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Processo de regulamentação de dispositivos médicos no brasil: da anvisa até o consumidor final
(Universidade Federal de São Carlos, 2024-08-02) Porto, Ingrid Graziele Carvalho; Cunha, Daniel; Backes, Eduardo Henrique; lattes.cnpq.br/6407713491620749
The medical device market in Brazil is constantly growing, highlighting the need to prove the efficacy and safety of these products, both nationally and internationally. Regulatory agencies, such as the National Health Surveillance Agency (ANVISA), are responsible for protecting the health of the population, ensuring this protection through the inspection of the production and sale of medical devices. The process of regularizing these devices is based on a set of legal instruments, including regulations, resolutions, and standards. In addition, companies that wish to manufacture these devices must obtain certifications and licenses. This study aims to analyze the Brazilian regulatory system for medical devices under the jurisdiction of ANVISA. The guidelines established by the regulatory agency and the stages of the regulatory process, from registration to post-registration, were addressed. In addition, an illustrative case study was presented, applying the topics discussed. Throughout the study, it was possible to observe that commercializing devices in Brazil is still complex and time-consuming, despite efforts to reduce the time through new regulations. This can discourage entrepreneurs and limit innovation in the medical sector, making it difficult for Brazilian patients to access new technologies and treatments. Therefore, it is important to seek solutions that streamline and simplify this process, creating a more favorable environment for developing and improving medical advances in the country without compromising the efficacy and safety of the products sold.
Efeito da administração de melatonina na recuperação metabólica após exercício de natação em ratos
(Universidade Federal de São Carlos, 2024-08-02) Cipriano, Alinson Eduardo; Beck, Wladimir Rafael; https://lattes.cnpq.br/3124811889307056; https://orcid.org/0000-0001-7176-2713; https://lattes.cnpq.br/1595337567309735; https://orcid.org/0000-0003-1970-5492
Melatonin has the potential to act in the recovery process after physical exercise, however, there are no studies on the effects of this compound on energy metabolism and tissue damage after isoload exercise. In isoload exercise, animals are subjected to the same workload in all exercise sessions, ensuring greater uniformity in the physical stimuli applied. This study aimed to evaluate how melatonin administration after isoload exercise impacts energy metabolism and markers of tissue damage. Sixty Wistar animals were subjected to a 60 min swimming exercise at 90% of their maximum aerobic capacity (iMAC), followed by intraperitoneal administration of melatonin (EM; 10 mg.kg-1) or control (Ex) of the same volume and components, except melatonin, and after that, the animals were euthanized 1, 3 or 24 hours. Blood was collected to analyze the concentration of lactate dehydrogenase, creatine kinase, glucose and triglycerides; skeletal muscle tissue (white and red gastrocnemius, and gluteus maximus) and liver for quantification of glycogen content; (soleus, white and red gastrocnemius, and gluteus maximus) and liver for quantification of triglyceride content; skeletal muscle tissue (gluteus maximus) and liver for quantification of the pool of amino acids and acylcarnitines. Tissue samples were extracted and had their amino acid and acylcarnitine profiles determined using flow injection analysis (FIA) coupled to targeted mass spectrometry (MS). Data were presented as mean ± standard deviation of the mean, submitted to the Two-way ANOVA test and Newman-Keuls post hoc was used to analyze the effects of melatonin (two levels) and the effect of time (three levels). Effect size analysis and confidence interval were used as complementary tests. A significance level of 5% was adopted for all analyses, performed using Statistics 7.0 software (StatSoft, Inc.; Tulsa, OK, United States). The results were divided into two chapters. In chapter 1, animals treated with melatonin did not show any significant results in the hepatic amino acid pool, but in skeletal muscle, melatonin increased the pool of amino acids such as arginine (F = 13.27; p = 0.001), glutamic acid (F = 5.92; p = 0.023), citrulline (F = 10.72; p = 0.003), glutamine (F = 8.15; p = 0.009), ornithine (F = 4.88; p = 0.037), proline (F = 15.13; p = 0.001) and serine (F = 7.23; p = 0.013) in relation to the control. Melatonin also increased the glycine pool 3 hours post exercise compared to the control group (EM3>Ex3; p = 0.034) and reduced the methionine pool 24 hours post exercise compared to the control group (EM24
Híbridos e espécies de pínus com potencial para produção de madeira e resina
(Universidade Federal de São Carlos, 2024-08-02) Menucelli, João Roberto; Aguiar, Ananda Virginia de; https://lattes.cnpq.br/5613653432409380; https://orcid.org/0000-0003-1225-7623; Longui, Eduardo Luiz; https://lattes.cnpq.br/9268347207438461; https://orcid.org/0000-0002-7610-9147; https://lattes.cnpq.br/5403540727952711; https://orcid.org/0000-0002-5615-6448
This study aimed to evaluate the potential of pine species and interspecific hybrids for wood and resin production. In 2013, a test of hybrids and pure pine species was implemented in the Pederneiras State Forest. The species used were: P. elliottii var. elliottii, P. caribaea var. hondurensis, P. caribaea var. bahamensis. The hybrids were: P. elliottii var. elliottii x P. caribaea var. hondurensis and P. elliottii var. elliottii x P. caribaea var. bahamensis. A randomized complete block experimental design was adopted with five treatments, three blocks of each treatment with 189 seedlings, for a total of 567 per treatment. The spacing used was 3.5 x 3.0 meters. At six years of age, the following traits were measured: diameter at breast height (DBH-cm) and total height (H-m), and individual volume (VOL-m³/arv). At seven years of age, the resin flow potential (RSN-g) was measured through microresination. The descriptive analysis was performed using the SELEGEN software. The analysis of variance was performed according to the REML/BLUP procedure in the R software. A significant difference at the 1% level was detected between treatments, only for height and DBH. The mean values (minimum to maximum) for height, DBH and resin flow were: 8 m (2 to 15.70 m), 13 cm (0.95 to 26.42 cm) and 0.50 g, (0.01 to 17.01 g), respectively. The correlations between the growth traits were high and significant, and for resin flow they were low and not significant. The observed phenotypic variation indicates that the hybrid between P. elliottii var. elliottii x P. caribaea var. bahamensis presented the best results and could generate significant gains for wood and resin production through the selection of individuals to compose commercial populations or pine genetic improvement trials.
Impacto da disseminação da informação sobre o Transtorno Do Espectro Autista: estudo misto exploratório
(Universidade Federal de São Carlos, 2024-08-02) Ramirez, César Antonio Fabián; Galvão, Maria Cristiane Barbosa; https://lattes.cnpq.br/9163421021115381; https://orcid.org/0000-0003-3971-5743; https://lattes.cnpq.br/7384265675189704; https://orcid.org/0009-0009-6448-9187
Autism spectrum disorder, also known by its abbreviation ASD, is a condition characterized by persistent deficits in two major areas: 1) social communication and social interaction; and 2) restricted and repetitive patterns of behavior, interests, and activities. This study evaluated the impact of disseminating information about autism to family members and caregivers of autistic children. This research was configured as a longitudinal exploratory mixed study (qualitative followed by quantitative). This type of research is focused on the emergence of new ideas and analysis of contexts so that the researcher has greater proximity to the subject. In the qualitative stage, the informational demands of the population on autism spectrum disorder were mapped in two scenarios, one in the Southeast and the other in the North region of Brazil. At this stage, it was observed that the main informational demands of the population about autism spectrum disorder are: family support, self-realization, characteristics of autism spectrum disorder, diagnosis, self-care features, affective features, cognitive features, communicational features, occupational features, origin of autism spectrum disorder, prejudice, treatment and cure. In the quantitative stage, eight informational contents were disseminated to 73 participants, caregivers of autistic children during the psychological consultation, in 2024, in the Northern Region of Brazil. In the dissemination process, the companions evaluated each of the contents, totaling 584 evaluations regarding the eight informational contents disseminated. Among the most significant findings, it is worth highlighting that the study participants claim that the information disseminated taught them something new (319, 54.6%), encouraged them to learn more about the subject (251, 43.0%), helped them to better understand autism (435, 74.6%) and prepared them to discuss autism with other people (361, 61.9%). As a contribution to the field of Information Science, knowledge was explained and systematized that can guide institutions, services and information systems that prioritize the care of the community involved with autism spectrum disorder.
Sapatonices em foco: explorando narrativas sapatonas em curtas-metragens brasileiros
(Universidade Federal de São Carlos, 2024-08-02) Santos, Jaqueline Aparecida dos; Saraiva, Leandro Rocha; https://lattes.cnpq.br/9499533247209958; https://lattes.cnpq.br/0812471355868954
This dissertation analyzes contemporary Brazilian short films whose narrative focus is on lesbian and slut experiences. The research investigates how cinematographic forms are appropriated for the production of slutty subjectivities and the creation of audiovisual content that addresses these themes, breaking with classic and cisheteronormative standards. This is based on an investigation of the narrative forms that develop in relation to the regime of visualities and the constitution of their own images, which escape the policies of control and surveillance of bodies. In this context, bodies are used as tools for documenting and affirming existence. This work is based on comparative analyses of short films, highlighting the creation of new limits of representation that reinforce deviant practices based on a policy of affirming differences, disorganizing cisheterosexual institutions on screen.
A língua na tela: descrição e análise da variação do objeto direto anafórico de terceira pessoa em legendas profissionais e fansubs
(Universidade Federal de São Carlos, 2024-08-02) Azevedo, Lívia Oliveira; Biazolli, Caroline Carnielli; https://lattes.cnpq.br/7908630593356660; https://orcid.org/0000-0002-8578-8102; https://lattes.cnpq.br/8184443512616074; https://orcid.org/0009-0001-3137-4991
Assuming that an examination of the intersections between linguistic variation and genres is not only desirable but essential to understand variation (Vieira; Lima, 2019; Biazolli; Berlinck, 2021; Lima, 2022; Vieira, in progress), this study aims to (i) discuss how the realization of third-person anaphoric direct object occurs in a corpus of subtitles for the TV show Grey’s Anatomy and (ii) describe audiovisual subtitles as a genre. Based on the theoretical and methodological framework of the Theory of Variation and Linguistic Change (Weinreich; Labov; Herzog, 2006[1978]; Labov, 1982, 2001, 2003, 2008[1972]), the first step of the research was the compilation of the corpus of subtitles, which gathered two samples: one of professional subtitles extracted from the Amazon Prime Video streaming platform using a user script, and another of fan-made subtitles downloaded for free from the Legendas.TV website – the so-called fansubs. With this material, the characterization of the subtitles based on the concept of genre (Bakhtin, 2016[1979]; Marcuschi, 2005, 2008, 2010) began, considering structural characteristics discussed through the principles of Audiovisual Translation (Zabalbeascoa, 2008; Díaz-Cintas, 2010; Remael, 2010; Franco; Araújo, 2011), and situational characteristics, based on the proposal of Biber and Conrad (2009). Simultaneously, all occurrences of the phenomenon were collected, and the independent variables of the study were defined, considering both the literature on the phenomenon available (cf. Omena, 1978; Duarte; 1986; Cyrino, 1994; Marafoni, 2004; Freire, 2005; Santana, 2016; Lima, 2022, among others), and the specificities of the genre at focus. After each occurrence was encoded, the statistical analysis of the data was conducted using the R platform (R Core Team, 2023). As a general result, a prevalence of the accusative clitic was observed in the corpus, with this being the most used variant in all contexts, except in two: when referring to antecedents that were not animated and as complements of non-finite forms, both of which had the null object as the most productive strategy. The phenomenon was correlated not only to linguistic but also to extralinguistic variables, including genre-related ones such as number of characters per line and per second. Combining the results of the statistical analyses with a qualitative examination focused on the subtitles, it was concluded that the analyzed samples seem to be quite homogeneous, with little difference between professional subtitles and fansubs, which suggests that the different production contexts of these two types of subtitles do not have a relevant impact on the linguistic uses observed. Furthermore, the realization of the third-person anaphoric accusative seemed to occur in a particular way in subtitles, presenting strong connection with the structural and situational specificities of this genre.
A perspectiva de adolescentes sobre o cuidado da saúde mental e contribuições da Unidade Básica de Saúde (UBS)
(Universidade Federal de São Carlos, 2024-08-02) Arenhart, Isis Fernanda; Barbosa Neto, Jair Borges; https://lattes.cnpq.br/9551566039906499; https://orcid.org/0000-0003-3358-7613; https://lattes.cnpq.br/1049020377748899
The age period known as adolescence includes a wide range of experiences, depending on multiple factors such as the territory where one lives, income levels, race, ethnicity, gender, and more. Studies show that mental health problems such as depressive and anxious disorders, non-suicidal self-injury, self-harming behaviors, suicide ideation and attempts, and suicide itself have been increasing in this population. However, child and adolescent mental health policies are relatively recent. The Primary Health Care Service (Unidade Básica de Saúde - UBS), as a part of the Psychosocial Care Network, has the mission of promoting health and territorial care. This study aimed to identify the perspective of adolescents on mental health care and possible contributions of the UBS, to explore the strategies participants used for their own mental health care, to understand how they accessed mental health care activities at the UBS, and to identify their perspectives on the weaknesses and strengths of the UBS in providing this care. Eight adolescents aged 15 to 19 years (under 20), users of a UBS in a large municipality in the interior of São Paulo state, participated in the study. Semi-structured individual interviews were conducted with the adolescents, using a brief video as a prompt along with guiding questions. A report was created for each interview, sent to the respective participant for validation. The data were then fully transcribed, with participants anonymized using fictitious names, and underwent thematic analysis. The strategies for mental health care used by the participants involved talking about their feelings, psychological care at the UBS, engaging in pleasurable activities, and problem-solving and coping attitudes. Access to mental health care at the UBS was facilitated by the support of a responsible family member and/or referral from the school, with previous contact or connection with a UBS worker also serving as a facilitator. Participants identified several scientifically well-documented weaknesses in access to the UBS, including transportation difficulties, long waiting times for care, limited human resources, and concerns about privacy and confidentiality. They also mentioned a lack of information about the unit's offers and how to access them. Participants who accessed mental health care at the UBS had varied experiences with the unit's reception. Despite the waits, the free service was seen as a positive point, along with the existence of priority criteria for urgent situations and the non-judgmental attitude of the professionals. The study underscored the significance of developing mental health initiatives within the school environment. Access to community facilities (sports, leisure, and culture) was also pointed out as important for promoting mental health. The findings highlight the necessity for intersectoral collaboration, advocating for integrated service planning, as well as continuous training for health professionals and others who work with adolescents, especially those in education services, to be prepared to provide support on mental health issues.
Expressão, purificação e caracterização das luciferases de Cratomorphus distinctus (Lampyridae) e Euryopa clarindae (Phengodidae) e sondagem de suas aplicabilidades
(Universidade Federal de São Carlos, 2024-08-02) Benites, Gabrielle Rodrigues; Viviani, Vadim Ravara; https://lattes.cnpq.br/3942043373510668; https://orcid.org/0000-0001-5558-9199; https://lattes.cnpq.br/8331548591902783; https://orcid.org/0009-0003-0675-4225
Luciferases are the enzymes that catalyze the bioluminescence reaction in organisms such as beetles. Bioluminescence has been used for bioanalytical purposes for decades, including ATP detection assays, enzymatic assays, microbiological contamination of products in the food industry, as a reporter gene for pollutant biosensors, intracellular pH and heavy metal indicators, and bioimaging. Our research group has cloned the largest number and variety of beetle luciferases in the world, some already having bioanalytical applications, however there are still several luciferases and mutant forms with interesting properties that we have produced, but which have not yet been well characterized and applied. With the aim of expanding the range of applications, especially in biosensors for pH and potentially toxic metals, we carried out the characterization of the pH-sensitive luciferases from the lampyrid C. distinctus and the orange light-emitting luciferase from the phengodid E. clarindae. To achieve this, we subcloned the luciferase cDNA from C. distinctus and E. clarindae into a pCold vector, transformed E. coli BL21DE3 bacteria and expressed and purified the two luciferases by affinity chromatography on nickel-agarose resin. The tests showed that the C. distinctus luciferase has a high catalytic efficiency for ATP and lower for LH2, when compared to other lampyrid luciferases, in addition to having excellent sensitivity to pH and metals, especially mercury. The E. clarindae luciferase showed a high KM for LH2 and low for ATP, when compared to luciferases from other phengodids. Thus, C. distinctus luciferase has potential applicability as a mercury and pH sensor protein; while the insensitive luciferase from E. clarindae has potential as a reporter gene. Furthermore, the orange light-emitting luciferase from E. clarindae constitutes another important model to understand the structure x bioluminescence spectra relationship in coleopteran luciferases and the origin of the different bioluminescence colors.