All Clinical Trials

Randomized controlled trial of a time motion study of time spent obtaining and charting vital signs for inpatients, comparing use of a wireless Bluetooth vital sign array as intervention versus routine vital sign obtainment activity on a general medical floor. Read Less

This research study aims to evaluate the safety and determine the optimal dose of a new experimental drug, vvDD-hIL2 (vaccinia virus double-deleted human interleukin 2), in patients with advanced abdominal cancer. The study will involve three dose levels, with three to six patients enrolled at each level. vvDD-hIL2 is a genetically modified vaccinia virus, derived from the virus previously used for smallpox vaccination. The modification is intended to target and destroy tumors while minimizing harm to healthy tissues by stimulating the body's immune response. Participants will receive an injection of vvDD-hIL2 directly into their abdominal tumors at AHN West Penn. The study team will monitor for side effects and assess tumor response to the treatment. Active participation will last up to two months, involving seven clinic visits and approximately four lab visits at AHN West Penn Hospital. Visits will include standard of care procedures as well as study-specific tests and exams. Most visits will last one to two hours, with some extending to two to three hours. The drug administration day will require a twelve-hour visit. Effectiveness and side effects will be evaluated through blood draws, oral swabs, urinalysis and tissue biopsies. Tissue samples will be used for genomic analysis and stored for potential future research. Data collected may also be used for future research purposes. Previous human trials of vvDD-hIL2 have reported side effects such as pain, rash or inflammation at the injection site, low-grade fevers, flu-like symptoms, and fatigue. There is a rare risk of rash transmission to close contacts with skin openings, and information on limiting contact and managing rash development will be provided. Read Less

This study is being done to assess mogamulizumab-associated rash in patients diagnosed with mycosis fungoides or sezary syndrome and treated with standard of care mogamulizumab. One of the most common side effects of mogamulizumab is a rash, currently named mogamulizumab-associated rash (MAR) which can look like MF or SS. However, mogamulizumab-associated rash (MAR) does not indicate failure of mogamulizumab, and may be a sign that the drug is working. If not properly evaluated, mogamulizumab-associated rash (MAR) could be misinterpreted as worsening of mycosis fungoides/sezary syndrome, which could lead doctors to recommend stopping mogamulizumab treatment early. The information learned by doing this research study may help tell the difference between mogamulizumab-associated rash (MAR) (sometimes also called "drug eruption") and worsening of the disease. It may also help to uncover information about the cause of mogamulizumab-associated rash (MAR). Read Less

The purpose of this study is to find out whether an 8-week digital health promotion program called COBRA is a safe and practical (feasible) option for older adults with cancer/OAC. Read Less

The Infrascanner model 2500 is a handheld, noninvasive device that is FDA-cleared to detect traumatic intracranial hematomas. FDA clearance K200203 was issued in 2020, K211617 added pediatric age group to the IFU in 2022, and K241389 approved higher laser power use to address dark skinned patients in 2024. This non randomized observational study aims to evaluate the utility of this device by evaluating its ability to provide decision support information to optimize care for patients with suspected traumatic intracranial hematomas. It is important to note that the intended use of the device is in accordance with its FDA approved indication. The intent is to generate actionable knowledge that along with standard clinical signs, facilitates the early detection of intracranial hemorrhage (ICH) in patients with suspected traumatic brain injury (TBI) in a combat setting. The ultimate goal is to modify and optimize international protocols for inexpensive, bedside, portable, and noninvasive detection of traumatic ICH in conflict zones across the globe. This multicenter, prospective, observational, implementation science study will evaluate the field utility of the Infrascanner Model 2500 in an active combat setting using a pragmatic, sequential research design consisting of two phases-baseline phase and device phase. Using the current Ukrainian medical care system, patients with suspected TBIs will be monitored, and their outcomes will be tracked using standard-of-care practices (baseline phase). After the baseline data collection period is complete, an amendment to the protocol will be submitted to initiate the device phase. After training and upon approval, the Infrascanner device will be deployed to the facilities described above to provide health care providers with additional decision support, and the impact of its use will be compared to the baseline data. The outcome of interest is the time from admission at each enrollment study location to a definitive CT scan diagnosis of ICH. The investigators hypothesize that the use of the device will provide decision support to health care providers, decrease the time to traumatic ICH detection, thus enabling more expedient care. This prospective study will include all patients with suspected combat-related head trauma identified by clinical signs of TBI, such as decreased GCS score, abnormal pupil exam, and/or asymmetrical motor exam, on admission to the clinical enrollment site (mobile hospital or regional clinical hospital) regardless of the presence of pharmacologic sedation. At the Vinnytsia hospital (Role 4), combat polytrauma preoperative patients will also be screened. Exclusion criteria include evidence of extensive scalp injury, including lacerations, avulsions, or abrasions that prevent proper placement of the Infrascanner device on a subject's head or prevent placement of the device in the specified locations. During the baseline phase (Figure 1), 100 patients will be enrolled at stabilization points and the mobile/first-line hospital, 100 will be enrolled at the second-line hospital, and 100 will be enrolled at the third-line hospital. Thus, from a total of 300 subjects, baseline data on the time from admission at each enrollment study location to a definitive CT scan diagnosis of ICH and treatment and early outcomes will be collected. Once the baseline phase is complete and the amendment for the device phase is approved, it will be initiated. During this device phase, the Infrascanner will be deployed to stabilization points and the three levels of care (mobile hospitals and regional clinical hospitals). Data collection will continue until 100 patients are enrolled in the device phase for the three levels of care. All data collection at the baseline and device phases will occur at the same locations, and the data elements will be identical, except for Infrascanner data collected during the device phase. By comparing data from the baseline and device phase, the investigators will assess the utility of the device to provide decision support information to providers and potentially reduce time to definitive diagnosis by CT scan and thus treatment, as well as the association between Infrascanner use and early patient outcomes. Read Less

This randomized pilot phase I trial studies the side effects of donor bone marrow derived mesenchymal stem cells in controlling heart failure in patients with cardiomyopathy caused by anthracyclines. Donor bone marrow derived mesenchymal stem cells may help to control symptoms of heart failure and improve heart function. Read Less

This phase I/II trial studies the side effects and best dose of CPX-351 in combination with quizartinib for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351, composed of chemotherapy drugs daunorubicin and cytarabine, works 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. Quizartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The goal of this study is to learn if the combination of CPX-351 and quizartinib can help to control acute myeloid leukemia and myelodysplastic syndrome. Read Less

This phase II trial studies how well venetoclax, SL-401, and chemotherapy works in treating patients with blastic plasmacytoid dendritic cell neoplasm. Venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. SL-401 is a recombinant protein consisting of IL-3 linked to a toxic agent called DT. IL-3 attaches to IL-3 receptors on tumor cells in a targeted way and delivers DT to kill them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax and SL-401 with chemotherapy may be an effective treatment for patients with blastic plasmacytoid dendritic cell neoplasm. Read Less

The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease. Read Less

This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B) Read Less

This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma Read Less

To increase the conversion rate from MRD-positive to MRD-negative CR in patients with newly diagnosed multiple myeloma (NDMM) receiving post-transplant maintenance therapy with belantamab mafodotin plus lenalidomide. Read Less