New Brunswich, New Jersey
Leveraging the Emergency Department (LEAD) Study
Phase
N/ASpan
105 weeksSponsor
Hackensack Meridian HealthNorth Bergen, New Jersey
Recruiting
TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors
Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the safety, tolerability, PK, PD, anti-tumor activity, and efficacy of TT-10, TT-4 and TT-10 + TT-4 (Dual Blockade). The Phase Ia portion of the study study will consist of three dose escalation cohorts, to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of TT-10, TT-4, TT-10 + TT-4 and will be conducted in participants with the following advanced cancers: Cohort A (TT-10): Renal cell cancer (RCC), castrate resistant prostate cancer (CRPC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN); who have failed or are not eligible for standard of care treatment. Cohort B (TT-4): Castrate resistant prostate cancer (CRPC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), endometrial cancer (EC) and ovarian cancer (OC); who have failed or are not eligible for standard of care treatment. Cohort C (TT-10 + TT-4): Tumor types from both cohorts will be included and prioritized based on the data observed.
Phase
1/2Span
236 weeksSponsor
Portage BiotechNorth Bergen, New Jersey
Recruiting
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Phase
3Span
151 weeksSponsor
Teva Branded Pharmaceutical Products R&D, Inc.North Bergen, New Jersey
Recruiting
The Computational and Neural Mechanisms Linking Decision-making and Memory in Humans
Phase
N/ASpan
253 weeksSponsor
Rutgers, The State University of New JerseyNew York, New York
Recruiting
Whole Genome Sequencing (WGS) on IVF Embryos and Individual Patients
This project proposes a paired non-inferiority trial utilizing the retrospective testing of research embryos to establish the optimized parameters for amplified trophectoderm biopsy and whole genome sequencing compared to traditional preimplantation genetic testing for aneuploidy (PGT-A). The primary outcome is the de novo mutation rate, which will be compared between embryos subjected to trophectoderm biopsy and whole genome sequencing versus reanalysis with Sanger sequencing. Trio testing will be performed for each embryo using DNA from the genetic parents in addition to embryo. The study will compare cases that include couples with at least one embryo deemed unsuitable for transfer. A paired study design will be used, with embryos from each couple split into two arms - one subjected to trophectoderm biopsy and whole genome sequencing, the other to reanalysis with targeted sequencing. Biopsied trophectoderm samples and the remaining embryo tissues from the whole genome sequencing arm will undergo sequencing. Sequencing will also be performed on DNA samples from each genetic parent. Derivation of de novo mutation rates is a key goal, as these provide insights into effects of paternal age and other factors on germline mutations in preimplantation embryos, increasing the knowledge of the risks associated with advanced paternal age. Secondary metrics will be investigated to supplement the analysis, including clean reads and clean bases indicating the amount of high-quality data for the source templates. Mapping rate, unique rate and duplicate rate, assessing data accuracy and quality. Comparison of multiple metrics will determine the optimized parameters for performing amplified trophectoderm biopsy and whole genome sequencing. This can then inform future research and clinical studies. The de novo mutation rate will be derived by modelling the observed mutation rate as a function of parental ages, specifically the paternal age. Whole genome sequencing of embryo samples as well as both parents will identify raw numbers of de novo mutations. The paternal age coefficient for the de novo mutation rate will be calculated using a regression model with the number of de novo mutations as the dependent variable and paternal age as the key independent variable. Covariates like maternal age and sequencing quality metrics will also be included to account for potential confounding factors. The regression model will determine the increase in de novo mutations per year of paternal age, providing the paternal age coefficient. Comparing embryos from older and younger males will reveal differences in mutation rates. The overall model will establish the quantitative relationship between paternal age and de novo mutations in preimplantation embryos based on the study's whole genome sequencing data.
Phase
N/ASpan
66 weeksSponsor
GenEmbryomics Pty. LtdNew York, New York
Recruiting
Lay-Delivered Behavioral Activation in Senior Centers
This Collaborative R01 application (UW, Cornell, USF) proposes to conduct an effectiveness trial of lay-delivered Behavioral Activation ("Do More, Feel Better"; DMFB), in comparison to MSW-delivered Behavioral Activation (MSW BA), for depressed (PHQ-9>10 and Ham-D>14) older (60+) senior center clients. The primary aim tests the effectiveness of DMFB, in comparison to MSW BA, on increasing overall activity level (target) and reducing depression symptoms. The investigators will test whether increased activity level predicts greater reduction in depression severity and whether increased activity's impact on depression is non-inferior across conditions. Secondarily, the investigators will test hypotheses associated with overall functioning, satisfaction with treatment, and client-level moderators. Lastly the investigators will explore longer-term client outcomes, delivery cost, and preparing for sustainability by exploring client, provider, and center factors related to intervention fidelity.
Phase
N/ASpan
253 weeksSponsor
University of WashingtonNew York, New York
Recruiting
Retrospective Study of Keloid Disorder
To retrospectively review and analyze clinical data that has already been collected from keloid patients including photographs taken of keloid lesions during routine practice of medicine by the investigators 1) To better understand natural history of keloid disorder (KD), 2)To determine the ethnic incidence and prevalence of keloid, 3) To determine the rate of familial keloids, 4) To determine response to different treatment modalities, 5) To determine risk factors for development and worsening of keloid lesions.
Phase
N/ASpan
370 weeksSponsor
Tirgan, Michael H., M.D.New York, New York
Recruiting
A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
Phase
3Span
97 weeksSponsor
Alumis IncNew York, New York
Recruiting
Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
Following informed consent, participants will undergo tests for heart health, physical function, memory testing, and brain structure and function using imaging (taking pictures of the brain with an MRI). Following these tests participants are randomized to a home-based walking program or health education for 6 months. Participants are given a fitness tracker and gets ongoing telephone coaching during the 6 months. After 6 months the tests are repeated.
Phase
N/ASpan
137 weeksSponsor
Columbia UniversityNew York, New York
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
The prevalence of Alzheimer disease (AD) is high and projected to increase. While there are multiple risk factors for AD, epidemiological data suggests that ~15% of AD risk may be attributed to sleep problems. Obstructive sleep apnea (OSA) is common among the elderly (30-55%), and the investigators have shown that cognitively normal older women with OSA have nearly double the risk of developing mild cognitive impairment (MCI) or dementia over 5 years. Further, the investigators have shown that in normal elderly, OSA predicts longitudinal increases in AD biomarkers. Our preliminary data also show that after positive airway pressure (PAP) withdrawal, OSA patients treated with PAP experienced significant overnight increases in plasma neurofilament light (NfL), a marker of neural injury. The present study is designed to overcome challenges identified in previous trials of treatment of OSA to slow cognitive decline and progression to AD. First, the most effective treatment for OSA, PAP therapy, has poor adherence (typically only 50% are adequately treated). Other common therapies include oral appliance therapy (OAT) which tends to be better tolerated but less effective. The investigators have piloted and propose for this study a rapid multimodal therapy initiation (RMMT) which ensures subjects will have effective therapy for their OSA that reduces OSA severity to AHI4%<10/hour and AHI3A (AKA pRDI) < 20/hour within 4 months. Second, most prior OSA treatment trials have focused primarily on symptomatic older adults (e.g. patients with MCI recruited from memory clinics), whereas early intervention in pre-symptomatic individuals may have stronger impact in preventing progression to AD. The investigators propose to enroll cognitively normal adults with newly diagnosed moderate-severe OSA (AHI4% >20/hour or AHI3A > 40/hour). Finally, selection of cognitive outcomes most responsive to OSA therapy has proved challenging. The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults (MoCA≥24, Clinical Dementia Rating [CDR]=0), ages 55-75, recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA (AHI4% >20/hour or AHI3A > 40/hour). An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%< 10/hour and AHI3A<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers. Both arms will include PSG and actigraphy, sleep-dependent memory and other cognitive evaluations, and blood draws at baseline, 3 and 24 months, with cognitive evaluation only at 12 months. Structural brain MRI will be performed at baseline. Because the investigators anticipate that 150 of 200 subjects will be well treated at 24 months, and 50 will not be, the investigators will additionally recruit ~50 subjects (on average 13 subjects per clinical site) with the same inclusion criteria who refuse treatment. These 50 subjects will perform baseline (blood draw and cognitive evaluations), 12-month (cognitive evaluation only), and 24-month (blood draw and cognitive evaluations) visits, allowing for a 24-month comparison of ~150 subjects with adequate treatment over 24 months to 100 subjects with inadequate treatment over 24 months. Our aims are: 1) To compare 3-month change in plasma AD biomarkers (NfL, p-tau, Aβ) in those randomized to OSA treatment and wait-list control groups (via both intention-to-treat and per-protocol analyses); 2) To test differences at 3 months in sleep-dependent declarative memory and cognitive scores (PACC and sub-domains) between the OSA treatment and wait-list control groups (via both intention-to-treat and per-protocol analyses); 3) To compare 24-month changes in AD biomarkers (NfL, p-tau, Aβ) and cognition in all successfully treated subjects and untreated controls.
Phase
N/ASpan
215 weeksSponsor
California Pacific Medical Center Research InstituteNew York, New York
Recruiting