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3802 Study Matches

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A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared with Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia (DIUR-014)

Chronocort Versus Standard Hydrocortisone Replacement Therapy to Treat Congenital Adrenal Hyperplasia in Participants Aged 16 Years and Over

Irina Bancos
All
16 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307325-P01-RST
22-001875
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Inclusion Criteria:


- Male or female participants must be aged 16 years or older at the time of signing the
informed consent/assent.

- In participants aged <18 years, height velocity must be less than 2 cm/year in the
last year and puberty must be completed (Tanner stage V).

- Participants with known classic CAH due to 21 hydroxylase deficiency diagnosed in
childhood with documented (at any time) elevated 17-OHP and with or without elevated
A4 and currently treated with hydrocortisone, prednisone, prednisolone or
dexamethasone (or a combination of the aforementioned glucocorticoids) and on stable
glucocorticoid therapy for a minimum of 3 months.

- Participants who are receiving fludrocortisone must be on a documented stable dose for
a minimum of 3 months prior to enrollment and must have stable renin levels at
screening.

- Female participants of childbearing potential and all male participants must agree to
the use of an accepted method of contraception during the study.

- A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and she is either not a woman of childbearing potential (WOCBP) or has
a negative pregnancy test at entry into the study. Note: females presenting with
oligomenorrhea or amenorrhea who are aged ≤55 years should be considered potentially
fertile and therefore should undergo pregnancy testing like all other female
participants.

- Capable of giving signed informed consent/assent which includes compliance with
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.


Exclusion Criteria:


- Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine >2 times
the upper limit of normal (ULN) or elevated liver function tests (alanine
aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).

- History of bilateral adrenalectomy.

- History of malignancy (other than basal cell carcinoma successfully treated >26 weeks
prior to entry into the study).

- Participants who have type 1 diabetes or receive regular insulin, have uncontrolled
diabetes, or have a screening HbA1c greater than 8%..

- Persistent signs of adrenal insufficiency or the participant does not tolerate
treatment at the end of the 4-week run-in period.

- Participants with any other significant medical or psychiatric conditions that in the
opinion of the Investigator would preclude participation in the study.

- Participants on regular daily inhaled, topical, nasal or oral steroids for any
indication other than CAH.

- Co-morbid condition requiring daily administration of a medication or consumption of
any material that interferes with the metabolism of glucocorticoids.

- Participants who are receiving <10 mg hydrocortisone dose at screening or the
hydrocortisone dose equivalent.

- Participants anticipating regular prophylactic use of additional steroids e.g. for
strenuous exercise.

- Participation in another clinical study of an investigational or licensed drug or
device within the 12 weeks prior to screening.

- Inclusion in any natural history or translational research study that would require
evaluation of androgen levels during the study period outside of this protocol's
assessments.

- Participants who have previously been exposed to Chronocort in any Diurnal study.

- Participants who routinely work night shifts and so do not sleep during the usual
night-time hours.

- Participants, who in the opinion of the Investigator, will be unable to comply with
the requirements of the protocol.

- Participants with a known hypersensitivity to any of the components of the Chronocort
capsules, the Cortef tablets, or the placebo capsules.

- Participants with congenital galactosemia, malabsorption of glucose and galactose, or
who are lactase deficient.

- Participants with a body weight of 45 kg or less.

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

Eligibility last updated 1/18/23. Questions regarding updates should be directed to the study team contact.

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A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Adaptive Dose-Ranging Study to Assess Safety and Efficacy of Intravenous OCE-205 in Adults Diagnosed With Cirrhosis With Ascites Who Have Developed Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI)

A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury

Douglas Simonetto
All
18 years to 75 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-307791-P01-RST
22-003530
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Inclusion Criteria:


- Signed informed consent form (ICF) by participant or their legal/authorized
representatives.

- Diagnosed with decompensated cirrhosis with ascites.

- Receiving albumin and has had appropriate diuretic withdrawal for at least 2 days
prior to randomization into the study.

- Beta-blockers should be discontinued 48 hours prior to randomization, unless doctor
deems necessary for appropriate medical treatment.

- No sustained improvement in renal function after both diuretic withdrawal and plasma
volume expansion with albumin.

- Female participants must have a negative pregnancy test prior to randomization and
agree to avoid becoming pregnant during the study and for 30 days after the end of
treatment. Male participants must agree to use 2 effective contraceptive methods
during the study and up to 30 days after the end of treatment.


Exclusion Criteria:


- Serum Creatinine >3.8 mg/dL.

- Large volume paracentesis (LVP ≥6L) within 4 days of randomization.

- Pulse oximeter reading of <90% on 2L or less.

- Sepsis and/or uncontrolled bacterial infection.

- Experienced shock within 72 hrs prior to screening.

- Model for End-Stage Liver Disease (MELD) score >35.

- Hypertension with a Systolic BP > 140 mmHg and/ or a Diastolic BP >100 mmHg.

- Treated with or exposed to nephrotoxic agents or has had exposure to radiographic
contrast agents within 72 hrs prior to screening.

- Has superimposed acute liver injury due to drugs, or toxins except for acute alcoholic
hepatitis.

- Proteinuria greater than 500 mg/dL.

- Impaired cardiac function as evidenced by symptoms consistent with New York Heart
Association Classification Class 2 or worse.

- Received Renal Replacement Therapy (RRT) within 4 weeks of randomization.

- Has had a Trans Jugular Intrahepatic Porto-systemic shunt (TIPS).

- Pregnant or breastfeeding.

- Diagnosed with a malignancy within the past 5 years.

- History or current evidence of any condition (COVID-19 positive with
respiratory/cardiac complications), therapy or laboratory abnormality that might
confound the results of the study, interfere with the participation for the full
duration of the study, or is not in the best interest to participate in the opinion of
the investigator.

- Participated in a study of an investigational medical product or device within the
last 8 weeks preceding screening.

- Experienced a major blood loss (≥500 mL) within the last 4 weeks prior to screening.

- Is stuporous or comatose at screening (West Haven scores III and IV). exhibiting
bradycardia.

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

Eligibility last updated 5/18/23. Questions regarding updates should be directed to the study team contact.

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Pilot project for measuring RNA species in exhaled breath condensate of lung cancer patients and healthy controls

Breath Condensate of Lung Cancer Patients and Healthy Controls to Measure RNA Species in Exhaled Breath Condensate

Farhad Kosari
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
2022-308824-P01-RST
22-007326
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Inclusion Criteria:

  • In the Lung Cancer group, any patient of 18 years or older with lung cancer.
  • In the control group, any 18 year or older volunteer with no history of Lung Cancer.


Exclusion Criteria:
 

  • Anyone with a history of lung disease, such as emphysema. Also, anyone with a history of cancer except Lung Cancer in the experimental group.

Eligibility last updated 7/15/22. Questions regarding updates should be directed to the study team contact.

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S2007, A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases

A Study to Test Sacituzumab Govitecan Therapy in Patients with HER2-Negative Breast Cancer and Brain Metastases

Roberto Leon Ferre
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-303648-P01-RST
21-002283
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Inclusion Criteria:

  • Participants must have histologically confirmed HER2-negative (per 2018 American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] joint guideline) invasive breast cancer that has metastasized to the brain.
    • NOTE: Pathology report must confirm HER2-negative invasive breast cancer. Brain metastases must be confirmed by radiology report.
  • Participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis >= 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy (in the opinion of the treating physician). In the rare case that a previously irradiated brain metastasis is the sole target lesion and if there is concern about possible radiation necrosis, patient is eligible only if there is clear progression in the previously radiated lesion. Computed tomography (CT) of the head cannot substitute for brain MRI. All central nervous system (CNS) disease must be assessed and documented on the S2007 Brain Metastases Baseline Tumor Assessment Form
  • Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to registration; all non-measurable disease must be assessed within 42 days prior to registration. Participants are NOT required to have extracranial disease, but must have scans done to document disease status at baseline. All extracranial disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
    • NOTE: Brain lesions should not be included on the Baseline Tumor Assessment Form (RECIST 1.1) for this study.
  • Participants must have had CNS progression after previous CNS-directed therapy (radiation therapy, surgery, or any combination of therapy)
  • Participants must have resolution of adverse event(s) of the most recent prior systemic anti-cancer therapy to < grade 2, with the exception of alopecia and =< grade 2 neuropathy, which are allowed
  • Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Participants must have Zubrod performance status 0 or 1
  • Participants must have history and physical exam obtained within 21 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1,500/mcL (obtained within 21 days prior to registration);
    • Platelet count ≥ 100,000/mcL (obtained within 21 days prior to registration);
    • Hemoglobin ≥ 9.0 g/dL (obtained within 21 days prior to registration);
    • Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN) (obtained within 21 days prior to registration);
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x institutional ULN (obtained within 21 days prior to registration);
    • Participants must have a serum creatinine ≤ 1.5 times the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 21 days prior to registration.
  • Participants must have adequate cardiac function.
  • Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification, and must be class 2B or better
  • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System.
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.


Exclusion Criteria:

  • Participants must not have had more than 2 seizures within 28 days prior to registration.
  • Participants must not have received systemic therapy (including small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 7 days prior to registration.
  • Participants must not have received anti-cancer biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to registration.
  • Participants must not have received nitrosoureas or mitomycin C within 42 days, metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days prior to registration -Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral agents that are strong CYP3A4 inhibitors or inducers and who are unwilling or unable to change to antiretroviral therapies without such interactions are ineligible because of the potential for pharmacokinetic interactions with sacituzumab govitecan (IMMU-132).
  • Due to potential drug interactions of anti-retroviral drugs with sacituzumab govitecan (IMMU-132), participants must not have known active or chronic hepatitis B virus (HBV) infection, requiring suppressive therapy or known active hepatitis C virus (HCV) infection. Participants with a known history of HCV infection must have been treated and cured -Participants must not have received enzyme-inducing anti-epileptic agents (e.g., carbamazepine, phenytoin, phenobarbital, primidone) within 7 days prior to registration or within 14 days of planned start of cycle 1, day 1 treatment, and participants must not be planning to receive enzyme-inducing anti-epileptic agents (e.g., carbamazepine, phenytoin, phenobarbital, primidone) for the duration of protocol treatment.
  • Participants must not be receiving warfarin (or other coumarin derivatives) at time of registration or be planning to receive warfarin (or other coumarin derivatives) for the duration of protocol treatment.
  • Participants who are able to switch to low molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs) prior to date of registration (and plan to remain off of warfarin or other coumarin derivatives) for the duration of protocol treatment) are eligible.
  • Patients must not be receiving or be planning to receive concomitantly any other anti-cancer therapy, including endocrine therapy.
    • NOTE: Concomitant hormone replacement therapy is allowed.
  • Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (> 4 mg daily dexamethasone [or bioequivalent]) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain ≤ 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion.
  • Participants must not have uncontrolled diabetes in the opinion of the treating investigator 21 days prior to registration.
  • Participants must not be pregnant or nursing. Women of reproductive potential must have a negative serum or urine pregnancy test within 7 days prior to registration. Women and men of reproductive potential must have agreed to use an effective contraceptive method for the duration of protocol treatment and for at least 6 months after the last dose of sacituzumab govitecan (IMMU-132). A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined, he/she is responsible for beginning contraceptive measures.
Biologic/Vaccine
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Stress Echo 2030: The Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging- Review (SE2030)

Stress Echo 2030

Patricia Pellikka
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305178-H01-RST
21-006982
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Inclusion Criteria:

  • Age 18+.
  • Undergoing a clinically indicated stress echo, Capacity to consent.
  • Prior diagnosis of the following:
  • Coronary Artery Disease
    • Undergoing SE for one of the following indications:
      • For Assessment of chest pain or dyspnea;
      • For reassessment after an abnormal test or assessment of known CAD (previous acute coronary syndrome and/or previous myocardial revascularization, prior CAD by invasive or noninvasive coronary angiography);
      • For risk stratification prior to high risk non-cardiac vascular surgery (such as liver transplant or major non-cardiac vascular surgery) in patients with poor functional capacity (< 4 METS) and/or suspected cardiac symptoms, in presence of a revised cardiac risk index (Lee criteria)  ≥ 2 (high risk surgery;
      • CAD;
      • congestive heart failure;
      • cerebrovascular disease;
      • diabetes mellitus on insulin;
      • serum creatinine > 2mg/ml).
  • Diastolic Heart Failure
    • Preserved EF;
    • Heart Failure score 1-5.
  • Hypertrophic Cardiomyopathy
    • Phenocopies such as infiltrative/ storage disease (e.g., Fabry, amyloid) will be excluded.
  • Post Chest Radio/Chemotherapy.
  • Tetralogy of Fallot (TOF)
    • Repaired TOF, double-outlet right ventricle Fallot type, tetralogy of Fallot with pulmonary atresia;
    • At least 1 year post-surgical or percutaneous procedure
    • Height > 140 cm;
    • New York Heart Association class I or II.
  • Mitral Regurgitation
    • Resting moderate mitral regurgitation (effective regurgitant orifice 0.2-0.39 cm^2, and regurgitant volume 30-59 ml) of ischemic origin.
  • Valvular Heart Disease
    • Asymptomatic severe aortic stenosis;
    • Low-flow, low-gradient aortic stenosis with reduced ejection fraction;
    • Low-flow, low-gradient aortic stenosis with preserved ejection fraction;
    • Asymptomatic severe or symptomatic non-severe primary mitral insufficiency;
    • Asymptomatic severe or symptomatic non-severe aortic regurgitation;
    • Asymptomatic severe or symptomatic non-severe mitral stenosis;
    • Asymptomatic severe or symptomatic non-severe multivalvular disease;
    • Post heart valve procedures (prostheses and valvuloplasty).


Exclusion Criteria:
 

  • Under the age of 18.
  • Unable to consent.
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MC210706 Efficacy and Safety Study of Neoadjuvant Efineptakin alfa (NT-I7) Plus Pembrolizumab in Recurrent Glioblastoma

Efineptakin alfa (NT-I7) Plus Pembrolizumab for the Treatment of Recurrent Glioblastoma

Jian Campian
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305737-P01-RST
21-011200
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Progressive or recurrent WHO Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma).
  • Have an enhancing mass on MRI amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery.
  • Willing to undergo resection or biopsy of their glioblastoma at Mayo Clinic in Rochester, MN.
  • ECOG Performance Status (PS) of 0 or 1 and KPS ≥ 70.
    • Note: PS must be assessed again within 7 days prior to first dose of study drug.
  • The following laboratory values obtained ≤ 15 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 100,000/mm^3;
    • Hemoglobin ≥ 9.0 g/dL without transfusion or EPO dependency (≤ 7 days prior to assessment);
    • Creatinine ≤ 2.0 x ULN OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml/min;
    • Total bilirubin ≤ 1.5 x ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels > 1.5 x ULN;
    • Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN;
    • INR/PT/aPTT ≤ 1.5 × ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only (POCBP).
    • Note: If testing done for eligibility is > 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.
  • POCBP or able to father a child must be willing to use adequate contraception starting with first dose through 120 days after last dose. 
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willing to provide tissue and blood samples for correlative research purposes.


Exclusion Criteria:

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

  • Pregnant persons.
  • Nursing persons.
  • Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception.
  • Signs or symptoms of life-threatening raised intracranial pressure: as defined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7 day delay in scheduling neurosurgery.
  • Prior treatment.
  • Received bevacizumab (AVASTIN) ≤ 28 days prior to registration.
    Note: Bevacizumab is allowed for symptom control during the adjuvant phase of the study.
  • Received a live vaccine ≤ 30 days prior to registration.
  • Major surgery ≤ 28 days prior to registration.
  • Requirement for dexamethasone dose of > 2mg/day ≤ 2 days prior to registration.
  • 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.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
  • 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.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Other active malignancy requiring systemic treatment ≤ 1 year prior to registration.
  • History of myocardial infarction ≤6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration.
    • Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Known history of active TB (Bacillus Tuberculosis).
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Hypersensitivity to pembrolizumab or any of its excipients.
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Biologic/Vaccine, Drug
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Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease (ABCVILD)

Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease

Avni Joshi
All
4 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306748-P01-RST
21-013267
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Inclusion Criteria:

  • Diagnosis of CVID according to the international consensus document (ICON):
    • Age 4 years or above;
    • Serum IgG at least 2 standard deviations below the age adjusted normal;
    • Decreased serum IgA and/or serum IgM;
    • Abnormal specific antibody response to immunization;
    • Exclusion of secondary immunodeficiency.
  • On replacement immunoglobulin for at least 6 months and willing to maintain throughout study.
  • Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.
  • Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 2 months of study entry.
  • Signed written informed consent.
  • Willing to allow storage of biological specimens for future use in medical research.
  • Females of childbearing potential must use a highly effective form of birth control such as hormone-based contraceptive, intrauterine device, or double barrier method.


Exclusion Criteria:

  • History of hypersensitivity to abatacept or any of its components.
  • Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months.
  • Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as >15mg/kg/day of methylprednisone or corticosteroid equivalent) within the past 3 months.
  • History of HIV infection (positive PCR).
  • Chronic untreated hepatitis B or C (positive PCR).
  • Active tuberculosis (TB) by positive QuantiFERON gold. If history of latent TB, then must supply evidence of completing treatment.
  • Persistent Epstein-Barr Virus (EBV) load ≥ 1,000 units/mL blood checked twice at least 1 month apart.
  • Other uncontrolled infections.
  • Live vaccine given within 6 weeks of the start of the trial.
  • Malignancy or treated for malignancy within the past year.
  • Currently pregnant or breast feeding.
  • Life expectancy less than 1 month.
  • Subjects unwilling to self-administer or have a parent/caregiver self-administer subcutaneous injections at home.
  • Other conditions that the investigators feel contraindicate participation in the study.

Eligibility last updated 12/22/21. Questions regarding updates should be directed to the study team contact.

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Evaluating Indirect Costs of Infertility and Fertility Treatment

Indirect Costs of Infertility and Fertility Treatments

Alessandra Ainsworth
All
25 years to 50 years old
This study is NOT accepting healthy volunteers
2022-310000-H01-RST
22-011583
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Inclusion Criteria:

  • ≥ 25 and ≤ 50 years of age.
  • English speaking.
  • Able and willing to consent and participate.


Exclusion Criteria:
 

  • Patients seen in REI practice not interested in family building (Aim 1 only).
  • Non-English speaking.
  • Age < 25.

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

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

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A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

A Trial to Investigate Long Term Effectiveness and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

Irina Bancos
All
23 years to 81 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-307528-P01-RST
22-009082
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Inclusion Criteria:


- Signing of the trial specific informed consent.

- Completion of the treatment period and Visit 7 assessments of trial TCH-306, including
collection and upload of Visit 7 DXA scan.

- Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial
hypertension or diabetic retinopathy stage 2 / moderate or above.


Exclusion Criteria:


- Diabetes mellitus if any of the following are met:

1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to
central laboratory at Visit 6 in trial TCH-306;

2. Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4
(DPP-4) inhibitors.

- Active malignant disease or history of malignancy. Exceptions are:

1. Resection of in situ carcinoma of the cervix uteri;

2. Complete eradication of squamous cell or basal cell carcinoma of the skin.

- Known history of hypersensitivity and/or idiosyncrasy to the investigational product
(somatropin or excipients).

- Female who is pregnant, plans to become pregnant, or is breastfeeding.

- Female participant of childbearing potential (i.e., fertile, following menarche and
until becoming post-menopausal unless permanently sterile) not willing throughout the
trial to use contraceptives as required by local law or practice.

- Male participant not willing throughout the trial to use contraceptives as required by
local law or practice. 

- Any disease or condition that, in the judgement of the investigator, may make the
participant unlikely to comply with the requirements of the protocol or any condition
that presents undue risk from the investigational product or trial procedures.

Eligibility last updated 3/31/22. Questions regarding updates should be directed to the study team contact.

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BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation (BRCA-P)

Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation

Sandhya Pruthi
Female
25 years to 55 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-100446-P01-RST
22-003230
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Inclusion Criteria:


- Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation
(variant class 4 or 5)

- Age >= 25 years and =< 55 years at randomization

- No evidence of breast cancer by MRI or mammography (MG) and clinical breast
examination within the last 6 months prior to randomization

- No clinical evidence of ovarian cancer at randomization

- Negative pregnancy test at randomization for women of childbearing potential

- No preventive breast surgery planned at time of randomization

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

- Written informed consent before any study-specific procedure is performed


Exclusion Criteria:


- Prior bilateral mastectomy

- History of ovarian cancer (including fallopian and peritoneal cancer)

- History of breast cancer

- History of invasive cancer except for basal cell or squamous cell skin cancer or
carcinoma in situ of the cervix, stage 1 papillary or follicular thyroid cancer,
atypical hyperplasia or LCIS (lobular carcinoma in situ)

- Pregnant or lactating women (within the last 2 months prior to randomization)

- Unwillingness to use highly effective contraception method during and within at least
5 months after cessation of denosumab/placebo therapy in women of childbearing
potential. (Note: Women of childbearing potential should be monitored for pregnancy
prior to each denosumab/placebo injection)

- Clinically relevant hypocalcemia (history and current condition), or serum calcium <
2.0 mmol/L (< 8.0 mg/dL)

* Hypocalcemia defined by calcium below the normal range (a single value below the
normal range does not necessarily constitute hypocalcemia, but should be 'corrected'
before dosing the subject). Monitoring of calcium level in regular intervals (usually
prior to investigational product [IP] administration) is highly recommended

- Tamoxifen, raloxifene or aromatase inhibitor use during the last 3 months prior to
randomization or for a duration of more than 3 years in total (current and prior
hormone replacement therapy [HRT] is permitted)

- Prior use of denosumab

- Subject has a known prior history or current evidence of osteonecrosis or
osteomyelitis of the jaw, or an active dental/jaw condition which requires oral
surgery including tooth extraction within 3 months of enrollment

- Concurrent treatment with a bisphosphonate or an anti-angiogenic agent

- Any major medical or psychiatric condition that may prevent the subject from
completing the study

- Known active infection with hepatitis B virus or hepatitis C virus

- Known infection with human immunodeficiency virus (HIV)

- Use of any other investigational product (current or prior aspirin or non-steroidal
anti-inflammatory drugs [NSAIDs] are permitted)

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A Randomized Phase 2 Non-inferiority Trial of (Z)-endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment for Premenopausal Women with ER+/HER2- Breast Cancer (EVANGELINE)

(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer

Matthew Goetz
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305880-P01-RST
22-011685
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Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in PK Run-in Cohort or the Treatment Cohort of this study:

  • Female sex assigned at birth; female to male transgender individuals are not eligible.
  • Age 18 years or older.
  • Not lactating, pregnant, or planning to become pregnant in the next year and agrees to take adequate steps to prevent becoming pregnant beginning at informed consent, during treatment and for 9 months after last dose and agree to not breast feed during treatment and for 3 months after last dose.
  • Must agree to use at least one non-hormonal highly effective method of contraception for the entire duration of study participation beginning at informed consent.
  • Premenopausal.
  • Pathologic confirmation of strongly estrogen receptor positive (ER+) (defined as estrogen receptor [ER] ≥ 67% or Allred Score 6-8) by local institution protocol.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
  • Nottingham (Elston-Ellis) Grade 1 or 2.
  • HER2- breast cancer (histologically confirmed) using American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
  • Clinical T2-T3 invasive breast cancer (per American Joint Committee on Cancer [AJCC] 8th edition clinical staging). Clinical N0 or N1 invasive breast cancer (per American Joint Committee on Cancer [AJCC] 8th edition clinical staging).
  • Magnetic resonance imaging (MRI) ≤ 35 days of registration.
  • Mammogram performed ≤ 90 days of registration (Treatment Cohort only)
  • Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
  • Willing to provide blood and breast tissue samples for research purposes.


Exclusion Criteria:
 

Subjects who meet any of the following criteria will be excluded from the PK Run-in Cohort and the Treatment Cohort:

  • Bilateral invasive breast cancer; Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion Note, patients with pre-malignant disease or DCIS/LCIS in the contralateral breast are eligible.
  • Any prior diagnosis or treatment for breast cancer, including carcinoma in situ, or history of any other active malignancy within the past 2 years prior to study entry, with the exception of:
    • Adequately treated in situ carcinoma of the cervix uteri;
    • Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin;
    • Any other malignancy with a life expectancy of more than 2 years.
  • Any uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection requiring systemic treatment with strong inhibitors/inducers of CYP450 enzymes (including bacterial infection, fungal infection, or detectable viral infection);
    • Symptomatic congestive heart failure;
    • Unstable angina pectoris;
    • Uncontrolled symptomatic cardiac arrhythmias;
    • Uncontrolled hypertension (defined as blood pressure > 160/90 mm Hg);
    • Uncontrolled diabetes (Hemoglobin A1c [HbA1c] > 7%);
    • Marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 470 milliseconds [msec]) using Fridericia’s QT correction formula seen ≤ 28 days of registration.
  • Any of the following co-morbid conditions:
    • Known cataracts or retinopathy;
    • History of deep vein thrombosis (DVT)/pulmonary embolism (PE);
    • Known activated protein C (APC) resistance, an inherited coagulation disorder.
  • Evidence of the following laboratory abnormalities ≤ 28 days of registration:
    • Creatine clearance < 60 mL/min;
    • Total bilirubin ≥ 1.5 x upper limit of normal (ULN);
    • Aspartate aminotransferase (AST) or alanine amino transferase (ALT) ≥ 2.5 x ULN;
    • Platelet count (PLT) ≤ 75,000/mm^3;
    • Hemoglobin (Hb) ≤ 10 g/dL.
  • Hormonal therapies including birth control and hormone replacement therapy during the study or within 1 week of registration or prior use of androgen-based therapy.
  • Allergy to endoxifen, goserelin, or exemestane or any of their components.
  • Participation in another investigational clinical trial ≤ 6 months of registration.
  • Known metastatic disease.

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

Eligibility last updated 12/20/23. Questions regarding updates should be directed to the study team contact.

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Tiered Inpatient Telemetry - Validation

Tiered Inpatient Telemetry

Peter Noseworthy
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307454-H01-RST
22-003171
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Inclusion Criteria:

  • Age 18+.
  • Capable of consenting.
  • Actively being monitored on Philips inpatient telemetry.


Exclusion Criteria:

  • Under the age of 18.
  • Unable to consent.
  • Pregnant patients.

Eligibility last updated 4/21/22. Questions regarding updates should be directed to the study team contact.

 

 

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A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY EVIDENCE OF ANTI-TUMOR ACTIVITY OF PF-07284892 (ARRY-558) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

PF-07284892 in Participants With Advanced Solid Tumors

Mojun Zhu
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-308369-P01-RST
22-005789
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Inclusion Criteria:


- Age ≥18 years at the time of informed consent.

- Histological or cytological diagnosis of ALK-positive advanced NSCLC, CRC with BRAF
V600E mutation, or RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumor.
Participants with ROS-positive NSCLC are also eligible for Part 1 and 2.

- Documentation evidence of biomarker mutation status.

- Part 3:

ALK-positive NSCLC with prior lorlatinib and no prior platinum-based chemotherapy (Cohort
1); with prior lorlatinib and prior platinum-based chemotherapy (Cohort 2); or with no
prior lorlatinib (Cohort 3).

BRAF V600E mutant CRC participants resistant to BRAFi plus EGFRi (Cohort 4 ); refractory to
BRAFi plus EGFRi (Cohort 5); or BRAFi plus EGFRi naïve (Cohort 6).

RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior SOC
(Cohort 7).


Exclusion Criteria:


- Brain metastasis larger than 4 cm.

- Active malignancy within 3 years.

- Systemic anti-cancer therapy or small molecule therapeutics within 2 weeks prior to
start of study treatment. Antibody based agents within 4 weeks prior to start of study
treatment. Mitomycin C or nitrosoureas within 6 weeks prior to start of study
treatment.

- For participants who may get lorlatinib or encorafenib on study, history of
interstitial lung disease.

- For participants who may get binimetinib on study, history or current evidence of
retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with
elevated creatine kinase (CK).

Eligibility last updated 5/27/22. Questions regarding updates should be directed to the study team contact.

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Treatment of head pain with the SPRINT® Peripheral Nerve Stimulation (PNS) System

SPRINT® Peripheral Nerve Stimulation (PNS) System to Treat Head Pain

Matthew Pingree
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308839-P01-RST
22-007771
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Inclusion Criteria:
 

  • At least 18 years old.
  • Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON) (e.g., in accordance with International Classification of Headache Disorders 3rd edition [ICHD-3] criteria).
  • Average occipital head pain score in the last week ≥ 4 on a scale of 0-10 (Brief Pain Inventory
    •Short Form [BPI-SF], question #5) at baseline.
  • Average occipital head pain interference score in the last week ≥ 4 on a scale of 0-10 (BPI-SF, question #9) at baseline.
  • Able to understand and willing to take part in study and comply with all study requirements.


Exclusion Criteria:

  • Change of prescribed medications affecting pain from 4 weeks prior to the Consent and Baseline Visit (Visit 1).
  • Radiofrequency ablation in the affected area within the last six months.
  • Botulinum toxin injection in the affected area within the last three months.
  • Steroid injection in the affected area within the last six weeks.
  • Other confounding therapies including previous destructive ganglionectomy, rhizotomy section or neurectomy procedure affecting C2/C3/occipital distribution.
  • Beck Depression Inventory (BDI-II) score of > 20.
  • Head pain is attributed to a headache condition other than CGH or ON, including (but not limited to) episodic or chronic migraine, tension-type headache, analgesic medication over-use or withdrawal headache, cluster headache, or vascular and non-vascular intracranial disorders.
  • Pain is primarily in the distribution of the lesser occipital nerves.
  • ID Migraine screener score of ≥ 2.
  • Current daily opioid use ≥ 50 MME (morphine milligram equivalents).
  • Compromised immune system based on medical history (i.e., human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS), immunosuppressive therapies such as chemo treatment, radiation, sepsis, active joint or overlying skin infection of the cervical or occipital regions), or other condition that in the opinion of the investigator places the subject at increased risk.
  • Implanted active cardiac implant (e.g., pacemaker or defibrillator); deep brain stimulator; metallic implant near the stimulation site such as cerebrospinal fluid (CSF) shunt or aneurysm clip; any other implantable neuro-stimulator whose stimulus current pathway may overlap with the SPRINT system, such as a spinal cord stimulator in the cervical region; or cochlear implant.
  • Severe traumatic brain injury (TBI), spinal cord injury, or other central nervous system (CNS) conditions including epilepsy that could be aggravated by the PNS treatment or confound the analysis.
  • Allergy to skin-contact materials (stickers, bandages, tape etc.).
  • Previous cervical or cranial occipital surgery, such as decompression of the occipital nerve(s), or cervical spine surgery such as laminectomy or fusion at or above the C3 level.
  • Participation in any drug or device trial in the past 30 days
  • Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement or bandaging) as determined by the Investigator.
  • Potential secondary gain conflicts of interest (e.g., pending claims or receiving disability).
  • Vulnerable populations (e.g., prisoners, individuals that report to investigators).
  • Pregnant or planning to become pregnant during the study treatment period (either urine dipstick or serum in females of reproductive potential to be assessed prior to lead placement procedure).

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.

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

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

Marina Walther-Antonio
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304449-H01-RST
21-004234
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Inclusion Criteria:

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


Exclusion Criteria:

  • Patients who are institutionalized or incarcerated.
  • Patients without the cognitive capacity to consent.
Device, Procedure/Surgery, Other
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OtoVU Design and Human Factors Validation

Human Factors Validation of OtuVU

Colin Lea Driscoll
All
18 years and over
This study is NOT accepting healthy volunteers
2022-309065-P01-RST
22-008174
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Inclusion Criteria:

Study participants taking  the role as circulating clinical personnel and scrub personnel must have the following:

  • A high school diploma, or equivalent, minimum level of education.
  • Professional working proficiency, or higher, in English.
  • Experience working in the OR and trained in aseptic technique.
  • The role of circulating clinical personnel can be undertaken by the following people: doctor, surgeon, surgical trainee, surgical technician, or other adequately trained personnel.
  • The role of scrub personnel can be undertaken by the following people: surgical technician, surgeon, surgical trainee, or other adequately trained personnel.

Study participants taking the role of the surgeon must have the following:

  • A good working knowledge of ENT anatomy.
  • Have worked with cadaveric tissue or live patients in the past.


Exclusion Criteria:
 

  • < 18 years of age. 
  • The role of surgeon can be undertaken by the following people: surgeon or surgical trainee. Individuals may take on multiple roles throughout the study, but not during the same test session.

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

Eligibility last updated 8/4/22. Questions regarding updates should be directed to the study team contact.

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Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe)

Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

Roberto Leon Ferre
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101225-P01-RST
20-000233
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Inclusion Criteria:

  • Signed and dated written informed consent.
  • Subjects ≥ 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Clinical stage IV invasive breast cancer or unresectable locoregional recurrence of invasive breast cancer meeting the following criteria:
    • Estrogen receptor (ER)/progesterone receptor (PR)-negative (≤ 5% cells) by immunohistochemistry (IHC) and human epidermal grow (HER2) negative (by IHC or fluorescence in situ hybridization (FISH));
    • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and which can be followed by computed tomography (CT) or magnetic resonance imaging (MRI). A measurable lytic bone lesion(s) and/or skin lesion(s) are allowed. Skin lesions must also be followed by photography with measuring tools within the photograph at each tumor evaluation time point. Ultrasound may be used to follow breast lesions not visible by CT following discussion with Study Chair;
    • Amenable to biopsy at the time of study entry;
    • Known tumor/immune cell PD-L1 status by any assay.
  • Adequate organ function including:
    • Cardiac ejection fraction at or above the institutional lower limit of normal, as assessed by either echocardiogram or multigated acquisition (MUGA) scan;
    • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L (may have received growth factor);
    • Platelets ≥ 100 x 10^9/L;
    • Hemoglobin ≥ 9 g/dL (may have been transfused);
    • Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN);
    • Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase (SGOT)) and alanine aminotransferase (ALT/serum glutamate pyruvate transaminase (SGPT)) ≤ 2.5 x ULN (or ≤ 5 x ULN if liver metastases are present);
    • Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as calculated using the Cockcroft-Gault (CG) equation;
    • Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 x ULN;
    • Thyroid stimulating hormone (TSH) within institutional normal limits (enrollment of patients with TSH levels above or below the institutional normal limit in situations where the patient has normal levels of triiodothyronine (T3) and free thyroxine (FT4) may be allowed following discussion with study chair);
    • Amylase ≤ 1 x ULN (Abnormality not of pancreatic origin is allowed);
    • Lipase ≤ 1 x ULN (Abnormality not of pancreatic origin is allowed).
  • Male and female patients of childbearing potential must agree to use at least two methods of acceptable contraception from 15 days prior to first trial treatment administration until at least 30 days after study participant's final dose of study drug(s).
    • * NOTE: Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e., patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrhoeic for 12 months without an alternative medical cause). Post-menopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women.
  • Patients unable to read/write in English are eligible to participate in the overall study but will not participate in the Patient-Reported Outcome questionnaires throughout the trial.
  • Re-enrollment of a subject that has discontinued the study as a pre-randomization screen failure (i.e., a consented patient who was not randomized and did not receive any study treatment) is permitted. If re-enrolled, the subject must be re-consented. Only the screening procedures performed outside of protocol-specified timing must be repeated; if biopsies and correlative blood samples were already obtained, and patient has not received any systemic anti-cancer therapy since they were obtained, they do not need to be repeated.


Exclusion Criteria:

  • More than 2 lines of chemotherapy in the metastatic setting.
  • More than 1 prior line of checkpoint inhibitor therapy in the metastatic setting.
  • Prior treatment with sacituzumab, govitecan.
  • Concurrent anticancer therapy. Required washout from prior therapies are as follows:
    • Chemotherapy: ≥ 14 days;
    • Major surgery: ≥ 14 days (provided wound healing is adequate);
    • Radiation: ≥ 7 days;
    • Investigational/biologic therapy (half-life ≤ 40 hours): ≥ 14 days;
    • Investigational/biologic therapy (half-life > 40 hours): ≥ 28 days;
    • Use of corticosteroids or immunosuppressive medication is exclusionary, except the following in the absence of active autoimmune disease:
    • Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g., topical, ocular, intra-articular, intranasal, and inhaled) -Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent are permitted;
    • Adrenal replacement steroid doses including doses > 10 mg daily prednisone are permitted;
    • A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., CT scan premedication against contrast dye allergy) or for treatment of nonautoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.
  • Previous malignant disease other than breast cancer within the last 5 years, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e., complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).
  • All subjects with central nervous system metastases and/or carcinomatous meningitis, except those meeting the following criteria: 
    • Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment;
    • No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable);
    • Subjects must be either off steroids or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
  • Receipt of any organ transplantation including allogeneic stem-cell transplantation.
  • Significant acute or chronic infections including, among others:
    • Known history of testing positive for human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) - testing is not required for this protocol;
    • A history of a positive test for hepatitis B virus (HBV) surface antigen (and/or core antibody) and/or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)
      •testing is not required for this protocol.
    • Active autoimmune disease with reasonable possibility of clinically significant deterioration when receiving an immunostimulatory agent:
    • Subjects with type 1 diabetes mellitus, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;
    • Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day
    • Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is acceptable.
  • History of interstitial lung disease that is symptomatic or which may interfere with the detection or management of suspected drug-related pulmonary toxicity.
  • Uncontrolled asthma (defined as having 3 or more of the following features of partially controlled asthma within 28 days prior to starting study treatment: Daytime symptoms more than twice per week, any limitation of activities, any nocturnal symptoms/awaking, need for reliever/rescue inhaler more than twice per week, or known lung function [peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1)] without administration of a bronchodilator that is < 80% predicted or personal best [if known]).
  • Current symptomatic congestive heart failure (New York Heart Association > class II), unstable cardiac arrhythmia requiring therapy (e.g., medication or pacemaker), unstable angina (e.g. new, worsening or persistent chest discomfort), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100mmHg), or known cardiac ejection fraction below the lower limit of institutional normal. Or any of the following occurring within 6 months (180 days) prior to first dose of avelumab: Myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack. (Use of antihypertensive medication to control blood pressure is allowed).
  • Patients who have neuromuscular disorders that are associated with elevated creatine kinase (CK).
  • History of acute or chronic pancreatitis.
  • History or current evidence of retinal vein occlusion (RVO), or current risk factors for RVO including uncontrolled glaucoma, ocular hypertension, history of hyperviscosity, or hypercoagulability syndromes (patients with a history of pulmonary embolism or deep vein thrombosis (DVT) are allowed on study if they are also on anticoagulation as noted in (16) below) ; history of retinal degenerative disease.
  • Requirement of anticoagulant therapy with oral vitamin K antagonists such as Coumadin (warfarin). Low-dose anticoagulants for the maintenance of patency in a central venous access device or the prevention of deep vein thrombosis or pulmonary embolism is allowed. Therapeutic use of low molecular weight heparin or factor Xa inhibitors are allowed provided patients are safely able to interrupt it prior to biopsy procedures.
  • Persisting toxicity related to prior therapy that has not reduced to grade 1 (National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0); however, alopecia and sensory neuropathy grade ≤ 2 is acceptable.
  • Known severe (grade ≥ 3 NCI-CTCAE v5.0) hypersensitivity reactions to monoclonal antibodies, or history of anaphylaxis.
  • Vaccination within 28 days of the first dose of study drugs and while on trial is prohibited, except for administration of inactivated vaccines (for example, inactivated influenza vaccine).
  • Pregnant or breastfeeding females.
  • Known current alcohol or drug abuse.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient's study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements.

Eligibility last updated 9/20/21. Questions regarding updates should be directed to the study team contact.

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MC210301 Long Term Followup of Patients Enrolled in MC1137 (BEAUTY) (BEAUTY)

Long-term Follow Up of Patients Previously Enrolled in MC1137 (BEAUTY)

Judy Boughey
Female
18 years and over
This study is NOT accepting healthy volunteers
2021-305936-P01-RST
21-010580
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Inclusion Criteria:

For patients still alive:

  • Enrolled in BEAUTY Study (MC1137) and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up.
  • Able to provide written informed consent.
  • Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.
  • Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.
  • Willingness to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY (Request tissue from prior biopsy of site of recurrence).
  • Ability to complete questionnaires by themselves or with assistance.

For patients who have died:

  • Enrolled in MC1137 and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up.
  • Existence of a family member willing to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY.


Exclusion Criteria:
 

  • Not enrolled in BEAUTY study (MC1137).

Eligibility last updated 6/30/22. Questions regarding updates should be directed to the study team contact.

 

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A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies

Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies

Paul Hampel
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306097-P01-RST
21-013100
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Key

Inclusion Criteria:


Confirmed diagnosis of one of the following:

NHL Cohorts:

1. MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment

2. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was
refractory to, at least 1 prior systemic therapy

3. DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy).

4. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1

CLL/SLL Cohorts:

5. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R
disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history

MCL cohorts:

6. WHO-defined MCL I. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the
investigatorr

WM cohorts:

g. WHO-defined WM (clinical and definitive histologic diagnosis) i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy; ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's Macroglobulinemia (Dimopoulos et al 2014)

- Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined as:

1. CLL: at least 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry

2. DLBCL, FL, MZL, SLL: at least 1 lymph node > 1.5 cm in longest diameter OR 1 extranodal lesion > 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Adequate organ function

- Adequate pancreatic function indicated by:

1. Serum amylase ≤ 1.5 x upper limit of normal (ULN)

2. Serum lipase ≤ 1.5 x ULN

Key
Exclusion Criteria:

Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer

- Known central nervous system involvement by lymphoma/leukemia

- Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome

- Prior therapy ≥ 2 months with or progression on a B-cell lymphoma-2 (Bcl-2) inhibitor

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

Eligibility last updated 1/8/24. Questions regarding updates should be directed to the study team contact.

Drug, Behavioral
Cancer, Chronic lymphocytic leukemia, Diffuse large b-cell lymphoma, Follicular lymphoma, Lymphoma, Mantle cell lymphoma, Non-Hodgkin's lymphoma, Recurrent cancer, Waldenstrom macroglobulinemia
Cancer treatment, Chronic lymphoid leukemia, disease, Diffuse non-Hodgkin's lymphoma, large cell (clinical), Follicular non-Hodgkin's lymphoma, Hematopoietic system, Lymphatic system, Malignant lymphoma - small lymphocytic, Mantle cell lymphoma, Medical Oncology, Waldenström macroglobulinemia, Zanubrutinib [USAN:INN], zanubrutinib, Zanubrutinib
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Impact of CardiolRxTM on Recurrent Pericarditis An Open Label Pilot Study

Impact of CardiolRxTM on Recurrent Pericarditis

Sushil Luis
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-309084-P01-RST
22-008276
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Inclusion Criteria:


1. Male or female 18 years of age or older

2. Diagnosis of at least two episodes of recurrent pericarditis*,

3. At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS)
within prior 7 days

4. One of;

1. C-Reactive Protein** (CRP) level ≥1.0 mg/dL within prior 7 days OR

2. Evidence of pericardial inflammation assessed by delayed pericardial
hyperenhancement on cardiac magnetic resonance imaging (CMR)

5. Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine
and/or corticosteroids (in any combination) for treatment of pericarditis in stable
doses

6. Male patients with partners of childbearing potential who have had a vasectomy or are
willing to use double barrier contraception methods during the conduct of the study
and for 2 months after the last dose of study drug.

7. Women of childbearing potential willing to use an acceptable method of contraception
starting with study drug administration and for a minimum of 2 months after study
completion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal
bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥40 mIU/mL
[or ≥ 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile.

- Diagnosis of pericarditis according to the 2015 European Society of Cardiology
(ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler
et al. 2015):

At least two of:

1. Pericarditic chest pain

2. Pericardial rub

3. New widespread ST-segment elevation or PR-segment depression according to
electrocardiogram (ECG) findings

4. Pericardial effusion (new or worsening)

- Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP


Exclusion Criteria:


1. Diagnosis of pericarditis that is secondary to specific prohibited etiologies,
including tuberculosis (TB); neoplastic, purulent, or radiation etiologies;
post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis

2. Estimated glomerular filtration rate (eGFR) <30 mL/min at screening

3. Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times
the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN

4. Sepsis, defined as documented bacteremia at the time of screening or other documented
active infection

5. Prior history of sustained ventricular arrhythmia

6. History of QT interval prolongation

7. QTc interval > 500 msec

8. Current participation in any research study involving investigational drugs or device

9. Inability or unwillingness to give informed consent

10. Ongoing drug or alcohol abuse

11. On any cannabinoid during the past month

12. Women who are pregnant or breastfeeding

13. Current diagnosis of cancer, with the exception of non-melanoma skin cancer

14. Any factor, which would make it unlikely that the patient can comply with the study
procedures

15. Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS),
administered at screening

16. On digoxin and/or type 1 or 3 antiarrhythmics

17. On immunosuppressive therapy with any of the following:

1. Rilonacept

2. Anakinra

3. Canakinumab

4. Methotrexate

5. Azathioprine

6. Cyclosporine

7. Intravenous immune globulin (IVIG)

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

Eligibility last updated 3/28/23. Questions regarding updates should be directed to the study team contact.

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A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (CLP05)

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Geoffrey Johnson
Male
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-304957-P01-RST
21-006009
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Inclusion Criteria:

  • Signed informed consent.
  • ≥ 18 years of age.
  • Eastern Cooperative Oncology Group performance status of 0 to 2.
  • Life expectancy > 6 months;.
  • Histological, pathological, and/or cytological confirmation of PCa.
  • Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SARbisPSMA uptake (standardized uptake value [SUV] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan.
    • NOTE: ALL OTHER ELIGIBILITY CRITERIA MUST BE FULFILLED BEFORE THE 64Cu-SAR-bisPSMA ADMINISTRATION IS PERMITTED. THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE DOSIMETRY PHASE;
  • Castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
  • Have progressive mCRPC despite prior androgen deprivation therapy and at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria:
    • Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL;
    • Soft-tissue progression defined as a ≥ 20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD  since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;
    • Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.
  • ≥ 1 metastatic lesion that is present at screening CT, magnetic resonance imaging (MRI), or bone scan imaging obtained ≤ 28 days prior to enrollment into the study.
  • Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.).
  • Participants must have adequate organ function:
  • Bone marrow reserve:
    • White blood cell (WBC) count ≥ 2.5 x 10⁹/L (2.5 x 109/L is equivalent to 2.5 x 10³/μL and 2.5 x K/μL and 2.5 x 10³/cc and 2500/μL); OR
    • Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L (1.5 x 10⁹/L is equivalent to 1.5 x 10³/μL and 1.5 x K/μL and 1.5 x 10³/cc and 1500/μL);
  • Platelets ≥ 100 x 10⁹/L (100 x 10⁹/L is equivalent to 100 x 10³/μL and 100 x K/μL and 100 x 10³/cc and 100,000/μL);
  • Hemoglobin ≥ 9 g/dL (5.59 mmol/L);
  • Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted;
  • Alanine aminotransferase or aspartate aminotransferase ≤ 3.0 x ULN OR ≤ 5.0 x ULN for participants with liver metastases;
  • Creatinine clearance or estimated glomerular filtration rate ≥ 50 mL/min.;
  • For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator;
  • For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.


Exclusion Criteria:

  • Major surgery within 12 weeks prior to enrollment into the study.
  • Brain metastasis.
  • Histologic  diagnosis  of  small  cell  or  neuroendocrine  prostate cancer.
  • Prior history of leukemia or Myelodysplastic Syndrome.
  • Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study.
  • Unmanageable urinary tract obstruction.
  • Evidence of progressive lesion(s) on MRI and/or CT (> 1 cm in mean   diameter) that is prostate-specific   membrane   antigen (PSMA)  negative  on  the  1  hour  ⁶⁴Cu-SAR-bisPSMA  PET/CT scan  as  determined  at  screening.
    • NOTE:  THIS  CRITERION  IS NOT APPLICABLE TO PARTICIPANTS IN THE DOSIMETRY AND DOSE ESCALATION PHASE.
  • Previous  treatment  with  any  systemic  radionuclide  (e.g.,  Lu, Strontium-89,   Samarium-153,    Rhenium-186,    Rhenium-188, Actinium-225,  Radium-223,  Iodine-131)  within  6 months  of treatment initiation;
  • Previous  treatment  with  any  systemic  anti-cancer  therapy  (e.g., chemotherapy, immunotherapy  or  biological  therapy  [including monoclonal  antibodies])  within  4  weeks prior  to  treatment  on study  with  the  exception  of  Luteinizing  Hormone  Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is  discontinued  prior  to  enrolment,  14  days  must  elapse after abiraterone discontinuation and 28 days after enzalutamide before participant can be enrolled) or low dose corticosteroids.
    • NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE DOSIMETRY PHASE.
  • Previous treatment with any investigational agents within 4 weeks prior enrollment into the study.
  • Known hypersensitivity to the components of the investigational products or its analogues.
  • Transfusion for the sole purpose of making a participant eligible for study inclusion.
  • Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  • Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that, in the opinion of the Investigator, would impair study participation or cooperation.
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer.
  • Any condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or carer at the time of release following the completion of therapy (e.g., uncontrolled urinary incontinence, high dependency care).
  • Participants in whom it is known that EBRT is scheduled after enrollment into the study.
    • NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE DOSIMETRY PHASE.
Drug
Cancer, Prostate cancer
Cancer treatment, Medical Oncology, Metastatic castration-resistant prostate cancer, Reproductive system
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Understanding the Baseball Swing Through Motion Capture (MoCap)

A Study of the Baseball Swing Through Motion Capture

Christopher Camp
Male
14 years to 30 years old
This study is NOT accepting healthy volunteers
2021-306490-H01-RST
21-012145
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Inclusion Criteria:

  • Age 15-30 years inclusive.
  • Male gender.
  • Active participation in collegiate level baseball as a batter.
  •  Unrestrictive baseball participation.
  • No current musculoskeletal complaints for which the subject is being treated.
  • Full pain-free range of motion (ROM) of the bilateral upper and lower limbs.
  • Willingness to participate in the study


Exclusion Criteria:
 

  • Current upper limb, lower limb, or spine musculoskeletal pain complaint for which the subject is taking prescribed medication, has modified activity, or received treatment from a medical care provider.
  • Known neurological, visual, or vestibular disease affecting balance or coordination.
  • Congenital deformity of the neck, upper extremity, or lower extremity.
  • Congenital or acquired scoliosis or significant thoracic kyphosis (>30 degrees).
  • History of connective tissue disease (defined as rheumatoid arthritis, systemic lupus erythematosus, or a seronegative spondylarthropathy).

Eligibility last updated 2/27/23. Questions regarding updates should be directed to the study team contact.

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Early Naturalistic Hands-on Autism Caregiver Training (ENHAnCE) Study (ENHANCE)

Early Naturalistic Hands-on Autism Caregiver Training

Andrea Huebner
All
2 years to 75 years old
This study is NOT accepting healthy volunteers
2022-307776-H01-RST
22-004265
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Inclusion Criteria:

  • Children diagnosed with autism spectrum disorder (ASD).
  • Between 2 years, 0 months to 4 years, 11 months of age.
  • With less than phrased speech.
  • Child must have at least one caregiver willing to participate in the study.


Exclusion Criteria:

  • Children and parents if they do not meet the above inclusion criteria.

     

Autism spectrum disorder
Autism spectrum disorder
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MC210806, Phase 2 study of MRD guided, fixed duration therapy for previously untreated chronic lymphocytic leukemia with LOXO-305 and venetoclax (MIRACLE) (MIRACLE)

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

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


- PRE-REGISTRATION
•INCLUSION CRITERIA

- Age >= 18 years.

- Confirmed diagnosis of CLL according to the International Workshop on (iw)CLL 2018
criteria or biopsy proven SLL according to the World Health Organization (WHO)
criteria.

- NOTE: The diagnosis of CLL requires the presence of > 5 × 10^9/L B lymphocytes in
the peripheral blood. Typically, CLL cells express CD19, CD5, and CD23, with
variable expression of CD20 (typically dim), and show kappa or lambda light chain
restriction.

- NOTE: A diagnosis of mantle cell lymphoma must be excluded by demonstrating a
negative cyclin D1 expression and/or a negative t(11;14) translocation.

- No prior CLL/SLL-directed therapy such as chemotherapy, immunotherapy, targeted
therapy with small molecule inhibitors, radiation therapy, or cellular therapy.

- NOTE: Nutraceutical treatments with no established benefit in CLL (such as
epigallocatechin gallate or EGCG, found in green tea or other herbal treatments
or supplemental vitamins) will not be considered prior CLL/SLL-directed therapy.

- NOTE: Prior corticosteroid therapy for an indication other than CLL/SLL will not
be considered prior CLL/SLL-directed therapy.

- NOTE: A short course of corticosteroid (e.g., =< 1 week of intravenous or =< 2
weeks of oral corticosteroid) given for acute SLL-related symptoms or impending
severe organ dysfunction is allowed.

- Provide written informed consent.

- REGISTRATION
•INCLUSION CRITERIA

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

- Meeting at least one of the following indications for treatment:

- Evidence of progressive marrow failure as manifested by the development of, or
worsening of, anemia (Hb < 11 g/dL) and/or thrombocytopenia (platelet counts <
100 × 10^9/L).

- Massive nodes (i.e., >= 10 cm in longest diameter) or progressive or symptomatic
lymphadenopathy.

- Progressive lymphocytosis with an increase of >= 50% over a 2-month period, or
lymphocyte doubling time (LDT) < 6 months. LDT can be obtained by linear
regression extrapolation of absolute lymphocyte counts obtained at intervals of 2
weeks over an observation period of 2 to 3 months; patients with initial blood
lymphocyte counts < 30 × 10^9/L may require a longer observation period to
determine the LDT. Factors contributing to lymphocytosis other than CLL (e.g.,
infections, steroid administration) should be excluded.

- Autoimmune complications including anemia or thrombocytopenia poorly responsive
to corticosteroids.

- Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung,
spine).

- Disease-related symptoms as defined by any of the following:

- Unintentional weight loss >= 10% within the previous 6 months.

- Significant fatigue (i.e., cannot work or unable to perform usual activities).

- Fevers >= 100.4°F or 38.0°C for 2 or more weeks without evidence of infection.

- Night sweats for >= 1 month without evidence of infection.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

- Absolute neutrophil count (ANC) >= 0.75 × 10^9/L (750/mm^3) (obtained =< 14 days prior
to registration)

- Platelet count >= 50 × 10^9/L (obtained =< 14 days prior to registration)

- Hemoglobin >= 8 g/dL (obtained =< 14 days prior to registration)

- Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and
prothrombin (PT) or international normalized ratio (INR) =< 1.5 × upper normal limit
(ULN) (obtained =< 14 days prior to registration)

- Total bilirubin =< 1.5 × ULN (or =< 3 × ULN if there is evidence of parenchymal liver
involvement with CLL/SLL); patients with hemolysis or Gilbert's disease may enroll if
indirect bilirubin is =< 3 × ULN and direct bilirubin is =< 1.5 × ULN (obtained =< 14
days prior to registration)

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 × ULN (or =<
5 × ULN if there is evidence of parenchymal liver involvement with CLL/SLL) (obtained
=< 14 days prior to registration)

- Calculated creatinine clearance >=40 ml/min using the Cockcroft-Gault formula.

- Negative serum pregnancy test done =< 7 days prior to registration, for persons of
childbearing potential only.

- NOTE: Persons of reproductive potential is defined as following: menarche and who
are not postmenopausal (and 2 years of non-therapy-induced amenorrhea) or
surgically sterile.

- Male and females of reproductive potential must agree to use a highly effective
(preferred) or an acceptable form of birth control during study treatment and for 6
months following the last dose of pirtobrutinib.

- Males must be willing to not donate sperm during the study and for 6 months after the
last dose of any study drug.

- Willingness to provide mandatory research blood, bone marrow, saliva, and stool
specimens for correlative research.

- Willing to return to enrolling institution for follow-up (during treatment and
Clinical Follow-up).


Exclusion Criteria:


- REGISTRATION
•EXCLUSION CRITERIA

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

- Pregnant persons.

- Nursing persons (lactating persons are eligible provided that they agree not to
breast feed while receiving treatment on the study or within 6 months of the last
dose of study treatment).

- Male or females of reproductive potential who are unwilling to employ adequate
contraception during treatment and for 6 months after pirtobrutinib.

- Evidence of Richter transformation.

- Central nervous system (CNS) involvement of CLL/SLL (e.g., any parenchymal,
leptomeningeal, cerebrospinal fluid [CSF], cranial or spinal nerve root involvement).

- Active uncontrolled autoimmune complications (e.g., active autoimmune hemolytic anemia
or clinically significant immune thrombocytopenia).

- Receiving any other investigational agent which would be considered as a treatment for
the CLL/SLL (with the exception of corticosteroid).

- Any of the following medication requirement or recent use:

- Requirement of a strong cytochrome P450 (CYP) 3A inhibitor or inducer during the
study.

- Use of a strong or moderate CYP3A inhibitor or inducer =< 7 days prior to
registration.

- Requirement of a strong P-glycoprotein 1 (PgP) inhibitor during the study.

- Anticoagulation with a vitamin K antagonist =< 7 days prior to registration or
anticipated use during the study.

- Vaccination with live vaccine =< 28 days prior to registration.

- NOTE: Because of their effect on CYP3A4, use of any of the following =< 3
days of study therapy start or planned use during study participation is
prohibited:

- Grapefruit or grapefruit products.

- Seville oranges or products from Seville oranges.

- Star fruit.

- Malabsorption syndrome or other condition that precludes enteral route of
administration.

- History of a bleeding diathesis (e.g., hemophilia, von Willebrand disease, etc.).

- Patients who have tested positive for Human Immunodeficiency Virus (HIV) are excluded
due to potential drug-drug interactions between anti-retroviral medications and
pirtobrutinib and risk of opportunistic infections with both HIV and irreversible BTK
inhibitors. For patients with unknown HIV status, HIV testing will be performed at
Screening and result should be negative for enrollment.

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens.

- Uncontrolled intercurrent illness including, but not limited to:

- Ongoing or active infection.

- Known active cytomegalovirus (CMV) infection is ineligible; unknown or
negative status are eligible.

- Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen
(HBsAg) are excluded. Patients with positive hepatitis B core antibody
(anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction
(PCR) evaluation. Patients who are hepatitis B PCR positive will be
excluded.

- Hepatitis C virus (HCV): If hepatitis C antibody result is positive, patient
will need to have a negative result for hepatitis C ribonucleic acid (RNA).
Patients who are hepatitis C RNA positive will be excluded.

- New York Heart Association (NYHA) Class III or IV or symptomatic congestive heart
failure.

- Documented left ventricular ejection fraction (LVEF) by any method of =< 40% =<
12 months prior to registration.

- Unstable angina or acute coronary syndrome =<3 months prior to registration.

- History of myocardial infarction =< 6 months prior to registration.

- Uncontrolled or symptomatic cardiac arrhythmia.

- NOTE: Patients with pacemakers are eligible if they have no history of
fainting or clinically relevant arrhythmias while using the pacemaker

- Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec on at
least 2/3 consecutive electrocardiograms (ECGs), and mean QTcF > 470 msec on all
3 ECGs, during screening.

- NOTE: QTcF is calculated using Fridericia's Formula (QTcF): QTcF=QT/?RR.

- NOTE: Correction for a widened QRS complex such as pacing, underlying bundle
branch block (BBB), etc. is allowed. e.g., "Adjusted QTcF" = measured QTcF -
(measured QRS
•90 ms).

- NOTE: Correction of suspected drug-induced QTcF prolongation can be
attempted at the investigator's discretion and only if clinically safe to do
so with either discontinuation of the offending drug or switch to another
drug not known to be associated with QTcF prolongation.

- History of cerebral vascular accident =< 6 months prior to registration.

- Ongoing inflammatory bowel disease (such as ulcerative colitis) requiring active
treatment.

- Oxygen dependent baseline lung disease (such as interstitial lung disease or
chronic obstructive pulmonary disease [COPD]).

- Psychiatric illness/social situations that would limit compliance with study
requirements.

- Major surgery =< 4 weeks prior to registration.

- Other active primary malignancy (other than localized non-melanotic skin cancer or
carcinoma in situ of the cervix) requiring treatment or limiting expected survival to
=< 2 years.

- NOTE: If there is a history of prior malignancy, the patient must not require
ongoing therapy such as radiation, chemotherapy, or immunotherapy for their
cancer. Patients on hormonal therapy for adequately treated nonmetastatic breast
or prostate cancer are permitted if they meet other eligibility criteria.

- Have a known hypersensitivity to any of the excipients of pirtobrutinib.

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

Eligibility last updated 10/12/23. Questions regarding updates should be directed to the study team contact.

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A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis (EPICS-III)

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

John Eaton
All
18 years to 75 years old
Phase 2/3
This study is NOT accepting healthy volunteers
2022-307656-P01-RST
22-003097
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Inclusion Criteria:


1. Males or females, between 18 and 75 years of age, both inclusive at screening.

2. Subjects on Ursodeoxycholic acid (UDCA) for at least 12 months at a therapeutic dose
(at least 13 mg/kg per day) and a stable dose for 6 months prior to Screening Visit
and having ALP ≥ 1.67 x ULN.

OR Subjects who are unable to tolerate UDCA and did not receive UDCA for at least 3
months prior to the date of screening and having ALP ≥ 1.67 x ULN.

3. History of confirmed PBC diagnosis, based on American Association for the Study of
Liver Disease [AASLD] and European Association for Study of the Liver [EASL] Practice
Guidelines, as demonstrated by the presence of at least ≥ 2 of the following 3
diagnostic factors:

1. History of elevated ALP levels for at least 6 months prior to screening

2. The subjects should have positive anti-mitochondrial antibodies (AMA) titer OR if
AMA is negative or in low titer (< 1:80), then the subjects should have PBC
specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the
major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])

3. Liver biopsy consistent with PBC

4. ALP ≥ 1.67 x ULN at both Visits 1 and 2 and with < 30% variance between the levels
from Visit 1 to Visit 2

5. Total bilirubin < 2 x ULN at screening (Visit 1)

6. Must provide written informed consent and agree to comply with the trial protocol


Exclusion Criteria:


1. Consumption of 2 standard alcohol drinks per day if male and 1 standard alcohol drink
per day if female for at least 3 consecutive months (12 consecutive weeks) within 5
year before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce
of spirits/hard liquor).

2. History or presence of other concomitant liver diseases at screening:

1. Chronic hepatitis B or C virus (HBV, HCV) infection. (Note: However, If the
subject has been treated for the HCV infection and has been cured for a duration
of more than 2 years from screening, such subjects can be enrolled in the study)

2. Primary sclerosing cholangitis (PSC).

3. Alcoholic liver disease.

4. Autoimmune hepatitis (AIH) indicative of PBC with overlap syndrome.

Note: The Paris criteria are commonly used to define the presence of PBC with
features of AIH and have been endorsed by EASL and AASLD. According to these
criteria, a diagnosis can be made in a patient with PBC as follows:

At least two of the following:

I. ALP > 2 x ULN or GGT > 5 x ULN. II. AMA > 1:40. III. Florid bile duct lesion
on histology. AND

At least two of the following three features:

I. ALT > 5 x ULN. II. Immunoglobulin G serum levels > 2 x ULN or smooth muscle
autoantibody positive.

III. Moderate to severe interface hepatitis on histology.

5. Hemochromatosis.

6. Non-alcoholic steatohepatitis (NASH) on historical biopsy.

3. Cirrhosis with complications, including history or presence of: spontaneous bacterial
peritonitis, hepatocellular carcinoma, encephalopathy, known large esophageal varices
or history of variceal bleeding and active or history of hepatorenal syndrome at
screening.

4. Clinically silent compensated cirrhosis (at screening), defined as (a) nodular liver
contour by abdominal imaging with at least one sign of liver dysfunction (> ULN INR or
< LLN serum albumin); or (b) prolonged INR (> ULN) and diminished albumin (< LLN); or
(c) platelet count <140x109/L with INR > ULN or serum albumin < LLN.

5. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
or which may diminish life expectancy to < 2 years, including known cancers.

6. Use of thiazolidinediones or fibrates (within 12 weeks prior to screening).

7. Use of obeticholic acid (OCA), azathioprine, cyclosporine, methotrexate,
mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (Note:
Prednisone dose should not be more than 10 mg per day); potentially hepatotoxic drugs
(including ?-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within
12 weeks prior to screening).

8. Use of drugs that are known CYP2C8 inhibitors/substrate within 4 weeks prior to
screening (refer to Appendix 7 for List of Known CYP2C8 Inhibitors/Substrate).

9. History of bowel surgery (gastrointestinal [bariatric] surgery in the preceding 1 year
or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity,
extensive small-bowel resection) or orthotopic liver transplant (OLT) or listed for
OLT.

10. Type 1 diabetes mellitus.

11. Unstable cardiovascular disease, including:

1. Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in
the 12 weeks before screening and throughout the Screening Period), acute
coronary syndrome in the 24 weeks before screening and throughout the Screening
Period, acute myocardial infarction in the 12 weeks before screening and
throughout the Screening Period or heart failure of New York Heart Association
class (III
•IV) or worsening congestive heart failure, or coronary artery
intervention, in the 24 weeks before screening and throughout the Screening
Period.

2. History/current unstable cardiac dysrhythmias.

3. Uncontrolled hypertension at screening.

4. Stroke or transient ischemic attack in the 24 weeks before screening.

12. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder,
coagulation disorders, or screening blood tests that, in the opinion of the
Investigator, indicate altered coagulability (e.g., PT, INR, aPTT) at screening.

13. An uncontrolled thyroid disorder

1. Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has
either not been treated with either radioactive iodine and/or surgery or that has
been treated with radioactive iodine and/or surgery, but has required ongoing
continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e.,
methimazole or propylthiouracil) in the 24 weeks before screening.

2. Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement
therapy or dose adjustment of replacement therapy in the 12 weeks before
screening.

14. History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 x
ULN at screening.

15. Subjects whose ALT, AST, or ALP exceeds by more than 50% on Visit 2 reading compared
to Visit 1. Note: If the ALT, AST, or ALP values on Visit 2 exceed by more than 50%
from Visit 1, then a third value will be measured (within 1- 2 weeks) to assess for
the trend. If the third value shows continued increase ≥ 10%, then subject is
considered ineligible for randomization.

16. Any of the following laboratory values at screening:

1. Platelets < 100 × 109/L

2. Albumin < 3.2 g/dL

3. eGFR < 60 mL/min/1.73 m2

4. ALP > 10 x ULN

5. ALT or AST > 250 U/L

17. Participation in another interventional clinical study and receipt of any other
investigational medication (within 12 weeks prior to randomization up to end of
study).

18. History of malignancy in the past 5 years and/or active neoplasm with the exception of
resolved superficial non-melanoma skin cancer.

19. Contraindications to Saroglitazar Magnesium or has any conditions affecting the
ability to evaluate the effects of Saroglitazar Magnesium.

20. Known allergy, sensitivity, or intolerance to the study drug, comparator, or
formulation ingredients.

21. Pregnancy-related exclusions, including:

1. Pregnant/lactating female (including positive pregnancy test at screening).

2. Fertile women and men, UNLESS using effective contraceptive methods (such as an
intra-uterine device or other mechanical contraception method with condom or
diaphragm and spermicide) throughout the study. For male subjects, contraception
measures (condom and spermicide) must be taken during the study, either by the
male participant or his female partner. (Note: Enrolled females otherwise must be
surgically sterilized for at least 24 weeks before screening or postmenopausal,
defined as 52 weeks with no menses without an alternative medical cause or
following sexual abstinence.)

22. History or other evidence of severe illness or any other conditions that would make
the subject, in the opinion of the Investigator, unsuitable for the study (such as
poorly controlled psychiatric disease, HIV, coronary artery disease, or active
gastrointestinal conditions that might interfere with drug absorption).

Drug, Other
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Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder

Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder

Kristin Zhao
All
18 years to 70 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-309853-P01-RST
22-011111
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Inclusion Criteria:


1. Subject is ≥ 18 and ≤ 70 years old at the time of enrollment/consent.

2. Subject has a diagnosis of NLUTD due to:

- Chronic, spinal cord injury at C3 to T8 classified as ASIA A-D on the AIS scale OR

- Multiple sclerosis OR

- Stroke.

3. Subject has symptoms of urinary urgency (>50% high urge voids) or increased frequency of micturition/self-catheterization (more than once every 2 hours) or incontinence between voids or catheterizations (> 5/day).

4. Subject must demonstrate detrusor overactivity (unintentional detrusor contraction > 10 cm H2O) on clinical urodynamic studies.

5. Subject has sterile urine or asymptomatic bacteriuria.

6. Subject's score is > 28 on NBSS survey.

7. Subject is at least one year post initial diagnosis at the time of enrollment (consent).

8. Subject's medical condition is stable.

9. Subject has adequate social support network to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator.

10. Subject has been informed of the nature of the study, can understand the requirements of the study, agrees to participate, and has signed the IRB/EC-approved informed
consent.


Exclusion Criteria:


1. Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.

2. Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.

3. Subject has participated in other transcutaneous or epidural spinal stimulation trials.

4. Subject has congestive heart failure, pulmonary disease necessitating supplemental oxygen use, chronic kidney disease (Stage III or higher), chronic liver disease (Child
Pugh class B or C) or poorly controlled diabetes (if diabetic, HbA1c > 8.0 within the preceding 6 months).

5. Subject has a concurrent neurological disease affecting the central nervous system, other than spinal cord injury or multiple sclerosis or stroke.

6. Subject has an implanted central or peripheral neuromodulator.

7. Subject has symptomatic, clinically significant autonomic dysreflexia attacks (characterized by headache and systolic blood pressure greater than 180 mmHg) more
than once a week.

8. Subject is dependent on an electro-magnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or other external device.

9. Subject has received intravesical botulinum toxin injection within 12 months preceding enrollment.

10. Subject's BMI is > 35.

11. Subject has history of morphologic bladder outlet obstruction (e.g., due to benign prostatic hyperplasia, urethral stricture and/or bladder neck contracture).

12. Subject has history of frequent symptomatic urinary tract infections, defined as receiving five or more courses of urinary tract infection-directed antibiotics within 12 months prior to enrollment.

13. For non-catheterizing subjects, post-void residual is > 100 mL measured by bladder ultrasound, bladder scanner, or one-time catheterization at the time of enrollment.

14. For female subjects, history or physical exam consistent with > Stage II pelvic organ prolapse as defined by the International Continence Society.

15. For male subjects older than 55 years of age,13,14 physical exam or medical imaging (e.g., transrectal ultrasound, abdominal/pelvic computed tomography or magnetic resonance imaging) consistent with prostate size > 50 cm.

16. Subjects with significant stress incontinence as defined by > 3 stress incontinence episodes per day, defined as incontinence episodes precipitated by increased
intra-abdominal pressure (e.g., cough, sneeze, Valsalva maneuvers, transfers, other forms of physical activity), stress incontinence demonstrated on physical exam or
abdominal leak point pressure < 100 cm H2O at bladder volume less than 200ml per urodynamics study.

17. Subject is pregnant or trying to become pregnant; or is nursing.

18. Subject has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that, in the opinion of the Investigator, will
preclude them from participation and completion of study procedures or requirements.

19. Subject has a medical condition or complications related to the use of certain medications that may affect validity of the study as determined by the Investigator.

20. Subject has a medical condition not listed above that may put the subject at risk as determined by the Investigator.

21. Subject is participating in or plans to participate in another research study that may interfere with study endpoints.

22. Subject is known or suspected to be non-compliant; and/or subject is unable or unwilling to comply with study requirements.

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

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

Device
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Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent

COMPASSION S3 Post-Approval Study

Allison Cabalka
All
Not specified
This study is NOT accepting healthy volunteers
2022-307973-P01-RST
22-004308
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Inclusion Criteria:

  • Dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve.
  • RVOT/PV (Pulmonic Valve) with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg.


Exclusion Criteria:

  • Inability to tolerate an anticoagulation/antiplatelet regimen.
  • Active bacterial endocarditis or other active infections.

Eligibility last updated 5/13/22. Questions regarding updates should be directed to the study team contact.

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Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of BI 907828 Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma

Brightline-1: A Study to Compare Bi 907828 With Doxorubicin In People With a Type of Cancer Called Dedifferentiated Liposarcoma

Thanh Ho
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2022-308162-P01-RST
22-006695
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Inclusion Criteria:


- Provision of signed and dated, written informed consent form (ICF) in accordance with
ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or
analyses.

- Male or female patients ≥18 years old at the time of signature of the informed consent
form (ICF). Women of childbearing potential (WOCBP) and men able to father a child
must be ready and able to use 2 medically acceptable methods of birth control per ICH
M3 (R2) that result in a low failure rate of less than 1% per year when used
consistently and correctly beginning at screening, during trial participation, and
until 6 months and 12 days after last dose for women and 102 days after last dose for
men. A list of contraception methods meeting these criteria is provided in the patient
information.

- Histologically proven locally advanced or metastatic, unresectable (surgery morbidity
would outweigh potential benefits), progressive or recurrent dedifferentiated
liposarcoma (DDLPS). Locally performed histopathological diagnosis will be accepted
for entry into this trial but will be confirmed by independent pathological review
while the patients receive treatment in this trial.

- Written pathology report indicating the diagnosis of DDLPS with positive mouse double
minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by
fluorescence in situ hybridization or next generation sequencing (NGS) must be
available.

- Formalin fixed paraffin embedded tumor blocks or slides must be available for
retrospective histopathological central review.

- Presence of at least one measurable target lesion according to Response Evaluation
Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one target
lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of
the target lesion.

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

- Patient must be willing to donate blood samples for the pharmacokinetics,
pharmacodynamics, and tumor mutation analysis.

- Patient willing to undergo a mandatory tumor biopsy at the time point specified in the
flowchart unless exempt.

- Adequate organ function


Exclusion Criteria:


- Known mutation in the TP53 gene (screening for TP53 status is not required).

- Major surgery (major according to the investigator's assessment) performed within 4
weeks prior to randomization or planned within 6 months after screening.

- Prior systemic therapy for liposarcoma in any setting (including adjuvant,
neoadjuvant, maintenance, palliative).

- Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the
previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in
situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered
cured by local treatment.

- Previous treatment with anthracyclines in any setting (systemic treatment with other
anticancer agents is allowed if completed at least 5 years prior to study entry with
the exception of hormone therapy).

- Patients who must or intend to continue the intake of restricted medications or any
drug considered likely to interfere with the safe conduct of the trial.

- Currently enrolled in another investigational device or drug trial, or less than 30
days since ending another investigational device or drug trial(s) or receiving other
investigational treatment(s).

- Patients not expected to comply with the protocol requirements or not expected to
complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other
condition that, in the investigator's opinion, makes the patient an unreliable trial
participant).

- Further exclusion criteria apply

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

Eligibility last updated 3/6/23. Questions regarding updates should be directed to the study team contact

Drug
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Improving Carpediem Outcomes in Neonates and Infants Through Collaboration (ICONIC)

ICONIC: Improving Carpediem Outcomes in Neonates and Infants Through Collaboration

Cheryl Tran
All
up to 4 years old
This study is NOT accepting healthy volunteers
2022-309472-P01-RST
22-004916
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Inclusion Criteria:

  • Treated with CARPEDIEM as part of standard of care at a participating institution.
  • Within the United States.


Exclusion Criteria:

  • Parents/legally authorized representative unable or unwilling to provide consent.

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

Eligibility last updated 9/12/22. Questions regarding updates should be directed to the study team contact.

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Genomic Testing for Well-treated Patients with Partial OTC Deficiency Who Experienced Sudden, Unexpected Death

OTC Deficiency Study

Amy White
All
Not specified
This study is NOT accepting healthy volunteers
2022-307225-H01-RST
22-001296
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Inclusion Criteria:

  • Deceased children with partial ornithine transcarbamylase (OTC) deficiency who were under strict treatment and died unexpectedly, and their parents.


Exclusion Criteria:
 

  • Lack of quality or significant volume of DNA from all submitted specimens.

Eligibility last updated 2/3/22. Questions regarding updates should be directed to the study team contact.

Genetic disorder, Inherited metabolic disorder
Ornithine carbamoyltransferase deficiency
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