Sep 15th, 2022 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

Sep 9th, 2022 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

Sep 23rd, 2022 - The purpose of this protocol is to provide a resource for clinical and laboratory research through enrollment of known immunodeficiency patients into a national registry, the US Immunodeficiency Network (USIDNET). The registry data will expand NIH s and the nation s knowledge base about immune deficiency disorders and genetic mutations that lead to these disorders. Additional registrants from N...

Sep 23rd, 2022 - Background: The administration of autologous tumor-infiltrating lymphocytes (TIL) can mediate complete, durable regressions in 20-25% of participants with metastatic melanoma. Recent studies have shown that these TIL predominantly recognize unique mutated neoantigens expressed by the cancer not shared by other melanomas. Administration of bulk autologous TIL to participants with a variety of ot...

Sep 23rd, 2022 - Despite substantial improvements in the overall health of our nation, racial and ethnic disparities in health and healthcare remain ubiquitous. Disparities are apparent after controlling for access to care, insurance, income, patient preferences, and clinical need, suggesting that providers and health systems are important contributors to racial disparities in healthcare. In its landmark report...

Sep 23rd, 2022 - PRIMARY OBJECTIVE: I. To evaluate the pathologic complete response (pCR) and residual cancer burden-index (RCB-I) rates of patients with triple-negative breast cancer (TNBC) who were non-responders to initial anthracycline and cyclophosphamide chemotherapy and who were treated with enzalutamide in combination with weekly paclitaxel in the neoadjuvant setting. SECONDARY OBJECTIVES: I. To estimat...

Sep 23rd, 2022 - Objective This protocol is being performed to 1) study the natural history and disease pathogenesis in patients with tumor related epilepsy, 2) collect prospective data on seizure outcomes following standard surgical treatment of brain tumors with associated seizures2, 3) follow the clinical course of patients after surgical resection of brain tumors with associated seizures, such as outcomes i...

Sep 23rd, 2022 - Primary Objectives: Phase I: To assess the safety and tolerability of nivolumab and vorolanib in combination in patients with refractory non small cell lung cancer naïve to checkpoint inhibitor therapy, non small cell lung cancer progressed on prior checkpoint inhibitor therapy considered primary refractory, non small cell lung cancer progressed on prior checkpoint inhibitor therapy considered ...

Sep 23rd, 2022 - Background: - Adoptive cell therapy (ACT) using autologous tumor infiltrating lymphocytes (TIL) can mediate the regression of bulky metastatic melanoma when administered along with highdose aldesleukin (IL-2) following a non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine. - Pembrolizumab, a monoclonal antibody that binds to PD-1 and blocks the P...

Sep 23rd, 2022 - Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan. Participants considered an adult according to local regulation at the time of obtaining informed consent participated in the study.

Sep 23rd, 2022 - Subject enrolment may proceed with information available on tumor HRAS status previously generated during the pre-screening phase, but all subjects must consent to provide tumor slides (or tumor tissue block) from a prior diagnostic biopsy for a retrospective testing of RAS gene status, including T81C polymorphism, and other potential biomarkers at a central facility. Tipifarnib will be adminis...

Sep 23rd, 2022 - Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes (NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants will be recruited nationally, but a subset (N=120) will be recruited locally to allow for biomarker collection . Our two-fold purpose i...

Sep 23rd, 2022 - Autologous leukapheresis for enrichment of PBMCs is performed after enrollment of the patient into the trial. Ex vivo generated DCs will be frozen and stored in the vapour phase of liquid nitrogen. At first surgery, tumor biopsies will be cultured under sphere-forming conditions under ex vivo conditions for enrichment of glioblastoma stem cells. mRNA will purified and amplified from these autol...

Sep 23rd, 2022 - This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Sep 23rd, 2022 - Background: Multiple ligament knee injuries (MLKIs) represent a spectrum of injury ranging from disruption of two ligaments to all four major ligaments of the knee. Concomitant injuries may include fractures and injuries to vessels, nerves, tendons, menisci and/or articular cartilage. As such, the treatment of MLKIs creates multiple complex problems fraught with complications such as poor wound...

Sep 23rd, 2022 - Objective: Despite recent advances in addiction neuroscience, achieving a breakthrough in predicting addiction treatment outcome has been difficult and long-term abstinence success unacceptably low. The aim of this study is to create a biomarker using various neuroimaging metrics that can predict treatment outcome in opioid, alcohol and dual opioid and alcohol use disorder patients. Study Popul...

Sep 23rd, 2022 - The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Sep 23rd, 2022 - PRIMARY OBJECTIVES: I. To assess the clinical benefit of combining radical surgery cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinical metastatic prostate cancer (mPCa). SECONDARY OBJECTIVES: I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific survival, complication rates, and quality of life...

Sep 23rd, 2022 - Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups (also known as an Arm): If you are in Arm A, you will receive standard chemotherapy in combination with erlotinib. If you are in Arm B, you will receive standard chemotherapy in combination with a placebo. If you are 1 of the first 30 patients...

Sep 23rd, 2022 - PRIMARY OBJECTIVES: I. To assess the safety of lenalidomide in combination with ipilimumab in autologous and allogeneic stem cell transplantation. SECONDARY OBJECTIVES: I. Overall response rate. II. Overall survival, progression-free survival. III. Cumulative incidence of acute and chronic graft-versus-host disease (GVHD) with the competing risk of relapse in allogeneic transplant patients. OUT...