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Phase II Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab (CaboNivoIpi) in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer Whose Cancer Progressed After One Prior VEGFR-Targeted Therapy

A Study to Test the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer

Mabel Ryder
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-122889-P01-RST
19-011000
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Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed papillary thyroid cancer (PTC), follicular thyroid cancer (FTC), or Hurthle cell thyroid cancer (HTC). Follicular variant of PTC or any of the above mixed histology will be allowed, as well as tall cell, insular, or poorly-differentiated thyroid cancers. Patients with anaplastic thyroid cancers (ATC) or medullary thyroid cancers (MTC) are not eligible.
  • Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Patients must have radioactive iodine (RAI)-refractory/resistant disease as defined by one or more of the following criteria: 
    • One or more measurable lesions that do not demonstrate RAI uptake;
    • Progressive disease (PD) (new lesion or progression of previously known lesions), as defined by RECIST v1.1, within 12 months of prior RAI therapy;
    • One or more measurable lesion present after cumulative RAI dose of > 600 mCi; or 
    • Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scan-positive disease (SUV ≥ 5 in tumor lesion).
  • The patient's disease must have progressed on one line of VEGFR-targeted therapy (including, but not limited to, sorafenib, sunitinib, vandetanib, pazopanib, or lenvatinib, etc.) as defined by PD per RECIST v1.1 while receiving VEGFR-targeted therapy. Patients who have received more than one line of prior VEGFR-targeted therapy will not be eligible.
  • Prior external beam radiation to extra-osseous disease, systemic cytotoxic chemotherapy or BRAF- or non-VEGFR-targeted therapies will be allowed, provided that > 4 weeks has elapsed since receiving prior treatment. Radiation to bone metastases is allowed up to 2 weeks prior to initiation of study treatment.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status  ≤ 2 (Karnofsky ≥ 60%).
  • Patients must have recovered to baseline or ≤ Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 1 from toxicities related to any prior treatments, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy .
  • Absolute neutrophils ≥ 1,500/mcL.
  • Platelets ≥ 100,000/mcL.
  • Hemoglobin ≥ 9 g/dL.
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); ≤ 3.0 x ULN for patients with Gilbert's syndrome.
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3.0 x institutional ULN .
  • Alkaline phosphatase ≤ 3.0 x institutional ULN; ≤ 5.0 x ULN with documented bone metastases.
  • Creatinine ≤ 1.5 x ULN OR creatinine clearance (CrCl) ≥ 50 mL/min (if using the Cockcroft-Gault formula).
  • Serum albumin ≥ 2.8 g/dL.
  • Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis.
  • Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg.
  • Serum phosphorus, calcium, magnesium, and potassium within institutional normal limits.
  • Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) test < 1.3 x ULN.
  • Patients with a history of human immunodeficiency virus (HIV) infection must be on an effective anti-retroviral regimen utilizing agents that do not strongly induce or inhibit cytochrome P450 (CYP) 3A4, and must have an undetectable viral load measured within 6 months prior to study registration.
  • Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
  • The effects of XL184 (cabozantinib), nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) 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. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of study therapy. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity: 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study therapy. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of < 1% per year. Men who receive study therapy and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of study therapy. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
  • WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level < 40 mIU/mL.
  • WOCBP and men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 5 and 7 months, respectively, after the last dose of study therapy. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days.
  • Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) must inform the treating physician immediately.
  • Patients must be able to swallow tablets.
  • Patients must be able to understand be willing to sign a written informed consent document.
  • Patients with impaired decision-making capacity (IDMC) will be eligible if they have a legally authorized representative (LAR) or caregiver available to assist them.


Exclusion Criteria:
 

  • Patients must not have had prior treatment with XL184 (cabozantinib), any MET-targeting tyrosine kinase inhibitor (TKI), or any MET-targeting monoclonal antibody (MetMAb), such as onartuzumab.
  • Patients must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
  • Patients must not have a tumor invading or encasing any major blood vessels, and must not have evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum, or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of XL184 (cabozantinib).
  • Patients must not have a diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy. Adjuvant hormonal therapy for history of prostate or breast cancer is allowed.
  • Patients must not have received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 4 weeks, or nitrosoureas/ mitomycin C within 6 weeks, before the first dose of study treatment. Patients may continue on bone-modifying agents (denosumab or bisphosphonates) with caution.
  • Patients must not have received radiation therapy:
    • o the thoracic cavity, abdomen, or pelvis within 4 weeks before the first dose of study treatment; 
    • To bone metastases within 14 days before the first dose of study treatment;
    • To any other sites within 4 weeks before the first dose of study treatment.
  • Patients must not have clinically relevant, ongoing complications from prior radiation therapy. Palliative (limited-field) radiation therapy is permitted as long as the patient does not have disease progression according to RECIST v 1.1.
  • Patients must not have received any type of small molecule kinase inhibitor (including investigational kinase inhibitors) within 4 weeks before the first dose of study treatment.
  • Patients must not have received any other type of investigational agent within 4 weeks before the first dose of study treatment.
  • Patients must not have a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 msec by electrocardiogram (EKG) within 28 days before the first dose of study treatment.
    • Note: if a single EKG shows a QTcF with an absolute value > 500 msec, two additional EKGs at intervals of approximately 3 min must be performed within 30 min after the initial EKG, and the average of these three consecutive results for QTcF will be used to determine eligibility.
  • Patients should not have known, untreated brain metastases or leptomeningeal metastases because of poor prognosis and concerns that progressive neurologic dysfunction could confound the evaluation of neurologic and other adverse events. However, patients will be eligible if metastases have been treated, and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment for metastases is complete and within 28 days prior to the first dose of study treatment.
  • Patients must not require concomitant treatment with oral anticoagulants (e.g., warfarin, direct thrombin, and factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel). The following anticoagulants are allowed: 
    • Low-dose aspirin for cardioprotection (per local applicable guidelines);
    • Low-dose low molecular weight heparins (LMWH);
    • Therapeutic doses of LMWH are allowed in patients without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
  • Patients must not require systemic corticosteroids treatment (≥ 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to study drug administration. Inhaled or topical steroids and adrenal replacement doses < 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if ≥ 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as is steroid pre-medication for contrast allergy.
  • Patients must not have a history of severe hypersensitivity reactions to any monoclonal antibodies.
  • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
  • Patients must not require concomitant treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, or St. John's wort). Because lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list. Medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, patients will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • Patients must not have uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
    • Cardiovascular disorders: 
      • Congestive heart failure New York Heart Association (NYHA) class 3 or 4;
      • Unstable angina pectoris;
      • Serious cardiac arrhythmias;
      • Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment within seven days prior to the first dose of study treatment;
      • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis [DVT], pulmonary embolism [PE]) within 6 months before first dose.
    • GI disorders including those associated with a high risk of perforation or fistula formation: 
      • The patient has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction;
      • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Complete healing of an intra-abdominal abscess must be confirmed before first dose.
    • Clinically significant hematuria, hematemesis, or hemoptysis or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose.
    • Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
    • Lesions invading or encasing any major blood vessels.
    • Other clinically significant disorders that would preclude safe study participation:
      • Serious non-healing wound/ulcer/bone fracture;
      • Uncompensated/symptomatic hypothyroidism;
      • Moderate-to-severe hepatic impairment (Child-Pugh B or C).
  • Patients must not have had major surgery (e.g., GI surgery or removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment and from minor surgery (e.g., simple excision or tooth extraction) at least 10 days before the first dose. Patients with clinically relevant ongoing complications from prior surgery are not eligible.
  • Pregnant women are excluded from this study because XL184 (cabozantinib) has the potential for teratogenic or abortifacient effects, and the effects of nivolumab and ipilimumab on the developing fetus are not well known. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued if the mother is treated with XL184 (cabozantinib), nivolumab, or ipilimumab.
  • Patients with ac
Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Head and neck cancer, Thyroid cancer
Biological therapy for cancer, Cabozantinib, Cancer treatment, Chemotherapy, Endocrine system, Ipilimumab, MDX-1106, Medical Oncology, Primary differentiated carcinoma of thyroid gland, Targeted drug therapy, cabozantinib, ipilimumab, nivolumab
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Mayo Clinic — Rochester, MN

Adapting a Smartphone-Delivered Self-Management Program and Behavioral Intervention for Positive Airway Pressure Therapy Initiation and Maintenance to Enhance Patient-Reported Outcomes and Patient-Provider Communication among Stroke Survivors with Obstructive Sleep Apnea

A Study to Evaluate the Use of a Smartphone App for Stroke Patients with Obstructive Sleep Apnea

Lori Rhudy
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122906-H01-RST
19-011113
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Inclusion Criteria
•Aim 1:

  • Clinical diagnostic testing via laboratory or home-based sleep study indicates diagnosis of obstructive sleep apnea.
  • Currently use an appropriate Apple (iOS9 or higher) or Android (4.2 or higher) smartphone device.
  • Able to read and understand English.
  • Prescribed continuous or auto-titrated PAP treatment for obstructive sleep apnea.
  • Stroke diagnosis with stroke event occurring within 36 months.

Inclusion Criteria
•Aim 2:
 

  • Clinical diagnostic testing via laboratory or home-based sleep study indicates diagnosis of obstructive sleep apnea.
  • Currently use an appropriate Apple (iOS9 or higher) or Android (4.2 or higher) smartphone device.
  • Able to read and understand English.
  • Prescribed continuous or auto-titrated PAP treatment for obstructive sleep apnea.
  • Stroke diagnosis with stroke event occurring no more than 10 years prior to referral to Center for Sleep Medicine.
  • Functional and cognitive  ability to manage smartphone application and PAP device with minimal to no assistance.
  • Agree to using a smartphone application and wearable wrist sensor.

Inclusion Criteria
•Aim 3:

  • Health care provider (MD, APRN, PA, RN) providing care to patients with OSA and history of stroke.
  • Sleep Medicine.
  • Primary Care.


Exclusion Criteria:
 

  • Communication or cognitive impairments that limit ability to read and/or follow directions.
  • Currently participating in other lifestyle programs (e.g., active, formal weight loss program or research study; smoking cessation program, etc.).
  • Has lost 10lb or 4.5kg or more over the past 4 weeks.
  • Other acute or severe health, cognitive, or psychological conditions that prevent participation.
  • Self-report of pregnant, lactating, or trying to become pregnant.
  • Decide to use different PAP device than ResMED Airsense 10.
  • Prescribed high-dose benzodiazepines (equivalent to > 1 mg lorazapam/night).
  • Daily opioid medication use at night.
  • Unwilling to discontinue use of any current wearable sensor for the duration of the trial.
  • Previous documented history of treatment/referral for claustrophobia.
  • Previous PAP use.
  • Other conditions determined by a sleep medicine team member that may interfere with full participation in the trial.
  • Planning to travel for more than seven consecutive nights during the trial.
  • Currently engaging in shiftwork defined as night shift or rotating day and night shifts.
  • Unwilling to have an in-person follow-up appointment at the Center for Sleep Medicine in Rochester.

 

    Behavioral, Other, Health technology assessment procedure
    Obstructive sleep apnea, Sleep apnea, Stroke
    Cerebrovascular accident, Nervous system, Obstructive sleep apnea syndrome, Uses home continuous positive airway pressure ventilation supply
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    Mayo Clinic — Rochester, MN

    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients with Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) Who Have an Inadequate Response with, Lost Response to, or Were Intolerant to Standard Therapies

    A Study to Evaluate the Safety and Effectiveness of AK002 in Patients with Active Eosinophilic Gastritis

    Joseph Murray
    All
    18 years to 80 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    0000-122923-P01-RST
    19-011316
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    Inclusion Criteria:

    • Provide written informed consent.
    • Male or female aged ≥ 18 and < 80 years at the time of signing the informed consent for entry.
    • Baseline endoscopic biopsy with ≥ 30 eosinophils/hpf in 5 hpf in the stomach and/or ≥ 30 eosinophils/hpf in 3 hpf in the duodenum, as determined by central histology assessment of biopsies collected during the screening EGD, without any significant cause for the eosinophilia.
    • Prior EGD may be used for eligibility as long as the EGD occurred within 30 days of the first screening visit for the AK002-016 study and was performed and centrally assessed as for the AK002-016 study.
    • Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.
    • A weekly average score of abdominal pain, nausea, and/or diarrhea ≥ 3 on the PRO questionnaire (score from 0–10) and a weekly average TSS of ≥ 10 for at least 2 weeks of screening.
    • Patients with inadequate or loss of response to, or who were intolerant to standard therapies for EG/EoD symptoms which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others.
    • If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study.
    • Willing and able to comply with all study procedures and visit schedule including follow-up visits.
    • Female patients must be either post-menopausal for at least 1 year with FSH level > 30 mIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.

    Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.


    Exclusion Criteria:

    • Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day of prednisone within 4 weeks prior to the screening visit.
    • Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to screening.
    • Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit.
    • Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug.
    • Active Helicobacter pylori infection, unless treated and confirmed to be negative prior to randomization and histology per repeat EGD and symptoms still qualify for enrollment after treatment.
    • Confirmed history of inflammatory bowel disease, celiac disease, achalasia, or esophageal surgery.
    • History of bleeding disorders and/or esophageal varices considered to be clinically significant by the Investigator.
    • Other significant causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA).
    • Confirmed diagnosis of Hypereosinophilic Syndrome (HES).
    • Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
    • Presence of an abnormal laboratory value considered to be clinically significant by the Investigator.
    • Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
    • History of malignancy, except carcinoma in situ, early stage prostate cancer, or non-melanoma skin cancers. However, cancers that have been in remission for more than 5 years and are considered cured, can be enrolled.
    • Treatment for a clinically significant helminthic parasitic infection within 6 months of screening.
    • Positive helminthic infection on Ova and Parasite (O&P) test.
    • Seropositive for Strongyloides stercoralis at screening, except for patients with past but resolved disease.
    • Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved disease.
    • Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. All types and formulations of vaccines (including live attenuated vaccines) authorized by FDA or other regulatory authority for the prevention of COVID-19 may be administered before, during, or after this study. The vaccine should not be administered within 7 days prior to and within 7 days after the administration of AK002 so that any side effects caused by either of the 2 medications can be more easily determined.
    • Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration or 90 days or 5 half-lives, whichever is longer, for biologic products.
    • Known history of alcohol, drug, or other substance abuse or dependence that is considered by the Investigator to be ongoing and clinically significant.
    • Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment.
    Drug, Other, Drug therapy
    Eosinophilic gastroenteritis, Gastritis, Gastroenteritis
    Digestive system, Eosinophilic duodenitis, Eosinophilic gastritis, Eosinophilic gastroenteritis
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    Mayo Clinic — Rochester, MN

    Resilient Living program for Patients with Advanced Cancer and Their Caregivers

    A Study to Evaluate A Resilient Living Program for Patients with Advancer Cancer and Their Caregivers

    Deirdre Pachman
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    0000-122943-H01-RST
    19-011510
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    Inclusion Criteria
    •Patients:

    • Age  ≥ 18 years old.
    • English fluency.
    • No diagnosed severe cognitive impairment.
    • Diagnosis of advanced, incurable solid tumor cancer.
    • Expected prognosis > 6 months.
    • Provide informed consent (written or electronic).
    • Ability to complete questionnaire(s) by themselves or with assistance.
    • Patient baseline distress score ≥ 4/10 OR identified as having distress that would benefit from program by care team or provider.
    • Ability to do first Resilient Living session in person.

    Inclusion Criteria - Caregivers:

    • Self-identifies as a caregiver of a patient that meets the above cancer diagnosis criteria, and who also participates in the study.
    • Provide informed consent (written or electronic).
    • Ability to complete questionnaire(s) by themselves or with assistance.
    • Age ≥ 18 years old.
    • English fluency.
    • No diagnosed severe cognitive impairment.
    • Ability to do first Resilient Living session in person.


    Exclusion Criteria:
     

    • As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded.
    • Other psychological co-morbidities such as untreated schizophrenia, bipolar disease.
    • Participated in the Mayo Clinic study entitled “Feasibility and Acceptability of a Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals with Advanced Cancer Undergoing Outpatient Chemotherapy."

     

    Behavioral, Other
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    Mayo Clinic — Rochester, MN

    A Phase 1b, Single-blind, Placebo-controlled, Adaptive Design, Outpatient Trial to Assess the Effects of Single Oral Tablet Doses of OPC-214870 on Photic-induced Paroxysmal Electroencephalogram Responses in Subjects Who Have Demonstrated Photoepileptiform Discharges on Electroencephalogram With or Without Seizures

    A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870

    David Burkholder
    All
    18 years to 64 years old
    Phase 1
    This study is NOT accepting healthy volunteers
    0000-122947-P01-RST
    19-011533
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    Inclusion Criteria:

    • Male and female subjects between 18 and 64 years of age, inclusive.
    • Body mass index (BMI) between 18 and 40 kg/m^2, inclusive.
    • Subjects with a diagnosis and history of photoparoxysmal response on EEG.
    • Subjects must be stable for 1 month prior to screening. Stable is defined as having no change in concomitant therapy and no worsening in the opinion of the investigator.
    • Subjects may be treatment-naïve to AEDs or currently treated with up to 3 AEDs.
    • Subjects must have a reproducible standardized photosensitivity range on EEG of at least 3 points in at least 1 eye condition.
    • Subjects who agree to remain abstinent, or practice double-barrier forms of birth control, from trial to screening through 90 days after the last dose of IMP, OR males and females of non-childbearing potential who are documented as sterile (i.e., male subjects who have undergone bilateral orchidectomy and female subjects who have undergone bilateral oophorectomy, bilateral salpingectomy, or hysterectomy, or who have been postmenopausal for at least 12 months.


    Exclusion Criteria:

    • History of non-epileptic seizures.
    • History of status epilepticus in the past 5 years.
    • An active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease, or any CNS disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results.
    • Positive urine drug screen for substance of abuse or upon check in to the trial site. Benzodiazepines are excluded as a drug of abuse, but are allowed as rescue medication or when part of subject's stable concomitant medication at enrollment.
    • History of drug and/or alcohol abuse within 24 months prior to screening.
    • Consumption of grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 7 days prior to dosing.
    • Consumption of more than 1 alcoholic drink within 24 hours prior to dosing. Food and beverages containing methylxanthines (caffeinated coffee, caffeinated tea, caffeinated soda, and chocolate) must remain stable throughout the trial.
    • Extreme physical activity within 24 hours before screening and visit.
    • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
    • Subject having taken an investigational drug within 30 days preceding screening.
    • Use of over-the-counter drugs, herbal medicines, or vitamin supplements within 14 days or 5 half-lives, whichever is longer, prior to dosing and antibiotics within 30 days prior to dosing.
    • Subjects who had neurosurgery in last 6 months. -Subjects on a ketogenic diet.
    • History of significant sleep disorders, or any disorder or activity that causes sleep deprivation.
    • Subjects who work "night shifts."
    • Subjects with uncontrolled sleep disorders; subjects should be on a stable dose of sleep medications.
    • History of, or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV), and/or HIV antibodies.
    Drug therapy, Drug, Other
    Epilepsy
    Epilepsy, Nervous system
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    Mayo Clinic — Rochester, MN

    The Impact of Automated Zonal Control of Indoor Air Pollutants on Cardiopulmonary Health, Sleep Quality, the Human-indoor Microbiome, and Comfort in a Simulated Apartment

    A Study to Evaluate the Impact of Automated Zonal Control of Indoor Air Pollutants in a Simulated Apartment

    Bruce Johnson
    All
    25 years and over
    This study is NOT accepting healthy volunteers
    0000-122958-P01-RST
    19-011638
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    Inclusion Criteria:

    • Individuals 25 years of age or over.
    • Individuals with a regular schedule of at least 5 working days a week that are not shift work.
    • Ability to relocate to the Well Living Lab for four weeks (25 nights).
    • Willing to remain in the lab after waking up until all specimens and measures are completed.
    • Ability to fulfill scripted tasks, including cooking and cleaning.
    • Ability to have blood drawn and urine samples collected one time prior to move-in and two times per week for a four-week period.
    • Ability to provide informed consent.


    Exclusion Criteria:
     

    • Individuals with abnormal blood tests of lipids or biomarkers of liver and kidney dysfunction.
    • Individuals who are smokers or having quit smoking <1 year prior.
    • Individuals who have a respiratory infection.
    • Individuals who have signs and symptoms of obstructive pulmonary disease, asthma, heart failure or cardiac arrhythmia.
    • Individuals who use corticosteroids, anti-arrhythmic medication, beta-blockers, anti-inflammatory drugs or aspirin.
    • Individuals who have occupations with increased air pollution exposure.
    • Women who are pregnant or intend to become pregnant during the duration of the study.
    • Women who are experiencing menopausal transition.
    • Individuals with a history of mood or psychiatric disorders.

    Individuals who perform shift work.

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    Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.

    A Study to Evaluate Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker

    Andres Acosta
    All
    18 years to 75 years old
    Not Applicable
    This study is NOT accepting healthy volunteers
    0000-122966-H01-RST
    19-011697
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    Inclusion Criteria:

    • Adults with obesity (BMI > 30Kg/m^2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
    • Age: 18-75 years old.
    • Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment.
    • Women of childbearing potential must agree to use a method of effective contraception during study participation.
    • Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to download the VitalCare (VitalTech Affiliates LLC) application from the Apple App Store.
    • Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures.


    Exclusion Criteria:

    • History of Abdominal bariatric surgery.
    • Weight is greater than 450 lbs. (204 kg).
    • Recent use (within the last three months) of any antiobesity medication.
    • Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months).
    • Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption; e.g., orlistat, within the last 6 months.
    • Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score > 11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
    • Hypersensitivity or contraindication to the study medication.
    • Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent.
    • Principal Investigator discretion.
    Drug, Other
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    An Early Feasibility Study to Explore a Novel Objective Pain Measurement Using a Wearable Biosensor and a Novel Mobile Platform in Patients with Endometriosis (OPINE) (OPINE)

    A Study to Evaluate a Wearable Biosensor and Mobile Platform in Endometriosis Patients

    Tatnai Burnett
    Female
    21 years to 49 years old
    This study is NOT accepting healthy volunteers
    0000-122972-P01-RST
    19-011719
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    Inclusion Criteria:

    • Able to give a written Informed Consent Form.
    • Patient who is willing to comply with study restrictions including E4® device management (wearing and charging the device) and Femme Rhythm Patient App Management (pairing E4® device and the patient Femme Rhythm App, and carrying the smartphone for answering questionnaires and data reporting).
    • Female patients aged ≥ 21 and < 50 years.
    • Patient who meets either A or B or both in the following criteria:
      • Confirmed diagnosis of endometriosis (laparoscopy/laparotomy) performed WITHIN 10 YEARS prior to the study participation;
      • Current clinical diagnosis (endometriotic cysts or deep infiltrating endometriosis detected by TVUS, TRUS or MRI) WITHIN 6 MONTHS prior to the study participation.
    • Patient who meets either A or B in the following criteria:
      • Patient is NOT treated with hormonal agents for endometriosis WITHIN 4 WEEKS prior to study participation, and have reqular menses (i.e., 21-38 days) within 38 days prior to the study participation;
      • Patient started hormonal agents for endometriosis, including combined oral contraceptives MORE THAN 8 WEEKS prior to the study participation, or progestins, danazol, GnRH agonists, GnRH antagonists or Progesterone and Levonorgestrel Releasing IUDs MORE THAN 12 WEEKS prior to the study participation, AND stable use of the medication is expected during the study period 6. Patient has a moderate to severe endometriosis associated pelvic pain using the Monthly Assessment of Endometriosis Pain within 28 days prior to study participation.


    Exclusion Criteria:

    • Patient is pregnant, or breast feeding or is planning a pregnancy during participation of the study or is less than 6 months postpartum, post-abortion, or post-pregnancy before participation.
    • Patient has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain (e.g., pelvic inflammatory disease).
    • Patient has more than five surgical histories in pelvic area.
    • Patient has a skin disease or condition that would interfere with the collection or interpretation of physiological data obtained through E4®
    • Patient required neuromodulator (a long-acting or immediate release narcotic, or gabapentin) during 3 months prior to the study participation.
    • Patient has a planned surgery during the study.
    • Patient had a surgery within 4 weeks prior to the study participation.
    • Patient has a planned trip overseas during the study participation.
    • Any other reason that, in the judgment of the investigator, would render the subject unsuitable for the study participation.
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    Longitudinal Study Evaluating Postpartum Recovery After Scheduled Cesarean Delivery with the Obstetric Quality of Recovery Tool

    A Study to Evaluate Postpartum Recovery After Cesarean Delivery Using the Obstetric Quality of Recovery Tool

    Emily Sharpe
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    0000-123005-H01-RST
    19-012077
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    Inclusion Criteria:

    • Women 18 years of age or older.
    • Patients who receive neuraxial anesthesia for elective cesarean delivery.
    • Singleton or multiple gestations.


    Exclusion Criteria:

    • Age < 18 years old.
    • Gestational age < 32 weeks.
    • Women whose infants have died or are in the neonatal intensive care unit after delivery.
    • Inability to read or understand written English.
    • Failed neuraxial anesthesia requiring general anesthesia.
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    The Role of WNT/b-catenin Signaling in Human Alveolar Macrophages (AMs) in Modulating Host Defense and Pulmonary Inflammation

    A Study to Evaluate the Role of WNT/b-catenin Signaling in Human Alveolar Macrophages (AMs) in Adjusting Inflammation

    Jie Sun
    All
    Not specified
    This study is NOT accepting healthy volunteers
    0000-123010-H01-RST
    19-012187
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    Inclusion Criteria:

    • Children 0-18-years-old.
    • Children who undergo flexible bronchoscopy with BAL as above part of their clinical management.


    Exclusion Criteria:

    • Exclusion criteria for the control and PBB groups included the presence of hereditary.
    • Respiratory diseases (such as cystic fibrosis), clinical history of primary aspiration, neuromuscular problems.
    • Primary or secondary immune deficiencies, invasive infections such as Mycobacterium tuberculosis.

     

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    Batch Enrollment for an Artificial Intelligence-Guided Intervention to Lower Neurologic Events in Patients With Unrecognized Atrial Fibrillation (BEAGLE) (BEAGLE)

    Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF

    Xiaoxi Yao
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    0000-123025-H01-RST
    19-012411
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    Inclusion Criteria:

    • Adult patients (18 years or older) who have had a 10-second 12-lead ECG at Mayo Clinic and have a CHA2DS2-VASc ≥ 2 for men or CHA2DS2-VASc ≥3 for women.
    • Adult patients who have AI-detected AF and are eligible for anticoagulation will be eligible for the first group of patients.
    • Adult patients who do not have AI-detected AF but are similar to the first group in other aspects will be eligible as part of the second group of patients.


    Exclusion Criteria:

    • Patients with diagnosed atrial fibrillation or atrial flutter, on anticoagulation or have another indication for anticoagulation (e.g., mechanical valve), missing DOB or sex in EHR, history of intracranial bleeding, history of end-stage kidney disease, or have an implantable cardiac monitoring device (pacemaker, debfibrillator, implanted loop recorded).
    • Patients who are deemed by research personnel to have limitations that would prevent them from being able to provide informed consent, use the patch, or complete interviews will not be included.
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    Effect of Olorinab on Gastrointestinal Transit in Patients with Irritable Bowel Syndrome

    A Study to Evaluate the Effect of Olorinab on Gastrointestinal Transit in Patients with Irritable Bowel Syndrome

    Michael Camilleri
    All
    18 years to 70 years old
    Phase 1/2
    This study is NOT accepting healthy volunteers
    0000-123045-P01-RST
    19-012613
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    Inclusion Criteria:

    • Individuals aged 18 to 70 years, inclusive, at Screening.
    • Clinical diagnosis of IBS-C or IBS-D according to Rome IV criteria at Screening.
    • Body mass index (BMI) 18.0 to 40.0 kg/m2, inclusive at Screening.
    • Understands the study procedures, is willing and able to comply with the study procedures, and is able to give informed consent.
    • Negative test results for alcohol and selected drugs at Screening and Day 1.
    • Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative for human immunodeficiency virus (HIV) antibody screens at Screening.
    • Subjects with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool) are to have had a diagnostic colonoscopy prior to Screening and after the onset of alarm features (for subjects with alarm features) to exclude non-IBS conditions per the Rome IV diagnostic algorithm for IBS.
    • If treated with any of the following medications, dosing must be stable for 90 days prior to Screening and the subject must agree to maintain the same dose of  medication throughout the study:
      • Tricyclic antidepressants, tetracyclic antidepressants (e.g., mirtazapine), selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), or anticonvulsants (e.g., pregabalin or gabapentin) for conditions other than IBS pain;
      • Benzodiazepines or non-benzodiazepine hypnotics, administered at bedtime for conditions other than IBS pain.


    Exclusion Criteria:

    • Pregnant or lactating.
    • Structural or metabolic diseases/conditions that affect the gastrointestinal system.
    • Diagnosis of IBS-M or unsubtyped IBS (IBS-U).
    • Unable to withdraw the following medications that alter GI transit for 72 hours prior to baseline colonic transit assay through the duration of treatment period, with the exception of rescue medicine usage (bisacodyl and loperamide):
      • Stimulant laxatives, osmotic laxatives, magnesium or aluminum-containing antacids, over the counter fiber, stool softeners, probiotics, bismuth subsalicylate, prokinetics;
      • Antibiotics, anticholinergics, antidiarrheals, antiflatulence agents, antispasmodics, chloride channel activators, bile acid sequestrants, cholinomimetics, 5-HT3 antagonists, 5-HT4 agonists, guanylate cyclase C agonists, opioid agonists or antagonists, sodium-proton exchanger NHE3 inhibitors.
        • Note: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection, and birth control pills or depot injections are permissible.
    • Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Screening and for the duration of the study that may confound efficacy assessments in the clinical judgment of the Investigator (or designee).
    • Any colonic or major abdominal surgery (e.g., bariatric surgery [including gastric banding], cholecystectomy, stomach surgery, small-/large-bowel surgery, or abdominal large vessel surgery), except that in IBS-C subjects a history of cholecystectomy more than 6 months prior to Screening is allowed. Procedures such as appendectomy, hysterectomy, caesarean section, or polypectomy are allowed as long as they have occurred at least 3 months prior to Screening.
    • History of colorectal cancer, inflammatory bowel disease, diverticulitis, ischemic colitis, microscopic colitis, bile acid diarrhea, or celiac disease.
    • History of organic abnormalities of the GI tract, intestinal obstruction, stricture, toxic megacolon, GI perforation, or impaired intestinal circulation (e.g., aortoiliac disease).
    • Other GI diseases such as peptic ulceration, GI bleeding, or GI inflammatory disease (e.g., esophagitis, gastritis, or duodenitis) within 6 months prior to Screening. The following conditions will not exclude a subject: acute gastritis that resolved without complication,
    • and gastroesophageal reflux disease (GERD).
    • Use of any of the following medications within 30 days prior to Screening and for the duration of the study:
      • Opioids;
      • The following are excluded if they are prescribed for IBS pain: tricyclic antidepressants, tetracyclic antidepressants (eg, mirtazapine), SSRIs, SNRIs, anticonvulsants (e.g., pregabalin or gabapentin);
      • Medical or recreational marijuana, tetrahydrocannabinol (THC), cannabidiol (CBD), synthetic cannabinoids, or other cannabis derivatives for any indication;
      • Benzodiazepines, or non-benzodiazepine hypnotics, unless administered at bedtime for conditions other than IBS pain.
    • Use of cigarettes or any other nicotine-containing products within 30 days of Screening.
    • Prior (within 15 days of Screening) or anticipated concomitant use of GI antibiotics.
    • Ongoing treatment with GLP-1 or amylin analogues or agonists.
    • Any elective major surgery planned or anticipated at any time during the study.
    • History of pancreatitis of any etiology, cholecystitis, or symptomatic gallbladder stone disease within 6 months prior to Screening.
    • Have received tube feeding, defined formula diets, or parenteral alimentation within 30 days prior to Screening.
    • History of cerebrovascular disease (e.g., stroke, transient ischemic attacks), acute coronary syndrome, myocardial infarction, or unstable angina within 6 months prior to Screening.
    • History or presence of:
      • Risk factors for Torsade de Pointes (eg, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
      • Sick sinus syndrome, second or third-degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QT interval corrected by Fridericia's formula (QTcF) interval, or clinically significant conduction abnormalities.
    • Clinically significant cardiac history or presence of ECG findings as judged by the Investigator or qualified designee at Screening or Day 1, including each criterion as listed below:
      • Abnormal sinus rhythm (heart rate < 40 or > 100 beats per minute [bpm]);
      • QTcF interval > 470 ms (If there is an abnormal result, ECGs are to be repeated 3 times to obtain a mean QTcF before excluding patient);
      • QRS interval ≥ 110 ms;
      • PR interval ≥ 220 ms.
    • Uncontrolled hypertension with an abnormal supine blood pressure defined as a systolic blood pressure (SBP) ≥ 160 mm Hg or a diastolic blood pressure (DBP) ≥ 100 mm Hg, confirmed by at least 1 repeated measurement at Screening.
    • Tachycardia defined as a resting heart rate ≥ 120 bpm or bradycardia defined as a resting heart rate of ≤ 40 bpm, confirmed by at least 1 repeated measurement at Screening.
    • Hypotension with an abnormal supine blood pressure defined as SBP < 90 mm Hg or DBP < 60 mm Hg, confirmed by at least 1 repeated measurement at Screening.
    • Orthostatic hypotension consisting of SBP decrease of ≥ 20 mm Hg or a DBP decrease of ≥ 10 mm Hg approximately 3 minutes after standing from a 5-minute supine position, confirmed by at least 1 repeated measurement at Screening.
    • Hepatic dysfunction (history of cirrhosis or abnormal serum alanine aminotransferase [ALT] or aspartate transaminase [AST] > 3 × upper limit of normal [ULN]); total direct bilirubin > 2 × ULN, or alkaline phosphatase > 2 × ULN at Screening.
    • Clinically significant renal insufficiency (i.e., serum creatinine > 2.5 mg/dL or estimated glomerular filtration rate [eGFR] ≤ 60 mL/min/1.73 m2) based on CKD-EPI equation at Screening.
    • History of insulin-dependent diabetes mellitus.
    • Significant history or clinical manifestation of any endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, GI, neurological or psychiatric disorder, malignancy (with the exception of treated basal cell carcinomas), or any other condition as determined by the Investigator (or designee), that would prevent the individual from participating in the study due to risk to the scientific validity of study assessments or to personal well-being of the subject.
    • History of severe head injury or history of seizures.
    • Current suicidal ideation or history of suicide attempt or a hospitalization for a major psychiatric condition within 1 year prior to Screening.
    • History of alcohol use disorder or substance use disorder within 2 years of Screening.
    • Subjects who do not agree to use a highly effective method of contraception if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (ie, actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of study treatment for female subjects and for 90 days after the last dose of study treatment for male subjects. Highly effective methods of contraception include the following:
      • Oral, implantable, transdermal or injectable contraceptives (starting ≥ 60 days before administration of study treatment) in combination with diaphragm with vaginal spermicide, cervical cap with vaginal spermicide, or male condom;
      • Standard intrauterine device (IUD; e.g., Copper T 380A IUD), intrauterine system (IUS; e.g., LNg 20 IUS
        •progesterone IUD), progesterone implant, or tubal sterilization (≥ 6 months after surgery) in combination with a female condom with spermicide, a diaphragm with vaginal spermicide, cervical cap with vaginal spermicide, or male condom;
      • Post vasectomy and male condom, partner using diaphragm with spermicide, cervical cap with spermicide, estrogen and progesterone oral contraceptives (“the pill”), estrogen and progesterone transdermal patch, vaginal ring, or progesterone
      • injection;
      • Complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. If a subject who is abstinent at the time of signing the informed consent form (ICF) becomes sexually active they must agree to use contraception as described previously;
      • Females who are surgically sterile (defined as women with documentation of prior hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as: 12 consecutive months with no menses without an alternative medical cause) are not considered to be of childbearing potential; otherwise women are considered to be of childbearing potential;
      • Male study participant must agree to utilize medically acceptable methods of contraception as described above with female partners of childbearing potential.
    • Use of any prescription medications/products or available over the counter (e.g., St John’s wort) which are known to chronically alter drug absorption or elimination processes and/or are known to induce or inhibit cytochrome P450 (CYP) 3A4/5 within 30 days or 5 half-lives (whichever is longer) prior to Screening.
    • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator or history of severe allergies (e.g., any history of anaphylaxis to medication[s] or allergens and/or asthma requiring hospitalization).
    • Identified active infection and/or fever (defined as axillary or forehead temperature ≥ 37.4°C, oral temperature ≥ 37.7°C, or rectal or ear temperature ≥ 38.3°C) at Screening or Day 1.
    • Blood donation or significant blood loss within 8 weeks prior to Screening.
    • Plasma donation within 7 days prior to Screening.
    • Participated in another clinical study (e.g., investigational drug or device study) within 30 days or 5 half-lives (whichever time period is longer) or 6 weeks for biologic therapies prior to Screening.
    • Consumption of foods and beverages containing grapefruit or Seville oranges within 14 days prior to Day 1.
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    GUARD-AF: ReducinG Stroke By Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals (GUARD-AF)

    A Study to Evaluate Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals

    David Rushlow
    All
    70 years and over
    Post Market
    This study is NOT accepting healthy volunteers
    0000-123055-P01-RST
    19-012705
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    Inclusion Criteria

    • Men and women, ≥ 70 years of age.
    • New or established patients in the primary care practice.
    • Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the CMS Medicare Claims Database and to access data from health records.
    • Health insurance by Medicare Parts A & B (Medicare Fee-for-service).


    Exclusion Criteria:

    • Oral anticoagulation (OAC) for any indication at the time of enrollment.
    • History of atrial fibrillation (AF) or atrial flutter (AFL) as documented in the patient’s current medical problem list.
    • Any condition the investigator considers a contraindication to OAC; e.g., bleeding that required medical attention or severe renal impairment.
    • Any condition the investigator considers will prevent compliance with study instructions.
    • Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders).
    • History of allergy to adhesive.
    • Patient is not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver
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    Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated into the iAPS in Pregnant Patients with Type 1 Diabetes with Extension into Outpatient at Home

    Evaluation of the Zone-MPC Control Algorithm Integrated into the iAPS in Pregnant Patients with Type 1 Diabetes

    Yogish Kudva
    Female
    18 years to 45 years old
    This study is NOT accepting healthy volunteers
    0000-123020-P01-RST
    19-012342
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    Inclusion Criteria:

    • Age ≥ 18 and ≤ 45 years at the time of screening.
    • Clinical diagnosis of type 1 diabetes.
    • Currently using an insulin pump at the time of screening.
    • HbA1c ≤ 9%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit.
    • Pregnant 140/7 to 326/7 weeks gestation.
    • Singleton pregnancy without any other significant known complications, such as preeclampsia, premature rupture of membranes, 2nd/3rd trimester bleeding, fetal growth or fluid abnormalities.
    • No proven or suspected fetal malformations diagnosed in the current pregnancy.
    • Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
    • Willing to switch to Novolog or Humalog, or continue Novolog or Humalog for the duration of closed-loop use.
    • Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
    • Willing to abide by the study protocol and use study-provided devices.
    • Have a care partner with the following responsibilities: knowing subject whereabouts and being promptly available for contact by study staff during the day and night, residing in the same dwelling as subject during the night, being agreeable to all device training during the supervised HCL session and additional training on hyper- and hypoglycemia treatment, and assisting with emergency care if needed, such as transportation to the hospital or emergency department.


    Exclusion Criteria:

    • Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination.
    • Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
    • Hemophilia or any other bleeding disorder.
    • Prior history of Preterm Premature Rupture of Membranes (PPROM).
    • Significant hyperemesis interfering with carbohydrate intake.
    • Laboratory results:
      • A1C > 9%;
      • Abnormal liver or renal function (Transaminase > 2 times the upper limit of normal, creatinine > 1.5 mg/dL);
      • Liver and renal function testing drawn at screening visit or within three months prior to screening (for other purposes) will suffice for enrollment purposes,
    • Dermatological conditions that would preclude wearing a CGM sensor or infusion site.
    • Any condition that could interfere with participating in the trial, based on investigator judgment.
    • Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
    • Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
    • History of severe hypoglycemia in the past 6 months.
    • History of DKA requiring hospitalization in the past 6 months.
    • Significant chronic kidney disease (eGFR < 60) or hemodialysis.
    • Significant liver disease.
    • History of adrenal insufficiency.
    • History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated.
    • History of high dose steroid use in the past 8 weeks.
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    A Phase I Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity o f Ascending Doses of PT0I (Pegtomarginase) in Subjects With Advanced Malignancies (PT01)

    A Study to Assess the Safety and Dose Escalation of Pegtomarginase (PT01)for Subjects with Advanced Malignancies

    Wen Wee Ma
    All
    18 years and over
    Phase 1
    This study is NOT accepting healthy volunteers
    0000-101155-P01-RST
    19-009924
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    Inclusion Criteria:

    • Able to understand and voluntarily sign an informed consent form (ICF).
    • Male and female adults ≥ 18 years of age at the time of informed consent 
    • Advanced solid malignancies for which no standard therapy is available. Subjects in whom available standard therapy is contraindicated may be eligible. 
    • For Dose Expansion Phase
      •Expansion Group A:
      • Histologically confirmed unresectable locally advanced or metastatic (AJCC stage IIIB, IIIC, or IV) cutaneous malignant melanoma for which no standard therapy is suitable. 
    • At least 1 measurable site of disease as defined per RECIST v1.1 criteria (Dose Expansion Phase) or evaluable disease (Dose Escalation Phase only).
    • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
    • Life expectancy of > 12 weeks.
    • Adequate hematologic status within 28 days prior to dosing as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: 
      • Absolute neutrophil count (ANC) ≥1.5 × 109/L
      • Platelet count ≥ 100 × 10^9/L 
      • Hemoglobin ≥ 90 g/L.
    • Adequate liver function as demonstrated by:
      • Serum bilirubin < 2 × the upper limit of normal (ULN);
      • Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN or ≤ 5 × ULN in subjects with liver metastases;
      • Gamma-glutamyl transferase ≤ 5 × ULN ;
      • Alkaline phosphatase ≤ 3 × ULN or ≤ 5 × ULN if bone or liver metastasis is present,
    • Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula.
    • Prothrombin time (PT) (or International Normalized Ratio [INR]) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN or within the intended therapeutic range within 72 hours before the first dose of study drug in subjects receiving anticoagulant therapy.
    • Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
    • Absence of any other malignancy which has been active or treated within the past 3 years, except for cervical intraepithelial neoplasia, and nonmelanoma skin cancers (basal cell and squamous cell carcinomas).
    • Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) OR agree to use a condom with spermicide and to not donate sperm during the study and for at least 90 days following last dose of PT01.
    • Female subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie,by hysterectomy and/or bilateral oophorectomy) or must be using highly effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 90 days after their last dose of PT01.
    • Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 72 hours prior to the first dose.
    • Peripheral forearm veins suitable for venous access including cannulation for infusion of PT01 and multiple blood sampling


    Exclusion Criteria:

    • Received prior arginase or arginine deiminase therapy.
    • Received recent anticancer therapy defined by: 
      • Chemotherapy, immunotherapy, hormonal therapy, and monoclonal antibodies (but excluding nitrosourea, mitomycin-C, targeted therapy) ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy to Grade≤1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.03) except for subjects with alopecia; subjects receiving luteinizing hormone-releasing hormone agonists may be considered for enrollment after discussion with the Sponsor;
      • Last administration of nitrosourea or mitomycin-C ≤ 42 days prior to starting study drug or who have not recovered from the side effects of such therapy to Grade ≤ 1;
      • Targeted therapy (e.g., sunitinib, sorafenib, pazopanib) ≤ 14 days prior to starting study drug, or who have not recovered from the side effects of such therapy to Grade ≤ 1; 
      • Radiotherapy ≤ 28 days prior to starting study drug or ≤ 14 days prior to starting study drug in the case of localized radiotherapy (e.g., for analgesic purpose or for lytic lesions at risk of fracture) or who have not recovered from radiotherapy toxicities to Grade ≤ 1.
    • Undergone major surgery (e.g., intrathoracic, intraabdominal, or intrapelvic), open biopsy, or significant traumatic injury ≤ 28 days prior to starting study treatment; subjects who have had minor procedures, percutaneous biopsies, or placement of vascular access device ≤ 7 days prior to starting study drug; or subjects who have not recovered from side effects of such procedure or injury.
    • Uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection requiring systemic antimicrobials (within 14 days prior to first dose), uncontrolled arterial hypertension (>160/100 mm Hg on antihypertensive medications), chronic pulmonary disease requiring oxygen, known bleeding disorders, uncontrolled endocrine diseases, altered mental status, or psychiatric illness/social situations that would limit compliance with protocol requirements.
    • Significant cardiac or pulmonary disease defined by New York Heart Association Class III or IV, history of myocardial infarction within 6 months prior starting study drug, significant unstable arrhythmia, or evidence of ischemia on ECG.
    • Symptomatic or uncontrolled brain metastases requiring current treatment (fewer than 28 days from last cranial radiation or from last steroids use).
    • Healing or open wound(s).
    • Lack of recovery of prior AEs to Grade ≤ 1 severity (except alopecia or lymphopenia) due to medications administered prior to the first dose of study drug.
    • Any other condition or finding (including social situation) that, in the opinion of the Investigator, may render the subject to be either at excessive risk for treatment complications or not able to provide evaluable outcome information.
    • Pregnant or breast-feeding women.
    • Known allergy to any of the formulation components of PT01.
    Biologic/Vaccine
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    Phase I Dose-Escalation and Dose-Expansion Trial of a Novel Glutaminase Inhibitor Telaglenastat (CB-839) HCl in Combination With Carfilzomib and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

    A Study to Evaluate CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma

    Wilson Gonsalves
    All
    18 years and over
    Phase 1
    This study is NOT accepting healthy volunteers
    0000-100861-P01-RST
    19-000142
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    Inclusion Criteria:
     

    • Patients must have relapsed and/or refractory myeloma and be experiencing disease relapse.
    • Patients must have measurable disease by International Myeloma Working Group (IMWG) criteria (any of the following):
      • Serum M-protein ≥ 0.5 g/dL or for IgA myeloma, an elevated IgA level by quantitative IgA nephelometry;
      • Urine M-protein ≥ 200 mg in a 24-hour collection; 
      • Serum free light chain level ≥ 10 mg/dL with an abnormal free light chain ratio;
      • Measurable plasmacytoma by cross sectional imaging (computed tomography [CT], magnetic resonance imaging [MRI] or [18F]-fluorodeoxyglucose positron emission tomography with CT [FDG PET/CT]); 
      • 20% or more light chain restricted, clonal plasma cells in the bone marrow.
    • At least two prior lines of therapy and all patients should have at least been exposed to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
    • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky >= 60%).
    • Leukocytes ≥ 3,000/mcL.
    • Absolute neutrophil count ≥ 1,000 cells/mm3 without growth factors (within 14 days of enrollment). 
    • Hemoglobin ≥ 8 g/dL (within 14 days of enrollment)
    • Platelets ≥ 50,000 cells/mm3 (≥ 30,000 cells/mm3 if bone marrow plasma cells ≥ 50% at enrollment).
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x institutional ULN.
    • Creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥ 40 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
    • Willingness to undergo interim bone marrow biopsy/aspiration for clinical purposes.
    • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. 
      • The effects of CB-839 HCl on the developing human fetus are unknown. For this reason and because carfilzomib caused embryo-fetal toxicity in pregnant rabbits at doses lower than the recommended dose, women of child-bearing potential and men must agree to use two effective methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of CB-839 HCl, carfilzomib, and dexamethasone administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CB-839 HCl, carfilzomib, and dexamethasone administration.
    • Ability to understand and the willingness to sign a written informed consent document.


    Exclusion Criteria:
     

    • Patients who are refractory or intolerant to carfilzomib (prior carfilzomib exposure accepted).
    • Patients who have received recent prior chemotherapy with:
      • alkylators (e.g., melphalan, cyclophosphamide) and anthracyclines ≤ 14 days prior to registration;
      • high dose corticosteroids and immunomodulatory drugs (thalidomide or lenalidomide) ≤ 7 days prior to registration; or
      • monoclonal antibodies ≤ 14 days prior to registration.
    • Patients who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1 except peripheral neuropathy).
    • Patients who are receiving any other investigational agents.
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to CB-839 HCl (telaglenastat), carfilzomib, or dexamethasone.
    • Patients with uncontrolled intercurrent illness.
    • Any of the following: 
      • Pregnant women or women of reproductive ability who are unwilling to use two effective methods of contraception from the time of signing the informed consent form through 4 months after the last dose of study drug, nursing women, and men who are unwilling to use birth control while taking the drug and for 4 months after stopping treatment;
      • Pregnant women are excluded from this study because carfilzomib is a PI with the potential for abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with CB-839 HCl (telaglenastat), carfilzomib, and dexamethasone, breastfeeding should be discontinued if the mother is treated with this drug combination.
    • Adverse cardiac history (unstable angina, myocardial infarction less than 4 months, New York Heart Association [NYHA] class III or IV congestive heart failure [CHF], ejection fraction [EF] <40%, uncontrolled arrhythmias).
    • Concomitant high dose corticosteroids other than what is part of treatment protocol (concurrent use of corticosteroids).
      • EXCEPTION: Patients may be on chronic steroids (maximum dose 10 mg/day prednisone equivalent) if they are being given for disorders other than myeloma; e.g., adrenal insufficiency, rheumatoid arthritis, etc.
    • Central nervous system (CNS) involvement.
    • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
    • Concurrent amyloid light-chain (AL) amyloidosis.
    • No history of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years with the following exceptions:
      • Adequately treated in situ carcinoma of the cervix uteri or the breast;
      • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
      • Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels not receiving any current therapy; or
      • Previous malignancy with no current evidence of disease, and which was confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
    • Patient has ≥ grade 3 peripheral neuropathy or grade 2 with pain on clinical examination during the screening period.
    • Major surgery within 14 days before study registration.
    • On concurrent treatment with an HIV protease inhibitor. HIV protease inhibitors can affect the unfolded protein response in myeloma cells as well as the activity of PIs.
    • Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
    • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of CB-839 HCl (telaglenastat) including difficulty swallowing, refractory vomiting, gastric resection or bypass, or duodenal/jejunal resection.

     

    Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy
    Cancer, Multiple myeloma, Plasma cell disorders, Recurrent cancer
    CB-839, Cancer treatment, Carfilzomib, Dexamethasone, Hematopoietic system, Immune system, Medical Oncology, Multiple myeloma, Targeted drug therapy, carfilzomib, dexamethasone
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    A Single-Arm Feasibility Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma

    A Study to Evaluate Gemcitabine, Cisplatin, and Nab-Paclitaxel to Treat Patients with High-Risk Liver Bile Duct Cancer Before Surgery

    Amit Mahipal
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    0000-122154-P01-RST
    19-004561
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    Inclusion Criteria:

    • Diagnosis of intrahepatic cholangiocarcinoma.
    • High-quality cross-sectional imaging by computerized tomography (CT) or magnetic resonant imaging (MRI) performed within 6 weeks prior to enrollment and showed a resectable, but high-risk, IHCCA confined to the liver, bile duct, and /or regional lymph nodes. Tumors will be considered high-risk if the high-quality, contrast-enhanced CT and/or MRI +/- positron emission tomography (PET) scan showed (must meet at least one of the criteria below):
      • T-stage ≥ Ib (Ib – IV);
      • Solitary lesion > 5 cm;
      • Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable;
      • Presence of major vascular invasion but still technically resectable;
      • Suspicious or involved regional lymph nodes (N1).
    • No distant extrahepatic disease (M0).
    • Adults ≥ 18 years of age.
    • Able to give informed consent.
    • Able to adhere to study visit schedule and other protocol requirements.
    • ECOG performance status of 0-1.
    • Adequate bone marrow reserves as evidenced by:
      • ANC ≥ 1,500 cells/μl; and
      • Platelet count ≥100,000 cells/μl; and
      • Hemoglobin ≥ 9 g/dL.
    • Adequate hepatic function as evidenced by:
      • Serum total bilirubin ≤ 1.5 x ULN; and
      • AST and ALT ≤ 2.5 x ULN; and
      • Albumin ≥ 3 g/dl.
    • Adequate renal function as evidenced by:
      • Ccreatinine ≤ 1.5 x ULN.
    • Male, or a non-pregnant and non-lactating female.
    • Women of child-bearing potential (defined as a sexually mature woman who:
      • has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries]; or 
      • has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception without interruption for 28 days prior to starting gemcitabine/cisplatin/nab- paclitaxel (including dose interruptions) until treatment with gemcitabine/cisplatin/nab-paclitaxel is complete.
    • Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/cisplatin/nab-paclitaxel and for 6 months followinggemcitabine/cisplatin/nab- paclitaxel discontinuation, even if he has undergone a successful vasectomy.


    Exclusion Criteria:

    • < 18 years of age.
    • Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0, grade 2 sensory neuropathy is defined as “moderate symptoms; limiting instrumental activities of daily living (ADLs).”
    • Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness/social situations.
    • Pregnancy (positive pregnancy test) or lactation.
    • Known CNS disease, except for treated brain metastasis.Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed.Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician.Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
    • Previous (within the past 5 years) or concurrent presence of other cancer, except non-melanoma skin cancer and in situ carcinomas.
    • History of allergy or hypersensitivity to any of the study drugs.
    • Current abuse of alcohol or illicit drugs.
    • Inability or unwillingness to sign the informed consent form.
    Drug
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    Mayo Clinic — Rochester, MN

    A Community-Based Prospective Cohort Study to Assess the Burden of Respiratory Syncytial Virus Infections in Older Adults in a North American Community

    A Study to Assess the Burden of Respiratory Syncytial Virus Infections in Older Adults in a North American Community

    Young Juhn
    All
    50 years and over
    This study is NOT accepting healthy volunteers
    0000-122113-H01-RST
    19-004142
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    Inclusion Criteria:

    • Southeast Minnesota (SEMN: Olmsted County and nearby counties including Dodge, Goodhue, Mower, Fillmore, Winona, and Wabasha,) residents (residency established at least one year prior to consent) aged 50 years or above at the time of consenting.
    • Those who have primary care physician at Mayo Clinic and a history of primary care visits to Mayo Clinic.
    • Those who authorizes use of their medical record for research.
    • Those who provide written consent to participate in the study.


    Exclusion Criteria:
     

    • Subjects without authorization for use of medical records for research.
    • Those who do not reside in SEMN at the time of enrollment.
    • Those who may go to health care providers other than Mayo Clinic Rochester (eg, Mayo Kasson, Olmsted Medical Center).
    • (This will not be applicable to Phase II study). Those who develop ARI after October 1, 2019 but prior to enrollment and are not able to come in for enrollment and swabbing within 7 days of symptoms.
    • Those who opt out for swab test and other study procedures.
    • Those who cannot ambulate or those who are bedridden (absolute or perhaps relative contraindications to the 6 minute walk such as uncontrolled/unstable cardiovascular, pulmonary, renal, endocrine, immunological or hepatic disorders).
    • Those with known cognitive impairment.
    • Those who had evidence of an ongoing systemic bacterial, fungal, or viral infection within 7 days prior to enrollment.
    • Those who reside out of Olmsted, Dodge, Goodhue, Mower, Fillmore, Winona, and Wabasha County, MN > 2 weeks during winter season the RSV season (Oct-April) and/or > 4 weeks during summer season (May-Sep).
    • Any reason in the opinion of the study PIs that someone would not be able to complete the requirements of the study for safety or other reasons.
    General infectious diseases, Respiratory syncytial virus infection
    Human metapneumovirus infection, Respiratory syncytial virus infection, Respiratory system
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    Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients with Ulcerative Colitis (PROPHETIC Study) (PROPHETIC Study)

    Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients with Ulcerative Colitis (PROPHETIC Study)

    William Faubion
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    0000-123052-P01-RST
    19-012700
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    Inclusion Criteria:

    • 18 years of age or older.
    • Male or nonpregnant, nonlactating females.
    • Diagnosis of ulcerative colitis (UC) for at least 3 months prior to screening.
    • Moderately to severely active ulcerative colitis (UC) (total MCS ≥ 6), with objective evidence of inflammation defined by a Mayo endoscopic subscore (MES) ≥ 2 and disease extending > 15 cm from the anal verge.
    • Physician plans to administer Janus Kinase Inhibitor Therapy for at least 8 weeks as part of standard of care (SOC).
    • Documentation of a negative test result for latent tuberculosis within the last 12 months, or according to routine clinical practice.
    • Able to participate fully in all aspects of this clinical trial, including collection of tissue biopsies.
    • Written informed consent must be obtained and documented.


    Exclusion Criteria:

    • Diagnosis of Crohn’s disease or indeterminate colitis.
    • An active, serious infection, including localized infections.
    • Concomitant administration of biological therapies for UC or potent immunosuppressants, such as azathioprine and cyclosporine. Subjects with previous exposure to these treatments should undergo an appropriate washout period according to local practice prior to starting tofacitinib, in keeping with routine clinical practice.
    • Hematology laboratory results that meet the following:
      • absolute lymphocyte count < 500 cells/mm3.
      • absolute neutrophil count < 1000 cells/mm3.
      • hemoglobin < 9 g/dL.
    • Interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
    • Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject’s ability to participate fully in the study.
    • Prior enrollment in the current study and having received tofacitinib.
    Drug
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    Mayo Clinic — Rochester, MN

    ARRAY 818-201, A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis (POLARIS)

    A Study to Evaluate a Standard-dose and High- dose Regimen of Encorafenib + Binimetinib in Patients with BRAFV600-mutant Melanoma Brain Metastasis

    Yiyi Yan
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    0000-100987-P01-RST
    19-004829
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    Inclusion Criteria:
     

    • Able to provide written informed consent. Adult patients under guardianship may participate if permitted by local regulations with the consent of their legally authorized guardian. All local regulations concerning patients under guardianship must be followed.
    • Age ≥ 18 years at the time of informed consent.
    • Histologically confirmed diagnosis of cutaneous melanoma with metastases to the brain.
    • Presence of BRAFV600 mutation in tumor tissue previously determined by a local PCR or NGS-based assay at any time prior to Screening or by a central laboratory during Screening.
    • Patients are required to submit archival or fresh tumor tissue and a blood sample prior to enrollment. Tissue samples will be used to determine BRAFV600-mutation status by central laboratory.
    • Must have at least 1 parenchymal brain lesion ≥ 0.5 cm and ≤ 4 cm, defined as an MRI contrast-enhancing lesion that may be accurately measured in at least 1 dimension. Note: Measurable intracranial lesions that have been previously irradiated and have not been shown to be progressing following irradiation should not be considered as target lesions.
    • Patients may have received the following prior therapies.

    Safety Lead-in, Phase 2 Randomized, Phase 2 Arm A Cohort 1:

    • May have received prior local therapy for brain metastases including but not restricted to brain surgery, whole brain radiotherapy (WBRT), stereotactic radiotherapy or stereotactic radiosurgery (e.g., gamma knife, linear-accelerated-based radiosurgery, charged particles, and CyberKnife). Multiple local (brain) therapies or combinations of local therapies are allowed. For patients receiving local therapy to all brain lesions (including WBRT), progression of pre-existing lesions based on RECIST 1.1 (> 20% increase in longest diameter on baseline scan) or new measurable lesions are required. For patients receiving local therapy for some but not all lesions, disease progression based on RECIST 1.1 is not required as long as there are remaining brain lesions that are measurable and not previously treated.

    Phase 2 Arm A Cohort 2:

    • Received no prior local therapy (e.g., brain surgery, craniotomy, SRS or SRT) for brain metastases;
    • All patients (Safety Lead-In and Phase 2): May have received prior immunotherapy;
    • All patients (Safety Lead-In and Phase 2): If receiving concomitant corticosteroids must be on a stable or decreasing dose (up to a total daily dose of 4 mg of dexamethasone or equivalent) for at least 2 weeks prior to first dose of study treatment.
    • An ECOG PS of 0 or 1 and Karnofsky score ≥ 80 (see Section 7.2.5).
    • Adequate bone marrow, organ function and laboratory parameters:
      • ANC ≥ 1.5 × 10^9 /L;
      • Hemoglobin ≥ 9 g/dL with or without transfusions;
      • Platelets ≥ 100 × 10^9 /L;
      • AST and ALT ≤ 2.5 × ULN; in patients with liver metastases ≤ 5 × ULN;
      • Total bilirubin ≤ 1.5 × ULN.
        • Note: Patients with documented Gilbert syndrome or hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled following discussion and agreement with the Sponsor Medical Monitor.
        • Serum creatinine ≤ 1.5 × ULN; OR calculated creatinine clearance > 50 mL/min by Cockcroft-Gault formula; OR estimated glomerular filtration rate > 50 mL/min/1.73m^2.
    • Female patients of childbearing potential must have a negative serum β-HCG test result.
    • Female patients of childbearing potential must agree to protocol-approved methods of contraception and to not donate ova from Screening until 30 days after the last dose of study drug.
    • Male patients must agree to use methods of contraception that are highly effective or acceptable and to not donate sperm from Screening until 90 days after the last dose of study drug.
    • The patient is deemed by the Investigator to have the initiative and means to comply with scheduled visits, treatment plan and study procedures.


    Exclusion Criteria:

    • ​​​​​​​Patients with symptomatic brain metastasis (e.g., have neurologic symptoms related to brain metastases).
    • Prophylactic or preventive anti-epileptic therapy.
      • Note: Anti-epileptic therapy indicated in order to prevent neurologic symptoms caused by a preexisting condition and not related to brain metastasis is allowed.
    • Known hypersensitivity or contraindication to any component of study treatment or their excipients.
    • Inability to swallow and retain study treatment.
    • Uveal or mucosal melanoma.
    • History of or current leptomeningeal metastases.
    • Treatment with SRS or craniotomy within 14 days prior to start of study treatment, or treatment with whole-brain radiation within 28 days prior to study treatment. Patients who received local therapy should have complete recovery with no neurological sequelae.
    • Either of the following:
      • Radiation therapy to non-brain visceral metastasis within 2 weeks prior to start of study treatment;
      • Continuous or intermittent small-molecule therapeutics or investigational agents within 5 half-lives of the agent (or within 4 weeks prior to start of study treatment, when half-life is unknown).
    • Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 6 months prior to enrollment. Patients who received BRAF or MEK inhibitors in the metastatic setting are excluded.
    • Is currently participating in a study and receiving an investigational agent; has received an investigational agent or used an investigational device within 14 days prior to start of study treatment.
    • Patients who have undergone major surgery (e.g., inpatient procedure with regional or general anesthesia) ≤ 6 weeks prior to start of study treatment. For minor surgical procedures ≤ 6 weeks prior to start of study treatment, consult the Sponsor Medical Monitor.
    • Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before starting study treatment. Note: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and patients with these may enroll.
    • Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, the following:
      • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) < 6 months prior to Screening;
      • Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2);
      • An LVEF < 50% as determined by MUGA or ECHO; d. Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy;
      • History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia); f. Triplicate average baseline QTcF interval ≥ 480 msec.
    • Continuous or intermittent small-molecule therapeutics or investigational agents within 5 half-lives of the agent (or within 4 weeks prior to start of study treatment, when half-life is unknown). 9. Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 6 months prior to enrollment. Patients who received BRAF or MEK inhibitors in the metastatic setting are excluded.
    • Is currently participating in a study and receiving an investigational agent; has received an investigational agent or used an investigational device within 14 days prior to start of study treatment.
    • Patients who have undergone major surgery (e.g., inpatient procedure with regional or general anesthesia) ≤ 6 weeks prior to start of study treatment. For minor surgical procedures ≤ 6 weeks prior to start of study treatment, consult the Sponsor Medical Monitor.
    • Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before starting study treatment. Note: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and patients with these may enroll.
    • Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, the following:
      • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) < 6 months prior to Screening;
      • Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2);
      • An LVEF < 50% as determined by MUGA or ECHO;
      • Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy;
      • History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
      • Triplicate average baseline QTcF interval ≥ 480 msec.
    • Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study.
    Drug, Administration of antineoplastic agent, Combination therapy, Drug therapy, RET proto-oncogene mutation analysis
    Brain lesions, Brain metastasis, Brain tumor, Cancer, Melanoma, Skin cancer
    Binimetinib [USAN:INN], Cancer treatment, Encorafenib [USAN:INN], Genetic mutation, Integumentary system, Lesion of brain, Medical Oncology, Metastatic malignant melanoma, Nervous system, Secondary malignant neoplasm of brain, Targeted drug therapy, binimetinib, encorafenib
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    Mayo Clinic Rochester, MN — Rochester, MN

    MC1924: SBRT with Immunotherapy for Mesothelioma (MC1924)

    SBRT with Immunotherapy for Mesothelioma

    Kenneth Olivier
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    0000-101197-P01-RST
    19-012226
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    Inclusion Criteria:

    • Age ≥ 18 years.
    • Histological confirmation of pleural mesothelioma.
    • ECOG Performance Status (PS) ≤ 2.
    • Negative pregnancy test done ≤ 14 days prior to registration, for women of childbearing potential only.
    • Provide written informed consent.
    • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
    • Willing to provide blood samples for correlative research purposes.
    • Patient has received or is planning to receive ICI for mesothelioma.


    Exclusion Criteria:

    • Pregnant women.
    • Nursing women.
    Biologic/Vaccine, Radiation
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    Mayo Clinic — Rochester, MN

    A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study with Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an Add-on to Standard of Care Therapy in Subjects with Inoperable or Persistent/Recurrent After-surgical Treatment Chronic Thromboembolic Pulmonary Hypertension (SELECT)

    A Study with to Assess the Effectiveness and Safety of Selexipag as Standard-of-Care Add-on in Subjects with Inoperable or Persistent/Recurrent After-surgical Treatment CTEPH

    Hilary DuBrock
    All
    18 years to 85 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    0000-122993-P01-RST
    19-011966
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    Inclusion Criteria:

    • Signed and dated informed consent form.
    • Male and female subjects from 18 to 85 years old (inclusive).
    • With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication committee.
    • With pulmonary hypertension (PH) in WHO FC I-IV.
    • Subject able to perform the 6-minute walk test (6MWT) with a minimum distance of 100 m and a maximum distance of 450 m at screening visit.
    • Women of childbearing potential must have a negative pregnancy test at screening and randomization and must agree to undertake monthly urine pregnancy tests, and to use a reliable method of birth control from screening visit up to at least 30 days after study treatment discontinuation. If a hormonal contraceptive is chosen it must be taken for at least 1 month prior to randomization.


    Exclusion Criteria:

    • Planned or current treatment with another investigational treatment up to 3 months prior to randomization.
    • Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc.).  If a patient uses a walking aid from time to time but does not have any co-morbid condition, and is able to perform a reliable and reproducible 6MWT on their own (i.e., without any walking aids), then they can be included.
    • Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation.
    • Known concomitant life-threatening disease with a life expectancy <12 months.

     

    Drug, Other
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    Global Prospective Case Series Using a Single-Use Duodenoscope (EX02)

    Global Prospective Case Series Using a Single-Use Duodenoscope

    Bret Petersen
    All
    18 years and over
    Post Market
    This study is NOT accepting healthy volunteers
    0000-122606-P01-RST
    19-008928
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    Inclusion Criteria:

    • 18 years or older.
    • Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
    • Scheduled for a clinically indicated ERCP or other duodenoscope-based procedure.


    Exclusion Criteria:

    • Potentially vulnerable subjects, including, but not limited to pregnant women.
    • Subjects for whom endoscopic techniques are contraindicated.
    • Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
    • Investigator discretion.
    Device, Duodenoscopy, Endoscopic retrograde cholangiopancreatography
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    Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2) (URIROX-2)

    Establishing the Safety and Effectiveness of Reloxaliase in Patients With Enteric Hyperoxaluria

    John Lieske
    All
    18 years and over
    Phase 3
    This study is NOT accepting healthy volunteers
    0000-122689-P01-RST
    19-009656
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    Inclusion Criteria:

    • Provided informed consent.
    • Age 18 years or older.
    • Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy).
    • Urinary oxalate ≥ 50 mg/24 hr.
    • Has at least 1 documented kidney stone within 2 years.


    Exclusion Criteria:

    • Acute renal failure or estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m^2.
    • Has a known genetic, congenital, or other cause of kidney stones.
    • Unable or unwilling to discontinue Vitamin C supplementation.
    • Cannot establish baseline kidney stone burden.
    Drug, Other
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    Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer (MAHOGANY)

    A Study to Evaluate the Combination of Margetuximab, Retifanlimab, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer

    Zhaohui Jin
    All
    18 years and over
    Phase 2/3
    This study is NOT accepting healthy volunteers
    0000-101007-P01-RST
    19-008640
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    Inclusion Criteria:

    • Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma:
      • Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%), and non-MSI-H per central review 1%), and non-MSI-H per central review;
      • Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment. 
    • Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing.
    • Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1.
    • Life expectancy ≥ 6 months.
    • At least one radiographically measurable target lesion.
    • Acceptable laboratory parameters and adequate organ function.


    Exclusion Criteria:

    • Other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions.
    • Patients with MSI-H status by central test in Cohort A, or patients with known MSI-H status in Cohort B.
    • History of allogeneic stem cell or tissue/solid organ transplant.
    • Central nervous system metastases.
    • Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise.
    • Prior neoadjuvant or adjuvant treatment with immunotherapy.
    Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy
    Cancer, Esophageal cancer, Stomach cancer
    Cancer treatment, Chemotherapy, Digestive system, Malignant neoplasm of cardio-esophageal junction of stomach, Malignant tumor of stomach, Margetuximab [USAN:INN], Medical Oncology, Metastatic HER2 positive gastroesophageal junction cancer, Positive genetic finding, Retifanlimab [USAN], Secondary malignant neoplasm of stomach, Targeted drug therapy, Tebotelimab, Trastuzumab, trastuzumab
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    Long Term Outcomes of Stenting in Chronic Mesenteric Ischemia

    A Study to Evaluate Long-Term Outcomes of Stenting in Chronic Mesenteric Ischemia

    Bernardo Mendes
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    0000-122909-H01-RST
    19-011137
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    Inclusion Criteria:

    • Adult patients, 18 years or older.
    • Patients who underwent an endovascular intervention with stenting of the mesenteric vasculature for chronic atherosclerotic mesenteric ischemia.


    Exclusion Criteria:
     

    • Subjects < 18 years of age.
    • Patient who underwent endovascular intervention without stent placement.
    • Patients who underwent open mesenteric revascularization.
    • Patient who underwent mesenteric stenting as a part of other procedures including fenestrated or branched endografting.
    • Patients who underwent mesenteric stenting for other indications other than chronic atherosclerotic mesenteric ischemia, including vasculitis, aneurysm, dissection, or acute mesenteric ischemia.
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    NRG-BR004, A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

    A Study of Taxane, Trastuzumab, and Pertuzumab With or Without Atezolizumab in Treating Metastatic Breast Cancer Patients

    Ciara O'Sullivan
    All
    18 years and over
    Phase 3
    This study is NOT accepting healthy volunteers
    0000-101062-P01-RST
    19-006737
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    Inclusion Criteria:
     

    • Adults, 18 years or older.
    • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines.
    • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease confirmed as described below; eligible patients include those with either: 
      • De novo metastatic disease presenting without prior history of HER2-positive breast cancer: 
        • Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient.
      • Locally recurrent or metastatic disease following prior therapy for early breast cancer: Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease.
      • There must be an interval of ≥ 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy.
    • Patients must have measurable disease based on RECIST 1.1, as determined by the site, to be eligible.
    • The tumor specimen obtained at the time of diagnosis of locally recurrent or metastatic disease must have been determined to be HER2-positive based on central testing according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (Wolff 2018); HER2 status will initially be assessed using a Food and Drug Administration (FDA)-cleared IHC assay; positive is defined as IHC 3+ staining intensity; if HER2 IHC results are equivocal (2+), then HER2 status will be determined using a FDA-cleared HER2 in situ hybridization (ISH) test according to ASCO/CAP guidelines; sites can send biopsy specimens for central testing which have been determined to be HER2-positive or initially equivocal by either IHC or ISH on local testing.
    • The tumor specimen obtained at the time of diagnosis used for HER2 testing must also have central testing for PD-L1 status; patients will be eligible irrespective of PD-L1 testing result including PD-L1 indeterminant.
    • The tumor specimen obtained at the time of diagnosis used for HER2 and PD-L1 testing should also have central testing for estrogen receptor (ER) and progesterone receptor (PgR) according to current ASCO/CAP guideline recommendations for hormone receptor testing; patients with 1% ER and PgR staining by IHC will be classified as negative; if sufficient material for central confirmation of ER and PgR is unavailable, local testing results for ER and PgR may be used for eligibility.
    • Localized palliative radiation therapy is allowed for symptom management if completed ≥ 14 days prior to randomization.
    • Patients must have imaging of the chest/abdomen/pelvis, preferably with a computed tomography (CT) scan, and a bone scan within 4 weeks prior to randomization; (NOTE: if a patient is unable to receive CT contrast, a magnetic resonance imaging [MRI] of the abdomen/pelvis and non-contrast chest CT should be performed; positron emission tomography/computed tomography [PET/CT] is not an acceptable alternative).
    • MRI of the brain (or contrast CT scan of the brain if patients are unable to undergo MRI) must be obtained in patients with symptoms suggesting possible central nervous system (CNS) metastatic disease; neuroimaging is recommended but not required in asymptomatic patients.
    • Absolute neutrophil count (ANC) must be ≥ 1200/mm^3 (within 14 days prior to randomization).
    • Platelet count must be ≥ 100,000/mm^3 (within 14 days prior to randomization).
    • Hemoglobin must be ≥ 8 g/dL (within 14 days prior to randomization).
    • Total bilirubin must be ≤ 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin ≤ ULN for patients with bilirubin levels > 1.5 x ULN (within 14 days prior to randomization).
    • Aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) must be ≤ 2.5 x ULN for the lab or ≤ 5 x ULN for patients with liver metastases (within 14 days prior to randomization).
    • Serum creatinine ≤ 1.5 x ULN or measured or calculated creatinine clearance ≥ 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab (within 14 days prior to randomization).
    • Patients not receiving anti-coagulant therapy must have prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 x ULN within 14 days prior to randomization; for laboratories that do not report an ULN for the INR assay, use ≤ 1.5 as the value for the ULN; patients receiving anti-coagulants should have a baseline INR assessed, but the value does not affect eligibility.
    • A serum thyroid-stimulating hormone (TSH), free T4, and AM (morning) cortisol must be obtained within 14 days prior to randomization to obtain a baseline value and be within normal limits for the local laboratory.
    • Left ventricular ejection fraction (LVEF) assessment must be performed within 6 weeks prior to randomization; (LVEF assessment performed by echocardiogram is preferred; however, multigated acquisition scan (MUGA) scan may be substituted based on institutional preferences); the LVEF must be ≥ 55% regardless of the cardiac imaging facility's lower limit of normal.
    • Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of child-bearing potential and men must agree to use adequate contraception (non-hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab/placebo and 7 months after the last dose of trastuzumab and pertuzumab; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.


    Exclusion Criteria:
     

    • Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions: 
      • Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met: 
        • Evaluable or measurable disease outside the CNS;
        • No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm);
        • No history of intracranial hemorrhage or spinal cord hemorrhage;
        • No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted;
        • No neurosurgical resection or brain biopsy within 28 days prior to randomization.
      • Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following: 
        • Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study;
        • No stereotactic radiation or whole-brain radiation within 4 weeks prior to randomization;
        • Screening CNS radiographic study 4 weeks from completion of radiotherapy and 2 weeks from discontinuation of corticosteroids.
    • Known leptomeningeal carcinomatosis.
    • Patients with metastatic disease limited to the CNS.
    • History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) with the exception of administration of trastuzumab or lapatinib concurrently with radiation therapy for brain metastases; toxicities related to lapatinib should be ≤ grade 1, per the CTCAE version (v)5.0 and must have been completed at least 2 weeks prior to randomization.
    • History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent.
    • Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease.
    • Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
    • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.
    • Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria).
    • History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy.
    • Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to: 
      • Active cardiac disease;
      • Angina pectoris that requires the current use of anti-anginal medication;
      • Ventricular arrhythmias except for benign premature ventricular contractions; 
      • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; 
      • Conduction abnormality requiring a pacemaker; 
      • Valvular disease with documented compromise in cardiac function; or 
      • Symptomatic pericarditis.
    • History of cardiac disease:
      • Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; 
      • History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%; or 
      • Documented cardiomyopathy.
    • Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) ≥ grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. 
    • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 
    • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant antibodies.
    • Known allergy or hypersensitivity to the components of the atezolizumab formulation or to any of the study drugs or excipients, (e.g., Cremophor EL).
    • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis: 
      • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible;
      • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible;
      • Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: 
        • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations;
        • Rash must cover less than 10% of body surface area (BSA);
        • Disease is well controlled at baseline and only requiring low-potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%); 
        • No acute exacerbations of underlying conditions within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids).
    • Treatment with systemic immunosuppressive medications (including but not limited to interferons, IL-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization 
    • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study.
      • Note: Intranasal and inhaled corticosteroids or systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or an equivalent corticosteroid are allowed.
    • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to randomization. 
    • Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV deoxyribonucleic acid (DNA) viral load per local guidelines
      •Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV ribonucleic acid (RNA).
    • Patients with clinically active tuberculosis. 
    • Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 4 weeks prior to randomization:
      • A stable regimen of highly active anti-retroviral therapy (HAART); and
      • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections; and
      • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests.
    • Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 
    • Prior allogeneic stem cell or solid organ transplantation.
    • Symptomatic peripheral ischemia. 
    • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or ≥ grade 1 pulmonary fibrosis, per the CTCAE v5.0, on screening chest CT scan.
    • Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such vaccine will be required during the study:
      • Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to randomization, during treatment or within 5 months following the last dose of atezolizumab/placebo. 
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease.
    Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
    Breast cancer, Cancer
    Atezolizumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, Chemotherapy for breast cancer, Malignant tumor of breast, Medical Oncology, Metastatic human epidermal growth factor 2 positive carcinoma of breast, Trastuzumab, atezolizumab, paclitaxel, pertuzumab, trastuzumab
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    A Phase 3 Multi-center, Long-term Extension Study Investigating the Efficacy and Safety of Abrocitinib, With or Without Topical Medications, Administered to Subjects Aged 12 Years and Older with Moderate-to-Severe Atopic Dermatitis (JADE EXTEND)

    A Study to Evaluate The Effectiveness and Safety of Abrocitinib, with or without Topical Medications, in Subjects Aged 12 Years and Older with Moderate-to-Severe Atopic Dermatitis

    Megha Tollefson
    All
    12 years and over
    Phase 3
    This study is NOT accepting healthy volunteers
    0000-121818-P01-RST
    19-001575
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    Inclusion Criteria:

    • Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
    • Male or female subjects of 12 years of age or older, at the time of informed consent and body weight greater than or equal to 40 kg. Adolescent subjects below the age of 18 years old will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years and older will be enrolled.
    • Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    • Must have completed the full treatment period of a qualifying Phase 3 study OR must have completed the full rescue treatment period of a qualifying Phase 3 study (if applicable).
    • Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
      • Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
      • Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
    • Female subjects of non childbearing potential must meet at least 1 of the following criteria:
      • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
      • Have medically confirmed ovarian failure; or
      • Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
    • Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
    • Must agree to avoid use of prohibited medications throughout the duration of the study.


    Exclusion Criteria:

    • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    • Currently have active forms of other inflammatory skin diseases; i.e., not AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.
    • Discontinued from treatment (or rescue treatment period/open-label run-in period, if applicable) early in a qualifying Parent study OR triggered a discontinuation criterion at any point during the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.
    • Ongoing adverse event in the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.
    • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    Drug, Other, Drug therapy
    Atopic dermatitis, Dermatitis
    Atopic dermatitis, Integumentary system
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    A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

    A Study to Evaluate KD025 in Subjects with Diffuse Cutaneous Systemic Sclerosis

    Ashima Makol
    All
    18 years to 100 years old
    Phase 2
    This study is NOT accepting healthy volunteers
    0000-122685-P01-RST
    19-009603
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    Inclusion Criteria:

    • Male and female subjects ≥ 18 years old.
    • Diagnosis of dcSSc according to the 2013 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria.
    • Must have disease duration (defined as interval from first non-Raynaud disease manifestation) of ≤ 5 years.
    • Must have mRSS of ≥ 15 but ≤ 35.
    • Active disease defined as any of the following within the 6 months prior to screening:
      • Increase in mRSS by ≥ 3 units;
      • Increase in mRSS by ≥ 2 units with involvement of 1 new body area;
      • Involvement of 2 new body areas;
      • Symptoms indicative of skin activity such as severe cutaneous itching or burning.
    • Subjects receiving concomitant immunosuppression must be on a stable dose for at least 3 months prior to screening.
    • Adequate organ and bone marrow functions evaluated during the 28 days prior to enrollment as follows:
      • Absolute neutrophil count ≥ 1.5 × 10^9 /L;
      • Platelet count ≥ 100 × 10^9 /L;
      • Total bilirubin ≤ 1.0 × upper limit of normal (ULN);
      • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal limits; and
      • Serum creatinine ≤ 1.5 × ULN. 
    • Female subjects of childbearing potential have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression:
      • Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug;
      • Sexually active women of childbearing potential enrolled in the study must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes:
        • IUD plus one barrier method;
        • on stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method; or
        • 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm), or a vasectomized partner.
    • For male patients who are sexually active and who are partners of premenopausal women: agreement to use 2 forms of contraception as in criterion above during the treatment period and for at least 3 months after the last dose of study drug.
    • Male subjects must not donate sperm for 3 months after last dose of study drug.
    • Able to provide written informed consent prior to the performance of any study-specific procedures.


    Exclusion Criteria:

    • Subject has corrected QT interval using Fredericia’s formula (QTcF) > 450 ms.
    • Ongoing use or current use of concomitant medication known to have the potential for QTc prolongation.
    • Female subject who is pregnant or breastfeeding.
    • Participated in another study with an investigational drug within 28 days of study entry (for studies involving biologics, within three half-lives of the biologic).
    • History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the Investigator, unsuitable for the study.
    • Chronic heart failure with New York Heart Association Classes II, III, or IV.
    • Acute or chronic liver disease (e.g., cirrhosis).
    • Positive human immunodeficiency virus (HIV) test.
    • Active hepatitis C virus (HCV), hepatitis B virus (HBV), or positive whole blood tuberculin test
    • Diagnosed with any malignancy within 3 years of enrollment, with the exception of basal cell or completely resected squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection
    • Has had previous exposure to belumosudil or known allergy/sensitivity to belumosudil, or any other ROCK2 inhibitor.
    • Scleroderma renal crisis within 4 months prior to enrollment.
    • FVC ≤ 50% Predicted.
    Drug
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    Aneurysm Growth and Enhancement Study - AGES (AGES)

    A Study to Analyze Aneurysm Growth and Enhancement

    Vance Lehman
    All
    18 years to 99 years old
    This study is NOT accepting healthy volunteers
    0000-122690-P01-RST
    19-009666
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    Inclusion Criteria:

    • Patients will be recruited who are undergoing MR Imaging studies as part of their routine clinical care for untreated intracranial aneurysms where no interventional treatment is planned.
    • Consent to research.


    Exclusion Criteria:

    • Unable to undergo MRI or have gadolinium (patients are already having these studies as part of routine clinical exam, so don’t foresee this being pertinent).
    • Atypical cause of aneurysm (e.g. infectious, related to atrial myxoma, dissecting, etc.).
    • Unable to remain still enough for diagnostic examinations.
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    Mayo Clinic — Rochester, MN