≥ 75,000/microliter.

- Total bilirubin within normal institutional limits unless the patient has Gilbert's
syndrome.

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤
8 x institutional upper limit of institutional limits.

- Glomerular filtration rate > 30 ml/min.

- International normalized ratio (INR) ≤ 1.3 unless the patient is on a therapeutic
medication.

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).

- The effects of lisinopril has been shown to be teratogenic in animal models. For this
reason, women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
entry and for the duration of study participation. Should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her study
physician immediately.

- Ability to understand and the willingness to sign a written informed consent document.
If a participant has impaired decision-making capacity (IDMC), their legal representative may replace them in this process.

- Systolic blood pressure ≥ 90 and ≤ 160 mm/Hg. Diastolic blood pressure ≥ 60 and ≤ 110 mm/Hg.


Exclusion Criteria:


- Prior or current use of an angiotensin converting enzyme inhibitor (ACEi) or
angiotensin II receptor antagonist (ARB) within 0-24 weeks prior to enrollment.

- Glomerular filtration rate ≤ 30 ml/min (for both male and female participants).

- History of decompensated liver disease, including ascites, hepatic encephalopathy, or
variceal bleeding.

- History of other causes of liver disease, including but not limited to alcoholic liver
disease, hepatitis B, hepatitis C, autoimmune disorders (primary biliary cholangitis,
primary sclerosing cholangitis, or autoimmune hepatitis), drug-induced hepatotoxicity,
Wilson's disease, iron overload, or alpha-1-antitryspin deficiency.

- History of liver transplantation.

- History of hepatocellular carcinoma (HCC) diagnosis.

- History of weight reduction surgery in the past 2 years or planned during the study.

- Within 6 months prior to the date of the screening visit, there must be no history of
the following cardiac events: unstable angina; myocardial infarction, coronary artery
bypass surgery or coronary angioplasty; transient ischemic attack or cerebrovascular
accident; emergency room visit or hospitalization for confirmed cardiovascular disease.

- Participants taking vitamin E ≥ 800 IU/day must be on a stable dose, defined as no
changes in prescribed dose, new vitamin E-containing medications, or discontinuation
for at least 180 days prior to the date of the screening visit and throughout study
participation.

- Participants taking anti-diabetic medications must be on a stable dose for at least 90
days prior to the date of the screening visit and in the period between the date of
the screening visit and enrollment.

- Current alcohol consumption > 21 oz/week for males or > 14 oz/week for females (1
oz/30 mL of alcohol is present in one 12 oz/360 mL beer, 4 oz/120 mL glass of wine,
and a 1oz/30 mL measure of 40 proof [20%] alcohol).

- Participants may not be receiving any other investigational agents, at the time of the
screening visit, or in the prior 30 days, or within 5 half-lives of the prior
investigational agent (whichever is longer).

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to lisinopril.

- Uncontrolled intercurrent illness or psychiatric illness/social situations that would
limit compliance with study requirements.

- History of human immunodeficiency virus (HIV) infection. HIV patients may develop
fatty liver as well as advanced fibrosis due to many causes including metabolic
syndrome, hyperuricemia, HIV-related lipodystrophy, genetic polymorphisms,
medications, and HIV itself. As the natural history of fatty liver in this population
is largely unknown, these patients will be excluded from this study.

- Women who are pregnant or breastfeeding. Pregnant women are excluded from this study
because lisinopril is an ACE Inhibitor with the potential for teratogenic or abortifacient effects.
Because there is an unknown but potential risk for adverse events (AEs) in nursing infants
econdary to treatment of the mother with lisinopril. Breastfeeding should be discontinued if
he mother is treated with lisinopril.

- Systolic blood pressure ≥ 161 mm/Hg. Diastolic blood pressure ≥ 111 mm/Hg.

- Participants taking lithium.

Drug, Procedure/Surgery, Other
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Novel 3D Model for Patient Surgical Airway Education

3D Anatomic Models of the Upper Airway for Surgical Airways

Eric Moore
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310743-H01-RST
23-001189
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Inclusion Criteria:

  • Patients age ≥ 18 years.
  • Patients who previously underwent a total laryngectomy or tracheostomy by an Otorhinolaryngology-Head and Neck Surgery department provider at Mayo Clinic Rochester [VAKM(M3] between January 1st, 1950 – present.
  • Patients who plan to undergo a total laryngectomy or tracheostomy by an Otorhinolaryngology-Head and Neck Surgery department provider at Mayo Clinic Rochester.
  • Patients with capacity to consent to the study.

Exclusion criteria:

  • Patients who declined Minnesota research authorization for the retrospective patient identification.

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

Eligibility last updated 1/31/23. Questions regarding updates should be directed to the study team contact.

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Stellate Ganglion Blockade for the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Placebo-Controlled Trial (SGBAF)

Stellate Ganglion Block to Prevent Atrial Fibrillation in Cardiac Surgery Patients

Erica Wittwer
All
60 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2022-307153-H01-RST
22-001106
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Inclusion Criteria:


- Patient presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.

- Patients scheduled to undergo mitral or aortic valve surgery with or without coronary
artery bypass grafting.


Exclusion Criteria:


- Patients with a history of permanent atrial fibrillation, left or right ventricular
assist device implantation or explantation.

- Patients with procedures not requiring cardiopulmonary bypass.

- Patients with procedures requiring deep hypothermic circulatory arrest.

- Patients with active infection or sepsis.

- Pre-operative immunosuppressive medication use (including steroid use).

- Pre-operative anti-arrhythmic medication use (aside from beta-blockers).

- Patients with Immunodeficiency syndrome.

- Patients with known neurologic disorder.

- Patients requiring left internal jugular central line placement.

- Performance of Maze procedures or left atrial appendage ligation procedures will not
exclude patients from potential enrollment as atrial fibrillation still occurs
postoperatively while the scarring from the Maze procedure forms.

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

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

Procedure/Surgery
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A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO) (MARIO)

A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

Paschalis Vergidis
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-308504-P01-RST
22-007406
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Inclusion Criteria:


- Subject is a male or female adult ≥ 18 years of age on the day the study informed
consent is signed.

- Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site
(excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).


Exclusion Criteria:


- Subject has any of the following forms of invasive candidiasis at Screening:

- Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed);

- Osteomyelitis;

- Endocarditis or myocarditis;

- Meningitis, endophthalmitis, or any central nervous system infection;

- Chronic disseminated candidiasis;

- Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract;

- Patients with a sole diagnosis of mucocutaneous candidiasis; i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or
Candida isolated solely from respiratory tract specimens;

- Patients with concurrent invasive fungal infection other than Candida spp.; e.g., cryptococcosis, mold infection or endemic fungal infection;

- Patients who failed a previous antifungal therapy for the same infection;

- Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive
candidiasis.

- Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).

- Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).

- Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding
initiation of IV echinocandin.

o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.

- Baseline QTcF ≥ 500 msec.

Eligibility last updated 6/13/22. Questions regarding updates should be directed to the study team contact.

Drug
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Sonograms Enable Looking Forward- Get Your iNformation 1 Trial (SELF-GYN1)

SELF-GYN1 (Sonograms Enable Looking Forward- Get Your iNformation 1 Trial)

Alessandra Ainsworth
Female
22 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-309826-P01-RST
22-010908
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Inclusion Criteria:

  • Woman, as defined by sex at birth.
  • Age 22 years or older at the time of eligibility screening.
  • Premenopausal.
  • BMI < 40 kg/m^2.
  • Unlikely to be pregnant during home scan, based on either current intrauterine device (IUD) or other birth control use or recent menstruation, defined as the home scan occurring between day 3 and 10 of the menstrual cycle based on patient self-report.
  • English-speaking and able to follow verbal instructions of the remote ultrasound. technologist as determined by the ability to complete the consent process unassisted.
  • Ability to manipulate a 1 lb. weight by hand.
  • Residence in state where a PI holds a valid license to practice medicine.
  • Ability to receive signature delivery of the investigational ultrasound device.
  • Ability to return the investigational ultrasound device by specified instructions.


Exclusion Criteria:

  • Pregnant or may be pregnant.
  • Has recently given birth, and has had fewer than 3 postpartum menstrual cycles.
  • Has recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to two wait cycles.
  • Has changed birth control within the current menstrual cycle (one 'washout' cycle is required).
  • Turtle Health employees.
  • Has known cancer of a pelvic organ, not currently in remission.
  • Not able to schedule a scan while meeting the requirements above prior to the end of the trial. For example, women who change birth control within the last cycle of the trial (and would require a 'washout cycle' that would delay trial close) or who are unable to schedule within the last few weeks of the trial after reasonable scheduling efforts have been made.
  • Previous hysterectomy or oophorectomy.
  • Does not have one or more of the following anatomic organs: vagina, left ovary, right ovary, or uterus.
  • Subjects with prior scanning experience are included in the trial (as they would be in the real world) but excluded from the primary image quality endpoint (due to experience potentially influencing that endpoint) and analyzed separately as a subgroup for that endpoint only. This sub-population is capped at 200 subjects (~20% of trial).

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

Eligibility last updated 10/14/22. Questions regarding updates should be directed to the study team contact.

Device
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Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 (AMXT 1501)

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

Terence Burns
All
18 years and over
ERROR, First In Human
This study is NOT accepting healthy volunteers
2022-308350-P01-RST
22-005690
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Clinical and radiographic evidence suggesting a diagnosis of a diffuse high grade glioma (HGG), or a prior diagnosis of a diffuse glioma.
  • Planned subtotal resection due to tumor location, size, or other clinical indication deemed appropriate by the surgeon.
  • Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of ceerebal spinal fluid (CSF) and blood samples collected on this protocol. Willing to remain in the hospital at Mayo Clinic (Rochester, MN) for three days added to their standard post-operative stay to undergo longitudinal microdialysis.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without transfusion within 7 days preceding the lab assessment (obtained ≤ 14 days prior to registration).
  • Platelet ≥ 100 x 10^9/L, without transfusion within 7 days preceding the lab assessment (obtained ≤ 14 days prior to registration)
  • Hemoglobin ≥ 9 g/dL, without transfusion support within 7 days preceding the lab assessment (obtained ≤ 14 days prior to registration).
  • Activated partial thromboplastin time/ partial thromboplastin time (aPTT/PTT) ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (obtained ≤ 14 days prior to registration)
  • Total serum bilirubin ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration).
  • The patient is clinically euthyroid.
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≤ 60 mL/min/1.73 m^2 for patients with serum creatinine levels above 1.5 x ULN (obtained ≤ 14 days prior to registration).
  • Negative serum or urine pregnancy test is required for female subjects of childbearing age.


Exclusion Criteria:

  • Patients who are not appropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings.
  • Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped.
  • Participants who are unable to swallow tablets or who are at risk for impaired absorption of oral medication.
    • NOTE: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection.
  • Patients with known hypersensitivity or allergy to DFMO or AMXT 1501.
  • Contraindication to MRI or administration of gadolinium.

Eligibility last updated 3/21/23. Questions regarding updates should be directed to the study team contact.

 

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Prognostic Ability of Magnetocardiography (MCG) in Patients Undergoing Cardiac Catheterization

Mesuron Avalon-H90 MCG Device Magnetocardiography Utility Measurement in Cardiac Catheterization

Mohamad Adnan Alkhouli
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310897-H01-RST
23-001785
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Inclusion Criteria:

  • Patients presenting to the catheterization laboratory to undergo non-emergent cardiac catheterization procedures including coronary angiography, percutaneous coronary intervention, right heart cath, ablation, myocardial biopsy.
  • Adult patients (18 years old or older).
  • Patient willing and able to give informed consent.


Exclusion Criteria:
 

  • Emergent procedure.
  • ST elevation > 1 mm on any two contiguous ECG leads.
  • Hemodynamic instability (SBP > 220 or < 80, HR > 160).
  • Patients < 18 years old (children).
  • Patients known or suspected to be pregnant.
  • Incarcerated patients (FMC patients).
  • Patients with a pacemaker or defibrillator.
  • Metal implants in the body (that are not MRI safe).
  • Patients that are unable to lie down in the MCG machine or stay still.
  • Patients who are unable to understand the informed consent process (ex: non-English speakers without an available interpreter, cognitive delay).
  • Patients without the capacity to provide written informed consent.

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

Eligibility last updated 2/17/23. Questions regarding updates should be directed to the study team contact.

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A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T) (VIALE-T)

A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Mithun Shah
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-123109-P01-RST
20-000406
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Inclusion Criteria:

  • Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
  • Subject must be diagnosed with AML by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic SCT or have received allogeneic SCT within the past 60 days. All types and WHO categories of AML56 and any number of previous lines of therapy may be included.
  • Blast percentage in bone marrow before transplant must be < 10%.
  • Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant.
  • Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol.
  • Participants ≥ 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.


Exclusion Criteria:

  • History of disease progression during prior treatment with venetoclax.
  • History of any other malignancy within 2 years prior to study entry, except for:
    • Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
    • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
    • Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent;
    • Myelodysplastic Syndrome.
  • Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.

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

Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.

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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE) (VANTAGE)

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

John Eaton
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306630-P01-RST
21-012853
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Inclusion Criteria:

  • Willing and able to provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study.
  • Male or female, age ≥ 18 years at the screening visit.
  • Have a diagnosis of PBC in line with the AASLD guidelines as demonstrated by having at least 2 of the following (Lindor et al. 2019):
    • History of sustained increased ALP levels > ULN first recognized at least 6 months prior to the screening visit (sustained ALP elevations at the time of screening is not required, recognizing that the ALP may have decreased on UDCA therapy);
    • Documented positive AMA titer (> 1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or PBC-specific ANA immuno-fluorescence patterns (multiple nuclear dots and/or punctuate nuclear rim);
    • Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts. Liver biopsy could have been done at any time in the past.
  • Those treated with UDCA will be allowed to enroll if they meet one of the following criteria at Visit 1:
    • A minimum of 8 weeks of stable treatment at a dose of ≤ 20 mg/kg/day; OR
    • A minimum of 8 weeks off treatment and consequently determined by the investigator to be clinically stable
  • Systemic therapies intended to address cholestatic pruritus, specifically fibrates, SSRIs, rifampin/rifampicin, gabapentin, cholestyramine, and opioid-receptor antagonists are allowed if one of the following criteria is met at the screening visit:
    • A minimum of 8 weeks of stable treatment (12 weeks of stable treatment for cholestyramine) OR b. A minimum of 4 weeks off treatment.
  • Average daily Adult ItchRO score ≥ 4 during screening to be enrolled in the study at Visit 2.
  • Overall compliance of ≥ 80% in daily completion of the Adult ItchRO assessments during the screening period.
  • To be eligible for randomization, participants must meet the following additional criteria specific to the 4-week, single-blind, placebo run-in period:
  • Completion of ≥ 80% of Adult ItchRO assessments during the single-blind, placebo run‑in period.
  • Study drug compliance of ≥ 80% during the single-blind, placebo run-in period


Exclusion Criteria:

  • Pruritus associated with an etiology other than PBC.
  • Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events (e.g., variceal bleeding, ascites, hepatic encephalopathy, hepatorenal syndrome).
  • Current symptomatic cholelithiasis or inflammatory gallbladder disease. Those with history of cholecystectomy ≥ 3 months before the screening visit may be eligible for enrollment.
  • History of small bowel surgery/resection impacting the terminal ileum (e.g., ileostomy, ileo-anal pouch, or other surgeries/conditions) that may disrupt the enterohepatic circulation.
  • Evidence, history, or suspicion of other liver diseases, including but not limited to:
    • Active hepatitis A or E infection;
    • Active hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) or presence of hepatitis B virus DNA;
    • c. Hepatitis C as defined by the presence of hepatitis C virus (HCV) antibody and positive HCV RNA. Infection documented to have been cured for >1 year prior to the screening visit may be eligible;
    • Secondary sclerosing cholangitis, autoimmune hepatitis, PSC, immunoglobulin G4-related cholangitis, Wilson disease, alpha-1-antitrypsin deficiency, or hemochromatosis;
    • Suspected or proven cholangiocarcinoma or hepatocellular carcinoma;
    • History of liver transplantation;
    • Histologically confirmed diagnosis of NASH;
    • Alcohol-related liver disease.
  • Unstable and/or serious medical disease that is likely to impair the participant’s ability to participate in all aspects of the study, confound efficacy and/or safety assessments, or result in substantially shortened life expectancy (e.g., any active malignancy including hematological malignancy, end-stage heart failure, active infection, acute and chronic diarrhea):
    • Previous history of malignancy, adequately treated/in remission, that in opinion of investigator and medical monitor does not impact participant safety and participation in the study, may be allowed. The investigator should contact the sponsor medical monitor to discuss these cases and seek approval before the screening period.
  • Moderate alcohol consumption as defined for this study by > 1 and > 2 standard drinks on average per day for women and men, respectively, within 24 weeks of screening visit. A standard drink is defined as 1.5 oz (one shot) of liquor, 5 oz of nonfortified wine, or 12 oz of beer (1 oz=29.57 mL; NIAAA).
  • Drug abuse within the 24 weeks prior to, or a positive drug screening result, at the screening visit unless it can be explained by a drug prescription:
    • Use of cannabinoids (legal, prescribed, or otherwise) is allowed, provided use is stable for at least 12 weeks prior to screening and throughout the entire study.
  • Women who are pregnant or nursing. Specific criteria for defining childbearing potential and acceptable methods of birth control are outlined in the protocol.
  • Known intolerance/hypersensitivity to volixibat or its excipients.
  • History of nonadherence to medical regimens, unreliability, medical condition, mental instability, or cognitive impairment that, in the opinion of the investigator, could compromise the validity of informed consent, compromise the safety of the participant, or lead to nonadherence with the study protocol or inability to conduct the study procedures.
  • Participation in an interventional clinical study within 4 weeks OR, if applicable, 5 times the half-life, whichever is greater, prior to the screening visit. Always adhere to other eligibility criteria that apply to specified concomitant medication.

Eligibility Criteria
•Open-Label Extension:

To maintain eligibility for the OLE, participants must:

  • Have successfully completed the 24-week double-blind study drug treatment period.
  • Have not experienced an AE(s) or SAE(s) related to volixibat during the double-blind study treatment period that led to permanent discontinuation.
  • Have no changes in their medical condition or treatment that would preclude their participation in the LTE period at the discretion of the investigator or medical monitor.
  • Complete ≥ 80% of Adult ItchRO assessments during the double-blind study treatment period.

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

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (PROGRESS) (INCB000928)

To Assess the Effectiveness, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

Robert Pignolo
All
12 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307240-P01-RST
22-001369
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Inclusion Criteria:

  • Informed consent/assent:
    • For adult participants (≥ 18 years of age), ability to comprehend and willingness to sign an ICF;
    • For adolescent participants (≥ 12 to < 18 years of age), written informed consent of the parent(s) or legal guardian and written assent from the adolescent participant.
      • Note: Adolescents who during the course of the study become legal adults will be asked for their consent to participate in the study.
  • Female and male adults and adolescents ≥ 12 years of age.
  • Clinical diagnosis of FOP (based on findings of congenital malformation of the great toes, episodic soft-tissue swelling, and/or progressive HO).
  • Participant-reported FOP disease activity within 1 year of the screening visit. This is defined as pain, swelling, and other signs and symptoms associated with FOP flare-ups or wosening of joint function or radiographic progression of HO (increase in site or number of HO lesions) with or without an association with flare-up episodes.
  • Ability to swallow and retain orally administered tablets, either whole or crushed and dispersed in foods or liquids.
  • Willingness to avoid pregnancy or fathering children based on the criteria below.
    • Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days after the last dose of study drug and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed.
    • Female participants of childbearing potential must have a negative pregnancy test at screening (serum) and before the first dose on Day 1 (urine). Female participants of childbearing potential must agree to take appropriate precautions to avoid pregnancy from screening through 190 days after the last dose of study drug and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
    • Women without childbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible.
  • Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation.
  • Willing and able to comply with study procedures and requirements and attend all study visits as defined in this Protocol.


Exclusion Criteria:

  • Pregnant or breast-feeding.
  • CAJIS score ≥ 24.
  • FOP disease severity that in the investigator's opinion precludes participation (e.g., ankyloses of most or all joints, symptomatic thoracic insufficiency syndrome, or recurrent respiratory infections).
  • History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
  • Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the participant, or interfere with interpretation of study data.
  • Presence of a clinically significant finding on echocardiogram (as assessed by the investigator).
  • Presence of an abnormal finding on ECG at screening that in the investigator's opinion is clinically significant and/or the following ECG parameters: QTcF interval > 450 milliseconds, QRS interval > 120 milliseconds, PR interval > 220 milliseconds, ECG evidence of Brugada syndrome, atrial fibrillation or atrial flutter, or Mobitz II or higher grade atrioventricular block.
  • Current treatment with a potent/strong inhibitor or inducer of CYP3A4 within 5 half-lives before the first dose of study treatment or expected to receive such treatment during the study.
    • Note: Topical ketoconazole is allowed.
  • Use of the following medications:
    • Imatinib 30 days prior to baseline (Day 1 visit);
    • Any medication that might interfere with HO formation in the 90 days before baseline (Day 1 visit);
    • Bisphosphonates within 1 year of screening.
  • Participation in an investigational drug study for the treatment of FOP or any other indication within 30 days or 5 half-lives (whichever is longer) before baseline (Day 1 visit).
  • Planning to receive a live vaccine during the course of the study or within 6 weeks after the last dose of study drug.
  • Known or suspected allergy to INCB000928 or any component of the study drug.
  • Known history of clinically significant drug or alcohol abuse as defined by the investigator in the l year before baseline (Day 1 visit).
  • Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
  • HIV, HBV, or HCV infection.

Note: Successfully treated HCV is allowed.

  • Participants with laboratory values at screening defined in Table 7.

Eligibility last updated 2/7/22. Questions regarding updates should be directed to the study team contact.

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Effects of Saccharomyces boulardii CNCM I-745 on Intestinal Barrier Function

Saccharomyces boulardii CNCM I-745 on Intestinal Barrier Function

Michael Camilleri
All
25 years to 65 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307883-H01-RST
22-003898
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Inclusion Criteria:

  • Healthy volunteers
    aging from 25 to 65 years (male or female).
  • Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination).
  • With a body mass index (BMI) comprised between 18 and 35 kg/m^2 and weight > 50 kg at Screening.
  • Able to comply with study requirements and to provide signed informed consent.
  • Has signed the informed consent form before beginning any study procedure.
  • Regular defecation (frequency and stool consistency, with at least about three bowel movements a week).
  • For women of childbearing potential :
    • A negative urine pregnancy test immediately prior to starting the study treatment;
    • Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal; i.e., 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more of the following acceptable methods of contraception that should be maintained throughout the study:
      • Surgical sterilization;
      • Hormonal contraception (implantable, patch, oral, intra-muscular);
      • Intra-uterine device;
      • Double barrier method (diaphragm plus condom);
      • At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance.


Exclusion Criteria:

  • History of hypersensitivity to the study treatments (active substance or excipients), brewer’s or baker’s yeast.
  • Contraindication and special warning to the study treatments according to the Summary of Product Characteristics (SmPCs).
  • History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average.
  • History of chronic or recurrent diarrhea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily.
  • Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago).
  • History of Clostridium difficile infection.
  • Active gastrointestinal disease.
  • Known chronic or recurrent systemic disorder (including diabetes and hypertension)  that may interfere with the study treatment evaluation.
  • Associated immune deficiency.
  • Severe hepatic or renal impairment.
  • Clinically relevant abnormalities in results of laboratory tests as per Investigator’s judgement.
  • Patients with a central venous catheter.
  • Oral or systemic antibacterial therapy during the 3 months prior to study enrollment.
  • NSAIDs and proton pump inhibitor treatment longer than 1 week, within 3 months prior to study enrollment.
  • Steroids within 6 weeks prior to study enrollment.
  • Use of medications affecting gastrointestinal transit or permeability within 7 days prior to the testing.
  • Use of artificial sweeteners, lactulose, mannitol within 2 days prior to the testing and during the 24 h testing period.
  • New prescription medications during the 2 weeks prior to study enrollment.
  • Use of probiotics or drugs that alters gut microbiota or function, during 4 weeks prior to study enrollment.
  • Intake of antifungals within 14 days prior to study enrollment.
  • Substantial changes in eating habits within 30 days prior to receiving the first dose of IMP product, as assessed by the Investigator.
  • Current smoker.
  • History or presence of drug or alcohol abuse.
  • Inability to abstain from intensive muscular effort the day before the intestinal permeability test.
  • Breast-feeding woman.
  • Patients enrolled in another clinical trial where they received an investigational treatment within the past 30 days.
  • Patients not able to fill in the study questionnaires.
  • Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.

Eligibility last updated 8/11/23. Questions regarding updates should be directed to the study team contact.

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A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer (ROCC)

Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04831580
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Inclusion Criteria:
1. Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell) 2. Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patients with tumor size less than or equal to 4 cm confirmed on MRI prior to randomization are eligible. 3. Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator. 4. Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard. 5. Patient must be age 18 years or older. 6. Patient must have ECOG performance status 0-1. 7. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women. 8. Patient must have signed an approved informed consent and authorization permitting the release of personal health information.
Exclusion Criteria:
1. Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation) 2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging). 3. Patient with inability to receive an MRI. 4. Patients with a tumor size greater than 4cm or on MRI confirmed prior to randomization are excluded. Patients with definite evidence of vaginal/parametrial involvement on MRI are excluded; if MRI findings are not definitive, then clinical examination must also not reveal parametrial or vaginal extension). 5. Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes). 6. Patients with a history of prior pelvic or abdominal radiotherapy. 7. Patients with a prior malignancy < 5 years from enrollment with the exception of non-melanoma skin cancer. 8. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg. 9. Patient compliance and geographic proximity that do not allow adequate follow-up. 10. Patients with poorly controlled HIV with CD4 counts <500.
Device: da Vinci, Other: open surgery
Cervical Cancer
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M Health Fairview University of Minnesota Medical Center-East Bank Hospital — Minneapolis, Minnesota Erin Zielinksi - (eezielin@umn.edu)
M Health Fairview University of Minnesota Medical Center-East Bank Hospital — Minneapolis, Minnesota Erin Zielinksi - (eezielin@umn.edu)

A Phase 1b/2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of LP352 in Subjects with Developmental and Epileptic Encephalopathies (PACIFIC)

Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies (PACIFIC)

David Burkholder
All
12 years to 65 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-307828-P01-RST
22-006714
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Key

Inclusion Criteria:


1. Male or non-pregnant, non-lactating female, age 12 to 65 years

2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and
epileptic encephalopathy

3. Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure
medications

4. All medications and epilepsy interventions must be stable for 4 weeks before screening
and are expected to remain stable during the study

5. The patient/parent/caregiver is able and willing to attend study visits, complete the
diary and take study drug as instructed

Key
Exclusion Criteria:


1. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac
valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or
abnormal blood pressure

2. Has glaucoma, renal impairment, liver disease or any other medical condition that
would affect study participation or pose a risk to the subject

3. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia
or at risk of suicidal behavior

4. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or
antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications
for weight loss

5. Positive test result on the drug screen, except tetrahydrocannabinol (THC) for
patients taking prescribed cannabidiol

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

Eligibility last updated 1/10/23. Questions regarding updates should be directed to the study team contact.

Drug
Encephalopathy, Epilepsy, Seizure
Central nervous system, Epileptic encephalopathy, Nervous system
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Smartwatch and Physician Well-Being: Are Wearables Part of the Solution?

Smartwatches as Part of the Solution for Physician Well-Being

Colin West
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308587-P01-RST
22-006596
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Inclusion Criteria:
 

  • Physician (residents/fellows or practicing faculty physician) employed by the University of Colorado School of Medicine or Mayo Clinic with no anticipated departure within 18 months of enrollment.
  • Physicians must be employed full-time or part-time (at 60% FTE or higher) and have an Android or iOS smart phone.  


Exclusion Criteria:

  • Not in the age range.
  • Not a physician employed by the University of Colorado School of Medicine or Mayo Clinic.
  • Does not own an Android or iOS smart phone. Non-reading subjects.
  • Residents/fellows in their last final year of their respective training program.

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

Behavioral, Device
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Mayo Clinic — Rochester, MN

Afrezza® INHALE-1 Study in Pediatrics (INHALE-1)

All
4 Years to 17 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04974528
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Inclusion Criteria:

• Assent from the pediatric subject, as appropriate, and fully informed consent from the parent(s) or legal guardian, as required by both state and federal laws and the local Institutional Review Board (IRB)
• Subjects ≥4 and <18 years of age
• Clinical diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) per the Investigator and have been using insulin for at least 6 months for T1DM, or at least 3 months for T2DM
• Treatment with basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks
• Bolus insulins are restricted to the RAAs insulin lispro, insulin aspart or insulin glulisine, including biosimilar products
• Basal insulins are restricted to insulin glargine, insulin degludec or insulin detemir, including biosimilar products
• Access to stable WiFi connection
• HbA1c ≥7.0% and ≤11%
• Average prandial dose of insulin ≥2 units per meal
• Utilized CGM for ≥70% of the time over a consecutive 14-day period preceding randomization
Exclusion Criteria:

• History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements
• Recent history of asthma (defined as using any medications to treat within the last year), any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease
• History of serious complications of diabetes (e.g., active proliferative retinopathy or symptomatic autonomic neuropathy), or likely need for specific treatment for diabetic retinopathy (laser photocoagulation, vitrectomy, other) in the next year
• FEV1 and FEV1/forced vital capacity (FVC) ≤80% of predicted Global Lung Function Initiative (GLI) value
• Inability to achieve an acceptable FEV1 and FVC reading for subjects ≥8 years of age would make the subject ineligible
• For subjects <8 years of age who are unable to achieve an acceptable FVC reading, FEV1 only may be assessed; inability to achieve an acceptable FEV1 would make the subject ineligible
• Respiratory tract infection within 14 days before screening (subject may return 14 days after resolution of symptoms for rescreening)
• Inability or unwillingness to perform study procedures
• Exposure to any investigational product(s), including drugs or devices, in the past 30 days
• Any disease other than diabetes or exposure to any medication that, in the judgment of the Investigator, may impact glucose metabolism and current or anticipated acute uses of glucocorticoids or weight loss medications, with the exception of metformin and/or GLP-1 agonists (if GLP-1 agonists used for at least the 3 months prior to enrollment) in subjects with T2DM
• Use of antiadrenergic drugs (e.g., clonidine)
• Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
• Current uncontrolled eating disorder (e.g., anorexia or bulimia nervosa)
• Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the Investigator or the Sponsor, would make the subject an unsuitable candidate for participation in the study
• Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for the preceding 6 months and/or positive urine cotinine test
• Female subject who is pregnant, breast-feeding, intends to become pregnant, or is of child-bearing potential, sexually active and not using adequate contraceptive methods as required by local regulation or practice
• An event of severe hypoglycemia, as judged by the Investigator, within the last 90 days prior to screening
• An episode of DKA requiring hospitalization within the last 90 days prior to screening
Biological: Afrezza, Biological: Rapid-acting Insulin Analog, Biological: Basal Insulin
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Diabetes Mellitus, Insulin, Inhaled, Afrezza, Technosphere, Pediatric
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Location Contacts
Children's Minnesota — Saint Paul, Minnesota Brittany Machus - (brittany.machus@childrensmn.org)
University of Minnesota — Minneapolis, Minnesota Shannon Beasley - (beasl103@umn.edu)

Understanding the Patient Experience in Progesterone Management for Endometrial Cancer and Complex Atypical Hyperplasia: A Qualitative Analysis

Understanding the Patient Experience in Progesterone Management for Endometrial Cancer and Complex Atypical Hyperplasia

Carrie Langstraat
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-307784-P01-RST
21-010212
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Inclusion Criteria:

  • Biopsy confirmed Grade 1-2 endometrioid endometrial cancer or complex atypical hyperplasia.
  • No major surgery within 3 months of diagnosis.
  • Diagnosis in the last 10 years.
  • BMI ≥ 40 kg/m^2.
  • English speaking.


Exclusion Criteria:

  • Non-English speaking.
  • Advanced stage endometrial cancer or histology other than endometrioid.

Eligibility last updated 5/13/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

A Multicenter, Open-Label Study With a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy

A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme

Sani Kizilbash
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304469-P01-RST
21-007546
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Inclusion Criteria:

1. Written informed consent from the patient or their legally authorized representative (LAR) prior to any study-related procedure, and willing and able to comply with the
protocol and aware of the investigational nature of this study.

2. At least 18 years of age.

3. KPS score of ≥ 60

4. A confirmed GBM diagnosis must be based on local review of tumor tissue from the
initial biopsy, surgery, or re-resection. A formal pathology report confirming GBM is
acceptable. It is not a requirement for slides to be sent to a central reviewer.

5. Recurrent or progressive GBM as evaluated by central review applying RANO criteria on
contrast MRI scans of the Baseline/Screening MRI scan obtained up to six weeks prior
to C1D1 and a historical scan taken before the Baseline/Screening scan that meets at
least 1 of the following criteria:

1. In the case of measurable disease, progression will be documented by ≥ 25%
increase in the sum of the perpendicular diameter products (SPDPs) of the
measurable contrast-enhancing (target) lesions or any new measurable lesions;

2. If the SPDPs cannot be reliably estimated due to the lesion's complex
conspicuity, shape, and contrast enhancement pattern, the volume of all
measurable and non-measurable lesions may be used instead, applying the same
threshold (≥ 25% increase) to confirm disease progression;

3. In the case of non-measurable lesions in the historical scan, any transformation
into measurable lesions (≥ 10 mm in both maximum perpendicular diameters) in the
Baseline/Screening scan will be evidence of progression;

4. If there are only non-measurable (non-target) lesions in the Baseline/Screening
scan, additional lesions/sites will be considered evidence of progression based
on the historical scan. Patients with new cerebrospinal fluid (CSF) seeding will
not be considered eligible;

5. If historical scans are unavailable, a radiology report of a scan taken before
the Baseline/Screening scan documenting the SPDPs from a previous scan of the
enhancing disease or its volume can be used by the central reviewer to assess
eligibility if it demonstrates the quality standards and acquisition guidelines
required;

6. If the scan obtained during standard of care (prior to initiation of formal
clinical screening and patient enrollment) is being used as the
Baseline/Screening scan and does not entirely conform to central reader quality
standards and acquisition guidelines (i.e., artifacts or missing sequences), this
can be used for the purpose of inclusion if the central reader in discussion with
the sponsor and PI agree it provides evidence based on standard clinical
practices of recurrence or progression;

7. Patients at first progression who are treated by re-resection or biopsy to
confirm progression do not require measurable disease at their post-operative
screening scan as their Baseline/Screening scan. These patients must be medically
stable after the procedure as assessed by the PI and have the Baseline/Screening
scan available by 7 days before starting treatment.

6. The tumor is localized supratentorially with no leptomeningeal (local or distant),
spinal or CSF metastases, and no ventricular invasion (explicit documentation of the
disease progression that would be problematic in evaluating the efficacy of this
drug).

7. O[6] methylguanine-DNA methyltransferase (MGMT) methylation status must be available;
results of routinely used methods for MGMT methylation testing (e.g.,
methylation-specific polymerase chain reaction or quantitative polymerase chain
reaction) are acceptable.

8. No more than 1 prior line of treatment (e.g., surgery followed by radiation with
concomitant chemotherapy, followed by adjuvant chemotherapy is considered as 1 line of
treatment). In addition, treatment with tumor treating fields (TTFields; Optune) is
acceptable if provided as first line therapy prior to progression or recurrence of
disease.

9. A second debulking surgery, additional radiation or gamma knife surgery during the
first line treatment or after progression, and for which the investigator does not
suspect pseudoprogression is acceptable, as long as no chemotherapy or immunotherapy
has been provided.

10. Recovery from toxicity/side effects of all prior therapy to Grade 1 or less, subject
to the investigator's discretion, except for alopecia; the following time intervals
from previous treatments are required to be eligible:

1. 12 weeks from the completion of radiation (to reduce risk of pseudoprogression),
unless progression is confirmed by biopsy;

2. 4 weeks from the end of any previous of chemotherapy;

3. 2 weeks from tumor biopsy if wound completely healed;

4. 4 weeks from any major surgery (maximal debulking surgery, either gross total
resection or partial resection), gamma knife surgery or significant traumatic
injury. Any surgery incisions or wounds must be completely healed.

11. A stable or decreasing dose of corticosteroids (or none) for brain edema for at least
5 days prior to baseline MRI and enrollment in the study to document disease
progression such that changes in the MRI are not related to the use of
corticosteroids.

12. Eligible for chemotherapy based on adequate bone marrow function and organ function
within 2 weeks of study treatment as defined by the following laboratory guidelines,
subject to the investigator's discretion:

1. Hematopoietic function: total white blood cell (WBC) count ≥ 3 × 10^3/µL, absolute
neutrophil count (ANC) ≥ 1.5 × 10³/µL, platelet count ≥75 × 10³/µL, hemoglobin ≥ 10
g/dL;

2. Hepatic function: bilirubin ≤ 1.5 × × the upper limit of normal (ULN) (excluding
Gilberts Syndrome, for which bilirubin must be ≤ 4 × ULN); aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) < 3 × ULN, and alkaline
phosphatase ≤ 2.5 × ULN;

3. Renal function: serum creatinine ≤ 1.5 × ULN or for patients with creatinine
levels above the ULN, estimated creatinine clearance of ≥ 60 mL/min, calculated
using the Cockcroft-Gault equation;

4. Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.

13. Women of childbearing potential must agree to practice a highly effective method of
contraception beginning at least 28 days before the start of treatment until at least
6.25 months after the last dose of study drug. Male study patients and their female
sexual partners of childbearing potential must agree to practice a highly effective
method of contraception starting from the time of informed consent until at least 3.5
months (no less than 104 days) after the last dose of study drug:

1. A woman of childbearing potential is defined as a woman who is not permanently
sterilized or postmenopausal. Postmenopausal is defined as 12 months with no
menses without an alternative medical cause;

2. Women of childbearing potential must have a negative serum or urine pregnancy
test at Screening;

3. A highly effective method of birth control is defined as one which results in a
low failure rate (i.e., less than 1% per year) when used consistently and
correctly, such as implants, injectables, combined oral contraceptives, some
intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. For
patients using a hormonal contraceptive method, information regarding all
medications being administered to the patient and their potential effects on the
contraceptive should be addressed.

14. Patients with prior malignancies must be disease-free for ≥ 5 years. Curatively treated
basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix,
breast, or bladder; or prostate cancer as well as benign tumors that will not
interfere with the treatment plan at the time of screening are allowed.


Exclusion Criteria:


1. Unable or not willing to comply with the protocol regulations.

2. Any additional chemotherapy (including but not limited to TMZ or immunotherapy) for
recurrent or progressive GBM after a first line treatment.

3. Prior treatment with bevacizumab.

4. Prior treatment with lomustine.

5. Known to have an IDH mutation prior to enrollment.

6. Screening/Baseline MRI showing a mass effect defined as significant compression of the
ventricular system and/or a midline shift with associated clinical symptoms deemed
inappropriate for the patient to enter a clinical trial. If there is otherwise
asymptomatic compression and/or midline shift and the patient fulfills all other
criteria, these patients are considered eligible.

7. Any condition (medical, social, psychological) that would prevent adequate information
and follow-up, including but not limited to clinically relevant psychiatric disorders,
legal incapacity, dementia, adults protected by law or altered mental status.

8. Presence of poorly controlled seizures, defined as occurring despite SOC or requiring
hospitalization.

9. Prior anthracycline cumulative dose more than 550 mg/m^2.

10. Heart disease:

1. LVEF < 50%;

2. Unstable angina;

3. CHF with New York Heart Association (NYHA) classification of 3 or 4;

4. Patients with baseline QT/QTc interval > 480 msec, a history of additional risk
factors for torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family
history of long QT syndrome) and using concomitant medications that significantly
prolong the QT/QTc interval;

5. History of myocardial infarction within 12 months of enrollment;

6. Severe arrhythmia not controlled by medication.

11. Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg and/or diastolic BP
> 100 mmHg) sustained over 2 measurements.

12. Known to be positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus
(HCV), human immunodeficiency virus (HIV), COVID-19 (currently positive at time of
screening), or any other acute viral, bacterial, or fungal infection (testing not
required unless symptomatic or suspected disease).

13. Patients with any other uncontrolled intercurrent medical conditions, including but
not limited to diabetes mellitus or chronic obstructive pulmonary disease that have
not been well controlled by medical management over the prior 3 months are ineligible
unless approved by the sponsor.

14. Women who are lactating or breastfeeding.

Drug
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Mayo Clinic — Rochester, MN

Seroprevalence Study of Pre-existing Immunity against Adenovirus-associated Virus Vector in Patients with MYBPC3-associated Hypertrophic Cardiomyopathy

Seroprevalence Study of Pre-existing Immunity for Adenovirus-associated Virus Vector in MYBPC3-associated Hypertrophic Cardiomyopathy

John Giudicessi
All
18 years to 65 years old
This study is NOT accepting healthy volunteers
2022-308260-P01-RST
22-005284
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Inclusion Criteria:
 

  • Signed informed consent.
  • Ages ≥18 to ≤65 years.
  • Diagnosed with HCM per American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines (maximal left ventricular wall thickness >13 mm).
  • Symptomatic HCM (New York Heart Association [NYHA] Class II-IV).
  • Confirmed Pathogenic/Likely Pathogenic MYBPC3 truncating mutation.


Exclusion Criteria:

  • Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy, immunoglobulin therapy, or monoclonal antibody therapy.
  • History of clinically significant liver disease, HBV, HCV, HIV, or latent tuberculosis infection.
  • Previously dosed with any investigational or approved gene therapy product at any time.

Eligibility last updated 4/17/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Effect of Ventilation and Filtration Control on Office Workers Performance and Health Outcomes

Workers Performance and Health Outcomes of Office Air Ventilation and Filtration Control

Bruce Johnson
All
18 years to 59 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-310054-P01-RST
22-011790
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Inclusion Criteria:

  • ≥ 18 and ≤ 59 years of age.
  • BMI ≥ 18.5.
  • Indoor office workers employed full-time at the Mayo Clinic or another business within and around Rochester, MN.
  • Report working a desk-based job, such as clerical and administrative staff.
  • Fully vaccinated and boosted against COVID-19.
  • Be willing to not wear a mask while in the office module.
  • Allowed to work from home for at least a whole week (5 consecutive workdays in Background Work-from-Home Condition).
  • Able to relocate to the WLL office during the workday, complete work in an open office space, be present for 80% of the total study for four consecutive work weeks, and be able to complete at least 80% daily tasks.
  • Each workday, short personal meetings/calls and lunch break outside the office is allowed, but the participants should spend no less than 6 hours per day in the office.
  • Be able to provide informed consent.


Exclusion Criteria:

  • Individuals who are lactating, pregnant, or intend to become pregnant during the study.
  • Shift-workers.
  • Individuals who are taking medications (either prescribed or over-the-counter) which may affect mental status.
  • Drug (illegal or prescription narcotic), nicotine, or alcohol dependency.
  • Individuals diagnosed with pre-existing respiratory, neurological, or severe sleep disorders given their potential impact on study outcomes;.
  • Individuals who have medical conditions associated with higher risk for severe COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html).

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

Eligibility last updated 11/16/23. Questions regarding updates should be directed to the study team contact.

Behavioral, Device
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Mayo Clinic — Rochester, MN

Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Patients With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study (BiCaZO)

BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study

Arkadiusz Dudek
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-310147-P01-RST
22-013003
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Inclusion Criteria:


- STEP 1
•SPECIMEN SUBMISSION INCLUSION CRITERIA

- Participants must have histologically confirmed melanoma that is stage III or IV,
unresectable, recurrent, or metastatic non-uveal melanoma OR Participants must have
histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) that is
either locally recurrent and non-amendable to curative therapy (e.g., radiation,
surgery) or metastatic. The primary tumor location must be the oropharynx, oral
cavity, hypopharynx, or larynx. Primary tumor site of nasopharynx (any histology) or
unknown primary tumor are not eligible.

- Note: For participants with primary oropharyngeal cancer, human papillomavirus
(HPV) or p16 status must be known prior to step 1 registration

- Participants must have disease presentation consistent with measurable disease. Note:
Current disease measurements will not be required until step 2 registration.

- Participants must have had documented progression within 12 weeks after the last dose
of PD-1 checkpoint inhibition-based therapy. Participants must have been receiving
checkpoint inhibition for a minimum of 6 weeks prior to progression. Participants who
recur during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant
anti-PD1 treatment are eligible if they have measurable disease and considered
unresectable.

- Participants with known human immunodeficiency virus (HIV)-infection must be receiving
anti-retroviral therapy and have an undetectable viral load test within 6 months prior
to step 1 registration

- Participants with evidence of chronic hepatitis B virus (HBV) infection must have
undetectable HBV viral load within 28 days prior to step 1 registration.

- Participants with a history of hepatitis C virus (HCV) infection must have no
detectable viral load within 28 days prior to step 1 registration.

- Participants must have recovered to baseline or ≤ Grade 1 Common Terminology Criteria
for Adverse Events (CTCAE) version (v) 5 toxicities related to any prior treatments,
unless adverse events are deemed clinically nonsignificant by the treating
investigator or stable on supportive therapy.

- Participants must be ≥ 18 years of age.

- Participants must have a Zubrod Performance Status 0 or 1.

- Participants must have adequate cardiac function. Participants with known history or
current symptoms of cardiac disease, or history of treatment with cardiotoxic agents,
must have a clinical risk assessment of cardiac function using the New York Heart
Association Functional Classification and must be class 2B or better to be eligible
for this trial.

- Have adequate tissue specimen from procedure obtained within 6 months prior to step 1
registration and after development of resistance to anti-PD-1/L1 therapy. Archival
tissue must consist of tumor block or at least 20 freshly cut serially sectioned and
numbered 4-5 micron unstained, positively-uncharged slides OR

Be willing to undergo research biopsy AND have tumor accessible for biopsy based on the
following criteria:

- Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies can be
obtained incidentally to a clinically necessary procedure and NOT for the sole purpose
of the clinical trial.

- Acceptable biopsy procedures are:

- Percutaneous biopsy with local anesthetic and/or sedation with an expected risk
of severe complications < 2%;

- Direct transoral biopsy (with or without local anesthetic and/or sedation) with
an expected risk of severe complications < 2%;

- Excisional cutaneous biopsy with local anesthetic and/or sedation with an
expected risk of severe complications < 2%;

- Biopsy with removal of additional tumor tissue during a medically necessary
mediastinoscopy, laparoscopy, gastrointestinal endoscopy, bronchoscopy or
craniotomy. No open surgical, laparoscopic or endoscopic procedure should be
performed solely to obtain a biopsy for this protocol;

- Removal of additional tumor tissue during a medically necessary surgical
procedure.

- Participants must have been offered the opportunity to participate in
specimen banking.

- Note: As a part of the Oncology Patient Enrollment Network (OPEN)
registration process the treating institution's identity is provided in
order to ensure that the current (within 365 days) date of institutional
review board approval for this study has been entered in the system.

- Participants must be informed of the investigational nature of this study and must
sign and give informed consent in accordance with institutional and federal guidelines.

- Participants with impaired decision-making capacity are eligible as long as their
neurological or psychological condition does not preclude their safe participation in
the study (e.g., tracking pill consumption and reporting adverse events to the
investigator).

- STEP 2 TREATMENT REGISTRATION INCLUSION CRITERIA

- Participants must have been eligible for step 1 registration.

- Participants must have had their tumor tissue submitted via the Southwest
Oncology Group (SWOG) Specimen Tracking System prior to step 2 registration.

- Participants registered during stage II of the protocol must have received
assignment to an open cohort from the SWOG Statistics and Data Management Center
based on their biomarker screening profile (not applicable for patients
registered during stage I of the protocol).

- Participants must have measurable disease. All measurable disease must be
assessed within 28 days prior to step 2 registration. All non-measurable disease
must be assessed within 42 days prior to step 2 registration. Note: All disease
must be assessed and documented on the Baseline Tumor Assessment Form (Response
Evaluation Criteria in Solid Tumors [RECIST] 1.1).

- For melanoma participants, computed tomography (CT) chest, abdomen and pelvis
must be obtained. For HNSCC participants, CT neck and chest must be obtained.
Further imaging (i.e., magnetic resonance imaging [MR] brain, CT abdomen/pelvis
or extremities, bone scan) will be performed as deemed appropriate by the
treating physician.

- Participants with treated brain metastases must have no evidence of progression
on the follow-up brain imaging after central nervous system (CNS)-directed
therapy.

- Participants with treated brain metastases must have discontinued steroid
treatment at least 14 days prior to step 2 registration.

- Participants must have a history and physical examination performed within 28
days prior to step 2 registration.

- Participants must be able to take oral medication without breaking, opening,
crushing, dissolving or chewing capsules.

- Leukocytes ≥ 3,000/uL (within 28 days prior to step 2 registration).

- Absolute neutrophil count ≥ 1,500/uL (within 28 days prior to step 2
registration).

- Platelets ≥ 100,000/uL (within 28 days prior to step 2 registration).

- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x ULN
for participants with Gilbert's disease (within 28 days prior to step 2
registration).

- Aspartate aminotransferase (AST) ≤ 3 x institutional ULN (within 28 days prior
to step 2 registration).

- Alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to
step 2 registration).

- Urinalysis: For baseline value (no required value for eligibility).

- Fridericia corrected QT interval (QTcF) ≤ 470 milliseconds on screening
electrocardiogram (ECG) (within 28 days prior to step 2 registration).

- Creatinine ≤ 3 x institutional ULN OR measured (OR calculated) creatinine
clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen
must have been drawn and processed within 28 days prior to Step 2 registration.


Exclusion Criteria:


- STEP 1
•SPECIMEN SUBMISSION EXCLUSION CRITERIA

- Participants must not have an active infection requiring systemic therapy (except HBV,
HCV or HIV as mentioned above).

- Participants must not have received surgery, chemotherapy, radiation therapy, biologic
agents, or steroids within 14 days prior to step 1 registration.

- Participants must not have received more than one prior primary radiotherapy regimen,
curative or adjuvant, to the head and neck, with the additional following criteria:

- If the primary radiation is combined with chemotherapy, a minimum of 16 weeks
will be required to have elapsed between the end of radiotherapy and step 1
registration. If the radiation is given alone, a minimum of 8 weeks will be
required to have elapsed between the end of radiotherapy and step 1 registration;

- Additional palliative radiotherapy regimens are permitted but cannot have been
administered to previously treated tissue (i.e., overlapping fields are excluded)
and must be completed at least 4 weeks prior to step 1 registration;

- Treatment areas should be healed with no sequelae from radiation therapy (RT)
that would predispose to fistula formation;

- Participants must not have received prior treatment with anti-VEGF therapies for any
reason;

- Participants must not have any known significant organ disfunction that, in the
opinion of the treating investigator, may impact suitability for receiving combination
nivolumab/cabozantinib treatment.

- Participants must not have active autoimmune disease requiring systemic steroids
(equivalent of > 10mg of prednisone) or other immune suppression. Exceptions:

- Type 1 diabetes mellitus;

- Hypothyroidism only requiring hormone replacement;

- Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic
treatment;

- Conditions not expected to recur in the absence of an external trigger.

- Participants must not have received an organ allograft.

- Participants must not have a history of hemoptysis (defined as ≥ 1/2 tsp of bright
red blood per day) or tumor bleeding within 90 days prior to step 1 registration.

- Participants must not have known central lung lesions involving major blood vessels
(arteries or veins) or a tumor encasing major blood vessels (e.g., carotid artery).

- Participants must not require concomitant anticoagulation with coumarin agents (e.g.,
warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor
betrixaban, or platelet inhibitors (e.g., clopidogrel).

- Participants must not require anticoagulants except for the following:

- Prophylactic use of low-dose aspirin for cardio-protection (per local
applicable guidelines) and low-dose low molecular weight heparins (LMWH);

- Therapeutic doses of LMWH or anticoagulation with direct factor Xa
inhibitors, rivaroxaban, edoxaban, or apixaban in participants without known
brain metastases who are on a stable dose of the anticoagulant for at least
1 week prior to step 1 registration without clinically significant
hemorrhagic complications from the anticoagulation regimen or the tumor.

- Participants must not have evidence of preexisting uncontrolled hypertension prior to
step 1 registration as documented by 2 baseline blood pressure readings taken at least
30 minutes apart within 28 days prior to step 1 registration. The baseline systolic
blood pressure readings must be ≤ 150 mmHg and the baseline diastolic blood pressure
readings must be ≤ 90 mmHg. Participants on antihypertensive therapies with
controlled blood pressure are eligible.

- Participants must not have a prior or concurrent malignancy whose natural history or
treatment (in the opinion of the treating physician) has the potential to interfere
with the safety or efficacy assessment of the investigational regimen.

- Participants must not be pregnant or nursing due to the known safety profiles of the
drugs in this study. Individuals who are of reproductive potential must have agreed to
use an effective contraceptive method with details provided as a part of the consent
process. A person who has had menses at any time in the preceding 12 consecutive
months or who has semen likely to contain sperm is considered to be of "reproductive
potential. In addition to routine contraceptive methods, "effective contraception"
also includes refraining from sexual activity that might result in pregnancy and
surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention)
including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion and
vasectomy with testing showing no sperm in the semen.

- STEP 2 TREATMENT REGISTRATION EXCLUSION CRITERIA

- Participants must not have experienced any significant health changes that, in the
opinion of the treating investigator, may impact continued suitability for receiving
combination nivolumab/cabozantinib treatment.

- Participants must not have received more than one prior primary radiotherapy regimen,
curative or adjuvant, to the head and neck, with the additional following conditions:

- If the primary radiation is combined with chemotherapy, a minimum of 16 weeks
will be required to have elapsed between the end of radiotherapy and step 2
registration. If the radiation is given alone, a minimum of 8 weeks will be
required to have elapsed between the end of radiotherapy and step 2 registration;

- Additional palliative radiotherapy regimens are permitted but cannot have been
administered to previously treated tissue (i.e., overlapping fields are excluded)
and must be completed at least 4 weeks prior to step 2 registration.

- Treatment areas should be healed with no sequelae from RT that would predispose
to fistula formation.

- Participants must not have received investigational agents or monoclonal antibodies
(except Food and Drug Administration [FDA] approved supportive care antibodies, such
as denosumab) within 28 days prior to step 2 registration.

- Participants must not have received any prior treatment with anti-VEGF based therapies.

- Participants must not have received administration of a live, attenuated vaccine
within 30 days prior to step 2 registration. Note: Participants may have received a
messenger ribonucleic acid (mRNA) or viral vector-based COVID-19 vaccine within 30
days prior to step 2 registration.

- Participants must not have received administration of any strong CYP3A4 inducers, such
as but not limited to rifampin, carbamazepine, enzalutamide, mitotane, phenytoin and
St. John's wort, within 14 days prior to step 2 registration.

- Participants must not have received administration of any strong CYP3A4 inhibitors,
such as but not limited to clarithromycin, itraconazole, ketoconazole, grapefruit
juice, indinavir, nelfinavir, ritonavir, nefazodone, saquinavir, and telithromycin,
within 5 times the half-life of the CYP3A inhibitor prior to step 2 registration.

- Participants must not have malabsorption syndrome.

- Participants must not have central lung lesions involving major blood vessels
(arteries or veins) or a tumor encasing major blood vessels (e.g., carotid artery).

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

Eligibility last updated 11/21/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Procedure/Surgery
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MC200802, Randomized phase 2 Study with Safety Run-in of PD-1 Inhibitor and IgG4 SIRPα-Fc Fusion Protein (TTI-622) and PD-1 Inhibitor and IgG1 SIRPα-Fc fusion Protein (TTI-621) in Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Phase 2 Study with TTI-622 and TTI-621 in Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Stephen Ansell
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2020-301522-P01-RST
21-003869
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Inclusion Criteria:

  1.  
  • Age ≥ 18 years.
  • Documented CD20+ mature B-cell neoplasm according to WHO classification (Swerdlow et al., 2016) as one of the following:
    • Diffuse large B-cell lymphoma NOS including:
    • Transformed lymphoma;
    • Richter’s transformation;
    • Germinal center B-cell type;
    • Activated B-cell type;
    • High-grade B-cell lymphoma (HGBCL), NOS);
    • Primary mediastinal (thymic) large B-cell lymphoma.
  • Patients with “double-hit” or “triple-hit” DLBCL (technically as HGBCL, with MYC and BCL2 and/or BCL6 rearrangements).
  • Follicular lymphoma 3B.
  • T-cell/histiocyte-rich large B cell lymphoma.
  • Large B-cell lymphoma with IRF4 rearrangement.
  • Primary cutaneous DLBCL, leg type.
  • EBV positive DLBCL, NOS.
  • DLBCL associated with chronic inflammation.
  • Intravascular large B-cell lymphoma.
  • ALK positive large B-cell lymphoma.
    • Relapsed, progressive and/or refractory disease (Cheson et al., 2007) following treatment with an anti-CD20 monoclonal antibody (e.g., rituximab)  in combination with chemotherapy
      • Measurable disease as defined below: 
      • Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm (or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis ≥ 1.0 cm) AND FDG positron emission tomography (PET) scan that demonstrates positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
  • FDG-nonavid lymphomas: Measurable disease with CT (or MRI) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis ≥ 1.0 cm.
  • ECOG Performance Status (PS) 0 or 1.
  • ≥ 4 weeks from last dose of anti-CD20 targeting therapy.      
  • ≥ 12 weeks post CAR T-cell therapy.
  • Resolution of all adverse events due to prior therapy to ≤ Grade 1 or baseline. NOTE: Patients with ≤ Grade 2 neuropathy may be eligible. Patients with endocrine-related AEs Grade ≤ 2 requiring treatment or hormone replacement may be eligible.  investigator
  • If receiving glucocorticoid treatment at screening, treatment must be tapered down and administered with a maximum of 10 mg daily in the last 14 days prior to registration.
  • The following laboratory values obtained ≤ 7 days prior to registration:
      •  
    • Absolute neutrophil count (ANC) ≥ 500/mm^3; growth factor support allowed in case of bone marrow involvement;
    • Absolute lymphocyte count  ≥200/mm^3;
    • Platelet count ≥75,000/mm3;
    • Hemoglobin ≥ 8.0 g/dL;
    • INR or PTT/aPTT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants;
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN), unless due to Gilbert’s disease (direct bili ≤ ULN);
    • Aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 2.5 x ULN;
    • Calculated creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula below:
    • Cockcroft-Gault Equation:
      • Creatinine clearance for males =    (140
        •age) (weight in kg) / (72) (serum creatinine in mg/dL);
      • Creatinine clearance for females = (140
        •age) (weight in kg) (0.85) / (72)(serum creatinine in mg/dL).
  • Provide informed written consent.
  • Negative pregnancy test done ≤ 3 days prior to registration, for persons of childbearing potential only.
  • Female of childbearing must agree to use a highly effective method of contraception during the treatment and for 120 days after the last dose of study treatment.
  • Male participants with female partners of childbearing potential must agree to refrain from donating sperm and one of the conception methods as described in Appendix V during the treatment and for 120 days after last dose study treatment.
  • Willing to return to the enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willing to provide mandatory tissue and blood samples for correlative research purposes.

Exclusion Criteria:

  • Primary ce ntral nervous system (CNS) lymphoma or known CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lu
  • Known past or current malignancy other than inclusion diagnosis, except for:
    1.  
    • Cervical carcinoma of Stage 1B or less;
    • Non-invasive basal cell or squamous cell skin carcinoma;
    • Non-invasive, superficial bladder cancer;
    • Prostate cancer with a current PSA level < 0.1 ng/mL;
    • Any curable cancer with a complete response (CR) of > 2 years duration.
  • Received < 2 prior systemic anti-cancer therapy including investigational agents ≤ 4 weeks or ≤5 half-lives, whichever is shorter, prior to registration.
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137) ≤ 4 weeks  prior to registration.
  • Known clinically significant cardiac disease, including:
    • Onset of unstable angina pectoris within 6 months of signing ICF;
    • Acute myocardial infarction within 6 months of signing ICF;
    • Congestive heart failure (grade III or IV as classified by the New York Heart Association and/or known decrease ejection fraction of < 45%).
  • Chronic ongoing infectious diseases (except hepatitis B or hepatitis C) requiring treatment (excluding prophylactic treatment) at the time of enrollment or ≤ the previous 2 weeks.
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy or primary immunodeficiency disorder. Low-dose steroids (≤10 mg daily of prednisone equivalent) is allowed.
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics).
  • Autologous HSCT ≤ 100 days prior or any prior allogeneic HSCT or solid organ transplantation.
  • Known human immunodeficiency virus (HIV) infection.
  • Exposed to live or live attenuated vaccine ≤ 4 weeks prior to registration.
  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
  • Uncontrolled intercurrent illness including, but not limited to:
    • ongoing or active infection;
    • uncontrolled infection requiring ongoing antibiotics;
    • symptomatic congestive heart failure;
    • unstable angina pectoris;
    • cardiac arrhythmia;
    • or psychiatric illness/social situations that would limit compliance with study requirements;
    • known substance abuse disorder.
  • Known hypersensitivity to pembrolizumab.
  • Major surgery other than diagnostic surgery ≤ 4 weeks prior to registration.
  • Prior radiation therapy ≤ 2 weeks prior to registration or who has not recovered from all  radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
    • Note:  A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
  • Active autoimmune disease such as Crohn’s disease, rheumatoid arthritis, Sjogren’s disease, systemic lupus erythematosus, or similar conditions requiring systemic treatment ≤ the past 3 months or a documented history of clinically severe autoimmune disease/syndrome difficult to control in the past.
  • EXCEPTIONS:
    • Vitiligo or resolved childhood asthma/atopy;
    • Intermittent use of bronchodilators or local steroid injections;
    • Hypothyroidism stable on hormone replacement;
    • Diabetes stable with current management;
    • History of positive Coombs test but no evidence of hemolysis;
    • Psoriasis not requiring systemic treatment;
    • Conditions not expected to recur in the absence of an external trigger.
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection.
  • Prior anti CD47 therapy.
  • Active use of anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on case by case basis.
  • There will be no restriction for daily aspirin < 81mg daily.
  • Co-morbid systemic illnesses  or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.

Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.

 

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Effect of Ileocolic-released Conjugated Bile Acid on Satiety, Entero-Endocrine Cell Function, and Body Weight in Patients with Obesity and Abnormal Satiety Phenotype

Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype

Andres Acosta
All
18 years to 65 years old
Phase 1
This study is NOT accepting healthy volunteers
2021-305478-H01-RST
21-008310
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Inclusion Criteria:


- Willing to provide consent.

- Patients with obesity BMI > 30 kg/m^2 and hungry gut phenotype.

- Gender: men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope for
the gastric emptying study.

- Otherwise healthy individuals or with controlled chronic medical conditions such as type 2 diabetes.


Exclusion Criteria:


- Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening the bowel disease questionnaire will be used to exclude subjects with irritable bowel syndrome.

- Subjects with stool type Bristol classification 6-7 per bowel disease questionnaire.

- Female subjects who are pregnant or breast-feeding.

- Use of anti-obesity medications upon screening (i.e., orlistat, phentermine-topiramate, liraglutide, semaglutide, bupropion-naltrexone), metformin or GLP-1 analogs.

- Individuals who are currently on treatment for unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine, and psychiatric disease.

- Any acute or chronic condition or other disease that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.

- Significant untreated psychiatric dysfunction based upon screening. Hospital Anxiety and
•Depression Inventory (HAD) score > 11 on depression scale, a self-administered
alcoholism screening test (AUDIT-C) score >4 in men or >3 in women, and difficulties with substance or eating disorders determined by the Questionnaire on Eating and Weight
•Patterns (binge eating disorders and bulimia); will mean the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The provider will review the patient's alcohol intake over
the past few months to confirm accuracy and determine study eligibility.

Dietary Supplement, Other
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ORACLE: Observation of Residual Cancer with Liquid Biopsy Evaluation (ORACLE)

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation (ORACLE)

Anastasios Dimou
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306218-P01-RST
21-011604
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Inclusion Criteria:

  • Age ≥ 18 years old; AND
  • Were treated with curative intent; AND
  • Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site; AND
  • Provided written informed consent to participate in the study; AND
  • Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent; AND
  • Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent; AND
  • Have at least one blood sample collected 4-12 weeks after completion of primary treatment of the Index Cancer.
  • Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:

Primary Study Cohorts:

  • Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III).
  • Cohort 2: Non-small cell lung cancer (stage II-III).
  • Cohort 3: Invasive breast carcinoma with all of the following:
    • Clinical stage T1-4/N0-3/M0 at presentation; AND
    • Completed preoperative systemic chemotherapy-containing regimen; AND
    • Underwent definitive surgical resection of the primary tumor; AND
    • Has pathological evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes; AND
    • Hormone receptor and HER2 status are known.

Exploratory Cohorts:

  • Cohort 4: Stage IIb-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent.
  • Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III).
  • Cohort 6: Gastric adenocarcinoma (stage II-III).
  • Cohort 7: Surgically resected pancreatic adenocarcinoma.
  • Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-III oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, paranasal sinus, and salivary gland cancers).
  • Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as stage IC-III or stage I that has high grade (grade 3-4) or clear cell histology).
  • Cohort 10: High-risk endometrial carcinoma (defined as having any of the following: serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply invasive (T1b or greater) endometrioid carcinoma, stage III disease (any histology)).
  • Cohort 11: High-risk renal cell carcinoma (defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent).
  • For the purposes of this study, participants receiving extended (> 6 months planned duration) non-chemotherapy systemic treatment will be considered in their end of primary treatment phase after the initial planned surgery, chemotherapy and/or radiation.
  • Determination of stage for eligibility assessment and enrollment should be based on pathologic stage unless the participant received pre-surgical/neoadjuvant therapy, in which case standard pre-treatment clinical staging will be used to determine eligibility.


Exclusion Criteria:

  • History of allogeneic organ or tissue transplant.
  • Index cancer has neuroendocrine histology.
  • History of another primary cancer, with the exception of the following (if adequately treated and the patient is without evidence of disease at the time of enrollment): in situ cancers, non-melanoma skin carcinoma, localized low-risk prostate cancer (Gleason score < 6) with PSA in the normal range, and stage I papillary thyroid carcinoma.
  • Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC).
  • Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test in the post-treatment surveillance setting at predicting/detecting recurrence.

Eligibility last updated 11/3/21. Questions regarding updates should be directed to the study team contact.

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A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies

A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in Patients With B-Cell Malignancies

Yucai Wang
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-307460-P01-RST
22-002313
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Inclusion Criteria :

1. Provision of signed and dated written informed consent prior to any study-specific
procedures, sampling, or data collection

2. Age ≥ 18 years

3. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise
noted) of one of the following: MZL (Part 1a and 1b only), FL (Part 1a only), MCL,
CLL/SLL, WM (Part 1a and 1b only), DLBCL (Part 1a only), or >2 treatments per the
Richter's transformation to DLBCL (Part 1a only).

4. Patients who have previously received a covalently-binding BTK inhibitor in any line
of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless
reason for discontinuation is intolerance).

5. For dose-finding and dose-expansion, patients who had previously received a
covalently-binding BTK inhibitor as monotherapy or in combination with other
anticancer agents are eligible for the study if they meet any of the following
criteria: discontinued the previous BTK inhibitor due to disease progression,
experienced disease progression after completing treatment with a BTK inhibitor or
discontinued the BTK inhibitor due to toxicity or intolerance.

6. Measurable disease by radiographic assessment or serum IgM level (WM only)

7. ECOG Performance Status of 0 to 2

8. Patients enrolling in the dose finding phase of the study may be previously treated
with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of
enrollment; patients with CLL/SLL or MCL enrolling in the expansion cohorts (Part 2)
must have been treated with a BTKi in a prior line of therapy.


Exclusion Criteria:


1. Prior malignancy (other than the disease under study) within the past 2 years, except
for curatively treated basal or squamous skin cancer, superficial bladder cancer,
carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate
cancer

2. Requires ongoing systemic treatment for any other malignancy

3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent)
corticosteroid treatment.

4. Current or history of central nervous system involvement including the brain, spinal
cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or
biopsy) by B-cell malignancy, regardless of whether patient had received treatment for
central nervous system disease

5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt
lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman
disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, GCB
DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary
cutaneous DLBCL
•leg type, DLBCL associated with chronic inflammation, primary
mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+
large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC
and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma
•NOS, B-cell lymphoma
unclassifiable with features intermediate between DLBCL and classical Hodgkin
lymphoma, or history of or currently suspected Richter's transformation of an indolent
lymphoma to an aggressive histology (only patients with Richter Transformation to
DLBCL are eligible for Part 1a).

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

Eligibility last updated 5/19/23. Questions regarding updates should be directed to the study team contact.

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A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Disease (PF-ILDs)

Cassandra Braun
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-308749-P01-RST
22-006681
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Inclusion Criteria:


1. Patients ≥ 18 years old at the time of signed informed consent.

2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

3. Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed).

4. Patients may be either:

- on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. (*stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks);

- not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g., either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.

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

6. DLCO ≥ 25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.

7. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.

8. Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g., Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.


Exclusion Criteria:


1. Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) < 0.7 at Visit 1.

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

3. Acute Interstitial Lung Disease (ILD) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).

4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.

5. Patients having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 (COVID-19) within 12 months of screening (based on investigators judgement).

6. Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period; e.g., hip replacement.
Registration on lung transplantation list would not be considered as planned major surgery.

7. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in
situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.

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

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

Eligibility last updated 9/1/23. Questions regarding updates should be directed to the study team contact.

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Noninvasive Ultrasound Assessment of Detrusor Dysfunction (QUBV)

Ultrasound Bladder Vibrometry

Azra Alizad
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306417-H01-RST
21-011734
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Inclusion Criteria;

  • Age ≥ 18 years old.
  • Scheduled to undergo UDS for clinical care of one of the included diagnoses.


Exclusion Criteria:

  • Obesity (BMI > 35kg/m^2).
  • Known neurologic disease impacting bladder function (e.g., spinal cord injury, multiple sclerosis, Parkinson’s, prior cerebrovascular accident).
  • Previous pelvic radiation therapy.
  • Previous radical pelvic surgery (such as for uterine or colorectal cancer).
  • Prior bladder surgery (including prostate resection).
  • Pregnant or breast-feeding women.

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

Benign prostatic hyperplasia
Benign prostatic hyperplasia, Reproductive system, Ultrasound
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