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3705 Study Matches

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

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

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

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


Exclusion Criteria:

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

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

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A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open Label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis

Namilumab in Subjects with Chronic Pulmonary Sarcoidosis

Eva Carmona Porquera
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306733-P01-RST
21-013316
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Inclusion Criteria:

  • Male or female age ≥ 18 years.
  • Is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form.
  • Have a ≥ 6-month history of documented sarcoidosis including histological confirmation in the subject’s medical records.
  • Have high-resolution computed tomography (HRCT) and PET scan consistent with active pulmonary sarcoidosis of the lung parenchyma confirmed by central read.
  • Have FVCp ≥ 50% to ≤ 90% and DLCO ≥ 50%.
  • If receiving prednisone (or equivalent), dose must have been ≤25 mg, and dose must have been stable for at least 4 weeks prior to randomization.
  • Symptomatic as indicated by mMRC Dyspnea scale >1 (i.e., Grade 2 or more) in the prior year.
  • If receiving methotrexate and/or other immunosuppressive therapy (IST) dose must have been stable for ≥ 3 months prior to randomization.
  • Female subjects must agree to use an approved highly effective birth control (BC) method (< 1% failure rate per year) throughout the study, unless documented to have a reproductive status of non-childbearing potential or is postmenopausal:
    • Non-childbearing potential defined as pre-menopausal female with medical history of bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or hysterectomy; hysteroscopic sterilization;
    • Postmenopausal defined as 12 months of spontaneous amenorrhea; otherwise, a follicle stimulating hormone (FSH) confirmation will be required. For females with questionable menopausal history (e.g., irregular menstrual periods and age > 40 years) a documented serum FSH level must be ≥ 30 mIU/mL;
    • Woman of childbearing potential (WCBP) who is already using an established method of highly effective contraception or agrees to use one of the allowed BC methods, for at least 28 days prior to the start of dosing, throughout the study, and for 4 months following the last dose of study drug.
  • Males who are sexually active must agree to use one of the allowed BC methods. Male subjects must also agree to sufficiently minimize the risk of pregnancy throughout study participation (and for 4 months following the last dose of study drug).
  • Body Mass Index (BMI) 18 to 40 kg/m^2 at screening.
  • Subjects must agree to steroid taper, and cessation of their IST therapy at randomization.
  • Completion of vaccination for COVID-19 at least 2 weeks prior to randomization.

Exlusion Criteria:

  • Hospitalized for any respiratory illness ≤ 30 days prior to screening.
  • Prednisone dose > 25 mg/day at any time in the previous 4 weeks.
  • ≥ 20% fibrosis as indicated on CT-scan that has been confirmed by central read prior to randomization.
  • eGFR ≤30 mL/min/1.73 m^2 (MDRD equation) or requiring hemofiltration or dialysis.
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3 × upper limit of normal range (ULN).
  • Platelet count <100,000 per mm^3.
  • Hemoglobin ≤ 9.5 g/dL.
  • Absolute neutrophil count < 1,000 per mm^3.
  • History of known anti-GM-CSF autoAb or tests positive at screening, or history of pulmonary alveolar proteinosis (PAP).
  • Use of biologic — approved or investigational agents (e.g., anti-TNFα, anti-IL-1, anti-IL-6, anti-IL-17, anti-IL-12/23 or specific anti-IL-23 inhibitors, anti CD20, anti-IL-18) within the 6 months prior to screening.
  • Prior use of immunoglobulin within 6 months prior to screening.
  • Prior use of any investigational immunomodulator (e.g., NRP2 modulator) within 6 months of screening.
  • Prior use of any JAK inhibitor within 3 months of screening.
  • Participation in another interventional clinical trial within 6 months prior to screening.
  • Known left ventricular ejection fraction (LVEF) ≤30% or NYHA class III or IV heart failure.
  • ECG abnormalities that warrant further investigation, in the opinion of the Investigator.
  • Pulmonary hypertension requiring therapy.
  • Systolic blood pressure (SBP)  < 90 or > 180 mm Hg; Diastolic blood pressure (DBP) < 60 or > 110 mm Hg.
  • Known COVID-19 infection within 3 months prior to screening.
  • Have received any live virus or bacterial vaccinations < 3 months of screening. Age-appropriate non-live vaccinations may be administered during screening so long as the last vaccine dose is administered at least 2 weeks prior to planned randomization.
  • Any infection requiring antibiotics or pulse of OCS where completion of treatment has been < 30 days prior to screening.
  • History of 3 or more lower respiratory tract infections requiring anti-microbial therapy in the past year.
  • Any history of mycetoma or fungal respiratory infection.
  • Requirement for supplemental oxygen at rest.
  • Prior history of, or likely to have any organ transplantation during study including OLE.
  • History of smoking (or vaping) in the prior year or current use. Occasional use (defined as less frequently than once per month) is allowable, though subjects should be counseled to remain abstinent during the study including OLE.
  • Other significant pulmonary disease likely to interfere with the primary endpoint, in the opinion of the Investigator.
  • Other autoimmune disease likely to require therapy during the study.
  • Symptoms and features of extra-PS that may warrant treatment in addition to that required for lung involvement.
  • Significant ischemic heart disease (i.e., myocardial infarction within 6 months, unstable angina or PCTA/stent within 1 month or planned intervention during study).
  • Known or suspected active and untreated/inadequately treated tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B or C infection. Subjects with latent TB may be enrolled if anti-TB therapy is commenced prior to randomization.
  • For women: pregnant or planning to become pregnant during the study or currently breastfeeding.
  • Prior history of any malignancy or lymphoproliferative disorder (not including fully resected basal cell carcinoma of the skin, fully resected intra-epithelial neoplasia or carcinoma in situ) within the past 5 years.

Eligibility last updated 12/23/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Other
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A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)

Open Nipple Sparing Mastectomy (NSM)

James Jakub
Female
18 years and over
This study is NOT accepting healthy volunteers
2021-306747-P01-RST
21-006696
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Inclusion Criteria:

  •  All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval.


Exclusion Criteria:
  

  • Patients who have not undergone open prophylactic NSM surgery.

Eligibility last updated 12/29/21. Questions regarding updates should be directed to the study team contact.

 

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Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease (ABCVILD)

Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease

Avni Joshi
All
4 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306748-P01-RST
21-013267
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Inclusion Criteria:

  • Diagnosis of CVID according to the international consensus document (ICON):
    • Age 4 years or above;
    • Serum IgG at least 2 standard deviations below the age adjusted normal;
    • Decreased serum IgA and/or serum IgM;
    • Abnormal specific antibody response to immunization;
    • Exclusion of secondary immunodeficiency.
  • On replacement immunoglobulin for at least 6 months and willing to maintain throughout study.
  • Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.
  • Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 2 months of study entry.
  • Signed written informed consent.
  • Willing to allow storage of biological specimens for future use in medical research.
  • Females of childbearing potential must use a highly effective form of birth control such as hormone-based contraceptive, intrauterine device, or double barrier method.


Exclusion Criteria:

  • History of hypersensitivity to abatacept or any of its components.
  • Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months.
  • Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as >15mg/kg/day of methylprednisone or corticosteroid equivalent) within the past 3 months.
  • History of HIV infection (positive PCR).
  • Chronic untreated hepatitis B or C (positive PCR).
  • Active tuberculosis (TB) by positive QuantiFERON gold. If history of latent TB, then must supply evidence of completing treatment.
  • Persistent Epstein-Barr Virus (EBV) load ≥ 1,000 units/mL blood checked twice at least 1 month apart.
  • Other uncontrolled infections.
  • Live vaccine given within 6 weeks of the start of the trial.
  • Malignancy or treated for malignancy within the past year.
  • Currently pregnant or breast feeding.
  • Life expectancy less than 1 month.
  • Subjects unwilling to self-administer or have a parent/caregiver self-administer subcutaneous injections at home.
  • Other conditions that the investigators feel contraindicate participation in the study.

Eligibility last updated 12/22/21. Questions regarding updates should be directed to the study team contact.

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Cardiovascular and Cognitive Implications of CNS hypersomnias and Their Treatments (CVCOGNARCIH)

Does Narcolepsy/Idiopathic Hypersomnia and Their Treatment(s) Alter Blood Pressure and Cognition

Virend Somers
All
18 years to 75 years old
This study is NOT accepting healthy volunteers
2021-306758-H01-RST
21-013321
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Inclusion Criteria:

  • Diagnosed with a CNS hypersomnia according to ICSD-3 classifications.
  • Age 18
    •75 years.
  • BMI between 18 and 40 kg/m^2.
  • Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol) by a clinical sleep specialist as part of routine medical care and covered by subject’s health insurance plan.
  • If subject has not yet started the prescribed medication, then subject must be willing to postpone starting medication until after completion of baseline assessment(s).
  • If subject has been taking a prescribed medication at a stable dose for at least 3 months and has been prescribed a new medication, then then subject may complete baseline assessment(s) while taking initial medication before starting new medication.


Exclusion Criteria:
 

  • Any change to medication(s) within the last 45 days.
  • History of chronic alcohol or drug abuse within the prior 12 months.
  • Heart failure, history of severe hypertension, or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study.
  • Use of any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) within 45 days of baseline assessment visit.
  • Participation in another study of an investigational drug within the 28 days prior to screening visit or currently.
  • Pregnancy and/or breast-feeding.
  • Subjects who, in the opinion of the Investigator, may not be suitable for the study.                     

Eligibility last updated 4/28/22. Questions regarding updates should be directed to the study team contact.

Diagnostic Test
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Tonation Breathing Technique, a Non-pharmacogenic Method to Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms - A Pilot Study (TBT)

Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms

Prema Peethambaram
Female
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306764-P01-RST
21-012300
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Inclusion Criteria:

  • Eligible patients are females with stage I-III breast cancer taking adjuvant AI (either standard dose of anastrozole 1 mg daily or letrozole 2.5 mg daily or exemestane 25 mg daily) for greater than 30 days experiencing AI induced musculoskeletal pain scores of 5 or higher on a Likert scale will be enrolled. Treating physicians determine if pain is secondary to an AI.  
  • ≥ 18 years old.
  • Subjects should have completed any planned surgery for breast cancer, chemotherapy and radiation therapy at least 30 days prior to enrollment.
  • Patients should have an ECOG performance score of 0-2. 


Exclusion Criteria:

  •  Age less than 18 years.
  • Significant underlying pulmonary disease.

Eligibility last updated 1/14/22.  Questions regarding updates should be directed to the study team contact.

 

Behavioral
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Myocardial 123I-MIBG Scintigraphy in Aging and Neurodegenerative Disease (MIBG)

Utility of MIBG Scintigraphy in Aging and Neurodegenerative Disease

Bradley Boeve
All
40 years to 90 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306776-H01-RST
21-012740
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Inclusion Criteria:

  • Diagnosis of one of one of the syndromes/diagnoses of interest using established criteria.
  • Age ≥ 40 to ≤ 90 inclusive.
  • STMS score above 10.
  • No active medical disorder that could preclude participation.
  • Stable medication regimen over previous four weeks.
  • Absence of certain medications that could significantly impact the myocardial 123I-MIBG.
  • For those with dementia, caregiver that is with the patient at least four hours/day for at least five days per week.
  • For those with dementia , or severe parkinsonism, patient and caregiver willing and able to participate in all study-related procedures.
  • Patient is capable of giving informed consent, or if apropriate, has caregiver capable of giving consent on the subject's behalf.


Exclusion Criteria:

  • Does not fulfill criteria for any of the desired diagnoses.
  • Age > 40 or < 90.
  • Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative.
  • Women who are pregnant or are breast-feeding an infant.
  • STMS score < 10.
  • Active medical disorder that could preclude participation in this protocol:
    • Hypersensitivity to the radioligand or iodine;
    • Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease;
    • Renal disease viewed by the physician to be too severe to warrant myocardial 123I-MIBG scintigraphy imaging;
    • History of significant alcohol or drug abuse;
    • Any other medical disorder considered by the study physicians as inappropriate for enrollment in this protocol.
  • Patient or caregiver unwilling or unable to participate in all study-related procedures.
  • Caregiver is not with a patient with dementia or severe parkinsonism at least 4 hours/day for at least 5 days/week.
  • Patient or caregiver unwilling or unable to provide informed consent.

Eligibility last updated 1/4/22. Questions regarding updates should be directed to the study team contact.

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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy. (Otsuka)

Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)

Ladan Zand
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306781-P01-RST
22-004474
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Inclusion Criteria:


- Male and female patients ≥ 18 years of age .

- Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m^2 must have had
a kidney biopsy performed within 36 months of the screening visit).

- Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to
screening. Patients who are on a stable dose of SGLT2i may participate if treatment
was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or
ARB may participate if their overall management conforms with standards of care and
other protocol requirements.

- Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0
g/day.

- eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73
m2), calculated using the CKD-EPI equation).


Exclusion Criteria:


- Secondary forms of IgAN or IgA vasculitis.

- Coexisting chronic kidney disease other than IgAN.

- Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy,
membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are
acceptable.

- Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If
MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or
crescents in > 25% of glomeruli is exclusionary. This does not apply to the
exploratory cohort.

- Nephrotic syndrome.

- Serum IgG < 600 mg/dL at screening.

- Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of
randomization.

- Participation in another interventional clinical trial and receipt of another
investigational drug within 30 days prior to the administration of IMP or 5 half-lives
from last investigational drug administration, whichever is longer.

- Chronic infectious disease, or acute infectious disease at time of screening.

- Type 1 diabetes, or poorly controlled Type 2 diabetes.

- Uncontrolled hypertension.

The protocol provides additional information about these and other inclusion and exclusion
criteria.

Biologic/Vaccine, Other
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A Protocol to Establish a Biobank of Controls for Post-COVID Studies

COVID Controls

Ravindra Ganesh
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306797-H01-RST
22-000008
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Inclusion Criteria:
  

  • Age ≥ 18 years.
  • Age and gender matched to biorepository cohort.
  • Population specific: 
    • For the never-COVID group – no history of having contracted COVID;
    • For COVID infection without post COVID cohort (+ COVID,
      •PASC), part of initial acute COVID biorepository;
    • time from onset of symptoms matched to biorepository cohort. 
    • For the + PASC group Included in the PASC biorepository.
  • Matched by age, sex and time of onset of symptoms, as appropriate be able to participate fully in all aspects of the study; and  
  • Have understood and signed study informed consent. 


Exclusion Criteria:
   

  • Active persistent COVID infection. 
  • < 40 kg in weight have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence. 
  • Women with a previously confirmed infection with the novel SARS-CoV-2 virus of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.   

Eligibility last updated 3/2/22. Questions regarding updates should be directed to the study team contact.

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Examine the Efficacy and Safety of ZX008 in Subjects with CDKL5 Deficiency Disorder Followed by an Open-Label Extension (Zogenix ZX008-2103)

A Study to Investigate the Effectiveness and Safety of ZX008 in Subjects with CDKL5 Deficiency Disorder

Elaine Wirrell
All
1 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-306806-P01-RST
22-000790
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Inclusion Criteria:


- Subject has a confirmed pathogenic or likely pathogenic mutation in the CDKL5 gene and
a clinical diagnosis of CDD with epilepsy onset in the first year of life, plus motor
and developmental delays.

- Subject is male or female, aged 1 to 35 years, inclusive, as of the day of the
Screening Visit.

- Subject must have failed to achieve seizure control despite previous or current use of
2 or more AETs.

- Subject is currently receiving at least 1 concomitant antiseizure treatment:
antiseizure medication (ASM), vagus nerve stimulation (VNS), responsive
neurostimulation (RNS), or ketogenic diet (KD).

- All medications or interventions for epilepsy (including VNS, RNS, and KD) must be
stable prior to screening and are expected to remain stable throughout the study.

- At the Screening Visit, parent/caregiver reports that subject has ≥ 4 countable motor
seizures(CMS) per week.


Exclusion Criteria:


- Subject has a known hypersensitivity to fenfluramine or any of the excipients in the
study drug.

- Subject has a diagnosis of pulmonary arterial hypertension.

- Subject has a clinically significant medical condition, including chronic obstructive
pulmonary disease, interstitial lung disease, or portal hypertension, or has had
clinically relevant symptoms or a clinically significant illness currently or in the 4
weeks prior to the Screening Visit, other than epilepsy, that would negatively impact
study participation, collection of study data, or pose a risk to the subject.

- Subject has current or past history of cardiovascular or cerebrovascular disease, such
as cardiac valvulopathy, myocardial infarction or stroke, severe ventricular
arrhythmias, or clinically significant structural cardiac abnormality, including but
not limited to mitral valve prolapse, atrial or ventricular septal defects, patent
ductus arteriosus, and patent foramen ovale with reversal of shunt. (Note: Patent
foramen ovale or a bicuspid aortic valve are not considered exclusionary).

- Subject has moderate to severe hepatic impairment.

- Subject has current eating disorder that suggests anorexia nervosa or bulimia.

- Subject has a current or past history of glaucoma.

- Subject is taking > 4 concomitant ASMs. Rescue medications are not included in the
count.

- Subject is receiving concomitant treatment with cannabidiol (CBD) other than
Epidiolex/Epidyolex or is being actively treated with tetrahydrocannabinol (THC) or
any marijuana product for any condition.

- Subject has participated in another interventional clinical trial within 30 days of
the Screening Visit or is currently receiving an investigational product.

- Subject has previously been treated with Fintepla® (fenfluramine) prior to the
Screening Visit.

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

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

Drug
Genetic disorder
Cyclin-dependent kinase-like 5 deficiency, Fenfluramine, Fenfluramine hydrochloride [USAN], fenfluramine, fenfluramine hydrochloride
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A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors (TRUST-II)

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

Anastasios Dimou
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306818-P01-RST
22-000109
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Inclusion Criteria:


1. Age ≥18 years (or ≥20 years as required by local regulations).

2. Histologically or cytologically confirmed diagnosis of locally advanced (including
inoperable Stage IIIA or IIIB NSCLC) or metastatic NSCLC or other solid tumors.

3. Evidence of ROS1 fusion by a validated assay.

4. Patients with central nervous system (CNS) involvement, including leptomeningeal
carcinomatosis, must be stable, either asymptomatic or previously treated and
controlled within 14 days of first dose.

5. The patient can be either ROS1 TKI treatment naïve or treated with prior ROS1 TKI(s).

6. The patient must have at least 1 measurable disease per RECIST 1.1 as assessed by the
investigator.

7. Eastern Cooperative Oncology Group Performance Status: 0 or 1.

8. Patient with a life expectancy ≥12 weeks based on the judgement of investigator.

9. Patients with adequate organ function meeting the following criteria:

1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤3.0 × upper
limit of normal (ULN) (or ≤5.0 × ULN, for patients with concurrent liver
metastases)

2. Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for patients with Gilbert syndrome
or if liver function abnormalities are due to underlying malignancy)

3. Absolute neutrophil count: ≥1,500/?L

4. Platelet count: ≥100,000/?L

5. Hemoglobin: ≥9.0 g/dL

6. Serum creatinine ≤1.5 × ULN

10. Patients must be able to practice required contraception during the study.

1. For males (irrespective of surgical sterilization [vasectomy]): agree to use
effective contraception methods during the study intervention period and for at
least 90 days after the last dose of investigational drug or agree with complete
abstinence.

2. Females without menses for at least 1 year prior to screening or documented to be
surgically sterilized. Women of childbearing potential (WOCBP) must agree to use
two concurrent highly effective methods of contraception or agree with complete
abstinence from sexual intercourse since the informed consent until 45 days after
the last dose of investigational drug. The patient is willing and capable to give
written informed consent.

11. The patient is willing and capable to comply with the study scheduled visits,
treatment plans, laboratory tests and other procedures.

12. The patient is willing and capable to comply with study site's COVID-19 policies.

Exclusion Criteria

1. Treatment with small molecule anticancer therapy including other investigational
agents or cytotoxic systemic anticancer therapy within 2 weeks (or 5 half-lives of the
compound, whichever is shorter) prior to the first dose of taletrectinib; Treatment
with immuno-oncology (IO) including immune checkpoint inhibitors within 4 weeks before
the first dose of taletrectinib.

2. Major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks before
the first dose of taletrectinib.

? Placement of vascular access device is not considered major surgery. Other minor
surgical procedures, such as catheter placement or minimally invasive biopsy, are
allowed.

3. Radiotherapy within 14 days before study treatment. Stereotactic radiosurgery (SRS),
stereotactic radiation therapy (SRT), and palliative radiation outside the chest and
brain are allowed but must be completed 1 week before starting study treatment.

4. Have been diagnosed with another primary malignancy other than NSCLC except for
adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively
treated non-metastatic prostate cancer; or patients with another primary malignancy
who are definitively relapse-free with at least 3 years elapsed since the diagnosis of
the other primary malignancy. Note: This criterion does not apply to patients to be
enrolled in Cohort 4.

5. Adverse events due to prior therapy are unresolved to ≤ CTCAE Grade 1 or has not
returned to baseline, by the first dose of taletrectinib except for AEs not
constituting a safety risk to the patient based on the judgment of investigators.

6. Patients with untreated spinal cord compression caused by tumor and/or cancerous
meningitis.

7. History or evidence of interstitial fibrosis, interstitial lung disease or
drug-induced pneumonitis.

8. Any gastrointestinal disorders that may affect absorption of oral medications.

9. Active and clinically significant bacterial, fungal, or viral infection including
hepatitis B virus (HBV), hepatitis C virus (HCV), or severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2), known human immunodeficiency virus (HIV) or acquired
immunodeficiency syndrome (AIDS)-related illness.

10. Clinically significant cardiovascular diseases within 3 months prior to the first dose
of taletrectinib: myocardial infarction, severe/unstable angina, coronary/peripheral
endovascular treatment, heart failure or cerebrovascular disorder including transient
ischemic attack.

11. Ongoing cardiac dysrhythmias of ≥ CTCAE Grade 2, uncontrolled atrial fibrillation of
any grade, or QT interval corrected for heart rate by Fredericia's formula (QTcF) >470
milliseconds, or symptomatic bradycardia <45 beats per minute; patient has family or
medical history of long QT syndrome.

12. Pregnancy or lactation/breastfeeding.

13. Use of food or drugs that are known potent cytochrome P450 3A4/5 (CYP3A4/5) inhibitors
or inducers or P-glycoprotein inhibitors or inducers within 14 days prior to the first
dose of study treatment and while on treatment.

14. Administration of agents with potential QT interval prolonging effect within 14 days
prior to first dose of study treatment and while on treatment.

15. Patients with other severe medical or mental diseases in whom the risk is increased by
the participation to the study or treatment with study treatment in the opinion of the
investigator.

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

Eligibility last updated 5/9/23. Questions regarding updates should be directed to the study team contact.

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The Effects of Glucagon on Hepatic Metabolism

The Effects of Glucagon on Hepatic Metabolism

Adrian Vella
All
25 years to 65 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-306820-H01-RST
22-000113
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Inclusion Criteria:


- Willing to participate

- Able to give consent


Exclusion Criteria:


- History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy.

- Active systemic illness or malignancy.

- Symptomatic macrovascular or microvascular disease.

- Contraindications to MRI (e.g. metal implants, claustrophobia).

- Hematocrit < 35%

- TSH < 0.4 or > 5.5.

- Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT
questionnaire

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

Eligibility last updated 4/6/23. Questions regarding updates should be directed to the study team contact.

Drug
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Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

Christi Patten
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-306821-H01-RST
22-000513
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Inclusion Criteria:

Index Participants will be eligible if they:

  • Are an ANAI person (based on self-reported race/ethnicity) and reside in Alaska.
  • Are aged ≥ 21 years (legal smoking age in Alaska).
  • Self-report smoking in the past 7 days, biochemically verified with breath expired air carbon monoxide (CO) > 4 ppm and saliva cotinine > 30 n/ml (positive Alere iScreen result).
  • Smoked > 3 cigarettes per day (cpd) over the past 3 months.
  • If other tobacco or nicotine product used, cigarettes are the main tobacco product used.
  • Are considering or willing to make a quit attempt.
  • Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad mini for the study duration.
  • Nominate one adult family member who will enroll.


Exclusion Criteria:

  • Used pharmacotherapy or a stop smoking program within the past 3 months.
  • Another person in the household is enrolled as the index participant.

Family Member Participants, regardless of smoking status or residence with the index participant, will be eligible if they:

  • Are ≥ 21 years old.
  • Are defined as family by the index participant.
  • Own or have access to a mobile phone or tablet with internet and text messaging capabilities or will be loaned an iPad mini for the study duration.
  • Both men and women and those from non-ANAI racial/ethnic groups.
  • Family members may only support one index participant to mitigate concern about lack of independence of household or other support networks, and potential for crosstreatment contamination, which could attenuate effects in the RCT.

Alaska Tribal Health System stakeholders:

  • Input from healthcare providers, cessation specialists, and THO leaders will be gathered to understand potential facilitators and barriers to adoption of the intervention within the ATHS. The ANTHC team will invite individuals to participate through phone and email communications.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

Other, Enrollment in smoking cessation program, Smoking cessation assistance, Smoking cessation education, Smoking cessation therapy
Cigarette smoker, Stop smoking services
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Evaluation of Cochlear Implantation at Mayo Clinic (ECI)

Evaluation of Cochlear Implantation

Matthew Carlson
All
Not specified
This study is NOT accepting healthy volunteers
2022-306830-H01-RST
22-000183
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Inclusion Criteria:

  • All patients that underwent cochlear implantation at the Mayo Clinic starting 1/1/1982.
  • If patients declined MN research authorization, they may be contacted for consent for approval.


Exclusion Criteria:

  • Patients that did not undergo cochlear implantation at the Mayo Clinic.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.

 

 

 

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A Comprehensive Translational Research Platform for Colorectal Cancer (CRC Platform)

A Comprehensive Translational Research Platform for Colorectal Cancer

Mojun Zhu
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306832-H01-RST
22-000163
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Cytologically or histologically confirmed colorectal cancer.
  • Undergoing biopsy or surgical procedures as part of routine clinical care.


Exclusion Criteria:

  • Individuals < 18 years.
  • Vulnerable patients.
  • Unable to provide informed consent.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.

 

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MC220301 Targeted Prevention of Post-Partum-Related Breast Cancer

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Kathryn Ruddy
Female
18 years to 45 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-306842-P01-RST
22-000606
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Inclusion Criteria
•Pre-Registration:

  • Age ≥ 18 years and ≤ 45 years of age.
  • Presence of lesion suspicious for benign breast disease on mammography and planned breast biopsy.
  • Had a live birth ≤ 5 years prior to pre-registration.
  • Pre-menopausal.
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willingness to provide mandatory blood and urine specimens for correlative research.
  • Willingness to provide mandatory tissue specimens for correlative research.

Inclusion Criteria
•Registration:

  • Age ≥ 18 years and ≤ 45 years of age.
  • Histological confirmation of benign breast disease (i.e., no evidence of DCIS or invasive cancer).
  • Registration must be completed ≤ 30 days after pre-registration biopsy performed for this study.
  • Hemoglobin ≥ 9.0 g/dL (obtained ≤ 30 days prior to registration).
  • Platelet count ≥ 100,000/mm^3 (obtained ≤ 30 days prior to registration.
  • Serum creatinine ≤ 2.0 mg/dl (obtained ≤ days prior to registration).
  • Negative pregnancy test done ≤ 7 days prior to registration.
  • Willing to use contraception while on treatment.
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willingness to provide mandatory blood and urine specimens for correlative research.
  • Willingness to provide mandatory tissue specimens for correlative research.
  • Willing to return to enrolling institution for follow-up.

Exclusion Criteria
•Pre-Registration:

  • History of breast cancer including ductal breast carcinoma in situ (DCIS).
  • Received systemic treatment for any other cancer at any time.
  • Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS) (no doses within ≤ 5 days prior to pre-registration and no more than four doses within ≤ 30 days prior to pre-registration).
  • Currently taking other agents for the prevention of breast cancer.
  • Currently taking anticoagulants.
  • Contraindication for aspirin use.

Exclusion Criteria
•Registration:

  • No research tissue collected during pre-registration biopsy performed for this study.
  • Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
    • NOTE: no doses within ≤ 5 days prior to registration and no more than four doses within ≤ 30 days prior to registration.
  • Co-morbid illnesses/conditions 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.
  • Any contraindication to aspirin use including but not limited to:
    • Bleeding disorders (e.g., hemophilia);
    • Stomach or intestinal bleeding ≤ 6 months prior to registration;
    • Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Currently taking anticoagulants.
  • Any malignancy requiring systemic therapy.
  • Currently pregnant or planning to become pregnant in the next 90 days.
  • Post-menopausal:
    • Prior bilateral surgical oophorectomy; or
    • No menses for > 1 year with estradiol levels within postmenopausal range, according to institutional standard.

Eligibility last updated 1/3/23. Questions regarding updates should be directed to the study team contact.

 

Procedure/Surgery, Behavioral, Drug
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The Effects of Glucagon on Hepatic Metabolism in People with Type 2 Diabetes after Caloric Restriction (The Effects of Glucagon on Hepatic Metabolism in People with Type 2 Diabetes after Caloric Restricti)

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

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

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


Exclusion Criteria:

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

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

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Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia (SCOPE-L)

Specialty Compared to Oncology Delivered Palliative Care for Treating Acute Myeloid Leukemia

Jacob Strand
All
18 years to 120 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-306867-P01-RST
22-000288
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Inclusion Criteria
•Patient:

  • Hospitalized patients (age ≥ 18 years) with high-risk AML defined as:
    • Patients with new diagnosis ≥ 60 years of age;
    • An antecedent hematologic disorder;
    • Therapy related-disease;
    • Relapsed or primary refractory AML.
  • Receiving treatment with either:
    • intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or
    • hypomethylating agents +/- additional agents or modification of this regimen on a clinical trial.

Inclusion Criteria
•Caregiver:

  • Adult (≥ 18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week.

Exclusion Criteria
•Patient:

  • Patients with a diagnosis of acute promyelocytic leukemia (APML).
  • Patients with AML receiving supportive care alone.
  • Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures.

Eligibility last updated 5/10/22. Questions regarding updates should be directed to the study team contact.

 

Behavioral
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(CAMPERR) cfMeDIP-seq Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

cfMeDIP-seq Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)

Lisa Boardman
All
40 years and over
This study is NOT accepting healthy volunteers
2022-306871-P01-RST
22-000686
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Case

Inclusion Criteria:


- Newly diagnosed (within 90 days) with cancer or a recurrence of a cancer diagnosed > 5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical,
Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple
Myeloma.

- Able and willing to provide informed consent.

- ≥ 40 years of age.

Case
Exclusion Criteria:


- Currently receiving any treatment for cancer.

- Currently taking any demethylating agents/DNA hypomethylating agents.

- Simultaneously diagnosed with two or more invasive cancers.

- Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years.

- Currently diagnosed with any chronic hematopoietic cancer (e.g., chronic CLL) in addition to the index cancer.

- Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g., MGUS) in addition to the index cancer.

- Women who are known to be pregnant (self-reported).

Control
Inclusion Criteria:


- Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed).

- Able and willing to provide informed consent.

- ≥ 40 years of age.

Control
Exclusion Criteria:


- Currently receiving any treatment for cancer.

- Currently taking any demethylating agents/DNA hypomethylating agents.

- Women who are known to be pregnant (self-reported).

Eligibility last updated 9/26/22. Questions regarding updates should be directed to the study team contact.

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Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion

Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion

Adrian Vella
All
25 years to 65 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-306876-H01-RST
22-000306
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Inclusion Criteria
•Obese Subjects with Type 2 Diabetes:

  • Age ≥ 25 or ≤ 65 years.
  • HbA1c ≤ 8.5% (type 2 diabetic subjects).
  • HbA1c ≤ 6.5% (obese and lean subjects).
  • BMI ≥ 28 Kg/M^2 (Obese subjects with and without type 2 diabetes).
  • BMI ≤ 25 Kg/M^2 (Lean subjects without type 2 diabetes).
  • Use of sulfonylureas or metformin only (type 2 diabetec subjects).
  • For female subjects: negative pregnancy test at the time of enrollment or study.
  • No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • No active systemic illness or malignancy.
  • No symptomatic macrovascular or microvascular disease.
  • No contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit > 35%.
  • TSH > 0.4 or < 5.5.
  • Consumption of < 2 alcohol drinks per day or < 14 per week or a negative AUDIT questionnaire.

Exclusion Criteria
•Obese Subjects with Type 2 Diabetes:

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

Inclusion Criteria
•Obese Subjects without Type 2 Diabetes:

  • BMI ≥ 28 Kg/M^2.
  • > 5% liver fat content, as determined by MRI using the proton density fat fraction (PDFF) technique.

Exclusion Criteria
•Obese Subjects without Type 2 Diabetes:

  • Age ≤ 25 or ≥ 65 years (match subjects with T2DM).
  • HbA1c ≥ 6.5%.
  • BMI ≤ 28 Kg/M^2.
  • Use of any glucose-lowering agents including metformin or sulfonylureas.
  • For female subjects: positive pregnancy test at the time of enrollment or study.
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit < 35%.
  • TSH < 0.4 or > 5.5.
  • Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.

Inclusion Criteria - Lean Subjects without Diabetes:

  • Age ≥ 25 or ≤ 65 years (match subjects with T2DM).
  • BMI ≤ 25 Kg/M^2). 

Exclusion Criteria
•Lean Subjects without Diabetes:

  • Age ≤ 25 or ≥ 65 years (match subjects with T2DM).
  • HbA1c ≥ 6.5%.
  • BMI ≥ 25 Kg/M^2.
  • Use of any glucose-lowering agents including metformin or sulfonylureas.
  • For female subjects: positive pregnancy test at the time of enrollment or study.
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit < 35%.
  • TSH < 0.4 or > 5.5.
  • Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
  • Liver fat content ≥ 5% as determined by MRI using the proton density fat fraction (PDFF) technique.

Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.

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Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young: BTTRFLY Project (BTTRFLY)

Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young

Patricio Gargollo
All
Not specified
This study is NOT accepting healthy volunteers
2022-306881-H01-RST
22-000353
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Inclusion Criteria:

  • Patients with a diagnosis of soft tissue sarcoma.


Exclusion Criteria:

  • Unable or unwilling to provide informed consent

Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.

 

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Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Saad Kenderian
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306884-P01-RST
22-000405
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Inclusion Criteria:

  • The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable.
  • The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted.
  • In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation.


Exclusion Criteria:

  • None.

Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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MC220802 Phase II Study Evaluating Maintenance In Light chain Amyloidosis (EMILIA) (EMILA)

Light Chain Amyloidosis Maintenance Evaluation

Eli Muchtar
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306896-P01-RST
22-011048
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Inclusion Criteria

  • Age ≥ 18 years.
  • Histological confirmation of AL amyloidosis with adequate typing (mass spectrometry, immunohistochemistry, immunofluorescence, immunogold).
  • AL amyloidosis with organ disease requiring therapy NOTE: There are no limitations in baseline measurable disease parameters.
  • Patients must have monoclonal protein studies (serum free light chain assay, serum immunofixation or serum MASS-FIX) obtained at time of diagnosis before induction therapy initiated and available for review to be enrolled. Patients are allowed to participate in this study if urine electrophoresis immunofixation study was not done at time of diagnosis or cannot be obtained.
  • Patients must achievement a hematological CR (irrespective of organ response achievement) or hematological VGPR (irrespective of organ response achievement) or hematological PR with at least one organ response after receiving Dara-CyBorD-based induction. For patients not assessable for hematological response (i.e., baseline dFLC < 50 mg/L), must achieve hematological CR, or dFLC < 10 mg/L or achieved organ response prior to randomization.
  • Study allows to enroll patients in whom bortezomib and/or cyclophosphamide were omitted from induction due to toxicity concerns or adverse effects. Patients must receive at least daratumumab and dexamethasone at induction to qualify for the study.
  • ECOG Performance Status (PS) 0, 1, 2 or 3.
  • The following laboratory values obtained ≤ 28 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1000/mm^3;
    • Platelet count ≥ 50,000/mm^3.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only:
    • NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

Exclusion Criteria 

  • Any of the following because this study involves an agent that has possible genotoxic, mutagenic and teratogenic effects:
    • Pregnant person;
    • Nursing person;
    • Persons of childbearing potential {and persons able to father a child} who are unwilling to employ adequate contraception.
  • Multiple myeloma at time of diagnosis as defined by any of the following:
    • Hypercalcemia: Serum calcium > 1 mg/dL higher than upper limit of normal or > 11 mg/dL;
    • Renal insufficiency: Creatinine clearance < 40 mL per min or serum creatinine > 2 mg/dL attributed to high circulating light chains (i.e., cast nephropathy) or hypercalcemia;
    • Anemia: Hemoglobin > 2 g/dL below lower limit of normal, or < 10 g/dL, attributed to high marrow myeloma infiltration;
    • Bone lesions: ≥ 1 osteolytic lesion on skeletal x-ray, CT, or PET-CT (bone imaging is not mandatory but based on clinical suspicion);
    • Clonal bone marrow plasma cells ≥ 60%;
    • >1 focal lesion on MRI (MRI is not mandatory but based on clinical suspicion);
      • If bone imaging (CT, MRI, PET-CT) was not done at time of diagnosis it is not needed to be performed at registration to rule out bone disease;
      • ≥ 40% BMPCs irrespective of the above.
    • The study will allow patients with Involved: uninvolved sFLC ratio ≥ 100 if this is the only criteria that defines multiple myeloma if all the above criteria are not met.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy:
    • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Uncontrolled intercurrent illness including, but not limited to:
    • ongoing or active infection.
    • unstable angina pectoris.
    • psychiatric illness/social situations that would limit compliance with study requirements.

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

Eligibility last updated 10/20/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Feasibility of Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension (PAH)

Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension

Hilary DuBrock
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306899-H01-RST
22-000414
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Inclusion Criteria:

  • Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).  
  • Age ≥ 18 years.
  • On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
  • NYHA class II-III symptoms.
  • able to complete a six-minute walk test.


Exclusion Criteria:

  • Patients experiencing syncope or exertional syncope.
  • Patients not experiencing exertional dyspnea.
  • Inability to walk.
  • Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).

Eligibility last updated 3/14/22. Questions regarding updates should be directed to the study team contact.

 

 

 

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A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Andrea Wahner Hendrickson
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-306904-P01-RST
22-000456
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Inclusion Criteria:


- Advanced solid tumor

- Measurable disease, per RECIST v1.1

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

- Adequate organ function


Exclusion Criteria:


- Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the
acute toxicities of previous therapy, except treatment-related alopecia or laboratory
abnormalities otherwise meeting eligibility requirements

- Received prior chemotherapeutic, investigational, or other therapies for the treatment
of cancer within 14 days with small molecule and within 28 days with biologic before
the first dose of TORL-1-23

- Progressive or symptomatic brain metastases

- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active,
uncontrolled infection

- History of significant cardiac disease


- History of myelodysplastic syndrome (MDS) or AML

- History of another cancer within 3 years before Day 1 of study treatment, with the
exception of basal or squamous cell carcinoma of the skin that has been definitively
treated. A history of other malignancies with a low risk of recurrence, including
appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate
cancer with a Gleason score less than or equal to 6, are also not excluded

- If female, is pregnant or breastfeeding

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

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

Drug
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Reducing Opioids after Percutaneous Stone Surgery (ROPES)

Reducing Opioid Prescription After Kidney Stone Removal Surgery

Kevin Koo
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306921-H01-RST
22-000494
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Inclusion Criteria:

  • Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
  • Adults ≥ 18 years old.
  • Ability to receive and respond to electronic text messages.


Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • Patients who require Intensive Care Unit admission after surgery.
  • Patients who have Clavien grade III or greater postoperative complications requiring additional intervention < 30 days after index procedure.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

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Advanced Cardiac Imaging Processing with the MUSIC Software for Imaging Integration Into Electroanatomic Mapping for Catheter Ablation Procedures of Ventricular Arrhythmias

Imaging Integration Into Electroanatomic Mapping for Catheter Ablation Procedures of Ventricular Arrhythmias

Konstantinos Siontis
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306923-H01-RST
21-010613
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Inclusion Criteria:
           

  • Male or female adults (≥ 18 years old).
  • Frequent premature ventricular complexes or documented episode(s) of sustained VT, or evidence of appropriate ICD therapy in patients already implanted with ICDs.
  • Structural heart disease, defined as impairment of left ventricular ejection fraction on echocardiography or MRI and/or presence of structural abnormality on imaging (myocardial late gadolinium enhancement on MRI, myocardial wall thinning, hypodensity or calcification on MDCT), and/or borderline, possible or definite diagnosis of arrhythmogenic right ventricular cardiomyopathy according to modified Task Force criteria.


Exclusion Criteria:
 

  • Contraindications to VT/PVC catheter ablation:
    • Current intra-cardiac thrombus;
    • Unstable angina and other acute or reversible cause;
    • Current or anticipated participation in any other clinical trial of a drug, device or biologic.
  • Unwillingness to undergo CT and/or MRI imaging.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

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The Development of a Shared Decision Making Encounter Tool for Bone Health Management Decisions

The Development of a Shared Decision Making Encounter Tool for Bone Health Management Decisions

Juan Brito Campana
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306930-H01-RST
22-000518
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Inclusion Criteria
•Patients:

  • Adults ≥ 18 years
  • Appointment to discuss osteoporosis management

Exclusion Criteria
•Patients:

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

Inclusion Criteria
•Clinicians:

  • Clinicians who meet with patients to discuss osteoporosis management.

Exclusion Critieria
•Clinicians:

  • None

Inclusion Critieria
•PAG Members:

  • Adults ≥ 18 years
  • Member of the Knowledge and Evaluation Research (KER) Unit Patient Advisory Group (PAG)

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

 

Osteoporosis
Musculoskeletal system, Osteoporosis screening
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Evaluation of the Cardiac and Metabolic Effects of Semaglutide in Heart Failure with preserved Ejection Fraction (CAMEO-SEMA) A Phase II, Prospective, Double-Blind Randomized Trial (CAMEO SEMA)

Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction

Barry Borlaug
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306933-H01-RST
22-000522
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Inclusion Criteria:

Subjects are eligible to be randomized in the study only if all of the following inclusion criteria and none of the exclusion criteria apply. To mirror the STEP-HFpEF trials CAMEO-SEMA will utilize essentially the same entry criteria, except for an EF cutoff. CAMEO-SEMA will use an EF value of ≥ 50% (rather than ≥ 45%) to define HFpEF, to harmonize with the recently published universal definition of HFpEF.59.

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • Age ≥ 18 years at the time of signing informed consent.
  • BMI ≥ 30.0 kg/m^2.
  • NYHA Class II-IV.
  • LVEF ≥ 50 % within the preceding year.
  • No hospitalizations due to heart failure in the preceding 30 days.
  • At least one of the following:
    • Mean PCWP ≥ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≥ 15 mmHg documented during catheterization at rest, or PCWP or LVEDP ≥ 25 mmHg documented during catheterization at exercise;
    • If BMI < 35.0: NT-proBNP ≥ 220 pg/mL (for patients with sinus rhythm) or NT-proBNP ≥ 660 pg/mL (for patients with persistent/permanent atrial fibrillation); if BMI ≥ 35.0: NT-proBNP ≥ 125 pg/mL (for patients in sinus rhythm) or NT-proBNP ≥ 375 pg/mL (for patients with persistent/ permanent atrial fibrillation) at screening (NT-proBNP analyzed by the central laboratory) in combination with at least one of the following (documented by echocardiography within 12 months prior to or at screening):
      • Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
      • PA systolic pressure > 35 mmHg;
      • Left atrial (LA) enlargement (LA width ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
      • LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm.
    • Hospitalization with a primary diagnosis of decompensated heart failure which required intravenous (IV) loop diuretic treatment, within the previous 12 months in combination with at least two of the following (documented by echocardiography within 12 months prior to or at screening):
      • Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
      • PA systolic pressure > 35 mmHg;
      •  
      • LA enlargement (LA width ≥ 3.8 cm or LA length ≥  5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
      • LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm;
      • Ongoing use of diuretic therapy for at least 30 days prior to screening.


Exclusion Criteria:

Cardiovascular-related:

  • Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
  • Systolic blood pressure > 160 mmHg at screening.
  • Planned coronary, carotid or peripheral artery revascularization.
  • Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, anemia, or more than moderate heart valve disease).
    • Amyloid cardiomyopathy may be present in 5-15% of patients presenting with the clinical syndrome of HFpEF,60-62 and patients with amyloid may respond differently to WL intervention. To enhance the scientific rigor of the trial by ensuring a homogenous population of true primary HFpEF, we will carefully evaluate for the presence of amyloid using the approach outlined in a recent scientific statement from the AHA,63 which is also consistent with our current clinical practice.
  • Specifically, potential participants will be evaluated for clues or risk factors for underlying cardiac amyloid including intolerance to antihypertensives, hypotension, orthostatic intolerance, persistent low-grade elevation in troponin, low QRS voltage on ECG, unexplained AV block or prior pacemaker, unexplained LV or RV wall thickening, impaired LV global longitudinal strain with apical sparing by echocardiography, family history of cardiomyopathy, neuropathy, autonomic dysfunction, carpal tunnel syndrome,  lumbar spinal stenosis, family history of polyneuropathy, or black race. Patients with these risk factors will undergo screening evaluation for amyloid prior to consent in CAMEO-SEMA as part of best clinical practice.  This includes screening for monoclonal light chain as first step, followed by hematology consultation if the screen is positive.  Patients with risk factors but no monoclonal light chain will then undergo Tc-99m-PYP scan to rule out cardiac amyloid.

Obesity-related:

  • Bariatric surgery prior to screening or planned bariatric surgery within the trial time course.
  • A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

Glycemia-related:

  • HbA1c ≥ 6.5% based on latest available value from medical records, no older than 3 months or if unavailable at local measurement at screening.
  • History of type 1 or type 2 diabetes (history of gestational diabetes is allowed).
  • Treatment with any GLP-1 receptor agonist within 90 days prior to the day of screening.

General health and safety:

  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • Presence of acute pancreatitis within the last 180 days prior to screening.
  • History or presence of chronic pancreatitis.
  • End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis.
  • Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.
  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Participation in any clinical trial of an approved or non-approved device for the treatment of heart failure or obesity within 30 days before screening.
  • Receipt of any investigational medicinal product within 30 days before screening.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
  • Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
  • Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
  • The criteria will be assessed at the investigator’s discretion unless otherwise stated.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug, Other
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A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Stephen Ansell
All
18 years to 101 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-306939-P01-RST
22-000750
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Inclusion Criteria:


- ≥ 16 years of age at the time of obtaining informed consent

- Eastern Cooperative Oncology Group performance status of 0 or 1 at screening

- At least one PET-avid measurable lesion according to Modified Lugano Criteria after
the last line of therapy.

- Confirmed histological diagnosis of active relapse/refractory cHL

- Failed at least 2 prior lines of systemic therapy.

- No previous treatment with anti-TIM-3.

- Adequate organ and bone marrow function

- Non-pregnant women and willingness of female patients to avoid pregnancy or male
participants willing to avoid fathering children through highly effective methods of
contraception

- Minimum body weight ≥ 40 kg for all participants.


Exclusion Criteria:


- Unresolved toxicities of ≥ Grade 2 from prior therapy

- Any prior ≥ Grade 3 imAE while receiving prior checkpoint inhibitor immunotherapy

- Patients with CNS involvement or leptomeningeal disease.

- History of organ transplantation (e.g., stem cell or solid organ transplant).

- Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose
of study intervention.

- Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B,
chronic or active hepatitis C, active COVID-19 infection

- History of arrhythmia which is requires treatment, symptomatic or uncontrolled atrial
fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia

- Uncontrolled intercurrent illness.

- Active or prior documented pathologically confirmed autoimmune or inflammatory
disorders.

- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation
pneumonitis requiring steroid treatment, or any evidence of clinically active ILD

- Other invasive malignancy within 2 years prior to screening

- Congenital long QT syndrome or history of QT prolongation associated with other
medications that cannot be changed or discontinued based on a cardiologist assessment

- Current or prior use of immunosuppressive medication within 14 days prior to the first
dose of study intervention

- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal
therapy for cancer treatment.

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

Eligibility last updated 4/11/23. Questions regarding updates should be directed to the study team contact.

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