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1.
JAMA Netw Open ; 6(1): e2250996, 2023 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-36648945

RESUMO

Importance: Discontinuation and nonpublication are established sources of avoidable waste among surgical trials, but rates of delayed completion and recruiting shortfalls remain unclear. Objectives: To examine the rate of delayed completion, incomplete enrollment, and discontinuation among randomized clinical trials in surgical populations and the duration of delays and extent of recruiting shortfalls among these trials. Design, Setting, and Participants: This cross-sectional study examined randomized clinical trials in surgical populations registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2014. Analysis was conducted between October 27, 2021, and June 30, 2022. Main Outcomes and Measures: The main outcomes were the percentages of trials completed on time or with full enrollment. Delays and recruiting shortfalls were identified by comparing projected enrollment and study timeframes prespecified at the time of registration with the actual study duration and enrollment reported on completion or discontinuation. Absolute and relative differences between planned and actual trial conduct were presented for discontinued trials and those completed with delays or recruiting shortfalls. Results: In total, 2542 randomized clinical trials in surgical populations were included in the study sample, of which 370 (14.6%; 95% CI, 13.2%-15.9%) were completed both on time and with full enrollment. Approximately 1 in 5 trials (20.4%; 95% CI, 18.9%-22.0%) were completed within their planned timeframe, and 1166 trials (45.9%; 95% CI, 43.9%-47.8%) met their prespecified enrollment target. The median delay among completed trials was 12.2 months (IQR, 5.1-24.3 months) or 66.7% (IQR, 30.1%-135.8%) longer than planned. Among completed trials that did not meet their prespecified enrollment target, the median recruiting shortfall was equivalent to 31.0% (IQR, 12.7%-55.5%) of the planned study sample. A total of 546 trials (21.5%; 95% CI, 19.9%-23.1%) were discontinued. The median time to discontinuation was 26.4 months (IQR, 15.2-45.7 months), and the median recruiting shortfall among discontinued trials was equivalent to 92.7% (IQR, 65.0%-100.0%) of the trial's prespecified enrollment target. Conclusions and Relevance: This cross-sectional study found that delayed completion, recruiting shortfalls, and untimely discontinuation were common among surgical trials. These findings highlight the importance of ensuring that investigators and funders do not overestimate the feasibility of planned trials.


Assuntos
Pesquisadores , Humanos , Estudos Transversais , Ensaios Clínicos Controlados Aleatórios como Assunto , Sujeitos da Pesquisa
2.
BMC Med Ethics ; 24(1): 4, 2023 Jan 19.
Artigo em Inglês | MEDLINE | ID: mdl-36658544

RESUMO

BACKGROUND: Current advances in biomedical research have introduced new ethical challenges in obtaining informed consent in low and middle-income settings. For example, there are controversies about the use of broad consent in the collection of biological samples for use in future biomedical research. However, few studies have explored preferred informed consent models for future use of biological samples in Malawi and South Africa. Therefore, we conducted an empirical study to understand preferred consent models among key stakeholders in biomedical studies that involve collection of biological samples in Malawi and South Africa. The main objective of the study was to explore views of key stakeholders on current policies on informed consent in Malawi and South Africa. METHODS: This was a qualitative study involving in-depth interviews and focus group discussions. Thirty-four in-depth interviews and 6 focus group discussions were conducted with REC members, Funders, Policymakers, CAB members and Research Participants in Malawi and South Africa to gather their views on models of informed consent. The study was conducted in Cape Town, South Africa, and Blantyre and Lilongwe in Malawi. RESULTS: Most key stakeholders preferred broad consent and tiered consent to specific consent. Some participants expressed a strong preference for specific consent to other models of informed consent in biomedical research. Few participants did not have any preference for a consent model, opting for any consent model which provides adequate information about the proposed research and what their national consent regulations require. Finally, very few participants preferred blanket consent to other informed consent models. CONCLUSIONS: This study aimed to help fill the gap in the scientific literature on key stakeholder views on consent models for future use of biological samples in Malawi and South Africa. The findings of the study have provided some evidence that may support policies on permissible consent models for future use of biological samples in sub-Saharan Africa considering the differences in informed consent regulations and guidelines. Finally, the findings can inform ongoing discussions on permissible consent models to be used for future use of biological samples.


Assuntos
Pesquisa Biomédica , Sujeitos da Pesquisa , Humanos , África do Sul , Malaui , Consentimento Livre e Esclarecido , Pesquisa Qualitativa
3.
J Cereb Blood Flow Metab ; 43(1): 59-71, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36071616

RESUMO

During sleep, reduced brain energy demands provide an opportunity for biosynthetic processes like protein synthesis. Sleep is required for some forms of memory consolidation which requires de novo protein synthesis. We measured regional cerebral protein synthesis rates (rCPS) in human subjects to ascertain how rCPS is affected during sleep. Subjects underwent three consecutive L-[1-11C]leucine PET scans with simultaneous polysomnography: 1. rested awake, 2. sleep-deprived awake, 3. sleep. Measured rCPS were similar across the three conditions. Variations in sleep stage times during sleep scans were used to estimate rCPS in sleep stages under the assumption that measured rCPS is the weighted sum of rCPS in each stage, with weights reflecting time and availability of [11C]leucine in that stage. During sleep scans, subjects spent most of the time in N2, N3, and awake and very little time in N1 and REM; rCPS in N1 and REM could not be reliably estimated. When stages N1 and N2 were combined [N1,N2], estimates of rCPS were more robust. In selective regions, estimated rCPS were statistically significantly higher (30-39%) in [N1,N2] compared with N3; estimated rCPS in N3 were similar to values measured in sleep-deprived awake scans. Results indicate increased rates of protein synthesis linked to [N1,N2] sleep.


Assuntos
Sujeitos da Pesquisa , Sono , Humanos , Leucina , Encéfalo/diagnóstico por imagem , Tomografia por Emissão de Pósitrons
4.
Biomolecules ; 12(12)2022 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-36551324

RESUMO

With the increased frequency of red ginseng extract (RGE) and lactic acid bacteria (LAB) co-administration, we aimed to investigate the interactions between RGE and LAB with regard to in vitro and in vivo deglycosylation metabolism and the pharmacokinetics of ginsenosides. As a proof-of-concept study, five healthy humans were administered RGE (104.1 mg of total ginsenosides/day) with or without co-administration of LAB (2 g, 1 billion CFU/day) for 2 weeks, and the plasma concentrations of ginsenosides in human plasma were monitored. The plasma exposure to compound K (CK), ginsenoside Rh2 (GRh2), protopanaxadiol (PPD), and protopanaxatriol (PPT) in the concomitant administration RGE and LAB groups increased by 2.7-, 2.1-, 1.6-, and 3.5-fold, respectively, compared to those in the RGE administration group, without a significant change in Tmax. The plasma concentrations of GRb1, GRb2, and GRc remained unchanged, whereas the AUC values of GRd and GRg3 significantly decreased in the concomitant administration RGE and LAB groups. To understand the underlying mechanism, the in vitro metabolic activity of ginsenosides was measured during the fermentation of RGE or individual ginsenosides in the presence of LAB for 1 week. Consistent with the in vivo results, co-incubation with RGE and LAB significantly increased the formation rate of GRh2, CK, PPD, and PPT. These results may be attributed to the facilitated deglycosylation of GRd and GRg3 and the increased production of GRh2, CK, PPD, and PPT by the co-administration of LAB and RGE. In conclusion, LAB supplementation increased the plasma concentrations of deglycosylated ginsenosides, such as GRh2, CK, PPD, and PPT, through facilitated deglycosylation metabolism of ginsenosides in the intestine.


Assuntos
Ginsenosídeos , Lactobacillales , Panax , Humanos , Lactobacillales/metabolismo , Extratos Vegetais , Panax/metabolismo , Sujeitos da Pesquisa
5.
Front Immunol ; 13: 956907, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36505477

RESUMO

Background: Parenteral anti-CD3 Mab (OKT3) has been used to treat transplant rejection and parental administration of a humanized anti-CD3 Mab (Teplizumab) showed positive effects in diabetes. Nasal administration of anti-CD3 Mab has not been carried out in humans. Nasal anti-CD3 Mab suppresses autoimmune diseases and central nervous system (CNS) inflammation in animal models. We investigated the safety and immune effects of a fully humanized, previously uncharacterized nasal anti-CD3 Mab (Foralumab) in humans and its in vitro stimulatory properties. Methods: In vitro, Foralumab were compared to UCHT1 anti-human CD3 mAb. For human administration, 27 healthy volunteers (9 per group) received nasal Foralumab or placebo at a dose of 10ug, 50ug, or 250ug daily for 5 days. Safety was assessed and immune parameters measured on day 1 (pre-treatment), 7, 14, and 30 by FACS and by scRNAseq. Results: In vitro, Foralumab preferentially induced CD8+ T cell stimulation, reduced CD4+ T cell proliferation and lowered expression of IFNg, IL-17 and TNFa. Foralumab induced LAP, TIGIT, and KLRG1 immune checkpoint molecules on CD8+ and CD4+ T cells in a mechanism independent of CD8 T cells. In vivo, nasal Foralumab did not modulate CD3 from the T cell surface at any dose. Immune effects were primarily observed at the 50ug dose and consisted of reduction of CD8+ effector memory cells, an increase in naive CD8+ and CD4+ T cells, and reduced CD8+ T cell granzyme B and perforin expression. Differentially expressed genes observed by scRNAseq in CD8+ and CD4+ populations promoted survival and were anti-inflammatory. In the CD8+ TEMRA population there was induction of TIGIT, TGFB1 and KIR3DL2, indicative of a regulatory phenotype. In the memory CD4+ population, there was induction of CTLA4, KLRG1, and TGFB whereas there was an induction of TGF-B1 in naïve CD4+ T cells. In monocytes, there was induction of genes (HLA-DP, HLA-DQ) that promote a less inflammatory immune response. No side effects were observed, and no subjects developed human anti-mouse antibodies. Conclusion: These findings demonstrate that nasal Foralumab is safe and immunologically active in humans and presents a new avenue for the treatment of autoimmune and CNS diseases.


Assuntos
Anticorpos Monoclonais , Linfócitos T CD8-Positivos , Humanos , Administração Intranasal , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Muromonab-CD3 , Sujeitos da Pesquisa
6.
Kennedy Inst Ethics J ; 32(3): 297-311, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36341598

RESUMO

Guidelines and regulations for medical research recognize that the experiences of humans and animals both matter morally. They thus set a presumption against harming research subjects, whether humans or animals, and mandate that the harms subjects experience should be the minimal necessary for achieving the scientific aims of the study. Beyond this, guidelines and regulations place upper limits on the extent to which human, but not animal, subjects may be harmed. They also mandate that human, but not animal, subjects should be compensated for the harms they experience. In this article, I argue that this common approach to regulating medical research is mistaken. In particular, there are upper limits on the extent to which animals may ethically be harmed in order to collect data to benefit others, and there are moral reasons to compensate them for the harms they experience. I conclude that guidelines and regulations for research with animals should be revised accordingly.


Assuntos
Experimentação Animal , Pesquisa Biomédica , Animais , Humanos , Sujeitos da Pesquisa , Princípios Morais
7.
Ethics Hum Res ; 44(6): 14-22, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36316972

RESUMO

Investigators commonly offer payments to research participants to promote recruitment and retention. Yet the ethics of offering monetary incentives to research participants continues to be debated. Prior conceptual work has addressed some of these concerns; there is, however, also a need for empirical evidence to understand the effects of payment on participants. Here, we report the results of a qualitative study comprising (1) discourse analysis of recruitment conversations between study coordinators and potential participants for an actual clinical trial and (2) semistructured interviews with participants addressing the effects of an incentive on their decision-making. Many participants reported that money had been a motivation for enrolling in the clinical trial but did not use reasoning that suggested undue influence or unjust inducement. These findings add to a growing body of literature suggesting that payment is an ethically acceptable tool for promoting recruitment and retention in clinical trials.


Assuntos
Motivação , Sujeitos da Pesquisa , Humanos , Pesquisa Qualitativa , Ensaios Clínicos como Assunto
8.
Sci Rep ; 12(1): 20438, 2022 Nov 28.
Artigo em Inglês | MEDLINE | ID: mdl-36443369

RESUMO

This study investigates how different motion planning algorithms, implemented on a collaborative robot (cobot), are perceived by 48 human subjects. The four implemented algorithms ensure human safety based on the concept of speed and separation monitoring, but differ based on the following characteristics: (a) the cobot motion happens either along a fixed path or with a trajectory that is continuously planned in real time via nonlinear model predictive control, to increase cobot productivity; (b) the cobot speed is further reduced-or not-in real time based on heart rate measurements, to increase perceived safety. We conclude that (1) using a fixed path-compared to real-time motion planning-may reduce productivity and, at least when heart rate measurements are not used to modify the cobot speed, increases perceived safety; (2) reducing cobot speed based on heart rate measurements reduces productivity but does not improve perceived safety; (3) perceived safety is positively affected by habituation during the experiment, and unaffected by previous experience.


Assuntos
Algoritmos , Sujeitos da Pesquisa , Humanos , Movimento (Física) , Frequência Cardíaca
9.
J Am Geriatr Soc ; 70(11): 3080-3086, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36184785

RESUMO

The majority of clinical trials currently and historically do not include older adults or non-white participants. While more women are being recruited, their numbers are still limited. It is very hard to interpret trial results and apply them to older adults when their participation in clinical trials is limited. The focus of this article is the lack of clinical trial participation by persons of diverse races and ethnicities and the presentation of a model infrastructure grounded in community engagement that is proving to be effective in increasing the interest and participation of older African Americans in research.


Assuntos
Ensaios Clínicos como Assunto , Diversidade Cultural , Sujeitos da Pesquisa , Idoso , Feminino , Humanos , Etnicidade
10.
J Indian Soc Pedod Prev Dent ; 40(3): 219-229, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36260461

RESUMO

Background: Passive immunization using egg yolk-based antibodies has been tested against oral microorganisms. Our study assessed the effect of immunoglobulin Y (IgY) formulations on Streptococcus mutans, Porphyromonas gingivalis, and Candida albicans in human subjects. Highlights: VS and UT independently searched articles using keyword combinations in four search engines; studies in English were selected. Either parallel-arm or split-mouth randomized controlled trials on healthy human subjects were considered. Ten studies remained in the selection; six studies compared the effect of IgY formulations on S. mutans, three on P. gingivalis, and one on C. albicans. Five studies (422 subjects) compared the effect of IgY formulations on S. mutans. When fixed-effect model (FEM) was applied, the risk ratio (RR) (confidence interval [CI]) was found to be 7.81 (6.00, 10.18). Three studies (167 subjects) compared the effect of IgY formulations on P. gingivalis. When FEM was applied, the RR (CI) was found to be 0.06 (-0.03, 0.15) in relation to reduction in probing depth. When FEM was applied, for percentage reduction in bleeding on probing (BOP), the RR (CI) was 1.99 (1.64, 2.41). Only one study (26 subjects) was available of IgY formulation and C. albicans; hence meta-analysis was not performed.The search was extended using Google Scholar, Semantic Scholar, cross-references and by contacting authors and researchers in the field which further yielded five articles. . Conclusions: IgY formulations were effective in the reduction of S. mutans. They were not effective on P. gingivalis in relation to probing depth but were effective in relation to reduction in BOP. No harms were reported. Evidence is of low quality due to high heterogeneity. The ROB was moderate and publication bias was low.


Assuntos
Imunoglobulinas , Porphyromonas gingivalis , Humanos , Imunoglobulinas/farmacologia , Imunoglobulinas/uso terapêutico , Streptococcus mutans , Sujeitos da Pesquisa , Ensaios Clínicos Controlados Aleatórios como Assunto
11.
Front Public Health ; 10: 1009203, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36164385

RESUMO

A variety of studies have been conducted in Occupational diseases (ODs) and this makes it difficult for researchers to identify new areas of study. Therefore, the present study was conducted by examining Web of Science data to identify hot topics and research topics on ODs. This is a scientometric study performed using CiteSpace and Gephi software for statistical analysis. The published article in Web of Sciences was searched using the keywords "Occupational disease*" OR "Occupational illness*" OR "Industrial disease*" OR "Industrial illness*". Finally, the countries and institutions and their cooperation, the most important and main topics discussed, and the path of future progress in ODs was analyzed. Preliminary results of the study show that out of 5,947 articles. The results of important journals showed that the American Journal of Industrial Medicine with 233 articles (6.02%), Oxford Occupational Medicine, and International Archives of Occupational and Environmental Health with 86 (2.22%), and 83 (2.15%), respectively. The two producing countries are the United States and Germany, which published 628 and 419 articles, respectively. The results of hot topics showed occupational exposures, epidemiology, mental health, and respiratory diseases were the most important keywords used in these 45 years. It can be concluded that Germany, with its current development trend in the coming years, will surpass the United States based on the number of articles and gain the first rank. Also, future studies can be conducted on respiratory diseases as the most important ODs and health care work as the most important job during the past years.


Assuntos
Doenças Profissionais , Sujeitos da Pesquisa , Alemanha , Humanos , Estados Unidos
12.
Annu Int Conf IEEE Eng Med Biol Soc ; 2022: 2937-2940, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-36086466

RESUMO

Cognitive control, the ability to rapidly shift one's attention and behavioral strategy in response to environmental changes, is often compromised across psychiatric disorders. One of the well-validated behavioral paradigms for tapping into the cognitive control circuits is a cognitive interference task, where subjects must suppress a natural response to follow a less intuitive rule. Slower response times on these tasks indicate difficulty exerting control to overcome response conflict. Conflict evokes robust electrophysiological signatures, such as theta (4-8 Hz) oscillations in the prefrontal cortex (PFC). However, the underlying neural mechanisms of conflict-evoked theta oscillations in the PFC are not clear. The objective of this work is to use a neural mass model (NMM) to find feasible cortical networks generating theta oscillations during conflict processing in human subjects. We used intracranial EEG (iEEG) recorded from dorsolateral PFC (dIPFC) and lateral temporal lobe (LTL) of human subjects with intractable epilepsy undergoing invasive monitoring, while they performed a multi-source interference task (MSIT). We used a dynamic causal modeling (DCM) framework to simulate dIPFC-LTL theta using a Jansen-Rit NMM. We found significant evidence for an LTL input into the dlPFC during the initial 500 ms of conflict processing compared to a bidirectional connection between the dlPFC and LTL. We conclude that a neural mass modeling framework can be used to elucidate candidate mechanisms of neural oscillations underlying conflict resolution in human subjects. Clinical Relevance- This can be used to find feasible target mechanisms for designing therapy in patients with compromised cognitive control. This framework can also be expanded to serve as an in-silico test bed for designing and testing neuromodulatory interventions such as electrical stimulation for improving cognitive control in mood/anxiety disorders.


Assuntos
Atenção , Córtex Pré-Frontal , Cognição/fisiologia , Humanos , Tempo de Reação/fisiologia , Sujeitos da Pesquisa
13.
BMC Med Educ ; 22(1): 697, 2022 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-36175947

RESUMO

BACKGROUND: Researchers are responsible for the protection of health research participants. The purpose of this study was to identify and prioritize the training needs of researchers involved in human health research in Cameroon. METHODS: It was a cross-sectional study conducted in all the Cameroon regions in the last quarter of 2020. It targeted researchers involved in human health research selected by systematic stratified sampling from health and training institutions, and health facilities. Data were collected using a face-to-face administered questionnaire deployed in Smartphones via the ODK-collect. The distribution of participants' exposure to research ethics training was described as well as their knowledge on the related regulatory texts. A score was used to rank the training needs identified by the participants. RESULTS: Of 168 reached participants, 134 (79.76%) participated in the study. A total of 103 (76.87%) researchers reported having received training in human health research ethics and 98 (73.13%) perceived need of training in research ethics. Of those involved in clinical, vaccine, and field trials, 63.64, 33.33, 52.53% have been exposed respectively to related training regarding participants' protection. Having received at least one training in research ethics significantly increase the proportion of researchers systematically submitting application for ethical evaluation prior to implementation (OR = 3.20 (1.31-7.78)). Training priorities identified by researchers include: guidelines and regulations on health research ethics and research participant's protection in Cameroon, procedures for evaluating research protocols, protection of research participants in clinical trials, and fundamental ethics principles. CONCLUSION: The coverage of researchers in training regarding research participant protection remains limited in a number of areas including those related to clinical trial participant protection and research participant protection in Cameroon. Improving this coverage and addressing perceived needs of researchers are expected to contribute in improving their ability in playing their role in research participant protection.


Assuntos
Ética em Pesquisa , Pesquisadores , Camarões , Ensaios Clínicos como Assunto , Estudos Transversais , Ética em Pesquisa/educação , Humanos , Determinação de Necessidades de Cuidados de Saúde , Projetos de Pesquisa , Pesquisadores/educação , Sujeitos da Pesquisa
14.
J Biomed Opt ; 27(8)2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35982528

RESUMO

SIGNIFICANCE: Morphological changes in the epidermis layer are critical for the diagnosis and assessment of various skin diseases. Due to its noninvasiveness, optical coherence tomography (OCT) is a good candidate for observing microstructural changes in skin. Convolutional neural network (CNN) has been successfully used for automated segmentation of the skin layers of OCT images to provide an objective evaluation of skin disorders. Such method is reliable, provided that a large amount of labeled data is available, which is very time-consuming and tedious. The scarcity of patient data also puts another layer of difficulty to make the model more generalizable. AIM: We developed a semisupervised representation learning method to provide data augmentations. APPROACH: We used rodent models to train neural networks for accurate segmentation of clinical data. RESULT: The learning quality is maintained with only one OCT labeled image per volume that is acquired from patients. Data augmentation introduces a semantically meaningful variance, allowing for better generalization. Our experiments demonstrate the proposed method can achieve accurate segmentation and thickness measurement of the epidermis. CONCLUSION: This is the first report of semisupervised representative learning applied to OCT images from clinical data by making full use of the data acquired from rodent models. The proposed method promises to aid in the clinical assessment and treatment planning of skin diseases.


Assuntos
Algoritmos , Tomografia de Coerência Óptica , Animais , Epiderme/diagnóstico por imagem , Humanos , Sujeitos da Pesquisa , Roedores , Tomografia de Coerência Óptica/métodos
15.
Niger J Physiol Sci ; 37(1): 147-152, 2022 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-35947852

RESUMO

The aqueous calyx extract of Hibiscus sabdariffa (HS) is widely consumed as a beverage in Northern Nigeria and other parts of the world. HS has been reported to lower blood pressure (BP) in animals and man. However, not much is known about the effect of HS on BP in different postures. We tested the hypothesis that HS may lower BP, heart rate (HR) and heart rate-pressure product or double product (DP) by attenuating the discharge of the autonomic nervous system in different postures. Experiments were performed in accordance with the Principles of the Declaration of Helsinki. Following ethical approval and informed consent, BP and HR were measured in different postures (supine, sitting and standing) in apparently healthy human subjects (n=20) before and after (+HS) the oral administration of 15mg/Kg HS. Mean arterial pressure (MAP; taken as representative BP) and DP were calculated. Results are expressed as mean ±SEM. Paired t test and ANOVA with a post hoc Bonferroni test were used for statistical analyses. P<0.05 was considered significant. In the supine position MAP, HR and DP were significantly (P<0.0001 each) reduced in the presence of HS (85.6±1.7mmHg, 72.1±1.1/min and 8716±320mmHg.bpm) compared to its absence (89.6±2.0mmHg, 73.7±1.6/min and 8921±444mmHg.bpm). Similar trends were observed in the sitting position in the presence of HS (85.4±2.7mmHg, 73.7±1.8/min and 9098±345mmHg.bpm vs its absence: 91.4±2.3mmHg, 77.1±1.9/min and 9388±478mmHg.bpm; P<0.0001, P<0.0001 and P=0.007 respectively) and in the standing position (+HS: 89.3±2.0mmHg,         78.1±1.8/min and 10164±230mmHg.bpm vs its absence: 94.3±2.1mmHg, 81.8±2.3/min and 10742±268mmHg.bpm; P<0.0001, P<0.0001 and P=0.007 respectively). In the absence of HS, HR and DP were significantly higher in the standing posture (81.8±2.3/min, 10742±268mmHg.bpm) compared to the sitting (77.1±1.9/min, 9388±478mmHg.bpm; P<0.05 and P<0.0001 respectively) and the supine (73.7±1.6/min, 8921±444mmHg.bpm; P<0.001 each) postures while the BP remained similar. A similar trend was observed across          the three postures in the presence of HS although the parameters were significantly lower. It is concluded that HS lowered BP, HR and DP by modulating autonomic mechanisms through the inhibition of both parasympathetic withdrawal and sympathetic nervous system discharge across the postures. Also the standing posture is associated more with a higher sympathetic nervous system discharge and a higher cardiac oxygen demand and workload than the sitting and supine postures in the absence or presence of HS.


Assuntos
Hibiscus , Animais , Pressão Sanguínea/fisiologia , Frequência Cardíaca/fisiologia , Humanos , Masculino , Extratos Vegetais/farmacologia , Postura/fisiologia , Sujeitos da Pesquisa
16.
Agora (Rio J.) ; 25(2): 47-53, maio-ago. 2022. graf
Artigo em Português | LILACS, Index Psicologia - Periódicos | ID: biblio-1403096

RESUMO

RESUMO: Parte-se da premissa da importância da pulsão invocante em relação ao retorno em direção ao eu e a reversão no contrário como uma função de torção no nível do Outro. Objetiva-se mostrar como esse movimento pulsional orienta a direção da análise, pois está na base das intervenções do analista. O artigo traz duas vinhetas clínicas que tentam operar no campo da torção do significante e da voz através da operação de chiffonnage. Conclui-se que o significante novo oriundo da intervenção do analista é guiado por uma torção no nível da voz, produzindo um efeito significativo na direção da análise.


Abstract: It starts from the premise of the importance of the invocative pulsion in relation to the return towards the self and the reversal to the contrary as a function of torsion at the level of the Other. The objective is to show how this pulsional movement guides the direction of analysis, as it is at the base of the analyst's interventions. The article brings two clinical vignettes that try to operate in the field of the torsion of the signifier and the voice through the chiffonnage operation. It is concluded that the new signifier arising from the analyst's intervention is guided by a torsion at the voice level, producing a significant effect in the direction of the analysis.


Assuntos
Psicanálise , Sujeitos da Pesquisa , Terapêutica
17.
J Empir Res Hum Res Ethics ; 17(4): 412-425, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35876356

RESUMO

PURPOSE: Editors often require ethical statements in research publications. This is particularly important with genetic data where discrimination may occur upon data disclosures. The purpose of this research is to determine if there was a positive trend of publishing ethical statements in dental genetic research. The study is limited to AXIN2 mutations which may be associated with oligodontia and cancer. METHODS: A MEDLINE search of 2011-2021 articles concerning AXIN2, oligodontia, and ethical statements was conducted. Reviews, nonhuman subject research, abstracts, and articles not written nor translated into English were excluded. RESULTS: Forty-four studies were found; 10 excluded. There were 25 (75.8%) with ethical statements, and 25 (75.8%) with participant consent statements. There was no significant difference by year in ethical statements over the ten years (p = 0.094). CONCLUSION: There is a need to encourage more ethical statements in publications especially for genetically sensitive topics to reassure readers of ethical practices.


Assuntos
Proteína Axina , Pesquisa em Odontologia , Consentimento Livre e Esclarecido , Proteína Axina/genética , Pesquisa em Odontologia/ética , Humanos , Mutação , Editoração , Sujeitos da Pesquisa
18.
Health Promot Pract ; 23(4): 543, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35848356

RESUMO

There are at least two Anarchas that appear in J. Marion Sims's autobiography. One, is the famed Anarcha from the Wescott Plantation who endured numerous experiments at Sims's hands, but there is also the Anarcha that appears earlier in Sims's self-story described here. She was described as a mulatta who assisted in a bloodletting of Sims himself. These two Anarchas appear to Sims as turning points in his own thinking, experience, and practice of and with medicine. I imagine this Anarcha speaking here, toward his description of her and the practice of bloodletting in the larger scope of Sims's infamous medical practices. To view the original version of this poem, see the supplemental material section of this article online.


Assuntos
Escravização , Ginecologia , Sujeitos da Pesquisa , Feminino , Humanos , Fístula Vesicovaginal
19.
Eur J Med Res ; 27(1): 137, 2022 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-35907902

RESUMO

BACKGROUND: Current biomarkers for the early detection of sepsis have low sensitivity and specificity. Serum microRNAs (miRNAs) have been proposed as novel noninvasive biomarkers for various diseases. The aim of the present study was to discover a novel diagnostic biomarker for sepsis in human subjects. METHODS: miRNA expression profiling was performed using peripheral blood from three sepsis patients in the sepsis stage and improved condition stage using microarray screening. The differentially expressed miRNAs were primary validated by real-time quantitative polymerase chain reaction (RT-qPCR) in a further set of 20 sepsis patients in the sepsis stage and improved condition stage. Finally, we validated the differentially expressed miRNAs in 95 sepsis patients and 66 nonsepsis patients. The validated miRNAs and patients' clinical indictors were analysed in a multivariate logistic regression model. The diagnostic value of the changed miRNA in sepsis was determined and compared with CRP and WBC by analysing the receiver operating characteristic (ROC) curves. RESULTS: According to the criteria, we detected 11 miRNAs regulated by the miRNA chip. RT-qPCR detection showed that the expression of hsa-let-7d-3p in sepsis patients was upregulated compared with that in nonsepsis patients. In a multiple logistic regression analysis, serum miRNA hsa-let-7d-3p was found to be an independent predictor of sepsis. Receiver operating characteristic curve (ROC) analysis showed that the area under the ROC curve of serum hsa-let-7d-3p was 0.696 [95% confidence interval (0.615, 0.778)]. CONCLUSION: The miRNA hsa-let-7d-3p was identified as a novel biomarker for the early detection of sepsis.


Assuntos
MicroRNA Circulante , MicroRNAs/genética , Sepse , Biomarcadores , MicroRNA Circulante/genética , Perfilação da Expressão Gênica , Humanos , Curva ROC , Sujeitos da Pesquisa , Sepse/diagnóstico , Sepse/genética
20.
Acta Neuropathol ; 144(3): 489-508, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35796870

RESUMO

Blood-based (BB) biomarkers for Aß and tau can indicate pathological processes in the brain, in the early pathological, even pre-symptomatic stages in Alzheimer's disease. However, the relation between BB biomarkers and AD-related processes in the brain in the earliest pre-pathology stage before amyloid pathology develops, and their relation with total brain concentrations of Aß and tau, is poorly understood. This stage presents a critical window for the earliest prevention of AD. Preclinical models with well-defined temporal progression to robust amyloid and tau pathology provide a unique opportunity to study this relation and were used here to study the link between BB biomarkers with AD-related processes in pre- and pathological stages. We performed a cross-sectional study at different ages assessing the link between BB concentrations and AD-related processes in the brain. This was complemented with a longitudinal analysis and with analysis of age-related changes in a small cohort of human subjects. We found that BB-tau concentrations increased in serum, correlating with progressive development of tau pathology and with increasing tau aggregates and p-tau concentrations in brain in TauP301S mice (PS19) developing tauopathy. BB-Aß42 concentrations in serum decreased between 4.5 and 9 months of age, correlating with the progressive development of robust amyloid pathology in APP/PS1 (5xFAD) mice, in line with previous findings. Most importantly, BB-Aß42 concentrations significantly increased between 1.5 and 4.5 months, i.e., in the earliest pre-pathological stage, before robust amyloid pathology develops in the brain, indicating biphasic BB-Aß42 dynamics. Furthermore, increasing BB-Aß42 in the pre-pathological phase, strongly correlated with increasing Aß42 concentrations in brain. Our subsequent longitudinal analysis of BB-Aß42 in 5xFAD mice, confirmed biphasic BB-Aß42, with an initial increase, before decreasing with progressive robust pathology. Furthermore, in human samples, BB-Aß42 concentrations were significantly higher in old (> 60 years) compared to young (< 50 years) subjects, as well as to age-matched AD patients, further supporting age-dependent increase of Aß42 concentrations in the earliest pre-pathological phase, before amyloid pathology. Also BB-Aß40 concentrations were found to increase in the earliest pre-pathological phase both in preclinical models and human subjects, while subsequent significantly decreasing concentrations in the pathological phase were characteristic for BB-Aß42. Together our data indicate that BB biomarkers reflect pathological processes in brain of preclinical models with amyloid and tau pathology, both in the pathological and pre-pathological phase. Our data indicate a biphasic pattern of BB-Aß42 in preclinical models and a human cohort. And most importantly, we here show that BB-Aß increased and correlated with increasing concentrations of Aß in the brain, in the earliest pre-pathological stage in a preclinical model. Our data thereby identify a novel critical window for prevention, using BB-Aß as marker for accumulating Aß in the brain, in the earliest pre-pathological stage, opening new avenues for personalized early preventive strategies against AD, even before amyloid pathology develops.


Assuntos
Doença de Alzheimer , Amiloidose , Doença de Alzheimer/patologia , Peptídeos beta-Amiloides , Animais , Biomarcadores , Estudos Transversais , Humanos , Camundongos , Fragmentos de Peptídeos , Sujeitos da Pesquisa , Proteínas tau
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