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The capability to produce suture material using three-dimensional (3D) printing technology may have applications in remote health facilities where rapid restocking of supplies is not an option. This is a feasibility study evaluating the usability of 3D-printed sutures in the repair of a laceration wound when compared with standard suture material. The 3D-printed suture material was manufactured using a fused deposition modelling 3D printer and nylon 3D printing filament. Study participants were tasked with performing laceration repairs on the pigs' feet, first with 3-0 WeGo nylon suture material, followed by the 3D-printed nylon suture material. Twenty-six participants were enrolled in the study. Survey data demonstrated statistical significance with how well the 3D suture material performed with knot tying, 8.9 versus 7.5 (p = 0.0018). Statistical significance was observed in the 3D-printed suture's ultimate tensile strength when compared to the 3-0 Novafil suture (274.8 vs. 199.8 MPa, p = 0.0096). The 3D-printed suture also demonstrated statistical significance in ultimate extension when compared to commercial 3-0 WeGo nylon suture (49% vs. 37%, p = 0.0215). This study was successful in using 3D printing technology to manufacture suture material and provided insight into its usability when compared to standard suture material.
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Estudos de Viabilidade , Impressão Tridimensional , Técnicas de Sutura , Suturas , Resistência à Tração , Animais , Suínos , Lacerações/cirurgia , Teste de Materiais , Nylons , Cicatrização , Humanos , Modelos Animais de DoençasRESUMO
INTRODUCTION: In United States, health care workers have been immersed in the COVID-19 pandemic since February 2020. Since availability of COVID-19 vaccines, there is limited literature investigating the incidence of unknown COVID-19 infections in physicians and Advanced Practitioner Providers (APPs) working in emergency departments (EDs). The primary objective is to determine the incidence unknown COVID-19 infection within a cohort of emergency physicians (EPs) and APPs. METHODS: Prospective observational study at a tertiary academic center with emergency medicine residency and 64,000 annual ED visits. EPs/APPs providing care to ED patients over the prior 12 months were eligible. Serum samples were collected between May 1 and June 30, 2022. Analysis utilized Luminex xMAP® SARS-CoV-2 Multi-Antigen IgG Assay for antibodies to Nucleocapsid, Receptor-binding domain, and Spike subunit 1. Mean Fluorescent Intensity (MFI) ≥ 700 was considered positive. Subjects completed 12 question survey assessing demographics and previously confirmed COVID-19 infection. Fisher's exact test evaluated associations of demographics and clinical characteristics with confirmed COVID-19 status. Analyses performed using SAS, Version 9.4. P < 0.05 considered statistically significant. RESULTS: Sixty-nine of 81 eligible subjects (85.2%) participated, 58.0% were male, 97.1% white, with mean age of 37. Eighteen subjects had MFI ≥ 700 strongly suggestive of prior infection, with 17.7% unknown. No statistically significant difference between age, gender, race, children in home, or household member with previously COVID-19 infection. CONCLUSION: Unknown previous COVID-19 infection was less then expected in this cohort of EPs/APPs, and no association with individual characteristics, previously infected household member, or children in the home.
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COVID-19 , Médicos , Criança , Humanos , Masculino , Estados Unidos/epidemiologia , Adulto , Feminino , COVID-19/epidemiologia , SARS-CoV-2 , Vacinas contra COVID-19 , Pandemias/prevenção & controle , Incidência , Anticorpos Antivirais , Imunoglobulina GRESUMO
BACKGROUND: The nasopharyngeal swab is the gold standard collection method for COVID-19, but is invasive and painful, subsequently resulting in poor patient acceptance. This investigation explores the process of developing and validating an alternative respiratory pathogen collection device that relies on a nasopharyngeal irrigation mechanic. The primary objective was to determine if sufficient pathological sampling can be achieved by mechanism of nasopharyngeal irrigation that is proportionate to the nasopharyngeal swab method. METHODS: The study device was designed using Shapr3D modeling software and fabricated on a fused deposition modeling printer. Fifteen participants were enrolled with each receiving a saline nasopharyngeal washing using the study device. Specimen adequacy was evaluated by two real-time reverse transcriptase polymerase chain reaction (PCR) testing methods to identify the presence of the human RNase P gene. Results were evaluated quantitatively through interpretation of the PCR cycle threshold (Ct). RESULTS: All 15 specimens tested positive for the presence of RNaseP, demonstrating specimen cellularity, adequate extraction of nucleic acids, and the absence of inhibitors to amplification. The mean Ct value was 29.5 (Applied Biosystems TaqPath RT-qPCR) and 30.7 (NECoV19). All participants felt the study device irrigation procedure was faster than the nasopharyngeal swab, with none experiencing any discomfort from the irrigation mechanism. CONCLUSION: The importance of early diagnostic testing and its role in countermeasures for communicable diseases such as COVID-19 is well established in the literature. Innovation to bolster our testing infrastructure is more important now than ever. This study was successful in developing and validating an alternative nasopharyngeal respiratory pathogen collection device that utilizes fluid debridement as its core mechanic. Data from this pilot study demonstrated the study device was successful in producing high-quality specimens for PCR testing. Feedback from the study participants was also in favor of the study device when compared to the nasopharyngeal swab.
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COVID-19 , Ácidos Nucleicos , Humanos , Pandemias , Projetos Piloto , COVID-19/diagnóstico , COVID-19/epidemiologia , Ribonuclease P/genética , SARS-CoV-2 , Nasofaringe , Manejo de Espécimes/métodos , Reação em Cadeia da Polimerase em Tempo RealRESUMO
BACKGROUND: Nurses are the primary clinicians who collect specimens for respiratory tract infection testing. The specimen collection procedure is time and resource-consuming, but more importantly, it places nurses at risk for potential infection. The practice of allowing patients to self-collect their diagnostic specimens may provide an alternative testing model for the current COVID-19 outbreaks. The objective of this paper was to evaluate the accuracy and patient perception of self-collected specimens for respiratory tract infection diagnostics. METHODS: A concise clinical review of the recently published literature was conducted. RESULTS: A total of 11 articles were included the review synthesis. The concept of self-collected specimens has a high patient acceptance rate of 83-99%. Self-collected nasal-swab specimens demonstrated strong diagnostic fidelity for respiratory tract infections with a sensitivity between 80-100%, this is higher than the 76% sensitivity observed with self-collected throat specimens. In a comparative study evaluating a professionally collected to a self-collected specimen for COVID-19 testing, a high degree of agreement (k = 0.89) was observed between the two methods. CONCLUSION: As we continue to explore for testing models to combat the COVID-19 pandemic, self-collected specimens is a practical alternative to nurse specimen collection.
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COVID-19/diagnóstico , Infecções Respiratórias/diagnóstico , Manejo de Espécimes/normas , COVID-19/epidemiologia , Teste para COVID-19 , Serviço Hospitalar de Emergência , Humanos , Pandemias , SARS-CoV-2 , Manejo de Espécimes/métodosRESUMO
A gene-level targeted enrichment method for direct detection of epigenetic modifications is described. The approach is demonstrated on the CGG-repeat region of the FMR1 gene, for which large repeat expansions, hitherto refractory to sequencing, are known to cause fragile X syndrome. In addition to achieving a single-locus enrichment of nearly 700,000-fold, the elimination of all amplification steps removes PCR-induced bias in the repeat count and preserves the native epigenetic modifications of the DNA. In conjunction with the single-molecule real-time sequencing approach, this enrichment method enables direct readout of the methylation status and the CGG repeat number of the FMR1 allele(s) for a clonally derived cell line. The current method avoids potential biases introduced through chemical modification and/or amplification methods for indirect detection of CpG methylation events.
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Epigênese Genética , Proteína do X Frágil da Deficiência Intelectual/genética , Análise de Sequência de DNA/métodos , Linhagem Celular , Metilação de DNA , Feminino , Síndrome do Cromossomo X Frágil/genética , Humanos , Sequências de Repetição em TandemRESUMO
Bilateral maxillary defects are a challenge for fibula free flap reconstruction (FFFR) surgery due to limitations in virtual surgical planning (VSP) workflows. While meshes of unilateral defects can be mirrored to virtually reconstruct missing anatomy, Brown class c and d defects lack a contralateral reference and associated anatomical landmarks. This often results in poor placement of osteotomized fibula segments. This study was performed to improve the VSP workflow for FFFR using statistical shape modeling (SSM) - a form of unsupervised machine learning - to virtually reconstruct premorbid anatomy in an automated, reproducible, and patient-specific manner. A training set of 112 computed tomography scans was sourced from an imaging database by stratified random sampling. The craniofacial skeletons were segmented, aligned, and processed via principal component analysis. Reconstruction performance was validated on a set of 45 unseen skulls containing various digitally generated defects (Brown class IIa-d). Validation metrics demonstrated promising accuracy: mean 95th percentile Hausdorff distance of 5.47 ± 2.39 mm, mean volumetric Dice coefficient of 48.8 ± 14.5%, compactness of 7.28 × 105 mm2, specificity of 1.18 mm, and generality of 8.12 × 10-6 mm. SSM-guided VSP will allow surgeons to create patient-centric treatment plans, increasing FFFR accuracy, reducing complications, and improving postoperative outcomes.
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Implantes Dentários , Retalhos de Tecido Biológico , Reconstrução Mandibular , Procedimentos de Cirurgia Plástica , Cirurgia Assistida por Computador , Humanos , Maxila/cirurgia , Crânio/cirurgia , Tomografia Computadorizada por Raios X/métodos , Cirurgia Assistida por Computador/métodos , Reconstrução Mandibular/métodos , FíbulaRESUMO
Background: Approximately 20% of adults in Vietnam have hypertension, and management of this chronic condition remains challenging. This study aimed to assess the effectiveness of a multicomponent intervention in reducing blood pressure (BP) in adults with uncontrolled hypertension. Methods: This cluster randomised controlled trial was conducted in sixteen communities (8 intervention and 8 comparison) in a rural setting in Vietnam (2017-2022). Consenting adults (aged ≥ 18 years) with uncontrolled hypertension were enrolled. Sixteen communities were equally randomised to an intervention or comparison group stratified by district. Consenting adults were assigned to study groups by community. The comparison arm received training sessions about hypertension prevention and management for health workers, and patient education materials. The intervention arm received training sessions about hypertension prevention and management for health workers, and patient education materials and three enhancement components including a storytelling intervention, home BP self-monitoring, and expanded community health worker services. The primary outcome was the difference in changes in patient's levels of systolic BP between the study groups over a 12-month follow-up period. Patients and outcome assessors were masked. Findings: A total of 671 patients (340: intervention, 331: comparison) were enrolled in the trial. The mean age was 66 years and 45% were men. At the 12-month follow-up, the mean systolic BP declined by 18.4 mmHg in the intervention group and 3.7 mmHg in the comparison group (differential decline of 14.7 mmHg [95% CI: 11.8-17.6]). The intervention group also achieved better BP control and medication adherence than the comparison group. There were no serious adverse events related to study participation. Interpretation: The results of this trial demonstrate that a multicomponent intervention can effectively reduce elevated BP in individuals with uncontrolled hypertension in Vietnam. Trial registration: This trial was registered at ClinicalTrials.gov, NCT03590691. Funding: National Heart, Lung, and Blood Institute.
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BACKGROUND: Mental health issues among retirees have become increasingly concerning because the aging population presents a significant challenge globally, particularly in Western countries. Previous studies on this issue are plagued with bias owing to lacking panel data and estimation strategies. This study investigated the depression levels of European adults around the time of retirement. METHODS: We used data obtained from Waves 1-7 of the Survey of Health, Ageing, and Retirement in Europe (SHARE) to create panel data covering the 2004-2017 period. Wave 3 (SHARELIFE) was excluded from the sample because it provided mismatched information. Fixed-effects (FE) and fixed-effects instrumental variables (FE-IV) models with multiple imputations were employed to examine the impacts of retirement on mental health before and after retirement, where being over pension age (normal and early) was used as the instrument variable. RESULTS: Our results indicated that retirement based on aspirational motivations (ß = - 0.115, p < 0.001) and positive circumstances (ß = - 0.038, p < 0.001) significantly reduced depression, whereas retiring under negative circumstances could deteriorate one's mental health (ß = 0.087, p < 0.001). FE and FE-IV models indicated that overall, retiring reduced retirees' depression (ß = - 0.096, p < 0.001 and ß = - 0.261, p < 0.001, respectively). The results of FE-IV models showed that adults planning to retire in the next two years experienced less depression compared with others in the workforce (λ = - 0.313, p < 0.01). These adults must have adjusted their lifestyles in response to their impending retirement, thereby evincing Ashenfelter's dip. Two years after retirement, when the "honeymoon" phase was over, retirees may have completely adapted to their new lives and the effect of retirement was no longer important. CONCLUSIONS: Retirement improves mental health before it happens, but not after. Increasing the pension eligibility age may postpone the beneficial effects of retirement on health. However, policy implications should be tailored according to the unique situations of each country, job sector, and population. Providing flexible schemes regarding retirement timing decisions would be better than a generalized retirement policy.
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Saúde Mental , Aposentadoria , Adulto , Humanos , Idoso , Envelhecimento , Pensões , Definição da ElegibilidadeRESUMO
Background: Many non-invasive methods have been studied for assessing the severity of fatty liver disease and carotid intima-media thickness (CIMT). However, the correlation between hepatic steatosis and CIMT has not been fully studied, either globally or in Vietnam. This study investigated the association between nonalcoholic fatty liver disease (NAFLD) and CIMT. Methods: A cross-sectional study was performed on 125 patients at the Cardiology Department, the Emergency Interventional Cardiology Department, and the Internal Cardiology Clinic of Thong Nhat Hospital. Results: Among the 125 patients in our study population, NAFLD was diagnosed in 56%, and the mean CIMT was 0.89 ± 0.48 mm. Normal CIMT was measured in 21% of patients, whereas 79% had an elevated CIMT. The NAFLD rates were significantly different between patients with normal and increased CIMT, at 26.9% and 69.6%, respectively (p = 0.001). Conclusions: Our study revealed a strong association between NAFLD and CIMT. NAFLD is currently considered a feature of metabolic syndrome, and an increase in the prevalence of NAFLD might result in an increase in the incidence of cardiovascular disease.
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Espessura Intima-Media Carotídea , Síndrome Metabólica , Hepatopatia Gordurosa não Alcoólica , Humanos , Estudos Transversais , Síndrome Metabólica/complicações , Síndrome Metabólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/diagnóstico por imagem , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Fatores de RiscoRESUMO
Sexually transmitted diseases are major causes of infertility, ectopic pregnancy, and premature birth. Here, we developed a new multiplex real-time polymerase chain reaction (PCR) assay for the simultaneous detection of nine major sexually transmitted infections (STIs) found in Vietnamese women, including Chlamydia trachomatis, Neisseria gonorrhoeae, Gardnerella vaginalis, Trichomonas vaginalis, Candida albicans, Mycoplasma hominis, Mycoplasma genitalium, and human alphaherpesviruses 1 and 2. A panel containing three tubes × three pathogens/tube was predesigned based on double-quenched TaqMan probes to increase detection sensitivity. There was no cross-reactivity among the nine STIs and other non-targeted microorganisms. Depending on each pathogen, the agreement with commercial kits, sensitivity, specificity, repeatability and reproducibility coefficient of variation (CV), and limit of detection of the developed real-time PCR assay were 99.0%-100%, 92.9%-100%, 100%, <3%, and 8-58 copies/reaction, respectively. One assay cost only 2.34 USD. Application of the assay for the detection of the nine STIs in 535 vaginal swab samples collected from women in Vietnam yielded 532 positive cases (99.44%). Among the positive samples, 37.76% had one pathogen, with G. vaginalis (33.83%) as the most prevalent; 46.36% had two pathogens, with G. vaginalis + C. albicans as the most prevalent combination (38.13%); and 11.78%, 2.99%, and 0.56% had three, four, and five pathogens, respectively. In conclusion, the developed assay represents a sensitive and cost-effective molecular diagnostic tool for the detection of major STIs in Vietnam and is a model for the development of panel detections of common STIs in other countries.
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Infecções Sexualmente Transmissíveis , Trichomonas vaginalis , Gravidez , Humanos , Feminino , Reação em Cadeia da Polimerase em Tempo Real , Reprodutibilidade dos Testes , Infecções Sexualmente Transmissíveis/diagnóstico , Infecções Sexualmente Transmissíveis/epidemiologia , Chlamydia trachomatis , Trichomonas vaginalis/genéticaRESUMO
Background: Various non-invasive methods have been studied for assessing the severity of fatty liver disease and coronary atherosclero-sis. However, the correlation between hepatic steatosis and coronary atherosclerosis has not been fully studied, either globally or specifically in Vietnam. This study investigated the association between nonalcoholic fatty liver disease (NAFLD) and coronary atherosclerosis using coronary computed tomography angiography (CCTA). Methods: An analytical cross-sectional study was performed, including 223 patients treated by the Cardiology Department, the Emergency Interventional Cardiology Departments, and the Internal Cardiology Clinic of Thong Nhat Hospital. Results: In our cohort of 223 patients, the NAFLD was detected in 66% of the population, the mean coronary artery stenosis (CAS) was 44.54% ± 20.23%, and the mean coronary artery calcium score (CACS) was 3569.05 ± 425.99, as assessed using the Agatston method. The proportion of patients with significant atherosclerotic plaque (CAS 50%) >was 32%, whereas the remaining 68% had insignificant stenosis. Among our study population, 16% had no coronary artery calcification, 38% had mild calcification, and 46% had moderate to severe calcification. In the group of NAFLD patients, 33.3% had significant atherosclerotic plaque, which was not significantly different from the rate in individuals without NAFLD (p = 0.51). Mild coronary artery calcification was detected in 37.4% of NAFLD patients, and moderate to severe calcification was detected in 48.3% (p = 0.45). Conclusions: NAFLD was not found to be strongly associated with coronary atherosclerosis in this study. More studies with larger sample sizes remain necessary to verify whether any correlation exists.
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Doença da Artéria Coronariana , Hepatopatia Gordurosa não Alcoólica , Placa Aterosclerótica , Humanos , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/epidemiologia , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/diagnóstico por imagem , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Placa Aterosclerótica/complicações , Placa Aterosclerótica/epidemiologia , Estudos Transversais , Tomografia Computadorizada por Raios X , Angiografia Coronária/métodos , Fatores de RiscoRESUMO
Neurocysticercosis (NCC) is a parasitic infection of the nervous system and is responsible for considerable morbidity and mortality. Praziquantel (PZQ) is one of the antiparasitics mostly used in managing NCC, however, there have been only a few studies on the treatment outcome of this drug. The present study aimed to evaluate the efficacy and safety of PZQ in patients with NCC. Sixty patients with typical characteristics of NCC received three 10-day cycles of PZQ and the interruption between these cycles was 10 days. Additional treatment included antiinflammation (steroids), antiepileptics and analgesics. Clinical and imaging studies were done at baseline and six months after therapy to assess the efficacy of treatment. Laboratory evaluation was done before and after each cycle to investigate laboratory safety profiles. By six months after finishing therapy, all patients had clinical improvement and 75% of them were free of symptoms. The rates of complete, partial or no resolution of cysts on brain magnetic resonance imaging were 61.7%, 28.3% and 10% respectively. The efficacy of therapy was not associated with the number of cysts. There was no difference between the levels of aspartate aminotransferase, alanine aminotransferase, urea and creatinine before and after treatment. Conclusion: Praziquantel is effective and safe in the treatment of patients with neurocysticercosis.
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Anti-Helmínticos , Cistos , Neurocisticercose , Alanina Transaminase , Albendazol/efeitos adversos , Anti-Helmínticos/efeitos adversos , Anticonvulsivantes/uso terapêutico , Antiparasitários/uso terapêutico , Aspartato Aminotransferases , Creatinina/uso terapêutico , Cistos/induzido quimicamente , Cistos/complicações , Cistos/tratamento farmacológico , Humanos , Neurocisticercose/complicações , Neurocisticercose/tratamento farmacológico , Neurocisticercose/parasitologia , Praziquantel/efeitos adversos , Esteroides/uso terapêutico , Ureia/uso terapêutico , VietnãRESUMO
BACKGROUND: Cosmetics manufacturers are focused on cosmetic delivery systems into the skin, but the level of diffusion of the systems in the skin tissues is not well understood. The current methods, such as Franz diffusion, assess analyte diffusion in the whole skin or artificial membranes, which has limitations for understanding skin delivery systems. AIMS: Our study aimed to create a transdermal delivery method which is based on dermal-epidermal separation of human skin, allowing us to assess each layer of skin separately for its efficacy. MATERIALS AND METHODS: During the experiment, resveratrol was used as the target analyte by applying it to the skin and then separating it into dermis and epidermis. Each layer is treated individually and subjected to a high-resolution mass spectrometry analysis to detect resveratrol levels. As a result, the efficiency of resveratrol diffusion in the dermal and epidermal layers of the skin can be evaluated. RESULTS: We found that resveratrol was detected in both the dermal and epidermal layers using our method. CONCLUSIONS: Hence, we developed a sensitive method for transdermal delivery testing that can be used to evaluate skin delivery systems for cosmetic or pharmaceutical purposes.
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Cosméticos , Absorção Cutânea , Humanos , Resveratrol , Pele/metabolismo , Administração Cutânea , Espectrometria de MassasRESUMO
Optical nanostructures have enabled the creation of subdiffraction detection volumes for single-molecule fluorescence microscopy. Their applicability is extended by the ability to place molecules in the confined observation volume without interfering with their biological function. Here, we demonstrate that processive DNA synthesis thousands of bases in length was carried out by individual DNA polymerase molecules immobilized in the observation volumes of zero-mode waveguides (ZMWs) in high-density arrays. Selective immobilization of polymerase to the fused silica floor of the ZMW was achieved by passivation of the metal cladding surface using polyphosphonate chemistry, producing enzyme density contrasts of glass over aluminum in excess of 400:1. Yields of single-molecule occupancies of approximately 30% were obtained for a range of ZMW diameters (70-100 nm). Results presented here support the application of immobilized single DNA polymerases in ZMW arrays for long-read-length DNA sequencing.
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Alumínio , RNA Polimerases Dirigidas por DNA/química , Enzimas Imobilizadas/química , Nanoestruturas/química , Óptica e Fotônica , Análise Serial de Proteínas/instrumentação , Análise Serial de Proteínas/métodos , DNA Circular/química , RNA Polimerases Dirigidas por DNA/isolamento & purificação , Vidro , Microscopia de Fluorescência/instrumentação , Microscopia de Fluorescência/métodos , Organofosfonatos/química , Polivinil/química , Propriedades de Superfície , Moldes GenéticosRESUMO
OBJECTIVE/BACKGROUND: Patients with immune thrombocytopenic purpura (ITP) often present with a severe reduction in platelet counts and suffer from an increased risk of bleeding. However, platelet counts do not accurately predict bleeding risk in these patients. METHODS: We thereby conducted a case series prospective study to compare the ability to predict hemorrhage in ITP patients between platelet counts and various rotational thromboelastometry (ROTEM) parameters. RESULTS: The inclusion criteria for patients diagnosed with acute, persistent, and chronic ITP were platelet counts of <30â¯×â¯109/L and no clinically significant bleeding (gradeâ¯≥â¯2 according to the WHO Bleeding Scale) at the beginning of the study. After 24 hours of follow-up, of the 45 enrolled patients, 14 (31.1%) experienced clinically significant bleeding. The mean platelet counts of patients with and without clinically significant bleeding were not statistically different (pâ¯=â¯.09). However, the mean EXTEM maximum clot firmness (MCF), EXTEM A10, EXTEM area under the curve (AUC), and platelet maximum clot elasticity (MCE) values of the two groups were statistically different (pâ¯<â¯.05). There was also a significant difference in IPF values between these two groups (pâ¯<â¯.05.) CONCLUSION: Results obtained from this preliminary study demonstrate that ROTEM parameters might be useful in predicting factors for hemorrhage in ITP patients. Future studies with a larger sample size is warranted to confirm our findings, which will allow prompt and effective bleeding management in ITP patients.
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Hemorragia , Púrpura Trombocitopênica Idiopática , Tromboelastografia , Adulto , Estudos Transversais , Feminino , Hemorragia/sangue , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Púrpura Trombocitopênica Idiopática/sangue , Púrpura Trombocitopênica Idiopática/complicaçõesRESUMO
BACKGROUND AND AIMS: ROTAVIN-M1® (licensed, frozen vaccine) and ROTAVIN (second-generation, liquid candidate vaccine) are two rotavirus vaccine formulations developed from a live attenuated G1P8 (KH0118) strain by Center for Research and Production of Vaccines and Biologicals (POLYVAC), Vietnam. This study compared the safety and immunogenicity of these two formulations. METHODS: A Phase 3, randomized, partially double-blinded, active-controlled study was conducted in healthy infants aged 60-91 days in Vietnam. Infants received two doses of ROTAVIN or ROTAVIN-M1 in a ratio of 2:1 with an interval of 8 weeks. Solicited reactions were collected for 7 days after each vaccination. Blood samples were collected pre-vaccination and 4 weeks after the second vaccination in a subset of infants. Non-inferiority criteria required that the lower bound of 95% confidence intervals (CIs) of the post-vaccination anti-rotavirus IgA GMC (Geometric Mean Concentration) ratio of ROTAVIN/ROTAVIN-M1 should be >0.5. A co-primary objective was to compare the safety of the two vaccines in terms of solicited reactions. RESULTS: A total of 825 infants were enrolled. The post-vaccination GMC was 48.25 (95% CI: 40.59, 57.37) in the ROTAVIN group and 35.04 (95% CI: 27.34, 44.91) in the ROTAVIN-M1 group with an IgA GMC ratio of 1.38 (95% CI: 1.02, 1.86) thus meeting the pre-set criteria for non-inferiority. A total of 605 solicited reactions were reported in 297 (36.0%) participants with 35.4% in the ROTAVIN group and 37.2% in the ROTAVIN-M1 group. There were no cases of intussusception or death reported in the study. CONCLUSIONS: Based on the data generated, it can be concluded that ROTAVIN is immunologically non-inferior and has similar safety profile to ROTAVIN-M1 when administered to infants in a two-dose schedule. Therefore, it can be considered as a more suitable option for programmatic use to prevent rotavirus diarrhoea in Vietnam and the Mekong region. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT03703336, October 11, 2018.
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Infecções por Rotavirus , Vacinas contra Rotavirus , Rotavirus , Anticorpos Antivirais , Povo Asiático , Humanos , Imunogenicidade da Vacina , Lactente , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/efeitos adversos , Vacinas Atenuadas/efeitos adversos , VietnãRESUMO
BACKGROUND: The COVID-19 pandemic has had a profound worldwide impact. Vietnam, a lower middle-income country with limited resources, has successfully slowed this pandemic. The objectives of this report are to explore the impact of the COVID-19 pandemic on the research activities of an ongoing hypertension trial using a storytelling intervention in Vietnam. METHODS: Data were collected in a mixed-methods study among 86 patients and 10 health care workers participating in a clinical trial designed to improve hypertension control. Several questions related to the impact of COVID-19 on patient's daily activities and adherence to the study interventions were included in the follow-up visits. A focus group discussion was conducted among health care workers to discuss the impact of COVID-19 on research related activities. RESULTS: Fewer patients in the intervention group reported that they faced difficulties in adhering to prescribed study interventions, wanted to receive a call from a dedicated hotline, or have a visit from a community health worker as compared with those in the comparison group. Most study patients are willing to participate in future health research studies. When asked about the potential use of mobile phones in health research studies, fewer patients in the intervention group felt comfortable using a mobile phone for the delivery of intervention and interviews compared with those in the comparison condition. Community health workers shared that they visited patient's homes more often than previously due to the pandemic and health care workers had to perform more virus containment activities without a corresponding increase in ancillary staff. CONCLUSIONS: Both patients and health care workers in Vietnam faced difficulties in adhering to recommended trial interventions and procedures. Multiple approaches for intervention delivery and data collection are needed to overcome these difficulties during future health crises and enhance the implementation of future research studies. TRIAL REGISTRATION: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).
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COVID-19/epidemiologia , Serviços de Laboratório Clínico/normas , Ensaios Clínicos como Assunto , Pessoal de Laboratório Médico/psicologia , Pacientes/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Serviços de Laboratório Clínico/estatística & dados numéricos , Feminino , Humanos , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente , VietnãRESUMO
BACKGROUND: Keloid scar is a fibroproliferative disorder characterized by increased deposition of extracellular matrix components. Hepatocyte growth factor (HGF), also known as the "scatter factor," and its receptor, a product of the Met oncogene, play multiple roles in regulating cell behavior. However, the role of this system in pathogenic fibrosis is still unclear. Our aim was to investigate and to clarify the role of HGF and its receptor c-Met in pathogenesis of keloid scars. METHODS: This study investigated the expression profile of HGF and c-Met in keloid and normal skin tissue. In addition, the role of normal and keloid keratinocytes in modulating the expression of fibroblast HGF (epithelial-mesenchymal interactions) was examined using a two-chamber serum-free coculture model. The effect of serum stimulation on fibroblast expression of HGF and c-Met was also studied. RESULTS: Increased levels of HGF and c-Met were observed in tissue extracts obtained from keloid tissue. Increased levels of HGF and c-Met localization were observed in the basal epidermis and in the dermis of keloid tissue compared with normal skin. Serum stimulation seemed to upregulate the expression of both HGF and c-Met in fibroblasts. Finally, coculture of keloid keratinocytes with keloid fibroblasts upregulated levels of both HGF and c-Met in keratinocyte cell lysates and conditioned media obtained from fibroblast culture. CONCLUSIONS: These findings emphasize the importance of the HGF/c-Met system in keloid biology and pathogenesis and suggest a possible target for therapeutic intervention in the prevention and treatment of keloids.
Assuntos
Fator de Crescimento de Hepatócito/metabolismo , Queloide/metabolismo , Proteínas Proto-Oncogênicas c-met/metabolismo , Análise de Variância , Western Blotting , Células Cultivadas , Fibroblastos/metabolismo , Humanos , Técnicas Imunoenzimáticas , Peptídeos e Proteínas de Sinalização Intercelular/sangue , Queloide/patologia , Queratinócitos/metabolismo , Regulação para CimaRESUMO
BACKGROUND: Growth factors and cytokines involved in the wound healing process seem to be immobilized at the cell surface and extracellular matrix via binding with proteoglycans, making them important modulators of cell dynamics. Our aim was to investigate the expression of two proteoglycans, namely syndecan-2 and decorin, and to elucidate their role in the pathogenesis of an aberrant wound healing process leading to keloid scar. METHODS: Intrinsic expression of syndecan-2, fibroblast growth factor (FGF)-2, and decorin in keloid tissue was investigated using Western blotting and immunohistochemistry. Normal and keloid fibroblasts were treated with serum to see the effects of serum growth factors on the expression of syndecan-2 and decorin. The role of epithelial-mesenchymal interactions in modulating syndecan-2, FGF-2, and decorin expression was investigated using an established two-chamber serum-free coculture model. Finally, the antifibrotic effect of decorin was investigated by studying its effect on the expression of extracellular matrix components. RESULTS: Syndecan-2 and FGF-2 were upregulated in keloid tissue; decorin was downregulated. Normal and keloid fibroblasts treated with serum led to increase in syndecan-2 and decrease in decorin expression. Under coculture conditions, syndecan-2 was shed in the conditioned media. FGF-2 was also upregulated under coculture conditions and, when added to fibroblast monocultures, increased shedding of syndecan-2. Decorin levels were upregulated under coculture conditions only in normal cocultures. Decorin was also able to decrease extracellular matrix proteins, highlighting its importance as an antifibrotic agent. CONCLUSION: Syndecan-2 and FGF-2 are not only overexpressed in keloid tissues but may interact with each other resulting in the shedding of syndecan-2, which in turn might activate a whole cascade of events responsible for a keloidic phenotype. In addition, decorin had an antifibrotic effect and could well be used as a potential therapeutic agent for keloids.
Assuntos
Proteínas da Matriz Extracelular/metabolismo , Queloide/metabolismo , Proteoglicanas/metabolismo , Sindecana-2/metabolismo , Análise de Variância , Western Blotting , Técnicas de Cocultura , Decorina , Regulação para Baixo , Matriz Extracelular/metabolismo , Fator 2 de Crescimento de Fibroblastos/metabolismo , Fibroblastos/metabolismo , Humanos , Técnicas Imunoenzimáticas , Queratinócitos/metabolismo , Fenótipo , Regulação para CimaRESUMO
BACKGROUND: Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster randomized trial design. METHODS: Sixteen communities will be randomized to either an intervention (8 communities) or a comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services, (2) home BP self-monitoring, and (3) a "storytelling intervention," which consists of interactive, literacy-appropriate, and culturally sensitive multi-media storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well. DISCUSSION: Results from this full-scale trial will provide health policymakers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam. TRIAL REGISTRATION: ClinicalTrials.gov NCT03590691 . Registered on July 17, 2018. Protocol version: 6. Date: August 15, 2019.