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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

602 Study Matches

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Assessment of Peripherally Circulating Plasma Proteins and Clinical Risks to Differentiate Epileptic Seizure from Psychogenic Nonepileptic Seizure

A Study to Assess Peripherally Circulating Plasma Proteins and Clinical Risks to Differentiate Epileptic Seizure from Psychogenic Nonepileptic Seizure

Gregory Cascino
All
18 years to 59 years old
This study is NOT accepting healthy volunteers
0000-122173-P01-RST
19-004730
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Inclusion Criteria
•ES and PNES Cohorts:

  • Aged 18-59 years old, inclusive.
  • Undergoing clinically indicated evaluation in the Mayo Clinic’s EMU.
  • Able to provide Informed Consent OR are accompanied by a LAR who can provide informed consent on their behalf.

Exclusion Criteria
•ES and PNES Cohorts:

  • Age 17 or under or age 60 or over.
  • Unable to provide Informed Consent, AND are not accompanied by a LAR who can provide informed consent on their behalf.
    • Note that individuals who are normally able to provide consent on their own behalf but suffer from an altered mental status after a seizure may not be provide informed consent in this post-ictal state.
  • Prisoners.
  • Individuals known to have any of the following conditions:
    • Systemic or metastatic cancers;
    • Brain tumors;
    • HIV or AIDS;
    • Acute or chronic central nervous infections;
    • Lennox-Gastaut Syndrome;
    • Genetic epilepsy syndromes (including but not limited to Dravet’s Syndrome and Tuberous Sclerosis Complex);
    • Central nervous system or systemic inflammatory autoimmune disorders (including but not limited to SLE, multiple sclerosis, and vasculitis).
  • Individuals with intracranial recording EEG electrodes.
  • Individuals who have undergone brain surgery for any reason within the past 6 months incliuding any type of invasive EEG monitoring.

Inclusion Criteria
•Control Subjects:

  • Aged 18-59 years old, inclusive.
  • Able to provide Informed Consent.

Exclusion Criteria
•Control Subjects:

  • Age 17 or under or age 60 or over.
  • Unable to provide Informed Consent (an LAR is not permitted to provide Informed Consent on a Control Subject’s behalf).
  • Prisoners.
  • Individuals known to have any of the following conditions:
    • Systemic or metastatic cancers;
    • Brain tumors;
    • HIV or AIDS;
    • Acute or chronic central nervous infections;
    • Lennox-Gastaut Syndrome;
    • Genetic epilepsy syndromes (including but not limited to Dravet’s Syndrome and Tuberous Sclerosis Complex);
    • Central nervous system or systemic inflammatory autoimmune disorders (including but not limited to SLE, multiple sclerosis, and vasculitis).
  • A history of either seizures or suspected seizures of any type (a single instance of febrile seizure prior to age 2 is allowed).
  • Treatment with an anti-seizure medication, for any reason, within two months prior to providing a blood sample.
  • Individuals who have undergone brain surgery for any reason within the past 6 months including any type of invasive EEG monitoring.

 

Epilepsy, Psychogenic nonepileptic seizure, Seizure
Dissociative convulsions, Epileptic seizure, Nervous system, Protein level - finding
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Mayo Clinic — Rochester, MN

Use of Multiscale Omics to Develop a Cohort Database and Study Platform in Breast Cancer Survivors

A Study to Develop a Cohort Database and Study Platform in Breast Cancer Survivors Using Multiscale Omics

Brent Bauer
Female
18 years to 75 years old
This study is NOT accepting healthy volunteers
0000-122295-H01-RST
19-005860
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Inclusion Criteria:

  • Adult females enrolled in the Mayo Clinic Biospecimen Resource for Breast Disease (IRB # 1815-04).
  • Current ages 18-75 years.
  • Have a prior diagnosis of stage 0-3 (in situ or invasive) breast cancer (BCS).
  • Have completed active therapy (surgery, radiation, and/or chemotherapy) (8-30  months approximately) prior to provision of the samples).
  • Age-matched females with no history of cancer (other than non-melanoma skin cancer) may be selected from the PRISM Study (IRB #18-002366 The Predicting Risk after Screening Mammogram (PRISM) Study) or the Mayo Clinic Breast Mammography practice.


Exclusion Criteria:
 

  • Male biological sex or gender.
  • Pregnant females (insufficient #s, skewed estrogen levels).
  • Unwilling to travel to Mayo Clinic Rochester to provide the blood and urine samples.
Breast cancer, Cancer, Ductal carcinoma in situ, Invasive lobular carcinoma, Lobular carcinoma in situ
Breast cancer supportive therapy and survivorship service, Chemotherapy, Chemotherapy for breast cancer, History of antineoplastic chemotherapy, History of carcinoma in situ of breast, History of invasive malignant neoplasm of breast, History of mastectomy, History of radiation therapy to breast area, Malignant tumor of breast, Mammogram, Medical Oncology
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Premier Hb9210TM Resolution System Reference Range Study Protocol

A Study of the Premier Hb9210TM Resolution System

James Hoyer
All
12 years to 22 years old
This study is NOT accepting healthy volunteers
0000-122330-P01-RST
19-006149
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Inclusion Criteria:

  • Ages 18 to 22 years old.


Exclusion Criteria:

  • Subjects outside the inclusion criteria age range.
Hemoglobin test
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Mayo Clinic — Rochester, MN

Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Ocular Hypertensive Subjects

A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension

Arthur Sit
All
18 years and over
Phase 4
This study is NOT accepting healthy volunteers
0000-122641-P01-RST
19-009222
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General

Inclusion Criteria:

  • Subjects must be ≥18 years of age, must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)‑approved ICF and are able and willing to comply with all treatment and follow-up/study procedures.
  • Females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must agree to use an acceptable method of contraception throughout their participation in the study.

Ocular

Inclusion Criteria:

  • Subjects must have a diagnosis of OHT in both eyes (IOP ≥ 22 mmHg prior to starting treatment with IOP-lowering medication) without evidence of glaucomatous optic neuropathy or visual field loss and have been receiving IOP-lowering medication for ≥ 3 months prior to Visit 1.
  • Subjects must undergo a washout of any existing ocular hypotensive medications in order to determine eligibility. Washout period will vary with the class of medication used (2-6 weeks).
  • Subjects must meet the following IOP requirements at Visit 3 (Eligibility Visit at End of Washout):
    • Intraocular pressure ≥ 22 mmHg and ≤ 32 mmHg in both eyes;
    • An increase in IOP of ≥ 20% over the screening visit (Visit 1) IOP in both eyes;
    • A difference in IOP between eyes ≤ 4 mmHg.
  • Subjects must have a BCVA in each eye of 20/50 (LogMAR +0.4) or better.

General


Exclusion Criteria:

  • Subjects participating in any drug or device clinical investigation within 30 days prior to Visit 1 (Screening) or who anticipate participating in any other drug or device clinical investigation within the duration of this study. 
  • Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
  • Female subjects who are pregnant or breastfeeding.
  • Subjects with Body Mass Index (BMI) ≥ 40.0. Subjects with BMI 35.0-39.9 may be excluded at the discretion of the PI.

Ocular


Exclusion Criteria:

Diseases

  • Participants who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and for 24 hours before check-in and during each study visit.
  • Participants with a central corneal thickness less than 480 μm or greater than 600 micrometer (μm) in either eye.
  • Participants with any condition that prevents reliable applanation tonometry (for example, significant corneal surface abnormalities) in either eye. 
  • Participants who are monocular. 
  • Participants with ocular conditions, which, in the opinion of the Investigator, will impact the study measurements, such as:
    • Active optic disc hemorrhage in either eye;
    • Current or a history of central/branch retinal vein or artery occlusion in either eye;
    • Current or a history of macular edema in either eye;
    • Very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and participants with angle closure, congenital, and secondary glaucoma, and with history of angle closure in either eye;
    • Diagnosis of a clinically significant or progressive retinal disease (for example, diabetic retinopathy, exudative or severe non-exudative macular degeneration) in either eye.
  • Participants with any intraocular infection or inflammation in either eye within 3 months prior to Visit 1 (Screening). 
  • Myopia greater than -4.00 diopter (D), or hyperopia greater than +2.000 Surgery.
  • Participants with a history of ocular laser surgery in either eye within the 3 months (90 days) prior to Visit 1 (Screening).
  • Participants with a history of laser trabeculoplasty, cyclophotocoagulation or glaucoma surgical procedures at any time prior to Visit 1 (Screening). 
  • Participants with a history of incisional ocular surgery other than routine uncomplicated cataract surgery or severe trauma in either eye within the 3 months (90 days) prior to Visit 1 (Screening).

Eligibility last updated 2/28/22. Questions regarding updates should be directed to the study team contact.

Drug, Other, Administration of drug or medicament via ophthalmic route, Drug therapy, Measurement of episcleral venous pressure using venomanometer, Provocative outflow facility test
Glaucoma, High blood pressure
Latanoprostene BUNOD [USAN:INN], Ocular hypertension, latanoprostene bunod, Cardiovascular system
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A Prospective, Observational, Multicenter, Open-Label, Pilot Study to Investigate Medication Adherence and Patient Reported Symptom Occurrence and Interference with Daily Life Comparing Once-Daily Envarsus XR® and Twice-Daily Immediate Release Tacrolimus in Adult Renal Transplant Recipients (SIMPLE)

A Study to Evaluate the Safety and Effectiveness of Once-Daily Envarsus XR? and Twice-Daily, Immediate-Release Tacrolimus in Adult Renal Transplant Recipients

Mark Stegall
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121943-H01-RST
19-002678
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Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • Patient is an adult (18 years of age or older).
  • Treatment with Envarsus XR® or immediate-release, twice-daily tacrolimus has been indicated by patient’s transplant care team. 
  • Patient is a recipient of a deceased or living donor kidney transplant.
  • Patient is able to comply with study procedures for the entire length of the study.
  • Patient has been informed about the study survey and has signed an informed consent form.


Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Patient is unable or unwilling to complete study patient reported outcome questionnaires.
  • Patient is currently receiving azathioprine
  • Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus)
  • Patient is currently receiving belatacept .
  • Patient has received investigational immunosuppression 1 month prior to transplant or post-transplant.
  • Patient is in a setting where a professional care taker is responsible for dispensing subject’s medication.
Deceased donor kidney transplant, Kidney transplant, Living donor kidney transplant, Nephropathy induced by tacrolimus, Tacrolimus, Transplanted kidney present, tacrolimus
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Mayo Clinic — Rochester, MN

Reiki Therapy – An Intervention in Hematology/Oncology Cancer Patients Hospitalized in an Inpatient Setting – A Pilot Study

A Study to Evaluate Reiki Therapy as an Intervention in Hematology/Oncology Cancer Patients Hospitalized in an Inpatient Setting

Brent Bauer
All
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-121699-H01-RST
19-000456
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Inclusion Criteria:

  • Hospitalized hematology-oncology patients, age 18 – 80 years old.
  • Able to speak English and complete surveys.
  • Able to read, understand and sign inform consent.

 


Exclusion Criteria:
 

  • Patient unwilling for reiki therapy.
  • Unable to give written consent.
  • Already having received or receiving other reiki treatment.
  • Pregnant women. (as verbalized by participant)/

 

Other, Reiki
Cancer
Cancer treatment, Integrative medicine, Malignant neoplastic disease, Medical Oncology
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Mayo Clinic — Rochester, MN

ME-522-001: A Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies

A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML

Kebede Begna
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101182-P01-RST
19-010929
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically-confirmed diagnosis of Follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia(CLL), diffuse large B-cell lymphoma (DLBCL), or AML:
    • Subjects must have disease that has relapsed or is refractory to 2 or more prior regimens and in need of treatment due to progressive disease.
  • Presence of measurable disease defined per the 2008 International workshop on CLL guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma (does not apply for AML subjects).
  • Adequate hematologic parameters unless clearly due to the disease under study.
  • Adequate renal and hepatic function, per laboratory reference range at screening


Exclusion Criteria:

  • For CLL subjects: only known histological transformation to an aggressive lymphoma.
  • For AML subjects:
    • Acute promyelocytic leukemia;
    • Peripheral blast count > 25 × 10^9/L.
  • Known central nervous system involvement.
  • Significant cardiovascular disease.
  • Significant screening ECG abnormalities.
  • Subjects who require warfarin, anti-cancer therapeutics or investigational agents.
  • Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of voruciclib therapy.
  • Receipt of an allogeneic transplant within 6 months or an autologous transplant within the preceding 3 months; evidence of ongoing graft-versus-host disease (GVHD).
  • Prior therapy with a cyclin-dependent kinase (CDK9) inhibitor.
  • Ongoing immunosuppressive treatment at the time of the start of voruciclib therapy, including systemic or enteric corticosteroids except as follows:
    • Prior to the start of voruciclib therapy, subjects may be using systemic corticosteroids (≤ 20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids;
    • During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed,
Drug
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Mayo Clinic — Rochester, MN

PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy

A Study to Assess Myocardial Blood Flow Changes in Oncology Patients

John Bois
All
18 years to 99 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-122636-H01-RST
19-009189
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Inclusion Criteria:

  • Individuals 18 years or older.
  • Individuals able and willing to give consent to under PET/CT.


Exclusion Criteria:

  • Age < 18 years old.
  • Women who are pregnant, or breast-feeding.
  • Unable or unwilling to give consent to undergo PET/CT.
Radiation
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (EMERALD-2)

A Study to Assess the Effectiveness and Safety of Durvalumab Alone or Combined with Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

Sean Cleary
All
18 years to 150 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-101020-P01-RST
19-005862
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Inclusion Criteria:
 

  • Male and female.
  • Provision of signed and dated written informed consent form (ICF) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, EU Data Privacy Directive in the EU) obtained from the patient (or legal representative / impartial witness where mandated & allowed by local regulations) prior to any mandatory study-specific procedures, sampling, and analyses, including screening evaluations.
  • Age ≥ 18 years at the time of screening. For patients aged < 20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative. Patients aged < 21 years must not be enrolled in Egypt or Singapore.
  • Histologically or cytologically (or radiologically for patients undergoing curative ablation) confirmed HCC, newly diagnosed, and successfully completed curative therapy (resection or ablation). (a) Hepatic resection and have the following pathologic and/or radiologic findings from surgery: (i) Any size with microvascular invasion (clear pathologic assessment on microvascular invasion: Yes or No) and/or satellite tumor (ii) 3 or less tumors, with at least one > 5 cm (iii) 4 or more tumors, ≤ 5 cm each (b) Ablation (radiofrequency or microwave, cryoablation, or PEI per institutional standard. Embolisation (e.g., TACE/TAE) is acceptable so long as it is part of the local planned ablative process) where all curative procedures are completed within a 12 week window, and have the following radiologic findings prior to ablation: (i) Solitary tumor, 3 to 5 cm (ii) 2 to 4 tumors, ≤ 5 cm each (iii) Exclude patients with 5 or more tumors.
  • Patients must be randomized within 12 weeks of completion of curative hepatic resection, or final curative ablation procedure.
  • Imaging to confirm disease-free status within 28 days prior to randomization.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 at enrollment.
  • Child-Pugh score of 5 or 6. 8 Patients with active HBV infection (as characterized by positive hepatitis B virus surface antigen [HBsAg] and/or anti-hepatitis B core antibodies (HBcAbs) with detectable HBV deoxyribonucleic acid (DNA) [≥10 IU/mL or above the limit of detection per local laboratory]) must receive antiviral therapy at least after enrollment (sign of ICF) per institutional practice. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment. Patients must show evidence of HBV stabilization or signs of viral response (e.g., reduction HBV DNA levels) prior to randomization. Patients who test positive for anti-HBcAb with undetectable HBV DNA (< 10 IU/mL or under the limit of detection per local laboratory) do not require antiviral therapy. These patients will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥ 10 IU/mL or above the limit of detection per local laboratory). Patients with detectable HBV DNA during the study must initiate and remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment.
  • Patients with active HCV infection (as characterized by the presence of detectable HCV ribonucleic acid (RNA)) must be managed per local institutional practice for the study duration.
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. A definition of post-menopausal.
  • Adequate organ and marrow function, as defined below. Criteria “a,” “b,” “c,” and “f” cannot be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose:
    • Hemoglobin ≥ 9 g/dL;
    •  Absolute neutrophil count ≥ 1000/µL;
    • Platelet count ≥ 65000/µL;
    • Total bilirubin (TBL) ≤ 2.0 × upper limit of normal (ULN);
    • Aspartate aminotransferase (AST) and ALT ≤ 5 × ULN;
    •  Albumin ≥ 2.8 g/dL;
    • International normalized ratio ≤ 1.6 (for patients receiving Warfarin, please consult with the study physician);
    • Urine protein 2+ or less;
    • Tested blood urea nitrogen or creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CL) ≥ 51 mL/min as determined by the Cockcroft-Gault formula (using actual WT) or 24-hour urine creatinine CL;
    • Males: Creatinine CL (mL/min)=WT (kg) × (140
      •Age) 72 × serum creatinine (mg/dL); Females:  Creatinine CL (mL/min) = WT (kg) × (140
      •Age) × 0.85 72 × serum creatinine (mg/dL).


Exclusion Criteria:
 

  • History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 3 months prior to randomization.
  • History of significant bleeding disorders, vasculitis, or a significant bleeding episode from the GI tract within 3 months prior to study randomization.
  • History of GI perforation and/or fistulae within 6 months prior to randomization.
  • Any history of nephrotic or nephritic syndrome.
  • Evidence of symptomatic congestive heart failure (New York Heart Association II to IV) or symptomatic or poorly controlled cardiac arrhythmia.
  • History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
  • Uncontrolled arterial hypertension defined by a systolic pressure ≥ 150 mm Hg or diastolic pressure ≥ 90 mm Hg despite standard medical management.
  • Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging undertaken at the screening visit, or within 6 months (24 weeks) of randomization.
  • Evidence of distant metastasis (except regional lymph node metastases related to the disease under study, per Appendix F), co-existing malignant disease or macrovascular invasion on baseline imaging.
  • History of hepatic encephalopathy within 12 months prior to randomization or requirement for medications to prevent or control encephalopathy (no lactulose, rifaximin, etc, if used for purposes of hepatic encephalopathy).
  • Evidence of portal vein thrombosis, visible on baseline/eligibility imaging, and patients with Vp1, Vp2, Vp3 and Vp4 (benign portal vein thrombosis is allowed, where not related to tumor thrombus, and anti-thrombotics may be used as needed).
  • Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g., paracentesis) to maintain symptomatic control, within 6 months prior to the first dose of study treatment. (a) Patients with ascites who have required pharmacologic intervention (e.g., diuretics) and who have been on stable doses of diuretics for ascites for ≥ 2 months before randomization are eligible.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [except for diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [e.g., granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, and uveitis]). The following are exceptions to this criterion:
    • Patients with vitiligo or alopecia;
    • Patients with hypothyroidism (e.g., following Hashimoto syndrome), stable on hormone replacement;
    • Any chronic skin condition that does not require systemic therapy;
    • Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician;
    • Patients with celiac disease controlled by diet alone.
    • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic GI conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase the risk of incurring AEs or compromise the ability of the patient to give written informed consent.
    • History of another primary malignancy except for the following:
      • Prostate cancer of pathologic stage less than or equal to T2cN0M0 determined from a prior prostatectomy without biochemical recurrence and who, in the opinion of the Investigator, are not deemed to require active intervention, or patients with incidental histologic findings of prostate cancer that has not been treated prior to the study and who do not require specific therapy for prostate cancer beyond the surgery described in the Clinical Study Protocol and also are considered to be at low risk for recurrence per the Investigator;
      • Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study treatment and of low potential risk for recurrence;
      • Adequately treated non-melanoma skin cancer or lentigo malignant without evidence of disease;
      • Adequately treated carcinoma in situ without evidence of disease;
      • Patients with another primary malignancy that is not active or expected to be clinically relevant in the next 5 years may be considered further to discussion with the Study Physician.
  • Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice) or human immunodeficiency virus (HIV; positive for HIV 1/2 antibodies).
  • Active co-infection with both HBV and hepatitis D virus.
  • Known allergy or hypersensitivity to any of the study treatments or any of the study treatment excipients.
  • History of aneurysm (Patients with a capped aneurysm may be included but only after consultation with the Study Physician).
  • Major surgery (as defined by the Investigator) within 28 days prior to randomization, or central venous access device placement within 7 days prior to randomization (biopsy from any type of surgery within 28 days is not an exclusion criteria, nor are procedures to treat varices).
  • Receipt of routine treatment for chronic condition with nonsteroidal anti-inflammatory agents (e.g., indomethacin, ibuprofen, naproxen, or similar agents) or other anti-platelet agents (e.g., clopidogrel, ticlopidine, dipyridamole, or anagrelide). Require minimum washout period of 5 days prior to randomization. Low dose aspirin (≤ 325 mg/day) is permitted. Prohibited concomitant medications with exceptions.
  • Receipt of prior systemic anticancer therapy for HCC.
  • History of allogeneic organ transplantation or those who are on a waiting list for liver transplantation.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment.
    • Note: Patients, if enrolled, should not receive live vaccine while receiving study treatment and up to 90 days after the last dose of study treatment.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment. The following are exceptions to this criterion:
    • Intranasal, inhalational, topical steroids, or local steroid injections (e.g., intra-articular injection);
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent;
    • Steroids as pre-medication for hypersensitivity reactions (e.g., CT-scan premedication).
  • Receipt of treatment with herbal medications labelled for the treatment of HCC (e.g., Huaier) within 14 days prior to first dose of study treatment.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of study treatment. Not engaging in sexual activity, per the patient’s preferred and usual lifestyle, for the total duration of the treatment and 6 months after the last dose of study treatment is an acceptable practice.
  • Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
  • Involvement in the planning and/or conduct of the study for both AstraZeneca staff and/or staff at the study site.

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

 

 

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Destruction of lesion of liver, Destructive procedure, Drug therapy, Immunotherapy for cancer, Removal of liver lesion
Cancer, Hepatocellular carcinoma, Liver cancer, Liver tumor
Ablation, At risk of malignancy, Bevacizumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, Digestive system, Durvalumab [USAN:INN], Liver cell carcinoma, Liver tumor ablation, Medical Oncology, bevacizumab, durvalumab
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Development of Technologies to Increase In-Seat Movement to Prevent Sitting Acquired Pressure Injuries in Wheelchair Users: AIM 3 Evaluation

Technologies to Increase In-Seat Movement to Prevent Sitting Acquired Pressure Injuries in Wheelchair Users

Susan Hallbeck
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122605-H01-RST
19-008916
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Inclusion Criteria:


- 18 years of age or older

- Be able to come to Mayo Clinic, UMN, or Georgia Tech campuses for study visits OR
participate in virtual video study visits

- Use a wheelchair for their primary form of mobility

- Use a skin protection and positioning wheelchair cushion

- Be able to perform weight shifts independently without assistance of another person (by moving themselves or using of power tilt)

- Own and are able to operate a smartphone with Apple or Android operating system

- Are willing to download and use the mobile apps on their phone


Exclusion Criteria:


- Are scheduled for flap surgery

- There is an active stage 3, 4, or unstageable pressure injury as defined by the National Pressure Injury Advisory Panel definitions anywhere on their sitting surface at time of enrollment

- Use of a custom molded wheelchair cushion or alternating air cushion

- Have/use the recline function on their power wheelchair

- Have/use the standing function on manual or power wheelchair

- Have a prescribed or limited sitting time of less than 5 hours per day

- Live in a long-term care facility or group home and require 24 hours/day assistance

- Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

Behavioral, Other
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Counseling and Uptake of Low Dose Tamoxifen by Patients at High Risk for Breast Cancer

A Study of Low Dose Tamoxifen for Patients at High Risk for Breast Cancer

Sandhya Pruthi
Female
35 years to 75 years old
This study is NOT accepting healthy volunteers
0000-122225-H01-RST
19-005289
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Inclusion Criteria:

  • Women ≥ 35 years old and ≤ 75 years old.
  • Women that meet at least one of the following:
    • NCI-BCRAT 5-year risk (> 3%) or that shows at least moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force or IBIS (version 8) risk calculator (> 8% for the 10-year risk);
    • History of atypical hyperplasia (30% lifetime risk for developing breast cancer);
    • LCIS (approximately 20% lifetime risk for developing breast cancer);
    • Status post-surgery (lumpectomy or unilateral mastectomy) for ER positive DCIS;
    • Status post-surgery (lumpectomy or unilateral mastectomy) for pleomorphic LCIS.
  • Willingness to complete surveys for the study.

Exclusion Criteria:

  • Women whose BCRAT falls below the threshold moderate according to the US Preventative Task Force or IBIS (version 8) 10 year risk of < 8%; OR do not have a surgical finding that demonstrates increased risk of developing invasive breast cancer.
  • Women with known BRCA1 and BRCA2 mutations.
  • Women with known contraindications to tamoxifen, raloxifene, exemestane or anastrozole.
  • Women unable to give informed consent.
  • Prior history of invasive breast cancer.
  • At-risk women due to prior radiation therapy to the chest.
  • Prior use of preventive medications (tamoxifen, raloxifene, exemestane or anastrozole) for breast cancer prevention.

 

Atypical hyperplasia of the breast, Breast cancer, Cancer, Ductal carcinoma in situ, Lobular carcinoma in situ
At high risk for breast cancer, Atypical hyperplasia, Atypical hyperplasia of breast, Cancer treatment, Intraductal carcinoma in situ of breast, Intraductal carcinoma, noninfiltrating, Lobular carcinoma in situ of breast, Medical Oncology, Pleomorphic lobular carcinoma in situ of breast, Tamoxifen [INN:BAN], tamoxifen, Hormone therapy for breast cancer, Targeted drug therapy
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Mayo Clinic — Rochester, MN

The Impact of Training with Whole Body EMS (EMS)

A Study to Evaluate the Impact of Training with Whole Body Electronic Muscle Stimulation (EMS)

Amir Lerman
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122037-H01-RST
19-003449
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Inclusion Criteria:

  • Subjects 18 years and older.
  • 80 healthy individuals employed at Mayo Clinic, Rochester MN. 


Exclusion Criteria:

  • Subjects under the age of 18.
  • Pregnant women.
  • Subjects with a history of liver or kidney disease, acute illness, taking medications (such as glucocorticoids).
  • Subjects who have conditions (such as chronic inflammatory muscular diseases or Cushing’s syndrome) that affect muscle mass.
  • Individuals with pacemakers and implantable cardiac defibrillators.
  • Individuals who conduct any other type of resistance training (> 45 minutes/week).
  • Individuals who have regular “high” alcohol consumption (> 80g/day on 5 days a week).
  • Subjects unable to consent to or participate in the 16-week EMS intervention or be available for follow up.
Behavioral, Other, Assessment of peripheral neurovascular function, Functional electrical skeletal muscle stimulation procedures
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J2G-MC-JZJB A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) (J2G-MC-JZJB)

A Study of Selpercatinib to Treat Participants with RET-Mutant Medullary Thyroid Cancer

John Morris
All
12 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101059-P01-RST
19-006266
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Inclusion Criteria:

  • Are of an acceptable age to provide informed consent according to local regulations and are at least 18 years of age (patients as young as 12 years of age will be allowed if permitted by local regulatory authorities and institutional review boards).
    • All patients of 12 years of age and older, after giving assent / legally designated representative/ participant written consent.
  • Histologically or cytologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease. Patients with mixed histology (e.g., incidental papillary thyroid cancer identified at the time of resection) are eligible if MTC is the dominant histology. Prior systemic or radiation therapy in the adjuvant setting may be allowed with discussion and approval by the Lilly medical team.
  • Radiographic progressive disease per RECIST 1.1 (Eisenhauer et al. 2009) at screening compared with a previous image taken within the prior 14 months as assessed by the BICR. Patients with measurable or non-measurable but evaluable disease are eligible; however, patients with non-measurable disease may not have disease limited to bone sites only.
  • A RET gene alteration identified in a tumor, germline DNA or blood sample (e.g., cfDNA). The RET alteration result should be generated from a laboratory with CLIA, ISO/IEC, CAP, or other similar certification. Lilly should be contacted to discuss test results from labs where such certification is not clearly demonstrated to determine eligibility; if certification is not required in the patient’s country, the Sponsor may allow enrollment using a result from a non-certified lab if sufficient evidence can be provided as to the accuracy of the result. A positive germline test for a RET mutation is acceptable given the test was determined by internal institutional quality standards and performed for clinical evaluation. In all cases, a redacted Molecular Pathology Report or other report(s) describing RET (and any co-occurring findings, if applicable) alteration analysis should be submitted to Lilly or designee during/prior to eligibility.
    • Mandatory provision of an unstained, archived tumor tissue sample in a quantity sufficient to allow for retrospective central analysis of RET mutation status (for confirmation). 
  • Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al. 1982) of zero to two.
  • Ability to swallow capsules and comply with treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
  • Patients must have discontinued from previous treatments as shown below and fully recovered.  Consult with the Lilly medical team for the appropriate length of time prior to the first dose of study treatment on additional therapies not mentioned.
  • Patients must have normal serum potassium, calcium, and magnesium levels (may be receiving supplements.
  • Men with partners of childbearing potential or women of childbearing potential must agree to use a highly effective contraceptive method (for example, intrauterine device [IUD], birth control pill, or barrier method) during treatment with study drug and for 4 months following the last dose of study drug.
    • Note: Unless not allowed by local regulations, women of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with males unless they agree to use contraceptive method known to be highly effective. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.
  • Women of childbearing potential must:
    • have a negative pregnancy test (serum or urine, consistent with local regulations) documented within 24 hours prior to treatment with study drug;
    • not be breast-feeding during treatment and for at least 4 months after the last dose of study drug.
  • Capable of giving signed informed assent/consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.


Exclusion Criteria:

  • An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. Examples include, but are not limited to RAS or BRAF gene mutations and NTRK gene fusions.
  • Symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Patients are eligible if neurologically stable and without increase in steroid dose for 14 days prior to the first dose of study treatment and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS).
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of study treatment, history of Torsades de pointes, or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 470 msec on more than one ECG during Screening. Correction of suspected drug-induced QTcF prolongation may be attempted at the investigator’s discretion if clinically safe to do so.  Patients who are intended to receive vandetanib if randomized to the control arm ineligible if QTcF is > 450 msec.
    • Note: Patients with implanted pacemakers may enter study without meeting QTc criteria due to nonevaluable measurement if QT changes are considered monitorable;
    • Note:  Patients with bundle branch block may be considered for study entry if QTc is appropriate by a formula other than Fridericia’s and if QT changes are considered monitorable.
  • Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment, a clinical diagnosis or symptoms of interstitial lung disease, or other serious medical conditions which in the medical judgment of the investigator would prevent the patient from safely participating (screening for chronic conditions is not required).
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
  • Uncontrolled symptomatic hyperthyroidism or hypothyroidism
  • Uncontrolled symptomatic hypercalcemia or hypocalcemia
  • Active hemorrhage or at significant risk for hemorrhage.
  • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ or malignancy diagnosed ≥ 2 years previously and not currently active.  Patients receiving adjuvant hormone therapy for breast or prostate cancer with no evidence of disease are eligible. Participants with MEN2-associated pheochromocytoma are eligible if the pheochromocytoma is, in the opinion of the investigator, documented to be stable or has been resected (and patient has fully recovered from surgery).
  • Prior systemic treatment with kinase inhibitor(s)
  • Are taking a concomitant medication that is known to cause QTc prolongation.
  • Have participated, within the last 30 days (4 months for studies conducted in Japan; 3 months for studies conducted in the UK), in a clinical study involving an investigational product.  If the previous investigational product has a long half-life, 5 half-lives or 30 days (4 months for studies conducted in Japan; 3 months for studies conducted in the UK) (whichever is longer) should have passed.  Exceptions will be considered on a case by case basis by the Lilly medical team.
  • Life expectancy ≤ 3 months
  • Have a known hypersensitivity to any of the excipients of selpercatinib, cabozantinib, or vandetanib.

Eligibility last updated 10/27/21.  Questions regarding updates should be directed to the study team contact.

Drug
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MC1931 Pharmacodynamic Study of Estrogen Suppression Threshold-Directed Therapy (ESTDT) of Anastrozole as Adjuvant Therapy for Early Stage Breast Cancer

Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer

Tufia Haddad
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101000-P01-RST
19-006637
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Inclusion Criteria
•Registration:

  • Women of age ≥ 18 years.
  • Histological confirmation of invasive breast carcinoma.
  • Stage I-III breast cancer
  • Estrogen receptor (ER) positive disease according to ASCO/CAP guidelines as ER≥1% positive nuclear staining.
  • Completion of all planned cancer treatments prior to registration:
    • surgical resection of breast and nodal surgery;
    • NOTE: Reconstructive surgery does not have to be completed
    • adjuvant radiation therapy, if needed; and
    • neoadjuvant and/or adjuvant chemotherapy, if needed.
  • Post-menopausal defined as
  • Age ³60 and amenorrhea >12 consecutive months OR
  • Previous bilateral oophorectomy OR
  • Age <60 and amenorrhea >12 consecutive months and documented follicle stimulating hormone (FSH) level within post-menopausal range according to institutional standard
  • NOTE: Patients who did not meet these criteria at time of diagnosis and received pre-operative (neoadjuvant) or post-operative (adjuvant) chemotherapy will not be allowed to participate.
  • ECOG Performance Status (PS) 0, 1, or 2 .
  • The following laboratory values obtained ≤14 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 70,000/mm^3;
    • Total bilirubin ≤ 1.5 x ULN;
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN.
  • Ability to swallow oral medication.
  • Provide written informed consent.
  • Willingness to provide mandatory blood specimens for correlative research.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

Exclusion Criteria
•Registration:

 

  • Pre-menopausal women receiving ovarian function suppression (goserelin, leuprolide, etc.).
  • Stage IV (metastatic) breast cancer.
  • HER2 positive breast cancer as defined by:
    • HER2 IHC ≥ 3+;
    • HER2/CEP17 ≥ 2.0;
    • HER2/CEP17 < 2.0 and average HER2 copy number of ≥ 6.0. signals/cell
  • Prior endocrine therapy for this breast cancer.
  • Exceptions:
    • Pre-operative aromatase therapy (anastrozole, letrozole, or exemestane)  and last treatment was ≥ 4 weeks prior to registration; OR
    • Pre-operative tamoxifen therapy and last treatment was ≥ 12 weeks prior to registration.
  • Currently receiving any of the following cancer-directed therapies:
    • Radiation therapy;
    • Systemic therapy such as chemotherapy (standard or investigational);
    • Bisphosphonate therapy started < 4 weeks prior to registration.
  • NOTE: If patient is currently on bisphosphonate therapy she must be on stable dose for ≥ 4 weeks prior to registration.
  • Patients not currently taking bisphosphonates will be allowed to start bisphosphonate therapy after completion of anastrozole (1mg and 10 mg daily (if given)). Information regarding bisphosphonate therapy will be collected.
  • Current use of systemic or topical exogenous estrogen or progesterone (menopausal hormone replacement therapy [HRT]).
  • Prior ovarian function suppression (leuprolide, goserelin, etc).
  • Inability to provide informed consent.
  • History of contralateral DCIS or invasive breast cancer.
  • NOTE: Exception allowed if:
    • Patient did not receive adjuvant endocrine therapy; OR
    • Patient received adjuvant endocrine therapy but has been off treatment for at least 6 months prior to registration.
  • Concurrent active malignancy or history of malignancy ≤ 3 years prior to registration.
  • NOTE: Exceptions allowed for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, papillary thyroid cancer, or non-melanoma skin cancer.
  • Prior prevention therapy with an aromatase inhibitor or a SERM.
  • Exception: Therapy with a SERM (tamoxifen or raloxifene) is allowed if patient has been off treatment for ≥ 6 months prior to registration.
Drug, Administration of antineoplastic agent, Drug therapy, Estrogen hormone therapy
Breast cancer, Cancer
Cancer treatment, Malignant tumor of breast, Medical Oncology, anastrozole, Anastrozole, Breast cancer surgery, Letrozole, letrozole, Hormone therapy for breast cancer
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A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage

AXIOS? for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE

Andrew Storm
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122296-P01-RST
19-005863
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Inclusion Criteria:

  • Patient requiring intervention for the management of symptoms associated with acute cholecystitis.
  • Patients referred for percutaneous drainage of the gallbladder who are not surgical candidates because of advanced age, anesthetic risk, significant co-morbidities and/or overall health.
  • Eligible for endoscopic intervention.
  • Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines [3]: -AC Grade I (mild) defined as acute cholecystitis in an otherwise healthy patient with mild local inflammatory changes and without organ dysfunction. Criteria for grade II or III not met. -AC Grade II (moderate) defined by any one of the following characteristics -Leukocytosis (>18,000 cells per mm3) -Palpable, tender mass in right upper quadrant -Symptom duration >72 hours -Marked local inflammation (gangrenous or emphysematous cholecystitis, pericholecystic or hepatic abscess, biliary peritonitis).
  • Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion.
  • 18 years of age or older.
  • Willing and able to comply with the study procedures and provide written informed consent form (ICF) to participate in the study. 


Exclusion Criteria:

  • AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of the following systems: -Cardiovascular
    •Hypotension requiring administration of ≥5μg/kg/min of dopamine or any dose of norepinephrine -Neurologic
    •decreased level of consciousness -Respiratory
    •PaO2/FiO2 <300 -Renal
    •Oliguria and Creatinine >2.0 mg/dl (>177 μmol/liter) -Hepatic
    •International normalized ratio >1.5 -Hematologic
    •Platelet count <100,000/mm3.
  • Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic gallbladder.
  • Hepatic abscess.
  • Ascites.
  • Advanced liver disease.
  • Subjects with abnormal coagulation or who require ongoing complete anticoagulation.
  • Bleeding diathesis.
  • Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum that might preclude endoscopic drainage.
  • Prior surgical, interventional radiology or endoscopic procedures for the treatment of acute cholecystitis.
  • Distance between gallbladder wall and duodenal or gastric wall > 1cm by US (ultrasound) at the time of drainage.
  • Patients with intervening gastric varices or vessels within a one centimeter radius of the device insertion location.
  • Patients that have allergies or are sensitive to any of the device materials.
  • Patients with contraindications to use of electrical devices.
  • Pregnancy.
  • Prisoners and other vulnerable populations.
Endoscopic insertion of stent into bile duct, Open insertion of bile duct stent, Percutaneous cholecystostomy, Device
Cholecystitis, Peritonitis
Abscess of liver, Acute cholecystitis, Acute emphysematous cholecystitis, Acute gangrenous cholecystitis, Bile peritonitis, Digestive system, Gallbladder tube placement, Pericholecystic abscess
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Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2 Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) (GSK208467)

A Study to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors

Steven Robinson
All
12 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100947-P01-RST
19-008233
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Inclusion Criteria:

  • Capable of giving signed informed consent including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. For participants <18 years of age (or the legal minimum age in the relevant country) their legal guardian must give informed consent. Pediatric participants will be included in age-appropriate discussion in order to obtain assent.
  • Participant must be ≥ 10 years of age at the time of signing the informed consent. Participant scheduled to receive clinical drug product supply must also weigh ≥ 40 kg. For participant scheduled to receive commercial drug product supply and weighing < 40kg, the Investigator must also consult with the Medical Monitor prior to inclusion.
  • Participant has a diagnosis of synovial sarcoma or myxoid/round cell liposarcoma, confirmed by local histopathology and with evidence of translocation per below: – for synovial sarcoma, the presence of a translocation between SYT on the X chromosome and SSX1, SSX2 or, SSX4 on chromosome 18 (may be presented in the pathology report as t (X;18)) is required; – for myxoid/round cell liposarcoma, the presence of a translocation t (12;16)(q13;p11) or the variant translocation t (12;22)(q13;q12) is required.
  • Participant has high-risk locally advanced (i.e. deeply seated, high grade, positive margins, large [≥5 cm], or locally recurrent) synovial sarcoma or myxoid/round cell liposarcoma.
  • Participant with synovial sarcoma or myxoid/round cell liposarcoma who is:
    • Newly diagnosed, previously untreated; OR
    • Relapsed after surgery or radiotherapy for localized disease; OR
    • Relapsed 1 year after adjuvant/neoadjuvant therapy for localized disease.
  • Male or female. Contraception requirements will apply at the time of leukapharesis and treatment.A representative tumor tissue specimen (archived or fresh biopsy) with associated pathology report should be available to perform NY-ESO-1 antigen expression analysis, unless a recent NY-ESO-1 expression test result from the same designated central laboratory, following the same procedures, has already been performed under a separate GSK-sponsored protocol or under another substudy. 

All the Inclusion Criteria in 1-7 must apply again prior to leukapheresis. In addition, the following criteria must also apply:

  • Life expectancy ≥ 24 weeks.
  • Participant has advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell liposarcoma. Unresectable refers to a tumor lesion in which clear surgical excision margins cannot be obtained without leading to significant functional compromise.
  • Participant must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles by a validated test in a designated central lab prior to leukapheresis.
    • NOTE: An HLA test result from the same designated central laboratory, following the same procedures, and performed under a separate GSK-sponsored protocol or under another substudy is acceptable.
  • Participant’s tumor has been pathologically reviewed by a designated central laboratory with confirmed positive NY-ESO-1 expression defined as:
    • 30% of cells that are 2+ or 3+ by immunohistochemistry.
    • NOTE: A NY-ESO-1 expression test result from the same designated central laboratory, following the same procedures, and performed under a separate GSKsponsored protocol or under another substudy is acceptable.
  • Left ventricular ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion.
  • Performance status: for participants 60, or for participants < 16 and Lansky > 60, or for participants ≥ 16 and < 18 years of age, Karnofsky > 60, or for participants or for participants ≥ 18 years of age, Eastern Cooperative Oncology Group (ECOG) of 0-1.
  • Participant must have adequate organ function and blood cell counts, within 7 days prior to the day of leukapheresis procedure (or first day of lymphodepletion during Treatment fitness assessment), as indicated by the following laboratory values.
  • Hematological
  • Absolute Neutrophil count (ANC) ≥1.5 x10^9 /L (without granulocute coloty-stimulating support);
  • Absolute Lymphocyte count (ALC) ≥ 0.5 x 10^9 /L;
  • Hemoglobin ≥ 8 g/dL or ≥ 5.6 mmol/L.
  • Platelets ≥ 100 x10^9 /L (not achieved by transfusion).
  • Creatinine clearance ≥ 40 mL/min.
  • Participants who are ≥ 18 and < 65 years of age must be assessed either:
    • by 24-hour urine creatinine collection; OR
    • by using Serum Creatinine (Scr) via an estimated creatinine clearance calculated as below: Step 1: estimated glomerular filtration rate (GFR) to be obtained from the Chronic kidney disease Epidemiology Collaboration (CKD-EPI) formula [Levey, 2009]:
    • Estimated GFR (mL/min/1.73m^2 ) = 141 × min(Scr/κ, 1), α × max(Scr/κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] where:
    • Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min(Scr/κ,1) indicates the minimum of Scr/κ or 1, max(Scr/κ,1) indicates the maximum of Scr/κ or 1, and Age is in years.
    • Step 2: correction factor to be applied per the American National Kidney Foundation in order to obtain the estimated creatine clearance in mL/min Estimated CrCl (mL/min) = Estimated GFR (mL/min/1.73 m^2 ) × BSA (m2 ) / 1.73 m^2.
  • Participants ≥ 65 years of age must have renal function measured either by 24-hour urine creatinine collection or by nuclear medicine EDTA GFR measurement, according to standard practice at the treating institution.  Participants <18 years of age must have renal function measured either by 24-hour urine creatinine collection or by nuclear medicine EDTA GFR measurement or by serum creatinine collection, according to standard practice at the treating institution.
  • Participants < 18 years of age must have GFR ≥ 70mL/min/1.73m^2 OR have a serum creatinine based on age/gender as follows:
    • Age Maximum serum creatinine (mg/dL) Male Female
    • Age 10 to < 13 years > 1.2
    • Age 13 to < 16 years > Male 1.5  | Female 1.4
    • Age 16 to < 18 years > Male 1.7 | Female 1.4
  • Hepatic
  • Total bilirubin
  • Participants with Gilbert’s Syndrome (only if direct bilirubin ≤ 35%) | ≤ 1.5 x ULN (isolated bilirubin ≤ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
  • ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if documented history of liver metastases)
  • Coagulation
  • International normalized ratio (INR) OR prothrombin time (PT)
  • Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants Nutritional status.
  • Albumin ≥ 3.5 g/dL
    • Participants may be transfused or receive growth factor treatment to meet minimum hematologic values up to 7 days prior to determining eligibility;
    • Adequate Organ Function will be reassessed for eligibility prior to lymphodepletion: if, upon consultation with the Medical Monitor, there is evidence from laboratory values that recovery from last anti-cancer treatment is underway, hematology labs may be considered acceptable and requirements waved to proceed with lymphodepletion.
  • Participant is fit for leukapheresis and has adequate venous access for the cell collection.
  • Male or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male Participants: Male participants are eligible to participate if they agree to the following during the intervention period starting at the first dose of chemotherapy for at least 12 months after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ gene modified cells in the participant’s blood, whichever is longer. Refrain from donating sperm Plus, either: Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below:
    • Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant (as a condom may break or leak);
    • Agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person.
  • Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    • Is not a WOCBP; OR
    • Is a WOCBP who will agree to use a barrier method (male condom) and use a contraceptive method that is highly effective (with a failure rate of < 1% per year) during the intervention period and for at least 12 months after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ gene modified cells in the participant’s blood, whichever is longer.  WOCBP should also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    • A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before any dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Female participants of childbearing potential (FCBP) must have a negative urine or serum pregnancy test.
  • Safety assessments will be reassessed again prior to lymphodepletion. Treatment fitness will be established in consultation with Medical Monitor.

In addition, the following criteria must also apply:

  • Participant has measurable disease according to RECIST v1.1.
  • Supportive radiotherapy has not affected > 25% of bone marrow.
  • A biopsy (excisional, incisional, or core) of non-target tumor tissue obtained within 90 days prior to initiating lymphodepleting chemotherapy is mandatory if cleanically feasible. This biopsy will be used as baseline for biomarker analyses. If it is not feasible to obtain a fresh biopsy, an archival tumor tissue (FFPE block) taken after completion of the participant’s last line of therapy, preferably within 90 days prior to initiating lymphodepleting chemotherapy, may be accepted at the discretion of the Medical Monitor (or designee). For participants who already provided a fresh biopsy for antigen expression and did not receive any supportive or intermediate anti-cancer therapy, the screening biopsy will be used for baseline.


Exclusion Criteria:

  • Participant has been previously treated for advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell liposarcoma.
  • Central nervous system (CNS) metastases.
  • Any other prior malignancy that is not in complete remission.
  • Exceptions include:
    • completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma (e.g., melanoma in situ, basal cell carcinoma, prostate cancer in-situ, periosteal osteosarcoma);
    • previous malignancies that have been definitively treated, and have been in remission for 5 years may be enrolled upon consultation with sponsor Medical Monitor or designee.
  • Previous treatment with genetically engineered NY-ESO-1 specific T cells.
  • Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
  • Prior gene therapy using an integrating vector.
  • Previous allogeneic hematopoietic stem cell transplant.
  • Clinically significant systemic illness: a. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the Investigator would compromise the participant’s ability to tolerate protocol therapy or significantly increase the risk of complications; OR
  • Prior or active demyelinating disease. Please note in particular that mandatory washout period restrictions must be respected before starting leukapheresis.

In addition, participants are not eligible for leukapharesis if any of the following criteria apply: 

  • Participant has history of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g., Crohn’s disease, systemic lupus) requiring steroids or other immunosuppressive treatments.
  • Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection;
    • Clinically significant cardiac disease defined by congestive heart failure New York Heart Association (NYHA) Class 3 or Class 4;
    • Uncontrolled clinically significant arrhythmia;
    • Acute coronary syndrome (angina or myocardial infarction) in last 6 months;
    • Interstitial lung disease (participants with existing pneumonitis as a result of radiation are not excluded; however, participants cannot be oxygen dependent).
  • Current active liver or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per Investigator assessment).
    • NOTE: Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, persistent jaundice or cirrhosis.
  • QTc > 480 msec.
    • NOTES: The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method, machine-read or manually over-read. The specific formula that will be used to determine eligibility for an individual participant should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial. For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP).
  • Participant has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, fludarabine, other agents used in the study.
  • Pregnant or breastfeeding females (due to risk to fetus or newborn).
  • Any prior treatment-related toxicities must be CTCAE (Version 5.0) ≤ Grade 1 at the time of initiating study intervention (except for non-clinically significant toxicities e.g., alopecia, vitiligo). Participants with Grade 2 toxicities that are deemed stable or irreversible (e.g., chemotherapy related arthritis or tendinitis, skin discoloration or erythema) can be enrolled.
  • Other standard of care lines of therapy are allowed only if guidelines and washout periods.
  • Investigational treatment within 30 days or 5 half-lives (whichever is shorter) prior to leukapheresis. Investigational vaccines (other than NY-ESO-1 vaccines that are not allowed) must follow the washout period. Exceptions to this rule must be evaluated by the Investigator in agreement with the Sponsor’s Medical Monitor (or designee).
  • Participant has active infection with HIV, HBV, HCV, EBV, CMV, syphilis, or HTLV as defined below:
    • Positive serology for HIV;
    • Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Participants who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation;
    • Active hepatitis C infection as demonstrated by hepatitis C RNA test. Participants who are HCV antibody positive will be screened for HCV RNA by any RT PCR or bDNA assay. If HCV antibody is positive, eligibility will be determined based on a negative Screening RNA value;
    • Positive test for syphilis (spirochete bacterium);
    • Positive serology for HTLV 1 or 2.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study. Treatment fitness will be established in consultation with Medical Monitor. Please note in particular that mandatory washout period restrictions must be respected before starting lymphodepletion.

In addition, participants cannot proceed with lymphodepletion or treatment if any of the following criteria apply:

  • Participant has received cytotoxic therapy within 3 weeks prior to lymphodepleting chemotherapy.
  • Systemic corticosteroids or any other immunosuppressive therapy within 2 weeks prior to lymphodepleting chemotherapy.
    • NOTE: Isolated doses of systemic corticosteroids are permitted to manage acute allergic reactions. Use of inhaled or topical steroids is not exclusionary.
  • Participant has received radiotherapy to the target lesions within 3 months prior to lymphodepletion. A lesion with unequivocal progression may be considered a target lesion regardless of time from last radiotherapy dose.
    • NOTE: There is no washout period for palliative radiation to non-target lesions.
  • Participant has received an anti-cancer vaccine within 2 months in the absence of tumor response. The participant should be excluded if their disease is responding to an experimental vaccine given within 6 months.
  • Participant has received live vaccine within 4 weeks prior to lymphodepletion or intends to receive live vaccine during the 3 month period following administration of GSK3377794.
  • Participant has received immune therapy (monoclonal antibody therapy, checkpoint inhibitors) within 4 weeks of lymphodepletion.
  • Participant had major surgery ≤ 28 days of first dose of study intervention.
Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer, Drug
Cancer, Sarcoma, Soft tissue sarcoma, Synovial sarcoma
Biological therapy for cancer, Cancer treatment, Cellular therapy, Medical Oncology, Metastatic sarcoma, Musculoskeletal system, NY-ESO-1, Synovial sarcoma
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A Phase 1/2 Study of GRT-C903/GRT-R904, a Vaccine Targeting Shared Neoantigens, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors

A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens

Amit Mahipal
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101128-P01-RST
19-008520
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Inclusion Criteria:
 

For Phase 1

  • MSS-CRC who are currently receiving systemic treatment with a fluoropyrimidine and oxaliplatin and/or irinotecan that may include a VEGF or EGFR targeting therapy as their 1L or 2L therapy for metastatic disease OR who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan that may include a VEGF or EGFR targeting therapy, but have not initiated a new line of therapy;
  • NSCLC who are currently receiving systemic treatment with an anti-PD-(L)1 antibody in combination with cytotoxic, platinum-based chemotherapy OR who have experienced disease progression following treatment an anti-PD-(L)1 antibody in combination with cytotoxic, platinum-based chemotherapy (or antiPD-(L)1 alone if patient refuses platinum-based chemotherapy), but have not initiated a new line of therapy;
  • PDA who are currently receiving systemic cytotoxic chemotherapy as their 1L therapy for metastatic disease OR who have experienced disease progression on 1L systemic cytotoxic chemotherapy, but have not initiated a new line of therapy;
  • Any solid tumor histology where the patient has experienced disease progression with all available therapies known to confer clinical benefit.

For Phase 2

  • MSS-CRC who are currently receiving systemic treatment with a fluoropyrimidine and oxaliplatin and/or irinotecan that may include a VEGF or EGFR targeting therapy as their 1L therapy for metastatic disease OR who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan that may include a VEGF or EGFR targeting therapy and have not received additional lines of systemic therapy in the metastatic setting;
  • NSCLC who are currently receiving systemic treatment with an anti-PD-(L)1 antibody in combination with cytotoxic, platinum-based chemotherapy OR who have experienced disease progression following treatment an anti-PD-(L)1 antibody followed by cytotoxic, platinum-based chemotherapy (or anti-PD-(L)1 alone if patient refuses platinum-based chemotherapy) and have not received additional lines of systemic therapy in the metastatic setting (Patients whose tumor harbors KRAS G12C may also receive a targeted therapy that inhibits KRAS G12C as prior therapy in addition to pembrolizumab and platinum-based chemotherapy);
  • PDA who are currently receiving systemic cytotoxic chemotherapy as their 1L therapy for metastatic disease OR who have experienced disease progression on 1L systemic cytotoxic chemotherapy and have received no more than 1 prior line of therapy in the metastatic setting;
  • Any solid tumor histology where the patient has experienced disease progression with all available therapies known to confer clinical benefit.
  • Patient’s tumor possesses one of the mutations as determined per local institutional standard.
  • ≥ 18 years of age.


Exclusion Criteria:
 

  • Tumors with genetic characteristics as follows:
    • For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK;
    • Patients with known MSI-high disease based on institutional standard.
  • Known exposure to chimpanzee adenovirus within the prior 5 months or any history of anaphylaxis in reaction to a vaccination or hypersensitivity to study drug components.
  • Bleeding disorder (e.g., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws.
  • Patient has received prior therapy consisting of anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, with the exception of patients with NSCLC or a mutation-positive solid tumor.
  • History of allogenic/solid organ transplant .
  • Active, known, or suspected autoimmune disease.
  • Active tuberculosis or recent (<2 week) clinically significant infection, or evidence of active hepatitis B or hepatitis C.
  • Known history of positive test for human immunodeficiency (HIV) or known acquired immunodeficiency syndrome (AIDS) Complete inclusion and exclusion criteria are listed in the clinical study protocol.
Biologic/Vaccine, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer, Prescription of therapeutic regimen, Oncolytic virus therapy
Cancer, Colon cancer, Lung cancer, Non-small cell lung cancer, Pancreatic cancer, Rectal cancer
Biological therapy for cancer, Cancer treatment, Digestive system, Malignant neoplasm of colon and/or rectum, Malignant tumor of pancreas, Medical Oncology, Metastatic non-small cell lung cancer, Non-small cell lung cancer, Respiratory system, Secondary malignant neoplasm of colon and/or rectum, Secondary malignant neoplasm of pancreas, Solid tumor configuration, Virotherapy
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Examining the Preliminary Efficacy, Feasibility, and Acceptability of an Exercise Intervention on Frailty After Kidney Transplantation

A Study to Examine The Effectiveness, Feasibility, and Acceptability of Exercise Intervention on Frailty After Kidney Transplantation.

Elizabeth Lorenz
All
18 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122561-H01-RST
19-008545
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Inclusion Criteria:

  • Patients age ≥ 18 years.
  • Have received a kidney transplantation.
  • Have a functioning allograft.


Exclusion Criteria:
 

  • Neuropsychiatric condition causing patient to be unable to provide consent.
  • Recipient of a combined organ transplant.
Behavioral, Therapeutic exercise, Transplant of kidney
Frailty, Kidney transplant, Normal renal function of transplanted kidney, Transplanted kidney present
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NRG-GY014, A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent Endometrioid/Clear Cell Carcinoma of the Ovary or Peritoneum, and Recurrent Low Grade Endometrioid Endometrial Adenocarcinoma

A Study of Tazemetostat in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Endometrial Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100972-P01-RST
19-003579
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Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of recurrent or persistent ovarian endometrioid or clear cell carcinoma, OR recurrent or persistent endometrioid endometrial adenocarcinoma; patients with recurrent endometrial cancer must have mismatch repair (MMR) immunohistochemistry completed; if they are found to be mismatch repair deficient, they should be offered treatment with immune checkpoint inhibition before consideration for treatment on trial; primary ovarian tumors must be at least 50% endometrioid or clear cell morphology, or have histologically documented recurrence with at least 50% endometrioid or clear cell morphology; institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian tumors (primary or recurrent lesions).
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be ≥ 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or MRI.
  • Patients must have had at least one, but no more than 3, prior cytotoxic regimens for management of primary disease; unlimited prior hormonal therapy, targeted therapy (including immunotherapy) or antiangiogenic therapy will be permitted.
  • Patients must have completed prior therapy:
    • Chemotherapy: cytotoxic
      • At least 28 days since last dose of chemotherapy prior to registration.
    • Chemotherapy: nitrosoureas
      • At least 6 weeks since last dose of chemotherapy prior to registration.
    • Chemotherapy: non-cytotoxic (e.g. small molecule inhibitor)
      • At least 28 days since last dose of chemotherapy prior to registration.
    • Monoclonal antibody(ies)
      • At least 28 days since last dose of monoclonal antibody prior to registration.
    • Immunotherapy
      • At least 28 days since last dose of immunotherapy prior to registration.
    • Radiotherapy (RT)
      • At least 14 days from last local site RT prior to registration,
      • At least 21 days from stereotactic radiosurgery prior to registration.
      • At least 12 weeks from craniospinal, ≥ 50% radiation of pelvis or total body irradiation prior to registration.
      • Patients with central nervous system (CNS) disease should demonstrate evidence of stabilization after the 28-day time point after definitive treatment.
      • Full recovery of radiation related side effects prior to registration.
      • All subjects must have evidence of measurable disease outside of the radiation field at the time of registration.
  • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 14 days prior to registration;
    • Imaging of the chest, abdomen and pelvis within 28 days prior to registration.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to registration.
  • Platelets ≥ 100,000/mcl (within 14 days prior to registration).
  • Absolute neutrophil count (ANC) ≥ 1,500/mcl (within 14 days prior to registration).
  • Hemoglobin (Hgb) ≥ 8 g/dL (within 14 days prior to registration).
  • Differential with no clinically significant morphologic abnormalities on complete blood count (CBC) testing; manual differential is encouraged, if clinically indicated, and in cases where an automated differential is abnormal (within 14 days prior to registration).
  • Creatinine ≤ 1.5 x institutional/laboratory upper limit of normal (ULN) (within 14 days prior to registration).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 14 days prior to registration).
  • Total serum bilirubin level ≤ 1.5 x ULN; direct bilirubin ≤ ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert's syndrome are eligible) (within 14 days prior to registration).
  • Women of childbearing potential must be willing and able to use adequate contraception (hormonal and barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; theoretically, CYP3A induction with tazemetostat use may result in the loss of efficacy in hormonal contraceptives, thus a barrier method of contraception must be used in addition to hormonal contraceptives due to the potential drug-drug interaction with tazemetostat.
  • The patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.


Exclusion Criteria:
 

  • Prior treatment with an investigational EZH2 inhibitor.
  • Patients who are unable to swallow pills or absorb orally administered medication.
  • A prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
  • Abnormalities known to be associated with MDS (e.g., del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g., JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing.
  • A prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL).
  • Severe, active co-morbidity per the treating investigator's discretion.
  • Pregnant or lactating patients.
  • Known human immunodeficiency virus (HIV) positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with tazemetostat; in addition, treatments involved in this protocol may be immunosuppressive, increasing the risk of lethal infections in this patient population.
  • Treatment with strong inhibitors or inducers of CYP3A within 14 days of registration and during the study treatment.
Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Cancer, Endometrial cancer, Ovarian cancer, Peritoneal cancer, Recurrent cancer
Malignant tumor of peritoneum, Medical Oncology, Adenocarcinoma of endometrium, Cancer treatment, Chemotherapy, Clear cell (mesonephric) neoplasm of ovary, Malignant tumor of ovary, Primary endometrioid carcinoma of endometrium of body of uterus, Recurrent malignant neoplastic disease, Recurrent ovarian cancer, Reproductive system, Targeted drug therapy, Tazemetostat, tazemetostat
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The Ability of the Spectral Topogram at Photon Counting Detector Computed Tomography (PCD-CT) to Predict Osteoporosis and Osteopenia: a Pilot Study

A Study to Evaluate the Spectral Topogram to Predict Osteoporosis and Osteopenia

Joel Fletcher
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122939-H01-RST
19-011485
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Inclusion Criteria:

  • Male and female patients aged 18 years or more.
  • Patients with IBD, Celiac disease, and a history of receiving a liver transplant, or potential conditions or on drugs that may predispose them to osteoporosis.
  • Ability to undergo a research DEXA scan on Gonda 2.
  • Patients able and willing to sign informed consent.


Exclusion Criteria:

  • Patients not meeting inclusion criteria will be excluded.
  • Patients unable or unwilling to provide informed consent.
  • Patients with metal artifacts affecting the regions of interest.
  • Pregnancy.
  • Body mass index of more than 30.

 

  •  

 

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ECG Belt for CRT Response

A Study to Evaluate an ECG Belt for CRT Response

Abhishek Deshmukh
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121823-P01-RST
19-001651
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Inclusion Criteria:

  • Age 18 years or older.
  • Indicated for CRT, with QRS duration ≥ 130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
  • Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented Myocardial Infarction, Non-LBBB.
  • LVEDD ≥ 55 mm, as determined by site.


Exclusion Criteria:
 

  • Permanent/persistent AF or presenting with AF.
  • Pre-existing or previous LV lead or other confounding devices; e.g., Left Ventricular Assist Device, Vagal Nerve Stimulator.
  • Currently implanted with IPG or ICD with > 10% RV pacing.
  • Permanent complete AV block.
  • Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study. 
  • Less than 1 year life expectancy.
  • Vulnerable adults.
  • Younger than 18 years of age.
Device
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PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant (PRI-VENT FSGS)

A Study to Evaluate Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant

Hatem Amer
All
1 years to 65 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122701-P01-RST
19-009880
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Inclusion Criteria:

  • Age 1-65 years at the time of kidney transplant.
  • Biopsy proven diagnosis of primary FSGS or minimal change disease.
  • History of nephrotic syndrome (proteinuria, edema, hypoalbuminemia).
  • First kidney transplant OR second or third kidney transplant with a history of recurrent FSGS in the first or second transplant
  • The patient (if  ≥ 18 years old) or the child's parent or guardian must be able and willing to give written informed consent and comply with the requirements of the study protocol. Patient assent if < 18 years old will be required per local IRB requirements. 
  • Negative urine pregnancy test prior to randomization (for females who are post-menarche). 
  • Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab. An individual who meets any of the following criteria will be excluded from participation in this study: 
    • Known genetic cause of FSGS;
    • Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.);
    • Received rituximab within 1 year prior to transplant;
    • Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins;
    • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
    • Known active bacterial, viral (e.g., HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit;
    • Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer);
    • ANC < 1.5 x 10^3;
    • Hemoglobin: < 8.0 gm/dL;
    • Platelets: < 100,000/mm;
    • AST or ALT > 2.5 x Upper Limit of Normal at the local institution's laboratory;
    • History of drug, alcohol, or chemical abuse within 6 months prior to screening visit;
    • Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential;
    • Concomitant malignancies or previous malignancies; 
    • History of psychiatric disorder that would interfere with normal participation in this protocol;
    • History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease);
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
    • Inability to comply with study and follow-up procedures.


Exclusion Criteria:

  • Known genetic cause of FSGS.
  • Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.).
  • Received rituximab within 1 year prior to transplant.
  • Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  • Known active bacterial, viral (e.g. HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit.
  • Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer)
    • ANC < 1.5 x 10^3;
    • Hemoglobin:  < 8.0 gm/dL;
    • Platelets:  < 100,000/mm;
    • AST or ALT  > 2.5 x Upper Limit of Normal at the local institution’s laboratory.
  • History of drug, alcohol, or chemical abuse within 6 months prior to screening visit.
  • Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential.
  • Concomitant malignancies or previous malignancies.
  • History of psychiatric disorder that would interfere with normal participation in this protocol.
  • History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease).
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • Inability to comply with study and follow-up procedures.

 

Drug, Procedure/Surgery
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Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer

Konstantinos Leventakos
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101023-P01-RST
19-005349
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Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration.
  • Patients must have received one pre-registration cycle of platinum/etoposide chemotherapy prior to study entry, with study registration required within 21 days from day 1 of the pre-registration cycle of chemotherapy and protocol treatment designed to begin 21 days after. If patient has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted.
  • Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of platinum/etoposide chemotherapy.
  • Minimal staging requirements include:
    • History/physical examination within 30 days prior to registration;
    • Positron emission tomography (PET)/computed tomography (CT) scan for staging within 45 days prior to registration;
    • CT chest/abdomen with IV contrast (unless contraindicated based on kidney function) within 45 days prior to registration
      •this can be obtained as part of PET/CT if CT imaging is of diagnostic quality.
      • Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy.
    • Magnetic resonance imaging (MRI) scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration. 
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration.
    • Absolute neutrophil count (ANC) ≥ 1, 500/cells/mm^3 (pre-registration cycle)
    • Platelet count ≥ 100,000 cells/mm^3 (pre-registration cycle).
    • Hemoglobin ≥ 9 g/dL (pre-registration cycle).
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (pre-registration cycle).
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.0 x ULN (pre-registration cycle).
    • Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2 (within 30 days prior to registration).
    • Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging.
    • Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential.
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.


Exclusion Criteria:
 

  • Definitive clinical or radiologic evidence of metastatic disease.
  • Definitive surgical resection of small cell lung cancer.
  • Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable.
  • Any prior atezolizumab or other immunotherapy agent.
  • Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs).
  • Patients with cytologically positive pleural or pericardial fluid are not eligible. 
  • An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • History of allogeneic organ transplant
  • History of primary immunodeficiency.
  • Severe, active co-morbidity defined as follows: 
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;
    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
    • Active tuberculosis;
    • Active hepatitis B (chronic or acute) or hepatitis C infection.
      • Note that if hepatitis status is unknown, hepatitis B/C testing is required:
        • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible.  Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test).
    • Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL):
      • CD4 count < 200 cells/microliter.
        • Note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
    • Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary. 
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months. 
    • Transmural myocardial infarction within the last 3 months.
    • Clinically significant interstitial lung disease. 
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for 150 days after the last dose of study drug (Arm 2); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Drug, Other, Radiation, Administration of antineoplastic agent, Combined chemotherapy and radiation therapy, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Small cell lung cancer
1,2-Diaminocyclohexaneplatinum II citrate, Atezolizumab, Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Etoposide, Medical Oncology, Radiation therapy, Respiratory system, Small cell carcinoma of lung, atezolizumab, carboplatin, cisplatin, etoposide
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Mayo Clinic — Rochester, MN

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer

Mina Hanna
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101023-P01-ALCL
19-005349
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Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration.
  • Patients must have received one pre-registration cycle of platinum/etoposide chemotherapy prior to study entry, with study registration required within 21 days from day 1 of the pre-registration cycle of chemotherapy and protocol treatment designed to begin 21 days after. If patient has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted.
  • Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of platinum/etoposide chemotherapy.
  • Minimal staging requirements include:
    • History/physical examination within 30 days prior to registration;
    • Positron emission tomography (PET)/computed tomography (CT) scan for staging within 45 days prior to registration;
    • CT chest/abdomen with IV contrast (unless contraindicated based on kidney function) within 45 days prior to registration
      •this can be obtained as part of PET/CT if CT imaging is of diagnostic quality.
      • Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy.
    • Magnetic resonance imaging (MRI) scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration. 
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration.
    • Absolute neutrophil count (ANC) ≥ 1, 500/cells/mm^3 (pre-registration cycle)
    • Platelet count ≥ 100,000 cells/mm^3 (pre-registration cycle).
    • Hemoglobin ≥ 9 g/dL (pre-registration cycle).
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (pre-registration cycle).
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.0 x ULN (pre-registration cycle).
    • Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2 (within 30 days prior to registration).
    • Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging.
    • Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential.
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.


Exclusion Criteria:
 

  • Definitive clinical or radiologic evidence of metastatic disease.
  • Definitive surgical resection of small cell lung cancer.
  • Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable.
  • Any prior atezolizumab or other immunotherapy agent.
  • Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs).
  • Patients with cytologically positive pleural or pericardial fluid are not eligible. 
  • An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • History of allogeneic organ transplant
  • History of primary immunodeficiency.
  • Severe, active co-morbidity defined as follows: 
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;
    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
    • Active tuberculosis;
    • Active hepatitis B (chronic or acute) or hepatitis C infection.
      • Note that if hepatitis status is unknown, hepatitis B/C testing is required:
        • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible.  Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test).
    • Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL):
      • CD4 count < 200 cells/microliter.
        • Note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
    • Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary. 
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months. 
    • Transmural myocardial infarction within the last 3 months.
    • Clinically significant interstitial lung disease. 
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for 150 days after the last dose of study drug (Arm 2); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Drug, Other, Radiation, Administration of antineoplastic agent, Combined chemotherapy and radiation therapy, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Small cell lung cancer
1,2-Diaminocyclohexaneplatinum II citrate, Atezolizumab, Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Etoposide, Medical Oncology, Radiation therapy, Respiratory system, Small cell carcinoma of lung, atezolizumab, carboplatin, cisplatin, etoposide
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Mayo Clinic Health System — Albert Lea, MN

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer

Amrit Singh
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101023-P01-MAIJ
19-005349
Show full eligibility criteria
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Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration.
  • Patients must have received one pre-registration cycle of platinum/etoposide chemotherapy prior to study entry, with study registration required within 21 days from day 1 of the pre-registration cycle of chemotherapy and protocol treatment designed to begin 21 days after. If patient has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted.
  • Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of platinum/etoposide chemotherapy.
  • Minimal staging requirements include:
    • History/physical examination within 30 days prior to registration;
    • Positron emission tomography (PET)/computed tomography (CT) scan for staging within 45 days prior to registration;
    • CT chest/abdomen with IV contrast (unless contraindicated based on kidney function) within 45 days prior to registration
      •this can be obtained as part of PET/CT if CT imaging is of diagnostic quality.
      • Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy.
    • Magnetic resonance imaging (MRI) scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration. 
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration.
    • Absolute neutrophil count (ANC) ≥ 1, 500/cells/mm^3 (pre-registration cycle)
    • Platelet count ≥ 100,000 cells/mm^3 (pre-registration cycle).
    • Hemoglobin ≥ 9 g/dL (pre-registration cycle).
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (pre-registration cycle).
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.0 x ULN (pre-registration cycle).
    • Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2 (within 30 days prior to registration).
    • Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging.
    • Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential.
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.


Exclusion Criteria:
 

  • Definitive clinical or radiologic evidence of metastatic disease.
  • Definitive surgical resection of small cell lung cancer.
  • Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable.
  • Any prior atezolizumab or other immunotherapy agent.
  • Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs).
  • Patients with cytologically positive pleural or pericardial fluid are not eligible. 
  • An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • History of allogeneic organ transplant
  • History of primary immunodeficiency.
  • Severe, active co-morbidity defined as follows: 
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;
    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
    • Active tuberculosis;
    • Active hepatitis B (chronic or acute) or hepatitis C infection.
      • Note that if hepatitis status is unknown, hepatitis B/C testing is required:
        • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible.  Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test).
    • Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL):
      • CD4 count < 200 cells/microliter.
        • Note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
    • Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary. 
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months. 
    • Transmural myocardial infarction within the last 3 months.
    • Clinically significant interstitial lung disease. 
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for 150 days after the last dose of study drug (Arm 2); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Drug, Other, Radiation, Administration of antineoplastic agent, Combined chemotherapy and radiation therapy, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Small cell lung cancer
1,2-Diaminocyclohexaneplatinum II citrate, Atezolizumab, Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Etoposide, Medical Oncology, Radiation therapy, Respiratory system, Small cell carcinoma of lung, atezolizumab, carboplatin, cisplatin, etoposide
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Mayo Clinic Health System — Mankato, MN

In Vivo Development of Sodium Magnetic Resonance Imaging Technology

Sodium MRI Pilot

Timothy Kline
All
18 years to 65 years old
This study is NOT accepting healthy volunteers
0000-123006-H01-RST
19-012099
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Inclusion Criteria:

  • Men and women.
  • Ages ≥ 18 to ≤ 65 years old.
  • Able to tolerate lying motionless, flat on one's back in an MRI scanner for no more than 60 minutes.
  • Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD).


Exclusion Criteria:

  • No contraindication to MRI.
  • No implanted devices within the body (shunts, clips, plates, etc.).
  • No dental braces or retainer wires.
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Mayo Clinic — Rochester, MN

EA1151, Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

A Study of 3-D Digital Mammography to Screen Patients for Breast Cancer

Katie Hunt
Female
45 years to 74 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-100404-P01-RST
19-004054
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Inclusion Criteria:
 

  • Patients must be women age 45 or older and under age 75 at the time of study entry.
  • Women of childbearing potential must not be known to be pregnant or lactating.
  • Patients must be scheduled for, or have intent to schedule, a screening mammogram.
  • Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol, to be performed at an American College of Radiology Imaging Network (ACRIN)-qualified facility.
  • Patients must be willing and able to provide a written informed consent.
  • Patients must not have new symptoms or signs of benign or malignant breast disease (e.g., bloody or clear nipple discharge, breast lump) based on physician physical exam or self breast exam that have not been previously worked up with imaging. Patients with physiologic nipple discharge or breast pain are eligible as long as other criteria are met.
  • Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
  • Patients must not have previous personal history of breast cancer including ductal carcinoma in situ.
  • Patients must not have breast enhancements (e.g., implants or radiopaque injections).

ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK 

To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:

  • Patients are pre-menopausal; or
  • Post-menopausal aged 45-69 with any of the following four risks factors:
    • Dense Breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
    • At least one benign breast biopsy with a diagnosis of Lobular Carcinoma in Situ (LCIS) or atypia of any kind (atypical ductal hyperplasia, atypical lobular hyperplasia, atypical hyperplasia NOS, or intraductal papilloma with atypia), or
    • Family history of breast cancer (first degree relative with breast cancer) or family history of breast cancer is not known, or, participant positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or
    • Currently on hormone therapy¹; or
  • Post-menopausal ages 70-74 with either of the following three risk factors:
    • Dense Breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense); or
    • At least one benign breast biopsy with a diagnosis of LCIS or atypia of any kind (atypical ductal hyperplasia, atypical lobular hyperplasia, atypical hyperplasia NOS, or intraductal papilloma with atypia); or
    • Currently on hormone therapy¹.
  • Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry. For the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to bilateral oophorectomy with either hysterectomy or endometrial ablation will be considered postmenopausal. Women who no longer have menses due to either hysterectomy or endometrial ablation, and who have at least one ovary will be considered premenopausal until age 52 and postmenopausal thereafter.
  • All other postmenopausal women are eligible for inclusion in the biennial screening regimen.
  • For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy1 AND for whom a prior mammogram interpretation is not available, breast density will be determined by the radiologist’s recording of it at the time of interpretation of the first study screening examination, either DM or TM. For those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic 2D portion of the TM examination. Such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the TMIST population.
  • ¹ For this study we define hormone therapies as those that increase breast cancer risk, including: estrogen, progesterone, estrogen/progesterone analogs, or hormonal birth control prescribed by a doctor, and include hormones in oral contraceptives, patch, gel, etc. BUT, for this study, Soy use is not considered hormone therapy.
  • Breast density will be determined by prior mammography reports, when available, or by radiologist review of prior imaging.
    • NOTE: If the latter method is used, a signed, dated attestation by the radiologist indicating the resulting determination must be kept as a record and made available for monitoring/auditing.
  • All other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report.
Diagnostic Test, Procedure/Surgery, Other, Digital breast tomosynthesis, Screening for malignant neoplasm of breast, Screening mammography
Breast cancer, Cancer
3D mammogram, Breast exam, Malignant tumor of breast, Mammogram, Medical Oncology
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Mayo Clinic — Rochester, MN

Scleral Contact Lens Fogging Study

A Study to Evaluate Fogging in Scleral Contact Lens

Muriel Schornack
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122535-H01-RST
19-008247
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Inclusion Criteria:

  • Age 18 or older.
  • Scleral lens wearers with a history of 6 months of at least 5 hours of scleral lens wear at least 5 days/week are invited to participate.


Exclusion Criteria:
 

  • Patients with active infections or unstable inflammation of the eyes are not eligible to participate.
  • Patients who have been refit into a different scleral lens design during the past 6 months.
  • Patients who are actively participating in the scleral lens fitting process.
Hazy vision, Reduced visual acuity, Contact lens fitting
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Mayo Clinic — Rochester, MN

An Open-Label, Single Arm, Phase II Study of Intraoperative GEMcitabine INtravesical Instillation in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma

A Study to Evaluate Gemcitabine in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma

Stephen Boorjian
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-122670-H01-RST
19-009444
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Inclusion Criteria:

  • Males and females, age 18 years or older.
  • Clinical diagnosis of localized (clinical AJCC stage Ta-T4N0M0) low- and high-grade UC of the renal pelvis and/or ureter.
  • Plan to undergo RNU.
  • Adequate bone marrow, renal and hepatic function:
    • Creatinine < 2.2 mg/dL (194 mmol/L);
    • Adequate hematologic function (hemoglobin > 9 g/dL; white blood cell count ≥ 3000/μL; platelet count >75,000/μL and <500,000/μL);
    • Serum bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase levels below 2 times the institution’s upper limits of normal.
  • Easter Cooperative Oncology Group (ECOG) performance status score 0
    •2.
  • Suitable candidate for surgery at the discretion of the investigator.
  • Patient must be capable of giving appropriate approved informed consent or have an appropriate representative available to do.
  • Patient with a prior malignancy allowed if adequately treated > 3 years ago with no current evidence of disease.
  • Patient with any current malignancy except for basal or squamous cell skin cancers, noninvasive cancer of the cervix, or any other cancer deemed to be of low-risk for progression or patient morbidity during the trial period (i.e. Gleason 6 prostate cancer, renal mass < 3 cm).
  • Women of childbearing potential (WOCBP) must have a negative pregnancy urine test within 28 days of registration, and be using an adequate method of contraception to avoid pregnancy prior to and for at least 6 months after gemcitabine instillation to minimize the risk of pregnancy.
  • Male patient who has a partner that is a WOCBP must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) and should avoid conceiving children prior to and for 6 months following gemcitabine instillation.


Exclusion Criteria:

  • Pure non-urothelial histology; urothelial carcinoma with differentiation allowed.
  • Evidence of nodal or distant metastases; enlarged retroperitoneal lymph nodes > 2cm or histologically positive lymph nodes.
  • History of UC of the bladder within 12 months preceding RNU, or receipt of intravesical therapy within 6 months.
  • History of or current prostatic urethral, urethral, or contralateral upper tract UC.
  • History of radical cystectomy or partial cystectomy.
  • Planned radical cystectomy at time of RNU.
  • Symptomatic urinary tract infection of bacterial cystitis (once satisfactorily treated, patients can enter the study).
  • Women who are pregnant or breastfeeding.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are involuntarily incarcerated.
  • Inability for adequate follow-up, including concerns for patient compliance or geographic proximity.
Drug
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Mayo Clinic — Rochester, MN

The Integrated Assessment of Gastric Functions

A Study to Evaluate Stomach Function

Xiao Jing Wang
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
0000-122172-H01-RST
19-004723
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Inclusion Criteria
•Healthy Volunteers:

  • Male and female volunteers aged 18-80 years old.
  • No significant medical conditions or gastrointestinal symptoms by interview or questionnaire:
    • Having capacity to provide written informed consent before participating in the study;
    • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Inclusion Criteria
•Patients:

  • Male and female volunteers aged 18-80 years.
  • Persistent upper gastrointestinal symptoms (nausea, vomting, bloating, post prandial fullness or post prandial pain) for > 6 months.
  • Having capacity to provide written informed consent before participating in the study.
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria
•Healthy Volunteers and Symptomatic Patients: 

  • Severe nausea or vomiting, which may preclude study assessments.
  • Use of medications that, in the opinion of the investigator have the potential, to alter GI motility (e.g., narcotics, medications with significant anticholinergic effects, prokinetic agents) and which cannot be discontinued for 4 half-lives prior to the imaging studies.
  • Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study.  A history of inflammatory bowel disease (e.g, Crohn’s disease or ulcerative colitis).  However, participants with microscopic or collagenous colitis will be eligible to participate.
  • Prior gastric or major intestinal (i.e., resection of > 50 cm) or colonic surgery (i.e., hemi or subtotal colectomy).  Appendectomy, cholecystectomy, tubal ligation, hysterectomy, herniorrhaphy, and limited colonic resection are permissible.
  • Participants who are allergic to eggs or decline to consume milk.
  • History of radiation therapy to the abdomen.
  • Pregnant women, breast-feeding women, prisoners and institutionalized individuals.
  • Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain.
  • Positive tissue transglutaminase antibodies (TTG).
  • Poor peripheral venous access, if central venous access is not available.
  • Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study.
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Mayo Clinic — Rochester, MN