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 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.
A SINGLE-CENTER OBSERVATIONAL STUDY OF PAIN PHENOTYPES IN PSORIATIC ARTHRITIS
This study is an observational study of individuals with psoriatic arthritis (PsA) to define types of pain. We aim to better understand the prevalence of persistent joint pain in PsA, better phenotype pain in PsA, and understand what psychosocial factors may contribute to the development of persistent pain. This study will help promote awareness of the impact of psychosocial factors in PsA and help provide preliminary data to designed adjuvant treatments for those with PsA and persistent pain.
A Single-Center Observational Study of Targeted Muscle Reinnervation in Amputees
This is a prospective, observational, longitudinal study that will follow the course of recovery for amputees who undergo targeted muscle reinnervation for treatment of limb pain.
A SINGLE-CENTER OBSERVATIONAL STUDY OF THE IMPACT OF TREMOR AFFECTING THE VOICE ON DEGLUTITION
Tremor affects ~1% of the global population or nearly 80 million people. In spite of this staggering figure, both nomenclature and treatment approaches are inconsistent. Many patients present with tremor affecting the voice, either in isolation or in combination with tremor of the limbs. Isolated vocal tremor was historically considered a clinical variant of essential tremor (ET). Recently updated classification criteria, however, exclude isolated voice tremor from ET classification. This controversy provides an ideal platform for meaningful patient-oriented research with the potential to substantively address issues related to communication-related disability.In the current study, we seek to understand differences in the clinical phenotypes between these two patient populations and the impact of voice tremor on structures of the upper aerodigestive tract and deglutition. In addition, foundational efficacy data regarding pharmacological therapy for patients with voice tremor will be collected.
A single-center observational study of the natural history and pathogenesis of hidradenitis suppurativa
A single-center observational study of the natural history and pathogenesis of hidradenitis suppurativa