New York Paid Clinical Trials

The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Read Less

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: * At a dose of 120µg. * In adults 60 years of age and older. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in Argentina. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study. * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Canada. Read Less

This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC). Read Less

Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib. Read Less

Newborns in the neonatal intensive care unit (NICU) are at high risk for wrong-patient errors. Effective 2019, The Joint Commission requires that health systems adopt distinct methods of newborn identification as part of its National Patient Safety Goals. Displaying patient photographs in the electronic health record (EHR) is a promising strategy to improve identification of children and adults, but is unlikely to be effective for identifying newborns. This study assesses the use of Pictographs as a "photo equivalent" for improving identification of newborns in the NICU. This multi-site, two-arm, parallel group, cluster randomized controlled trial will test the effectiveness of Pictographs for preventing wrong-patient order errors in the NICU. Pictographs consist of three elements: 1) pictorial symbols of easy-to-remember objects (e.g., rainbow, lion); 2) the infant's given name (when available); and 3) a color-coded border indicating the infant's sex. The study will be conducted at three academic medical centers that utilize Epic EHR. All parents or guardians will be asked to select a unique Pictograph for each infant admitted to the NICU to be displayed on the isolette and in the EHR for the duration of the infant's hospital stay. All clinicians with the authority to place electronic orders in the study NICUs will be randomly assigned to either the intervention arm (Pictographs displayed in the EHR) or the control arm (no Pictographs displayed in the EHR). The main hypothesis is that clinicians assigned to view Pictographs in the EHR will have a significantly lower rate of wrong-patient order errors in the NICU versus clinicians assigned to no Pictographs. The primary outcome is wrong-patient order sessions, defined as a series of orders placed for a single patient by a single clinician that contains at least one wrong-patient order. The Wrong-Patient Retract-and-Reorder (RAR) measure, a validated, reliable, and automated method for identifying wrong-patient orders, will be used as the primary outcome measure. The Wrong-Patient RAR measure identifies one or more orders placed for a patient that are retracted within 10 minutes, and then reordered by the same clinician for a different patient within the next 10 minutes. In the validation study conducted at a large academic medical center, real-time telephone interviews with clinicians confirmed that 76.2% of RAR events were correctly identified by the measure as wrong-patient orders. Read Less

This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Pompe Registry, regardless of whether she is receiving disease-specific therapy (such as ERT with alglucosidase alfa or avalglucosidase alfa) and irrespective of the commercial product with which she may be treated. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Pompe disease during pregnancy, regardless of whether they receive disease-specific therapy, such as ERT with alglucosidase alfa or avalglucosidase alfa. Read Less

The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities. The objectives of the Registry are: * To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase) * To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I * To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care Read Less

The proposed Virtual Reality as an Adjunct to Pain Management for Geriatric Patients in the ED (VRAP-ED) project will take place in the Emergency Medicine Department at Maimonides Medical Center. It seeks to enhance the analgesic practices for geriatric patients with acute painful conditions in the emergency setting. Although virtual reality (VR) has demonstrated effectiveness in reducing pain and anxiety in various clinical settings for juveniles and adults, the analgesic efficacy of VR for geriatric ED patients lacks established data. The project will use a geriatric-focused VR platform. The project intends to improve pain management for almost 200 geriatric patients by evaluating the effectiveness of virtual reality (VR) in reducing pain and its impact on anxiety \& stress reduction. The research project will conduct a randomized clinical trial to investigate the analgesic efficacy and impact on anxiety \& stress by using VR as an adjunct to the standard of care (SOC) for pain management in elderly patients presenting to the ED with acute musculoskeletal pain. This will be investigated through a prospective, randomized, non-blinded clinical trial conducted over two years. Eligible patients will be randomly assigned to either the control (SOC) or intervention (SOC+VR) groups. The expected outcomes of this research study will provide insight into the feasibility of using VR in a busy emergency setting for one of the most commonly encountered painful syndromes and to assess the analgesic efficacy as well as the satisfaction of VR application by both patients and ED clinicians. Read Less

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod. All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer. The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod. Read Less

This study will evaluate the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention for caregivers of people with Alzheimer's disease and related dementias (ADRD). PICT provides training in observational pain assessment and coaching in effective pain communication techniques. It will recruit participants from programs of all-inclusive care for the elderly (PACE) and partnering health care clinics. The investigators hypothesize that PICT will help caregivers to recognize and communicate about pain in their care recipients. Read Less

The HIV diagnosis rate among African-born Black women is the highest of all Black individuals living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis (PrEP) are two effective means of decreasing HIV risk among women, but they remain suboptimal among Black women. The specific aims of this study are: 1. To culturally adapt two widely utilized, evidence-based HIV prevention interventions originally designed for US born Black women (Sister-to-Sister (S2S) and Sisters Informing Sisters about Topics on AIDS (SISTA)) for use by African-born women 2. To conduct a randomized controlled comparative effectiveness trial (RCT) to determine the effectiveness of adapted versions of S2S versus SISTA on increasing condom use and PrEP uptake among African-born women. The adapted versions of these interventions will be given new names that resonate with the African culture. The adapted version of S2S intervention will be called "Dada Kwa Dada (DKD)" intervention while the adapted version of SISTA intervention will be called "DADA" intervention. "DADA" means "Sister" in Swahili and other languages in Eastern and Western Africa. Read Less

This study is being done to compare the effectiveness of three different skills trainings to cope with distress. These three trainings are: 1) an attention skills training, 2) an attention and reflective thought skills training, and 3) a health and wellness education training. Read Less