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In this research, we applied electrospinning to create a two-component biodegradable polymeric scaffold containing polysuccinimide (PSI) and antibacterial salts. Antibacterial agents for therapeutical purposes mostly contain silver ions which are associated with high environmental impact and, in some cases, may cause undesired immune reactions. In our work, we prepared nanofibrous systems containing antibacterial and tissue-regenerating salts of zinc acetate or strontium nitrate in different concentrations, whose structures may be suitable for developing biomedical wound dressing systems in the future. Several experiments have been conducted to optimize the physicochemical, mechanical, and biological properties of the scaffolds developed for application as wound dressings. The scaffold systems obtained by PSI synthesis, salt addition, and fiber formation were first investigated by scanning electron microscopy. In almost all cases, different salts caused a decrease in the fiber diameter of PSI polymer-based systems (<500 nm). Fourier-transform infrared spectroscopy was applied to verify the presence of salts in the scaffolds and to determine the interaction between the salt and the polymer. Another analysis, energy-dispersive X-ray spectroscopy, was carried out to determine strontium and zinc atoms in the scaffolds. Our result showed that the salts influence the mechanical properties of the polymer scaffold, both in terms of specific load capacity and relative elongation values. According to the dissolution experiments, the whole amount of strontium nitrate was dissolved from the scaffold in 8 h; however, only 50% of the zinc acetate was dissolved. In addition, antibacterial activity tests were performed with four different bacterial strains relevant to skin surface injuries, leading to the appearance of inhibition zones around the scaffold discs in most cases. We also investigated the potential cytotoxicity of the scaffolds on human tumorous and healthy cells. Except for the ones containing zinc acetate salt, the scaffolds are not cytotoxic to either tumor or healthy cells.
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BACKGROUND: This study aims to create a comprehensive framework for the development and implementation of digital medication adherence technologies (DMATech), focusing on critical stages where engagement of medication users (MU) is considered meaningful, i.e. adds significant value, as agreed upon by participating stakeholders. METHODS: Through a literature review and expert consensus, a framework was outlined covering key DMATech development and implementation phases and steps. An in-person workshop with MU representatives and adherence experts, using the Nominal Group Technique, further refined these stages for MU engagement. RESULTS: The DMATech framework included three phases: 'Innovation,' 'Research and Development,' and 'Launch and Implementation,' each encompassing multiple steps. The workshop, attended by five MU representatives and nine adherence experts, identified critical stages for MU input including context analysis, ideation, proof of concept, prototype creation, DMATech's iteration, critical evaluation, healthcare implementation, real-world assessment, and improvement. Nevertheless, there was a divergence of consensus regarding the importance of MUs engagement in regulatory, financial, and marketing aspects. CONCLUSIONS: This study provides a holistic framework for DMATech development and implementation and underscores the necessity of MU engagement at various stages. Modes of MU engagement cannot be generalized; a case-by-case evaluation of engagement strategies is essential.
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Background and purpose:
Human brain aneurysms may often prove fatal if not recognized in time and treated accordingly. The understanding of development and rupture of aneurysms can significantly be improved by the application of numerical modelling, which in turn, requires the knowledge of mechanical properties of vessel wall. This study aims to identify assumed differences with respect to age, sex, spatial orientation, and rupture by utilizing detailed statistical analysis of uniaxial tensile measurements of human brain aneurysm samples, performed by the authors in a previous project.
. Methods:At surgery of 42 patients, aneurysm fundi were cut distally to the clip. In each case, depending on size, varying number of stripes (altogether 88) were prepared and uniaxial stress-strain measurements were performed. Quantities related to the capacity, energy absorption or stiffness were determined and statistically analysed.
. Results:The number of specimens in the aneurysm sample was sufficient to establish statistical differences with respect to sex and rupture (p<0.05). No significant differences were detected in orientation, though higher values of stresses and deformations were obtained in the circumferential direction compared to the meridional direction.
. Conclusion:Significant differences between sexes with respect to ultimate deformations were demonstrated according to expectation, and the hypothesis on equality of energy capacity could be supported. Similarity of curves with respect to specimen orientation was also observed and ruptured aneurysm sacs tended to be smaller in size. It seems that differences and trends described in this paper are realistic and need to be applied in numerical modelling.
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Aneurisma Roto , Aneurisma Intracraniano , Humanos , Aneurisma Intracraniano/fisiopatologia , Aneurisma Intracraniano/cirurgia , Masculino , Feminino , Fenômenos Biomecânicos , Aneurisma Roto/fisiopatologia , Estresse Mecânico , Pessoa de Meia-Idade , Resistência à Tração , Adulto , Fatores SexuaisRESUMO
There are controversial data about the effect of carotid endarterectomy regarding postoperative cognitive function. Our aim was to analyze the effect of cerebral tissue saturation monitored by near-infrared spectroscopy (NIRS) on cognitive function. Perioperative data of 103 asymptomatic patients undergoing elective carotid surgery under general anesthesia were analyzed. Preoperatively and 3 months after the operation, MMSE (Mini Mental State Examination) and MoCA (Montreal Cognitive Assessment) tests were conducted. For cerebral monitoring, NIRS was used, and the lowest rSO2 value and the degree of desaturation were calculated. Cognitive changes were defined as one standard deviation change from the preoperative test scores, defined as postoperative neurocognitive decline (PNCD) and cognitive improvement (POCI). PNCD was found in 37 patients (35.92%), and POCI was found in 18 patients (17.47%). Female gender, patients with diabetes, and the degree of desaturation were independently associated with PNCD. The degree of desaturation during the cross-clamp period negatively correlated with the change in the MoCA scores (R = - 0.707, p = 0.001). The 15.5% desaturation ratio had 86.5% sensitivity and 78.8% specificity for discrimination. For POCI, a desaturation of less than 12.65% had 72.2% sensitivity and 67.1% specificity. POCI was associated with lower preoperative MOCA scores and a lower degree of desaturation. We found a significant relation between the change of postoperative cognitive function proven by the MoCA test and cerebral tissue saturation during the clamping period in patients undergoing carotid endarterectomy.
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Background and purpose:
Neurocognitive aging and the associated brain diseases impose a major social and economic burden. Therefore, substantial efforts have been put into revealing the lifestyle, the neurobiological and the genetic underpinnings of healthy neurocognitive aging. However, these studies take place almost exclusively in a limited number of highly-developed countries. Thus, it is an important open question to what extent their findings may generalize to neurocognitive aging in other, not yet investigated regions. The purpose of the Hungarian Longitudinal Study of Healthy Brain Aging (HuBA) is to collect multi-modal longitudinal data on healthy neurocognitive aging to address the data gap in this field in Central and Eastern Europe.
. Methods:We adapted the Australian Imaging, Biomarkers and Lifestyle (AIBL) study of aging study protocol to local circumstances and collected demographic, lifestyle, mental and physical health, medication and medical history related information as well as recorded a series of magnetic resonance imaging (MRI) data. In addition, participants were also offered to participate in the collection of blood samples to assess circulating inflammatory biomarkers as well as a sleep study aimed at evaluating the general sleep quality based on multi-day collection of subjective sleep questionnaires and whole-night electroencephalographic (EEG) data.
. Results:Baseline data collection has already been accomplished for more than a hundred participants and data collection in the second
session is on the way. The collected data might reveal specific local trends or could also indicate the generalizability of previous findings. Moreover, as the HuBA protocol also offers a sleep study designed for thorough characterization of participants’ sleep quality and related factors, our extended multi-modal dataset might provide a base for incorporating these measures into healthy and clinical aging research.
Besides its straightforward national benefits in terms of health expenditure, we hope that this Hungarian initiative could provide results valid for the whole Central and Eastern European region and could also promote aging and Alzheimer’s disease research in these countries.
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Envelhecimento , Encéfalo , Masculino , Humanos , Estudos Longitudinais , Hungria , Austrália , Encéfalo/patologia , Envelhecimento/patologia , BiomarcadoresRESUMO
Even though electrospinning is getting more and more attention, the preparation of 3D nanofibrous meshes is still a big challenge that limits the application of electrospun materials, especially in tissue engineering. To overcome this problem, several solutions are introduced but most of them focus on the postprocessing of the electrospun meshes. This paper presents a straightforward novel method that utilizes the joint effect of the addition of CaCl2 and the relative environmental humidity (RH), which can induce the random 3D formation of polysuccinimide (PSI) electrospun fibers with different such as wrinkled or ribbon-like structures. Although the effect of humidity and inorganic salt additives on the micro and macrostructure of electrospun fibers is known, the connection between the two in this manner has never been presented. To investigate the effect, fibers with different PSI and CaCl2 concentrations at different humidity RH levels are prepared, and their microstructure is visualized with high-resolution scanning electron microscopy (SEM). To reveal the nature of the interaction between the polymer and the CaCl2, Fourier-transformed infrared (FTIR), X-ray diffraction (XRD), and thermogravimetry (TGA) measurements are carried out and 3D nanofibrous structures are obtained.
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Ácido Aspártico/análogos & derivados , Nanofibras , Engenharia Tecidual , Cloreto de Cálcio , Umidade , Engenharia Tecidual/métodos , Polímeros , Nanofibras/químicaRESUMO
(1) Background and Objectives: Morbid obesity significantly increases the prevalence of comorbidities, such as heart disease, restrictive lung disease, stroke, diabetes mellitus and more. (2) Methods: Patients undergoing gastric sleeve surgery were divided into three groups with BMI between 30-34.9 kg/m2 (Group I), 35-39.9 kg/m2 (Group II), and over 40 kg/m2 (Group III). Preoperative examinations included cardiac ultrasound, respiratory function and laboratory tests, and preoperative comorbidities were also recorded. Following a one-year follow-up, we compared the rate of weight loss in the three groups at six months and one year following surgery, specifically, the effect of surgery on preoperative comorbidities at one year. (3) Results: The weight loss surgeries performed were successful in all three groups. Preoperative laboratory examinations, an echocardiogram and respiratory function results showed no clinically significant difference, except moderate elevations in blood lipid levels. Hypertension was the most common comorbidity. (4) Conclusions: In our patient population, hypertension and diabetes were the only comorbidities with a high prevalence. It can be explained by the relatively younger age among the patients (mean age 44.5 years) and the fact that they had not yet developed the pathological consequences of severe obesity. Consequently, while performing the surgery at a relatively younger age, it seems far more likely that the patient will return to a more active and productive life and enjoy a better quality of life. Additionally, the perioperative risk is lower, and the burden upon health systems and health expenditure is reduced by preventing comorbidities, in particular, multimorbidity. On this basis, it may be advisable to direct patients who do not exhaust the classical indications for bariatric surgery toward the surgical solution at a younger age. Our results suggest it is not worth waiting for comorbidities, especially multimorbidity, to appear.
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Hipertensão , Laparoscopia , Obesidade Mórbida , Humanos , Adulto , Resultado do Tratamento , Qualidade de Vida , Estudos Retrospectivos , Laparoscopia/métodos , Comorbidade , Obesidade Mórbida/complicações , Obesidade Mórbida/epidemiologia , Obesidade Mórbida/cirurgia , Hipertensão/epidemiologia , Gastrectomia/métodos , Redução de PesoRESUMO
Underserved and hard-to-reach population groups are under-represented in vaccine trials. Thus, we aimed to identify the challenges of vaccine trial participation of these groups in member countries of the VACCELERATE network. Seventeen National Coordinators (NC), each representing their respective country (15 European countries, Israel, and Turkey), completed an online survey. From 15 eligible groups, those that were more frequently declared underserved/hard-to-reach in vaccine research were ethnic minorities (76.5%), persons experiencing homelessness (70.6%), illegal workers and refugees (64.7%, each). When prioritization for education on vaccine trials was considered, ethnic groups, migrants, and immigrants (5/17, 29.4%) were the groups most frequently identified by the NC as top targets. The most prominent barriers in vaccine trial participation affecting all groups were low levels of health literacy, reluctance to participate in trials due to engagement level, and low levels of trust in vaccines/vaccinations. This study highlighted population groups considered underserved/hard-to-reach in countries contained within the European region, and the respective barriers these groups face when participating in clinical studies. Our findings aid with the design of tailored interventions (within-and across-countries of the European region) and with the development of strategies to overcome major barriers in phase 2 and phase 3 vaccine trial participation.
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INTRODUCTION: Obesity is a modern-day epidemic that places a significant and growing burden on the health systems of societies and their financial resources. OBJECTIVE: Our prospective, descriptive clinical study aimed to investigate the effect of laparoscopic gastric sleeve surgery in morbidly obese patients through a one-year follow-up. METHOD: In our study, we included 151 patients who underwent laparoscopic gastric sleeve surgery. We performed cardiac ultrasound, respiratory function and laboratory tests for pre-operative examination, possible co-morbidities were assessed, and the parameters of morbid obesity were also recorded, before surgery, half a year and one year after. RESULTS: Patients' body mass index decreased by 26.9% in the first six months and by 35.4% overall at one year, and body fat percentage decreased by 26.2% and 35%, respectively, over the same time intervals. The average age of patients was 41 years. Pre-operative cardiac ultrasound, respiratory function and laboratory tests showed no significant pathological abnormalities and a low rate of co-morbidities were associated with obesity (hypertension 51.7%, type two diabetes mellitus 13.8%). DISCUSSION: Based on the one-year follow-up data, the surgery was effective in weight loss, but long-term results can be expected at the five-year assessment, as there is a risk of repeated weight gain. Based on our study, in the case of failure of conservative treatment, it is recommended to perform the surgery at a young age, achieving the appropriate weight loss before the appearance or further aggravation of co-morbidities. Thus, the perioperative risk (and the probability of the subsequent development or further deterioration of co-morbidities) will decrease; conversely, the number of years spent in a better quality of life will increase. CONCLUSION: Laparoscopic sleeve gastrectomy is an effective weight loss procedure in the short term. If conservative treatment is ineffective, it is worthwhile to steer the patient towards invasive procedures as soon as possible to reduce the perioperative risk and the number of years spent in poor quality of life. Orv Hetil. 2023; 164(44): 1749-1754.
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Laparoscopia , Obesidade Mórbida , Humanos , Adulto , Obesidade Mórbida/complicações , Obesidade Mórbida/cirurgia , Estudos Prospectivos , Qualidade de Vida , Gastrectomia , Redução de PesoRESUMO
Optical insulation of the unit eyes (ommatidia) is an important prerequisite of precise sight with compound eyes. Separation of the ommatidia is ensured by pigment cells that organize into a hexagonal lattice in the Drosophila eye, forming thin walls between the facets. Cell adhesion, mediated by apically and latero-basally located junctional complexes, is crucial for stable attachment of these cells to each other and the basal lamina. Whereas former studies have focused on the formation and remodelling of the cellular connections at the apical region, here, we report a specific alteration of the lateral adhesion of the lattice cells, leaving the apical junctions largely unaffected. We found that DAAM and FRL, two formin-type cytoskeleton regulatory proteins, play redundant roles in lateral adhesion of the interommatidial cells and patterning of the retinal floor. We show that formin-dependent cortical actin assembly is crucial for latero-basal sealing of the ommatidial lattice. We expect that the investigation of these previously unreported eye phenotypes will pave the way toward a better understanding of the three-dimensional aspects of compound eye development.
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Proteínas de Drosophila , Animais , Proteínas de Drosophila/genética , Proteínas de Drosophila/metabolismo , Forminas/metabolismo , Drosophila/metabolismo , Citoesqueleto/metabolismo , Retina/metabolismo , Olho/metabolismo , Proteínas Adaptadoras de Transdução de Sinal/metabolismoRESUMO
The prevalence of acute pancreatitis in pregnancy is low; similarly to the non-pregnant population, the outcome varies from mild to fatal forms. Occurrence of the disease in pregnancy is mostly in the third trimester or the postpartum period. The most common cause of acute pancreatitis is cholelithiasis but hypertriglyceridemia, fatty diet, obesity and alcohol consumption are further predisposing factors. A 27-year-old twin-pregnant woman developed acute severe pain 2 days after a cesarean section. Labor tests showed elevated amylase (1080 U/L) and lipase (2670 U/L) serum levels. For the purpose of pain relief, we inserted an epidural catheter and indicated an abdominal computer tomography examination. The abdominal imaging did not show morphological disorder of the pancreas or cholangial obstruction. We performed conservative therapy, early per os feeding, pain relief and fluid resuscitation. On the postpartum 7. day, the serum pancreas enzyme levels decreased to normal and the patient - with her babies - was discharged home. Though acute pancreatitis is a rare event in pregnancy, we should consider it in cases with acute, typical or non-typical pain. It is challenging to differentiate the disease from the acute syndromes of pregnancy. Orv Hetil. 2023; 164(31): 1231-1234.
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Trabalho de Parto , Pancreatite , Complicações na Gravidez , Humanos , Gravidez , Feminino , Adulto , Cesárea/efeitos adversos , Doença Aguda , Pancreatite/etiologia , Pancreatite/terapia , Complicações na Gravidez/etiologia , Complicações na Gravidez/terapia , DorRESUMO
Background: Hormone level changes after heart surgeries are a widely observed phenomenon due to neurohormonal feedback mechanisms that may affect postoperative morbidity and mortality. The current study aimed to analyze the changes in thyroid and sex hormones in the first 24 postoperative hours after heart surgery. Methods: This prospective, observational study (registered on ClinicalTrials.gov: NCT03736499; 09/11/2018) included 49 patients who underwent elective cardiac surgical procedures at a tertiary heart center between March 2019 and December 2019. Thyroid hormones, including thyroid-stimulating hormone (TSH), triiodothyronine (T3), and thyroxine (T4), and sex hormones, including prolactin (PRL) and total testosterone, were measured preoperatively and at 24 h postoperatively. Results: Significant decreases in serum TSH (P < 0.001), T3 (P < 0.001) and total testosterone (P < 0.001) levels were noted, whereas T4 (P = 0.554) and PRL (P = 0.616) did not significantly change. Intensive care unit (ICU) hours (P < 0.001), mechanical ventilation (P < 0.001) and Vasoactive-Inotropic Score (VIS) (P = 0.006) were associated with postoperative T3 level. ICU hours were associated with postoperative T4 level (P = 0.028). Postoperative and delta testosterone levels were in connection with lengths of stay in ICU (P = 0.032, P = 0.010 respectively). Model for End-Stage Liver Disease (MELD) scores were associated with thyroid hormone levels and serum testosterone. Conclusions: T3 may represent a marker of nonthyroidal illness syndrome and testosterone may reflect hepatic dysfunction. In addition, PRL may act as a stress hormone in female patients.
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Procedimentos Cirúrgicos Cardíacos , Doença Hepática Terminal , Humanos , Feminino , Estudos Prospectivos , Índice de Gravidade de Doença , Hormônios Tireóideos , Tireotropina , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , TestosteronaRESUMO
Introduction: Meaningful patient involvement in health technology assessment (HTA) is essential in ensuring that the interests of the affected patient population, their families, and the general public are accurately reflected in coverage and reimbursement decisions. Central and Eastern European (CEE) countries are generally at less advanced stages of implementing HTA, which is particularly true for patient involvement activities. As part of the Horizon2020 HTx project, this research aimed to form recommendations for critical barriers to patient involvement in HTA in CEE countries. Methods: Built on previous research findings on potential barriers, a prioritisation survey was conducted online with CEE stakeholders. Recommendations for prioritised barriers were formed through a face-to-face workshop by CEE stakeholders and HTx experts. Results: A total of 105 stakeholders from 13 CEE countries completed the prioritisation survey and identified 12 of the 22 potential barriers as highly important. The workshop had 36 participants representing 9 CEE countries, and 5 Western European countries coming together to discuss solutions in order to form recommendations based on best practices, real-life experience, and transferability aspects. Stakeholder groups involved in both phases included HTA organisation representatives, payers, patients, caregivers, patient organisation representatives, patient experts, health care providers, academic and non-academic researchers, health care consultants and health technology manufacturers/providers. As a result, 12 recommendations were formed specified to the CEE region's context, but potentially useful for a broader geographic audience. Conclusion: In this paper, we present 12 recommendations for meaningful, systematic, and sustainable patient involvement in HTA in CEE countries. Our hope is that engaging more than a hundred CEE stakeholders in the study helped to spread awareness of the importance and potential of patient involvement and that the resulting recommendations provide tangible steps for the way forward. Future studies shall focus on country-specific case studies of the implemented recommendations.
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Participação do Paciente , Avaliação da Tecnologia Biomédica , Humanos , Avaliação da Tecnologia Biomédica/métodos , Europa (Continente)RESUMO
BACKGROUND: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. METHODS: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experience, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clinical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study characteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selection process. RESULTS: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppression by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in several indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interventional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxoviridae/influenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. CONCLUSIONS: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe.
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COVID-19 , Orthomyxoviridae , Vacinas , Adulto , Criança , Humanos , SARS-CoV-2 , Europa (Continente)RESUMO
Purpose: The frailty concept has become a fundamental part of daily clinical practice. In this study our purpose was to create a risk estimation method with a comprehensive aspect of patients' preoperative frailty. Patients and methods: In our prospective, observational study, patients were enrolled between September 2014 and August 2017 in the Department of Cardiac Surgery and Department of Vascular Surgery at Semmelweis University, Budapest, Hungary. A comprehensive frailty score was built from four main domains: biological, functional-nutritional, cognitive-psychological and sociological. Each domain contained numerous indicators. In addition, the EUROSCORE for cardiac patients and the Vascular POSSUM for vascular patients were calculated and adjusted for mortality. Results: Data from 228 participants were included for statistical analysis. A total of 161 patients underwent vascular surgery, and 67 underwent cardiac surgery. The preoperatively estimated mortality was not significantly different (median: 2.700, IQR (interquartile range): 2.000-4.900 vs. 3.000, IQR: 1.140-6.000, P = 0.266). The comprehensive frailty index was significantly different (0.400 (0.358-0.467) vs. 0.348 (0.303-0.460), P = 0.001). In deceased patients had elevated comprehensive frailty index (0.371 (0.316-0.445) vs. 0.423 (0.365-0.500), P < 0.001). In the multivariate Cox model an increased risk for mortality in quartiles 2, 3 and 4 compared with quartile 1 as a reference was found (AHR (95% CI): 1.974 (0.982-3.969), 2.306 (1.155-4.603), and 3.058 (1.556-6.010), respectively). Conclusion: The comprehensive frailty index developed in this study could be an important predictor of long-term mortality after vascular or cardiac surgery. Accurate frailty estimation could make the traditional risk scoring systems more accurate and reliable.
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Procedimentos Cirúrgicos Cardíacos , Fragilidade , Humanos , Idoso , Fragilidade/etiologia , Idoso Fragilizado , Estudos Prospectivos , Avaliação Geriátrica/métodos , Complicações Pós-Operatórias/etiologia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Fatores de Risco , Medição de RiscoRESUMO
BACKGROUND: The pan-European VACCELERATE network aims to implement the first transnational harmonized and sustainable vaccine trial Volunteer Registry, being a single entry point for potential volunteers of large-scale vaccine trials across Europe. This work exhibits a set of harmonized vaccine trial-related educational and promotional tools for the general public, designed and disseminated by the pan-European VACCELERATE network. OBJECTIVE: This study primarily aimed to design and develop a standard toolkit to increase positive attitudes and access to trustworthy information for better access and increased recruitment to vaccine trials for the public. More specifically, the produced tools are focused on inclusiveness and equity, and are targeting different population groups, including underserved ones, as potential volunteers for the VACCELERATE Volunteer Registry (older individuals, migrants, children, and adolescents). The promotional and educational material is aligned with the main objectives of the Volunteer Registry to increase public literacy and awareness regarding vaccine-related clinical research or trials and trial participation, including informed consent and legal issues, side effects, and frequently asked questions regarding vaccine trial design. METHODS: Tools were developed per the aims and principles of the VACCELERATE project, focusing on trial inclusiveness and equity, and are adjusted to local country-wise requirements to improve public health communication. The produced tools are selected based on the cognitive theory, inclusiveness, and equity of differently aged and underrepresented groups, and standardized material from several official trustworthy sources (eg, COVID-19 Vaccines Global Access; the European Centre for Disease Prevention and Control; the European Patients' Academy on Therapeutic Innovation; Gavi, the Vaccine Alliance; and the World Health Organization). A team of multidisciplinary specialists (infectious diseases, vaccine research, medicine, and education) edited and reviewed the subtitles and scripts of the educational videos, extended brochures, interactive cards, and puzzles. Graphic designers selected the color palette, audio settings, and dubbing for the video story-tales and implemented QR codes. RESULTS: This study presents the first set of harmonized promotional and educational materials and tools (ie, educational cards, educational and promotional videos, extended brochures, flyers, posters, and puzzles) for vaccine clinical research (eg, COVID-19 vaccines). These tools inform the public about possible benefits and disadvantages of trial participation and build confidence among participants about the safety and efficacy of COVID-19 vaccines and the health care system. This material has been translated into several languages and is intended to be freely and easily accessible to facilitate dissemination among VACCELERATE network participant countries and the European and global scientific, industrial, and public community. CONCLUSIONS: The produced material could help fill knowledge gaps of health care personnel, providing the appropriate future patient education for vaccine trials, and tackling vaccine hesitancy and parents' concerns for potential participation of children in vaccine trials.
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COVID-19 , Comunicação em Saúde , Vacinas , Criança , Adolescente , Humanos , Idoso , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Europa (Continente)RESUMO
BACKGROUND: Hypercoagulability and thrombo-inflammation are the main reasons for death in COVID-19 patients. It is unclear whether there is a difference between D-dimer levels in patients without or with COVID-19 acute respiratory distress syndrome (ARDS). METHODS: We searched PubMed, EMBASE, and ClinicalTrails.gov databases looking for studies reporting D-dimer levels in patients without or with COVID-19 ARDS. Secondary endpoints included length of hospital stay, and mortality data at the longest follow-up available. RESULTS: We included 12 retrospective and 3 prospective studies with overall 2,828 patients, of whom 1,404 (49.6%) had non-COVID-19 ARDS and 1,424 had COVID-19 ARDS. D-dimer levels were not significantly higher in non-COVID-19 ARDS than in COVID-19 ARDS patients (mean 7.65 mg/L vs. mean 6.20 mg/L MD 0.88 [CI: -0.61 to 2.38] p = 0.25; I² = 85%) while the length of hospital stay was shorter (non-COVID-19 mean 37.4 days vs. COVID-19 mean 48.5 days, MD -10.92 [CI: -16.71 to -5.14] p < 0.001; I² = 44%). No difference in mortality was observed: non-COVID-19 ARDS 418/1167 (35.8%) vs. COVID-19 ARDS 467/1201 (38.8%). CONCLUSIONS: We found no difference in the mean D-dimer levels between non-COVID-19 ARDS and COVID-19 ARDS patients.
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COVID-19 , Produtos de Degradação da Fibrina e do Fibrinogênio , Síndrome do Desconforto Respiratório , Humanos , COVID-19/complicações , Estudos Prospectivos , Síndrome do Desconforto Respiratório/virologia , Estudos Retrospectivos , Produtos de Degradação da Fibrina e do Fibrinogênio/análiseRESUMO
Biocompatible nanofibrous systems made by electrospinning have been studied widely for pharmaceutical applications since they have a high specific surface and the capability to make the entrapped drug molecule amorphous, which increases bioavailability. By covalently conjugating drugs onto polymers, the degradation of the drug as well as the fast clearance from the circulation can be avoided. Although covalent polymer-drug conjugates have a lot of advantages, there is a lack of research focusing on their nano-formulation by electrospinning. In this study, polysuccinimide (PSI) based electrospun fibrous meshes conjugated with dopamine (DA) are prepared. Fiber diameter, mechanical properties, dissolution kinetics and membrane permeability are thoroughly investigated, as these are crucial for drug delivery and implantation. Dopamine release kinetics prove the prolonged release that influenced the viability and morphology of periodontal ligament stem cells (PDLSCs) and SH-SY5Y cells. The presence of dopamine receptors on both cell types is also demonstrated and the uptake of the conjugates is measured. According to flow cytometry analysis, the conjugates are internalized by both cell types, which is influenced by the chemical structure and physical properties. In conclusion, electrospinning of PSI-DA conjugates alters release kinetics, meanwhile, conjugated dopamine can play a key role in cellular uptake.
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Dopamina , Neuroblastoma , Humanos , Dopamina/farmacologia , Sobrevivência Celular , Sistemas de Liberação de Medicamentos , Polímeros/farmacologia , Polímeros/químicaRESUMO
BACKGROUND: Glucocorticoids reduce mortality in hospitalized patients with severe and critical coronavirus disease 2019 (Covid-19), although a possible harm was documented in patients with Covid-19 not requiring oxygen. METHODS: We searched Embase, BioMed Central, medRxiv, bioRxiv, PubMed, and the Cochrane Central Register of Controlled Trials for any randomized trial or matched study ever performed on adult patients with Covid-19 not receiving oxygen therapy treated with intravenous or oral glucocorticoids versus any comparator (standard therapy or placebo); there were no restrictions on dose or time of administration. The primary end point was all-cause mortality at the longest available follow-up. RESULTS: Five randomized trials and one propensity-matched study involving 6634 hospitalized patients not on oxygen were finally included (3704 received glucocorticoids and 2930 received standard treatment). The overall mortality of patients treated with glucocorticoids was significantly higher than the mortality of patients in the control group (509 of 3704 [14%] in the glucocorticoid group vs. 294 of 2930 [10%] in the control group; odds ratio, 1.56 [95% confidence interval, 1.27 to 1.92], with three articles reporting mortality events and contributing to the combined odds ratio; P<0.001; number needed to harm=27). CONCLUSIONS: Glucocorticoid use likely increases mortality in hospitalized patients with Covid-19 not receiving oxygen, with a number needed to harm of 27. (PROSPERO number CRD42022342996.)
Assuntos
COVID-19 , Glucocorticoides , Humanos , Oxigênio , SARS-CoV-2RESUMO
INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has evidenced the key role of vaccine design, obtention, production and administration to successfully fight against infectious diseases and to provide efficient remedies for the citizens. Although clinical trials were rapidly established during this pandemic, identifying suitable study subjects can be challenging. For this reason, the University Hospital Cologne established a volunteer registry for participation in clinical trials first in Germany, which has now been incorporated into the European VACCELERATE clinical trials network and grew to a European Volunteer Registry. As such, VACCELERATE's Volunteer Registry aims to become a common entry point for potential volunteers in future clinical trials in Europe. METHODS: Interested volunteers who would like to register for clinical trials in the VACCELERATE Volunteer Registry can access the registration questionnaire via http://www.vaccelerate.eu/volunteer-registry. Potential volunteers are requested to provide their current country and area of residence, contact information, including first and last name and e-mail address, age, gender, comorbidities, previous SARS-CoV-2 infection and vaccination status, and maximum distance willing to travel to a clinical trial site. The registry is open to both adults and children, complying with national legal consent requirements. RESULTS: As of May 2022, the questionnaire is available in 12 countries and 14 languages. Up to date, more than 36,000 volunteers have registered, mainly from Germany. Within the first year since its establishment, the VACCELERATE Volunteer Registry has matched more than 15,000 volunteers to clinical trials. The VACCELERATE Volunteer Registry will be launched in further European countries in the coming months. CONCLUSIONS: The VACCELERATE Volunteer Registry is an active single-entry point for European residents interested in COVID-19 clinical trials participation in 12 countries (i.e., Austria, Cyprus, Germany, Greece, Ireland, Lithuania, Norway, Portugal, Spain, Sweden and Turkey). To date, more than 15,000 registered individuals have been connected to clinical trials in Germany alone. The registry is currently in the implementation phase in 5 additional countries (i.e., Belgium, Czech Republic, Hungary, Israel and the Netherlands).