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3290 Study Matches

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The Effect of Semaglutide in Subjects with Non-cirrhotic, Non-alcoholic Steatohepatitis (Essence)

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) (ESSENCE)

Alina Allen
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-304521-P01-RST
20-013372
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Inclusion Criteria:

  • Age above or equal to 18 years at the time of signing informed consent.
  • Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to screening visit (V1).
  • Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN classification7 based on a central pathologist evaluation of the baseline liver biopsy.
  • A histological NAS ≥ 4 with a score of 1 or more in both steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.


Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product or related products. 2. Previous participation in this trial. Participation is defined as randomisation. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. Argentina, Belgium, Brazil and EU/EEC countries: See local requirements in Appendix 9 (Section 10.9). 4. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 180 days before the screening visit (V1)* . Participation is defined as exposure to investigational medicinal product and includes any post-treatment follow up period. 5. Documented causes of chronic liver disease other than NAFLD.
  • Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
  • Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
  • Known or suspected excessive consumption of alcohol (> 20 g/day for women or > 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
  • Presence or history of hepatocellular carcinoma at randomisation.
  • Treatment with vitamin E (at doses ≥ 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A).** In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.
  • ALT > 5 times ULN at screening (V2A).
  • AST > 5 times ULN at screening (V2A).
  • Doubling of ALT or AST level between V1 and V2A deemed clinically significant in the opinion of the investigator.
  • Total bilirubin > 1.5 mg/dL at screening (V2A). Total bilirubin level > 1.5 mg/dL is allowed if conjugated bilirubin is within normal range.
  • Alkaline phosphatase levels > 2 x ULN at screening (V2A).
  • INR of prothrombin time ≥ 1.35 at screening (V2A).
  • MELD score > 12 points at screening (V2A).
  • eGFR < 30 mL/min/1.73 m^2 as defined according to the CKDEPI creatinine equation (KDIGO 2012)39 at screening (V2A).
  • HbA1c > 80 mmol/mol (9.5%) at screening (V2A).
  • Thrombocyte count less than 150,000 per microliter of blood (V2A), unless it reflects the patient's habitual thrombocytes level and there is no presence of portal hypertension in the opinion of the investigator.
  • For subjects with T2D: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening (V2A) and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examinations.
  • Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).
  • Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
  • Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, previous interventions that, due to reversal or removal, does not have any influence on the patient’s weight, in the opinion of the investigator, are allowed.
  • Presence or history within the past 5 years prior to screening (V2A) of malignant neoplasms other than hepatocellular carcinoma. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
  • Presence of acute pancreatitis within the past 180 days prior to screening (V2A).
  • History or presence of chronic pancreatitis at screening (V2A).
  • History or presence of type 1 diabetes.
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • Any of the following: myocardial infarction, stroke, classification of heart failure New York Heart Association (NYHA) Class IV, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 90 days prior to the day of screening (V2A) and between screening and randomisation.
  • Unstable body weight defined as more than 5% self-reported change in body weight in the period from 90 days prior to the screening visit (V1). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, the body weight should be stable in the opinion of the investigator from time of biopsy until screening (V1).
  • Any condition which, in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
  • Any subject where a substantial weight loss in the investigator’s opinion might jeopardise subject’s safety.

* Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention (e.g., vaccine) or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening (V1).

**Dose is considered stable if the total daily dose has not changed within the time frame. Shifts between generic drugs and brand-names is allowed as long as the total daily dose is not changed.

Eligibility last updated 5/18/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug
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Impact of Health Coaching on Outcomes of Post-COVID Syndrome: A Pilot Study (HC_PCOCC)

Health Coaching Post COVID

Ravindra Ganesh
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304525-H01-RST
21-004509
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Inclusion Criteria:

  • Male or female, ≥ 18 years of age.
  • Prior positive SARS-CoV-2 testing.
  • Persistent symptoms meeting diagnosis of PoCoS.
  • Access to electronic platform (email, device, internet).
  • English speaking.


Exclusion Criteria:

  • Individual, < 18 years of age.
  • Acute COVID infection.
  • No prior positive COVID testing.

 

Health coaching, Behavioral, Health coaching of subject
Coronavirus disease 2019, General infectious diseases, Post-COVID-19 syndrome
COVID-19, Chronic post-COVID-19 syndrome, Disease caused by 2019 novel coronavirus, Post-acute COVID-19, Respiratory system, Wellness coaching
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RNS® System Responsive Stimulation for Adolescents with Epilepsy (RESPONSE) Study (RESPONSE)

RNS® System RESPONSE Study

Brian Lundstrom
All
12 years to 17 years old
Pivotal
This study is NOT accepting healthy volunteers
2021-304527-P01-RST
21-004926
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Inclusion Criteria:

  • Subject has disabling motor simple partial seizures, complex partial seizures, and/or  secondarily generalized seizures. Disabling refers to seizures that are severe enough  to cause injuries, or significantly impair functional ability in domains including  employment, psychosocial education and mobility.
  • Subject has seizures that are distinct, stereotypical events that can be reliably  counted, in the opinion of the investigator, by the subject or parent/caregiver.  
  • Subject had an average of three or more disabling motor simple partial seizures,  complex partial seizures and/or secondarily generalized seizures over the two most  recent consecutive 30-day periods, with no 30-day period with less than two seizures  per subject and/or parent/caregiver report.  
  • Subject failed treatment with a minimum of two anti-seizure medications (used in  appropriate doses) with adequate monitoring of compliance and the effects of  treatment, as determined by the investigator.  
  • Subject has undergone diagnostic testing as part of his/her standard care that has identified no more than two epileptogenic regions.  
  • Subject is male or a female of childbearing potential using a reliable method of  contraception (hormonal, barrier method, surgical or abstention).  
  • Subject is age 12 or older but will be less than age 18 (has not reached 18th  birthday) at the time of implantation with the RNS System.  
  • Subject is able to maintain an electronic diary alone or with the assistance of a  competent individual.  
  • Subject is able to attend clinic appointments in accordance with the study schedule.  
  • Subject and/or parent/guardian must be willing and able to provide informed consent  and assent when appropriate.
  • Subject is not currently implanted with an RNS Neurostimulator or NeuroPace Leads.  
  • In the investigator's opinion, subject is able to tolerate a neurosurgical procedure.  


Exclusion Criteria:
 

  • Subject has been diagnosed with primarily generalized seizures.  
  • Subject requires procedures that are contraindicated based on current RNS System  labeling.
  • In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease.
  • Subject has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Subjects with post-ictal psychiatric symptoms need not  be excluded.
  • Subject is pregnant.  
  • Subject is participating in a therapeutic investigational drug or other device study.
  • Subject is implanted with an electronic medical device that delivers electrical energy to the brain.
  • Subject has been diagnosed with psychogenic or non-epileptic seizures.  
  • Subject has experienced unprovoked status epilepticus in the preceding year.  
  • Subject is taking chronic anticoagulants.  
    • Note: For contraindications, refer to current physician labeling (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
Device
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Patient and Provider Attitudes Toward Weight Loss in the Setting of Sleep Disordered Breathing

A Study to Evaluate Attitudes Toward Weight Loss in Sleep Apnea

Kara Dupuy-McCauley
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304531-H01-RST
21-004469
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Inclusion Criteria
•Patients:

  • Age ≥ 18 years.
  • Abnormal in-lab polysomnogram or home sleep apnea test demonstrating moderate-to-severe obstructive sleep apnea (AHI≥15) and/or obesity hypoventilation syndrome.
  • BM I ≥ 35kg/m^2.

Exclusion Criteria
•Patients:

  • Age < 18.
  • None or mild OSA on polysomnogram.
  • BMI < 35.
  • Greater than 20% central events on diagnostic or therapeutic portion of polysomnogram.
  • Systolic heart failure with ejection fraction ≤ 45%.
  • Active malignancy.

Inclusion Criteria
•Providers:

  • Must be a sleep medicine provider (MD, DO, NP, PA, RN), at any of the Mayo Clinic main campuses (Rochester, Jacksonville, Scottsdale).

Exclusion Criteria
•Providers:

  • None.
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A Randomized, Parallel-arm, Active Control, Multicenter Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

A Study to Evaluate the Safety and Effectiveness of Dextenza® to Treat Ocular Pain and Inflammation Following Pediatric Cataract Surgery

Erick Bothun
All
up to 5 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-304535-P01-RST
21-004579
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Inclusion Criteria:

  • The subject’s Legally Authorized Representative (LAR) provides written informed consent, approved by the appropriate Institutional/Independent Review Board and is able to comply with study requirements and visit schedule.
  • Is 0-3 years of age.
  • Has a cataract and is expected to undergo cataract surgery with or without implantation of a posterior chamber intraocular lens.
  • To be eligible for participation, subjects must undergo primary cataract surgery.


Exclusion Criteria:

  • Any intraocular inflammation in the study eye.
  • Over 3 years of age.
  • Ocular hypertension or glaucoma.
  • Evidence of acute external ocular infections.
Drug
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Molecular and Biochemical Testing for Suspected Hereditary Disorders

A Study to Evaluate Molecular and Biochemical Testing for Suspected Hereditary Disorders

Linda Hasadsri
All
Not specified
Not Applicable
This study is NOT accepting healthy volunteers
2021-304543-H01-RST
21-004405
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Inclusion Criteria:

Both of the following criteria must be met for inclusion in this study OR Family members who are clinically unaffected or affected with the same suspected disorder as a patient with VUS:

  • Clinically suspected diagnosis of a genetic disorder.
  • All genetic testing performed to date has been equivocal.
  • Examples of “equivocal” results include:
    • A variant or variants of uncertain significance identified in a gene or genes of interest; borderline hypo- or hypermethylation on a previous targeted methylation assay such as methylation-sensitive MLPA; borderline droplet count or copy number detected by ddPCR or qPCR, respectively;
    • A single mutation identified in a gene of interest, such as via Sanger sequencing, next generation sequencing, or chromosomal microarray, associated with an autosomal recessive disorder in which two mutations must be present in order to be causative (i.e., no second mutation was identified); a pathogenic or likely pathogenic finding that is inconsistent with the current clinical phenotype of the patient  (i.e., the patient’s presentation is still unsolved) or inconsistent with the currently known mode of inheritance for a particular genetic disorder.


Exclusion Criteria:

  • Blood transfusion within the past 2 weeks.
  • Previous bone marrow transplant.
  • Chemotherapy or radiation therapy within the past 6 months.

Eligibility last updated 3/7/22. Questions regarding updates should be directed to the study team contact.

Diagnostic Test
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A Phase 1/1b Dose Escalation Study of Abemaciclib and Olaparib for Recurrent Platinum-Resistant Ovarian Cancer

Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-304544-P01-RST
21-004662
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Inclusion Criteria:

  • Patients must have histologically confirmed recurrent platinum-resistant epithelial ovarian carcinoma (EOC) of any histology, as defined by progression within 6 months of the last dose of platinum-based chemotherapy. Both primary platinum resistant and acquired platinum resistant patients are allowed.
  • High-grade serous histology is required (for the dose expansion cohort only).
  • Patients must have received 1-3 prior systemic therapies.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
  • Hemoglobin ≥ 10 g/dL (within 28 days prior to administration of study treatment).
  • Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.
  • Absolute neutrophil count ≥ 1,500/mcL (within 28 days prior to administration of study treatment).
  • Platelets ≥ 100,000/mcL (within 28 days prior to administration of study treatment).
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment).
  • Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 times ULN and direct bilirubin within normal limits are permitted.
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN (within 28 days prior to administration of study treatment).
  • Patients must have creatinine clearance estimated of ≥ 51 mL/min using the Cockcroft-Gault equation or based on a 24-hour urine test (within 28 days prior to administration of study treatment).
  • Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 (within 28 days prior to administration of study treatment). Estimated GFR calculated using Cockcroft-Gault equation.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
  • Patients with treated brain metastases are eligible if patient is stable for at least 4 weeks status post (s/p) radiation therapy and off corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the screening period.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • Postmenopausal or evidence of non-childbearing status, a negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as:
    • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments;
    • Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50;
    • Radiation-induced oophorectomy with last menses > 1 year ago;
    • Chemotherapy-induced menopause with > 1 year interval since last menses;
    • Surgical sterilization (bilateral oophorectomy or hysterectomy).
  • The effects of abemaciclib and olaparib on the developing human fetus are unknown. For this reason and because CDK-and PARP-inhibiting agents are known to be teratogenic, women of child-bearing potential and their partners, who are sexually active, must agree to the use of one highly effective form of contraception and their partner must use a male condom prior to study entry, for the duration of study participation, and for 1 month after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • For the dose expansion cohort, patients must have disease amenable to biopsy for correlative studies, specifically at least 1 tumor accessible and safe for biopsy on office exam or tumor that a radiologist deems is safe for biopsy in interventional radiology department based on imaging (dose expansion cohort only). For the dose escalation cohort, patients with evaluable disease are acceptable.

For inclusion in i) the optional genetic research and ii) the optional biomarker research, patients must fulfill the following criteria:

  • Provision of informed consent for genetic research prior to collection of sample.
  • Provision of informed consent for biomarker research prior to collection of sample.
  • If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.
  • Patients may not have received prior CDK 4/6 inhibitors. Previous PARP inhibitor use is allowed in front-line treatment but not for recurrent disease.
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] grade ≤ 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy).
  • Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 28 days is required between end of radiotherapy and randomization.
  • For agents other than chemotherapy, a 4 week washout period is required. Previous bevacizumab use is allowed.
  • Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible.


Exclusion Criteria:

  • Patients who are receiving any other investigational agents.
  • History of allergic reaction or hypersensitivity attributed to compounds of similar chemical or biologic composition to abemaciclib, olaparib or any of the excipients of these products.
  • Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because abemaciclib is a CDK-inhibiting agent and olaparib is a PARP inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with abemaciclib and olaparib, breastfeeding should be discontinued if the mother is treated with abemaciclib and olaparib.
  • Other malignancy unless curatively treated with no evidence of disease for ≥ 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma.
  • Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT [QTcF] prolongation > 500 ms, electrolyte disturbances, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest, etc.), or patients with congenital long QT syndrome.
  • Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML).
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection that, in the judgment of the investigator, would preclude participation in this study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g., estimated creatinine clearance < 30 ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea).
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • Patients with an active systemic fungal infection.
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Feasibility and Acceptability of Virtual Dignity Therapy for Palliative Care Patients with Advanced Cancer

Virtual Dignity Therapy for Palliative Care Patients with Advanced Cancer

Deirdre Pachman
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304559-P01-RST
21-005065
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Inclusion Criteria:

  • Age ≥ 18 years.
  • English fluency.
  • No diagnosed dementia.  
  • Diagnosis of advanced cancer.  
  • Expected prognosis > 6 months.
  • Provide informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.


Exclusion Criteria:

  • Other psychological co-morbidities such as untreated schizophrenia, bipolar disease.
  • Recent suicide attempt or psychiatric illness severe enough that hospitalization has been necessary in last 6 months.
  • Active delirium.
  • Participation in concurrent legacy offerings through the palliative care clinic.

Eligibility last updated 10/26/21. Questions regarding updates should be directed to the study team contact.

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Improve the Patients’ Recovery by Engagement and Partnerships with Family- CaregiveRs to End Delirium (iPREPARED) – A Feasibility and Acceptability Study (iPREPARED)

Improve the Patients’ Recovery by Engagement and Partnerships with Family- CaregiveRs to End Delirium

Heidi Lindroth
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304577-H01-RST
21-005022
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Inclusion Criteria
•Patient:

  • 60 years of age or older.
  • Have 1 risk factor for delirium (pre-existing cognitive impairment, vision/hearing impairment, identified as high risk for falls, illness rated as severe).
  • Estimated length of stay of 24 hours or more in hospital.
  • Have an informal caregiver (18 years of age or older, family member or friend) willing to participate.

Exclusion Criteria
•Patient:

  • Patient lacks capacity to consent.
  • Unable to communicate or participate in study due to language barriers or sensory deficits.
  • Prisoners.
  • Documented history of dementia in the medical record.
  • Upon enrollment dementia is indicated with a MoCA score of ≤ 18.
  • Patient admitted to hospice service or actively dying.
  • Delirium present upon admission to hospital.
  • COVID-19 positive test.

Inclusion Criteria
•Caregiver:

  • 18 years of age or older.
  • Family member, friend, or neighbor of the patient willing to participate in the study and support the patient during the study period (support can be in-person or virtual).

Exclusion Criteria
•Caregiver:

  • Unable or unwilling to participate due to language barriers, availability, or other communication barriers.

Eligibility last updated 5/19/22. Questions regarding updates should be directed to the study team contact.

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TVMR With the Innovalve System Trial - Early Feasibility Study (TWIST-EFS) (TWIST-EFS)

TVMR With the Innovalve System Trial - Early Feasibility Study

Charanjit Rihal
All
18 years and over
Phase 1, First In Human
This study is NOT accepting healthy volunteers
2021-304606-P01-RST
21-004739
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Inclusion Criteria:


- Clinically significant, symptomatic mitral regurgitation.

- High risk for open-heart surgery.

- Meets anatomical criteria.


Exclusion Criteria:


- Unsuitable anatomy.

- Patient is inoperable.

- EF< 30%.

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.

Device
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CPDPC16-04: Evaluation of a Mixed Meal Test to Diagnosis and Characterize Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)

Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)

Yogish Kudva
All
40 years to 84 years old
This study is NOT accepting healthy volunteers
2021-304639-P01-RST
21-002688
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Inclusion Criteria:

  • All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
  • Patients must be ages ≥ 40 and < 85.
  • Patients must have a diagnosis of one of the following based on study definitions.
  • New Onset Diabetes (< 3 years) in subjects with Pancreatic Cancer (PDAC).
  • New Onset Diabetes (< 9 years) in subjects with Chronic Pancreatitis.
  • New Onset Diabetes (< 3 years) in subjects without Pancreatic disease (i.e., T2DM).
  • Long standing T2DM (≥ 3 years) without Pancreatic disease.
  • Long standing diabetes (≥ 3 years) in subjects with PDAC.
  • Long standing diabetes (≥ 9 years) subjects with chronic pancreatitis.
  • Non-diabetic subjects with PDAC.
  • Non-diabetic subjects with chronic pancreatitis.
  • Non-diabetic controls without Pancreatic disease.


Exclusion Criteria:

  • Subjects must not have any significant medical illnesses (including diabetes) that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate study interventions.
  • Diabetes not stable enough to permit holding of diabetes medications.
  • Subjects taking higher doses of insulin (≥ 0.75 unit/kg/day).
  • Subjects in the non-pancreatic disease subgroup (i.e., T2DM) on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon [exenatide], Ozempic [semaglutide], Trulicity [dulaglutide]). Conversely, the use of these medications is permitted for subjects in the CP and PDAC groups.
  • Patients currently receiving oral steroid medications.
  • Hospitalization for acute pancreatitis within 2 months before study visit (with the exception of subjects enrolled into the PDAC group as this may be a symptom of the disease).
  • The presence of a symptomatic cyst in subjects with CP. The presence of a cyst in subjects with pancreatic cancer is not an exclusion, including cancer arising from a mucinous cystic lesion.
  • Any subject with a pancreatic cancer histologic subtype other than adenocarcinoma (e.g., subjects with pancreatic neuroendocrine tumors are excluded).
  • Previous pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure).
  • Previous treatment for pancreatic cancer, including chemotherapy or radiation.
  • Previous vagotomy or gastric surgery, including endoscopic gastric reduction procedures.
  • Previous diagnosis of gastroparesis.
  • Patients on treatment for any cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
  • Allergy or intolerance to ingredients in Boost drink.
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Describing the Hearing Phenotype of Individuals with Mitochondrial Disease

A Study to Evaluate the Hearing Phenotype of Individuals with Mitochondrial Disease

Linda Hasadsri
All
0 years to 65 years old
This study is NOT accepting healthy volunteers
2021-304641-H01-RST
21-004870
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Inclusion Criteria:

  • Individuals ages 18-65, inclusive.
  • Known history of sensorineural or mixed hearing loss (not known to be due to infection) or history of hearing loss of unknown etiology.
  • Positive MITOP test result (only for the retrospective analysis-Part 1).


Exclusion Criteria:

  • Patients < 18 years or > 65 years.
  • Patients or guardians of patients unable to provide informed consent.
  • Patients using implantable hearing devices (ex. Cochlear implant, osseointegrated devices, etc.).
  • Patients with sudden changes (or fluctuating) hearing (bilateral or unilateral).
  • Patients with ear drainage and/or ear pain noted (bilateral or unilateral).
  • Patients unable to provide informed consent or whose legal guardian cannot provide informed consent.
  • Patients unable to perform GoAudio hearing test due to intellectual disability.
  • Patients with no motor control of fingers.
  • Patient with known/confirmed active conductive hearing loss.
  • Negative MITOP test result (only for the retrospective analysis-Part 1).
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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.
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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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Noninvasive Evaluation of the Intrarenal Microvasculature in ADPKD (IMADPKD)

A Study to Evaluate the Intrarenal Microvessels in Autosomal Dominant Polycystic Kidney Disease

Maria Irazabal Mira
All
18 years to 40 years old
This study is NOT accepting healthy volunteers
2021-304711-H01-RST
21-005117
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Inclusion Criteria
•Patients with ADPKD:

  • Male and female subjects, 18
    •40 years of age.
  • Previous diagnosis of ADPKD (based on Ravine et al. criteria).
  • Class 1 A-E according to imaging classification.
  • Estimated GFR > 70 mL/min/1.73 m^2 (CKD-EPI).
  • Ability to provide written, informed consent.


Exclusion Criteria:

  • Class 2 according to imaging classification.
  • Concomitant systemic disease affecting the kidney.
  • Diabetes mellitus.
  • Predicted urine protein excretion in > 1 g/24 hrs, and or Abnormal urinalysis.
  • Patients that are part on an interventional study or are taking tolvaptan.
  • Pregnant or lactating women.
  • History of hypersensitivity allergic reactions to ultrasound contrast agents.
  • High risk cardiac disease (such as unstable hospital in-patients or ICU patients.

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

 

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TRAjectories and Clinical ExpeRiences of ICD Therapy (TRACER-ICD) Study (TRACER-ICD)

TRAjectories and Clinical ExpeRiences of ICD Therapy (TRACER-ICD) Study

Peter Noseworthy
All
65 years and over
This study is NOT accepting healthy volunteers
2021-304722-P01-RST
21-005174
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Inclusion Criteria:

  • Patient receiving new primary prevention ICD (excluding cardiac resynchronization therapy).
  • Age ≥ 65 years.
  • English-speaking (assessment instruments are only available/validated in English).
  • Sufficient cognitive ability to provide consent (i.e., answer simple questions on study participation, purpose and procedures).


Exclusion Criteria:

  • Individuals < 65 years.
  • Non-English speaking.
  • Inability to provide consent.
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PARADIGM: PARAvalvular Leak Closure With the Amplatzer Valvular Plug occluDer for Interventional Transcatheter Closure for PVL With Surgical bioloGical and Mechanical Heart Valve (PARADIGM)

PARADIGM: Amplatzer Valvular Plug for PVL Closure

Charanjit Rihal
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304724-P01-RST
21-005182
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Inclusion Criteria:


- Subject is implanted with a mechanical or biological surgical valve in the aortic or
mitral position

- Note: Subjects in European countries can only be implanted with a mechanical valve in
the aortic or mitral position

- Subject has a clinically significant paravalvular leak with a severity grade of
moderate or higher, associated with signs of heart failure and/or hemolysis
necessitating recurring blood transfusions.

- Subject has one clinically significant PVL defect that can be closed with a single AVP
III as assessed pre-procedurally

- Subject has provided written informed consent

- Subject is ≥18 years old


Exclusion Criteria:


- Subject has a rocking valve or extreme dehiscence of the prosthetic valve involving
more than 40% of the sewing ring

- Subject's PVL(s) originates from a transcatheter aortic or mitral valve replacement,
or from rapid deployment or sutureless surgical replacement valves

- Subject has a prosthetic aortic valve and prosthetic mitral valve which both have a
clinically significant paravalvular leak.

- Subject who is hemodynamically unstable or who cannot undergo an elective procedure

- Subject with active endocarditis or other active infection

- Subject has within the last 6 months a previously documented intracardiac mass,
vegetation, tumor, or thrombus which would interfere with placement of the AVP III

- Subject has inadequate vasculature for delivery of the AVP III

- Subject has unsuitable anatomy for PVL closure using the AVP III (such as a PVL
associated with an abscess cavity or a pseudoaneurysmal sac) or anatomy where the AVP
III would interfere with other intracardiac or intravascular structures (such coronary
ostia)

- Subjects who are unable to receive intraprocedural anticoagulant therapy

- Pregnant or nursing subjects or subjects who plan pregnancy during the clinical
investigation follow-up period.

- Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results.

- Life expectancy is less than 1 year in the opinion of the Investigator

- Incapacitated individuals, defined as persons with mental illnesses or handicaps that
impair their ability to provide informed consent, or individuals without legal
authority to provide informed consent.

- Individual who are currently participating in an investigational drug or device study
that has not reached the primary endpoint or that may confound the results of this
study

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

Eligibility last updated 10/5/22. Questions regarding updates should be directed to the study team contact

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Microvessel Ultrasound Imaging of Cutaneous Angiosarcoma (MVI Angiosarc)

A Study to Evaluate Skin Angiosarcoma Imaging with Ultrasound

Tiffany Sae-Kho
All
21 years and over
This study is NOT accepting healthy volunteers
2021-304725-H01-RST
21-005183
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Inclusion Criteria:

  • Patients over the age of 21.
  • New diagnosis of cutaneous angiosarcoma of the breast or scalp.
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Diagnosed with cutaneous angiosarcoma of the breast or scalp and scheduled for trimodality therapy.


Exclusion Criteria:

  • Individual under the age of 21.
  • Unwilling to consent to microvessel ultrasound imaging.

 

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Metabolic Fingerprinting of Young Patients with Autosomal Dominant Polycystic Kidney Disease and Healthy Volunteers (METADPKD)

A Study to Analyze Metabolic Fingerprinting in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and Controls

Maria Irazabal Mira
All
0 years to 18 years old
This study is NOT accepting healthy volunteers
2021-304728-H01-RST
21-005194
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Inclusion Criteria:

  • Male and female subjects, 0
    •18 years of age, inclusive.


Exclusion Criteria:

  • Previous personal or family history of kidney disease.
  • A concomitant systemic disease that may affect the kidney (e.g., lupus, hepatitis B or C, amyloidosis, diabetes mellitus).
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Immune Aging (IA)

Immune Aging

Jorg Goronzy
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304730-H01-RST
21-005196
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Inclusion Criteria:

  • Adults, ≥ 18 years of age.


Exclusion Criteria:

  • Individuals under 18 years of age.
  • History of chemotherapy for malignancies.
  • Immunosuppressive therapy for autoimmune disease.
  • Chronic comorbidities not controlled on medication.
  • Acute infectious disease.
  • Pregnancy.

Eligibility last updated 4/25/22. Questions regarding updates should be directed to the study team contact.

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Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY (EASY AF)

Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY

Ammar Killu
All
22 years to 79 years old
This study is NOT accepting healthy volunteers
2021-304738-P01-RST
21-005229
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Inclusion Criteria:

  • Male or female age ≥ 22 years and < 80 years.
  • Clinical decision to proceed with AF ablation procedure.
  • Ablation procedure to be completed with General Anesthesia.
  • Ablation procedure to be completed with use of radiofrequency catheter ablation.


Exclusion Criteria:

  • History of various esophageal pathology such as esophageal achalasia, varices, strictures, web, carcinoma, tumor/mass, scleroderma, Mallory-Weiss tear, Barrett's esophagitis, diverticulum, banding, laceration, perforation, balloon dilatation.
  • Presence of a pH probe deployed in the esophagus.
  • Planned AF ablation procedure to be completed with laser energy or with cryo-energy.
  • Acute or uncontrolled psychiatric illness.
  • Unable to undergo upper endoscopy.
  • Enrollment in another FDA clinical trial.
  • Unstable medical condition(s) that precludes safely completing study protocol.
  • Subject is incarcerated.
  • Subject is pregnant.
  • Subject is unable to comprehend the details of the study.
  • The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the investigational device procedure and study-related follow up visit requirements.
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EA6191: The BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma with elevated LDH

A Study to Evaluate Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced Melanoma

Robert McWilliams
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304740-P01-RST
21-005230
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Inclusion Criteria:

  • Patient must have locally advanced unresectable stage IIIC or stage IV melanoma.
  • Patient must have BRAF V600E or BRAF V600K tumor genotype based on a Clinical Laboratory Improvement Act (CLIA) approved assay.
  • Patient must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Baseline measurements of sites of disease must be obtained within 3 weeks prior to study randomization.
  • Patient must have been treated with prior immune checkpoint inhibitor therapy (anti PD-1 antibody, anti-CTLA-4 antibody or a combination regimen including either or both agents) either in the adjuvant or metastatic setting.
  • Patient may have received investigational agents in combination with standard therapy, as long as it was adhering to the timeframes.
  • Patient must have discontinued active immunotherapy (IL-2, interferon, anti-CTLA-4 antibody, anti-PD-1 antibody etc.) or chemotherapy at least 4 weeks prior to randomization.
  • Patient must have discontinued any oral targeted therapy at least 2 weeks prior to randomization.
  • Patients must not receive any other investigational anticancer therapy during the period on study or the 4 weeks prior to randomization.
  • Patient may have been treated with prior adjuvant therapy including combined BRAF and MEK inhibitor therapy. Patients will be eligible if they tolerated this therapy and did not discontinue the therapy due to toxicity AND ≥ 6 months have elapsed since the end of adjuvant BRAF and MEK inhibition. If patients received BRAF and MEK inhibitor therapy in the metastatic setting, they are not eligible.
  • Patient may have been treated with prior chemotherapy or radiation therapy.
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or abstaining from sexual intercourse for the duration of their participation in the study and for 4 months after the last dose of protocol treatment.
  • Patient must have recovered from clinically significant reversible toxicities from previous treatment prior to randomization. Abnormal laboratory values may be grade 1, as long as they meet the eligibility criteria.
  • Patient must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
  • Patient must have the ability to understand and the willingness to sign a written informed consent document.
  • Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Absolute neutrophil count ≥ 1,500/mcL (obtained ≤ 14 days prior to protocol randomization).
  • Platelets ≥ 100,000/mcL (obtained ≤ 14 days prior to protocol randomization).
  • Total bilirubin ≤ institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization).
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3.0 x institutional ULN (obtained ≤ 14 days prior to protocol randomization).
  • Creatinine ≤ 1.5 x institutional ULN (obtained ≤ 14 days prior to protocol randomization).
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patient with asymptomatic new or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that CNS specific treatment is not required.
    • NOTE: Patient with treated brain metastases are eligible. No brain imaging is required, however, 1 week must elapse after gamma knife therapy. Patient treated with whole brain radiation that have been stable for 2 months are eligible. Patient are excluded if they have leptomeningeal disease or metastases causing spinal cord compression that are symptomatic or untreated or not stable (documented by imaging) for at least 3 months or requiring corticosteroids.
  • Patients on a stable dose of corticosteroids for at least 1 month or who have been off of corticosteroids for at least 1 week are eligible.


Exclusion Criteria:

  • Patients who are known to be experiencing an objective partial response to immunotherapy at the time of study enrollment are not eligible.
  • Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
    • has achieved menarche at some point;
    • has not undergone a hysterectomy or bilateral oophorectomy; or
    • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Patient must not have a history of interstitial lung disease (ILD) or chronic pneumonitis.
    • NOTE: If there is radiographic evidence of ILD that is clinically insignificant and asymptomatic, the patient would be eligible.
  • Patient must not have porphyria or psoriasis due to risk of disease exacerbation unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.
  • Patient must not have a previously documented retinal vein occlusion.
  • Patient must not have a history or evidence of increased cardiovascular risk including:
    • Left ventricular ejection fraction (LVEF) < institutional lower limit of normal measured within 14 days prior to randomization;
    • A QT interval corrected for heart rate using the Bazett's formula ≥ 480 msec;
    • Current clinically significant uncontrolled arrhythmias.
    • Exception: Patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible;
    • Acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization;
    • Abnormal cardiac valve morphology (≥ grade 2) documented by echocardiogram unless a cardiologist concludes the valve abnormality is not clinically significant. Patients with grade 1 abnormalities (i.e., mild regurgitation/stenosis) are eligible;
    • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • Patient with known serious concurrent infection or medical illness, including psychiatric disorders, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety are not eligible.
  • Patient must not be receiving concurrent therapy for their tumor (i.e., chemotherapeutics or investigational agents). Radiotherapy delivered to palliate pain is allowed as long as it is not targeting a lesion that meets RECIST criteria for progression. Radiation therapy to the surgical bed with gamma knife radiotherapy while on treatment during the first cycle is allowed for small volume surgically resected brain metastases. Gamma knife radiotherapy for known active, asymptomatic small volume central nervous system (CNS) lesions may be performed during the first cycle while on study. Radiotherapy for new CNS lesions identified beyond the first cycle is not allowed on study.
  • Patient must not have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug, or excipients or to dimethyl sulfoxide (DMSO).
  • Patient must not have received cytochrome P450 enzyme-inducing anticonvulsant drugs (extended-interval aminoglycoside dosing [EIADs]) (i.e., phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine) within 4 weeks prior to randomization.
  • Patient must not have a current use of a prohibited medication.

 

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Prehabilitation for Advanced Ovarian Cancer Patients

Prehabilitation

Amanika Kumar
Female
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304741-P01-RST
21-005226
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Inclusion Criteria:

  • Females, age 18 years or older.
  • Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer based on imaging and physician diagnosis.
  • Suspected Stage IIIC or IV disease based on clinician staging and imaging.
  • Curative intent treatment with platinum-based chemotherapy.
  • Planned surgical intervention at some point during treatment course.
  • Ability to read English.
  • No diagnosed severe cognitive impairment.
  • Ability to provide informed consent.
  • Ability to utilize technology to watch online modules for the Resilient Living Program.


Exclusion Criteria:

  • Females under 18 years of age.
  • Hemiplegia or paraplegia.
  • Current pregnancy.
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Evaluation of Cardiac Surgical Technical Skills & Operating Team Non-Technical Practices Through Digital Recordings to Advance Cardiac Surgical Outcomes

Evaluation of Cardiac Surgical Technical Skills & Operating Team Non-Technical Practices Through Digital Recordings to Advance Cardiac Surgical Outcomes

John Stulak
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304743-P01-RST
21-005235
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Inclusion Criteria:

  • Patients 18 years of age and older.
  • Undergoing a cardiac surgery at participating centers.
  • Intraoperative team members involved in cardiac surgery at participating centers.


Exclusion Criteria:

  • Individuals under 18 years of age.
     
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MC210809, Evaluating Mechanisms of Immunomodulator Sensitivity and Resistance in Multiple Myeloma (MC210809)

Study to Evaluate Mechanisms of Immunomodulator Sensitivity and Resistance in Multiple Myeloma

Wilson Gonsalves
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304747-P01-RST
21-006597
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Cohort A: Patient must have smoldering multiple myeloma requiring treatment and no prior therapies.
  • Cohort B: Patient must have newly diagnosed myeloma requiring treatment and no prior therapies.
  • Cohort C: Patient must have relapsed or refractory multiple myeloma with at least one prior therapy for their multiple myeloma but not refractory to all IMiDs.
  • Cohort D: Patient must have relapsed or refractory multiple myeloma with Lenalidomide as part of a maintenance regimen as their most recent therapy.
  • Measurable disease.
  • Provide written informed consent.
  • Patient must be considered for treatment with an IMiD containing regimen.
  • ECOG Performance Status (PS) 0, 1, 2 or 3.
  • The following laboratory values obtained ≤ 14 days prior to registration:
    • Hemoglobin ≥ 7.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1000/mm^3;
    • Platelet count ≥ 50,000/mm^3;
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome, in which case the direct bilirubin must be ≤ 1.5 X ULN;
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement);
    • PT/INR/aPTT ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy;
    • Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula below:
  • Cockcroft-Gault Equation:
  • Creatinine clearance for males =
  • (140
    •age)(weight in kg) ( 72)(serum creatinine in mg/dL);
  • Creatinine clearance for females = (140
    •age)(weight in kg)(0.85) ( 72)(serum creatinine in  mg/dL).
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
    • NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.  
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willingness to provide mandatory blood and bone marrow specimens for correlative research.
  • Willing to follow the requirements of the Pomalyst® REMS program.


Exclusion Criteria:

  • An agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • 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.
  • History of myocardial infarction ≤ 6 months.

Eligibility last updated 11/28/22. Questions regarding updates should be directed to the study team contact.

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MK-1026-003: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Sameer Parikh
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304753-P01-RST
21-005473
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Inclusion Criteria:


- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7
days prior to allocation

- Has a life expectancy of at least 3 months, based on the investigator assessment

- Has the ability to swallow and retain oral medication

- Participants who are Hepatitis B surface antigen (HBsAg)-positive are eligible if they
have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have
undetectable HBV viral load prior to randomization

- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable at screening

- Has adequate organ function

- Male participants agree to refrain from donating sperm and agree to either remain
abstinent from heterosexual intercourse as their preferred and usual lifestyle OR
agree to use contraception, during the intervention period and for 12 days after last
dose of study intervention

- Female participants not pregnant or breastfeeding are eligible to participate if not a
woman of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive
method that is highly effective OR remain abstinent from heterosexual intercourse as
their preferred and usual lifestyle during the intervention period and for at least 30
days after the last dose of study intervention

- Participants with HIV are eligible if they meet all of the following: the CD4 count is
>350 cells/uL at screening, the HIV viral load is below the detectable level, are on a
stable ART regimen for at least 4 weeks prior to study entry, and are compliant with
their ART

Part 1 and Part 2 (Cohorts A to C)

- Has a confirmed diagnosis of CLL/SLL with

- At least 2 lines of prior therapy (Part 1 only)

- Part 2 Cohort A: CLL/SLL participants who are relapsed or refractory to prior
therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi),
and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received
and failed, been intolerant to, or determined by their treating physician to be a
poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a
PI3Ki per local guidelines

- Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at
least 1 line of prior therapy and are BTKi treatment naive

- Part 2 Cohort C: CLL/SLL participants with 17p deletion or tumor protein p53
(TP53) mutation who are relapsed or refractory following at least 1 line of prior
therapy

- Has active disease for CLL/SLL clearly documented to initiate therapy

- Has evaluable core or excisional lymph node biopsy for biomarker analysis from an
archival or newly obtained biopsy at Screening (optional for participants
enrolling in Part 1)

Part 2 (Cohorts D to G)

- Has a confirmed diagnosis of and response to previous treatment of one of the
following:

- Participants with Richter's transformation who are relapsed or refractory
following at least 1 line of prior therapy (Cohort D)

- Participants with pathologically confirmed MCL, documented by either
overexpression of cyclin D1 or t(11;14), who are relapsed or are refractory to
chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)

- Participants with MZL (including splenic, nodal, and extra nodal MZL) who are
relapsed or refractory to chemoimmunotherapy and a covalent irreversible BTKi
(Cohort F)

- Participants with FL who are relapsed or refractory to chemoimmunotherapy,
immunomodulatory agents (i.e. lenalidomide plus rituximab) (Cohort G)

- Have measurable disease defined as at least 1 lesion that can be accurately measured
in at least 2 dimensions with spiral CT scan

- Has a lymph node biopsy for biomarker analysis from an archival or newly obtained
biopsy at Screening

Part 2 (Cohort H): confirmed diagnosis of WM; participants who are relapsed or refractory
to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi

- Has active disease defined as 1 of the following: systemic symptoms, physical
findings, laboratory abnormalities, coexisting disease

- Has measurable disease, satisfying any of the following: at least 1 lesion that can be
accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement
must be >15 mm in the longest diameter or >10 mm in the short axis); IgM ≥450 mg/dL;
or bone marrow infiltration of 10%

- Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at
Screening or a lymph node biopsy from an archival


Exclusion Criteria:


- Has active HBV/HCV infection (Part 1 and Part 2)

- Has a history of malignancy ≤3 years prior to providing documented informed consent
except for adequately treated basal cell or squamous cell skin cancer or in situ
cervical cancer

- Has active central nervous system (CNS) disease

- Has an active infection requiring systemic therapy

- Has received prior systemic anti-cancer therapy within 4 weeks prior to allocation

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study intervention

- Has any clinically significant gastrointestinal abnormalities that might alter
absorption

- History of bleeding disorders

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

Eligibility last updated 11/30/22. Questions regarding updates should be directed to the study team contact.

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The Effect of Etavopivat on Oxygen-binding Affinity, Skeletal Muscle Blood Flow, Maximal Oxygen Uptake During Exercise in Hypoxia: A Single-arm Crossover Trial

FORMA Study

Michael Joyner
All
18 years to 50 years old
Phase 1
This study is NOT accepting healthy volunteers
2021-304762-H01-RST
21-005324
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Inclusion Criteria:

  • Subjects must have the ability to understand, and sign written informed consent, which must be obtained prior to any study-related procedures being completed.
  • Adult female subjects of non-childbearing potential may participate in the study if they are either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or are post-menopausal, defined as spontaneous amenorrhea for at least 2 years as of screening visit.
  • Sexually active female subjects of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) or sexually active male subjects may participate in the study if they agree to use a medically accepted contraceptive regimen during their participation in the study and for 90 days after the last administration of study drug. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy and include:
    • For male subjects enrolled in the study include the following:
      • Condoms with spermicide; or
      • Surgical sterilization of subject at least 26 weeks before the Screening Visit (vasectomy).
    • For female subjects enrolled in the study include the following:
      • Intrauterine device for at least 12 weeks before the Screening Visit;
      • Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks before the Screening Visit;
      • Diaphragm used in combination with spermicide; or
      • Male partner: condom with spermicide.
  • Male subjects must agree to abstain from sperm donation and not plan to father a child (including sperm donation) through 90 days after administration of the last dose of study drug.
  • Female subjects may not be pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 90 days of last study drug administration.
  • Female subjects must have a negative result for the urine pregnancy test at the Study Visit #1 (screen and enrollment) and within 24-48 hours of each visit where exercise and hypoxia are involved.
  • Subjects must have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), and human immunodeficiency virus (HIV) antibody at the Screening Visit or documented in the medical chart within the last 1 year.
  • Subjects must be willing and able to abide by all study requirements (including the ability to swallow study tablets) and restrictions.
  • Subjects must be adult males or females between 18 and 50 years of age (inclusive) at the time of the screening visit.
  • Subjects must be in general good health, based upon the results of medical history and a physical examination performed by a physician, with vital signs, laboratory profile, and a 12-lead ECG, as judged by the Investigator at Screening and first period Check-in. Screening assessments may be repeated once (blood pressure may be repeated twice) at the Investigator’s discretion.
  • Subjects must have a body mass index (BMI) within the range of 18 kg/m^2 to 33 kg/m^2 (inclusive) and a minimum body weight of 50 kg at the Screening Visit; all participants will be evaluated on a case-by-case basis and inclusion in the study will be up to the discretion of the principal investigator.
  • Subjects must refrain from vigorous exercise and alcohol for 24 hours and caffeine 12 hours before study visits.
  • Subjects must have a negative urine test for drugs of abuse (opiates, benzodiazepines, amphetamines, cannabinoids, cocaine, barbiturates, and phencyclidine), cotinine, and alcohol at the Screening Visit.
  • Subjects will be screened for COVID-19 infection based on the Mayo Clinic’s institutional guidelines on the dates of the study visits.


Exclusion Criteria:

  • History of gastrointestinal (GI) surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, with the exception of appendectomy.
  • History of malignancy within previous 5 years (other than successfully treated basal cell or squamous cell skin cancer, or carcinoma-in-situ of the cervix);includes prostatic intraepithelial neoplasia (PIN).
  • History of clinically significant arrhythmia, left or right bundle branch block, 2nd or 3rd degree atrioventricular (AV) block, pacemaker or implantable cardioverter-defibrillator.
  • Abnormal and clinically significant 12-lead ECG, including QT interval corrected for heart rate according to Fridericia’s formula (QTcF) > 450 ms, QRS interval ≥ 120 ms, PR interval > 220 ms, based on average of triplicated ECG, assessed at Screening and first study (pre-treatment) visit. If any of these test results are out of range the test can be repeated once.
  • Systolic blood pressure < 90 or > 150 mmHg (or > 95th percentile for age) or diastolic blood pressure < 50 or > 95 mmHg (or > 95th percentile for age), at Screening and first period Check-in. If blood pressure is out of range, up to two repeated assessments are permitted.
  • A family history of QT prolongation or sudden cardiac death.
  • History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus.
  • Has had an acute illness considered clinically significant by the Investigator within 14 days prior to the study drug administration.
  • History of alcohol abuse or dependence within one year prior to Screening or regular use of alcohol within 6 months prior to the Screening Visit (self report more than 14 units of alcohol per week; one unit = 150 mL wine, 360 mL beer or 45 mL of 40% alcohol).
  • Has used any product containing nicotine within 90 days prior to the Screening Visit or intends to use any product containing nicotine during the course of the study.
  • Use of a prohibited prescription or non-prescription drugs and dietary supplements (including herbal and alternative medications), as specified in Section 6.2.
  • Has received an investigational drug, including vaccines (COVID-19 vaccines and booster shots), within five times the elimination half-life (if known) or within 30 days (if the elimination half-life is unknown) prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study.
  • History of allergy or hypersensitivity to etavopivat or excipients.
  • Subject has a history of chronic skin conditions including psoriasis, eczema or any recurring rash/dermatitis requiring oral or topical corticosteroids or chronic skin softeners within 12 months prior to screening;
  • Difficulty with venous or arterial access or unsuitable or unwilling to undergo intravenous or intra-arterial catheter insertion.
  • Has lost or donated > 550 mL (or > 10 mL/kg if < 18 yrs) of whole blood or blood products within 12 weeks prior to study drug administration.
  • Investigator has reason to believe that the subject may be unable to fulfill the protocol visit schedule or requirements.
  • Has any finding that, in the view of the Investigator, would compromise the subject’s safety requirements.
  • Evidence of clinically significant (or undergoing active medical treatment) hematologic, renal, endocrine, pulmonary, cardiac, GI, hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies), or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.
  • Laboratory results (serum chemistry, hematology) outside the normal range at the Screening Visit that are considered clinically significant in the opinion of the Investigator. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator.
  • Iron deficiency (as evidenced by abnormal iron level, and/or serum ferritin).
  •  Any elevation of aspartate aminotransferase and alanine aminotransferase.
  • > 1.5× the upper limit of normal (ULN), and bilirubin greater than ULN at the Screening Visit is exclusionary; or
  • Platelet count, absolute neutrophil count, absolute lymphocyte count, and hemoglobin level above or below the limit of normal, at Screening or first Check-in. If any of these test results are out of range, the test may be repeated once.
  • Currently prescribed or taking any medications or supplements (see Section 6.2.1). Any over-the-counter medications or supplements will be evaluated by the primary investigator/sponsor medical monitor on a case-by-case basis.

Eligibility last updated 10/7/22. Questions regarding updates should be directed to the study team contact.

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Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized Clinical Trial (ACH)

Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized Clinical Trial

Xiaoxi Yao
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304764-H01-RST
21-005335
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Inclusion Criteria:

  • Adult patients, 18 years of age and older.
  • Present to one of the participating hospitals.
  • Have a chief complaint of one of the target diagnoses.
  • Are within a certain geographical area (based on zip codes).
  • Have a health insurance plan that covers ACH services.
  • Have the capacity to consent or could assent with the consent of a health care proxy who is physically present.


Exclusion Criteria:

  • The patient is not suitable for ACH or inpatient hospital care based on:
    • being a nursing home patient;
    • on or requiring dialysis;
    • positive for COVID-19;
    • having discharge order;
    • requiring intensive care unit (ICU) level of care;
    • history of drug abuse.
  • Patients will also need to meet the clinical stability criteria.
  • Do not have the capacity to consent or assent with the assistance of a health care proxy.

 

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