All Clinical Trials

Current disease-modifying therapies for multiple sclerosis (MS) aim to prevent the development of new lesions; unfortunately, no current FDA-approved therapies promote central nervous system (CNS) repair mechanisms. Thus, strategies to promote functional recovery from lesion-related deficits in adults with MS remain an unmet need. This is a pilot study designed to test the feasibility, safety and preliminary efficacy of non-invasive (transcutaneous, applied by surface electrodes over the skin) electrical spinal cord stimulation combined with occupational therapy for restoring upper extremity sensorimotor function in adults with multiple sclerosis. Participants with multiple sclerosis and impaired upper extremity function will complete two separate 6-week intervention sessions: 6 weeks of occupational therapy combined with transcutaneous spinal cord stimulation and 6 weeks of occupational therapy alone. The order of these interventions will be randomized, and each intervention will be separated by a 6-week washout period. The investigators hypothesize that: 1. transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants 2. transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone 3. transcutaneous spinal cord stimulation combined with therapy will lead to improvements in symptoms related to quality of life (pain, spasticity, and bladder symptoms) compared to occupational therapy alone Read Less

The Sinai Vein Stent Registry aims to establish and maintain a registry of patients who have undergone a vein stent placement procedure at The Mount Sinai Medical Center. The purpose of this study is to monitor and evaluate the long-term outcomes of venous stents placed to treat venous outflow obstruction. Outcome variables that will be assessed are: patency rate, reintervention rate, occurrence of any complications, clinical improvement, and quality of life. Venous outflow obstruction is defined as a stenosis and/or occlusion seen primarily in the ilio-femoral vein and inferior vena cava, and infrequently in the subclavian vein, brachiocephalic vein, or superior vena cava. While vein stent placement procedures are currently being performed in the United States, using stents which are commercially available and FDA-approved for use in arterial interventions, at this time there are no stents that are FDA-approved for use in veins. The placement of stents in veins holds tremendous promise as a treatment for venous outflow obstruction, but review of current literature has showed a paucity of published data on the long-term outcomes of this treatment. The study is composed of two arms, a retrospective arm and a prospective arm. Any patient over the age of 18 who has undergone or is scheduled to undergo a vein stent placement procedure is eligible for this study. A HIPAA waiver and waiver of informed consent are being requested for the retrospective arm for patients who have undergone a vein stent placement procedure from January 1st 2012 to date of study onset, as it is not possible to contact all patients in the retrospective arm (i.e., lost to follow-up, no longer follows-up with a study physician). This study is only interested in the collection and analysis of data; the clinical care and outcomes of research subjects will not be affected by their participation in this study. An IDE application has been submitted to the FDA for use of the Wallstent™ (manufactured by Boston Scientific, Inc.) in veins as treatment for venous outflow obstruction. The primary stents being used as treatment for venous outflow obstruction at Mount Sinai is the Wallstent™, mainly due to the fact that only Wallstents™ are available in the appropriate sizes to be used in veins. In rare occasions or exceptional circumstances, a smaller self-expanding nitinol stent may be used. Due to the extremely rare frequency of stents other than Wallstents™ being used and the impracticality (if not impossibility) of obtaining IDEs for all other stents, the investigators believe it is appropriate to exclude usage of these stents from the study data. To confirm, the purpose of this study is to monitor and evaluate long-term outcomes of the venous stents/the vein stent placement procedure, not specifically the Wallstent™ itself. Read Less

The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer. Read Less

Patients with severe hematochezia (bright red blood per rectum) may have a bleeding source proximal to the colon. Visualization of the entire gastrointestinal tract using a second-generation colon capsule endoscopy system could improve diagnostic yields and form the basis for a new approach to early diagnosis that could change guidelines and practice management in these patients. The hypothesis of this study is that urgent colon capsule endoscopy will have higher rates of lesion localization and diagnosis and reduced time to diagnosis than the standard tagged red blood cell scanning and/or angiography. In this study, the eligible patients with severe hematochezia are enrolled to undergo an evaluation with the capsule endoscopy in addition to the standard tests including a tagged RBC scan and/or an angiogram. The outcomes in terms of diagnostic yields of the capsule endoscopy will be compared to the standard tests. Read Less

This study is designed to evaluate whether epigenetic markers in overweight men with type 1 diabetes (T1D) or type 2 diabetes (T2D) can be improved with a 3 month lifestyle intervention or program focused in glycemic intervention. Read Less

Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive disturbances such as polycystic ovary syndrome (PCOS). The purpose of this research study is to determine whether the ovary can serve as a reliable predictor of normal or abnormal development by following the trajectory of ovarian morphology in conjunction with menstrual cyclicity using 3D transabdominal ultrasound imaging in a prospective cohort study of adolescents. A secondary objective is to identify potential environmental factors such as diet and the gut microbiome which influence the trajectory towards normal or abnormal reproductive development. Read Less

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF). Read Less

This is an R01 funded project that focuses on the utility of metabolomics as a biomarker for OSA. Aims 1 and 3 leverages banked samples previously collected from subjects with and without OSA at the University of Pennsylvania and University of Iceland. Aim 2 is a prospective study that will collect serum samples from OSA subjects at the University of Pennsylvania and the University of Iceland. Read Less

This phase II trial studies the effect of belantamab mafodotin, pomalidomide, and dexamethasone in treating patents with high-risk myeloma. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. Chemotherapy drugs, such as pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving belantamab mafodotin, pomalidomide, and dexamethasone may kill more cancer cells. Read Less

This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed. Read Less

This is a pilot study determining the feasibility of combination treatments, pembrolizumab and stereotactic ablative radiotherapy (SBRT) in subjects with soft-tissue sarcoma. These are subjects who have metastatic disease initially, or recurrent or progressive disease that is not eligible for curative surgery. Read Less

Interventional study to use erector spinae plane block (ESPB) on diagnoses of posterior or lateral rib fractures, vertebral fractures, pancreatitis, pancreatic cancer, renal colic, and back pain for multimodal pain therapy to determine its assistance with pain relief as well as the patient's use of opiates after block completion Read Less