Pediatric traumatic injury is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression, deficits in physical recovery, social functioning and quality of life, which if unaddressed, may contribute to increased use of health care services. In 2015 our team launched the Trauma Resilience and Recovery Program (TRRP) at Medical University of South Carolina, a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care – one of the few in the US - that provides early intervention and direct services to improve access to evidence-based mental health care after traumatic injury for children, adults and families. We have found this model of care to be feasible and acceptable to adolescent patients (ages 12-17) at each level of service. TRRP includes 3 major steps: (1) in-hospital education, brief risk reduction session, and tracking patients' emotional recovery via an automated text-messaging system, (2) a 30-day screen via telephone to identify patients who are good candidates for psychological treatment, and (3) providing referral to best-practice telehealth-based or in-person assessment and treatment. We have partnered with three accredited Level I and II pediatric trauma centers, Prisma-Health Upstate, Children's of Alabama, and Boston Children's Hospital, and propose a multi-site hybrid 1 effectiveness-implementation randomized controlled trial with 300 adolescent (ages 12-17) traumatic injury patients to assess the extent to which TRRP promotes improvement in quality of life and emotional recovery and gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. This study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.
This study is for patients who have been diagnosed with relapsed or refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL). The overall goal of this study is to find out what effect, good and/or bad, the drug inotuzumab ozogamicin has on children and young adults with relapsed or refractory B-ALL. Participants can expect to be on this study for up 2 months and followed for up to 5 years.
This study is for patients who have newly diagnosed diagnosed BCR-ABL acute lymphoblastic leukemia (ALL). This study is being done to determine the effects (good or bad) of using the combination of a Tyrosine Kinase Inhibitor (TKI), steroids and blinatumomab versus treatment with steroids, Tyrosine Kinase Inhibitor (TKI) and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab.
This study is for patients that have been diagnosed with early-stage (Stage I or II) Hodgkin lymphoma (HL)(cHL). The main purpose of this study is to compare the effects, good and/or bad, of brentuximab vedotin and nivolumab (Bv-NIVO) against standard therapy for people with HL to find out which is better. Participants can expect to be in the study for up to 54 months.
In this study, the participants will take pembrolizumab for 24 months or get pembrolizumab plus a course of radiation therapy for 24 months until the cancer progresses. After the study treatment is finished, the study doctor will continue to follow the participants condition for a total of 3 years. Some risks in this study is that pembrolizumab with radiation may not be as good as the usual approach for cancer shirking or stabilizing. Some risks associated with pembrolizumab and radiation which are reduction in blood counts, mouth or throat pain and difficulty swallowing. The potential benefit of this study is that radiation and chemotherapy/pembrolizumab can be effective at shrinking or stabilizing the cancer. The purpose of this study is to compare using pembrolizumab with radiation to pembrolizumab without radiation.
The purpose of this study is to learn more about long-term safety (good or bad effects) of avacopan and its efficacy (how well it is working) in treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.
Avacopan is currently approved as an adjunctive (another treatment used along with primary treatment) treatment in adult people with severe active ANCA-associated vasculitis in the US and is also approved in the EU, Canada, Japan, and other countries.
In this study, avacopan will be compared with a placebo (a drug that looks likes the study medication but does not contain any medication). This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) into a treatment group. You will have an equal chance of being placed in either of the 3 following groups: treatment with avacopan for 5 years in group A, or treatment with avacopan for 1 year followed by placebo for 4 years in group B, or treatment with placebo for 5 years in group C. The study is also a double-blinded study, meaning you and your study doctor will not know what you are receiving, the avacopan or placebo.
The study is sponsored by Amgen, Inc. Participation in the study will require 27 visits to the MUSC main campus over approximately 63 months, and visits will include the following procedures: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and medical history review), and health questionnaires. You will also be provided with a paper diary to record any missed doses/overdoses of the study drug.
Compensation is available for participation.
This study is for subjects that have been diagnosed with mantle cell lymphoma that has spread and has not responded to treatment. This study is testing an "investigational" (not yet FDA approved) study drug called glofitamab. The purpose of this study is to compare the effects, good or bad, of glofitamab (experimental arm) versus bendamustine plus rituximab (BR) or rituximab plus lenalidomide (R-Len;the control arm) on subjects with relapsed/refractory mantle cell lymphoma. Your total time in the study and the number of assessments in the follow up visits, will depend on how your MCL responds to study treatment. This could range from 1 day to more than 24 months. The screening period may last up to 28 days (4 weeks) and may involve more than one visit to the clinic.
The purpose of this study is to better understand how practicing a new skill builds a stable memory and how this memory is maintained over time as one gets older. A better understanding how memories are controlled in healthy aging may help to develop better treatments for memory problems.
The study's main question is how the different brain regions communicate with each other when one is retrieving memories of a well-practiced skill. Specifically, when and where the brain waves that are related to skill memory are produced. The brief changes in the brain will be recorded with functional magnetic resonance imaging (fMRI), a medical technology that looks at blood flow in the brain. To assess electrical changes in the brain, the brain waves, electroencephalography (EEG) will be used. Combining EEG and fMRI will allow the precise detection of the exact location where the brain is active at any moment in time.
This study is conducted at the Medical University of South Carolina (MUSC). The study will take about one to two weeks and involves two visits to MUSC including an interview and combined brain recording and brain scan during task practice (EEG-fMRI) and up to 7 days of online skill practice at home. Volunteers in this research study must be free of any brain disease or brain injuries and have to be in good health status. Approximately 40 volunteers will take part in this study.
Quitting smoking is hard, and many Veterans struggle even with current treatments. This study is testing a safe, non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS), which is already FDA-approved to help people stop smoking. We're comparing two types—standard and personalized—to see which works better. We aim to find the best option to help Veterans quit for good.
This phase 2 study is enrolling patients who have acute myeloid leukemia (AML) with certain biomarkers. This study is being done to see the effectiveness of different combinations of drugs to treat AML. It will involve 3 groups of patients receiving different combinations of Gilteritinib, Azacitidine and Venetoclax. Gilteritinib is an investigational drug, Azacitidine and Venetoclax are FDA approved. The main purpose of the study is to see if the amount of leukemia in the patient's body can be lowered by adding the drug Gilteritinib to the Standard of Care of treating AML with Azacitidine and Venetoclax. The study will include approximately 147 patients. The patients will be randomized into the three groups (like flipping a coin), Group 1 will receive just Azacitidine + Venetoclax, Groups 2 and 3 will also receive Gilteritinib but Group 2 will receive it for more time within a treatment cycle. Patients will complete screening after participating in this treatment trial or SOC therapies. Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that the study drugs may not be as good as the usual approach for their cancer or condition at shrinking or stabilizing their cancer. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.