A sham-controlled pilot trial of focused ultrasound modulation of the globus pallidus interna in schizophrenia
The primary objectives of this study are to examine the tolerability of pulsed low-intensity focused ultrasound (PLIFUS) and its effects on brain function measured via fMRI functional connectivity and symptom response in individuals with schizophrenia. A neuronavigated single-element piezoelectric device will be utilized to noninvasively deliver transcranial PLIFUS sonication to the right globus pallidus interna, a brain region implicated in schizophrenia. We aim to enroll N=12 participants with schizophrenia in a random order, sham-controlled crossover trial of a single session of PLIFUS counterbalanced with a single sham sonication session, one week apart. After the participant provides written informed consent, a medical and psychiatric evaluation will be performed to determine eligibility for inclusion in the study, followed by a structural MRI to guide neuro-navigation. The first intervention visit will include a 10 minute PLIFUS sonication or sham sonication, preceded and followed by fMRI and an exit medical examination. Psychiatric symptoms will be assessed immediately prior to sonication/sham, during sonication/sham and 5 minutes, 30 minutes, 60 minutes, 1 day and 7 days after sonication/sham. The second intervention visit will consist of sonication or sham preceded and followed by fMRI in addition to symptom assessments and post-sonication/sham medical evaluation. Participants will be closely monitored during and after procedures for tolerability and adverse effects, including 1 and 7 day follow-up visits. The goal of this pilot study is to establish feasibility and tolerability and to determine whether the sonication procedure produces effects on the imaging biomarker and on symptoms prior to proceeding to therapeutic trials using repeated administration. If PLIFUS effects on fMRI and symptom ratings are not detected in the first 4 completers, subsequent participants will receive 3 sessions over 5 days.
A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI
The primary purpose of this research is to evaluate whether ZyMot, a microfluidic sperm processing device, will lead to a higher percentage of better-quality embryos following insemination with intracytoplasmic sperm injection (ICSI) compared to sperm processed with density gradient, our standard sperm separation technique.
A Single-Arm Phase 2 Study Of Daratumumab In Previously Treated Stk11/Lkb1 Mutated Non-Small Cell Lung Cancer
This is a single arm, signal finding study of daratumumab in metastatic NSCLC patients with an STK11/LKB1 mutation. Patients will have received previous standard of care treatment including chemotherapy, immunotherapy and targeted therapy. We plan to enroll a total of 14 patients. Patients will be treated with the standard subcutaneous dosing of daratumumab (weekly for 8 administrations, then every 2 weeks for 8 administrations then every 4 weeks until progression). All follow-up visits and imaging will be performed as per standard of care. This is a signal finding stud
A single arm phase II study of ADjuvant Endocrine therapy subcutaneous Pertuzumab and Trastuzumab fixed-dose combination for patients with anatomic stage I hormone receptor-positive HER2-positive breast cancer (ADEPT)
This is a single arm open-label phase II trial of adjuvant Fixed Dose Combination (FDC) of subcutaneous (SC) trastuzumab (H) plus pertuzumab (P) and endocrine therapy without chemotherapy in patients with stage I hormone receptor-positive (HR+) and HER2-positive (HER2+) breast cancer. The primary endpoint is invasive disease-free survival when treated with a "de-escalated" regimen of hormonal and dual HER2-targeted therapy, with omission of a chemotherapy backbone. Eligible patients will have anatomic stage I (according to AJCC 8th edition anatomic staging table), HR+ and HER2+ breast cancer. HER2 positivity will be confirmed by central testing in all patients. Patients may be either pre- or post-menopausal. Patients must be naïve to systemic therapy for this cancer and have undergone primary breast surgery, with surgical pathology demonstrating stage I disease. After completion of primary breast surgery, patients will be registered to the trial, and receive adjuvant subcutaneous trastuzumab and pertuzumab (1 year), and hormonal therapy (at least 5 years). Patients will also receive adjuvant radiation therapy if deemed necessary per institutional practice. Patients will be followed for a total of 10 years for long-term disease outcomes. Patients will also participate in quality of life (QOL) surveys and symptom questionnaires at various time points through the course of study treatment and during follow-up. A subset of patients will participate in a single arm crossover substudy during four cycles of their overall therapy to receive two cycles of IV infusion followed by two cycles of SC FDC administration of HP, to specifically evaluate time and motion endpoints related to IV versus SC administration. Lastly, this study requires submission of tumor blocks or slides in order to perform biomarker analyses as well as blood draws for correlative analyses.
A single-center longitudinal study of the diagnosis clinical course risk factors causes and treatment of cognitive impairment in aging Alzheimer s disease (AD) and related disorders
The purpose is to study the diagnosis, clinical course, risk factors, causes and treatment of cognitive impairment in aging, Alzheimer’s disease (AD) and related disorders. AD patients and normal control subjects will be recruited to receive complete evaluations. These subjects, along with all previously evaluated subjects will be followed-up until death. Basic research on normal aging and the causes of AD will also be conducted. Eligible subjects include those with AD and related conditions, persons with mild cognitive impairment, and people with normal cognitive function for age.
A Single-Center Observational Barrier Assessment and Implementation of a Tailored Educational Intervention for Families of Children with Epilepsy in a Medically Underserved Population
This study aims to identify the socioeconomic/cultural disparities and patient perspective barriers in a medically underserved population (Bellevue Hospital). This will be followed by an implementation period with the design of an individualized educational intervention for families of patients with pediatric epilepsy. This pilot study will incorporate the use of questionnaires, data analysis, educational intervention development, social media, and videography to both assess the inequality experienced by this population and improve their health outcomes. Studies have evaluated the patient and family perspectives on epilepsy surgery, but there has been no study to our knowledge that incorporates an educational component built from these results.
A SINGLE-CENTER OBSERVATIONAL LONGITUDINAL STUDY ON THE EFFECT OF SLOW WAVE SLEEP (SWS) CHARACTERISTICS AND RACE AND ETHNICITY ON AMYLOID BURDEN (A MARKER OF ALZHEIMER S DISEASE RISK) AMONG COGNITIVELY NORMAL ELDERLY.
African-Americans (AAs) have an increased prevalence of both Alzheimer’s disease (AD) and vascular risk factors for AD such as diabetes and hypertension when compared to whites. This larger component of AD-dementia has traditionally been associated with vascular risk and supported by studies showing that AAs with clinical AD more frequently have mixed pathology on autopsy. However, in a recent community based study of non-demented elderly, black race was associated with higher amyloid burden after adjusting for vascular risk factors, suggesting the presence of additional physiological differences on AD-risk by race in the early stages of the disease. The purpose of this study is to test whether poor slow wave sleep (SWS) quantity (SWS duration) and quality (slow wave activity, SWA) is one of these physiological factors.
A single-center observational longitudinal study to monitor skeletal muscle aging with quantitative MRI
The muscles in your legs and shoulders change as you get older and they become weaker. The purpose of this study is to investigate new magnetic resonance imaging (MRI) techniques to look at these changes in your muscle over time. We will try and understand how changes in your muscle relate to muscle weakness, and whether there are differences in healthy people.
A Single Center Observational Study for the Characterization of Eye Movement Abnormalities Patients with Movement Disorders using the neuroClues Technology
Eye movements are frequently affected in individuals with different movement disorders, including Parkinson’s disease (PD), atypical Parkinsonism, but also cases of ataxia, myoclonus, and chorea, among the others. These findings can represent a valuable biomarker for early diagnosis and to be used as outcome measures in clinical trials. The purpose of this study is to characterize the eye movements in different Movement Disorder conditions using a NeuroCluesTM, a new recording systems for eye movements that could be easily integrated in the clinical practice.
A SINGLE-CENTER OBSERVATIONAL STUDY OF CLINICAL OUTCOMES FOLLOWING TREATMENT OF LEIOMYOMA WITH COMBINATION THERAPY UTILIZING GNRH ANALOGS AND TRANSCERVICAL FIBROID ABLATION
This is a prospective cohort study of patients who will receive TFA following medical therapy for fibroid care between 1/2023 and 1/2024 at our institution. Clinical variables of interest will be collected by chart review by the study team and will include characteristics of fibroids including diameter, location and volume, volume of uterus, medical management prior to TFA, need for surgical reintervention within 6-12 months following TFA due to heavy menstrual bleeding, and ultrasound and lab data prior to TFA and at 3, 6 and 12 months post procedure. Additional quality of life data collected by surveys will be summarized at all specified time points.