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3289 Study Matches

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NRG-GU009, Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*) (PREDICT-RT)

Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score

Bradley Stish
Male
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-304286-P01-RST
21-003483
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Inclusion Criteria:

PRIOR TO STEP 1 REGISTRATION

  • Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration.
  • High-risk disease defined as having at least one or more of the following:
    • PSA > 20 ng/mL prior to starting ADT;
    • cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]);
    • Gleason score of 8-10;
    • Node positive by conventional imaging with a short axis of at least 1.0 cm;
    • Appropriate stage for study entry based on the following diagnostic workup:
      • History/physical examination within 120 days prior to registration;
      • Bone imaging within 120 days prior to registration;
        • Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative Na F PET/CT or negative axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed).
    • Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or Na F PET will still be eligible.
    • CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only.
    • Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by > 10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e., N1), but whose nodes do not meet traditional size criteria for positivity (i.e., they measure ≤ 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration.
    • Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration).
    • Platelet count ≥ 100,000 x 10^9/uL independent of transfusion and/or growth factors (within 120 days prior to registration).
    • Creatinine clearance (CrCl) ≥ 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration).
    • For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility.
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) within 120 days prior to registration.
      • Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject is eligible.
      • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within 120 days prior to registration).
      • Serum albumin ≥ 3.0 g/dL (within 120 days prior to registration).
  • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy (didanosine [DDI] is not permitted) with undetectable viral load within 6 months are eligible for this trial and have a CD4 count ≥ 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to abiraterone acetate and apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with abiraterone acetate and apalutamide.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated.
    • Note: HBV viral testing is not required for eligibility for this protocol.
  • 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.
    • Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.

PRIOR TO STEP 2 RANDOMIZATION

  • Confirmation of Decipher score.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. Note: Apalutamide may interfere with HCV drugs.
  • Patients on HCV medications should alert their infectious diseases physician if they get randomized to apalutamide due to the possibility that apalutamide can affect the bioavailability of some HCV medications. HCV viral testing is not required for eligibility for this protocol.

For patients entering the Intensification Cohort ONLY:

  • Patients must discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to Step 2 randomization.

For patients entering the Intensification Cohort ONLY:

  • Serum potassium ≥ 3.5 mmol/L prior to Step 2 randomization.


Exclusion Criteria:

PRIOR TO STEP 1 REGISTRATION

  • Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e., bone scan, CT scan, MRI).
  • Prior systemic chemotherapy within ≤ 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration.
  • Prior radical prostatectomy.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  • Current use of 5-alpha reductase inhibitor.
    • Note: If the alpha reductase inhibitor is stopped prior to randomization the patient is eligible.
  • Didanosine (DDI) antiretroviral therapy is not permitted.
  • History of any of the following:
    • Seizure disorder;
    • Current severe or unstable angina;
    • New York Heart Association Functional Classification III/IV;
      • Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
    • History of any condition that in the opinion of the investigator, would preclude participation in this study.
  • Evidence of any of the following at registration:
    • Active uncontrolled infection requiring IV antibiotics;
    • Baseline moderate and severe hepatic impairment (Child-Pugh class B & C);
    • Inability to swallow oral pills;
    • Any current condition that in the opinion of the investigator, would preclude participation in this study.
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is ≤ 60 days prior to registration; Please note: baseline PSA and testosterone must be obtained prior to the start of any ADT.

PRIOR TO STEP 2 RANDOMIZATION

  • Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration.

For patients entering the Intensification Cohort ONLY:

  • Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily.

For patients entering the Intensification Cohort ONLY:

  • Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] ≥ 160 mmHg or diastolic BP ≥ 100 mmHg);
  • Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment.
Drug, Other, Radiation
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Acupuncture Therapy for COVID-Related Olfactory Loss

Acupuncture Therapy for COVID-Related Olfactory Loss

Janalee Stokken
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304290-H01-RST
21-003531
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Inclusion Criteria:

  • 18 years or older.
  • Patients with post-viral olfactory dysfunction > 4 weeks.
  • History of positive COVID-19 PCR.


Exclusion Criteria:

  • Less than 18 years of age.
  • Active sinus infection.
  • New diagnosis of untreated CRS.
  • Prior diagnosis of dementia or Parkinson’s disease.
  • Prior head trauma or neurosurgical procedure resulting in olfactory loss.
  • Patients who do not speak or read English.
  • Patients unable to understand and sign the study consent.

 

Acupuncture, Administration of steroid, Procedure on olfactory system, Other
Coronavirus disease 2019, General infectious diseases, Loss of smell
Acupuncture, Chronic post-COVID-19 syndrome, Disorder of smell, Loss of sense of smell, Post-acute COVID-19, Respiratory system
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Phase 2 study of MRD guided, fixed duration therapy for previously untreated chronic lymphocytic leukemia with LOXO-305 and venetoclax (MIRACLE) (MIRACLE)

MRD Guided, Fixed Duration Therapy With Loxo-305 and Venetoclax for Previously Untreated Chronic Lymphocytic Leukemia

Yucai Wang
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304292-P01-RST
22-004216
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Inclusion Criteria
•Pre Registration:

  •  Age ≥ 18 years.
  •  Confirmed diagnosis of CLL according to the iwCLL 2018 criteria (Hallek et al., 2018) or biopsy proven SLL according to the WHO criteria:
    • NOTE: The diagnosis of CLL requires the presence of  > 5 × 10^9/L B lymphocytes in the peripheral blood. Typically, CLL cells express CD19, CD5, and CD23, with variable expression of CD20 (typically dim), and show κ (kappa) or λ (lambda) light chain restriction;
    • NOTE: A diagnosis of mantle cell lymphoma must be excluded by demonstrating a negative cyclin D1 expression and/or a negative t(11;14) translocation.  
  •  No prior CLL/SLL-directed therapy such as chemotherapy, immunotherapy, targeted therapy with small molecule inhibitors, radiation therapy, or cellular therapy:
    • NOTE: Nutraceutical treatments with no established benefit in CLL (such as epigallocatechin gallate or EGCG, found in green tea or other herbal treatments or supplemental vitamins) will not be considered prior CLL/SLL-directed therapy;
    • NOTE: Prior corticosteroid therapy for an indication other than CLL/SLL will not be considered prior CLL/SLL-directed therapy;
    • NOTE: A short course of corticosteroid (e.g., ≤ 1 week of intravenous or ≤ 2 weeks of oral corticosteroid) given for acute SLL-related symptoms or impending severe organ dysfunction is allowed.
  •  Provide written informed consent.

Inclusion Criteria
•Registration:

  • Patients with SLL must have a measurable B-cell clone (of CLL immunophenotype) in either peripheral blood or bone marrow (e.g., by flow cytometry) at baseline.

Meeting at least one of the following indications for treatment:

  • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (Hb < 11 g/dL) and/or thrombocytopenia (platelet counts < 100 × 10^9/L).
  • Massive (i.e., ≥ 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
  • Massive nodes (i.e., ≥ 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
  • Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period, or lymphocyte doubling time (LDT) < 6 months. LDT can be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months; patients with initial blood lymphocyte counts < 30 × 109/L may require a longer observation period to determine the LDT. Factors contributing to lymphocytosis other than CLL (e.g., infections, steroid administration) should be excluded.
  • Autoimmune complications including anemia or thrombocytopenia poorly responsive to corticosteroids.
  • Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine).
  • Disease-related symptoms as defined by any of the following:
    • Unintentional weight loss ≥ 10% within the previous 6 months;
    • Significant fatigue (i.e., cannot work or unable to perform usual activities);
    • Fevers ≥ 100.4°F or 38.0°C for 2 or more weeks without evidence of infection;
    • Night sweats for ≥ 1 month without evidence of infection.
  •  ECOG Performance Status (PS) 0, 1 or 2 (Appendix I).
  •  The following laboratory values obtained ≤14 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 0.75 × 10^9/L (750/mm^3);
    • Platelet count ≥ 50 × 10^9/L;
    • Hemoglobin ≥ 8 g/dL;
    • Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or international normalized ratio (INR) ≤1.5 × upper normal limit (ULN);
    • Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN if there is evidence of parenchymal liver involvement with CLL/SLL); patients with hemolysis or Gilbert’s disease may enroll if indirect bilirubin is ≤ 3 × ULN and direct bilirubin is ≤1.5 × ULN;
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN (or ≤ 5 × ULN if there is evidence of parenchymal liver involvement with CLL/SLL);
    • Calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula:
      • Creatinine clearance for males = (140 – age) (weight in kg)  (72) (serum-creatinine in mg/dL);
      • Creatinine clearance for females = (140 – age) (weight in kg) (0.85) (72) (serum-creatinine in mg/dL).
  • Negative serum pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only:
    • NOTE: Persons of reproductive potential is defined as following: menarche and who are not postmenopausal (and 2 years of non-therapy-induced amenorrhea) or surgically sterile.
  • Male and females of reproductive potential must agree to use a highly effective (preferred) or an acceptable form of birth control during study treatment and for 6 months following the last dose of pirtobrutinib.
  •  Males must be willing to not donate sperm during the study and for 6 months after the last dose of any study drug.
  •  Willingness to provide mandatory research blood, bone marrow, saliva, and stool specimens for correlative research.
  •  Willing to return to enrolling institution for follow-up (during treatment and Clinical Follow-up).

Exclusion Criteria - Pre-Registration:

  • < 18 years old. 

Exclusion Criteria - Registration: 

 Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

  • Pregnant persons.
  • Nursing persons (lactating persons are eligible provided that they agree not to breast feed while receiving treatment on the study or within 6 months of the last dose of study treatment).
  • Male or females of reproductive potential who are unwilling to employ adequate contraception during treatment and for 6 months after pirtobrutinib.
  •  Evidence of Richter transformation.
  •  CNS involvement of CLL/SLL (e.g., any parenchymal, leptomeningeal, CSF, cranial or spinal nerve root involvement).
  •  Active uncontrolled autoimmune complications (e.g., active autoimmune hemolytic anemia or clinically significant immune thrombocytopenia).
  •  Receiving any other investigational agent which would be considered as a treatment for the CLL/SLL (with the exception of corticosteroid).
  •  Any of the following medication requirement or recent use:
    • Requirement of a strong cytochrome P450 (CYP) 3A inhibitor or inducer (Appendix II) during the study;
    • Use of a strong or moderate CYP3A inhibitor or inducer (Appendix II) ≤ 7 days prior to registration;
    • Requirement of a strong PgP inhibitor (Appendix II) during the study;
    • Anticoagulation with a vitamin K antagonist ≤7 days prior to registration or anticipated use during the study;
    • Vaccination with live vaccine ≤ 28 days prior to registration.
      • NOTE: Because of their effect on CYP3A4, use of any of the following ≤ 3 days of study therapy start or planned use during study participation is prohibited:
        • Grapefruit or grapefruit products;
        • Seville oranges or products from Seville oranges;
        • Star fruit.
  •  Malabsorption syndrome or other condition that precludes enteral route of administration.
  •  History of a bleeding diathesis (e.g., hemophilia, von Willebrand disease, etc.).
  •  Patients who have tested positive for Human Immunodeficiency Virus (HIV) are excluded due to potential drug-drug interactions between anti-retroviral medications and pirtobrutinib and risk of opportunistic infections with both HIV and irreversible BTK inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result should be negative for enrollment.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  •  Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection:
      • Known active cytomegalovirus (CMV) infection is ineligible; unknown or negative status are eligible;
      • Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation. Patients who are hepatitis B PCR positive will be excluded;
      • Hepatitis C virus (HCV): If hepatitis C antibody result is positive, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA). Patients who are hepatitis C RNA positive will be excluded.
    • New York Heart Association (NYHA) Class III or IV or symptomatic congestive heart failure;
    • Documented LVEF by any method of ≤ 40% ≤ 12 months prior to registration;
    • Unstable angina or acute coronary syndrome ≤ 3 months prior to registration;
    • History of myocardial infarction ≤ 6 months prior to registration;
    • Uncontrolled or symptomatic cardiac arrhythmia:
      • NOTE: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker.
    • Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec on at least 2/3 consecutive electrocardiograms (ECGs), and mean QTcF > 470 msec on all 3 ECGs, during Screening:
      • NOTE: QTcF is calculated using Fridericia’s Formula (QTcF): QTcF = QT/(RR0.33);
      • NOTE: Correction for underlying bundle branch block (BBB) allowed;
      • NOTE: Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator’s discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.
    • History of cerebral vascular accident ≤ 6 months prior to registration;
    • Ongoing inflammatory bowel disease (such as ulcerative colitis) requiring active treatment;
    • Oxygen dependent baseline lung disease (such as interstitial lung disease or COPD);
    • Psychiatric illness/social situations that would limit compliance with study requirements.
  •  Major surgery ≤ 4 weeks prior to registration.
  •  Other active primary malignancy (other than localized non-melanotic skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to ≤ 2 years:
    • NOTE: If there is a history of prior malignancy, the patient must not require ongoing therapy such as radiation, chemotherapy, or immunotherapy for their cancer. Patients on hormonal therapy for adequately treated nonmetastatic breast or prostate cancer are permitted if they meet other eligibility criteria.
  •  Have a known hypersensitivity to any of the excipients of pirtobrutinib.

Eligibility last updated 9/30/22. Questions regarding updates should be directed to the study team contact.

Drug
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Evaluation of the Clinical Performance and Safety of an Investigational Fully Covered Biliary Stent with Anti-migration Flaps for the Palliative Treatment of Malignant Biliary Obstruction HANAROSTENT® Biliary Flap Lasso Stent System IDE Study (H-IDE)

A Study to Evaluate the Safety of HANAROSTENT® Biliary Flap Lasso Stent System Use to Treat Cancer Patients with Biliary Obstruction

Ryan Law
All
18 years and over
Pivotal
This study is NOT accepting healthy volunteers
2021-304302-P01-RST
21-003551
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Inclusion Criteria:

  • Presence of inoperable malignant nonhilar extrahepatic biliary obstruction.
  • Clinical symptoms of biliary obstruction.
  • ≥ 18 years of age.
  • Willing and able to provide informed consent.


Exclusion Criteria:

  • Participation in another investigational study within 90 days prior to consent.
  • Strictures that could not be traversed by the delivery system.
  • Perforation of any duct within the biliary tree.
  • Presence of a biliary SEMS.
  • Presence of any esophageal or duodenal stent.
  • Contraindications to endoscopy.
  • Sensitivity to any components of the stent or delivery system.
  • Active hepatitis.
  • Intrahepatic metastases that extensively involve both lobes of the liver.
  • Life expectancy of < 3 months.
Device
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Understanding the Long-term Impact of COVID-19 on the Brain Through Advanced MR Imaging and Spectroscopy (COVID-BRAIN)

A Study to Evaluate COVID Brain Advanced Imaging Network

Kejal Kantarci
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304303-P01-RST
21-003548
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Inclusion Criteria:

  • Participants must be 18 years or older.
  • Participants must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.
  • Individuals who had no known COVID-19 exposure (for controls) or had PCR or antibody confirmed COVID-19 who present with neurological symptoms in the months after infection and fit one of the following criteria during the acute phase of the infection:
    • ambulatory with no or mild symptoms;
    • hospitalized but on no oxygen; or
    • hospitalized but on oxygen administered via a nasal cannula, mask or non-invasive ventilation; i.e., individuals with WHO Ordinal Scale40 scores 0-5. 
  • English or Spanish speaking (based on self-stated primary language).
  • Clear of any contraindications for MRI.


Exclusion Criteria:

  • Patients under 18 years of age.
  • Medical conditions likely to interfere with the study, including chronic neurologic conditions, restless leg syndrome, structural abnormalities such as subdural hematoma, intracranial neoplasms, end-stage renal disease, severe chronic obstructive pulmonary disease (COPD) needing oxygen, end-stage liver disease, active psychiatric illness, active drug abuse, stroke unrelated to COVID-19 or heart attack 6 months before study enrollment, active cancer, concurrent illnesses or treatments interfering with cognitive function such as dementia or normal pressure hydrocephalus.
  • Individuals who had COVID-19 and required mechanical ventilation.
  • Pregnant women.
  • Inability to undergo MRI scanning, including but not limited to claustrophobia, unable to remain still in an MRI scanner for more than 30 minutes, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs.
  • Inability to adhere to study protocol for whatever reason.
Coronavirus disease 2019, General infectious diseases, Post-COVID-19 syndrome
COVID-19, Disease caused by 2019 novel coronavirus, MRI, Respiratory system
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Immune Dysfunction in Autoimmune Disease (IDAD)

Immune Dysfunction in Autoimmune Disease

Cornelia Weyand
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304304-H01-RST
21-003556
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Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis defined by ACR/EULAR criteria.
  • Diagnosis of immune-mediated disease affecting the joint, the lung, the muscle, the nervous system, the heart, or the vascular system. Diagnosis will be made by a qualified rheumatologist.


Exclusion Criteria:

  • Chronic viral infection.
  • History of chemo/radiotherapy.
  • History of cancer.
  • Healthy Controls:
    • Personal or family history of autoimmune disease;
    • Personal history of chemo/radiotherapy;
    • Personal history of cancer (with the exception of basal cell carcinoma of the skin);
    • Personal or family history of immunodeficiency.
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CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients (LuTK02)

GMCI Plus Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC

Janani Reisenauer
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304312-P01-RST
21-005087
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Inclusion Criteria:


1. Patients with Stage III/IV NSCLC on first line treatment with anti-PD-1/PD-L1 (ICI)
+/- chemotherapy for their current stage of disease and fits into one of the following
cohorts as determined by investigator, preferably as per RECIST 1.1: Cohort 1) have
persistent but stable disease at least 18 weeks after starting ICI treatment, or
Cohort 2) have radiographic progressive disease at least 18 weeks after starting ICI
treatment

2. RECIST evaluable disease including a lesion that is amenable to injection

3. Able and willing to undergo a pre-treatment and on-treatment biopsies, if feasible

4. ECOG Performance status of 0 or 1

5. 18 years of age or older

6. Granulocyte count (ANC) ≥ 1,000/mm3

7. Hemoglobin ≥ 8 g/dl (patients may be transfused to meet this criterion)

8. Platelets ≥ 75,000/mm3

9. Total bilirubin ≤ 1.5 x upper limit of normal, except for patients with known Gilbert
disease who must have total bilirubin ≤ 3 x upper limit of normal

10. SGOT (AST) ≤ 5x upper limit of normal and if elevated, not clinically significant such
that ICI can continue

11. INR no more than 0.2 above upper limit of normal and aPTT not >1.2 x upper limit of
normal, and value is acceptable for patient to undergo injection procedure. If on
anti-coagulation, it must be clinically acceptable to hold anti-coagulation for the
injection procedures per investigator discretion

12. Serum creatinine < 2mg/dl and calculated creatinine clearance > 30ml/min

13. Clinically stable and able to continue ICI for at least the 12-week treatment period

14. Patients must give study specific informed consent prior to enrollment and any study
specific procedures


Exclusion Criteria:


1. Patients with a history of severe hypersensitivity reaction to ICI

2. Patients who require ongoing therapy with disease-modifying antirheumatic drugs
(DMARDs), immunomodulators or systemic immunosuppressive drugs including systemic
corticosteroids (>10 mg prednisone per day or equivalent)
•premedication for ICI or
chemotherapy is allowed

3. Patients with a history of active autoimmune disease requiring treatment in the past 2
years

4. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, active hepatitis, or psychiatric illness/social situations that
would limit compliance with study requirements

5. Women who are pregnant, lactating or intend to become pregnant during the study

6. Patients who are known to be HIV positive

7. Patients with a history of hypersensitivity or allergic reactions to valacyclovir or
acyclovir

8. Patients with significant heart disease (New York Heart Association Functional
Classification III or IV)

9. Patients with continuous oxygen dependence >2L/min at rest

10. Tumor impinging on a neurovascular structure such that inflammation in the site may
put patient at risk of compromise as determined by the investigator

11. Patients with uncontrolled brain metastases as per investigator

12. Patients with liver metastases involving more than half of the liver

13. Patients with known EGFR mutation, ALK fusion, or ROS1 fusion positive NSCLC, or that
are receiving tyrosine kinase inhibitor (TKI) agents/ALK/ROS1 inhibitors

14. Patients with known interstitial lung diseases (ILDs) requiring active therapy
(Radiographic fibrosis not requiring therapy is allowed)

15. Patients receiving vascular endothelial growth factor (VEGF) inhibitors (including
bevacizumab, ramucirumab) within the past 2 months or five half-lives, whichever is
longer

16. Patients must have no concurrent malignancy requiring treatment (except squamous or
basal cell skin cancers)

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

Eligibility last updated 12/28/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Procedure/Surgery
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Development of a Patient-centered Quality of Life Outcome Measure After Parotidectomy (PQOL)

Parotidectomy QOL Score

Eric Moore
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304321-H01-RST
21-003658
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Inclusion Criteria:

  • Males or females, ≥ 18 years old.
  • Recently underwent parotidectomy at Mayo Clinic Rochester (range: 1 day – 1 year).
  • Surgical indication for benign and malignant tumors.


Exclusion Criteria:

  • No concurrent surgeries at the time of parotidectomy.
  • No prior parotid surgery.
  • No adjuvant radiotherapy or chemotherapy after parotidectomy and before this survey.
  • History of Bell’s palsy or other cause of facial nerve dysfunction.
  • History of facial cosmetic surgery (EXCEPT rhinoplasty).
  • History of chronic salivary disease.
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Protocol Title: Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE) (GMROR2163)

FRACTIONATE

Paul Brown
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304350-P01-RST
21-003768
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Inclusion Criteria

  • Age ≥ 18 years old
  • Diagnosis of Brain Metastases
    • Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.).
    • Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible.
  • Size of Brain Metastases
    • At least one intact metastasis (not previously treated with radiosurgery) must measure > 2.0 cm and < 4.0 cm in maximal extent on the contrasted pre-treatment MRI brain scan obtained ≤ 28 days prior to registration.
    • If the largest lesion measures ≥ 2.0 to < 4.0 cm in maximal extent the patient will be randomized.
  • Able to undergo contrast enhanced MRI Brain
  • Negative urine or serum pregnancy test completed ≤7 days prior to registration, for women of childbearing potential only
  • Patient willing and able to provide written informed consent
  • Karnofsky Performance Status (KPS) ≥ 50
  • ECOG Performance Score of (PS) ≥ 2
  • Past radiosurgery or resection is allowed as long as no definitive evidence of progression in these locations.
    • Note: Repeat radiosurgery to the same location/lesion is not allowed on this protocol.

Exclusion Criteria

  • Any patient who has received previous whole brain radiation
  • Any brain metastasis that is located in the brainstem measuring ≥ 2.0 cm in maximal extent.
  • Any patient with definitive evidence of leptomeningeal metastasis (LMD).

NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator’s discretion based on level of clinical suspicion.{Kim, 2017 #2840}

  • Any patient with an intact brain metastasis measuring > 4.0 cm

Radiation
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A Prospective Study of Endoscopic Ultrasound Shear Wave Elastography for Assessment of Liver Fibrosis (SWE)

A Study to Evaluate Liver Stiffness with Shear Wave Elastography

Vinay Chandrasekhara
All
18 years and over
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
2021-304355-H01-RST
21-003779
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Inclusion Criteria:

  • Adults over 18 years of age who are undergoing EUS procedures.
  • Subjects with history of chronic liver disease, advanced fibrosis or cirrhosis.
  • Subjects without any history of chronic liver disease.
  • Subjects who underwent MR elastography within six (6) months of enrollment will be eligible to participate in the study.
  • Subjects able to give appropriate consent to the study or have an appropriate representative to do so.


Exclusion Criteria:

  • Subjects who may have MRI-incompatible metal implants/devices.
  • Subjects with severe claustrophobia who may not tolerate MR elastography. 

Eligibility last updated 11/8/21. Questions regarding updates should be directed to the study team contact.

Device, Diagnostic Test
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Mayo Clinic — Rochester, MN

Elucidating the Relationship Between Autonomic Nervous System Regulation and Physical Performance

Down-Regulation and Physical Performance

David Holmes
All
18 years to 30 years old
This study is NOT accepting healthy volunteers
2021-304358-H01-RST
21-003799
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Inclusion Criteria:

  • Aged 18-30 years.
  • Routinely involved in physical fitness activities.


Exclusion Criteria:

  • Age less than 18 or over 30 years.
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Staging Classification of Moderate to Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Mohamad Adnan Alkhouli
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304388-H01-RST
21-003928
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Inclusion Criteria:

  • Moderate or more tricuspid regurgitation.


Exclusion Criteria:
 

  • Prior tricuspid valve prosthesis.
  • Pacemaker/defibrillator that would impede MRI imaging.
  • Planned tricuspid valve surgery.
  • Primary liver pathology.
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Phase 1 Study to Determine the Safety and Efficacy of Onvansertib, A Novel, Oral, PLK1 Inhibitor in Patients With Proliferative Chronic Myelomonocytic Leukemia (CMML) Relapsed/Refractory or Intolerant to Available Therapies

Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia

Mrinal Patnaik
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-304390-P01-RST
22-005600
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Inclusion Criteria:


- PRE-REGISTRATION
•INCLUSION CRITERIA:

- Age ≥ 18 years.

- Histological confirmation of World Health Organization (WHO)-defined diagnosis of proliferative chronic myelomonocytic leukemia (CMML) (white blood cell (WBC) count ≥ 13,000/mm^3).

- Relapsed/refractory following treatment with hydroxyurea; or at least 4 cycles of treatment with hypomethylating agents; or who are intolerant of treatment with either therapy.

Note: Prior exposure to erythropoiesis stimulating agents is allowed.  Hydroxyurea may continue for the first 28 days on study. Continuation of hydroxyurea beyond the first cycle must be discussed with the principal investigator (PI).

- Willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy.

- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).

- Willingness to provide mandatory bone marrow specimens for correlative research.

- ECOG performance status (PS) 0, 1 or 2.

- Recovered to grade 1 or baseline or established as sequelae from all toxic effects of previous therapy except alopecia.

- Platelet count ≥ 20,000/mm^3 (obtained ≤ 14 days prior to pre-registration).

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3 x ULN for patients with Gilbert's syndrome) (obtained ≤ 14 days prior to pre-registration).

- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 14 days prior to pre-registration).

- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/m^2 using the Cockcroft-Gault formula (obtained ≤ 14 days prior to pre-registration).

- Ability to complete questionnaire(s) by themselves or with assistance.

- Willingness to provide mandatory blood specimens for correlative research.

- REGISTRATION
•INCLUSION CRITERIA:

- For a man or a woman of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of any study drug. Adequate contraception is defined as follows:

- Complete true abstinence.

- Consistent and correct use of one of the following methods of birth control:

- Male partner who is sterile prior to the female patient's entry into the study and is the sole sexual partner for that female patient;

- Implants of levonorgestrel;

- Injectable progestogen;

- Intrauterine device (IUD) with a documented failure rate of less than 1% per year;

- Oral contraceptive pill (either combined or progesterone only);

- Barrier method, for example: diaphragm with spermicide or condom with spermicide in combination with either implants of levonorgestrel or injectable progestogen;

- WOCBP must have a negative serum or urine pregnancy test ≤ 7 days prior to registration.

- NOTE: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as
amenorrhea > 12 consecutive months); or women on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an IUD or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), must be considered to be of child-bearing potential.

- NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.


Exclusion Criteria:


- PRE-REGISTRATION
•EXCLUSION CRITERIA:

- Previous exposure to an alternative (investigational) PLK1 inhibitor.

- MDS/MPN overlap syndromes other than CMML.

- Prior allogeneic hematopoietic stem cell transplantation.

- Active central nervous system disease.

- Concurrent active malignancy, except adequately treated nonmelanoma skin cancer.  History of curatively treated in situ cancer of the cervix, curatively treated in situ cancer of the breast, or other solid tumors curatively treated is allowed as long as there is no evidence of disease for > 2 years.

- New York Heart Association (NYHA) class III/IV heart failure or active angina/angina equivalents.

- Anticancer chemotherapy or biologic therapy administered within 2 weeks (and at least 4 elimination half-lives for clinical trial agents) prior to pre-registration.

NOTE:  Hydroxyurea is allowed for the first 28 days on study. Continuation of hydroxyurea beyond the first cycle must be discussed with the PI.

- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.

- Major surgery ≤ 6 weeks prior to pre-registration.

- Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (e,g,, intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection).

- Unable or unwilling to swallow study drug.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant nonhealing or healing wounds, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.

- Known active infection with human immunodeficiency virus (HIV) with measurable viral titer, hepatitis B surface antigen positivity, or hepatitis C with measurable viral titer. NOTE: Patients with antibody to hepatitis B core antibody are eligible if they have no measurable viral titer. Patients who have had a hepatitis B virus (HBV) immunization are eligible.

- Patient is receiving any live vaccine (e.g., varicella, pneumococcus) ≤ 28 days prior to pre-registration.

NOTE: messenger ribonucleic acid (mRNA)-based (e.g., Pfizer or Moderna) or replication-deficient virus (e.g., Oxford/AstraZeneca) COVID 19 vaccines are permitted.

- Disease requiring systemic treatment with systemic immunosuppression with steroid steroids at a dose of ≥ 20 mg/day prednisone (or equivalent).

Exceptions: Intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids.

- Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug.

- Strong CYP3A4 inhibitors/inducers as identified per institutional guidelines.

- QT interval with Fridericia's correction (QTcF) > 470 milliseconds. In the case of potentially correctible causes of QT prolongation, (e.g., medications, hypokalemia), the electrocardiogram (ECG) may be repeated once during screening and that result may be used to determine eligibility.

- REGISTRATION
•EXCLUSION CRITERIA:

- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown:

- Pregnant persons;

- Nursing persons;

- Persons of childbearing potential who are unwilling to employ adequate contraception.

- Increased risk of Torsade des Pointes (TdP) defined as follows:

- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 480 msec [CTCAE Grade ≥ 2] using Fredericia's QT correction
formula);

- A history of additional risk factors for TdP (e.g., heart failure, family history of long QT syndrome).

Drug
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EONHL1-20: A Global Multicenter Phase 1/2 Trial of EO2463, a Novel Microbial-Derived Peptide Therapeutic Vaccine, as Monotherapy, and in Combination With Lenalidomide and Rituximab, for Treatment of Patients With Indolent Non-Hodgkin's Lymphoma (SIDNEY)

A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma

Jose Villasboas Bisneto
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-304402-P01-RST
21-003995
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Inclusion Criteria
•Cohorts 1 and 4:

  • Patients having relapsed/refractory, biopsy-proven grade 1, 2 or 3A, FL or MZL.
  • ECOG performance status 0 to 2.
  • Have received at least one prior line of treatment.

Inclusion Criteria
•Cohort 2:

  • Patients having newlydiagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL.
  • ECOG performance status 0 or 1.
  • Patients not be in need of standard of care therapy according to the assessment of the treating physician.
  • Patients with only one prior treatment and a high-risk profile as defined by first progression of disease within 24 months of diagnosis (the exclusion is not applicable for patients with more than one prior line treatment).

Inclusion Criteria
•Cohort 3:

  • Patients having newly-diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL.
  • ECOG performance status 0 or 1.
  • Low tumor burden by Groupe d'Etude des Lymphomes Folliculaires criteria.
  • Patients in need of therapy according to the assessment of the treating physician.

Inclusion Criteria
•Cohorts 1-4:

  • Patients with an age ≥ 18 years old.
  • Patients who are human leukocyte antigen (HLA)-A2 positive.
  • Patients should have radiologically measurable disease with a lymph node or tumor mass greater than or equal to 1.5 cm in at least one dimension.
  • Males or non-pregnant, non-lactating, females.
  • Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
  • Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures.


Exclusion Criteria:

  • Patients treated with dexamethasone > 2 mg/day or equivalent (i.e., 13 mg/day of prednisone, or 53 mg/day of hydrocortisone) within 14 days before the first EO2463 administration, unless required to treat an adverse event.
  • Patients with grade 3B FL or transformation to an aggressive lymphoma subtype.
  • Patients with only one prior treatment and a high-risk profile as defined by first progression of disease within 24 months of diagnosis (the exclusion is not applicable for patients with more than one prior line treatment).
  • Patients with prior exposure to EO2463.
  • Patients treated with immunotherapy (meaning immunostimulatory or immunosuppressive therapy; beside excluded, or allowed, compounds per other inclusion/exclusion criteria specifications), radionuclide therapy, radiotherapy, cytoreductive therapy, or received treatment with any other investigational agent within 28 days before the first EO2463 administration.

Exclusion Criteria
•Cohorts 1 and 4:

  • Patients who have received rituximab or other B cell ablation therapy within 8 weeks of start of study treatment.

Exclusion Criteria
•Cohorts 1-4:

  • Patients with abnormal laboratory values.
  • Patients with persistent Grade 3 or 4 toxicities.
  • Uncontrolled central nervous system (CNS) metastasis.
  • Other malignancy or prior malignancy with a disease-free interval of less than 3 years.
  • Patients with clinically significant disease.
  • Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barré syndrome).
  • Patients with history of solid organ transplantation or hematopoietic stem cell transplantation.
  • Pregnant and breastfeeding patients.
  • Patients with history or presence of human immunodeficiency virus and/or potentially active hepatitis B virus/hepatitis C virus infection.
Biologic/Vaccine, Drug
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An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Participants With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants or Other Causalities

A Study to Evaluate MYK-491 to Treat Patients with Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants

Naveen Pereira
All
18 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-304412-P01-RST
21-004042
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Inclusion Criteria:


- Has stable primary dilated cardiomyopathy due to either MYH7 or TTN variant

- Has adequate acoustic windows for echocardiography

- Maximum of 3 family members with same variant can be enrolled


Exclusion Criteria:


- Significant structural cardiac abnormalities including valvar dysfunction on Screening
transthoracic echo(s)

- A pathogenic variant implicated in DCM of another gene other than MYH7 or TTN

- Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g.,
inotropes, afterload reduction, or diuretics)

- Presence of protocol specified laboratory abnormalities at Screening

- Recent acute coronary syndrome or angina pectoris (<90 days)

- Recent hospitalization for heart failure (<90 days)

Eligibility last updated6/21/22. Questions regarding updates should be directed to the study team contact.

 

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A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) (HUDSON)

A Study of Benralizumab in Patients With Eosinophilic Esophagitis

Puanani Hopson
All
12 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-304415-P01-RST
21-004056
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Inclusion Criteria:

  • Participant must be at least 12 years of age at the time of signing the ICF or informed assent form.
  • Clinician confirmed diagnosis of EG/EGE for at least 3 months prior to screening.
  • Participants who have documented previous diagnosis of eosinophilic gastritis, with or without duodenitis, or eosinophilic duodenitis alone. This will be confirmed by biopsy for the purpose of this study, defined as a gastric count of ≥ 30 eosinophils/hpf in at least 5 hpfs and and/or duodenal eosinophil count ≥30 eosinophils/hpf in at least 3 hpfs without any other cause for the gastrointestinal eosinophilia (e.g., parasitic or other infection or malignancy). Participants can have duodenal only disease and be enrolled in the duodenal only subject population. 
  • At Visit 1 (screening), participants who in the investigator’s judgement have a history of symptoms of abdominal pain, nausea, bloating, early satiety, and/or loss of appetite to an extent that they would meet criteria 5 at Visit 2.
  • At Visit 2 (randomisation), participants who are symptomatic, defined as having a mean SAGED score > 12 (on a 0 to 50 point scale) over the last 14 days of the run-in period.
  • Must be adherent to daily PRO assessments:
    • Must complete 70% SAGED, DSQ, and Bristol Stool Form Scale assessments between Visit 1 and Visit 2; AND
    • Must have completed at least 8 of 14 SAGED assessments in the 14 days prior to randomization.
  • If on background medications for EG/EGE during the study, background medications have been stable for at least 4 weeks prior to the run-in period.
    • Patient must agree not to change type of background medication or dosage during the study unless medically indicated or allowed by protocol during Part C OLE after Week 52 as clinically indicated. If a medication for EG/EGE (including swallowed steroids, systemic steroids and PPI) is discontinued prior to screening, there should be a washout period of at least 8 weeks prior to screening. 
  • Negative serum pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (enrollment).
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Female participants:
    • Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age-specific requirements apply:
    • Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and have follicle stimulating hormone levels in the postmenopausal range.  Until FSH is documented to be within menopausal range, she should be treated as a WOCBP:
      • Women ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
  • Female participants that are WOCBP must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. WOCBP who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control, as defined below, from enrollment throughout the study and until at least 12 weeks after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together. All women of child bearing potential must have a negative serum pregnancy test result at Visit 1.
  • Highly effective birth control methods include:
    • Combined (estrogen and progestogen ) hormonal contraception associated with ;inhibition of ovulation- oral, intravaginal, or transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation- oral, injectable, or implantable;
    • Intrauterine device;
    • Intrauterine hormone-releasing system;
    • Bilateral tubal occlusion;
    • Sexual abstinence, ie refraining from heterosexual intercourse (The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient);
    • Vasectomized sexual partner provided that partner is the sole sexual partner of the WOCBP study patient and that the vasectomized partner has received medical assessment of the surgical success.
  • Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.


Exclusion Criteria:

  • Any disorder, including, but not limited to, cardiovascular, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
    • Affect the safety of the patient throughout the study;
    • Influence the findings of the studies or their interpretations;
    • Impede the patient’s ability to complete the entire duration of study.
  • Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, or celiac disease.
  • Hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis.
  • Current malignancy, or history of malignancy, except for patients who have had basal cell, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date of informed consent, and assent when applicable was obtained. Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent, and assent when applicable, was obtained.
  • History of anaphylaxis to any biologic therapy or vaccine.
  • Current active liver disease:
    • Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis;
    • Alanine aminotransferase or aspartate aminotransferase level > 3 times the upper limit of normal, confirmed by repeated testing during the run-in period. Transient increase of aspartate aminotransferase/alanine aminotransferase level that resolves by the time of randomization is acceptable if in the Investigator's opinion the patient does not have an active liver disease and meets other eligibility criteria.
  • Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent or assent (if applicable) is obtained that has not been treated with or has failed to respond to standard of care therapy.
  • Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during run-in period, which in the opinion of the Investigator, may put the patient at risk, because of his/her participation in the study, or may influence the results of the study, or the patients' ability to complete entire duration of the study.
  • Known immunodeficiency disorder including testing positive for HIV.
  • Concomitant use of immunosuppressive medication (including but not limited to:
    • methotrexate, cyclosporine, and azathioprine.
  • Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent or assent is obtained.
  • Receipt of live attenuated vaccines 30 days prior to date of informed consent or assent.
  • Receipt of inactive vaccines within 7 days of informed consent or assent.
  • Receipt of any marketed or investigational biologic (monoclonal or polyclonal antibody) within 4 months or 5 half-lives prior to the date informed consent or assent (if applicable), is obtained, whichever is longer, and during the study period.
  • Previous participation in a benralizumab clinical study.
  • Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives prior to randomization, whichever is longer.
  • Participants with a known hypersensitivity to benralizumab or any of the excipients of the product.
  • Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group from 6 weeks prior to start of the run-in period and unable or unwilling to remain on a stable diet until the completion of Week 52.
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
  • For women: currently pregnant confirmed with positive pregnancy test or breast-feeding.

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

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ROF2181: Prospective comparative effectiveness trial of carbon ion therapy, surgery, and proton therapy for the management of pelvic sarcomas (soft tissue/bone) involving the bone (The PROSPER Study) (ROF2181)

A Study to Evaluate Carbon Therapy vs. Proton Therapy for Pelvic Sarcomas

Ivy Petersen
All
15 years and over
This study is NOT accepting healthy volunteers
2021-304421-P01-RST
21-004080
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Inclusion Criteria:


- Males and females >= 15 years of age

- Newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma,
osteosarcoma, Ewing sarcoma with bone involvement, rhabdomyosarcoma (RMS) with bone
involvement or non-RMS soft tissue sarcoma with bone involvement

- No evidence of distant sarcoma metastases as determined by clinical examination and
any form of imaging

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2

- Patients capable of childbearing must agree to use adequate contraception

- Ability to complete questionnaire(s) by themselves or with assistance

- Ability to provide written informed consent

- Chemotherapy per institutional guidelines is allowed


Exclusion Criteria:


- Patients receiving palliative treatment

- Recurrent disease

- Males and females < 15 years of age

- Previous radiation therapy to the site of the sarcoma or area surrounding it such that
it would be partially or completely encompassed by the radiation volume needed to
treat the current sarcoma. In other words, treatment on this study would require
re-irradiation of tissues

- Patients with distant sarcoma metastases

- Benign pelvic bone histologies

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate contraception

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

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

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Understanding Social Determinants of Health and Patients’ Perspectives on Barriers to Utilizing Telehealth During COVID-19 Pandemic (NSITE)

NSITE: Novel Strategies to Increase Telehealth Engagement

Pravesh Sharma
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304423-H01-RST
21-004523
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Inclusion Criteria:

  • Male or female, age ≥ 18 years as of April 2020.
  • Patient at Mayo Clinic (Arizona, Florida or Minnesota) or Mayo Clinic Health System.
  • Has not utilized telehealth services since April 2020 but attended face-to-face appointments only for non-emergent outpatient clinical care.


Exclusion Criteria:

  • Anyone not meeting inclusion criteria.

 

Coronavirus disease 2019, General infectious diseases
COVID-19, Disease caused by 2019 novel coronavirus, Respiratory system, Telemedicine
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CC-96191-AML-001: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

A Study to Evaluate CC-96191 to Treat Participants With Relapsed or Refractory Acute Myeloid Leukemia

Mithun Shah
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-304428-P01-RST
21-004123
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Inclusion Criteria:

  • Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • Subject is ≥ 18 years of age at the time of signing the ICF.
  • Relapsed or refractory CD33 positive AML at last visit by local assessment as defined by the World Health Organization (WHO) Classification who have failed or who are ineligible for or have refused all available therapies for AML which may provide clinical benefit.
  • Subjects who have received prior treatment with a CD33-targeted therapy may be included in the study. 6. Subject has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion without conditioning.
  • Subjects must have the following screening laboratory values:
    • Total White Blood Cell count (WBC) < 25 x 10^9 /L prior to first infusion. Treatment with hydroxyurea to achieve this level is allowed;
    • Potassium, calcium (corrected Ca or free [ionized] Ca), and magnesium within normal limits or correctable with supplements;
    • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3.0 x upper limit of normal (ULN), unless considered due to leukemic organ involvement, in which case AST and ALT can be ≤ 5.0 x ULN;
    • Uric acid ≤ 7.5 mg/dL (446 μmol/L). Prior and/or concurrent treatment with hypouricemic agents (e.g., allopurinol, rasburicase) are allowed;
    • Serum total bilirubin ≤ 1.5 x ULN, unless considered due to Gilbert's syndrome (e.g., a gene mutation in UGT1A1), in which case serum total bilirubin must be ≤ 3.0 mg/dL;
    • Estimated serum creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated;
    • International normalized ratio (INR) < 1.5 x ULN and aPTT < 1.5 x ULN (for subjects not receiving therapeutic anticoagulation);
    • Platelets (plts) ≥ 15,000/µL with transfusions allowed;
    • Hemoglobin (Hgb) ≥ 7 g/dL with transfusions allowed.
  • Females of childbearing potential (FCBP)* must:
    • Either commit to true abstinence** from heterosexual contact or agree to use, and be able to comply with, at least one highly effective method of contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; or vasectomized partner), from signing the ICF, throughout the study, including during dose interruptions, and for at least 105 days following the last dose of CC-96191. The selected contraceptive method will be reviewed and evaluated on a monthly basis, and this will be noted in source documents; and
    • Have two negative pregnancy tests as verified by the Investigator prior to starting CC-96191. She must agree to ongoing pregnancy testing during the course of the study, through 105 days following treatment discontinuation. This applies even if the subject practices true abstinenceb from heterosexual contact. The subject may not receive IP until the Investigator has verified that the result of the pregnancy test is negative;
    • Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at Screening;
    • Have a negative serum or urine pregnancy test (Investigator’s discretion) within 72 hours prior to the first dose (Cycle 1 Day 1) of study treatment, and within 72 hours prior to Day 1 of every subsequent cycle (note that the Screening serum pregnancy test can be used as the test prior to Day 1 study treatment if it is performed within the prior 72 hours). A serum or urine pregnancy test (investigators discretion) must also be performed at treatment discontinuation and at 105 days following treatment discontinuation;
    • Avoid conceiving for 105 days after the last dose of CC-96191;
    • Agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. This applies even if the subject practices true abstinenceb from heterosexual contact.
  • Males must practice true abstinence** (which must be reviewed, evaluated and source documented on a monthly basis) or agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a FCBP and will avoid conceiving from signing the ICF, while participating in the study, during dose interruptions, and for at least 105 days following CC-96191 discontinuation, even if he has undergone a successful vasectomy. *A female of childbearing potential is a sexually mature woman who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).
  • **True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].


Exclusion Criteria:

  • Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Subject has any condition; e.g., active or uncontrolled infection, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Subjects with previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D1:
    • Acute symptoms must have resolved and based on investigator assessment in consultation with the medical monitor, there are no sequelae that would place the subject at a higher risk of receiving study treatment.
  • Previous SARS-CoV-2 vaccine within 14 days of C1D1. For vaccines requiring more than one dose, the full series (e.g., both doses of a two-dose series) should be completed by at least 14 days prior to C1D1 when feasible and when a delay in C1D1 would not put the study subject at risk.
  • Subject has any condition that confounds the ability to interpret data from the study.
  • Subject is suspected or proven to have acute promyelocytic leukemia (FAB M3) based on morphology, immunophenotype, molecular assay, or karyotype.
  • Subject has received systemic anticancer therapy (including investigational therapy) or radiotherapy < 28 days or 5 half-lives, whichever is shorter, prior to the start of study treatment. Hydroxyurea is allowed to control peripheral leukemia blasts.
  • Subjects with prior autologous hematopoietic stem cell transplant who, in the investigator’s judgment, have not fully recovered from the effects of the last transplant (e.g., transplant-related side effects).
  • Prior allogeneic HSCT with either standard or reduced intensity conditioning ≤ 6 months prior to dosing.
  • Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted.
  • Subject has persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2.
  • Subject has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening.
  • Subject has immediate life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation. The subject should be afebrile for at least 72 hours.
  • History of concurrent second cancers requiring active, ongoing systemic treatment.
  • Subject is known seropositive or active infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus or hepatitis C virus.
  • Subject with a positive SARS-CoV-2 test during Screening will be required to delay dosing for a minimum of 10 days from the last positive test or resolution of symptoms, whichever is longer.
  • Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    • Left ventricular ejection fraction (LVEF) < 45% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO);
    • Complete left bundle branch or bifascicular block;
    • Congenital long QT syndrome;
    • Persistent or clinically meaningful ventricular arrhythmias;
    • QT interval with Fridericia’s correction (QTcF) ≥ 470 msec on Screening electrocardiogram (ECG) (mean of triplicate recordings);
    • Unstable angina or myocardial infarction ≤ 3 months prior to starting CC-96191;
    • Congestive heart failure (New York Heart Association Class III or IV) ≤ 12 months prior to the first dose of CC-96191.
  • Subject is a pregnant or lactating female.
  • Prior live virus vaccines within at least 4 weeks prior to starting study drug.
  • Subject has known or suspected hypersensitivity to any of the components or any of the excipients of the study treatment.

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

 

Behavioral, Drug
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Improving Communication and Healthcare Outcomes for Patients with Communication Disabilities (INTERACT): Clinical Trial Phase (INTERACT)

Improving Communication and Healthcare Outcomes for Patients with Communication Disabilities

Sean Phelan
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304436-P01-RST
21-004152
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Inclusion Criteria:

  • All patients 18 years and older.
  • Individuals who attend the participating study clinics and identify as having a CD.
  • If a patient is unable to provide consent, his/her legal guardian will serve as a proxy respondent.


Exclusion Criteria:

  • Individuals less than 18 years old.
  • Patient participants: Individuals without a communication disability
  • Healthcare team participants: Individuals who do not work at participating study sites.

 

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Prospective, Multi-Site Pilot Study to Evaluate Improvement in Disease Management and Communication for Patients with Multiple Myeloma or Amyloidosis Using the “Patient Appointment Companion” Tool

Appointment Companion Tool

Morie Gertz
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304445-P01-RST
21-004204
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Inclusion Criteria:

  • Diagnosis of multiple myeloma (MM) and/or amyloidosis (Systemic AL or ATTR).
  • Age ≥ 18 years old.
  • Planned monitoring and/or treatments as per standard of care for the incident disease.
  • Anticipated return to clinic within 1-4 weeks of study enrollment, for a clinic visit that includes pre-visit PAC.


Exclusion Criteria:

  • Age < 18 years old.
  • Diapated return to clinic within 1-4 weeks of study enrollment, for a clinic visit that includes pre-visit PAC.

 

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“Answers in Hours” A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures

Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors

Nicholas Chia
All
18 years and over
Early Phase 1
This study is NOT accepting healthy volunteers
2021-304449-H01-RST
21-004234
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Inclusion Criteria:

  • ≥ 18 year old (yo) male (M) or female (F).
  • Undergoing pancreaticoduodenectomy or total pancreatectomy for any benign or malignant indication with informed consent.
  • Women who are pregnant.


Exclusion Criteria:

  • Patients who are institutionalized or incarcerated.
  • Patients without the cognitive capacity to consent.
Device, Procedure/Surgery, Other
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Post-Kidney Transplant Weight Gain: An Opportunity for Improved Outcomes (KTxWeightGain)

A Study to Analyze Weight Gain in Post-Kidney Transplant Subjects

Jennifer Hill
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304454-P01-RST
21-004245
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Inclusion Criteria:

  • Male or female, 18 years of age or older.
  • Recent transplantation (< 1 year).
  • Diagnosis of type 2 diabetes pre-transplant.
  • Recipient of a first time, solitary kidney transplant between August 1, 2020 and January 1, 2021.


Exclusion Criteria:

  • Individuals < 18 years of age.
  • Prior transplants and/or combined organ transplant.
  • Type 1 diabetes.
  • No documented follow-up.

 

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The Role of Interferon-gamma in Antifungal Immunity (IFN)

A Study to Evaluate Interferon-gamma in Antifungal Immunity

Paschalis Vergidis
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304461-H01-RST
21-004259
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Inclusion Criteria

Subjects must meet the following inclusion criteria to qualify for the study:

  • Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
  • Males or females ≥18 years of age.
  • Have received solid organ transplant or allogeneic hematopoietic stem cell transplant at any time or have another immunocompromising condition.

Exclusion Criteria

Subjects must NOT meet any of the following exclusion criteria to qualify for the study:

  • Severe neutropenia (absolute neutrophil count <500 cells/microL).
  • Profound lymphopenia (<300 cells/microL).
  • The Principal Investigator (PI) is of the opinion the subject should not participate in the study.
  • Females who are pregnant.

Eligibility last updated 11/3/22. Questions regarding updates should be directed to the study team contact.

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Barriers to Mayo Obstetric Care (TRANSCEND)

Barriers to Mayo Obstetric Care

Vanessa Torbenson
Female
18 years and over
This study is NOT accepting healthy volunteers
2021-304462-H01-RST
21-004266
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Inclusion Criteria:

  • Female patient, age 18 or older.
  • A patient at Community Health Services, Inc. Clinic in Rochester, MN (CHSI).
  • Currently pregnant or have been pregnant within the last 18 months.


Exclusion Criteria:
 

  • Does not speak English or Spanish.
  • Under the age of 18.
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HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue (NEXT)

HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors

Jonathan Schwartz
All
0 years to 10 years old
Phase 4
This study is NOT accepting healthy volunteers
2021-304466-P01-RST
21-004267
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Inclusion Criteria:

  • Children ≥ 10 years old at the time of definitive confirmatory eligibile histologic or cytological diagnosis of eligible CNS tumor within the brain or spinal cord.
  • Children who have not previously received either irridation or chemotherapy (except corticosteriods).  

CNS Embryonal Tumors:

  • All children less than 120 months (10 years) of age, irrespective of clinical stage, with a diagnosis of any of the following CNS embryonal tumors are eligible, whether located primarily in the brain or spinal cord: pineoblastoma, pineal anlage tumor, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS embryonal tumor, not otherwise specified.


Exclusion Criteria:

  • Children < 10 years of age.
  • The exclusive focus is on medulloblastoma and other CNS embryonal tumors of the brain or spinal cord as follows:

Medulloblastoma:

  • Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis.
  • Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis.
  • Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection.

Eligibility last updated 1/6/22. Questions regarding updates should be directed to the study team contact.

 

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    Assessment of Spinopelvic Parameters Based on Radiographic View and Patient Positioning

    A Study to Assess Spinopelvic Parameters Based on Radiographic View and Patient Positioning

    Matthew Abdel
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-304481-H01-RST
    21-004350
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    Inclusion Criteria:

    • Age  ≥ 18 years old.
    • Ability to provide informed consent.
    • 40 subjects total:
      • Sex: 20 men, 20 women;
      • Hip pathology: 20 presenting for following total hip arthroplasty (THA), 20 without hip degenerative joint disease (DJD);
        • Age: 40 patients aged 18-100


    Exclusion Criteria:

    • Individuals < 18 years old.
    • Patient with lumbosacral hardware, contralateral THA, or DJD in contralateral hip (only for 20 patients without hip DJD).
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    Evaluating Patient Reported Outcome Measures in Children with Eye Conditions (PedEyeQ)

    A Study to Evaluate Patient Reported Outcome Measures in Children with Eye Conditions

    Erick Bothun
    All
    Not specified
    This study is NOT accepting healthy volunteers
    2021-304494-H01-RST
    21-004385
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    Inclusion Criteria:

    • Children ages 0 to 17 years and one parent/legal guardian.
    • Current or previous diagnosis of an eye condition.
    • Any treatment status: pre-treatment, post-treatment, current treatment, no treatment.
    • Neurodevelopmental delay and/or systemic health disorders allowed.


    Exclusion Criteria:

    • Individuals ≥ 18 years of age.
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    Mayo Clinic — Rochester, MN

    Immune Changes in Chronic Rhinosinusitis with Nasal Polyps and Aspirin Sensitivity After Aspirin Desensitization

    Immune Changes in Chronic Rhinosinusitis with Nasal Polyps and Aspirin Sensitivity After Aspirin Desensitization

    Erin O'Brien
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-304498-H01-RST
    21-004400
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    Inclusion Criteria - CRSwNP:

    • Age 18 years and older.
    • Both males and females.
    • Meet clinical definition of CRS which is 12 weeks with at least 2 of the major criteria for diagnosis within the past 24 months (nasal discharge, nasal obstruction, facial congestion, facial pain-pressure-fullness or decrease in sense of smell).
    • Presence of nasal polyps as evidenced by a CT scan or rhinoscopy.

     Inclusion Criteria
    •wsf AERD aspirin desensitization

    • Age 18 years and older.
    • Both males and females.
    • Be Aspirin sensitive (AERD)
    • AERD
      •Meet clinical definition of aspirin exacerbated respiratory disease as identified through clinical history and/or prior positive aspirin intolerance and scheduled to undergo an aspirin challenge and desensitization in the allergic diseases clinical laboratory.

    Inclusion Criteria - AERD non-Aspirin desensitization:

    • Age 18 years and older.
    • Both males and females.
    • Meet clinical definition of aspirin exacerbated respiratory disease as identified through clinical history and/or prior positive aspirin intolerance.
    • Contraindication to Aspirin therapy or by patient choice.

    Exclusion Criteria
    •All Groups:

    • Cystic fibrosis.
    • Known pregnancy at the time of appointment.
    • Cigarette smoking in the last 6 months.
    • Common Variable Immunodeficiency Disease.
    • EGPA or small vessel vasculitis.
    • Primary ciliary dyskinesia.
    • Primary immune deficiency disorder.
    • Oral corticosteroids in the past 2 weeks before visit.
    • Intramuscular corticosteroids in the past 6 weeks before visit.
    • Current cancer treatment with immunotherapy and chemotherapy.
    • Treatment with biologics at the time of enrollment.
    • Zileuton.

    Eligibility last updated 12/20/21. Questions regarding updates should be directed to the study team contact.

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    A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of CFT7455 in Subjects With Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma (CFT7455-1101)

    A Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

    Eli Muchtar
    All
    18 years and over
    Phase 1/2
    This study is NOT accepting healthy volunteers
    2021-304502-P01-RST
    21-004436
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    Inclusion Criteria:


    1. Be willing and able to provide signed informed consent for the trial.

    2. Age ≥18 years at the time of signed consent.

    3. Have histologically or cytologically-confirmed NHL or MM that is r/r disease and must
    not be candidates for regimens known to provide clinical benefit to be eligible for
    the study.

    4. MM subject must have a documented diagnosis of MM and measurable disease at
    enrollment. Measurable disease is defined as:

    - M-protein ≥0.5g/dL by Serum Protein Electrophoresis (sPEP) or

    - ≥200mg/24-hour urine collection by Urine Protein Electrophoresis (uPEP) or

    - Serum Free Light Chain (FLC) levels >100 mg/L involved light chain and an
    abnormal kappa/lambda (?/?) ratio in subjects without measurable serum or urine
    M-protein or

    - For subjects with immunoglobulin class A (IgA), myeloma whose disease can only be
    reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥
    0.50g/dL.

    5. Prior treatments for MM subjects must have the following:

    - Received at least 3 prior anti-myeloma regimens including at least 2 consecutive
    cycles of lenalidomide, pomalidomide, a proteasome inhibitor a glucocorticoid and
    an anti-CD38 antibody (induction with or without a bone marrow transplant with or
    without maintenance therapy is considered one regimen).

    - Refractory disease defined as disease that is nonresponsive to therapy (failure
    to achieve minimal response or development of progressive disease) or disease
    progression within 60 days from the last dose of their last myeloma therapy.

    6. NHL subjects must have documented diagnosis of NHL and measurable disease defined by
    measurable disease (consistent with Lugano classification) defined as at least one
    lesion that can be accurately measured in at least two dimensions with PET-CT,
    documented within 4 weeks of their projected cycle one day one (C1D1) visit. Minimum
    measurement must be >15 mm in the longest diameter.

    7. NHL subjects must have received the following regarding prior therapy:

    - Peripheral T-cell Lymphoma: At least one prior line containing alkylator-based
    chemotherapy. Note: For subjects with Anaplastic Large Cell Lymphoma (ALCL), the
    subject must also have received CD30 antibody therapy.

    - Mantle Cell Lymphoma: ≥2 lines of therapy, including CD20 antibody and alkylator
    chemotherapy, and a Bruton's tyrosine kinase (BTK) inhibitor.

    - Follicular Lymphoma: ≥2 lines of therapy, including CD20 antibody therapy and
    alkylator chemotherapy.

    - Diffuse Large B-cell Lymphoma: ≥2 lines of therapy, including prior CD20 antibody
    therapy, and has received prior autologous bone marrow transplant (or is
    ineligible for bone marrow transplant).

    - Other NHL: Subjects must have been treated with all standard of care therapies
    available to the subject which, in the assessment of the investigator, may be
    beneficial to the subject.

    8. A female participant is eligible to participate if she is not pregnant, not
    breastfeeding, and at least one of the following conditions applies:

    - A woman of non-childbearing potential (i.e., physiologically incapable of
    becoming pregnant) defined as pre-menopausal females with a documented tubal
    ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous
    amenorrhea [in questionable cases a blood sample with simultaneous follicle
    stimulating hormone (FSH) > 40 MIU/mL and estradiol < 40 pg/mL (<147 pmol/L) must
    be obtained].

    - Females on hormone replacement therapy (HRT) and whose menopausal status is in
    doubt will be required to use one of the contraception methods specified in the
    study protocol if they wish to continue their HRT during the study. Otherwise,
    they must discontinue HRT to allow confirmation of postmenopausal status prior to
    study enrollment.

    - Agree to having ongoing pregnancy tests during the study and after
    discontinuation of the study.

    9. A male participant must have either had a prior vasectomy or agree to use a condom
    during the treatment period and for at least 90 days after the last dose of study
    treatment.


    Exclusion Criteria:


    1. Presence of central nervous system (CNS) disease.

    2. Has received prior radiotherapy within 2 weeks of start of study treatment.

    3. Have active pneumonitis.

    4. Have any of the following:

    - Non-secretory or oligosecretory MM

    - Plasma cell leukemia

    - Systemic light chain amyloidosis

    - Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin
    changes (POEMS) Syndrome

    - Lymphoblastic lymphoma

    - Mycosis fungoides

    - Sezary syndrome

    - Primary cutaneous T-cell lymphomas

    - Primary CNS lymphoma

    - B-cell or T-cell prolymphocytic leukemia

    5. Subjects with a peripheral neuropathy ≥ Grade 2.

    6. Known malignancy other than study indication that is progressing or has required
    treatment within the past three years.

    7. Received live, attenuated vaccine within four weeks of first dose.

    8. Known history of human immunodeficiency virus (HIV) infection. No HIV testing is
    required unless mandated by local health authority.

    9. Subjects with positive test for Hepatitis B surface (HBS-Ag) or Hepatitis B core (HBc)
    antigen.

    10. Subjects with positive test for hepatitis C (HCV) infection are excluded regardless of
    viral load. If hepatitis C antibody test is positive, a confirmatory test should be
    performed. If the test is negative, subject is eligible for this trial.

    11. Concurrent administration of strong CYP3A modulators.

    12. Is pregnant, breastfeeding, or expecting to conceive or father children within the
    projected duration of the study, starting with the screening visit through 120 days
    after the last dose of study treatment.

    13. Subjects on proton pump inhibitors (PPIs). The last dose of PPIs must be administered
    seven days prior to administration of study drug. Antacids are acceptable when
    administered in a staggered dosing manner with CFT7455.

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

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

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