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Impact of Surgical Removal or Reduction Procedures on Markers of Immune Function in Adult Patients with Renal and Bladder Tumors and Pediatric Patients with Genitourinary Tumors

Impact of Surgical Removal or Reduction Procedures on Markers of Immune Function in Adult Patients with Renal and Bladder Tumors and Pediatric Patients with Genitourinary Tumors

Bradley Leibovich
All
Not specified
This study is NOT accepting healthy volunteers
0000-118924-H01-RST
16-006956
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Inclusion Criteria  

Subjects ≥ 18 years of age:

  • Age 18+ years
  • Able to give informed consent
  • Undergoing elective treatment for a solid renal/bladder tumor:
    • Partial nephrectomy/cystectomy
    • Radical nephrectomy/cystectomy
    • Nephrectomy + tumor thrombectomy
    • Cytoreductive nephrectomy +/- metastasectomy for metastatic RCC
    • Radiofrequency ablation or cryotherapy
    • Transurethral resection
    • Metastasectomy for mUC

Subjects < 18 years of age:

  • Age 0-17 years
  • Parent/Guardian able to give informed consent, and subject able to give assent (ages 7-17)
  • Undergoing elective treatment for genitourinary mass, and/or metastases from primary genitourinary tumor, and/or recurrence of genitourinary malignancy, any location, with tissue being obtained via:
    • Nephrectomy
    • Partial nephrectomy
    • Open biopsy
    • Percutaneous biopsy
    • Resection of mass

Exclusion Criteria

Subjects ≥ 18 years of age:

  • Bilateral tumors
  • Salvage procedure (i.e. treatment for a recurrent tumor)
  • Immunosuppressed patient (Use of immunosuppressive medications in past 90 days (Examples include: oral or IV corticosteroids (topical creams or nasal sprays are OK), anti-metabolites (ex. azathioprine, methotrexate), biologics (ex. infliximab), chemotherapy) or imunosuppressive condition (ex. transplant, immunodeficiency syndromes, HIV/AIDS)
  • Auto-immune disease (ex. lupus, rheumatoid arthritis, inflammatory bowel disease, etc.)
  • Pregnancy

Subjects < 18 years of age:

  • Metastases to kidney from non-renal primary
  • Auto-immune disease (ex. lupus, rheumatoid arthritis, inflammatory bowel disease, etc.)
  • Pregnancy

 

Cancer, Kidney tumor
Medical Oncology, Neoplasm of kidney, Urinary system
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Mayo Clinic — Rochester, MN

A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ Technology in Adults with Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP) (2IQP)

A Randomized Trial Evaluating Control-IQ Technology in Adults With Type 2 Diabetes (2IQP)

Yogish Kudva
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2023-310782-P01-RST
23-001432
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Inclusion Criteria:

  • Age ≥ 18 years old at time of screening.
  • Currently resides in the U.S. or Canada with the ability to complete in-person study visits at one of the participating clinical sites.
  • Clinical diagnosis, based on investigator assessment, of type 2 diabetes of at least 6 months duration at time of screening.
  • Using basal-bolus insulin therapy with at least one injection containing rapid-acting insulin per day or an insulin pump for at least 3 months prior to enrollment, with no major modification to insulin regime in the last 3 months (mixed insulin with a rapid component is acceptable).
  • If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications, dose has been stable for the 3 months prior to screening; and participant is willing to not change the dose unless required for safety purposes.
  • Participant willing to not initiate use of any new glucose-lowering medications during the trial.
  • Willing to use an approved insulin while using the study pump if assigned to the AID group.
  • Willing to not use concentrated insulin above U-100 or inhaled insulin while using the study pump.
  • Willing to participate in the study meal and exercise challenges if assigned to the AID group, and have a care partner, trained in hypoglycemia treatment guidelines, to include glucagon use, present during and immediately after the exercise challenges.
  • Has the ability to read and understand written English.
  • Investigator believes that the participant has the cognitive capacity to provide informed consent.
  • Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study.
  • No medical, psychiatric, or other conditions, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study.  This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, and other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse.
  • Participants capable of becoming pregnant must meet one of the following criteria:
    • has a negative urine pregnancy test and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. The following contraceptive measures are considered adequate:
    • Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);
    • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
    • Placement of an intrauterine device or intrauterine hormone-releasing system;
    • Bilateral tubal occlusion;
    • Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository);
    • Has a vasectomized or sterile partner (where partner is sole partner of subject) and where vasectomy has been confirmed by medical assessment; 
    • Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject; or
    • Participant is of non-childbearing potential due to menopause with at least one year since last menses or a medical condition confirmed by the investigator.


Exclusion Criteria:

  • Current use of hybrid closed-loop system.
  • Current use of systemic glucocorticoids or anticipated use of glucocorticoids during the RCT (topical or inhaled -ie, non-systemic is acceptable).
  • Current use of sulfonylurea or meglitinide medications.
  • Current use of hydroxyurea.
  • Tape allergy or skin condition that will preclude use of the study pump or CGM.
  • Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c.
  • Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 2 months, or sexually active without use of contraception.
  • Current participation in another diabetes-related interventional clinical trial.
  • Anticipated change of residency or travel for more than 7 days at a time during the study that may, per investigator judgment, interfere with the completion of study visits, contacts, or procedures.
  • Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.

Eligibility last updated 5/2/23. Questions regarding updates should be directed to the study team contact.

Device
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Spasticity After Spinal Cord Injury

Spasticity After Spinal Cord Injury

Ronald Reeves
All
18 years to 75 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-308052-P01-RST
22-004493
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Inclusion Criteria
•for individuals with spinal cord injury (SCI):  

  • Chronic SCI (≥ 1 year of injury).
  • Incomplete spinal cord injury at T12 or above.
  • Males and Females.
  •  Ages 18-75 years.

Inclusion Criteria - for non-spastic individuals with SCI:

  • MAS scores of 0 and 1.

Inclusion Criteria - for spastic individuals with SCI:

  • MAS scores of 2, 3 and 4.
  • The ability to perform a voluntary flexion and extension of the elbow and/or knee or ankle.
  • The ability to reach and grasp an object.

Inclusion Criteria
•for health controls:

  •  Males and females.
  • Ages 18-75 years.
  • Right-handed.
  • Able to perform elbow and/or knee or ankle flexion and extension.

Exclusion Criteria - for individuals with SCI and healthy controls:

  • Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease.
  • Any debilitating disease prior to the SCI that caused exercise intolerance.
  • Premorbid, ongoing major depression or psychosis, altered cognitive status.
  • History of head injury or stroke.
  • Pacemaker.
  • Metal plate in skull.
  • History of seizures.
  • Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
  • Pregnant females.
  • Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk.

Eligibility last updated 5/8/23. Questions regarding updates should be directed to the study team contact.

Behavioral
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Multisite survey of drivers with homonymous visual field loss

Survey of Homonymous Visual Field Loss Drivers

Alaina Softing Hataye
All
16 years and over
This study is NOT accepting healthy volunteers
2022-310261-P01-RST
22-012747
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Inclusion Criteria:

Homonymous Field Loss

  • Homonymous field loss (homonymous hemianopia, homonymous quadranopia or homonymous scotoma).
  • Current driver.
  • At least 16 years old.
  • English speaking (because the survey will be conducted verbally in English).

Normal Vision

  • Normal vision (no significant diagnoses of diseases that could cause visual field loss or otherwise impair vision).
  • Current driver.
  • At least 16 years old.
  • English speaking (because the survey will be conducted verbally in English).


Exclusion Criteria:
 

  • < 16 years of age. 

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

Eligibility last updated 12/6/22. Questions regarding updates should be directed to the study team contact.

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RAndomized, Double BlINd, PlaceBo Controlled, Multicenter, 12 Weeks Phase 2 Study To Evaluate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZ-3102 Patients WITH GM2 Gangliosidosis or Niemann Pick Type C Disease (RAINBOW) (RAINBOW)

ORAL AZ-3102 in Patients With GM2 Gangliosidosis or Niemann Pick Type C Disease

Marc Patterson
All
12 years and over
Phase 2
This study is NOT accepting healthy volunteers
2023-310828-P01-RST
23-002080
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Inclusion Criteria:
 

  • Male and female patients ≥ 12 and ≤ 20 years of age at informed consent signature.
  • Total SARA score ≥ 1 at Baseline.

GM2:

  • Genetically and biochemically confirmed diagnosis of Tay-Sachs or Sandhoff disease NA.

NP-C:

  • Genetically confirmed diagnosis of NP-C;
  • Miglustat-naïve patients unwilling or unable to take miglustat, OR, Patients who have discontinued miglustat because of confirmed gastrointestinal safety/tolerability issues. Miglustat must have been discontinued at least 1 month prior to Baseline visit.
  • A male participant with a female partner of childbearing potential is eligible if he agrees to follow the contraceptive guidance.
  • If a female participant is a WOCBP and is having a male partner, she must agree to follow the contraceptive guidance.
  • Willing and able to complete protocol assessments.
  • Parent and/or legal guardian is able to read, understand, and sign the informed consent. Where appropriate, assent will also be sought for patients who have not reached the age of majority or who are not able to sign the consent form. A consent maybe be sought for patients who have reached the age of majority (PI decision). No genetic test will be done as part of the study.


Exclusion Criteria:
 

  • Any abnormal conditions at baseline visit which in the opinion of the PI could interfere with study assessments (e.g., severe infection).
  • History of medical conditions other than GM2 gangliosidosis/NP-C that in the opinion of the PI would confound scientific rigor or interpretation of results.
  • Presence of another inherited neurologic disease.
  • The dose of anti-epileptic treatment(s) was not stable and/or a new anti-epileptic treatment (drug or procedure) was prescribed during the last month before baseline.
  • Patient with Gilbert syndrome and/or total bilirubin > 2 x ULN (isolated bilirubin > 2 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%).
  • Platelet count < 100 x 10^9 /L.
  • Presence of moderate or severe renal impairment (estimated GFR < 60 mL/min/1.73 m^2 )
  • Prior participation in a clinical study with an investigational drug within 3 months prior to Baseline.
  • Patient with a positive serum pregnancy test (tested only for women of childbearing potential) at baseline.
  • Breast feeding ongoing at baseline or planned during the study.
  • ECG with an average of triplicate QTcF interval > 440 msec.
  • Received treatment with enantiomers of N-Acetyl-Leucine, gene therapy, stem cell transplantation, or with any other azasugars (iminosugars) compound with similar mechanism of action within 3 months before baseline (except for miglustat for which it is 1 month).
  • Any known allergy to azasugars or any excipients.
  • Evidence of suicidal ideation with intent (Type 4-5) on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. Only in patients judged by the PI cognitively capable to understand the concept of suicide.

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

Eligibility last updated 2/10/23. Questions regarding updates should be directed to the study team contact.

Drug
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EZH-302: A Phase 1b/3 Double-blind, Randomized, Active-controlled, 3-stage, Biomarker Adaptive Study of Tazemetostat or Placebo in Combination With Lenalidomide Plus Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma

A Study to Evaluate Tazemetostat Combined with Lenalidomide Plus Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma

Jose Villasboas Bisneto
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2020-301074-P01-RST
20-006107
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Inclusion Criteria:

  • Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
  • Males or females are ≥ 18 years of age (≥ 20 years for Taiwan) at the time of providing voluntary written informed consent.
  • Life expectancy ≥ 3 months before enrollment.
  • Subjects with a history of hepatitis B or C are eligible on the condition that subjects have adequate liver function as defined by Inclusion Criterion and are hepatitis B surface antigen negative and/or have undetectable hepatitis C virus (HCV) RNA.
  • Have histologically confirmed FL, Grades 1 to 3A.
  • Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:
    • Systemic therapy includes treatments such as:
      • Rituximab monotherapy;
      • Chemotherapy given with or without rituximab;
      • Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.
    • Systemic therapy does not include, for example:
      • Local involved field radiotherapy for limited-stage disease;
      • Helicobacter pylori eradication.
    • Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criteria.
    • Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed;
    • Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.
  • Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression < 6 months after last dose).
  • Have measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • For subjects who have experienced any clinically significant toxicity related to a prior anticancer treatment (i.e., chemotherapy, immunotherapy, and/or radiotherapy):
    • At the time the subject provides voluntary written informed consent, all toxicities have either resolved to Grade 1 per National Cancer Institute CTCAE Version 5.0; OR
    • Are clinically stable and no longer clinically significant.
  • Have provided sufficient tumor tissue for EZH2 mutation testing and to allow for stratification:
    • If EZH2 mutation status is known from site-specific testing, subjects can be enrolled, but additional tissue will be required for confirmatory testing of EZH2 status at studyspecific laboratories. If the archival tumor sample was collected more than 15 months prior to administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections are also acceptable.
    • NOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor’s or Designee Medical Monitor.
  • Time between prior anticancer therapy and first dose of tazemetostat as follows:
    • Cytotoxic chemotherapy – At least 21 days;
    • Noncytotoxic chemotherapy (eg, small molecule inhibitor) – At least 14 days;
    • Nitrosoureas – At least 6 week;
    • Monoclonal and/or bispecific antibodies or CAR T – At least 28 days;
    • Radiotherapy – At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.
  • Adequate renal function defined as calculated creatinine clearance ≥ 40 mL/minute per the Cockcroft and Gault formula.
  • Adequate bone marrow function:
    • Absolute neutrophil count (ANC) ≥ 1000/mm^3 (≥ 1.0 × 10^9 /L) if no lymphoma infiltration of bone marrow OR ANC ≥ 750/mm^3 (≥ 0.75 × 10^9 /L) with bone marrow infiltration;
    • Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days;
    • Platelets ≥ 75,000/mm^3 (≥ 75 × 10^9 /L)
    • Evaluated at least 7 days after last platelet transfusion;
    • Hemoglobin ≥ 9.0 g/dL;
    • May receive transfusion.
  • Adequate liver function:
    • Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert’s syndrome;
    • Alkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if subject has liver metastases).
  • International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless on warfarin, then INR ≤ 3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended.
  • Females of childbearing potential (FCBP) must have two negative urine or serum pregnancy tests (beta-human chorionic gonadotropin [β-hCG] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening prior to dosing. The first pregnancy test must be performed within 10 to 14 days prior to first dose of study drug and the second pregnancy test must be performed within 24 hours prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of these pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic [amenorrhea following cancer therapy does not rule out childbearing potential] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).
  • Females of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:
  • Examples of highly effective methods:
    •Intrauterine device (IUD), Hormonal (ovulation inhibitory combined [estrogen and progesterone] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrelreleasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel])
    •Bilateral tubal ligation
    •Partner’s vasectomy (if medically confirmed [azoospermia] and sole sexual partner).
  • Examples of additional effective methods:
    •Male latex or synthetic condom
    •Diaphragm
    •Cervical Cap.
    • NOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.
  • All study participants enrolled must be registered into the mandatory Revlimid REMS™ program for the US or Revlimid Global PPP for ex-US and be willing and able to comply with the requirements of the Revlimid REMS™ or Revlimid Global PPP program as appropriate for the country in which the drug is being used. a. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program (for the US) or Revlimid Global PPP (for ex-US). During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, and at days 14 and 28 following the last dose of lenalidomide. Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR have had a total hysterectomy and/or bilateral oophorectomy.
  • Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.
    • NOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.


Exclusion Criteria:

  • Prior exposure to tazemetostat or other inhibitor(s) of EZH2.
  • Prior exposure to lenalidomide.
  • Grade 3b, mixed histology, or FL that has histologically transformed to DLBCL (subjects transformed from DLBCL to FL may be enrolled).
  • Has thrombocytopenia, neutropenia, or anemia of Grade ≥ 3 (per CTCAE Version 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
  • Has a prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL).
  • Subjects with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases.
  • Subjects taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. John’s wort).
  • Are unwilling to exclude Seville oranges, grapefruit juice, AND grapefruit from their diet.
  • Major surgery within 4 weeks before the first dose of study drug.
    • Note: Minor surgery (e.g., minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.
  •  Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat.
  • Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia.
  • Prolongation of corrected QT interval using Fridericia’s formula (QTcF) to ≥ 480 msec at screening or history of long QT syndrome.
  • Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat whereas subjects greater than 3 months since deep vein thrombosis/pulmonary embolism are eligible but recommended to receive prophylaxis.
  • Have an active infection requiring systemic therapy.
  • Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation.
  • Inability to be treated with a Pneumocystis prophylaxis medication.
  • Active viral infection with or seropositive for hepatitis B virus (HBV): HBV surface antigen (HBsAg) positive OR HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable HBV DNA. NOTE: Subjects who are HBsAg negative, anti-HBs positive and/or anti-HBc positive, but with undetectable viral DNA and normal ALT are eligible. Subjects who are seropositive due to HBV vaccination (HBsAg negative, HBV surface antibody [anti-HBs] positive, and HBV core antibody [anti-HBc] negative) are eligible. Consult Sponsor’s or Designee Medical Monitor with questions regarding testing or results prior to enrollment.
  • Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA), human immunodeficiency virus (HIV), AND/OR human T-cell lymphotropic virus 1 (as measured by positive HTLV-1 antibody).
    • NOTE: Subjects with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible. Consult Sponsor’s or Designee Medical Monitor with questions regarding testing or results prior to enrollment.
  • Any other major illness that, in the Investigator’s judgment, will substantially increase the risk associated with the subject’s participation in this study OR interfere with their ability to receive study treatment or complete the study.
  • Female subjects who are pregnant or lactating/breastfeeding.
  • Subjects who have undergone a solid organ transplant.
  • Subjects with malignancies other than FL.
    • Exception: Subjects with another malignancy who have been disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Biologic/Vaccine, Drug, Other
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A Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B530, an Autologous Logic-gated Tmod™ Chimeric Antigen Receptor T Cell (CAR T), in Heterozygous HLA-A*02 Adult Subjects With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression (EVEREST-1)

A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Subjects With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression

Julian Molina
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2023-311070-P01-RST
23-004326
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Key

Inclusion Criteria:


1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A*02:01 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy.

2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, or other solid tumors associated with CEA expression. Measurable disease is required with lesions of >1.0 cm by computed tomography (CT). (Soluble CEA is not acceptable as the sole measure of disease).

3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol.

4. Has adequate organ function as described in the protocol.

5. ECOG performance status of 0 to 1.

6. Life expectancy of ≥ 3 months.

7. Willing to comply with study schedule of assessments including long term safety follow up.

Key
Exclusion Criteria:


1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative.

2. Prior allogeneic stem cell transplant.

3. Prior solid organ transplant.

4. Cancer therapy within 3 weeks or 3 half lives of A2B530 infusion.

5. Radiotherapy within 28 days of A2B530 infusion.

6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months.

7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of
PE or DVT if greater than 3 months from time of enrollment, and adequately treated.

8. Requires supplemental home oxygen.

9. Females of childbearing potential who are pregnant or breastfeeding.

10. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B530.

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

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

Biologic/Vaccine, Diagnostic Test
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Childhood ADPKD Database Study

Childhood ADPKD Database Study

Christian Hanna
All
Not specified
This study is NOT accepting healthy volunteers
2021-305046-P01-RST
21-006386
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Inclusion Criteria:

  • Diagnosed with ADPKD prior to 18 years of age.
  • Demonstration of ADPKD by clinical information, imaging studies, biopsy, autopsy, or genetic testing.


Exclusion Criteria:

  • Patients with autosomal recessive polycystic kidney disease (ARPKD), urinary tract malformations or major congenital anomalies of other systems suggesting a diagnosis other than recessive hepato-renal fibrocystic diseases.   
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A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (ARTEMIDE-01)

A Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Konstantinos Leventakos
All
18 years to 130 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308746-P01-RST
22-010542
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Inclusion Criteria:

  • Written informed consent.
  • Aged 18 or above.
  • Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation.
  • Documented PD-L1 expression by PD-L1 IHC per local report.
  • Confirmed progression during treatment with a CPI-including regimen.
  • ECOG performance status of 0 or 1 at enrolment.
  • Life expectancy of ≥ 12 weeks at enrolment.
  • Adequate bone marrow, liver and kidney function.


Exclusion Criteria:

  • Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion.
  • Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation).
  • Previous treatment with an anti-TIGIT therapy.
  • Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
  • Primary or secondary resistance after treatment with 2 or more regimens including a CPI.
  • Symptomatic central nervous system (CNS) metastasis.
  • Thromboembolic event within 3 months prior to enrolment.
  • Other invasive malignancy within 2 years prior to screening.

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

 

Drug
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Spondyloarthritis Research Program: Biorepository of biosamples from patients with psoriatic arthritis

Biorepository of Biosamples From Patients With Psoriatic Arthritis in the Spondyloarthritis Research Program

Elena Myasoedova
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308759-H01-RST
22-007176
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Inclusion Criteria:

  • All patients with PsA diagnosed after 2005.
    • Diagnosis defined as a clinical diagnosis by a rheumatologist.
  • Ability to consent.

A multifaceted approach will be utilized for recruitment of PsA patients for the study:

  • Recruitment letters will be sent to the PsA patients identified in the Rochester Epidemiology Project (REP) cohort.
  • PsA patients seen in the Division of Rheumatology that are not in REP will also be actively recruited.
  • New patients referred to our Division would also be eligible for recruitment.


Exclusion Criteria:

  • Individuals who do not comprehend English (i.e., participants must be able to read and sign a consent form without the assistance of an interpreter.)
  • Individuals who are unable to sign consent (e.g., mentally challenged, those declared legally incompetent).
  • Individuals regarded as belonging to a vulnerable population (e.g., prisoners).
  • Antibiotic exposure within two weeks of stool microbiome collection.
  • Patients who have a history of malignancy, exception: documented history of cured non-metastatic squamous or basal cell skin carcinoma will be allowed.

Eligibility last updated 3/29/2023. Questions regarding updates should be directed to the study team contact.

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Satisfaction and Feasibility Evaluation of an Electronic Massager - Expert Manipulative Massage Automation (EMMA) (EMMA)

Satisfaction, Tolerance, and Feasibility Evaluation of an Electronic Massage

Tony Chon
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-310333-H01-RST
22-013099
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Inclusion Criteria:

  • Age 18 years or older.
  • Ability to provide informed consent.
  • Women of childbearing potential who self-report not being pregnant and agree to employ an effective method of birth control (surgical sterilization or oral contraceptives, barrier method with spermicides intrauterine device, etc.) during the study period.
  • Ability to complete all aspects of this trial.


Exclusion Criteria:
 

  • Pregnancy or breastfeeding.
  • Patients with inability of staying in a prone position.
  • Patients with bleeding disorders.
  • Patients with a current diagnosis of cancer or being treated for cancer.
  • Patients with allergies and/or local skin affectations.
  • An unstable medical or mental health condition as determined by the physician investigator.

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

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Device
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A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics (CHINOOK) (CHINOOK)

Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics (CHINOOK)

Karina Keogh
All
18 years to 70 years old
Phase 4
This study is NOT accepting healthy volunteers
2020-302701-P01-RST
20-011574
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Inclusion Criteria:

  • Male or female aged 18 through 70 years.
  • Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12  months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.
  • Morning pre-BD FEV1 ≥ 50 to < 80% of predicted normal value (PNV) and ≥ 1 liter (L) or morning pre-BD FEV1 ≥ 50 to < 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was < 80% of PNV.
  • A blood eosinophil count meeting any of 3 criteria below:
    • ≥ 300 cells/µL during screening at Visit 1 or Visit 2; OR
    • ≥ 220 to < 300 cells/µL during screening at Visit 1 or Visit 2 and documented eosinophil count of ≥ 300 cells/µL in the past 12 months; OR
    • ≥ 150 to < 300 cells/µL during screening at Visit 1 or Visit 2 PLUS one of the following:
    • Presence of nasal polyps; or
    • Pre-BD FVC < 65% predicted at Visit 2.
  • Negative pregnancy test.
  • Asthma control questionnaire (ACQ-6) > 1.5.
  • Fewer than 12 exacerbations within the 6 months prior to Visit 3.


Exclusion Criteria:

  • Any disease or concomitant medication which could affect study results or safety of study participants, including:
    • current smokers;
    • history of cancer;
    • life-threatening asthma;
    • clinically important pulmonary disease other than asthma.
  • Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
  • Previously received:
    • benralizumab;
    • live attenuated vaccines 30 days prior to the date of  randomization;
    • bronchial thermoplasty in the last 24 months prior to Visit 1;
    • any investigational non-biologic within 22 days (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer; 
    • Receipt of any marketed (eg, omalizumab, mepolizumab and reslizumab) or investigational biologic for the treatment of asthma within 4 months or 5 half-lives prior to the date informed consent is obtained, whichever is longer. Exception: Participants on stable therapy for 3 months prior to the date informed consent is obtained can participate in the study if they intend to stay on treatment throughout the study with marketed biologic products that are not likely to interfere with the safety assessment and/or efficacy of benralizumab (eg, for the treatment of osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic diseases).
  • Currently pregnant, breastfeeding or lactating women.
  • Radiological findings suggestive of a respiratory disease other than asthma that is contributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, eg, ACR Lung-RADS v2022, (ACR 2022) without appropriate follow-up prior to randomization. Radiological findings suggestive of acute infection. Screening period may be extended for cases of acute infection and based on case-by-case discussion between investigator and AstraZeneca Study Physician.

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

Eligibility last updated 1/2/24. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Other
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Prevalence and Risk Factors for Pentosan Polysulfate Maculopathy: A Population-Based Analysis (PPS)

A Population-Based Analysis of the Prevalence and Risk Factors for Pentosan Polysulfate Maculopathy

Matthew Starr
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306393-H01-RST
21-011416
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Inclusion Criteria:

  • Patients with a diagnosis of interstitial cystitis.
  • One group of patients with interstitial cystitis who report a history or current use of pentosan polysulfate sodium.
  • An age-matched control group of patients with interstitial cystitis who deny a history or current use of pentosan polysulfate sodium.


Exclusion Criteria:

  • Patients without a diagnosis of interstitial cystitis.

Eligibility last updated 11/9/21. Questions regarding updates should be directed to the study team contact.

 

Residents of the 9-county area surrounding Rochester, MN with a diagnosis of interstitial cystitis identified via the Rochester Epidemiology Project (REP). All patients with a diagnosis of interstitial cystitis will be called via telephone to determine if they have ever taken or are currently taking PPS. Patients who have a history of PPS use or current PPS use will be recruited for a dilated funduscopic examination along with ultra-widefield fundus photography (Optos California icg, Dunfermline, Scotland, UK), ultra-widefield fundus autofluorescence (Optos California icg), spectral-domain macula optical coherence tomography (OCT) (Spectralis, Heidelberg Engineering), and near infrared reflectance (NIR) (Spectralis, Heidelberg Engineering) to screen for evidence of pentosan polysulfate maculopathy. Patients with a diagnosis of interstitial cystitis who denied a history of PPS use will also be recruited to an age-matched control cohort and undergo a dilated funduscopic examination along with ultra-widefield fundus autofluorescence, spectral-domain macula OCT, and NIR to screen for pattern dystrophy-like changes.

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A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension (NEOS)

Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

Jan-Mendelt Tillema
All
10 years to 17 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-305011-P01-RST
21-006245
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Inclusion Criteria
•Core Part:

  • Signed informed consent/assent must be obtained prior to participation in the study
  • Between 10 to < 18 years of age (i.e., have not yet had their 18th birthday) at randomization.
  • A diagnosis of MS as defined by the consensus definition for pediatric MS (Thompson et al 2018).
  • Expanded Disability Status Scale (EDSS) score of 0 to 5.5 (inclusive) at Screening.
  • At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior to screening or evidence of one or more new T2 lesions compared to prior MRI conducted within 12 months prior to randomization (including screening MRI) or one or more Gd-enhancing T1 lesions on MRI conducted within 12 months prior to randomization.

Inclusion Criteria
•Extension Part:

  • Re-consent / assent must be obtained prior to E-Day 1 in the Extension part.
  • Participants who complete the Core Part on randomized double-blind treatment.

Exclusion Criteria
•Core Part:

  • Participants with progressive MS.
  • Participants meeting the definition of ADEM (Krupp et al 2013); participants meeting criteria for neuromyelitis optica (Wingerchuk et al 2006) or tested positive for aquaporin 4 (AQP4) at Screening; participants tested positive for anti-MOG at Screening.
  • Participants with widespread and symmetric white matter alterations in the Screening MRI suggestive of other demyelinating disorders (e.g., metabolic disorders, mitochondrial disorders).
  • Homozygosity for CYP2C9*3, or refusal to test for CYP2C9.
  • Participants with an active, chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. Sjögren’s disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (acquired immunodeficiency syndrome (AIDS), hereditary immune deficiency, drug-induced immune deficiency) or tested positive for HIV at Screening.
  • Participants with neurological symptoms consistent with PML or confirmed PML.
  • Participants diagnosed with macular edema during the Screening period.
  • Participants with severe active systemic bacterial, viral or fungal infections, including tuberculosis.
  • Participants with any severe cardiac disease or significant findings on the screening ECG, such as:
    • History of symptomatic bradycardia or recurrent syncope;
    • Known ischaemic heart disease;
    • History of congenital heart disease (except conditions such as small patent ductus arteriosus, atrial septal defect, ventricular septal defect, or an ECG or rhythm abnormality, which have been assessed by a pediatric cardiologist and considered to be clinically insignificant);
    • Cerebrovascular disease;
    • History of myocardial infarction;
    • Congestive heart failure;
    • History of cardiac arrest;
    • Resting (sitting) heart rate < 55 bpm (in participants 12 years or older) and <60 bpm (in participants below 12 years);
    • Severe untreated sleep apnea;
    • Sick sinus syndrome or sino-atrial heart block;
    • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block) ;
    • QTcF interval > 450 msec in males and > 460 msec in females or relevant risk factors for QT prolongation (e.g., hypokalaemia, hypomagnesemia, congenital QT prolongation) or treatment with QT prolonging drugs with a known risk of Torsades de pointes or history of familial long QT syndrome or known family history of Torsades de Pointes;
    • Uncontrolled arterial hypertension despite prescribed medications.
  • Participants with any pulmonary conditions, as determined by the investigator, including severe asthma defined as per the 2010 World Health Organization (WHO) uniform definition on severe asthma (Bousquet et al 2010);
  • Participants with any of the following neurologic/psychiatric disorder:
    • History of any type of epileptic seizure(s) as well as psychogenic non-epileptic seizure(s) during the past 12 months before screening;
    • Ongoing substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the participant’s ability to cooperate and comply with the study procedures;
    • History of clinically significant CNS disease (e.g., stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS.
  • Participants with a score of “yes” on item 4 or item 5 of the Suicidal Ideation section of the C‑SSRS, if this ideation occurred in the past 6 months, or with a score of “yes” on any item of the Suicidal Behavior section, except for “Non-Suicidal Self Injurious Behavior”, if this behavior occurred in the past 2 years.
  • Any history of malignancy of any organ system
  • Any of the following conditions or treatments that may impact the safety of the participant:
    • Participants with any history of or active severe respiratory disease as determined by the investigator;
    • Severe hepatic impairment (Child-Pugh class C) or any chronic liver or biliary disease, acute or chronic pancreatitis, with the exception of Gilbert’s syndrome;
    • Participants with severe renal insufficiency (GFR <30 mL/min/1.73 m^2).
  • Any of the following abnormal laboratory values as confirmed by the central laboratory prior to first study drug administration:
    • Positive results of screening period testing for serological markers for hepatitis A, B, C and E indicating acute or chronic infection;
    • Anti-HAV IgM positive;
    • If HBs Ag and/or anti-HBc positive, HBV-DNA Polymerase Chain Reaction (PCR) will be performed (if negative, participant can be included);
    • If anti-HCV antibody positive, HCV-RNA PCR will be performed (if negative, participant can be included);
    • If anti- HEV IgM or IgG positive, HEV-RNA PCR will be performed (if negative, participant can be included).
Biologic/Vaccine, Drug
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Artificial Intelligence Enhanced ECG to detect Cardiac Amyloidosis: Protocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY) (PREDICT-AMY)

Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis

Angela Dispenzieri
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308271-P01-RST
22-005311
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Inclusion Criteria:

  • Mayo Clinic cardiology or hematology providers who care for adult patients.
  • Mayo Clinic providers who consent to participate on this study.


Exclusion Criteria:

  • None.

Eligibility last updated 7/14/23. Questions regarding updates should be directed to the study team contact.

 

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A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate Cancer (ASCLEPIuS)

A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer (ASCLEPIuS)

Brian Davis
Male
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308423-P01-RST
22-005953
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Inclusion Criteria:

  • Pathologic biopsy proven adenocarcinoma of the prostate.
  • At least one of the following criteria:
    • - cN1 on conventional or PET imaging;
    • - Grade group 5;
    • - Grade group 4 and PSA ≥ 10 ng/mL;
    • - Grade group 3 and PSA ≥ 20 ng/mL;
    • - High probability of Radiographic T3 on MRI AND Grade group ≥ 2;
    • - Grade Group 3 AND PSA ≥10 ng/mL AND ≥ 50% positive biopsy cores.
  • Age ≥ 18.
  • ECOG < 1.
  • Adequate organ and marrow function as defined per protocol.
  • Use of highly effective contraception (e.g., condoms) for the duration of treatment and a minimum of 90 days thereafter. Men must also agree not to donate sperm for the duration of the study participation, and for at least 90 days thereafter.
  • International Prostate Symptoms Score (IPSS) ≤ 20.
  • Medically fit for treatment and agreeable to follow-up.
  • Ability to understand and the willingness to sign a written informed consent.
  • Tissue available for MiOncoSeq testing to assign DNA repair deficiency status.


Exclusion Criteria:

  • Clinical or radiographic evidence of distant metastatic disease by CT/bone scan.
  • Clinical or radiographic evidence of high probability of clinical T4 disease.
  • Prostate gland size > 80 cc measured by ultrasound or MRI.
  • Prominent median lobe assessed by treating physician.
  • Lack of tissue from biopsy to be sent for correlative studies.
  • Any prior treatment for prostate cancer (incudes TURP, chemotherapy, radiation therapy, or anti-androgen therapy).
  • Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
  • Prohibited 3 months before participant registration and during administration of study treatment: non-steroidal anti-androgens (e.g., bicalutamide, flutamide, nilutamide), steroidal antiandrogens (megestrol acetate, cyproterone acetate), oral ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals.
  • History of prior pelvic radiation therapy.
  • Concurrent treatment with strong CYP3A4 inducers such as phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital.
  • Enrollment concurrently in another investigational drug study within 1 month of registration.
  • History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer.
  • History of or active Crohn's disease or ulcerative colitis.
  • Contraindication to or inability to tolerate MRIs.
  • Patients with severe depression.
  • Uncontrolled diabetes or known HbA1c >10.
  • Any gastrointestinal disorder affecting absorption.
  • Active pituitary or adrenal dysfunction.
  • Patients with significant cardiovascular disease potentially including severe / unstable angina, recent history of myocardial infarction, clinically significant heart failure, cerebrovascular disease, venous thromboembolic events, clinically significant arrhythmias).
  • Uncontrolled hypertension with persistently elevated systolic blood pressure > 160 mmgHg or diastolic blood pressure > 100 mmHg despite anti-hypertensive agents.
  • Prolonged QTc > 450 ms or any ECG changes that interfere with QT interval interpretation.
  • Major surgery within 1 month of registration.
  • History of myelodysplastic syndrome or leukemia.
  • A known hypersensitivity to niraparib, abiraterone acetate, leuprolide, and/or prednisone.
  • Active infection or other medical condition that would be a contraindication to prednisone use.
  • Patients with known active hepatitis or chronic liver disease including cirrhosis.
  • Any condition that in the opinion of the investigator would preclude participation in this study.

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.

Drug, Radiation
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Safety and Feasibility Study of the Cellspan™ Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement

Cellspan™ Esophageal Implant for Short Segment Esophageal Replacement

Dennis Wigle
All
18 years and over
Phase 1, First In Human
This study is NOT accepting healthy volunteers
2023-310993-P01-RST
23-002117
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Inclusion Criteria:

  • Subject ≥ 18 years of age.
  • The patient has medical conditions requiring esophageal reconstruction, such as, but not limited to: 
    • Refractory benign esophageal strictures (RBES);
    • Esophageal perforation (full thickness);
    • Chronic/persistent esophageal fistula;
    • Combination of esophageal perforations/fistula with RBES;
    • The patient must have failed at least 3 previous treatment modalities to correct the medical esophageal condition (a-d).
  • If RBES:
    • Steroid treatment;
    • Esophageal balloon dilation (EBD);
    • Stent use > 6 months;
    • Endoscopic incisional repair.
  • If esophageal perforation:
    • Fibrin glue;
    • Endoscopic clips and/or suturing;
    • Stent > 6 months;
    • Primary surgical repair.
  • If Chronic/Persistent fistula(e):
    • Fibrin glue;
    • Endoscopic clips and/or suturing;
    • Stent > 6 months;
    • Primary surgical repair.
  • If Combination Perforation/fistula with RBES:
    • Fibrin glue;
    • Endoscopic clips and/or suturing;
    • Stent use > 6 months;
    • Primary surgical repair. 
  • The patient must be a surgical candidate for a short segment esophageal reconstruction (< 6 cm full circumferential segmental excision).
  • The location of the esophageal segment for surgical resection is within the thoracic cavity, defined as, at least 4 cm above gastroesophageal junction (GEJ) and at least 4 cm below the larynx.
  • Patient must be a high-risk candidate for minimally invasive esophageal reconstruction, based upon the investigator's determination (for example, laparoscopic gastric pull-up (GPU) is not an option due to a medical contraindication).
  • All patients must be made aware and must be amenable to a delayed rescue repair surgical procedure in the event the CEI fails to restore a patent durable biologic esophageal conduit.


Exclusion Criteria:

  • Pre-existing implants/structures adjacent to target surgical location for implant that could cause abrasion of the scaffold/regenerated tissue (e.g., pacemaker lead, vascular clips, vascular grafts).
  • Known clinical contraindication that would obfuscate the use of the covered metallic stent to be used as an adjunct to the procedure
  • Post ablation stricture for Barrett's esophagus treated less than 1 year prior to planned procedure
  • Patient has a comorbidity or contraindication that would preclude any study required procedures including adipose tissue biopsy and esophageal resection surgery.
  • Comorbidities are defined from a subset of the Charlson Comorbidities Index (CCI, Yamashita 2018) scoring system and include:
    • diabetes mellitus (CCI = 1);
    • connective tissue disorders (CCI = 1);
    • immune compromised;
    • chemotherapy (within 60 day clearance);
    • inability to tolerate major thoracotomy;
    • active infection at the biopsy or thoracotomy incision site;
    • peripheral vascular disease (CCI = 1);
    • all patients with a CCI > 2.
  • Life expectancy of less than 1 year.

Eligibility last updated 6/20/23. Questions regarding updates should be directed to the study team contact.

Combination Product
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MC220802 Phase II Study Evaluating Maintenance In Light chain Amyloidosis (EMILIA) (EMILA)

Light Chain Amyloidosis Maintenance Evaluation

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

  • Age ≥ 18 years.
  • Histological confirmation of AL amyloidosis with adequate typing (mass spectrometry, immunohistochemistry, immunofluorescence, immunogold).
  • AL amyloidosis with organ disease requiring therapy.
  • NOTE: Disease requiring therapy is referred to the time of diagnosis. There are no limitations in baseline measurable disease parameters.
  • Patients must have monoclonal protein studies (serum free light chain assay, serum immunofixation or serum MASS-FIX) obtained at time of diagnosis before induction therapy initiated and available for review to be enrolled.
  • NOTE: Patients are allowed to participate in this study if urine electrophoresis immunofixation study was not done at time of diagnosis or cannot be obtained.
  • Patients must have completed 6 cycles of Dara-CyBorD-based induction treatment ≤84 days prior to registration.
  • Patients must have achieved a hematological CR (irrespective of organ response achievement) or hematological VGPR (irrespective of organ response           achievement) or hematological low-dFLC PR (irrespective of organ response             achievement) or hematological PR with at least one organ response after receiving Dara-CyBorD-based induction.
  • NOTE: Patients with. baseline dFLC <5 mg/dL, must have achieved hematological CR, or dFLC <1 mg/dL or achieved organ response prior to randomization.
  • Patients in whom bortezomib and/or cyclophosphamide were omitted from induction due to toxicity concerns or adverse effects are allowed. Patients must receive at least daratumumab and dexamethasone at induction to qualify for the study.
  • NOTE: Dexamethasone use does not need to be carried to end of induction for eligibility consideration.
  • ECOG Performance Status (PS) 0, 1, 2 or 3. 
  • The following laboratory values obtained ≤28 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL;
    • Absolute neutrophil count (ANC) ≥1000/mm^3;
    • Platelet count ≥ 50,000/mm^3.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Provide written informed consent. NOTE: Informed consent required ≤90 days prior registration.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).


Exclusion Criteria:

  • Any of the following because this study involves an agent that has possible genotoxic, mutagenic and teratogenic effects:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential {and persons able to father a child} who are unwilling to employ adequate contraception.
  • Received > 1 cycle of daratumumab maintenance after end of induction therapy and prior to registration.
  • Multiple myeloma at time of diagnosis as defined by any of the following:
    • Hypercalcemia: Serum calcium > 1 mg/dL higher than upper limit of normal or > 11 mg/dL;
    • Renal insufficiency: Creatinine clearance < 40 mL per min or serum creatinine > 2 mg/dL attributed to high circulating light chains (i.e., cast nephropathy) or hypercalcemia;
    • Anemia: Hemoglobin > 2 g/dL below lower limit of normal, or < 10 g/dL, attributed to high marrow myeloma infiltration;
    • Bone lesions: ≥1 osteolytic lesion on skeletal x-ray, CT, or PET-CT (bone imaging is not mandatory but based on clinical suspicion);
    • Clonal bone marrow plasma cells ≥ 60%;
    • >1 focal lesion on MRI (MRI is not mandatory but based on clinical suspicion);
    • If bone imaging (CT, MRI, PET-CT) was not done at time of diagnosis it is not needed to be performed at registration to rule out bone disease;
    • ≥ 40% BMPCs irrespective of the above;
    • The study will allow patients with Involved: uninvolved sFLC ratio ≥ 100 if this is the only criteria that defines amyloidosis if all the above criteria are not met.
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]).
  • NOTE:  Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.
  • EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. 
  • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Uncontrolled intercurrent illness including, but not limited to:
    • ongoing or active infection;
    • unstable angina pectoris;
    • psychiatric illness/social situations that would limit compliance with study requirements.

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

Eligibility last updated 12/5/23.   Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

Gregory Nuttall
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-308674-H01-RST
22-006895
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Inclusion Criteria:

  • Patient undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.


Exclusion Criteria:

  • Are unable to grant informed consent or comply with study procedure.
  • Allergy or known sensitivity to magnesium or Renacidin.
  • Expected or high risk of bladder extravasation.
  • Ongoing atrial fibrillation prior to surgery.
  • Are undergoing emergency surgery.
  • Are pregnant.
  • Known hypermagnesemia.
  • Patients with neuromuscular weakness (e.g., Myasthenia gravis) due to magnesium's muscle weakening effect.
  • Patients with myocardial compromise or cardiac conduction defects because of magnesium's anti-inotropic effects.
  • Patients with renal insufficiency, glomerular filtration rate less than 30, since magnesium is eliminated by the kidneys resulting in exaggerated rise in serum magnesium.
  • Patients with concomitant use of a calcium channel blocker since magnesium sulfate could act synergistically to suppress muscular contractility.

Eligibility last updated 5/15/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Mayo Clinic — Rochester, MN

Global Cardio Oncology Registry (G-COR) (G-COR)

Global Cardio Oncology Registry

Joerg Herrmann
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309830-P01-RST
22-010918
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Inclusion Criteria:


- New cardio-oncology consultation for breast cancer patients; or

- New cardio-oncology consultation for Hodgkin's or non-Hodgkin's lymphoma patients; or

- New cardio-oncology consultation for acute or chronic leukemia patients; or

- New cardio-oncology consultation for multiple myeloma or AL amyloidosis; or

- New cardio-oncology consultations for immune check-point inhibitors cardiac
evaluation.

- All patients have to be 18 years old or older.


Exclusion Criteria:


- Cardio-oncology patients who have previously had cardio-oncology evaluation and follow
up by the investigators.

- Minors less than 18 years old.

- Inability or unwillingness to consent to participate.

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

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

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Mayo Clinic — Rochester, MN

Social Determinants of Health in Hepatobiliary Cancer Patients

Hepatobiliary Cancer Patients Social Determinants

Nguyen Tran
All
18 years to 90 years old
This study is NOT accepting healthy volunteers
2022-310192-H01-RST
22-012368
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Inclusion Criteria:

  • ≥ 18 years of age with hepatobiliary cancers and SEA American self-report (they or their family members are from/had been from Cambodia, Laos, or Vietnam) are eligible.
  • Newly diagnosed hepatobiliary cancers.


Exclusion Criteria:
 

  • < 18 years of age. 

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

Eligibility last updated 12/2/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Mood Stabilizer Pharmacogenomics Biobank (MoStGEN)

Mood Stabilizer Pharmacogenomics Biobank (MoStGen)

Satyajit Mohite
All
18 years to 80 years old
This study is NOT accepting healthy volunteers
0000-123267-H01-MAIJ
20-001658
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Inclusion Criteria:

  • Age 18-80 years, male, female, any race/ethnicity.
  • Diagnosis of bipolar I disorder or bipolar II disorder, or bipolar (BP) schizoaffective defined by DSM-IV or DSM-V criteria, SCID- confirmed. If patient has already completed a DSM-IV or DSM-V SCID within one year of enrollment, they will not be required to repeat the SCID assessment.
  • Ability for a referring clinician or research clinician to complete a retrospective clinical assessment of response to lithium, mood stabilizing anticonvulsants(carbamazepine, oxcarbamazepine, divalproex sodium, lamotrigine, zonisamide) typical and atypical antipsychotics, stimulants and related compounds (modafinil / armodafinil) and, unimodal antidepressants utilizing the Alda scale.


Exclusion Criteria:
 

  • Inability to speak English.
  • Inability or unwillingness to provide informed consent or scoring less than 80% on the comprehension assessment (CA) form.
  • Unwilling to consent to providing biospecimens to be stored in the biobank for an indefinite amount of time and to be used in future research studies of as yet unknown design.
  • Actively psychotic or suicidal symptoms.
  • Involuntary patients.
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Mayo Clinic Health System — Mankato, MN

Pain assessment in MCSA participants

Pain Assessment in Mayo Clinic Study of Aging Participants

Nafisseh Warner
All
65 years and over
This study is NOT accepting healthy volunteers
2022-308665-H01-RST
22-006804
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Inclusion Criteria:

  • Mayo Clinic Study of Aging (MCSA)  participants who are being approached for a subsequent MCSA visit.
  • ≥ 65 years of age.


Exclusion Criteria:
 

  • < 65 years of age. 

Eligibility last updated 6/28/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Measuring Endoscopic Stone Size in Ureteroscopic Renal Surgery (MESSURES)

Real-Time Ureteroscopic Stone Measurement Impact and Decision Making

Kevin Koo
All
18 years and over
This study is NOT accepting healthy volunteers
2023-311227-H01-RST
23-002946
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Inclusion Criteria:

  • Must be ≥ 18 years old.
  • Individual undergoing elective ureteroscopy and laser lithotripsy for renal or ureteral stones.


Exclusion Criteria:
 

  • Under 18 years of age.
  • Individual cannot be undergoing elective ureteroscopy and laser lithotripsy for renal or ureteral stones.

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

Eligibility last updated 3/20/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Life Course: Associations of Early Life Adversity and Neighborhood Environment with Traumatic Brain Injury (TBI) Outcomes in the TBI Model Systems National Database

Early Life Adversity and Neighborhood Environment with Traumatic Brain Injury Outcomes

Thomas Bergquist
All
18 years and over
This study is NOT accepting healthy volunteers
2023-311542-P01-RST
23-004808
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Inclusion Criteria

  • Must first enroll in the TBIMS National Database (IRB 69-03).
  • Be at least 18 years old at the time of injury.
  • Be able to provide self-report information about their childhood (no proxy reporting).
  • Must provide informed consent to share their address with the TBIMS National Database.

Exclusion Criteria 

  • Non English speaking.
  • Enrolled in the TBIMS National Database but 16 or 17 years old.

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

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

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Mayo Clinic — Rochester, MN

Toward Use of the Synergy-based SoftHand Pro for Activities of Daily Living by Persons With Transradial Limb Loss: A Multi-site Clinical Trial

A Study to Evaluate SoftHand Pro for Daily Activities of Transradial Amputees

Kristin Zhao
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304698-H01-RST
21-005070
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Inclusion Criteria:

  • the individual can successfully use their prosthesis, list the components used and that their current prosthesis is fitting properly (by performing a tension analysis);
  • the individual had a unilateral transradial amputation more than 6 months before the clinical evaluation because, to use a myoelectric prosthesis, the residual limb volume needs to be stable;
  • the individual is a current user of one of two common myoelectric prosthetic hands: Sensor Hand Speed and Bebionic (both Ottobock).


Exclusion Criteria:
 

  • individuals who have had transradial amputation for less than 6 months;
  • individuals who have been fit and trained to use a prosthesis but chose not to use one;
  • clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy;
  • orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed);
  • visual problems that would interfere with the grasping;
  • co-existing central nervous system disease with symptoms that limit upper extremity function (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson’s disease, dystonia) revealed in medical history;
  • limited range of motion as assessed through range of motion testing;
  • inability to follow study instructions;
  • use of medications that might affect sensory and/or motor functions.
Behavioral, Device
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Mayo Clinic — Rochester, MN

Interactive Care Plan Using a Remote BP Monitoring Device in Primary Care: A Feasibility Pilot Study

Interactive Care Plan Using a Remote BP Monitoring Device in Primary Care

Ramona Dejesus
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307893-H01-RST
22-003926
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Inclusion Criteria:

  • Community dwelling adult patients 18 years and older.
  • Diagnosis of hypertension defined as bp of > 140/90, who would benefit from BP management.
  • Paneled in Onalasca Primary care practice.
  • Has established a patient online secured account.
  • Has a compatible mobile device (with Bluetooth connectivity).
  • Able to give consent to participate in research study (consent and HIPAA form).


Exclusion Criteria:

  • Non-English speaking.
  • Residing in skilled care facilities.
  • Has cognitive impairment.
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Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR (VAPOR 2)

Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

Lance Mynderse
Male
50 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2023-310921-P01-RST
23-001866
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Inclusion Criteria:

  • ≥ 50 years of age; with life expectancy of ≥ 10 years.
  • 20-80 cc prostate size measured by MRI.
  • ≤ 15 ng/ml PSA.
  • Cancer stage less than or equal to T2c.
  • Within 6 months of signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal). This must include a standard sector biopsy obtaining 12-16 cores.
  • ≤ 15mm diameter of lesion as measure by greatest diameter.
  • Subject is willing and able to adhere to specific protocol visits and required testing throughout study.
  • Is geographically stable and near the site or able and willing to travel back to site for follow-up visits involving diagnostic tests or treatment.
  • Able and willing to provide written consent to participate in the study.


Exclusion Criteria:

  • MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE).
  • Contraindications to MRI.
  • Subjects with an installed pacemaker or other potentially electrically conductive implants implanted within 200mm (8 inches) of the procedure area. Implants that are within 200mm (8 inches) and can be turned off for the duration of the study procedure are acceptable.
  • Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck.
  • Treated within the last 5 years for genital cancer.
  • Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use.
  • Currently taking medications that have hormonal effects on the prostate or PSA, such as: 5 alpha reductase inhibitors (if on for < 6 months), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12 month wash-out), or Testosterone supplementation.
  • Active urinary tract infection.
  • Active or clinically chronic prostatitis or granulomatous prostatitis.
  • Active lower and upper urinary tract malignancy (excluding prostate cancer meeting the inclusion criteria).
  • Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS.
  • Unable to stop taking antiplatelet medications or other blood thinning agents.
  • Known allergy to nickel.
  • Alergic to medication required by the study such as MRI contrast or anesthesia.
  • Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
  • Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator regarding the study or affects the ability to complete the study quality of life questionnaires.
  • Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing.
  • Subject is considered vulnerable such as incarcerated or cognitively impaired.

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

Eligibility last updated 12//27/03. Questions regarding updates should be directed to the study team contact.

Device
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Treatment of Established Chemotherapy-Induced Neuropathy with N-Palmitoylethanolamide, a Cannabimimetic Nutraceutical: A Randomized Double-Blind Phase II Pilot Trial

PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy

Charles Loprinzi
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305481-P01-RST
22-006397
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Inclusion Criteria:


- Age >= 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

- NOTE: Patients with a history of metastatic cancer or an ECOG performance status of 2 must have laboratory (lab) work completed =< 28 days prior to registration

- Pain, numbness, tingling or other symptoms of CIPN of >= 3 months (90 days) duration for which the patient is seeking an intervention

- Neurotoxic chemotherapy must have been completed >= 3 months (90 days) prior to registration and there must be no further planned neurotoxic -chemotherapy for > 2 months after registration Note: The study is limited to those with taxane- and/or platinum-based neuropathy

- Patient must note tingling, numbness or pain symptoms of at least a four out of ten =< 7 days prior to registration.

- Note: On a 0-10 scale where zero was 'no problem' and ten being 'as bad a problem that could be imagined': how much of a problem has numbness, tingling, and/or
pain in your fingers and/or toes been in the past week?

- Patient must be able to speak, read and comprehend English

- For women of childbearing potential only, a negative urine or serum pregnancy test done =< 14 days prior to registration is required

- A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

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

- Life expectancy >= 6 months

- Platelet count > 100,000/mm^3

- NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration

- Absolute neutrophil count (ANC) >= 1,000/mm^3

- NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration

- Hemoglobin > 11 g/dL

- NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration

- Serum transaminase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) =< 1.2 x upper limit of normal (ULN)

- NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have these labs completed =< 28 days prior to registration

- Alkaline phosphatase =< 1.2 x ULN

- NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration

- Serum creatinine =< 1.2 x ULN

- NOTE: Patients with a history of metastatic cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration

- Able to swallow oral medication

- Provide written informed consent =< 28 days prior to registration


Exclusion Criteria:


- Currently receiving neurotoxic chemotherapy for a second cancer or recurrence of the primary cancer

- Impaired decision-making capacity (such as with a diagnosis of dementia or memory loss)

- Evidence of residual cancer, per routine clinical practice-based parameters

- Comorbid conditions:

- Previous diagnosis of diabetic or another non chemotherapy induced peripheral neuropathy

- Previous history of peripheral neuropathy prior to receiving neurotoxic chemotherapy

- Neuropathy from human immunodeficiency virus (HIV) infection. Note: Patients with HIV infections are eligible as long as they do not have a neuropathy from their
viral illness

- Concurrent use of a cannabis product  (tetrahydrocannabinol [THC] and/or cannabidiol
[CBD]). Patients should have discontinued these products >= 4 weeks prior to registration

- Current or previous use of PEA

- Currently receiving or planning to start any of the following agents: opioids, duloxetine, gabapentin or pregabalin. Patients are eligible if they discontinue these medications >= 1 week prior to registration

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

- Pregnant persons

- Nursing persons

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

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

Eligibility last updated 11/30/23. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug, Other
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A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies

A Study to Investigate LYL797 in Adults With Solid Tumors

Roberto Leon Ferre
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307449-P01-RST
22-003580
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Inclusion Criteria:


- ≥ 18 years of age at time of informed consent

- Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or
locally advanced and unresectable that is ROR1+ by central laboratory
immunohistochemistry (IHC)

- Measurable disease including a target lesion and an additional lesion for biopsy

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

- Adequate organ and marrow function

- Women of childbearing potential must have a negative pregnancy test at screening

- All participants must agree to practice highly effective methods of contraception


Exclusion Criteria:


- Prior treatment with any adoptive T-cell therapy or anti-ROR1 therapy

- Prior solid organ transplantation

- Active, untreated brain metastasis or leptomeningeal disease; stable, treated brain
involvement by disease is allowed

- Untreated or active infection at the time of screening or leukapheresis

- HIV-positive, HTLV-1-positive, active acute or chronic HBV or HCV, or active
tuberculosis

- Impaired cardiac function or clinically significant cardiac disease

- Uncontrolled pleural or pericardial effusion

- Systemic corticosteroids or other immunosuppressive medications within 14 days of
leukapheresis

- Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or
Factor Xa inhibitors

- Pregnant or lactating/nursing women

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

Eligibility last updated 5/4/23. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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