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1.
Indian J Occup Environ Med ; 27(3): 197-204, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-38047175

RESUMEN

Introduction: Employees are placed in various job rotations between two or more tasks or vocations at regular intervals to ensure that they are exposed to all elements of the company. Job rotation is a methodical approach that permits employees to avoid boredom while also allowing them to develop and grow. Both management and personnel objectives are met with this strategy. It aids in the identification of employee potential and abilities. Through job rotation, employees are exposed to all aspects of the company. Employee abilities and competencies are evaluated ahead of time to ensure that the employee is deployed in the best possible position. However, it does permit the pursuit of personal interests while gaining practical knowledge in a variety of industries or processes. The present study was undertaken with an aim to assess the effect of job rotation on the nursing staff in a private hospital of Vadodara. Methodology: The study was cross-sectional in nature where the perception of the nursing staff was gathered through a structured questionnaire. The questionnaire assessed the perception of the staff on a five point likert scale from strongly agree to strongly disagree. The sample size of the study was 126. Mann Whitney Test and Kruskal Wallis test was used to assess the effect of job rotation with respect to gender and age, years of experience respectively. The statistical analysis was undertaken at 95% confidence level with statistical significance at a p value of less than 0.05. Results: The results depicted that there was no difference in the perception towards effect of job rotation with respect to gender and age group. However, with respect to job rotation not interrupting the employees' work life and no effect on personal life, there was statistical significant difference with respect to the years of experience of the nursing staff as the p value was less than 0.05. Conclusion: Job rotation, in their opinion, causes frequent interruptions in both the job and personal life of those who participate in it. The nurses working in the hospital came up with appropriate job rotation ideas that took into consideration their age and years of experience. It appears that most of the criteria indicate that the nursing staff members were satisfied with their job rotation, which lends support to the findings of the study.

2.
Biotechnol J ; 18(9): e2200599, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37218550

RESUMEN

The production of biopharmaceutical products carries an inherent risk of contamination by adventitious viruses. Historically, these manufacturing processes have incorporated a dedicated virus filtration step to ensure product safety. However, challenging process conditions can lead to passage of small viruses to the permeate pool and an overall decrease in the desired virus logarithmic reduction value (LRV) for the process. The implementation of serial virus filtration has improved the robustness of such processes, albeit concerns about increased operating times and process complexity have limited its implementation. This work focused on optimizing a serial filtration process and identifying process control strategies to provide maximum efficiency while ensuring proper controls for process complexity. Constant TMP was identified as the optimal control strategy, which combined with the optimal filter ratio, resulted in a robust and faster virus filtration process. To demonstrate this hypothesis, data with two filters connected in series (1:1 filter ratio) are presented for a representative non-fouling molecule. Similarly, for a fouling product, the optimal setup was a combination of a filter connected in series to two filters operated in parallel (2:1 filter ratio). The optimized filter ratios bring cost- and time-savings benefits to the virus filtration step, thereby offering improved productivity. The results of risk and cost analyses performed as part of this study combined with the control strategy, offer companies a toolbox of strategies to accommodate products with different filterability profiles in their downstream processes. This work demonstrates that the safety advantages of performing filters in series can be achieved with minimal increases in time, cost, and risk.


Asunto(s)
Productos Biológicos , Virus , Filtración/métodos
3.
J Indian Prosthodont Soc ; 22(2): 111-121, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36511022

RESUMEN

Aim: To compare marginal bone loss (MBL), implant survival rate and prosthetic complications of implant-supported splinted and non-splinted restorations (NSR). Settings and Design: This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines (PRISMA). The PROSPERO registry, which keeps track of prospective systematic reviews, also received this paper (CRD42021229477). Material and Methods: An electronic search was done in PubMed, the Cochrane Central Trials Register, Scopus, Science Direct, and Google Scholar searches were carried out. The search was limited to articles published in English and covered the period from January 2010 to August 2020. Statistical Analysis Used: To conduct the meta analysis, researchers employed methodologies such as continuous measurement and odds ratios. Results: For both qualitative and quantitative analysis, 19 scientific studies were chosen. 3682 implants were placed in 2099 patients with a mean age of 59 years (splinted, 2529; non-splinted, 1153); the mean age was not provided in 5 trials. For splinted restorations, there were statistically significant differences in MBL, indicating the former has less MBL than for NSR. Splinted restorations had much greater survival rates than NSR, according to a qualitative study. Rest prosthesis complications with or without splinting were essentially the same. Conclusions: Splinted implant restorations lost less bone than non-splinted implant restorations, according to this meta analysis. This was particularly true for posterior restorations. Lower implant failure was associated with splinted restorations. Restorations with and without splinting had the same level of prosthetic problems.


Asunto(s)
Pérdida de Hueso Alveolar , Implantes Dentales , Humanos , Persona de Mediana Edad , Prótesis Dental de Soporte Implantado/efectos adversos , Prótesis Dental de Soporte Implantado/métodos , Fracaso de la Restauración Dental , Implantes Dentales/efectos adversos , Pérdida de Hueso Alveolar/etiología , Estudios Prospectivos , Tasa de Supervivencia
4.
Biologicals ; 72: 27-32, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-34226123

RESUMEN

Virus removal filtration processes in biopharmaceutical manufacturing are developed, optimized and validated for viral clearance using laboratory scale filters. Thus, the scalability of these filters is critical for accurately extrapolating filtration performance and reliably extending viral clearance to manufacturing scale. Virus removal filter manufacturers generally validate scalability of filtration performance based on various filtration parameters, and virus removal capability is extended to manufacturing scale filters using inert, size-appropriate particles such as gold nanoparticles to avoid the risks associated with using mammalian viruses in large feed volumes. In this study, we use bacteriophage PP7 as a parvovirus model to directly demonstrate viral clearance on Planova™ BioEX virus removal filters across all scales, including manufacturing scale. Filters with hollow fibers from three spinning series with filter sizes ranging from 0.0003 to 4.0 m2 were tested for virus removal, flux, and protein recovery performance using BSA spiked with PP7. Complete viral clearance was observed across all filter sizes with PP7 LRV of ≥4.7 or higher. Flux and protein recovery were also consistent. These results demonstrate the scalability of filtration performance and consistent virus removal at all sizes, supporting the use of laboratory scale filters to validate viral clearance at manufacturing scales.


Asunto(s)
Bacteriófagos/aislamiento & purificación , Filtración/métodos , Nanopartículas del Metal , Parvovirus , Oro , Laboratorios , Parvovirus/aislamiento & purificación
5.
J Clin Endocrinol Metab ; 106(1): 108-119, 2021 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-32968804

RESUMEN

OBJECTIVE: To examine the effects of common treatments for polycystic ovary syndrome (PCOS) on a panel of hormones (reproductive/metabolic). DESIGN: Secondary analysis of blood from a randomized controlled trial of three 16-week preconception interventions designed to improve PCOS-related abnormalities: continuous oral contraceptive pills (OCPs, N = 34 subjects), intensive lifestyle modification (Lifestyle, N = 31), or a combination of both (Combined, N = 29). MATERIALS AND METHODS: Post-treatment levels of activin A and B, inhibin B, and follistatin (FST), as well as Insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 2 (IGFBP-2), glucagon, glucagon-like peptide 1 (GLP-1) and 2, and oxyntomodulin were compared to baseline, and the change from baseline in these parameters were correlated with outcomes. RESULTS: Oral contraceptive pill use was associated with a significant suppression in activin A, inhibin A, and anti-mullerian hormone (AMH), but a significant increase in FST. IGF-1, IGFBP-2, glucagon, and GLP-2 levels were significantly decreased. Oxyntomodulin was profoundly suppressed by OCPs (ratio of geometric means: 0.09, 95% confidence interval [CI]: 0.05, 0.18, P < 0.001). None of the analytes were significantly affected by Lifestyle, whereas the effects of Combined were similar to OCPs alone, although attenuated. Oxyntomodulin was significantly positively associated with the change in total ovarian volume (rs = 0.27; 95% CI: 0.03, 0.48; P = 0.03) and insulin sensitivity index (rs = 0.48; 95% CI: 0.27, 0.64; P < 0.001), and it was inversely correlated with change in area under the curve (AUC) glucose [rs = -0.38; 95% CI: -0.57, -0.16; P = 0.001]. None of the hormonal changes were associated with live birth, only Activin A was associated with ovulation (risk ratio per 1 ng/mL increase in change in Activin A: 6.0 [2.2, 16.2]; P < 0.001). CONCLUSIONS: In women with PCOS, OCPs (and not Lifestyle) affect a wide variety of reproductive/metabolic hormones, but their treatment response does not correlate with live birth.


Asunto(s)
Terapia Conductista , Anticonceptivos Orales/uso terapéutico , Hormonas/sangre , Síndrome del Ovario Poliquístico/terapia , Adolescente , Adulto , Terapia Conductista/métodos , Terapia Combinada , Anticonceptivos Orales/farmacología , Femenino , Humanos , Incretinas/sangre , Estilo de Vida , Obesidad/sangre , Obesidad/complicaciones , Obesidad/terapia , Síndrome del Ovario Poliquístico/sangre , Síndrome del Ovario Poliquístico/complicaciones , Estudios Retrospectivos , Factor de Crecimiento Transformador beta/sangre , Resultado del Tratamiento , Estados Unidos , Adulto Joven
6.
Biotechnol Prog ; 34(5): 1213-1220, 2018 09.
Artículo en Inglés | MEDLINE | ID: mdl-30194917

RESUMEN

Viruses can arise during the manufacture of biopharmaceuticals through contamination or endogenous expression of viral sequences. Regulatory agencies require "viral clearance" validation studies for each biopharmaceutical prior to approval. These studies aim to demonstrate the ability of the manufacturing process at removing or inactivating virus and are conducted by challenging scaled-down manufacturing steps with a "spike" of live virus. Due to the infectious nature of these live viruses, "spiking studies" are typically conducted in specialized biological safety level-2 facilities. The costs and logistics associated with these studies limit viral clearance analysis during process development and characterization. In this study, a noninfectious Minute Virus of Mice-Mock Virus Particle (MVM-MVP) was generated for use as an economical small virus spiking surrogate. An immunoglobin G containing solution was spiked with live MVM or MVM-MVP and processed through Planova nanofiltration units. Flux decay data was collected and particle reduction values were calculated from TCID50 and Immuno-qPCR analysis. The data indicated comparable filtration performance and particle reduction between infectious MVM and noninfectious surrogate, MVM-MVP. This proof of concept study suggests the feasibility of utilizing MVPs for predictive size-based viral clearance assessments during process development and characterization as an alternative to homologous infectious virus.


Asunto(s)
Ultrafiltración/métodos , Animales , Filtración/métodos , Ratones , Virus Diminuto del Ratón , Virión , Inactivación de Virus
7.
J Cardiothorac Surg ; 9: 55, 2014 Mar 21.
Artículo en Inglés | MEDLINE | ID: mdl-24656312

RESUMEN

BACKGROUND: Thrombotic events are a common complication of left ventricular assist device placement and warrant prophylactic anticoagulation. Heparin is the most common anticoagulant used for prophylaxis of thrombotic events in left ventricular assist device patients as a transition to oral anticoagulants but carries the risk of heparin-induced thrombocytopenia. Limited data is available for the treatment of heparin-induced thrombocytopenia in this patient population. We report an evaluation of 8 left ventricular assist device patients with suspected or confirmed HIT started on fondaparinux at the time of heparin-induced platelet-factor-4 antibody positivity. METHODS: Adult patients were reported if they were heparin-induced platelet antibody positive, tested via enzyme-linked immunusorbent assay, post-operative after left-ventricular assist device, and were initiated on fondaparinux at the time of heparin-induced platelet antibody positivity. Waiver of informed consent was granted from the institutional review board. Baseline demographics, clinical course of HIT, safety and efficacy variables were collected. RESULTS: Eight patients receiving fondaparinux were identified and included in this report. The patient group was on average 49 years old, weighing 95 kg, with calculated BMI 28.8 and consisted primarily of Caucasian males. Three patients developed new thromboses after initiation of fondaparinux for heparin-induced thrombocytopenia. Only one patient had a major bleeding event of an overt bleed after initiation of fondaparinux therapy. CONCLUSIONS: Given the lack of major bleeding in this evaluation, fondaparinux could be a potentially safe treatment option for left ventricular assist device patients that are heparin-induced platelet antibody positive pending confirmatory testing results. Given the development of new thromboses in 3 of 8 patients, concern exists about the efficacy of fondaparinux in this patient population. Significant limitations exist regarding these conclusions in this evaluation. Controlled, systematic evaluations are necessary to delineate safety and efficacy of fondaparinux for heparin-induced thrombocytopenia in this population.


Asunto(s)
Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Corazón Auxiliar , Heparina/efectos adversos , Polisacáridos/uso terapéutico , Trombocitopenia/inducido químicamente , Adulto , Femenino , Fondaparinux , Heparina/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Polisacáridos/efectos adversos , Estudios Retrospectivos
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