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

3159 Study Matches

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Intraindividual comparison of hepatic intraarterial versus systemic intravenous 68Ga-PSMA PET/CT in HCC: Pilot study

Comparison of Hepatic Intraarterial vs. Systemic Intravenous 68Ga-PSMA PET/CT to Treat Hepatocellular Carcinoma

Scott Thompson
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-304645-P01-RST
21-004930
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Inclusion Criteria:

  • Patients with either an imaging diagnosis of HCC by CT or MRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC.
  • Already enrolled in ongoing Transform the Practice or Department of Defense 68Ga-PSMA studies.
  • PSMA avid HCC detected by 68Ga-PSMA PET/CT after intravenous administration of 68Ga-PSMA confirmed by a board certified nuclear radiologist.
  • Undergoing planned hepatic artery embolization (HAE) per standard clinical care.
  • Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent.


Exclusion Criteria:

  • Subjects requiring emergent surgery for a ruptured/bleeding HCC.
  • Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan.
  • Subjects with higher than the weight/size limitations of PET/CT scanner.

Eligibility last updated 10/8/21. Questions regarding updates should be directed to the study team contact.

 

Drug, Radiation
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A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

Matthew Block
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-304648-P01-RST
21-007200
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Inclusion Criteria:

  • Female or male patients, aged at least 18 years (no upper limit of age).
  • ECOG PS 0 or 1.
  • Life expectancy of at least 3 months.
  • Patients with histologically or cytologically documented metastatic or refractory/recurrent HPV-16 + cancer: cervical, vulvar, vaginal, penile and anal.
  • Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression.
  • No more than one prior systemic treatment for recurrent /metastatic disease.
  • Prior treatment for recurrent or metastatic disease is not required for:
    • Patients with recurrence/progression within 6 months after completion of prior multimodal therapy for localized or locally advanced disease;
    • Patients who are unsuitable for platinum-based therapy;
    • Patients who refuse chemotherapy or other standard therapies for the treatment of metastatic or recurrent disease.
  • Limited hepatic disease for patients with liver metastases at baseline.
  • Availability of tumor tissue from biopsy.
  • At least one measurable lesion by CT scan according to RECIST 1.1.
  • Adequate hematological, hepatic and renal function.
  • Negative blood pregnancy test at screening for women of childbearing potential.
  • Highly effective contraception for both male and female patients if the risk of conception exists during the study period and for 3 months after the last study treatment administration.


Exclusion Criteria:

  • Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints).
  • Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to the first study treatment, with the exception of patients with adrenal insufficiency who may continue corticosteroids at physiological replacement dose, equivalent to ≤ 10 mg prednisone daily. Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
  • Patients with CNS metastases except those with brain metastases treated locally and clinically stable during 4 weeks prior to start of study treatment, and those without ongoing neurological symptoms that are related to the brain localization of the disease.
  • Other active malignancy requiring concurrent systemic intervention.
  • Patients with previous malignancies other than the target malignancy to be investigated in this trial (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
  • Patient with any organ transplantation, including allogeneic stem cell transplantation.
  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTC), any history of anaphylaxis, or uncontrolled asthma.
  • Any known allergy or reaction to eggs, gentamycin or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products.
  • Any known allergy or reaction to any component of anti-PD-L1/PD-1 or its excipients.
  • Patients with history of interstitial lung disease.
  • Patients with active, known, or suspected auto-immune disease or immunodeficiency, except type I diabetes mellitus, hypothyroidism only requiring hormone replacement or skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment.
  • Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication/active intervention.
  • History of uncontrolled intercurrent illness including but not limited to:
    • Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mmHg or lower);
    • Uncontrolled diabetes (e.g., hemoglobin A1c ≥ 8%).
Biologic/Vaccine, Drug
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Comprehensive characterization of coronary atherosclerotic disease using photon counting- detector dual-source CT and its impact on patient management

Clinical Impact of Cardiac Photon Counting CT

Cynthia McCollough
All
18 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-304663-H01-RST
21-004933
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Inclusion Criteria:

  • Adult male and adult  female patients age 18 to 99 years of age.
  • Patients referred for  coronary artery cardiac CT imaging or nuclear medicine or MRI cardiac perfusion within the Department of Radiology or Cardiology.
  • Patients who are able and willing to sign the informed consent will be enrolled.
  • Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).

 


Exclusion Criteria:

  • Minors.
  • Patients unable to provide written informed consent.
  • Pregnancy.
  • eGFR ≤ 30  (1,2).
  • History of prior moderate or severe contrast reaction includes: unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
  • Any history of required premedication prior to iodinated contrast administration. 
  • Patients that consent to participation but do not undergo their clinically-indicated, contrast-enhanced CT, or nuclear medicine or MR perfusion scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).
  • Patients with coronary artery bypass grafts.
  • Patients experiencing atrial fibrillation, premature ventricular contractions or other heart rhythm abnormalities.
  • Hospitalized patients or patients under care in the Emergency Department.

Specific exclusion criteria only for participation in the cardiac stress test arm of this study (requiring administration of Regadenoson):

  • Anything by mouth within three hours of the examination.
  • Known hypersensitivity to Regadenoson, Adenosine, or Dipyridamole.
  • Active ongoing wheezing or poorly controlled asthma or COPD (hospitalized within last month or receiving treatment for flair within last month).
  • Second (type I or II) or third degree atrioventricular (AV) block or sinus node dysfunction unless patient has functioning artificial pacemaker.
  • Ingested greater than 4 oz. of caffeine within the last 12 hours.
  • Currently experiencing unstable coronary syndrome.
  • Uncontrollable seizures within the last 3 months.
Device
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Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot & Other Congenital Heart Diseases

Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot

Alexander Egbe
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304694-H01-RST
21-005062
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Moderate (or greater) PR based on quantitative Doppler echocardiography.
  • Able to undergo CMRI. 


Exclusion Criteria:

  • Individiuals < 18 years.
  • Prior history of atrial or ventricular arrhythmias.
  • Current diuretics use.
  • Predicted peak velocity of < 60%.
  • Pregnant women.
  • Unable to undergo cardiac magnetic resonance imaging (CMRI).

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

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

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

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

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


Exclusion Criteria:

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

A Study to Evaluate COVID Brain Advanced Imaging Network

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

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


Exclusion Criteria:

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

Immune Dysfunction in Autoimmune Disease

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

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


Exclusion Criteria:

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

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

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

  • Patients with Stage III/IV NSCLC on treatment with anti-PD-1/PD-L1 (ICI) +/- chemotherapy and:
    • have persistent but stable disease at least 18 weeks after starting ICI treatment, b) have radiographic progressive disease at least 18 weeks after starting ICI treatment;
    • have radiographic progressive disease at least 18 weeks after starting ICI treatment; or
    • have refractory disease defined as progressed by imaging at least 9 weeks after starting ICI treatment.
  • Measurable disease including a lesion that is amenable to injection.
  • Able and willing to undergo a pre-treatment and on-treatment biopsy.
  • ECOG Performance status of 0 or 1.
  • 18 years of age or older.
  • Granulocyte count (ANC) ≥ 1,000/mm.
  • Peripheral lymphocyte count ≥ 500/mm.
  • Hemoglobin ≥ 8 g/dl (patients may be transfused to meet this criterion).
  • Platelets ≥ 75,000/mm.
  • Total bilirubin ≤ 1.5 x upper limit of normal, except for patients with known Gilbert disease who must have total bilirubin ≤ 3 x upper limit of normal.
  • SGOT (AST) ≤ 5 x upper limit of normal and if elevated, not clinically significant such that ICI can continue.
  • INR/aPTT within normal limits or, if on anti-coagulation, it must be clinically acceptable to hold anti-coagulation for the injection procedures as appropriate.
  • Serum creatinine < 2 mg/dl and calculated creatinine clearance > 30 ml/min.
  • Clinically eligible and willing to continue ICI.
  • Patients must give study specific informed consent prior to enrollment.


Exclusion Criteria:

  • Patients with a history of severe hypersensitivity reaction to ICI.
  • Patients who require ongoing therapy with systmeic immunosuppressive drugs including systemic corticosteroids (> 10 mg prednisone per day or equivalent)
    •premedication for ICI or chemotherapy is allowed.
  • Patients with a history of active autoimmune disease requiring treatment in the past 2 years.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active hepatitis, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Women who are pregnant, lactating or intend to become pregnant during the study.
  • Patients who are known to be HIV positive.
  • Patients with a history of hypersensitivity or allergic reactions to valacyclovir or acyclovir.
  • Patients with significant heart disease (New York Heart Association Functional Classification III or IV).
  • Patients with oxygen dependence (daily use)
  • Tumor impinging on a neurovascular structure such that inflammation in the site may put patient at risk of compromise as determined by the investigator.
Biologic/Vaccine, Drug, Procedure/Surgery
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Development of a Patient-centered Quality of Life Outcome Measure After Parotidectomy (PQOL)

Parotidectomy QOL Score

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

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


Exclusion Criteria:

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

FRACTIONATE

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

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

Exclusion Criteria

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

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

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

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

A Study to Evaluate Liver Stiffness with Shear Wave Elastography

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

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


Exclusion Criteria:

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

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

Device, Diagnostic Test
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Elucidating the Relationship Between Autonomic Nervous System Regulation and Physical Performance

Down-Regulation and Physical Performance

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

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


Exclusion Criteria:

  • Age less than 18 or over 30 years.
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Effect of Rapamycin to Improve Cardiac Function in Frail Older Adults with Heart Failure with Preserved Ejection Fraction: A Randomized Pilot and Proof-of-Concept Study

A Randomized Study to Evaluate the Effect of Rapamycin in Improving Cardiac Function in Older Adults with Heart Failure

Mandeep Singh
All
60 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-304364-H01-RST
21-003837
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Inclusion Criteria:

  • Age ≥ 60 years.
  • Diagnosis of HFpEF by either H2FEPF score of 6-9 or HFA-PEFF score of 5-6, or invasively confirmed diagnosis of HFpEF (resting pulmonary capillary wedge pressure ≥ 15mmHg or ≥ 25mmHg with exercise).
  • Diagnosis of computable phenotype of frailty rests on screening questions about ability to climb two flights of stairs, activities of daily living, living environment, wearing of dentures/hearing aids, and whether the patient uses assistive devices.


Exclusion Criteria:

  • Individuals < 60 years old.

Eligibility last updated 5/9/22. Questions regarding updates should be directed to the study team contact.

Drug
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Staging Classification of Moderate to Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

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

  • Moderate or more tricuspid regurgitation.


Exclusion Criteria:
 

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

Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia

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


- PRE-REGISTRATION
•INCLUSION CRITERIA:

- Age ≥ 18 years.

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

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

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

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

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

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

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

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

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

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

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

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

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

- Willingness to provide mandatory blood specimens for correlative research.

- REGISTRATION
•INCLUSION CRITERIA:

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

- Complete true abstinence.

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

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

- Implants of levonorgestrel;

- Injectable progestogen;

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

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

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

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

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

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


Exclusion Criteria:


- PRE-REGISTRATION
•EXCLUSION CRITERIA:

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

- MDS/MPN overlap syndromes other than CMML.

- Prior allogeneic hematopoietic stem cell transplantation.

- Active central nervous system disease.

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

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

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

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

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

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

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

- Unable or unwilling to swallow study drug.

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

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

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

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

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

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

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

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

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

- REGISTRATION
•EXCLUSION CRITERIA:

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

- Pregnant persons;

- Nursing persons;

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

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

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

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

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

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

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

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

Inclusion Criteria
•Cohort 2:

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

Inclusion Criteria
•Cohort 3:

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

Inclusion Criteria
•Cohorts 1-4:

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


Exclusion Criteria:

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

Exclusion Criteria
•Cohorts 1 and 4:

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

Exclusion Criteria
•Cohorts 1-4:

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

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

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


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

- Has adequate acoustic windows for echocardiography

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


Exclusion Criteria:


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

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

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

- Presence of protocol specified laboratory abnormalities at Screening

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

- Recent hospitalization for heart failure (<90 days)

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

 

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

A Study of Benralizumab in Patients With Eosinophilic Esophagitis

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

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


Exclusion Criteria:

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

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

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Cell Biological Interrogation of Patient-derived AVM Cell Lines (AVM)

Cell Biological Interrogation of Patient-derived Arteriovenous Malformation Cell Lines

David Daniels
All
Not specified
This study is NOT accepting healthy volunteers
2021-304805-H01-RST
21-005465
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Inclusion Criteria:

  • Adult and pediatric patients.
  • Undergoing surgical resection of their brain AVM.
  • Have not undergone previous stereotactic radiosurgery or endovascular embolization.  


Exclusion Criteria:

  • Have undergone previous stereotactic radiosurgery or endovascular embolization.

Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.

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CORT125134-551, A Phase 1b, Open-Label Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production

Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production

Mabel Ryder
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-304821-P01-RST
21-010660
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Inclusion Criteria:


- Histologically or cytologically confirmed ACC (advanced unresectable and/or
metastatic)

- Measurable disease based upon RECIST v1.1 as determined by the Investigator.

- Documented GC excess (too much cortisol).

- For patients who have received mitotane within 3 months prior to screening, mitotane
levels must be <4 mg/L at screening.

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

- Adequate organ and bone marrow function (determined through blood and urine tests)

- Negative pregnancy test for patients of childbearing potential at the Screening and
every 6 weeks (+ or
•7 days) in female patients of childbearing potential.


Exclusion Criteria:


- Major surgery within 4 weeks prior to enrollment. If the participant underwent major
surgery, they must have recovered adequately prior to starting study treatment.

- Have received and responded (complete response [CR] or partial response [PR]) to prior
treatment with any prior checkpoint inhibitor or any other agents targeting T-cell
stimulation pathways

- Taking a concomitant medication that is a strong Cytochrome P450 3A (CYP3A) inducer,
or that is a substrate of CYP3A with a narrow therapeutic index

- Known untreated parenchymal brain metastasis or have uncontrolled central nervous
system (CNS) metastases. Patients must not require steroids and must be neurologically
stable without corticosteroids for a minimum of 3 weeks prior to the commencement of
the study. Patients with neurologic symptoms must undergo a CT/MRI to rule out occult
CNS metastases.

- Requirement for chronic systemic GC treatment, such as active autoimmune disease
requiring systemic treatment (corticosteroids or other immunosuppressive medication)

- Patients requiring inhaled glucocorticoids but have no other alternative treatment
option if their condition deteriorates during the study.

- Clinically relevant toxicity from prior systemic cytotoxic therapies or radiotherapy
that in the opinion of the Investigator has not resolved to NCI-CTCAE v5.0 Grade 1 or
less prior to the first dose of relacorilant.

- Treated with the following prior to the first dose of relacorilant:

1. Any investigational product, systemic anticancer therapy, or radiation therapy
within 21 days

2. Antibodies or anticancer vaccines within 60 days

3. Mifepristone or other GR antagonists within 5 half-lives of these medications

4. Adrenostatic medications within 5 half-lives of these medications

- History of severe hypersensitivity to another monoclonal antibody

- Other concurrent cancer or a history of another invasive malignancy within the last 3
years that has a likelihood of recurrence of >30% within the next 5 years. Adequately
treated basal and squamous skin cancers, ductal carcinoma in situ, cervical cancer,
prostate cancer, non-muscle invasive urothelial cancer or other tumors curatively
treated with no evidence of disease are permissible.

- Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis
C virus or hepatitis B virus including: Chronic or active hepatitis B as diagnosed by
serologic tests. In equivocal cases, hepatitis B or C polymerase chain reaction may be
performed and must be negative for enrollment.

- Clinically significant uncontrolled condition(s) or a condition which, in the opinion
of the Investigator, may confound the results of the trial or interfere with the
patient's participation, including but not limited to:

1. Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction
3 months before study entry.

2. Active infection that requires parenteral antibiotics.

3. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.

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WO42758 - A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients with Metastatic Colorectal Cancer (Intrinsic) (Intrinsic)

A Study Evaluating the Safety and Effectiveness of Therapies in Patients with Metastatic Colorectal Cancer

Joleen Hubbard
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-304824-P01-RST
21-006012
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Inclusion Criteria:


- Signed next-generation sequencing (NGS) Biomarker Eligibility Informed Consent Form

- Age >= 18 years at time of signing Informed Consent Form

- Biomarker eligibility as determined at a College of American Pathologists/clinical
laboratory improvement amendments (CAP/CLIA)-certified or equivalently accredited
diagnostic laboratory using a validated test

- Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1

- Life expectancy >= 3 months, as determined by the investigator

- Histologically confirmed adenocarcinoma originating from the colon or rectum

- Metastatic disease

- Prior therapies for metastatic disease

- Ability to comply with the study protocol, in the investigators judgment

- Measurable disease (at least one target lesion) according to Response Evaluation
Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

- Availability of an archival tissue sample for exploratory biomarker research

- Adequate hematologic and organ function within 14 days prior to initiation of study
treatment

- For women of childbearing potential: Must have a negative serum pregnancy test result
within 14 days prior to initiation of study treatment and agreement to remain
abstinent or use contraceptive measures

- For men: agreement to remain abstinent or use contraceptive measures, and agreement to
refrain from donating sperm

Exclusion Criteria

- Current participation or enrollment in another interventional clinical trial

- Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is
shorter) prior to start of study treatment

- Treatment with investigational therapy within 28 days prior to initiation of study
treatment

- Pregnant or breastfeeding, or intending to become pregnant during the study

- History of or concurrent serious medical condition or abnormality in clinical
laboratory tests that, in the investigator's judgment, precludes the patient's safe
participation in and completion of the study or confounds the ability to interpret
data from the study

- Severe infection within 4 weeks prior to initiation of study treatment or any active
infection that, in the opinion of the investigator, could impact patient safety

- Incomplete recovery from any surgery prior to the start of study treatment that would
interfere with the determination of safety or efficacy of study treatment

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures (once monthly or more frequently)

- Uncontrolled tumor-related pain

- Uncontrolled or symptomatic hypercalcemia

- Clinically significant and active liver disease

- Known HIV infection

- Symptomatic, untreated, or actively progressing CNS metastases

- History of leptomeningeal disease or carcinomatous meningitis

- History of malignancy other than CRC within 2 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death

- Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction,
physical examination finding, or clinical laboratory finding that contraindicates the
use of an investigational drug, may affect the interpretation of the results, or may
render the patient at high risk from treatment complications

- Requirement for treatment with any medicinal product that contraindicates the use of
any of the study treatments, may interfere with the planned treatment, affects patient
compliance, or puts the patient at higher risk for treatment-related complications

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

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact.

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Activated Prothrombin Complex Concentrate FEIBA to Optimize Postcardiopulomonary Bypass Hemostasis in Pediatric Cardiac Patients

A Study to Compare FEIBA to Alternative Blood Products in Treating Children After Cardiac Surgery

Elena Ashikhmina
All
up to 5 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-304831-H01-RST
21-005539
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Inclusion Criteria:

  • Weight ≤ 15 kg.
  • Elective cardiac surgery with cardiopulmonary bypass.
  • Coagulopathic bleeding after cardiopulmonary bypass.
  • Availability and willingness of the parent/legal guardian to provide informed consent.


Exclusion Criteria:

  • Presence of mechanical circulatory support at the time of randomization or POD 0 and 1.
  • Patient or family history of coagulopathy and/or thromboses.
  • Preoperative anticoagulation (excluding low dose heparin for “line prophylaxis”).
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AVB500-OC-004/GOG-3059: A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-S6-500 in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)

A Study to Evaluate AVB-S6-500 with Paclitaxel vs Paclitaxel in Patients with Platinum-resistant Recurrent Ovarian Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-304837-P01-RST
21-008315
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Inclusion Criteria:


- Histologically confirmed and documented recurrent ovarian, fallopian tube, or
peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are
eligible.

- Aged 18 years or older

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

- Platinum-resistant disease (defined as progression within ≤6 months from completion of
most recent platinum-containing regimen and calculated from the date of the last
administered dose of platinum therapy).Subject may have been treated with additional
regimen(s) subsequent to determination of platinum resistance.

- Available archived tumor tissue or if archived tissue is not available, a fresh tumor
biopsy.

- Received at least 1 but not more than 4 prior therapy regimens.

Note: Maintenance therapy OR hormonal therapies should not be counted as a separate
therapy.

Note: Patients who have not received prior bevacizumab must be deemed medically
inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been
unable to receive bevacizumab due to lack of access.

- Measurable disease according to RECIST v1.1 criteria

- Normal gastrointestinal function.

- At least 28 days between termination of prior anticancer or hormonal therapy and first
administration of batiraxcept.

- Full recovery from all treatment-related toxicities to Grade 1 or less, except
alopecia.


Exclusion Criteria:


- Tumors in the breast or bone

- Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid
therapy for the management of their treated CNS metastases may not be on >10 mg/day
prednisone or equivalent or have demonstrated signs or symptoms of neurologic
instability for 28 days or less prior to randomization.

- Primary platinum-refractory disease (defined as progression during or within 4 weeks
after completion of the first platinum regimen)

- Is being treated with concurrent anticancer therapy or other interventional treatments
administered for their underlying ovarian cancer.

- Received prior therapy with PAC in the platinum-resistant recurrent setting

- Evidence of clinically significant third spacing (e.g., pleural effusions, ascites,
anasarca, etc.) that requires therapeutic intervention within 28 days prior to first
dose of batiraxcept/placebo

Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.

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Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy

A Study to Evaluate Mesenchymal Stem Cells to Treat Multiple System Atrophy

Wolfgang Singer
All
30 years to 70 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-304839-H01-RST
21-005569
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  1.  

Inclusion Criteria:

  • Males or females aged 30-70 years, who are willing and able to give informed consent.
  • Clinical diagnosis of MSA, fulfillin,g consensus criteria for probable MSA.
  • UMSARS I (omitting question 11) between 5 and 17, and able to walk unaided (i.e. abl,e to walk at least 50 yards without the use of a cane or walker, and without other support such as holding on to an arm or touching walls).
  • Anticipated survival of at least 3 years in the opinion of the investigator.
  • Normal cognition as assessed by the Montreal Cognitive Assessment (MOCA).  We will require a value ≥ 26.


Exclusion Criteria:

  • Pregnant or breastfeeding women, and women of childbearing potential who do not agree to practice an acceptable method of birth control. Acceptable methods of birth control in this study are: surgical sterilization, intrauterine devices, partner’s vasectomy, a double-protection method (condom or diaphragm with spermicide), hormonal contraceptive drug (i.e., oral contraceptive, contraceptive patch, long-acting injectable contraceptive) with a required second mode of contraception. 
  • Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the study or might affect study results. These include conditions causing significant CNS or autonomic dysfunction, clinically significant peripheral neuropathy, active malignant neoplasm, amyloidosis, active autoimmune disease, immunocompromised state, active infection, congestive heart failure (NYHA III or IV), recent (< 6 months) myocardial infarction, history of stoke with residual deficits, uncontrolled diabetes mellitus, alcoholism,  orthopedic problems that compromise mobility and activity of daily living, significant liver or kidney disease, thrombocytopenia (< 50 x 10^9/L), disorders affecting coagulation, and patients on active anticoagulation.
  • Participants who have taken any investigational products within 90 days prior to baseline, or with expected effects lasting beyond 60 days prior to baseline.
  • Medications that could affect clinical evaluations are permitted but need to be withdrawn at least four half-lives prior to study visits. Those include medications used to treat motor symptoms, such as levodopa and other anti-Parkinsonian medications.
  • Patients with contraindication to any of the study procedures, in particular MRI scanning.
Biologic/Vaccine, Other
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A Phase 2 Open-Label Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Nedosiran in Pediatric Patients from Birth to 11 Years of Age with Primary Hyperoxaluria and Relatively Intact Renal Function (PHYOX8)

A Study to Evaluate the Safety, Tolerability and Effectiveness of Nedosiran in Pediatric Patients with Primary Hyperoxaluria and Relatively Intact Renal Function

David Sas
All
up to 11 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-304881-P01-RST
21-005579
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Inclusion Criteria:

  • Birth to 11 years of age inclusive, at the time of signing the informed consent.
  • Documented diagnosis of PH1 or PH2 confirmed by genotyping (historically available genotype information is acceptable for study eligibility).
  • Average spot Uox to creatinine ratio at Screening above 2 times the 95th percentile for age (Matos et al, 1999):
    • > 0.44 mol/mol in participants < 6 months;
    • > 0.34 mol/mol in participants from 6 months to < 12 months;
    • > 0.26 mol/mol in participants 12 months to < 2 years;
    • > 0.20 mol/mol in participants from 2 to < 3 years; and
    • > 0.16 mol/mol in participants from 3 to 5 years.
  • Estimated GFR at Screening ≥ 30 mL/min normalized to 1.73 m^2 BSA. For infants aged less than 12 months, serum creatinine below the 97th percentile of a healthy population (Boer et al., 2010).
  • Participants must have been on a stable treatment regimen for PH for 3 months prior to Day 1 and parent(s)/legal guardian should be willing to ensure participant remains on the same stable treatment regimen during the study.
  • Body weight ≥ 10 kg.
  • Male or female.
  • Participant’s parent or legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day according to the SoA (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant using the rating scales during the scheduled study visits; accurately and reliably dispense study intervention as directed.
  • Affiliated with or is a beneficiary of a health insurance system (if applicable per national regulations).


Exclusion Criteria:

  • Prior renal or hepatic transplantation; or planned transplantation within the study period.
  • Currently receiving dialysis or anticipating requirement for dialysis during the study period.
  • Plasma oxalate (Pox) > 30 μmol/L at Screening.
  • Documented evidence of clinical manifestations of severe systemic oxalosis (including preexisting retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations).
  • Presence of any condition or comorbidities that would interfere with study compliance or data interpretation or potentially impact participant’s safety including, but not restricted to:
    • Severe intercurrent illness;
    • Known causes of active liver disease/injury or transaminase elevation (e.g., alcoholic liver disease, nonalcoholic fatty liver disease/steatohepatitis [NAFLD/NASH]);
    • History of serious mental illness that includes, but is not limited to, schizophrenia, bipolar disorder, or severe depression requiring hospitalization or pharmacological intervention;
    • Clinically relevant history or presence of cardiovascular, respiratory, gastrointestinal, hematological, lymphatic, neurological, musculoskeletal, genitourinary, immunological diseases, including dermatological including rash, severe eczema or dermatitis, or connective tissue diseases or disorders.
  • Use of an RNAi drug within the last 6 months.
  • History of 1 or more of the following reactions to an oligonucleotide-based therapy:
    • Severe thrombocytopenia (platelet count ≤ 100,000/μL);
    • Hepatotoxicity, defined as ALT or AST > 3 times the upper ULN and total bilirubin > 2 × ULN or INR > 1.5;
    • Severe flu-like symptoms leading to discontinuation of therapy;
    • Localized skin reaction from the injection (graded severe) leading to discontinuation of therapy;
    • Coagulopathy/clinically significant prolongation of clotting time.
  • Participation in any clinical study in which they received an IMP within 4 months or 5 times the half-life of the drug (whichever is longer) before Screening:
    • For IMPs with the potential to reduce urine and/or plasma oxalate concentrations, these concentrations must have returned to historical baseline levels prior to Screening.
  • Liver function test (LFT) abnormalities: ALT and/or AST > 1.5 × ULN for age and gender.
  • Known hypersensitivity to nedosiran, or any of its ingredients.
  • Inability or unwillingness to comply with the specified study procedures, including the lifestyle considerations.

Eligibility last updated 5/11/22. Questions regarding updates should be directed to the study team contact.

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Understanding How Cognitive Performance and Physiological Measures Change After Acute Stress and How Different Sensory Features of a Relaxation Room Help Recovery

A Study to Evaluate How Cognitive Performance and Physiological Measures Change After Acute Stress

Colin West
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304922-H01-RST
21-005885
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Inclusion Criteria:

  • Adults at least age 18.
  • Participants are able to remain in the Well Living Lab for 3-4 hours.
  • Participants are able to perform scripted tasks.
  • Participants are able to provide informed consent
  • Participants are able to wear the wearable devices at all times during the study
  • Participants have completed a COVID vaccine regimen and can provide written documentation verifying vaccination status at least fourteen (14) days prior to the commencement of the research study.


Exclusion Criteria:

  • Participants with a reported history of diagnosed mood, anxiety, or major health disorders.
  • Participants who have used steroid-based medications within the past three years.
  • Participants with a history of drug/alcohol abuse.
  • Participants with or recovering from nicotine dependency who cannot use a nicotine patch.
  • Participants who consume excessive amounts of caffeine.
  • Participants who have had severe sleep disturbance (e.g., shift work, chronic insomnia).
  • Women who are pregnant or intend to become pregnant at the time of the study.
  • Participants with a history of diagnosed cognitive impairment.
  • Participants taking any medications that might affect the physiological measures of interest.
  • Participants with anything that might affect collecting the physiological measures of interest (e.g., cosmetic products, head coverings, head products, etc.).
Behavioral
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Mayo Clinic — Rochester, MN

A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 Tablet in Adult Patients with Advanced Cholangiocarcinoma (TT420C1206)

A Study to Evaluate the Safety and Effectiveness of TT-00420 in Adults with Advanced Cholangiocarcinoma

Lionel Aurelien Kankeu Fonkoua
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304924-P01-RST
21-005915
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Inclusion Criteria:

  • ≥ 18 years of age, at the time of signing informed consent.
  • Histologically or cytologically documented advanced/metastatic or surgically unresectable cholangiocarcinoma who have received at least one line of prior systemic chemotherapy. Patients will be assigned to 1 of 4 cohorts:
    • Cohort A1: FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor;
    • Cohort A2: FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor;
    • Cohort B: other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions;
    • Cohort C: negative for FGFR alterations (FGFR wild-type).
  • At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors.
  • Documentation of FGFR gene alteration status.
  • ECOG performance status of 0 or 1.
  • Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by:
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 /L;
    • Hemoglobin (Hgb) ≥ 8 g/dl;
    • Platelets (plt) ≥ 75 x 10^9 /L;
    • AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present;
    • Total bilirubin ≤ 1.5 x ULN;
    • Calculated 24-hour clearance ≥ 50 mL/min (Cockcroft Gault formula).
  • Negative pregnancy test within 72 hours before starting study treatment in all premenopausal women and women < 12 months after the onset of menopause.
  • Must agree to take sufficient contraceptive methods to avoid pregnancy (including male and female participants) during the study and until at least 6 months after ceasing study treatment.
  • Able to sign informed consent and comply with the protocol.


Exclusion Criteria:

  • Women who are pregnant or lactating.
  • Women of child-bearing potential (WOCBP) who do not use adequate birth control.
  • Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g. evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases) Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment.
  • Patients with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy.
  • Patients with the following mood disorders as judged by the Investigator or a psychiatrist:
    • Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia; a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others);
    • ≥ CTCAE grade 3 anxiety.
  • Impaired cardiac function or significant diseases, including but not limited to any of the following:
    • LVEF < 45% as determined by MUGA scan or ECHO;
    • Congenital long QT syndrome;
    • QTcF ≥ 480 msec on screening ECG;
    • Unstable angina pectoris ≤ 3 months prior to starting study drug;
    • Acute myocardial infarction ≤ 3 months prior to starting study drug.
  • Patients with uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic at Screening).
  • Patients with:
    • unresolved diarrhea ≥ CTCAE grade 2; or
    • impairment of gastrointestinal (GI) function; or
    • GI disease that may significantly alter the absorption of TT-00420.
  • Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., uncontrolled hypertriglyceridemia [triglycerides > 500 mg/dL], or active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
  • Patients who have received chemotherapy, targeted therapy, or immunotherapy ≤ 5 half-lives or 3 weeks, whichever is shorter, (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug.
  • Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy.
  • Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy.
  • Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.
  • Patients who are currently receiving treatment with strong CYP3A inhibitors or inducers ≤ 2 weeks prior to starting study drug.
  • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory; patients with well controlled HIV might be enrolled per investigator’s discretion and Sponsor approval).
  • Evidence of active infection with Hepatitis B or Hepatitis C that is not adequately controlled. For patients with known prior history of Hepatitis B or Hepatitis C, enrollment may be allowed per investigator’s discretion and Sponsor approval.
  • Inability to swallow or tolerate oral medication.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient’s safe participation and compliance in the trial.

 

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COllaborative, National QUality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients (CONQUER) (CONQUER)

A Registry to Track Scleroderma Progression

Ashima Makol
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304932-P01-RST
21-005952
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Inclusion Criteria:

  • Patients 18 and older, inclusive; AND
  • Patients who meet the 2013 ACR/EULAR classification criteria for systemic sclerosis; AND
  • < 5 years from onset of first non-RP symptom attributed to systemic sclerosis.


Exclusion Criteria:

  • Patients under 18 years of age.
  • Patients with cognitive impairment that will interfere with conducting the study. Study staff should determine if the patient, at that moment, has the cognitive capacity to understand what the study entails, assent to participate, and complete the assessments. If there is question as to whether a patient may meet this criterion, RCs/RAs should defer to the site PI trained on the study to help determine; OR
  • Patients who are non-English Speaking. The patient must be able to proficiently read, speak, and understand English in order to be eligible.
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The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Trial (PABST-BR)

A Study to Evaluate Practical Anemia Bundle for SusTained Blood Recovery

Matthew Warner
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304949-H01-RST
21-006511
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Inclusion Criteria:


- Provision of signed and dated informed consent form (may be completed by legal proxies
for those patients unable to provide consent, i.e. sedation/intubation)

- Stated willingness to comply with all study procedures and availability for the
duration of the study, including follow-up assessments

- Current ICU admission at Mayo Clinic Rochester with anticipated ICU duration >48 hours
after enrollment

- Current ICU duration < 7 days

- Patients embedded in the local or regional Mayo Clinic Health System to facilitate
post-hospitalization outcome assessment

- Moderate-to-severe anemia (i.e. hemoglobin concentration < 10 g/dL) at the time of
enrollment, with the hemoglobin concentration assessed no more than 24 hours prior to
enrollment. If RBC transfusion has been administered between the qualifying hemoglobin
assessment and enrollment, a repeat hemoglobin will be required prior to enrollment to
ensure that it remains < 10 g/dL.


Exclusion Criteria:


- Recent or current iron or erythropoiesis stimulating agent (ESA) use (i.e.
darbepoetin, Aranesp, erythropoietin, Epogen, Procrit, Retacrit) within 30 days of
enrollment, exclusive of oral iron for general nutritional support (e.g. multivitamin
with iron)

- Severe anemia prior to hospitalization (i.e. hemoglobin <9 g/dL within 90 days of
admission)

- Known allergic reactions to iron or EPO

- Inability to complete outcome assessments (i.e. not expected to survive
hospitalization, unable to make follow-up appointments, non-ambulatory, dementia or
other severe cognitive impairment, visual impairment i.e. blind or legally blind)

- Pregnancy or breastfeeding at time of enrollment

- Inability to receive pharmacologic venous thromboembolic prophylaxis except in
patients with recent surgical or gastrointestinal bleeding

- Active or suspected thrombosis (i.e. deep venous thrombosis, pulmonary embolism, acute
arterial thrombus within 3 months)

- Uncontrolled sepsis (i.e. <48 hours of appropriate antimicrobial therapy and/or lack
of definitive source control)

- Having received ≥10 units of allogeneic RBCs in the 48 hours before enrollment

- Acute coronary syndrome or ischemic stroke within 3 months

- Weight less than 40 kg

- Concerns with study enrollment expressed by the clinical team

- Mechanical circulatory support devices

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

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

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Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing – Ascertaining Serial Cancer Patients to Enable New Diagnostic II (DETECT-ASCEND 2) (ASCEND 2)

A Study to Detect Cancers Through Elective Plasma-based CancerSEEK Testing

Amrit Singh
All
50 years and over
This study is NOT accepting healthy volunteers
2021-304965-P01-MAIJ
21-006028
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Inclusion Criteria
•All Subjects:

  • ≥ 50 years of age
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information or personal data to the study investigator.

Inclusion Criteria
•Cancer Subjects Only:

  • Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian, esophageal cancer, head and neck squamous cell, thyroid, small intestine, cervical, anal, vulva, or testis confirmed through pathology reports and/or clinical/radiographic data; or
  • Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.


Exclusion Criteria:

  • Prior or concurrent cancer diagnosis defined as:
    • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
    • Recurrence of the same primary cancer within any timeframe; OR
    • Concurrent diagnosis of multiple primary cancers.
  • Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
  • Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
  • Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
  • Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
  • IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
  • Individual has a condition the Investigator believes would interfere with the subject’s ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
  • Participant has an active febrile infection prior to blood draw.
  • History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Mankato, MN