Baltimore, MD Paid Clinical Trials

FIREFLY-1 is an ongoing, Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known RAF alteration. Read Less

The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users. Participants will be randomized to either treatment with low dose volar fibroblast injections (n=10) or to vehicle control (n=10). Participants will undergo a biopsy to harvest volar skin for fibroblast expansion and tattooing to identify injection sites on the residual limb. Fibroblasts will be processed at the Hopkins Cellular Therapy Core Lab and volar cells primed for injection will be sent to participating centers for administration. Participants randomized to the treatment group will be treated with low-dose cells. Injections will be administered on at least 1 and up to three separate days over the course of one week. Participants randomized to the vehicle control group will receive injection of cryoprotectant. All participants will be followed at 2 weeks, 1, 2, and 3 months after the last injection. These visits will include a clinical evaluation for complications, non-invasive assessments of skin firmness and thickness, skin appearance, and patient-reported outcomes. After the final monitoring visit, individuals randomized to the vehicle control group will have the opportunity to receive the volar fibroblast injections and will be followed for an additional 3 months. The investigators hypothesize that (1) There will be no difference in the rate of serious adverse events among patients treated with volar fibroblast injections compared with patients treated with vehicle control, and (2) Patients treated with volar fibroblast injections will have firmer skin on the residual limb compared with patients tread with vehicle alone. Read Less

This phase II trial studies how well TPIV100 and sargramostim work in treating patients with HER2 positive, stage II-III breast cancer that has residual disease after chemotherapy prior to surgery. It also studies why some HER2 positive breast cancer patients respond better to chemotherapy in combination with trastuzumab and pertuzumab. TPIV100 is a type of vaccine made from HER2 peptide that may help the body build an effective immune response to kill tumor cells that express HER2. Sargramostim increases the number of white blood cells in the body following chemotherapy for certain types of cancer and is used to alert the immune system. It is not yet known if TPIV100 and sargramostim will work better in treating patients with HER2 positive, stage II-III breast cancer. Read Less

A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI. Read Less

The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis surgical and non-operative treatment in patients with Cerebral Palsy. Read Less

Youth are disproportionately affected by the current opioid crisis with catastrophic consequences, and young adults with opioid use disorder (OUD) often struggle with adherence to relapse prevention medications. The Youth Opioid Recovery Support (YORS) model is a promising, innovative, wrap-around approach that addresses barriers to medication adherence and treatment engagement in an effort to improve public health outcomes in this vulnerable young adult population. This study seeks to refine the YORS intervention through stakeholder input and pilot iterative testing followed by an efficacy randomized controlled trial. This project will significantly contribute to our knowledge base of practical strategies to address the opioid crisis. Read Less

The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a placebo with respect to its antiviral activity in healthy adult participants inoculated with Dengue Serotype 3. Read Less

This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight. This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month. Read Less

The goal is to develop a nationwide registry to track longitudinal clinical outcomes of and store imaging data related to numerous corneal conditions. There are two main objectives including the establishment of the first nationwide corneal transplant registry in the United States to include information related to the donor tissue, recipient, surgical procedure, and long-term clinical outcomes. Ultimately, this prospective data collection will allow us to determine prognostic factors for successful corneal transplantation and create an algorithm to guide clinical practice based on real world outcomes. The second objective is to collect and create a database of historical, de-identified optical coherence topography (OCT) and corneal topography images to ultimately develop artificial intelligence (AI) based diagnostic and prognostic algorithms for corneal disease and surgery. Read Less

The purpose of this study is to learn about the effects of a study medicine, WGI-0301 to find the best dose for treating solid tumors, and to see how safe and tolerable the study drug is for patients with solid tumors. The study is also done to learn how the study drug is taken up by your body; this is called Pharmacokinetic (PK) studies and how the study drug affects the body; this is called Pharmacodynamics (PD) Read Less

The United States is experiencing an unprecedented opioid epidemic with a rapid increase in overdose deaths. Medications for opioid use disorder (MOUD) including methadone, buprenorphine, and extended-release naltrexone are efficacious and the recommended standard of care, yet barriers to sustained MOUD treatment reduce the overall efficacy of MOUD. Rates of MOUD retention are alarmingly low and MOUD dropout predicts opioid use/relapse, overdose, and death. While previous research has identified predictors of MOUD retention and adherence, there are no evidence-based interventions to improve MOUD retention. Recovery support services are a broad set of strategies to promote healthy outcomes among individuals with substance use disorder (SUD) that are typically separate from standard professional treatment. Among those strategies most utilized are peer recovery support services (PRSS) and recovery residences (RRs). PRSS include coaching, mentoring, education, and other supports delivered by individuals uniquely qualified by their lived experience with SUD. PRSS are increasingly utilized in a range of clinical settings, and advantages of PRSS include inherent shared understanding of addiction and a high degree of acceptance and understanding that is not found in most professional relationships. Existing research tentatively supports PRSS; however, the evidence to date is sparse and comes with significant methodological limitations and inconsistencies that make it difficult to conclude the efficacy of PRSS. No studies have examined the role of PRSS in promoting retention in MOUD. RRs provide a supportive living environment for persons in recovery from SUD and are widely utilized in the United States with an estimated 17,943 residences in 2020. Despite their proliferation, the evidence for RRs is only moderate and diminished by methodological weaknesses. Further, individuals on MOUD seeking housing through RRs often face increased MOUD-related stigma or may be disqualified from a RR for taking MOUD and need additional support to navigate these challenges. The potential synergistic benefits of combining PRSS and RRs to improve MOUD retention are considerable. PRSS and RRs are already mainstays in the recovery support services repertoire and could be leveraged to support MOUD retention. For example, more frequent, informal outreach typical of PRSS could facilitate regular monitoring of shifting attitudes and behaviors related to MOUD. The structure and accountability embedded in RRs could be used to support MOUD adherence and retention. Waxing and waning motivation to participate in MOUD treatment is common, and standard treatment is often unsuccessful at identifying early signs of future dropout or facilitating re-engagement after dropout. We will recruit participants on MOUD in RRs and provide them with PRSS using approaches such as recovery coaching and care navigation with a particular focus on supporting retention in MOUD care. PRSS will also provide assertive outreach between episodes of care, emphasize continuation in treatment and other recovery activities after leaving a RR (either successfully or unsuccessfully), and emphasize return to care after treatment dropout and/or relapse. The peers will be deeply embedded within the local provider community and care continuum to facilitate ease of care navigation. The ultimate goal of our research agenda is to test the efficacy of a PRSS intervention among individuals with OUD living in RRs through a rigorous trial. The eventual trial design would be informed by preparatory activities and experience proposed in this planning project. Preparatory activities proposed in this project include three major phases. Phase 1 - preparation for the intervention including: building a network of RRs that will be recruitment sites in the pilot RCT, recruiting and training peer support specialists, conducting focus groups and interviews to gather stakeholder input, and developing PRSS approaches to promote MOUD retention. Phase 2 - pilot test the PRSS intervention by randomizing N=50 individuals on MOUD recruited from collaborating RRs to either: a 24-week course of the PRSS intervention added to usual services, or usual services without the PRSS intervention. Phase 3 - gather additional input from former participants and RR staff post-intervention to further refine the intervention, and use lessons learned to inform our trial design and data collection procedures for the next-step R01 application. Read Less

The Anti-Aβ mAb CED Study is a prospective, longitudinal coverage with evidence development (CED) study using clinical data, patient assessments, and administrative claims data of the Medicare population, conducted in accordance to the National Coverage Determination (NCD) on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD). Read Less