JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Recurrent lateral patellar instability affects a young active population, resulting in significant morbidity and loss of function. Little data exists regarding which patients are likely to be successful with an isolated MPFL reconstruction versus which patients are at high risk of failure of an isolated MPFL and would do better with concomitant bony correction at the index operation. The JUPITER group consists of high-volume patellofemoral surgeons across the United States, and was organized to facilitate the collection of clinical and radiographic outcomes following surgical and non-surgical treatment of patellar instability. With the proposed work (JUPITER 4.0), the group aims to prospectively enroll a new cohort of consecutive patients with recurrent patellar instability that would undergo isolated MPFL reconstruction regardless of radiographic measurements or anatomic risk factors to address two specific aims - 1) what patient, injury, and surgical factors lead to recurrent instability and poor 2-year PROs (Pedi-IKDC, Kujala, KOOS 12, HSS Pedi-FABS, BPII 2.0, PROMIS 25, PROMIS 29) following isolated MPFL reconstruction and 2) the creation of an instability severity index score, with the long-term objective of identifying preoperatively, patients with a high risk of failure of an isolated MPFL reconstruction who may be better served with concomitant bony procedure.
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 Phase 1/1b Study of ASP2138 in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to 2 targets at the same time: CLDN18.2 and a protein called CD3 found on immune cells, called T-cells. ASP2138 works by binding to both the tumor cell and CD3 which "tells" the immune system to attack the tumor.ASP2138 is a potential new treatment for people with stomach cancer, gastroesophageal junction cancer, (cancer where the tube that carries food (esophagus) joins the stomach) or pancreatic cancer. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help to find a suitable dose and to check for potential medical problems from the treatment.Adults 18 years or older with stomach cancer, gastroesophageal junction cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body.The main aims of the study are to check the safety of ASP2138, how well it is tolerated, and to find a suitable dose of ASP2138 to be used later in this study.This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP2138.The study will have 2 phases. In phase 1, different small groups of people will receive lower to higher doses of ASP2138. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP2138 to use later in the study. The first group will receive the lowest dose of ASP2138. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP2138. The panel will do this for each group until all groups have received ASP2138, or until suitable doses have been selected for later in the study. Doctors will also check how each type of cancer is responding to ASP2138.In phase 1b, other different small groups will receive suitable doses of ASP2138 found from phase 1. This phase will check how each type of cancer responds to ASP2138. The response to ASP2138 is measured using scans and blood tests. Doctors will continue to check all medical problems throughout the study.ASP2138 will be given through a vein in the arm. This is called an infusion. People will receive weekly infusions of ASP2138 in a 14-day (2-week) treatment cycle. People will continue to receive treatment until: their cancer gets worse; they have medical problems they can't tolerate; they ask to stop treatment; the doctors decide that continuing treatment is no longer in that person's best interest; the study is ended by the sponsor. Doctors will check if people had any medical problems from ASP2138. Other checks will include medical examinations, checking the nervous system, blood and urine tests and vital signs. Nervous system checks include checking peoples state of mind, reflexes, balance, movement and muscle strength. Vital signs include medical examinations, body temperature, breathing rate, and blood oxygen levels. Electrocardiograms (ECG) will be done to check the heart rhythm during the study. People will receive ASP2138 in a hospital. They will have blood tests and doctors will check for medical problems. People will also visit the clinic on certain days during their treatment, with extra visits during the first 3 cycles of treatment.People will visit the clinic after treatment has finished. The doctors will check for more medical problems. Other checks will include medical examinations, blood and urine tests, and vital signs. People will also have an ECG.After this, people will visit the clinic for a check-up several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.
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.
Genetic evaluation of patients with undiagnosed diseases
The purpose of this study is to use extensive sequencing of the DNA (genetic material inherited from parents) or RNA (transcripts of the DNA), and functional characterization of patient-derived cells if necessary, to identify the cause of an individual's undiagnosed medical condition. Today, advances in technology allow us to sequence all the portions of the DNA containing instructions for the proteins in the body (whole exome sequencing, abbreviated WES), all of a person's DNA (called whole genome sequencing, abbreviated WGS), or RNA (called RNA-sequencing, abbreviated RNA-seq). WES, WGS, and RNA-seq have been used recently to make diagnoses for individuals suffering from diseases that doctors cannot figure out but seem to be due to errors in the DNA. Generally, the doctors first order many conventional medical tests, including some more limited DNA sequencing tests, before resorting to WES or WGS. For this study, we intend to use WES, WGS and/or RNA-seq as one of the first tests for individuals suffering from problems that suggest that they might be caused by errors in the DNA. The purpose is to provide diagnoses to patients with undiagnosed disease, find out how often we can make a diagnosis in this way, see if we can arrive at that answer more rapidly, and what effect finding a diagnosis has on a patient's medical care and well-being.
Global Pediatric Orthopedic Implant Safety & Efficacy (Global POISE) Clinical Follow-Up Program
The purpose of this research study is to evaluate the safety and efficacy (how well they do their job) of OrthoPediatrics medical implants.
Mechanisms of Peripheral Vascular Disease
The proposed study will enable the use of human tissue samples and outcome data by basic and clinical investigators for research into the biology, causes, prevention and therapy of patients with documented peripheral arterial vascular disease secondary to atherosclerosis. The collection of paired information will provide important clinically relevant findings that will add to the growing understanding of the natural history of plaque formation in the arteries of the periphery and will enable to decipher the molecular mechanisms in this pathology. We will prospectively collect both tissue to study the mechanism of the natural history of PAD. We will also collect relevant clinical and medical information on these subjects and continue to collect follow-up information on the surgical patients using their medical records in order to follow their outcome.
Mobilis Laboratory Subject Registry
The Mobilis Laboratory Subject Registry is a tool used to recruit healthy individuals and those with stroke for IRB-approved studies. The Registry will include circumscribed demographic and medical information on enrolled participants.
Prospective multicenter study of the PRESERFLO MicroShunt in subjects with refractory open-angle glaucoma
The purpose of this research study is to evaluate the safety and efficacy of a medical device that is implanted into the eye and designed to reduce eye pressure in patients with Glaucoma.
Mechanisms of Vascular Aneurysms
Our mission is to enable the use of human tissues with outcome data by basic and clinical investigators for research into the biology, causes, prevention and therapy of patients with documented arterial pathology (e.g. aortic dissection, lower extremity aneurysm, aortic aneurysm). Paired clinical information about disease history and research into vascular events will enable clinically relevant findings. We will prospectively collect both tissue samples and blood samples to study the mechanisms of the natural history of aneurysms and potential circulating biomarkers. We will be collaborating with Dr. Gelb in order to obtain tissue and blood from healthy controls during the organ procurement. We will also collect relevant clinical and medical information on these subjects and continue to collect follow-up information on the surgical patients using their medical records in order to follow their outcome. The tissue and blood will be stored indefinitely.