Radiation Exposure During Invasive Cardiovascular Procedures: Portable Shielding System Versus Standard Lead Aprons.

Introduction Significant progress in the field of interventional cardiology has led to a rise in percutaneous procedures and an increase in the risk of radiation exposure at the workplace. Staff health has been put at risk due to the limitations of conventional radiation protective techniques. Innovative methods, such as RAMPART, have promising prospects for enhancing radiation safety. The purpose of this study was to evaluate RAMPART's effectiveness and practicality in comparison to conventional protective techniques with a lead apron and shield (LAS) during cardiac interventional procedures. Method One hundred elective cardiac procedures were enrolled in this prospective single-center research study. Two groups were formed from the participants: standard protection (group A) and RAMPAT system (group B). Real-time dosimeters were used to track the radiation dosage, dosage reduction factor, dosage reduction percentage, and likelihood of exceeding the limit, which were included in the data. Proceduralists were urged to use different strategies to reduce exposure. The study was approved by an ethical committee and ran from June 2023 to August 2023. Results When comparing the RAMPART group to the conventional protection group, neck-level radiation exposure was considerably lower for all workers. There were no notable variations in the exposure of the waist. The RAMPART group was shown to be superior in minimizing radiation exposure, as evidenced by dose reduction metrics. The groups had comparable procedural characteristics. Conclusion Compared to conventional LAS, the RAMPART system dramatically reduces radiation exposure to the entire body.

The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application.

INTRODUCTION: This project aimed to retrospectively obtain, review, and extract key safety data from medical records of participants enrolled in RAMPART, the NIH-supported Rapid Anticonvulsant Medication Prior to ARrival Trial of intramuscular midazolam versus intravenous lorazepam for pre-hospital treatment of status epilepticus, to support a US new drug application (NDA) for intramuscular midazolam. METHODS: A collaborative partnership was established between the NDA sponsor, the RAMPART trial lead academic institution, US government agencies, and contract research organizations to retrieve, review, and extract relevant safety data from the medical records of RAMPART participants and summarize those data to include in an NDA submitted to the US Food and Drug Administration (FDA). RESULTS: Key data in the medical records of 890 RAMPART trial participants (1020 enrollments, including 130 repeat enrollments) were reviewed and extracted into a project database. Safety events occurred in 771 (86.6%) participants, and included additional information not collected in the RAMPART trial. This database also enabled subgroup analyses based on medical history and prior/concurrent medications, building upon previous analyses according to age, sex, and race. No previously unrecognized safety patterns were identified, and no association was observed between efficacy and medical history or medication usage. CONCLUSIONS: The use of unstructured real-world retrospective medical record data can effectively support an NDA submission in place of conducting another interventional clinical trial. This retrospective medical records review and extraction of additional safety data contributed to the FDA approval of intramuscular midazolam for the pre-hospital treatment of status epilepticus in 2018. CLINICALTRIALS: GOV: NCT00809146.

RAMPART: A model for a regulatory-ready academic-led phase III trial in the adjuvant renal cell carcinoma setting.

The development of therapeutics in oncology is a highly active research area for the pharmaceutical and biotechnology industries, but also has a strong academic base. Many new agents have been developed in recent years, most with specific biological targets. This has mandated the need to look at different ways to streamline the evaluation of new agents. One solution has been the development of adaptive trial designs that allow the evaluation of multiple agents, concentrating on the most promising agents while screening out those which are unlikely to benefit patients. Another way forward has been the growth of partnerships between academia and industry with the shared goal of designing and conducting high quality clinical trials which answer important clinical questions as efficiently as possible. The RAMPART trial (NCT03288532) brings together both of these processes in an attempt to improve outcomes for patients with locally advanced renal cell carcinoma (RCC), where no globally acceptable adjuvant strategy after nephrectomy currently exist. RAMPART is led by the MRC CTU at University College London (UCL), in collaboration with other international academic groups and industry. We aim to facilitate the use of data from RAMPART, (dependent on outcomes), for a future regulatory submission that will extend the license of the agents being investigated. We share our experience in order to lay the foundations for an effective trial design and conduct framework and to guide others who may be considering similar collaborations. Trial Registration: ISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39. CTA #: 20363/0380/001-0001. MREC #: 17/LO/1875. ClinicalTrials.gov Identifier: NCT03288532 RAMPART grant number: MC_UU_12023/25. . RAMPART Protocol version 5.0.

RAMPART: A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse.

BACKGROUND: 20-60% of patients with initially locally advanced Renal Cell Carcinoma (RCC) develop metastatic disease despite optimal surgical excision. Adjuvant strategies have been tested in RCC including cytokines, radiotherapy, hormones and oral tyrosine-kinase inhibitors (TKIs), with limited success. The predominant global standard-of-care after nephrectomy remains active monitoring. Immune checkpoint inhibitors (ICIs) are effective in the treatment of metastatic RCC; RAMPART will investigate these agents in the adjuvant setting. METHODS/DESIGN: RAMPART is an international, UK-led trial investigating the addition of ICIs after nephrectomy in patients with resected locally advanced RCC. RAMPART is a multi-arm multi-stage (MAMS) platform trial, upon which additional research questions may be addressed over time. The target population is patients with histologically proven resected locally advanced RCC (clear cell and non-clear cell histological subtypes), with no residual macroscopic disease, who are at high or intermediate risk of relapse (Leibovich score 3-11). Patients with fully resected synchronous ipsilateral adrenal metastases are included. Participants are randomly assigned (3,2:2) to Arm A - active monitoring (no placebo) for one year, Arm B - durvalumab (PD-L1 inhibitor) 4-weekly for one year; or Arm C - combination therapy with durvalumab 4-weekly for one year plus two doses of tremelimumab (CTLA-4 inhibitor) at day 1 of the first two 4-weekly cycles. The co-primary outcomes are disease-free-survival (DFS) and overall survival (OS). Secondary outcomes include safety, metastasis-free survival, RCC specific survival, quality of life, and patient and clinician preferences. Tumour tissue, plasma and urine are collected for molecular analysis (TransRAMPART). TRIAL REGISTRATION: ISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39, CTA #: 20363/0380/001-0001, MREC #: 17/LO/1875, ClinicalTrials.gov Identifier: NCT03288532, RAMPART grant number: MC_UU_12023/25, TransRAMPART grant number: A28690 Cancer Research UK, RAMPART Protocol version 5.0.

Dataset on the deposits of the semi-circular rampart around the former Viking settlement Hedeby and its vicinity.

Soils and sediments are able to preserve traces of human activity in the form of morphological, geochemical and geophysical properties of materials. Thanks to that the study of these materials may provide valuable information about the formation and functioning of archaeological sites. Materials transported for earthwork construction and their configuration preserve important information on the past landscape development, the anthropogenic transformation of the landscape as well as the process of the fortification formation. The UNESCO heritage site Hedeby was one of the most significant proto-towns in Northern Europe and an important trading center in the Viking Age. The town was surrounded by the semi-circular fortification rampart connected to the Danevirke, the Danish fortification system. Due to its dimensions (maximum height 10 m) and good preservation state, the semi-circular rampart is one of the most prominent features of the area. In this article the data on the physico-chemical analysis of the materials from the cores along a coring transect across the semi-circular rampart are presented. The following properties were determined: pH, weight percentage of gravel, charcoal, artefacts, and bones, loss on ignition, magnetic susceptibility, grain size distribution ≤2 mm, elemental concentrations. The data is valuable for geoarchaeological analysis of the landscape transformation and the earthwork construction at Hedeby including the reconstruction of the process and the techniques used in the Viking Age. Data on the buried soil found underneath the rampart deposits might provide insight into the surface soils characteristics prior to the rampart construction.

Ninety years of change on a low wooded island, Great Barrier Reef.

We assess 90 years of change on a Low Wooded Island (Low Isles, Great Barrier Reef), employing drones and topographic profiling to accurately survey ramparts, mangroves, the reef flat and the sand cay. A comparison with maps from the 1928-1929 Great Barrier Reef Expedition revealed the redistribution of an outer rampart and inward movement of shingle ridges. Remarkable lateral expansion of the mangrove woodland some 400 m has occurred as carbonate sand deposition has increased reef flat elevation, obscuring coral microatolls. The sand cay has stayed relatively constant in size, moving approximately 44 m in a northeasterly direction and rotating slightly. We conclude that the existing configuration of landforms probably represents an equilibrium with local biophysical conditions, including sea level, wave dynamics, vegetation growth, storms and cyclones. The variable nature of ramparts and the presence of a trough that prevents the continuous spread of mangroves across a uniformly flat colonization surface precludes the interpretation of landform changes with respect to a geomorphic evolutionary sequence. Moreover, longer-term implications of environmental change for these landforms can only be evaluated once the specific nature of the local carbonate budget, including the relative contribution of corals, foraminifera and Halimeda has been elucidated.