New York, New Jersey Clinical Trials

S Sadia Morium

First-in-human Study of 7MW4911 in GI Cancer

This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.

K Kathleen Ryan, MD

Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 …

G Giselle Singer

Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome

This is a single-center, open-label, basket phase 2b trial that will enroll Down Syndrome (DS) participants with at least one inflammatory skin condition (Atopic Dermatitis (AD) and/or Alopecia Areata (AA)). Patients will receive Abrocitinib 100 mg daily for 12 weeks. Responders (defined as achieving Eczema Area and Severity Index (EASI) …

L Laura Gemmell, MD

HELIOS: Human Embryo Illumination to Enhance Development

Embryos need a lot of energy to grow, but as women get older, the "power plants" of the cells (called mitochondria) don't work as well. This makes it harder for embryos to develop normally. One possible way to help is with a gentle light treatment called photobiomodulation (PBM). This uses …

E Elena Silverman, MS

Study of Cannabidiol and Neuroimaging on Stress

Dysregulation in stress responsivity is a growing psychiatry-transdiagnostic fundamental phenomenon, with limited therapeutic strategies. With the legalization of medical and recreational cannabis, many people consume cannabidiol (CBD; a nonintoxicating cannabinoid) to alleviate stress response, without the benefit of scientific guidance. To address this gap, the investigators propose a rigorous translational …

H Howard S. Hochster, MD

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with standard dosing in the control arm.

J Jaymee Lopez

AMEND TS Early Feasibility Study

Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.

S Steven Shamah, MD

Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients

evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.

DESCANSO, a Mental Health Intervention for Depression, Insomnia, and Fatigue Symptoms in Latino People With Cancer

The purpose of this study is to improve ways of providing mental health support to Spanish-speaking Latino participants who have cancer and experience depression, insomnia, and fatigue. Investigators will test a special mental health intervention called DESCANSO/REST (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep). The intervention can be delivered through telehealth.

K Katarzyna Pasciak, BS

SAINT in Postpartum Depression (PPD)

This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment. It will enroll 192 women within six months postpartum who are …