New Jersey Paid Clinical Trials

Researchers are doing this study to look at whether sexual health counselling and using non-hormonal moisturizer at the start of ovarian suppression may be able to prevent or reduce side effects such as vaginal dryness and sexual dysfunction. Researchers will compare how effective this prevention intervention works compared to the usual approach, which is to treat these side effects after they start. All participants will also complete surveys about their sexual health. This information will help researchers learn more about the sexual health of women with breast cancer receiving ovarian suppression. Read Less

This is a multicenter, randomized clinical comparative effectiveness trial (RCT) in which patients with untreated OUD presenting to a Northwell Health Emergency Department (ED), NYULH-Brooklyn, NYULH-Tisch, and Bellevue Hospital will be randomized (1:1) to be managed clinically through either a standard ED visit or an extended visit through ED observation (EDOU). Read Less

In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Read Less

The primary objective of this study is to compare Assay results to diagnoses determined by currently accepted standards for lung cancer detection. This will be accomplished by analysis of sputum samples from three cohorts including healthy Participants, high risk Participants, and cancer patient Participants using the Assay as developed in accordance with findings of bioAffinity protocol BA-001 to confirm assay results. Adjustments will be made as necessary to finalize Assay design for clinical trials and commercialization. The secondary objective of this study is to determine optimum methods for collection of sputum samples. Three sputum collection methods used by high risk Participants will be compared. Individuals at high risk for lung cancer will be assigned to one of three sputum collection cohorts including (1) acapella® airway assist device under medical supervision to obtain a single sputum sample; (2) acapella® airway assist device to obtain a sputum sample over a three-day period, and (3) individuals who under medical supervision will collect a single sputum sample assisted by nebulization of between 0.9% to 10% hypertonic saline. Samples will be compared to determine the optimal collection method for sample analysis by CyPath® Lung. Read Less

Magnetic resonance imaging (MRI) is currently one of the standard diagnostic imaging methods used to diagnose tumor stage before treatment in the Radiation Oncology Department. It is also used to check responses to radiation after treatment. However, MRI isn't traditionally used in planning for radiation treatment or in checking treated tumor and tissue changes during radiation treatment. The goal is to find out the possible benefits of MRI imaging techniques in these settings of radiation treatment. The research aims are to study the possibility of using devices with new abilities such as the MR-Linac. The MR-Linac combines a radiation treatment machine with a diagnostic MRI scanner. This device will improve the quality of MRI-guided radiation treatment. The MR-Linac has functions that are currently not available in other combined imaging and radiation delivery devices. The MR-Linac does not provide additional imaging capabilities that are not currently available in other imaging devices. Participating in this study would NOT change the current treatment plans, this will allow the investigators to use the MRI methods in research and future patient care. Read Less

The purpose of this study is to compare two types of imaging for sentinel lymph node (SLN) mapping in people with early-stage vulvar cancer. The researchers will compare indocyanine green near-infrared (ICG-NIR) imaging with lymphoscintigraphy. All participants in this study will be scheduled for standard surgical treatment at Memorial Sloan Kettering Cancer Center (MSK). This surgical treatment includes SLN mapping (with both lymphoscintigraphy and ICG-NIR imaging) and SLN biopsy. Read Less

The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support. Read Less

This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined. Read Less

The investigators will screen all mechanically ventilated ED patients for study eligibility and will enroll all consecutive patients satisfying inclusion and exclusion criteria. The study design is a pragmatic, multicenter, stepped wedge cluster randomized trial, enrolling at five sites over a 3-year period, divided into six time periods of six months. Prior to the study, each site will be randomized to their position within the design. One site will cross to the intervention period (i.e. succinylcholine as default neuromuscular blocker) every six months from the 2nd to 6th time period. Cluster order will be determined by computer-based randomization. To begin, each site will be exposed to control conditions; by the end of the study, each site will be exposed to intervention conditions. Patients in the control phase will receive usual care, and this phase will be entirely observational. After six months, a site will enter a 2-month transition phase. In this phase, the investigators will implement the intervention, similar to how they have implemented other ED-based interventions for mechanically ventilated patients. The investigators will engage and educate ED clinicians on the importance of AWP prevention and the study objectives. The intervention framework relies on the use of "nudges", without restricting choice. The use of neuromuscular blockers (i.e. "paralytic" medications) is already part of routine care in the ED in order to facilitate endotracheal intubation and initiation of mechanical ventilation for patients with acute respiratory failure. The two most common neuromuscular blockers used in the ED are succinylcholine and rocuronium. The preliminary data show a strong association between rocuronium (a longer-acting neuromuscular blocker) use and AWP. Therefore, this study aims to improve care by educating caregivers on AWP and the use of the neuromuscular blockers, which are already routinely used, and studying that process in a rigorous fashion. The default neuromuscular blocker in the intervention phase will be succinylcholine. Succinylcholine will be the default over rocuronium because: 1) it has safely been the default neuromuscular blocker of choice in the ED for \>40 years ; 2) its 5-minute duration of action greatly reduces AWP risk; 3) the preliminary data regarding an increased risk of AWP with rocuronium and 4) ED rocuronium use has increased despite no patient-centered studies showing benefit over succinylcholine. Passive alerts (i.e. graphics, pocket cards) will also be strategically placed in the ED, and active alerts will be used as reminders before every nursing shift (i.e. "the huddle"). After this transition phase, the site will begin the intervention phase, and patients will again receive clinician-directed care, just after the intervention. Read Less

This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined. Read Less

This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. Read Less

The REACH study is for people with CF who do not take cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The goal of the REACH study is to collect research data, including health data and specimens, from people with CF who do not take CFTR modulators. This data may be used to inform CF research, help design CF clinical trials and support the development of new treatments for people with CF who do not take CFTR modulators. Another goal of this study is to learn about research involvement for people with CF who do not take CFTR modulators, engage them in research, and give them an opportunity to learn about what is involved in participating in a CF research study. Read Less