The new (challenging) role of academia in biomaterial translational research and medical device development.
Ontology highlight
ABSTRACT:
SUBMITTER: Kleinbeck K
PROVIDER: S-EPMC3746065 | biostudies-other | 2012 Dec
REPOSITORIES: biostudies-other
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| S-EPMC7347785 | biostudies-literature
Project description:Translational medicine has become a priority, but there is still a big difference between the arrival of new treatments and investment. Basic science should not be neglected because the translation from basic research is not sustained in the absence of basic research. The purpose of this literature review was to analyze the translational medicine in the liver transplant field: liver ischemia-reperfusion injury (IRI), immunosuppression, clinical and surgical complications, small-for-size syndrome (SFSS), rejection, and ongoing innovations (liver machine, liver preservation, artificial livers, and regenerative medicine). We performed a systematic literature review that were updated in October 2016. The searches were performed in the Cochrane Central Register of Controlled Trials and Review, PubMed/Medline, Embase, and LILACS databases. All the selected studies on the management of translational medical research in liver transplantation (LT) were analyzed. Initially the search found 773 articles. Methodological viewing and analysis of the articles, followed by the application of scientific models, including translational medicine in the liver transplant field. In conclusions, this review demonstrates the application of scientific research with translation medical benefits regarding the LT. The literature has a great tendency, improvements and investments in the study of translational medicine in LT. Innovative studies and technologies from basic science help to clarify clinical doubts. Moreover, evidence increases the importance of scientific research in quality of clinical practice care.
| S-EPMC6286921 | biostudies-literature
Project description:BackgroundWomen choosing a levonorgestrel-releasing intrauterine system may experience changes in their menstrual bleeding pattern during the first months following placement.ObjectiveAlthough health care professionals (HCPs) can provide counseling, no method of providing individualized information on the expected bleeding pattern or continued support is currently available for women experiencing postplacement bleeding changes. We aim to develop a mobile phone-based medical app (MyIUS) to meet this need and provide a digital companion to women after the placement of the intrauterine system.MethodsThe MyIUS app is classified as a medical device and uses an artificial intelligence-based bleeding pattern prediction algorithm to estimate a woman's future bleeding pattern in terms of intensity and regularity. We developed the app with the help of a multidisciplinary team by using a robust and high-quality design process in the context of a constantly evolving regulatory landscape. The development framework consisted of a phased approach including ideation, feasibility and concept finalization, product development, and product deployment or localization stages.ResultsThe MyIUS app was considered useful by HCPs and easy to use by women who were consulted during the development process. Following the launch of the sustainable app in selected pilot countries, performance metrics will be gathered to facilitate further technical and feature updates and enhancements. A real-world performance study will also be conducted to allow us to upgrade the app in accordance with the new European Commission Medical Device legislation and to validate the bleeding pattern prediction algorithm in a real-world setting.ConclusionsBy providing a meaningful estimation of bleeding patterns and allowing an individualized approach to counseling and discussions about contraceptive method choice, the MyIUS app offers a useful tool that may benefit both women and HCPs. Further work is needed to validate the performance of the prediction algorithm and MyIUS app in a real-world setting.
| S-EPMC8317031 | biostudies-literature
Project description:Stem cell biology represents a challenging research area with a huge potential translational approach. This review focuses on the most recent findings on stem cell basics and clinics in several fields of research, as final outcome of the 10th conference held by Stem Cell Research Italy (SCR Italy) in Naples, Italy in June 2019. Current state-of-the-art and novel findings on stem cell research are discussed, bringing together basic and applied research with the newest insights in stem cell therapy.
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Project description:Developing valid and reliable instruments is crucial but costly and time-consuming in health care research and evaluation. The Food and Drug Administration and the National Institutes of Health have set up guidelines for developing patient-reported outcome instruments. However, the guidelines are not applicable to cases of small sample sizes. Instead of using an exact estimation procedure to examine psychometric properties, our Bayesian Instrument Development (BID) method integrates expert data and participant data into a single seamless analysis. Using a novel set of priors, we use simulated data to compare BID to classical instrument development procedures and test the stability of BID. To display BID to non-statisticians, a graphical user interface based on R and WINBUGS is developed and demonstrated with data on a small sample of heart failure patients. Costs were saved by eliminating the need for unnecessary continuation of data collection for larger samples as required by the classical instrument development approach.
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Project description:The involvement of medical students in scientific research has been widely advocated over the last decades in order to fulfill the need for a new generation of physicians who can apply evidence-based medicine. Efforts to involve medical students in scientific research have been described by individual institutions. In developing countries, students are less involved in research owing to the limited time and resources. Hereby, we describe our three-year experience with a novel model for medical student research in Egypt.
| S-EPMC6325031 | biostudies-literature
Project description:Gastric cancer is currently the third leading cause of cancer-related deaths worldwide, usually diagnosed at late stages. The development of new biomarkers to improve its prevention and patient management is critical for disease control. piRNAs are small regulatory RNAs important for gene silencing mechanisms, mainly associated with the silencing of transposable elements. piRNA pathways may also be involved in gene regulation and the deregulation of piRNAs may be an important factor in carcinogenic processes. Thus, several studies suggest piRNAs as potential cancer biomarkers. Translational studies suggest that piRNAs may regulate key genes and pathways associated with gastric cancer progression, though there is no functional annotation in piRNA databases. The impacts of genetic variants in piRNA genes and their influence in gastric cancer development remains elusive, highlighting the gap in piRNA regulatory mechanisms knowledge. Here, we discuss the current state of understanding of piRNA-mediated regulation and piRNA functions and suggest that genetic alterations in piRNA genes may affect their functionality, thus, it may be associated with gastric carcinogenesis. In the era of precision medicine, investigations about genetic and epigenetic mechanisms are essential to further comprehend gastric carcinogenesis and the role of piRNAs as potential biomarkers for translational research.
| S-EPMC7139476 | biostudies-literature
Project description:ObjectivesIncreased demands are placed on emergency services and their role and ability to act in incidents in challenging environments, for example, road tunnels. Collaboration between officers from emergency services (fire brigade, police and ambulance services) is important for an effective rescue effort. In Gothenburg, Sweden, a position as a senior ambulance officer (SAO) within the emergency medical services (EMS) has been introduced to support the regular force during major incidents. The aim of this paper was to explore the perceptions and experiences of the SAO's new management role in challenging incidents, such as those occurring in road tunnels.DesignA qualitative interview study.SettingThe study was carried out from February to June 2019 in Gothenburg, Sweden, which is a municipality with several road tunnels and a population of approximately 580 000 people. SAOs collaborate with the corresponding function within the police and fire brigade, both having senior officers at major incident sites.ParticipantsTwelve SAOs.MethodsThe study used semistructured interviews. The collected data were analysed using qualitative content analysis.ResultsAccording to SAOs' experience, prehospital medical management included not only leadership, but also planning, training and indepth knowledge of, for example, tunnel environments. Furthermore, SAOs adopted an encouraging and teaching role for their colleagues. SAOs' responsibilities also included proactive planning together with the fire brigade and police, which was regarded as enhancing interorganisational collaboration. An overall theme emerged which the SAOs described as 'A new holistic approach to EMS leadership and management'.ConclusionsThe participants considered that the new SAO role not only seems to improve the prehospital medical management, but also makes the EMS command structure during challenging incidents symmetrical with the fire brigade and police command structure. The implementation of national guidelines is desirable and is requested by the SAOs.
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Project description:Efforts to understand spinal cord injury (SCI) and other complex neurotrauma disorders at the pre-clinical level have shown progress in recent years. However, successful translation of basic research into clinical practice has been slow, partly because of the large, heterogeneous data sets involved. In this sense, translational neurological research represents a "big data" problem. In an effort to expedite translation of pre-clinical knowledge into standards of patient care for SCI, we describe the development of a novel database for translational neurotrauma research known as Visualized Syndromic Information and Outcomes for Neurotrauma-SCI (VISION-SCI). We present demographics, descriptive statistics, and translational syndromic outcomes derived from our ongoing efforts to build a multi-center, multi-species pre-clinical database for SCI models. We leveraged archived surgical records, postoperative care logs, behavioral outcome measures, and histopathology from approximately 3000 mice, rats, and monkeys from pre-clinical SCI studies published between 1993 and 2013. The majority of animals in the database have measures collected for health monitoring, such as weight loss/gain, heart rate, blood pressure, postoperative monitoring of bladder function and drug/fluid administration, behavioral outcome measures of locomotion, and tissue sparing postmortem. Attempts to align these variables with currently accepted common data elements highlighted the need for more translational outcomes to be identified as clinical endpoints for therapeutic testing. Last, we use syndromic analysis to identify conserved biological mechanisms of recovery after cervical SCI between rats and monkeys that will allow for more-efficient testing of therapeutics that will need to be translated toward future clinical trials.
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Project description:Central nervous system (CNS) or brain metastasis is an emerging area of interest in organ-specific metastasis research. Lung and breast cancers are the most common types of primary tumors to develop brain metastases. This disease complication contributes significantly to the morbidity and mortality of both of these common cancers; as such, brain metastasis is designated an unmet medical need by the US Food and Drug Administration (FDA). Recently, an increase in incidence of CNS disease has been noted in the literature for breast cancer, while it has been an ongoing major complication from lung cancer. Progress in treating brain metastases has been hampered by a lack of model systems, a lack of human tissue samples, and the exclusion of brain metastatic patients from many clinical trials. While each of those is significant, the major impediment to effectively treating brain metastatic disease is the blood-brain barrier (BBB). This barrier excludes most chemotherapeutics from the brain and creates a sanctuary site for metastatic tumors. Recent findings on the biology of this disease and translational leads identified by molecular studies are discussed in this article.
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