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  • Product Surveillance Registry

    Phase

    N/A

    Span

    1466 weeks

    Sponsor

    Medtronic

    New Brunswick, New Jersey

    Recruiting

  • Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

    All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

    Phase

    N/A

    Span

    3027 weeks

    Sponsor

    Medtronic

    New Brunswick, New Jersey

    Recruiting

  • Diabetes Electronic Prompt for Improved Care Coordination and Treatment in the ED

    Type 2 Diabetes (T2D) is a growing public health crisis with rates of diabetes steadily increasing over the last 10 years. The ED is commonly the first point of contact for individuals who present with symptoms of hyperglycemia, often with very severe (HbA1C > 10%) underlying diabetes. However, there is currently no national guideline or clinical policy for the ED management of patients who are not in diabetic ketoacidosis (DKA) or in a hyperglycemia hyperosmolar state (HHS). The investigators hypothesize that there are two subgroups who may benefit from greater care coordination initiated from the ED: patients who are newly-diagnosed with severe T2D and patients whom T2D is poorly-controlled despite medication adherence. This study designs electronic prompt practice advisories that nudge ED providers towards more aggressive treatment pathways. It is currently unknown whether alert tools can improve the delivery and coordination of care of patients with severe T2D presenting to the ED.

    Phase

    N/A

    Span

    53 weeks

    Sponsor

    Rutgers, The State University of New Jersey

    New Brunswick, New Jersey

    Recruiting

  • Lung Function Monitoring During Hypoxemia Episodes

    This is an observational study evaluating changes in lung volume during hypoxemia episodes (HEs or desaturation episodes) in spontaneously breathing very preterm infants. We postulate that HEs can be differentiated into distinct subtypes based on alterations in lung volume. Additionally, the severity and duration of HEs correlates with the degree of changes in lung volumes. Therefore, we are performing an observational study in very preterm infants with spontaneous HEs and classifying these episodes into different subtypes of Apnea, forced exhalation, mixed, and unclassified subtypes according to changes in lung volume. Lung volume will be measured non-invasively using electrical impedance tomography (EIT) device (Sentec Inc, RI, USA). In brief, the device consists of a soft belt with 32 embedded electrodes which is placed around the chest of the infant and applies a weak alternating current and measures returning voltage. The measured returning voltage is dependent on the electrical conductivity of the underlying tissue. The reconstruction algorithm creates an image of regional impedance distribution in real time. These data are then used to compute lung volume parameters at different phases of respiratory cycle providing end expiratory lung impedance reflective of EELV, tidal impedance reflective of tidal volume, and regional distribution of ventilation. The changes in lung volume parameters will be used to differentiate HEs into different subtypes and correlated with degree and severity of HEs. In addition, we will also measure cerebral tissue oxygen saturation (CrSO2) to monitor changes in tissue oxygenation with hypoxemia episodes and changes in lung volume.

    Phase

    N/A

    Span

    122 weeks

    Sponsor

    Rutgers, The State University of New Jersey

    New Brunswick, New Jersey

    Recruiting

  • Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy

    The proposed CONTEMP-ICD trial is a prospective, multicenter, open-label, randomized controlled trial; enrolling 3290 participants with HFrEF, on stable and optimal guideline-directed medical therapy (GDMT), who are eligible for a primary prevention ICD, but have a low predicted arrhythmic risk. Enrolled participants will be randomized in a 1:1 ratio to non-ICD vs. ICD treatment arms. The investigators hypothesize that, in participants with HFrEF who have a low predicted arrhythmic risk, non-ICD vs. ICD is non-inferior with respect to the primary endpoint of all-cause mortality and superior survival free of major cardiovascular (CV) events. This study will recruit adults 18 years of age and older with heart failure. Participants will be asked to complete questionnaires. Information from medical records will be gathered including medical history, physical exam, medications, blood work results, and imaging. Visits will be at initial, three, six months, and every six months beyond six months. For those who get an ICD device an interrogation will be collected at the visits.

    Phase

    N/A

    Span

    313 weeks

    Sponsor

    University of Rochester

    New Brunswick, New Jersey

    Recruiting

  • A Randomized Trial Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

    Phase

    3

    Span

    234 weeks

    Sponsor

    AbbVie

    New Brunswick, New Jersey

    Recruiting

  • A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

    This is open-label, multi-center study to evaluate the safety and preliminary efficacy of AZD0486 administered as monotherapy and in combination with other anticancer agents in participants with mature B-cell hematologic malignancies. This master study currently includes 3 substudies and each substudy focusing on a defined population: Substudy 1: Relapsed/refractory (R/R) Chronic lymphocytic leukaemia (CLL)/ Small lymphocytic leukaemia (SLL) Substudy 2: R/R Mantle-cell lymphoma (MCL) Substudy 3: Large B-cell lymphoma (LBCL) or R/R B-cell non-Hodgkin lymphoma (B-NHL) (not applicable to US) The study will have the following sequential periods: 1. Screening period of 28 days 2. Treatment period 3. Follow-up period

    Phase

    1/2

    Span

    326 weeks

    Sponsor

    AstraZeneca

    New Brunswick, New Jersey

    Recruiting

  • Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants

    Phase

    1

    Span

    227 weeks

    Sponsor

    Iovance Biotherapeutics, Inc.

    New Brunswick, New Jersey

    Recruiting

  • AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

    This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of AZD0486 monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 to 80 years of age with relapsed or refractory B-NHL.

    Phase

    2

    Span

    238 weeks

    Sponsor

    AstraZeneca

    New Brunswick, New Jersey

    Recruiting

  • Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

    This first-in-human clinical trial will begin with an exploration of MRTX1719 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure sufficient safety experience, PK information, compare food effect and relative bioavailability between capsules and tablets, and early evidence of clinical activity are available.

    Phase

    1

    Span

    203 weeks

    Sponsor

    Bristol-Myers Squibb

    New Brunswick, New Jersey

    Recruiting

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