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3289 Study Matches

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Piloting a Referral System to Address the Educational Needs of Patients with Dexamethasone-Induced Hiccups

A Study to Evaluate the Educational Needs of Patients with Dexamethasone-Induced Hiccups

Aminah Jatoi
All
18 years and over
This study is NOT accepting healthy volunteers
2020-303230-H01-RST
20-013404
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Inclusion Criteria:

  • English-speaking patient (aged 18 or older).
  • Has received dexamethasone either intravenously or as a prescription in the past 2 weeks. 
  • Patients do not have to be experiencing hiccups at the time of contact, but it is anticipated that these patients will likely have recurrent symptoms based on further or episodic dexamethasone treatment. 
  • Patients must currently be in an outpatient setting, as it is unlikely that an educational session would be relevant or of value to an inpatient.


Exclusion Criteria:

  • Individuals under 18 years of age.
Hiccups
Chronic hiccup, Dexamethasone, Hiccoughs, Respiratory system, dexamethasone
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A Longitudinal Biorepository to Study Patients with Bleeding Secondary to Hereditary Hemorrhagic Telangiectasia (HHT), Gastric Antral Vascular Ectasia (GAVE), Small Bowel Angioectasia (SBA) and Occult GI Bleeding (OGIB) (GAVE)

A Study to Create an Hereditary Hemorrhagic Telangiectasia and Gastric Anal Vascular Ecstasia Biorepository

Vivek Iyer
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303242-H01-RST
20-012134
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Inclusion Criteria:

  • Ages 18 years of age or older.
  • Patients with bleeding secondary to HHT, GAVE, SBA and OGIB.
  • Age and sex matched patients without bleeding (controls).
  • Patients willing to provide written informed consent.


Exclusion Criteria:

  • Unwillingness/unable to provide informed consent.

 

 

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Stereotactic biopsy Split-Course Radiation Therapy – Diffuse Midline Glioma (SPORT-DMG) (GMROR2162)

SPORT-DMG

Anita Mahajan
All
1 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-303260-P01-RST
21-000069
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Inclusion Criteria:

  • Age ≥ 1 year(s) old (no maximum age).
  • Radiologic appearance of diffuse midline glioma of the pons, including diffuse infiltration of ≥ 50% of the pons on MRI, with or without extension to the midbrain and/or medulla oblongata with at least 1 of the 3 brainstem symptoms (cranial nerve deficit, long tract sign, or cerebellar sign).
  • If all features of this clinicoradiologic criteria are met, then patients can continue on protocol with or without a biopsy.
  • If all features of this clinicoradiologic criteria are not met, patients must receive a brainstem lesion biopsy to be treated on protocol. If this cannot be completed, patients will be withdrawn from the study.
  • If biopsy has already been completed at an outside institution, pathology must be reviewed at Mayo Clinic for trial enrollment.
  • Able to undergo MRI Brain.
  • Negative urine pregnancy test completed ≤ 7 days prior to registration, for women of childbearing potential only.
  • Primary language of English or Spanish for patients and their caregiver.
  • Patient or caregiver willing and able to provide written informed consent.
  • Caregiver able to complete questionnaires by themselves or with assistance.
  • Willing to return to enrolling institution for follow-up during the active monitoring phase of the study.


Exclusion Criteria:

  • Any patient who has received previous radiation to the brain.
  • Any patient who has received previous chemotherapy.
  • Any patient with a diagnosis of neurofibromatosis type 1 or 2 (NF1 or NF2).
  • Any of the following:
    • Pregnant women;
    • Nursing women;
    • Women of childbearing potential who are unwilling to employ adequate contraception.
  • 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, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Other active malignancy ≤ 5 years prior to registration.
    • EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix.
    • NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer.
  • Patients > 16 years with an Eastern Cooperative Oncology Group (ECOG) score ≥ 4 and patients ≤ 16 years with a Lansky play scale ≤ 20.

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

Radiation
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Dried Blood Spot (DBS) Testing to Assess Post COVID-19 Vaccination Antibody Response (DBS)

Dried Blood Spot COVID-19 Vaccination Response (Enrolling by Invitation Only)

Elitza Theel
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303270-H01-RST
21-000098
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Inclusion Criteria:

  • Adults ≥ 18 years old.
  • DLMP employees who work on-site at SDSC.
  • Plan to complete the two dose SARS-CoV-2 vaccination schedule.


Exclusion Criteria:

  • Children < 18 years old.
  • Subjects who have previously been diagnosed with SARS-CoV-2 infection.
  • Subjects who test SARS-CoV-2 antibody positive on the pre-vaccination sample indicating prior infection.

 

Coronavirus disease 2019, General infectious diseases
COVID-19, COVID-19 antibody testing, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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PLS Natural History Study (PLS)

PLS Natural History Study

Eric Sorenson
All
25 years and over
This study is NOT accepting healthy volunteers
2021-303290-P01-RST
21-000194
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Inclusion Criteria:

  • Adult participants (≥ 25 years of age).
  • PLS diagnosis is based on the new PLS diagnostic criteria.
  • Symptom onset was no more than 15 years prior to baseline.
  • Ability to independently walk with or without an assistive device (e.g., walker) at the baseline evaluation.
  • In cases where a molecular test has been done prior to enrollment in this study, HSP or HSP- related mutations are negative.
  • Expected to have at least some bulbar symptoms (dysarthria, dysphagia, drooling or pseudobulbar affect); however, the absence of these symptoms will not exclude participants when molecular testing is negative for known HSP.
  • UMN symptoms and signs in a region other than the legs.
  • Normal brain and spinal cord neuroimaging except for changes expected for PLS.
  • No active major neurological diseases other than PLS and no history of major neurological diseases.
  • No major unstable medical diseases that require treatment (e.g., active cancer, dialysis) in the past 6 months.
  • Participant is residing within a commutable distance to the study site and is willing to visit the study site as required.
  • No history of ALS or PLS in immediate family and no family history of hereditary spastic paraplegia (HSP).
  • gia (HSP) If disease duration is less than 5 years, no significant lower motor neuron (LMN) degeneration upon the EMG examination within 12 months before enrollment (evident entrapment neuropathy or radiculopathy are acceptable). If EMG tests were not done in this period, an EMG test should be obtained through regular patient care (through insurance) in order to make a diagnosis of PLS (this cost will not be covered by this research study). If disease duration is more than 5 years and at least one EMG was performed post-diagnosis, an EMG examination 12 months prior to enrollment is not required.
  • Participant understands the study’s purpose, has capacity to consent, and is willing to sign the informed consent form.


Exclusion Criteria:

  • Unwilling or unable to give informed consent.
  • UMN symptoms and signs only in the legs.
  • Unwilling or unable to visit the study site as required.
  • Clinically obvious cognitive impairment that precludes obtaining informed consent, as determined by the site PI.
  • Participating in clinical treatment trials.

Eligibility last updated 5/3/22. Questions regarding updates should be directed to the study team contact.

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A Prospective, Multicenter Investigation of the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures (NSM Intuitive Jakub)

A Study to Evaluate the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures

James Jakub
Female
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-303294-P01-RST
21-000213
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Inclusion Criteria:

  • Subject is female.
  • Subject has a BMI ≤ 29.
  • Subject is between 18 and 80 years of age.
  • Subject is a candidate for a unilateral or bilateral nipple sparing mastectomy procedure with mmediate reconstruction.
  • Subject is at increased risk for breast cancer and is seeking prophylactic NSM surgery.
  • Subject has no presence of occult cancer as confirmed by physical exam and by preoperative imaging per institution’s guidelines.  Known carriers of pathogenic BRCA1/2 mutations should have negative breast MRI.
  • Subject has breast ptosis ≤ Grade 2.
  • Subject has cup size ≤ C.
  • Subject is at low to moderate risk for anesthesia (ASA class I, II or III).
  • Subject is willing and able to provide written informed consent.
  • Subject is willing and able to comply with the study protocol requirements including follow up examinations up to 5 years (+/- 90 days) post operatively.


Exclusion Criteria:

  • Subject has current or prior history of ipsilateral in-situ or invasive breast carcinoma.
  • Subject has had previous breast surgery of the ipsilateral breast (excluding needle or core biopsies).
  • Subject has an inflammatory and/or infectious skin condition and/or unhealed wounds on the ipsilateral breast.
  • Subject has had chemotherapy for contralateral breast cancer within 3 weeks.
  • Subject has had previous radiation treatment to the ipsilateral breast/chest area.
  • Subject is planned to have other concomitant procedures (oophorectomy, hysterectomy, etc.).
  • Subject has a current history of smoking or has smoked within 1 month of screening.
  • Subject has hemoglobin A1C levels ≥ 8.
  • Subject has a high risk for anesthesia (ASA class ≥ IV) or significant medical comorbidities (i.e., cardiac, pulmonary and neurologic) that preclude longer anesthesia times.
  • Subject is contraindicated for general anesthesia or surgery.
  • Subject has a known bleeding or clotting disorder.
  • Subject is pregnant or suspected to be pregnant or is lactating.
Device, Procedure/Surgery
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A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) (MT-1186-A02)

A Study to Determine the Effectiveness and Safety of Oral Edaravone Administered in Subjects with Amyotrophic Lateral Sclerosis

Nathan Staff
All
18 years to 75 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-303340-P01-RST
21-000703
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Inclusion Criteria:

  • Subjects must provide a signed and dated informed consent form (ICF) to participate in the study.
  • Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study.
  • Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
  • Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed.
  • Subjects will be diagnosed with Definite ALS or Probable ALS according to the El Escorial revised criteria for the diagnosis of ALS.
  • Subjects with a baseline score ≥ 2 points on each individual item of the ALSFRS- R at screening and baseline visits.
  • Subjects have a screening and baseline %forced vital capacity (FVC) ≥ 70%.
  • Subjects with 1 to 4 points decline for 8 weeks in ALSFRS-R total score between screening and baseline visits.
  • Subjects whose first symptom of ALS has occurred within 2 years of providing written informed consent.


Exclusion Criteria:

  • Subjects with a history of spinal surgery after the onset of ALS, such as surgery for cervical spondylosis or a herniated disc, or plans for such surgery during the study period.
  • Exclusions Related to Other Neurological Disorders (including, but not limited to the following)
  • Subjects with the possibility that the current symptoms may be symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy, cannot be ruled out.
  • Exclusions Related to General Health or Concomitant Conditions
  • Subjects undergoing treatment for a malignancy.
  • Subjects with a complication that could have a significant effect on efficacy evaluations, such as Parkinson's disease or syndrome, schizophrenia, bipolar disorder, and dementia.
  • Subjects who have the presence or history of any clinically significant (CS) disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator.
  • Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).
  • Subjects of childbearing potential unwilling to use acceptable method of contraception from the screening visit until 3 months after the last dose of study medication.
  • Subjects who are sexually active who do not agree to use contraception during the study period.
  • Subjects who have a significant risk of suicidality. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the 3 months before the screening visit.
  • Subjects who have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations greater than 2 times the upper limit of normal (ULN) at screening.
  • Subjects with a Glomerular Filtration Rate (GFR) < 30 mL/Min Per 1.73 m2 at screening, using the Larsson Equation.
  • Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.
  • Subjects with hereditary problems of fructose intolerance (eg, fructose, sucrose, invert sugar, and sorbitol).
  •  Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer, before providing informed consent for the present study.
  • Subjects who have received any previous treatment with edaravone.
  • Subjects who have received stem cell therapy.
  • Subjects who are unable to take their medications orally at baseline (Visit 2).
Drug
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Development of an EEG Diagnostic for Alzheimer’s Disease: A Feasibility Study (DEEGDAD)

A Study to Develop an EEG Diagnostic for Alzheimer’s Disease

Erik St. Louis
All
65 years to 85 years old
This study is NOT accepting healthy volunteers
2021-303344-H01-RST
21-000676
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Inclusion Criteria:

  • Unimpaired APOE e4/4 homozygotes age 65-75 and APOE e3/4 heterozygotes age 75-85 for the preclinical AD subset and age, sex, and education matched APOE e4 noncarriers for the unaffected controls. 
  • Biomarker confirmation for preclinical diagnosis will be utilized to the extent possible (a subset of 130 members of our cohort have undergone amyloid-PET resulting in approximately 45 who are amyloid positive).

Exclusion Criteria:

  • Previous stroke.
  • Severe head injury.
  • Craniotomy.
  • Any other potentially confounding neurologic illness (typically anything that causes structural brain damage). 
  • Psychoactive medication use will not be an absolute exclusionary criterion in patients with moderate to severe dementia but patients who are relatively drug-free will be prioritized to the extent they are available within the study period. 
  • Psychoactive drug use will be exclusionary in the prospectively obtained clinical patients.

 

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    A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects with Acute Traumatic Cervical Spinal Cord Injury (Mitsubishi)

    A Study to Assess the Effectiveness and Safety of MT-3921 in Subjects with Acute Traumatic Cervical Spinal Cord Injury

    Ronald Reeves
    All
    18 years to 75 years old
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-303348-P01-RST
    21-000734
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    Inclusion Criteria:

    • Provide written informed consent from subjects, an impartial witness (for a subject who is physically unable to sign the informed consent form, but able to provide his/her consent by some other means [e.g., speaking, nodding, blinking]), or the subject’s legally authorized representative (LAR) (for a subject who lacks capacity to consent for him/herself [e.g., a subject without mental capacity to consent]), prior to beginning any study procedures.
    • Cervical spinal cord injury who meet either of the following criteria:
      • AIS A with ISNCSCI neurological level of injury between C4 and C7 (for C4, the subject must have at least 1 point of motor activity within the ZPP inclusive of C5 to T1);
      • AIS B or C with ISNCSCI neurological level of injury between C4 and C7, and UEMS ≤ 28.
    • Male and female subjects, age between 18 and 70 years at time of consent.
    • Body mass index (BMI) < 40 kg/m^2.
    • Acute traumatic spinal cord injury subjects who can receive MT-3921 as soon as possible after the injury, at least within 48 hours from the time of the injury.
    • Willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing informed consent.
    • Both female and male subjects of childbearing potential must agree to use of contraception or abstinence during the study.


    Exclusion Criteria:

    • Any concomitant injury that, in the judgement of the Investigator, interferes with the performance, interpretation or validity of neurological examinations (including fractures requiring casts), such as but not limited to multiple spinal cord lesions, brachial/lumbar plexus injury, cauda equina injury or traumatic brain injury defined by a Glasgow Coma Scale (GCS) <14 at time of examination.
    • Poly-traumatic Injury as defined by Injury Severity Score (ISS) values > 25 at time of Screening.
    • Penetrating spinal cord injuries.
    • Complete transection of the spinal cord or spinal cord contusion size > 3 cm determined by MRI.
    • Subjects who are highly anticipated to be dependent on long-term mechanical ventilation (e.g., beyond 10-14 days), which would interfere with study procedures including neurological exams.
    • Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the Investigator, may increase the risks associated with study participation, and would preclude successful participation in the study.
    • Subjects with history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), except for adequately treated hepatitis B (HBV) and hepatitis C virus (HCV) with documentation of sustained virologic response defined as undetectable HCV RNA at least 12 weeks after the end of treatment.
    • History of anaphylaxis or significant allergy to any food and medications.
    • History or presence of malignancy within the last 3 years prior to screening, except subjects who have been treated successfully with no recurrence for >1 year of basal cell or squamous cell carcinoma of the skin or in-situ cervical cancer.
    • Subjects with hereditary fructose intolerance.
    • Psychoactive substance use disorder at any time during the 3 months preceding study entry (as defined by Diagnostic and Statistical Manual of Mental Disorders [DSM-5]).
    • Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening.
    • Pregnant or nursing women.
    Biologic/Vaccine, Other
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    DIELECTRIC CHARACTERIZATION OF LUMINAL GASTROINTESTINAL TISSUE: A FEASIBILITY STUDY

    Dielectric Tissue Characterization

    Cadman Leggett
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-303351-H01-RST
    21-000393
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    Inclusion Criteria:

    • Patients over the age of 18 years.
    • Ability to provide informed consent.
    • Patients scheduled for gastrointestinal endoscopy and clinically indicated resection through our advanced endoscopy practice at Mayo Clinic Saint Mary Hospital, Alfred 6 Endoscopy Unit; or
    • Patients undergoing clinically indicated surgical resection of the gastrointestinal tract (esophagus, stomach, small bowel, colon).


    Exclusion Criteria:
        

    • Patients in who endoscopic or surgical resection is contraindicated.
    • Patients who are pregnant.

    Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.

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    BB2121-EAP-001, Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release (BB2121-EAP-001)

    A Study to Evaluate the Safety and Effectiveness of Idecabtagene Vicleucel to Treat Multiple Myeloma

    Yi Lin
    All
    18 years and over
    Not Applicable
    This study is NOT accepting healthy volunteers
    2021-303357-P01-RST
    21-000419
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    Inclusion Criteria:

    • Subject has multiple myeloma, 18 years of age or older and subject or legally authorized representative is able to sign the informed consent form.
    • Subject had a subject-specific batch of idecabtagene vicluecel manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria. The Sponsor has determined that the nonconforming idecabtagene vicleucel may be released for use under the Expanded Access Protocol.
    • Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject.
    • Subject is clinically stable, has recovered from any prior toxicities prior to receiving lymphodepleting chemotherapy, and has adequate bone marrow function to receive lymphodepleting chemotherapy.
    • Females of childbearing potential must:
      • Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact;
      • Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the lymphodepleting chemotherapy;
      • Agree to abstain from breastfeeding during study participation and for at least 12 months following lymphodepleting chemotherapy;
      • There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with nonconforming idecabtagene vicluecel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician.
    • Male subjects must:
      • Practice true abstinence or agree to use a condom;
      • There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with nonconforming idecabtagene vicluecel. Any decision regarding contraception after infusion should be discussed with the treating physician.
    • Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy. There are insufficient exposure data to provide any recommendation concerning the duration of refraining from tissue donation following treatment with nonconforming idecabtagene vicluecel. Therefore, participants treated with nonconforming idecabtagene vicluecel should not donate blood, organs, tissues, and cells for transplantation.


    Exclusion Criteria:

    • Subject has a hypersensitivity to the active substance or to any of the excipients.
    • Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of AEs associated with lymphodepleting chemotherapy or exclude them from treatment with nonconforming idecabtagene vicluecel.
    • Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol, complying with protocol requirements or confound the ability to interpret the data in the Investigator's judgement.
    • Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement.
    • Pregnant or nursing women or has intention of becoming pregnant during the study.
    Biologic/Vaccine
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    ACNS1833, A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1) (ACNS1833)

    A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients with Low-Grade Glioma

    Jonathan Schwartz
    All
    2 years to 21 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    2021-303367-P01-RST
    21-000601
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    Inclusion Criteria:

    • Patients must have a body surface area (BSA) of ≥ 0.5 m^2 at enrollment
    • Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1 and that has not been treated with any modality besides surgery.
      • Note: Patients may be newly-diagnosed OR previously diagnosed, and there is no required time frame between biopsy/surgery and treatment initiation.
    • Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and/or radiation) are eligible.
    • Patients must have two-dimensional measurable tumor ≥ 1 cm^2 to be eligible.
    • Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma.
    • Patients with metastatic disease or multiple independent primary LGG are eligible.
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:
      • Age: Maximum Serum Creatinine (mg/dL) -2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female) -6 to < 10 years: 1 mg/dL (male); 1 mg/dL (female) -10 to < 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female) -13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female) ≥ 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL).
    • Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
    • Albumin ≥ 2 g/dL.
    • Left ventricular ejection fraction (LVEF) ≥ 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram.
    • Corrected QT (QTc) interval ≤ 450 msec by electrocardiography (EKG).
    • Absolute neutrophil count ≥ 1,000/uL (unsupported).
    • Platelets ≥ 100,000/uL (unsupported).
    • Hemoglobin ≥ 8 g/dL (may be supported).
    • Patients with a known seizure disorder should be stable and should not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment.
    • Patients 2-17 years of age must have a blood pressure that is ≤ 95th percentile for age, height, and gender at the time of enrollment (with or without the use of anti-hypertensive medications).
    • Patients ≥ 18 years of age must have a blood pressure ≤ 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications).
      • Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension.
    • For all patients, a magnetic resonance imaging (MRI) of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 4 weeks prior to enrollment.
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
    • Patients must have the ability to swallow whole capsules.


    Exclusion Criteria:

    • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted.
    • Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible.
    • Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals grade I/II histology.
    • Patients may not be receiving any other investigational agents.
    • Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/ treatment.
    • Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible.
    • Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
    • Lactating females who plan to breastfeed their infants are not eligible.
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks. after stopping study therapy are not eligible.
      • Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo.
    • Known genetic disorder that increases risk for coronary artery disease.
      • Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented.
    • Symptomatic heart failure.
    • New York Health Association (NYHA) class II-IV prior or current cardiomyopathy.
    • Severe valvular heart disease.
    • History of atrial fibrillation.
    • Current or past history of central serous retinopathy.
    • Current or past history of retinal vein occlusion or retinal detachment.
    • Patients with uncontrolled glaucoma.
    • If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible.
    • Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E.
    • Surgery within 2 weeks prior to enrollment, with the exception of surgical biopsy, placement of a vascular access device or cerebral spinal fluid (CSF) diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt.
      • Note: Patients must have healed from any prior surgery.
    • Patients who have an uncontrolled infection are not eligible.

    Eligibility last updated 10/18/21. Questions regarding updates should be directed to the study team contact.

     

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    CRDF-001- A Phase 2 Study of Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Patients With Metastatic Pancreatic Ductal Adenocarcinoma (CRDF-001)

    A Study to Analyze Onvansertib Treatment in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

    Wen Wee Ma
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-303370-P01-RST
    21-000443
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    Inclusion Criteria:

    • Histologically or cytologically confirmed metastatic PDAC
    • Has received 1 prior gemcitabine-based chemotherapy as first line therapy for metastatic disease. Progression after completion of neoadjuvant or adjuvant therapy of < 6 months in duration is considered 1 line of therapy for metastatic disease
    • Has measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan
    • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
    • Must be willing and able to undergo a tissue biopsy at screening; participants who, in the opinion of the investigator, do not have tissue that is accessible for biopsy are excepted from this criterion
    • Women of childbearing potential: (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use adequate contraception for the duration of study participation and for 4 months after the last dose of nal-IRI. Male subjects must agree to refrain from sperm donation during the study and for 4 months after the last dose of nal-IRI
    • Ability to understand and the willingness to sign a written informed consent document. Signed informed consent form must be obtained prior to initiation of study evaluations and/or activities
    • International Normalized Ratio (INR) < 1.5 unless on warfarin
    • Participants with prior malignancy and who were treated with no evidence of active disease more than 2 years from initial diagnosis are eligible
    • Age ≥ 18 years
    • Participants must have adequate organ and bone marrow function


    Exclusion Criteria:

    • Prior treatment with irinotecan, nal-IRI, or investigational PLK1 inhibitor
    • Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and myocardial infarction within 3 months of initiation of therapy
    • History of interstitial pneumonitis or interstitial lung disease
    • Participants with microsatellite instability-high (MSI-H) tumors with no prior immune checkpoint inhibitor exposure
    • Pregnancy or lactation
    • Participant has active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
    • QT interval with Fridericia's correction (QTcF) > 470 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate electrocardiograms (ECGs). In the case of potentially correctible causes of QT prolongation, (eg, medications, hypokalemia), the triplicate ECG may be repeated once during Screening and that result may be used to determine eligibility
    • Planned concomitant use of medications known to prolong the QT/QTc interval
    • Participant has undergone major surgical resection within 4 weeks prior to enrollment
    • Participant received radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to study entry
    • Participant has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the participant to receive an experimental research drugs
    • Serious psychiatric or medical conditions that could interfere with treatment
    • Major bleeding in the last 4 weeks
    • More than 1 prior chemotherapy regimen administered in the metastatic setting
    • Unable or unwilling to swallow oral medication -Use of strong CYP3A4 or UGT1A1 inhibitors or strong CYP3A4 inducers. Participants currently receiving these agents who are able to switch to alternate therapy are not excluded. Inhibitors should be stopped at least one week prior to the first dose of protocol therapy and inducers should be stopped at least two weeks prior to initiation of protocol therapy.
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    Mayo Clinic — Rochester, MN

    Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes (REGENT-1-US Study) (Regent-1)

    A Study to Analyze a Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes

    Andrew Storm
    All
    22 years to 65 years old
    Not Applicable, First In Human
    This study is NOT accepting healthy volunteers
    2021-303378-P01-RST
    21-000469
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    Inclusion Criteria:

    • 22- 65 years of age.
    • Current diagnosis of T2D.
    • History of T2D for at least 3 years and less than or equal to 10 years.
    • HbA1C of 7.5-10.0%, inclusive.
    • BMI 24-40 kg/m^2, inclusive.
    • On two to three non-insulin glucose lowering mediations, with one at maximum tolerated dose and another at half-maximum dose at least, with no changes in medication for at least 12 weeks prior to baseline visit prior to baseline visit.
    • History of failed attempt to reach glycemic goal by lifestyle modifications.
    • Weight stability (defined as a < 5% change in body weight) for at least 12 weeks prior to the screening visit.
    • Agree not to donate blood during participation in the study.
    • Able to comply with study requirements and understand and sign the Informed Consent Form.
    • Women of childbearing potential must be using an acceptable method of contraception throughout the study.
    • Willing and able to use CGM for the duration of the study and comply with study visits and study tasks as required per protocol.
    • Proof of COVID 19 vaccination.


    Exclusion Criteria:

    • Diagnosed with type 1 diabetes.
    • History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
    • Probable insulin production failure, defined as overnight fasting C-peptide serum <1 ng/mL (333pmol/l).
    • Previous use of any types of insulin for > 1 month (at any time, except for treatment of gestational diabetes) in last 2 years.
    • Current use of insulin.
    • Hypoglycemia unawareness.
    • History of ≥1 severe hypoglycemia episode (defined by needing for third-party assistance) in past 6 months from the screening visit.
    • Known autoimmune disease, as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder. (Participants with adequately controlled primary hypothyroidism may be included).
    • Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.
    • Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.
    • Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen).
    • History of, or gastrointestinal symptoms suggestive of gastroparesis.
    • Acute gastrointestinal illness in the previous 7 days.
    • Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease.
    • History of chronic or acute pancreatitis.
    • Known active hepatitis or active liver disease other than NASH/NAFLD.
    • Alcoholic liver disease, as indicated by ANI > 0.
    • Current use of anticoagulation therapy (such as warfarin) that cannot be discontinued for 7 days before and 14 days after the procedure.
    • Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 14 days before and 14 days after the procedure.
    • Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.
    • Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.
    • Use of drugs known to affect GI motility (e.g., Metoclopramide).
    • Use of weight loss medications such as Meridia, Xenical, Phentermine or over-the-counter weight loss medications (prescription medication).
    • Currently taking, or unable to stop taking dietary supplements or herbal agents, including vitamin C or multivitamins containing vitamin C at > 500 mg per day, multivitamins containing biotin (vitamin B7), and supplements for hair, skin, and nail growth. Multivitamins not containing biotin are permitted.
    • Persistent anemia, defined as hemoglobin < 10 g/dL.
    • Known history of hemoglobinopathy.
    • Known history of blood donation or transfusion within 3 months prior to the Screening Visit.
    • Known history of cardiac arrythmia.
    • Significant cardiovascular disease, including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the Screening Visit.
    • Estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73m^2 (estimated by MDRD).
    • Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.
    • History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at screening).
    • With any implanted electronic devices or duodenal metallic implants
    • Not a candidate for upper GI endoscopy or general anesthesia.
    • Active illicit substance abuse or alcoholism (> 2 drinks/day regularly).
    • Active malignancy within the last 5 years (excluding non-melanoma skin cancers).
    • Women breastfeeding.
    • Participating in another ongoing clinical trial of an investigational drug or device.
    • Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
    • Critically ill or has a life expectancy < 3 years.
    • Additional exclusion criteria to be confirmed during the screening process:
      • HbA1c < 7.5% or > 10% at baseline visit;
      • Any severe hypoglycemic event since the screening visit;
      • CGM readings < 54 mg/dl in more than 1% of time by CGM since the screening visit;
      • CGM readings > 360 mg/dL in more than 1% of time.
      • Mean of 3 separate blood pressure measurements > 180 mmHg (systolic) or > 100 mmHg (diastolic).
    • Women of child-bearing potential with a positive urine pregnancy test at baseline visit.
    • LA Grade C or greater esophagitis on endoscopy.
    • Abnormalities of the GI tract preventing endoscopic access to the duodenum.
    • Anatomic abnormalities in the duodenum that would preclude the completion of the treatment procedure, including tortuous anatomy.
    • Endoscopic observation of upper gastrointestinal abnormality such as ulcers, polyps, varices, strictures, congenital or intestinal telangiectasia.
    • Any other anatomical or endoscopic abnormalities/characteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure.
    Device
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    (ECTX) JAB-3312-1003 / A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients with Advanced Solid Tumors (JAB-3312-1003)

    Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients with Advanced Solid Tumors

    Wen Wee Ma
    All
    18 years and over
    Phase 1/2
    This study is NOT accepting healthy volunteers
    2021-303398-P01-RST
    21-000517
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    Inclusion Criteria:

    • Written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses.
    • Patient must be ≥ 18 years of age at the time of signature of the informed consent form (ICF).
    • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
    • Has histologically or cytologically confirmed cancer that meets the following criteria:

    Dose Escalation Phase

    • Has metastatic disease, or locally advanced disease that is not a candidate for curative surgery or curative radiation;
    • Cohort A0 (JAB-3312 + pembrolizumab):
      • Advanced solid tumors;
      • Prior treatment with PD-1/PD-L1 agents is allowed.
    • Cohort B0 (JAB-3312 + binimetinib):
      • Advanced solid tumors with known mutations in KRAS;
      • Naïve to MEK, SHP2, or extracellular signal-regulated kinase (ERK) inhibitors.
    • Cohort C0 (JAB-3312 + sotorasib):
      • Any KRAS-G12C mutant tumors;
      • Prior treatment with KRAS G12C inhibitors is allowed.
    • Cohort D0 (JAB-3312 + Osimertinib):
      • Advanced NSCLC with sensitive EGFR mutation including EGFR exon 21 L858R or exon 19 deletion mutation, or T790M mutation;
      • Prior treatment with osimertinib is allowed.

    Dose Expansion Phase

    • Cohorts A1, A2, A3 (JAB-3312 + pembrolizumab):
      • Naïve to anti-PD-1/PD-L1 agents (A1 and A2 cohort only);
      • Have provided a formalin-fixed tumor tissue sample (collected within ≤ 18 months) from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been done.
    • Cohort A1 (NSCLC):
      • Patients with metastatic or locally advanced NSCLC who are not candidates for curative surgery or curative radiation;
      • Do not have an epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, or other actionable molecular alterations that can be treated with Food and Drug Administration-approved targeted agents.
      • PD-L1 tumors expression of 1% or greater (tumor proportion score [TPS] ≥ 1%) as determined by a local institutional standard;
      • Received no prior systemic treatment for advanced disease.
    • Cohort A2 (HNSCC):
      • Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HNSCC that is considered not amenable to further therapy with curative intent;
      • Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx are allowed;
      • Tumors expressing PD-L1 (combined positive score [CPS ≥ 1) as determined by a local institutional standard;
      • Received no prior systemic treatment for advanced disease.
    • Cohort A3 (ESCC):
      • Histologically or cytologically confirmed diagnosis of metastatic or locally advanced ESCC that is not amenable for curative intervention;
      • Received at least 1 previous line of standard systemic therapy for advanced disease. Must either demonstrate progression or become intolerant to the previous line of therapy.
    • Cohort B1, B2 (JAB-3312 and binimetinib):
      • Naïve to MEK or ERK inhibitors;
      • Have provided a formalin-fixed tumor tissue sample (collected within ≤ 18 months) from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made;
      • KRAS mutation identified through local or central laboratory testing using archival tissue or liquid biopsy;
      • Pancreatic ductal adenocarcinoma (PDAC) and mCRC are metastatic in nature.
    • Cohort B1 (PDAC):
      • Patients must have histologically or cytologically confirmed PDAC;
      • Received only 1 previous line of standard systemic therapy for metastatic disease. Must either demonstrate progression or become intolerant to the previous line of therapy.
    • Cohort B2 (mCRC):
      • Patients must have histologically or cytologically confirmed mCRC;
      • Received at least 2 and no more than 4 previous lines of standard systemic therapy for metastatic disease. Must either demonstrate progression or become intolerant to the previous line of therapy.
    • Cohort C1 (JAB-3312 + sotorasib) (NSCLC):
      • Advanced NSCLC with KRAS G12C mutation;
      • Received at least one prior systemic therapy;
      • Naïve to KRAS G12C inhibitor treatment.
    • Cohort D1 (JAB-3312 + osimertinib) (NSCLC):
      • Prior response to osimertinib based treatment and followed by radiological confirmed disease progression;
      • Osimertinib must have been included as the last systemic therapy as first line or second line prior to study enrollment;
      • Platinum-based treatment naïve advanced NSCLC patients;
      • Histologic transformation from NSCLC to SCLC after osimertinib treatment is excluded.
    • Patients with a life expectancy ≥ 3 months.
    • Patients must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Tumor lesions that have been irradiated ≥ 4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated.
    • Patients whose laboratory data at screening meet the following criteria:
      • ANC ≥ 1.5 × 10^9 /L;
      • Platelets ≥ 150 × 10^9 /L;
      • Hemoglobin ≥ 9 g/dL;
      • Albumin ≥ 3.5 g/dL;
      • Serum bilirubin ≤ 1.5 × ULN, or ≤ 3.0 × ULN for subjects with Gilbert’s Syndrome;
      • AST and ALT within normal limits for patients without liver metastasis, ≤ 2.5 × ULN for patients with liver metastasis;
      • International normalization ratio (INR) 6 weeks prior to Screening;
      • Kidney function is normal with an estimated glomerular filtration rate > 60 mL/min (measured using Cockcroft-Gault equation).
    • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to study entry. Women of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhea, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms), or have had surgical bilateral oophorectomy, hysterectomy, or bilateral tubal ligation > 6 weeks prior to screening.
    • Male or female patients: Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study until 3 months following the last dose of JAB-3312 or binimetinib, or 4 months following the last dose of pembrolizumab, whichever is longer. Male patients must also refrain from donating sperm during their participation in the study until 3 months following the last dose of JAB-3312 or binimetinib, or 4 months following the last dose of pembrolizumab, whichever is longer.
    • Patients must be able to swallow and retain orally administered medication.


    Exclusion Criteria:

    • History (≤ 3 years) or presence of hematological malignancies.
    • History (≤ 3 years) of other cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, ductal carcinoma in situ, prostatic intraepithelial neoplasia, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer.
    • Known serious allergy to JAB-3312, pembrolizumab, binimetinib, sotorasib, osimertinib or excipients (e.g., microcrystalline cellulose).
    • History (≤ 6 months before the start of study treatment) of severe autoimmune disease (including ≥ Grade 3 or recurrent Grade 2 immune-related adverse events (AEs) of prior immuno-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).
    • Brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone (for cohort D0 and D1, patient is also eligible if brain or spinal metastases are well controlled by prior treatment of osimertinib), with no radiographic evidence of progression or hemorrhage for ≥ 28 days before the start of study treatment and has not received any systemic corticosteroids for ≥ 28 days before the start of study treatments.
    • History (≤ 6 months before the start of study treatment) of pericarditis (any grade) or pericardial effusion (Grade ≥ 2).
    • History (≤ 6 months before the start of study treatment) of interstitial lung disease, radiation pneumonitis which required steroid treatment, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or organizing pneumonia. Radiation-induced pneumonitis (fibrosis) in the radiation field is permitted.
    • History (≤ 4 weeks before the first dose of study treatment) of Grade ≥ 2 pleural effusion.
    • Symptomatic ascites that requires therapeutic intervention within last 4 weeks before the start of treatment.
    • Active infection requiring systemic treatment within 7 days prior to the first dose of study treatment.
    • History of seropositive status for human immunodeficiency virus (HIV) at any time before the start of treatment as determined by presence of anti-HIV-1 or anti-HIV-2 antibodies.
      • Note: Testing for seropositive status during screening will be at the discretion of the investigator in patients without previously reported results.
    • Has active hepatitis B, or hepatitis C infection.
      • Note: Patients will be tested for hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening.
      • Note: Patients with hepatitis B (hepatitis B virus surface antigen positive [HepBsAg+]) who have controlled infection (serum hepatitis B virus DNA polymerase chain reaction [PCR] that is below the limit of detection) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA.
      • Note: Patients who are hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be enrolled into the study. Patients with controlled infections must undergo periodic monitoring of HCV RNA per treating physician.
    • History of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator and sponsor, could affect the patient’s participation in the study such as:
      • Nonmalignant illnesses that are uncontrolled or whose control may be jeopardized by this study treatment;
      • Nonmalignant decompensated liver disease;
      • Significant gastrointestinal abnormalities or a chronic condition, including inability to swallow the formulated product, delayed gastric emptying, chronic active Crohn's disease that requires steroid therapy at any dose, refractory nausea and vomiting, and/or prior surgical procedures affecting absorption or requirement for intravenous (IV) alimentation.
    • History (≤ 6 months before the start of study treatment) of any of the following: acute myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident.
    • Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
      • Significant ventricular or supraventricular arrhythmias (patients with sinus arrhythmia or chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible);
      • Left ventricular ejection fraction (LVEF) ≤ 50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 6 months before the start of study treatments and at screening;
      • Resting bradycardia (470 msec at Screening using Fridericia’s formula (QTcF), determined as the mean of 3 QTcF values from the screening triplicate ECG.
    • History (≤ 6 months before the start of study treatment) of significant eye inflammatory, central serous retinopathy, uveitis, or evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome).
    • Patients experiencing unresolved Grade >1 toxicity before the start of study treatment except for hair loss (alopecia), Grade 2 neuropathy (if permitted by the investigator and medical monitor), hemoglobin 9 to 10 g/dL, and hypothyroidism that requires thyroid hormone supplements but is asymptomatic under stable therapy, with thyroid hormone results acceptable to the investigator and medical monitor, and Grade > 1 abnormal laboratory results which are not considered clinically significant by the investigator and medical monitor.
    • Patients who are planning to do strenuous exercise after the first dose of study treatment. Strenuous activity should be avoided given its risk for elevated creatine kinase (CK) while on binimetinib.
    • Patients who have neuromuscular disorders that are associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis spinal muscular atrophy).
    • Women who are pregnant or breast-feeding.
    • Has received or will receive a live vaccine within 30 days prior to the first administration of study treatment. Seasonal flu vaccines that do not contain live vaccine are permitted.
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. Prior and Concomitant Therapy. 
    • History of an allogeneic bone marrow or solid organ transplant.
    • Use of systemic anticancer agent (except for hormonal therapy for prostate cancer and breast cancer, therapy for bone metastases or cancer-related hypercalcemia) or investigational drug is prohibited ≤ 28 days for biologics and IV chemotherapy, or ≤ 14 days or 5 half-lives for small molecules, whichever is shorter prior to the first dose of JAB-3312.
    • History of therapeutic radiation ≤ 28 days, or palliative radiation ≤ 14 days prior to the first dose of JAB-3312.
    • Use of drugs known to be moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index is prohibited ≤ 14 days or 5 half-lives, whichever is longer, before the start of study treatment until the end-of-treatment (EOT). Some of these medications may be allowed at the investigator’s discretion after approval by the medical monitor.
    • Use of herbal drugs and supplements known to be moderate or strong CYP3A4 inhibitors or inducers or sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index is prohibited ≤ 14 days or 5 half-lives, whichever is longer, before the start of study treatment until the EOT. These herbal medications include but are not limited to: St. John's wort, cannabis (including “medical marijuana”), kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cumin, and ginseng. Some of these medications may be allowed at the investigator’s discretion after approval by the medical monitor.
    • History (≤ 28 days before the start of study treatments) of major surgery or trauma or likelihood to require surgery at any time until the permanent discontinuation of treatment (the significance will be determined by the investigator after consultation with the medical monitor).
    • Patients who start erythropoietin or granulocyte colony-stimulating factor, pegfilgrastim, or filgrastim ≤ 4 weeks before start of study treatment.
    • History (≤ 4 weeks before the first dose of JAB-3312) of transfusion of whole blood, red blood cells or platelet packets.
    • History (≤ 2 weeks or 5 half-lives, whichever is longer, before the start of study treatments) of medications with known risk of Torsades de Pointes (cardiac arrhythmia due to drug-induced QTc prolongation).
    • Use of histamine 2 (H2)-receptor antagonists, proton pump inhibitors, and/or antacids within 3 days or 5 half-lives (whichever is longer) prior to starting JAB-3312.

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

    Biologic/Vaccine, Drug
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    Maternal EGF presence in breastmilk and infant stool

    A Study to Evaluate Breast Milk Proteins in Infant Stool

    Kathryn Knoop
    All
    up to 50 years old
    This study is NOT accepting healthy volunteers
    2021-303403-H01-RST
    20-012812
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    Inclusion Criteria:

    • Low Birth Weight (LBW) and/or Preterm infants and mothers. Admissions to either NICU will be screened based on gestational age or birth weight.
    • Subjects included will be considered by birth weight (LBW, < 2500 grams), or gestational age (preterm, < 36 weeks). Subjects will be between the age of 3 days and 6 months old (corrected gestational age) at the time of enrollment. Cohort will be targeted to mother-infant dyads with infants born after March 2021 and ongoing through study fill.
    • Cohort will be targeted to subjects with an anticipated duration of hospitalization 2 weeks or greater.
    • Cohort will be targeted to subjects on a specified diet: either maternal milk, donor milk, or infant formula based.  
    • Written informed consent will be obtained before enrollment.


    Exclusion Criteria:

    • Major congenital anomalies involving the intestinal tract.
    • Custodial issues that would prohibit consent.

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

    Premature birth
    Reproductive system, Very low birth weight infant, Very preterm maturity of infant
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    MElanoma Research Lymph node prediction Implementation National_001 (MERLIN_001) (MERLIN_001)

    MElanoma Research Lymph node prediction Implementation National_001 (MERLIN_001)

    Tina Hieken
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-303408-P01-RST
    21-000516
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    Inclusion Criteria:

    • Newly diagnosed (biopsy within 120 days of study enrollment) invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines).
      • pT1b-pT3 (Breslow thickness ≥ 0.8 mm to 4.0 mm) cN0M0; or
      • pT1a (Breslow thickness < 0.8 mm) cN0M0 AND one or more of the following:
        • Mitotic rate ≥ 2/mm2.
        • Patient age at time of primary melanoma biopsy < 40 years old.
        • Presence of lymphovascular invasion.
    •  Male or female, age ≥ 18 years.
    • Elected to undergo sentinel lymph node biopsy per the treating physician’s recommendation.


    Exclusion Criteria:

    • Full primary melanoma pathology report unavailable.
    • Documented clinically apparent nodal metastases at diagnosis.
    • Distant metastatic disease (M1a,b,c,d) clinically present at primary diagnosis.
    • Any prior or concurrent primary invasive melanoma mapping to the same draining lymph node basin(s).
    • Documented history of another (prior or concurrent) primary invasive melanoma of T1b or greater at any site within the last 5 years.
    • Previous surgery in or radiation therapy to the draining lymph node basin(s) of the current primary melanoma.
    • Ocular, vulvar, perianal or mucosal melanomas or melanocytic tumors of uncertain malignant potential (MELTUMP) or atypical Spitz tumors.
    Cancer, Melanoma, Skin cancer
    Cancer treatment, Integumentary system, Malignant melanoma of skin, Medical Oncology, Sentinel node biopsy
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    Tricuspid Regurgitation due to Atrial Fibrillation – Impact of Rhythm Control and Early Surgery (TR-ES Study) (TR-ES)

    A Study to Analyze Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

    Yogesh Reddy
    All
    18 years and over
    Phase 1/2
    This study is NOT accepting healthy volunteers
    2021-303409-H01-RST
    21-000537
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    Inclusion Criteria:

    • Age ≥ 18 years.
    • Moderate-severe to severe TR due to atrial enlargement.
    • Ambulatory (not wheelchair/scooter dependent).
    • Ejection fraction > 40%.


    Exclusion Criteria:

    • Systolic pulmonary artery pressure > 70 mmHg. with a fixed pulmonary vascular resistance > 7 Wood units by catheterization.
    • Ejection fraction < 40%.
    • Obstructive hypertrophic cardiomyopathy.
    • Constrictive pericarditis or tamponade.
    • Active myocarditis.
    • Complex congenital heart disease.
    • Other valve disease requiring surgical intervention.
    • Terminal illness (other than HF) with expected survival of less than 1 year.
    • Pregnancy or breastfeeding mothers.

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

    Procedure/Surgery
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    Bioavailablity of Maternal EGF during LOS

    A Study to Evaluate Breastmilk Proteins and Sepsis

    Kathryn Knoop
    All
    72 hours to 6 months old
    This study is NOT accepting healthy volunteers
    2021-303412-H01-RST
    20-012814
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    Inclusion Criteria:

    • Born between after March 2021, though inclusion may be expanded to allow for recruitment of infants meeting criteria.
    • Inclusion will be based on infant's age and health status
    • Positive blood bacterial culture of possible enteric originating bacteria as defined by Dr. Levy and Dr. Knoop.
    • Birth weight (LBW, <1500 grams) or gestational age ( preterm, < 36 weeks).
    • Subjects will be between the age of 3 days and 6 months old at the time of enrollment.
    • Written informed consent will be obtained before enrollment.


    Exclusion Criteria:

    • Major congenital anomalies involving the major congenital anomalies involving the GI tract, urogenital system, or another system if known to carry an infectious risk.
    • Custodial issues that would prohibit consent.

    Eligibility last updated 2/17/22.  Questions regarding updates should be directed to the study team contact.

    Sepsis
    Late-onset neonatal sepsis
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    Mayo Clinic — Rochester, MN

    A Phase 1/2, Open-Label, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INZ-701 in Adults With ENPP1 Deficiency (ENPP-INZ)

    Evaluation of Safety, Tolerability, and Effectiveness of INZ-701 in Adults With ENPP1 Deficiency

    Robert Wermers
    All
    18 years to 64 years old
    Phase 1/2
    This study is NOT accepting healthy volunteers
    2021-303417-P01-RST
    21-000543
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    Inclusion Criteria:

    • Must provide written or electronic consent after the nature of the study has been explained, and prior to any research-related procedures.
    • Clinical diagnosis of Autosomal Recessive Hypophosphatemic Rickets 2 (ARHR2) supported by prior or concurrent genetic testing of the ENPP1 gene.
    • Male or female, 18 to 64 years of age.
    • Plasma PPi < lower limit of normal (LLN) at screening.
    • Willing to withhold treatment with oral phosphate and vitamin D analogs (e.g., calcitriol) beginning at least 14 days prior to first dose of INZ-701 and throughout the Treatment Period.
    • If using, discontinue use of bisphosphonates for 6 months prior to initiation of the study.
    • Women of child-bearing potential (WOCBP as defined in Clinical Trial Facilitation Group (CTFG) 2014) must have a negative urine pregnancy test at Screening and at all additional pregnancy tests during the study.
    • Fertile males with partners of child-bearing potential and WOCBP must agree to use 2 highly effective forms of contraception (per CTFG 2014) from the period following the first dose of INZ-701 through 25 days after last dose of INZ-701.
    • Males who are sexually active must agree to use condoms from the period following first dose of INZ-701 through 25 days after the last dose of INZ-701.
    • In the opinion of the Investigator, must be willing and able to complete all aspects of the study.
    • Agree to provide access to relevant medical records.


    Exclusion Criteria:

    • In the opinion of the Investigator and/or Sponsor, presence of any clinically significant disease (outside of those considered associated with the diagnosis of ENPP1 Deficiency) that precludes study participation or may confound interpretation of study results.
    • Clinically significant abnormal laboratory result at screening, including but not limited to, elevations of aspartate aminotransferase, alanine aminotransferase, bilirubin, or creatinine greater than 2 times the upper limit of normal.
    • Known active fungal, bacterial, and/or viral infection including human immunodeficiency virus, hepatitis B virus, or hepatitis C virus. If status is unknown, a local test should be completed prior to enrollment.
    • Known intolerance to INZ-701 or any of its excipients.
    • Unable or unwilling to discontinue the use of any prohibited medication (bisphosphonates, anti-fibroblast growth factor 23 (FGF23) [e.g., burosumab], calcimimetics, antacids, systemic corticosteroids, parathyroid hormone suppressors) or procedures.
    • Receipt of any other investigational new drug or use of an investigational device within 4 weeks prior to the first dose of INZ-701.
    Drug
    Specific enzyme deficiency
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    RESONANCE–REgiStry Of the NAtural history of recurreNt periCarditis in pEdiatric and adult patients (RESONANCE)

    A Study to Analyze the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients

    Sushil Luis
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-303430-P01-RST
    21-000605
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    Inclusion Criteria
    •Patients with Active Recurrent Pericarditis:

    • Physician-confirmed (or confirmation in medical records) diagnosis of Recurrent Pericarditis (RP) defined as an initial acute, episode and at least one pericarditis recurrence after the initial acute episode.
    • Experienced at least one pericarditis episode in the 3 years prior to inclusion.
    • Under the care of a physician for the treatment and management of RP.
    • Currently prescribed medication for RP.
    • Able to read and understand English or Spanish.
    • Have access to technology to complete ePROs.
    • Provided informed consent or assent, as required by local regulations.

    Inclusion Criteria
    •Patients with Inactive Recurrent Pericarditis:

    • Physician-confirmed (or confirmation in medical records) diagnosis of RP defined as an initial, acute, episode and at least one pericarditis recurrence after the initial, acute episode.
    • Patient had a last episode occurring at least 3 years and up to 5 years before registry inclusion.
    • Resolution of RP symptoms confirmed with no further RP treatment for 3 years prior to registry enrollment.

    Exclusion Criteria
    •Patients with Active Recurrent Pericarditis
    :

    • Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full remission, post-thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases, except SJIA and adult Still’s disease, HIV.
    • Appears to have an impairment (e.g., cognitive, hearing, visual) or insufficient English or Spanish proficiency that could interfere with ability to complete patient-completed assessments.
    • Currently enrolled in a therapeutic investigational drug or device study.

    Exclusion Criteria
    •Patients with Inactive Recurrent Pericarditis:

    • Experienced a pericarditis episode within 3 years from enrolling in the registry.
    • Currently receiving RP treatment prescribed by a treating physician (e.g., CS, colchicine).
    • Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full remission, post-thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases except SJIA and adult Still’s disease, HIV.
    • Enrolled in a therapeutic investigational clinical trial during the observation period.
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    A Pivotal, Prospective, Multi-centre, Randomize Control, Blinded Study Evaluating the Efficacy of a Dexamethasone Eluting Slim Modiolar Electrode (CI632D) in the Reduction of Fibrosis as Compared to a Standard Slim Modiolar Electrode (CI632) in a Newly Implanted Adult Population with Bilateral, Post-Linguistic, Moderate to Profound Sensorineural Hearing Loss (CI-DEX)

    A Study to Evaluate the Effectiveness of a Dexamethasone Eluting Slim Modiolar Electrode in the Reduction of Fibrosis in a Newly Implanted Adult Population with Bilateral, Post-Linguistic, Moderate to Profound Sensorineural Hearing Loss

    Aniket Saoji
    All
    18 years and over
    Not Applicable, Pivotal
    This study is NOT accepting healthy volunteers
    2021-303433-P01-RST
    21-001708
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    Inclusion Criteria:


    - Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss
    at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a
    pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.

    - 18 years or older at time of consent.


    Exclusion Criteria:


    - Abnormal cochlear and middle ear anatomy

    - History with cochlear implant surgery

    - Allergy to dexamethasone

    - Women who are pregnant or plan to become pregnant

    - Unable/unwilling to comply to study requirements

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

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

    Device, Behavioral
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    PRGN3006-001, A Phase 1/1b Safety Study of PRGN-3006 Adoptive Cellular Therapy in Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndrome (PRGN)

    PRGN-3006 Adoptive Cellular Therapy Relapsed or Refractory AML or High Risk MDS

    Hassan Alkhateeb
    All
    18 years and over
    Phase 1
    This study is NOT accepting healthy volunteers
    2021-303437-P01-RST
    21-000754
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    Inclusion Criteria:


    - Participants must be diagnosed with either relapsed or refractory AML (including
    extramedullary disease) or higher risk MDS/CMML.

    - Absolute lymphocyte count ≥ 0.2 k/?L.

    - Karnofsky performance status score ≥60%.

    - Life expectancy ≥ 12 weeks from the time of enrollment.

    - Pretreatment calculated or measured creatinine clearance (absolute value) of ≥ 40
    mL/minute or Cr > 2x upper limit of normal (ULN).

    - Serum bilirubin ≤ 2.0 mg/dL or total bilirubin ≤ 3.0 x IULN with direct bilirubin
    within normal range in participants with well documented Gilbert's syndrome or
    hemolysis or who require regular blood transfusions

    - Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) < 3.0 x IULN.

    - Ejection fraction measured by echocardiogram (ECHO) or multi gated acquisition scan
    (MUGA) > 45%.

    - Participant does not require supplemental oxygen or mechanical ventilation AND has an
    oxygen saturation by pulse oximetry of ≥ 92% or higher on room air.

    - Negative serum pregnancy test. Note: Women of child-bearing potential and men must
    agree to use adequate contraception prior to study entry and for at least 1 year
    following study treatment (T cell infusion); should a woman participant or female
    partner of a male participant become pregnant or suspect that she is pregnant while
    participating on the trial, she should inform her treating physician immediately.

    - Participant has a matched bone marrow donor and is otherwise able to receive a bone
    marrow transplant (dose escalation part only)

    - Participants who have undergone allo-SCT are eligible if they are at least 3 months
    post SCT, have relapsed AML/MDS as defined above, are not on treatment or prophylaxis
    for GVHD for at least 6 weeks before administration of CAR T cells, and have no active
    GVHD.

    - All participants must have the ability to understand and willingness to sign a written
    informed consent.


    Exclusion Criteria:


    - Diagnosis of acute promyelocytic leukemia (APL M3): t(15;17)(q22;q12); (promyelocytic
    leukemia [PML]/retinoic acid receptor [RAR] alpha [a]) and variants excluded.

    - Known central nervous system (CNS) leukemic involvement that is refractory to
    intrathecal chemotherapy and/or cranio-spinal radiation; participants with a history
    of CNS disease that have been effectively treated to complete remission ( i.e. no
    blasts in cerebrospinal fluid [CSF] by cytology and flow cytometry) will be eligible.

    - Prior treatment with investigational CAR T therapy for any disease.

    - Participants enrolled in another investigational therapy protocol for their disease
    within 14 days or 5 half-lives of enrollment, whichever is shorter.

    - Ongoing uncontrolled serious infection, symptomatic congestive heart failure, unstable
    angina pectoris, uncontrolled cardiac arrhythmia, poorly controlled pulmonary disease
    or psychiatric illness/social situations that would limit compliance with study
    requirements.

    - Human immunodeficiency virus (HIV) seropositivity, or active hepatitis B or C
    infection based on testing performed within 28 days of enrollment.

    - Participants requiring agents other than hydroxyurea to control blast counts within 14
    days of study enrollment.

    - Participants with presence of other active malignancy within 1 year of study entry;

    - Participants with adequately resected basal or squamous cell carcinoma of the skin, or
    adequately resected carcinoma in situ (e.g. cervix) may enroll irrespective of the
    time of diagnosis.

    - Pregnant and lactating women are excluded from this study

    - History of allergic reactions attributed to compounds of similar chemical or
    biological composition to cetuximab (anti-EGFR).

    - Active autoimmune disease requiring systemic immunosuppressive therapy (i.e. >10mg of
    prednisone daily or equivalent).

    - Participant, who in the opinion of the investigator, may not be able to comply with
    the safety monitoring requirements of the study.

    Eligibility last updated 6/27/22. Questions regarding updates should be directed to the study team contact.

    Drug
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    Role of Early Intervention on Patient Outcomes in Patients Admitted with Substance Use Disorders - Phase II

    Early Intervention for Patients with Substance Use Disorders

    Robert Kirchoff
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-303482-H01-RST
    21-000557
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    Inclusion Criteria:

    • Adult, ≥ 18 years old.
    • Patients who received an LADC consultation associated with their hospital admission.
    • Deemed to have capacity.


    Exclusion Criteria:

    • < 18 years old.
    • Consult placed but not completed.
    • Patient who have declined survey or study involvement.
    • Lack of capacity.
    • Non-English speaking.

     

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    68284528MMY2003, A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma (CARTITUDE-2)

    A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma

    Yi Lin
    All
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    2021-303483-P01-RST
    21-000891
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    Inclusion Criteria:


    - Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a
    proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide
    refractory per International Myeloma Working Group (IMWG) guidelines

    - Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease
    progression per IMWG criteria less than or equal to (<=) 12 months after treatment
    with autologous stem cell transplantation (ASCT) or <=12 months from the start of
    anti-myeloma therapy for participants who have not had an ASCT

    - Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and
    B-cell maturation antigen (BCMA)-directed therapy

    - Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total
    cycles of initial therapy, including induction, high-dose therapy, and ASCT with or
    without consolidation

    - Cohort E: Have newly diagnosed multiple myeloma without prior therapy (one cycle of
    prior therapy before enrollment is acceptable) and classified as high risk defined as
    either: 1) International Staging System (ISS) stage III criteria, Beta 2 microglobulin
    greater than or equal to (>=) 5.5 milligram per liter (mg/L) (via local or central
    laboratory assessment) or 2) high risk cytogenetic features del(17/17p), t (14;16),
    t(14;20), 1q amplification (at least 4 total copies) in at least 20 percent (%) of the
    total plasma cell population

    - Cohort F:

    - Participant must have a documented efficacy response of very good partial response
    (VGPR) or better, without progressive disease prior to enrollment, as assessed per
    IMWG 2016 criteria

    - Received initial therapy as specified below. The dose/schedule of cycles administered
    will be as per standard of care. It is acceptable for up to 1 cycle of the
    protocol-specified regimens to be missing one of the listed agents (example, held due
    to toxicity). Acceptable combinations include: At least 5 to 8 cycles of initial
    therapy with daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd). The
    dose/schedule of cycles administered will be as per standard of care or; at least 4 to
    8 cycles of initial therapy with daratumumab, lenalidomide and dexamethasone (D-Rd)
    or; at least 4 to 8 cycles of initial therapy with a carfilzomib-based triplet or
    quadruplet regimen

    - Cohorts A, B, C, E:

    - Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram
    per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours

    - Light chain multiple myeloma in whom only measurable disease is by serum free light
    chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal
    serum immunoglobulin kappa lambda FLC ratio

    - Cohort A: For participants with neither serum nor urine measurable disease, baseline
    positron emission tomography/ computed tomography (PET/CT) or whole -body magnetic
    resonance imaging (MRI) may be used to satisfy the measurable disease criteria. A
    minimum of one lesion with a bi-dimensional measurement of at least 1 centimeter
    (cm)*1 cm is required

    - Cohorts B, C: For participants with neither serum nor urine measurable disease,
    baseline positron emission tomography/ computed tomography (PET/CT) or whole body
    magnetic resonance imaging (MRI) may be used to satisfy the measurable disease
    criteria

    - Cohorts A, B, C, D, E, F: Eastern Cooperative Oncology Group (ECOG) performance status
    grade of 0 or 1


    Exclusion Criteria:


    - Cohorts A, B, D, F: Any therapy that is targeted to BCMA

    - Cohorts A, B, C, D, F: Prior treatment with chimeric antigen receptor T (CAR-T)
    therapy directed at any target

    - Cohorts A, B, C, D, F:

    - Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or
    to Grade 1 or less except for alopecia or peripheral neuropathy

    - Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone
    within the 7 days (Cohort A, B, C, F) or 14 days (Cohort D) prior to apheresis

    - Serious underlying medical condition, such as (a) evidence of active viral or
    bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic
    fungal infection; (b) active autoimmune disease or a history of autoimmune disease
    within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d)
    any history of Parkinson's disease or other neurodegenerative disorder

    - Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system
    (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple
    myeloma

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

    Eligibility last updated  8/16/22. Questions regarding updates should be directed to the study team contact.

    Drug, Biologic/Vaccine
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    Center for Regenerative Medicine Allogeneic Cartilage Bank

    The Establishment of an Allogeneic Cartilage Bank for the Center for Regenerative Medicine

    Daniel Saris
    All
    18 years to 60 years old
    This study is NOT accepting healthy volunteers
    2021-303488-H01-RST
    21-000825
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    Inclusion Criteria:

    • Adults aged 18 - 60 years of age.
    • Scheduled for a total hip or total knee arthroplasty.
    • Must have acceptable radiographs demonstrating adequate healthy cartilage tissue for donation.


    Exclusion Criteria:

    • Subjects < 18 and > 60 years of age.
    • Failure to meet 21 CFR 1271 donor eligibility criteria based on responses to a Tissue Donor History Questionnaire (administered during Visit 1).
    • Positive infectious disease result on any test in the infectious disease screening panel collected during Visit 1 or post-operatively (including HBsAg Screen, HBc Total Ab, HBV NAT, HCV NAT, HIV-1 NAT, HCV Ab Screen, HIV-1/-2, plus O Ab Screen, HTLV-I/-II Ab Screen, T. cruzi Total Ab, Syphilis Ab Screen, West Nile Virus NAT, ZIKA NAT ), and medical records review.
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    A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB8802 in Healthy Volunteers and in Patients with Enteric Hyperoxaluria (Synlogic)

    A Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB8802 in Healthy Volunteers and in Patients with Enteric Hyperoxaluria

    John Lieske
    All
    18 years to 74 years old
    Phase 1
    This study is NOT accepting healthy volunteers
    2021-303500-P01-RST
    21-001059
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    Inclusion Criteria:

    • Age ≥ 18 to ≤ 74 years.
    • Able and willing to voluntarily complete the informed consent process.
    • Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, follow-up visits, and compliance with all study procedures.
    • Enteric hyperoxaluria secondary to Roux-en-Y bariatric surgery (at least 12 months post-surgery).
    • Urinary oxalate ≥ 70 mg/24 hours (mean of at least 2 urine collections during Screening).
    • Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception (such as condom with spermicide) combined with an acceptable method of contraception for their non-pregnant female partner(s) (as defined in Inclusion Criterion #7) after informed consent, throughout the study, and for a minimum of 3 months after the last dose of IMP, and who do not intend to donate sperm in the period from Screening until 3 months following administration of the investigational medical product.
    • Female subjects who meet 1 of the following:
      • Woman of childbearing potential (WOCBP) must have a negative pregnancy test (human chorionic gonadotropin) at Screening and at baseline prior to the start of IMP and must agree to use acceptable method(s) of contraception, combined with an acceptable method of contraception for their male partner(s) after informed consent, throughout the study and for a minimum of 3 months after the last dose of IMP. Acceptable methods of contraception include hormonal contraception, hormonal or non-hormonal intrauterine device, bilateral tubal occlusion, complete abstinence, vasectomized partner with documented azoospermia 3 months after procedure, diaphragm with spermicide, cervical cap with spermicide, vaginal sponge with spermicide, or male or female condom with or without spermicide.
      • Premenopausal woman with at least 1 of the following:
        • Documented hysterectomy;
        • Documented bilateral salpingectomy;
        • Documented bilateral oophorectomy;
        • Documented tubal ligation/occlusion;
        • Sexual abstinence is preferred or usual lifestyle of the subject.
      • Postmenopausal women (12 months or more amenorrhea verified by FSH assessment and over 45 years of age in the absence of other biological or physiological causes).

    Inclusion Criteria
    •Part 2:

    • Age ≥ 18 to ≤ 74 years.
    • Able and willing to voluntarily complete the informed consent process.
    • Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, follow-up visits, and compliance with all study procedures.
    • Enteric hyperoxaluria secondary to history of malabsorption after bariatric surgery or surgical short-bowel syndrome.
    • Urinary oxalate ≥ 45 mg/24 hours (mean of 2 samples during screening). (Tier 1 urinary oxalate must be ≥ 40 mg/24 hours to be eligible for Tier 2 screening).
    • If taking probiotic supplements (enriched foods excluded), has been on stable, well-tolerated dose for at least 2 weeks prior to Day 1.
    • Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception (such as condom with spermicide) combined with a recommendation for use of an acceptable method of contraception for their non-pregnant female partner(s) after informed consent, throughout the study, and for a minimum of 3 months after the last dose of IMP, and who do not intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
    • Female subjects who meet 1 of the following:
      • WOCBP must have a negative pregnancy test (human chorionic gonadotropin) at screening and at baseline prior to the start of IMP and must agree to use acceptable method(s) of contraception, combined with a recommendation for use of an acceptable method of contraception for their male partner(s) after informed consent, throughout the study and for a minimum of 3 months after the last dose of IMP. Acceptable methods of contraception include hormonal contraception, hormonal or non-hormonal intrauterine device, bilateral tubal occlusion, complete abstinence, vasectomized partner with documented azoospermia 3 months after procedure, diaphragm with spermicide, cervical cap with spermicide, vaginal sponge with spermicide, or male or female condom with or without spermicide;
      • Premenopausal woman with at least 1 of the following:
      • Documented hysterectomy;
      • Documented bilateral salpingectomy;
      • Documented bilateral oophorectomy;
      • Documented tubal ligation/occlusion;
      • Sexual abstinence is preferred or usual lifestyle of the subject c. Postmenopausal women (12 months or more amenorrhea verified by FSH assessment and over 45 years of age in the absence of other biological or physiological causes).
    • Screening laboratory evaluations (e.g., chemistry panel, complete blood count with differential, prothrombin time [PT]/activated partial thromboplastin time [aPTT], urinalysis) and electrocardiogram (ECG) must be within normal limits or judged to be not clinically significant by the investigator. A single repeat evaluation is acceptable.


    Exclusion Criteria:

    • Acute or chronic medical (including COVID-19 infection), surgical, psychiatric, or social condition or laboratory abnormality that may increase subject risk associated with study participation, compromise adherence to study procedures and requirements, or may confound interpretation of study safety or PD results and, in the judgment of the investigator, would make the subject inappropriate for enrollment.
    • Acute renal failure or estimated glomerular filtration rate <45 mL/min/1.73 m2.
    • Unable or unwilling to discontinue vitamin C supplementation for the study duration
    • Diagnosis of primary hyperoxaluria or any other cause of hyperoxaluria.
    • Pregnant (self or partner), or lactating.
    • Taking any type of systemic (e.g., oral or intravenous) antibiotic within less than 5 times the halflife of the antibiotic prior to Day 1.
      • Exception: topical antibiotics are allowed.
    • Major surgery (an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity) or inpatient hospital stay within the past 3 months prior to screening.
    • Currently taking or plans to take any type of systemic (e.g., oral or intravenous) antibiotic within 30 days prior to Day 1 through the final safety assessment.
      • Exception: topical antibiotics are allowed.
    • Major surgery (an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity) or inpatient hospital stay within the past 3 months prior to Screening.
    • Planned surgery, hospitalizations, dental work, or interventional studies between Screening and last anticipated visit.
    • Intolerance of or allergic reaction to EcN or any of the ingredients in SYNB8802 or placebo formulations.
    • Dependence on alcohol or drugs of abuse.
    • History of or current immunodeficiency disorder including autoimmune disorders and HIV antibody positivity.
    • Hepatitis B surface antigen positivity (subjects with hepatitis B surface antibody positivity and hepatitis B core antibody positivity are not excluded, provided that the hepatitis B surface antigen is negative).
    • Hepatitis C antibody positivity, unless a hepatitis C virus ribonucleic acid test is performed, and the result is negative.
    • Administration or ingestion of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to Screening Visit; or current enrollment in an investigational study.
    • History of bacteremia within 30 days prior to the anticipated first dose of IMP.
    • History of inflammatory bowel disease.

    Eligibility last updated 2/1/22. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    MOR208C310: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL) (frontMIND)

    Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

    Grzegorz Nowakowski
    All
    18 years to 80 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    2021-303502-P01-RST
    21-001047
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    Inclusion Criteria:

    • Written informed consent.
    • Age 18 to 80 years at time of signing of the ICF.
    • Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible: 
      • DLBCL, NOS including GCB type, ABC type;
      • T-cell rich large BCL;
      • Epstein-Barr virus-positive DLBCL, NOS;
      • Anaplastic lymphoma kinase (ALK)-positive large BCL;
      • Human herpes virus-8 (HHV8)-positive DLBCL, NOS;
      • High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma);
      • Note: Patients must be appropriate candidates for R-CHOP. If an investigator deems a patient with a known double- or triple-hit lymphoma (HGBL) should be treated more aggressively (e.g., dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab [DA-EPOCH-R] or cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and cytarabine [Hyper CVAD]), this patient would not be considered eligible for this study;
      • DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma;
      • FL grade 3b.
    • Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review.
    • IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients ≤ 60 years of age).
    • Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing lymphoma according to the local pathology report) and the start of treatment (C1D1) ≤ 28 days.
    • ECOG performance status of 0, 1, or 2.
    • Left ventricular ejection fraction equal to or greater than lower limit of institutional normal range, assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan.
    • Adequate hematologic function.
    • Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended.
    • Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm.


    Exclusion Criteria:

    • Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms; e.g., primary mediastinal (thymic) large B-cell lymphoma, Burkitt's lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma.
    • History of prior non-hematologic malignancy except for the following:
      • Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening;
      • Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer;
      • Adequately treated carcinoma in situ without current evidence of disease;
      • Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment;
      • Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines;
      • Known CNS lymphoma involvement;
      • Known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay);
      • Pregnancy or lactation;
      • History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent.
    Drug, Other, Behavioral
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    Mayo Clinic — Rochester, MN

    Detection of Plasma DNA Methylation MeTHylation in Peripheral Blood from Patients with Hepatocellular HEpatocellular CarcinomaCarciNomA (ATHENA) (MRD HCC)

    Detection of Plasma DNA Methylation in Peripheral Blood from Patients with Hepatocellular Carcinoma

    Nguyen Tran
    All
    18 years and over
    This study is NOT accepting healthy volunteers
    2021-303511-H01-RST
    21-000878
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    Inclusion Criteria:


    - Adult, age >= 18

    - Patients with resectable hepatocellular carcinoma


    Exclusion Criteria:


    - Females who are pregnant or attempt to become pregnant

    - Patient with significant anemia (hemoglobin [Hb] < 7g/dL)

    - Patient has known cancer outside of the liver 5 years prior to current blood
    collection (not including basal cell or squamous cell skin cancers)

    - Patient has had a biopsy to the target organ and/or lesion within 3 days before blood
    collection

    - Patient has had an intervention to completely remove current target pathology

    Eligibility last updated 8/2/22. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN

    Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty (LB-SISBCISB)

    Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

    Jason Panchamia
    All
    18 years and over
    Phase 4
    This study is NOT accepting healthy volunteers
    2021-303529-H01-RST
    21-000908
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    Inclusion Criteria:

    • Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III.
    • Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
    • Patients 18 years of age and older.
    • Able to provide informed consent for him or herself.


    Exclusion Criteria:

    • Chronic pain syndromes.
    • Chronic opioid use (> 1 month) with OME > 5 mg/day OR acute opioid use (< 1 month) with OME > 30 mg/day.
    • Body mass index (BMI) > 45 kg/m^2.
    • Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e., celecoxib) and local anesthetics.
      • *defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever.
    • Personal or family history of malignant hyperthermia.
    • Major systemic medical problems such as:
      • Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) < 50 units/m^2 (if labs are available), currently on dialysis, or highly suspected based on history;
      • Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver;
      • Pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation < 93% on room air;
      • History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury.
    • Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, and refusal).
      • + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus.  Patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to regional anesthesia.
    • Known to be currently pregnant or actively breastfeeding.++
      • ++ All surgical patients are currently screened using a standardized Pregnancy Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf).
    •  Impaired cognition (e.g., Alzheimer’s disease, moderate to severe dementia, encephalopathy)   .
    • Non-English speaking.

    Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.

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    Mayo Clinic — Rochester, MN