Assessment of clinical outcomes in patients with post-traumatic stress disorder: analysis from the UK Medical Cannabis Registry.

BACKGROUND: The current paucity of clinical evidence limits the use of cannabis-based medicinal products (CBMPs) in post-traumatic stress disorder (PTSD). This study investigates health-related quality of life (HRQoL) changes and adverse events in patients prescribed CBMPs for PTSD. METHODS: A case-series of patients from the UK Medical Cannabis Registry was analyzed. HRQoL was assessed at 1-, 3-, and 6-months using validated patient reported outcome measures (PROMs). Adverse events were analyzed according to the Common Terminology Criteria for Adverse Events version 4.0. Statistical significance was defined as p < 0.050. RESULTS: Of 162 included patients, 88.89% (n = 144) were current/previous cannabis users. Median daily CBMP dosages were 5.00 (IQR: 0.00-70.00) mg of cannabidiol and 145.00 (IQR: 100.00-200.00) mg of Δ9-tetrahydrocannabinol. Significant improvements were observed in PTSD symptoms, sleep, and anxiety across all follow-up periods (p < 0.050). There were 220 (135.8%) adverse events reported by 33 patients (20.37%), with the majority graded mild or moderate in severity (n = 190, 117.28%). Insomnia and fatigue had the greatest incidence (n = 20, 12.35%). CONCLUSIONS: Associated improvements in HRQoL were observed in patients who initiated CBMP therapy. Adverse events analysis suggests acceptability and safety up to 6 months. This study may inform randomized placebo-controlled trials, required to confirm causality and determine optimal dosing.

Assessment of clinical outcomes of medicinal cannabis therapy for depression: analysis from the UK Medical Cannabis Registry.

BACKGROUND: Although pre-clinical experiments associate cannabinoids with reduced depressive symptoms, there is a paucity of clinical evidence. This study aims to analyze the health-related quality of life changes and safety outcomes in patients prescribed cannabis-based medicinal products (CBMPs) for depression. METHODS: A series of uncontrolled cases from the UK Medical Cannabis Registry were analyzed. The primary outcomes were changes from baseline in the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Sleep Quality Scale (SQS), and EQ-5D-5 L at 1, 3, and 6 months. Secondary outcomes included adverse events incidence. RESULTS: 129 patients were identified for inclusion. Median PHQ-9 at baseline was 16.0 (IQR: 9.0-21.0). There were reductions in PHQ-9 at 1-month (median: 8.0; IQR: 4.0-14.0; p < 0.001), 3-months (7.0; 2.3-12.8; p < 0.001), and 6-months (7.0; 2.0-9.5; p < 0.001). Improvements were also observed in GAD-7, SQS, and EQ-5D-5L Index Value at 1, 3, and 6 months (p < 0.050). 153 (118.6%) adverse events were recorded by 14.0% (n = 18) of participants, 87% (n = 133) of which were mild or moderate. CONCLUSION: CBMP treatment was associated with reductions in depression severity at 1, 3, and 6 months. Limitations of the study design mean that a causal relationship cannot be proven. This analysis provides insights for further study within clinical trial settings.

Depression is a highly prevalent mental health condition with approximately one in five people affected by at least one episode of depression in their lifetime. Two cardinal symptoms of depression are low mood and loss of interest. Since depression is such a debilitating condition, improving quality of life is an important part of treatment.Antidepressant medications are currently an important part of treating depression, but the variability in their effectiveness means that there is a need for alternative treatments. Medicinal cannabis, which contains certain chemicals from the cannabis plant, has received growing interest as a potential novel treatment for depression. Due to the lack of clinical studies on the use of medicinal cannabis to treat depression, this study aims to assess the effects of medicinal cannabis on quality of life in patients suffering from depression.The study included 129 patients treated with medicinal cannabis for depression at Sapphire Medical Clinics. The results showed that medicinal cannabis was associated with improvements in depression and anxiety symptoms, as well as health-related quality of life, and sleep quality after 1, 3, and 6 months of treatment. Although there were numerous adverse events in a small number of patients, most of these were mild or moderate. A major limitation is that this study cannot determine the extent to which medicinal cannabis is directly responsible for the improvements in depression symptoms that were observed. Future studies should focus on conducting clinical trials which can better evaluate the true treatment effects of medicinal cannabis for depression.

Avaliação do potencial de morbimortalidade por COVID-19 em comunidades quilombolas rurais de Goiás, Brasil / Assessment of the potential for morbidity and mortality from COVID-19 in rural quilombola communities in Goiás, Brazil

Objetivo: analisar o potencial de morbimortalidade por COVID-19 em comunidades quilombolas rurais. Métodos: estudo transversal, com 26 comunidades do Estado de Goiás. Utilizou-se o método Analytic Hierarchy Process (AHP) que hierarquiza critérios para estimar o índice de prioridade de morbimortalidade por COVID-19, sendo eles: sexo masculino, idade ≥ 60 anos, diabetes, câncer, hipertensão, tabagismo, dislipidemia e obesidade. Resultados: de 1.672 entrevistados, 52,0% eram homens, 19,0% ≥ 60 anos, 5,5% autor referiram diabetes, 19,6% hipertensão, 9,2% dislipidemia, 1,3% obesidade, 0,4% câncer e 13,9% tabagismo. Houve menor índice de prioridade na Comunidade Engenho 2, e maior em Buracão; sendo: idade ≥ 60 anos em Quilombo do Magalhães; sexo masculino em Kalunga dos Morros; diabetes e hipertensão em Tomás Cardoso; dislipidemia em Almeidas; obesidade em Buracão; câncer em Água Limpa; tabagismo em José de Coleto. Conclusão: houve diferentes potenciais de morbimortalidade por COVID-19, demonstrando qual comunidade apresenta maior/menor prioridade para ações estratégicas para enfrentamento da pandemia.

Objective: to analyze the potential for morbidity and mortality from COVID-19 in rural quilombola communities. Methods:cross-sectional study, with 26 communities in the State of Goiás. The Analytic Hierarchy Process (AHP) method was used, which ranks criteria to estimate the COVID-19 morbidity and mortality priority index, namely: male gender, age ≥ 60 years, diabetes, cancer, hypertension, smoking, dyslipidemia and obesity. Results: among the 1,672 respondents, 52.0% were men, 19.0% ≥ 60 years, 5.5% self-reported diabetes, 19.6% hypertension, 9.2% dyslipidemia, 1.3% obesity, 0.4% cancer and 13.9% smoking. There was a lower priority index in the Engenho 2 community, and higher in the Buracão; where: age ≥ 60 years in the Quilombo do Magalhães; male gender in the Kalunga dos Morros; diabetes and hypertension in the Tomás Cardoso; dyslipidemia in the Almeidas; obesity in the Buracão; cancer in the Água Limpa; smoking in the José de Coleto. Conclusion: there were different potential for morbidity and mortality from COVID-19, demonstrating which community has the highest/lowest priority for strategic actions to face the pandemic.

Cuidados com o uso de insulinas disponibilizadas pelo sus: subsídios para o controle em diabetes mellitusManagement of insulin available by sus: support to control diabetes mellitus / Management of insulin available by sus: support to control diabetes mellitus / Cuidado en el uso de insulinas proporcionado porsus: subvenciones para el cuidado de diabetes mellitus

RESUMO Objetivo: Descrever os cuidados com o uso de insulinas disponibilizadas pelo SUS e analisar os fatores associados aos cuidados inadequados. Método: Estudo transversal com 113 pessoas com Diabetes Mellitus de um ambulatório de Goiânia-GO. Foram coletados dados em prontuários sobre conservação, preparo e administração de insulina que foram classificados em adequados e inadequados. Resultados: Do total de participantes,58,4% eram mulheres e a média de idade foi 48 anos. Hipertensão arterial foi relatada por 70,8% e 89,0% apresentaram hemoglobina glicada ≥7%. A totalidade dos usuários de insulina realizavam pelo menos um tipo de cuidado inadequado e 62,8% realizavam quatro ou mais. Os mais frequentes foram:conservarem locais não recomendados (46,7%), não aplicar insulina 30 minutos antes da refeição (87,5%), não avaliar presença de grumos no frasco de insulina NPH (71,9%) e não retirar a insulina da geladeira entre 15 e 30 minutos antes da aplicação (88,7%). Não houve diferença estatisticamente significante com as variáveis de exposição analisadas, porém a maior proporção de quatro ou mais cuidados inadequados ocorreu nas mulheres, nos jovens, naqueles com 11 ou mais anos de estudo, tempo de doença superior a 10 anos e, entre os que aplicam insulina uma ou duas vezes ao dia. Conclusão: Houve alta prevalência de cuidados inadequados e grande variabilidade de práticas, reforçando a importância da implementação da linha de cuidados em Diabetes Mellitus em todos os níveis de atenção à saúde.

RESUMEN Objetivo: describirlos cuidados con el uso de insulinas proporcionados por el Sistema Único de Salud (SUS) y analizar los factores asociados a los cuidados inadecuados. Método: estudio transversal con 113 personas con Diabetes Mellitus de un ambulatorio de Goiânia-GO-Brasil. Fueron recolectados datos en registros médicos sobre conservación, preparación y administración de insulina que fueron clasificados en adecuados e inadecuados. Resultados: del total de participantes, 58,4% era mujeres y el promedio de edad fue 48 años. La hipertensión arterial fue relatada por 70,8%;y 89,0% presentaron hemoglobina glicada ≥7%. La totalidad de los usuarios de insulina realizaban por lo menos un tipo de cuidado inadecuado y 62,8% realizaban cuatro o más. Los más frecuentes fueron: conservar en locales no recomendables (46,7%), no aplicar insulina 30 minutos antes de la comida (87,5%), no evaluar presencia de grumos en el envase de insulina NPH (71,9%) y no sacar la insulina de la heladera entre 15 y 30 minutos antes de la aplicación (88,7%). No hubo diferencia estadísticamente significante con las variables de exposición analizadas, perola mayor proporción de cuatro o más cuidados inadecuados ocurrió entre las mujeres, en los jóvenes, en aquellos con 11 o más años de estudio, tiempo de enfermedad superior a 10 años y, entre los que aplican insulina una o dos veces al día. Conclusión: hubo alta prevalencia de cuidados inadecuados y gran variabilidad de prácticas, reforzando la importancia de la implementación de la línea de cuidados en Diabetes Mellitus en todos los niveles de atención a la salud.

ABSTRACT Objective: To describe management practices of insulin provided by the SUS and analyze the factors associated with insulin management mistakes. Method: Cross-sectional study addressing 113 individuals with Diabetes Mellitus from an outpatient clinic in Goiânia, GO, Brazil. Data concerning insulin storage, preparation, and administration were collected from the patients' medical records and classified as appropriate or inappropriate. Results: 58.4% of participants were women aged 48 years old on average. Hypertension was reported by 70.8%, and glycated hemoglobin was ≥7% in 89.0%. All the patients made at least one insulin management mistake, and 62.8% made four or more mistakes. The most frequent mistakes were: storing insulin in non-recommended places (46.7%), not injecting insulin 30 minutes before meals (87.5%), not checking for the presence of lumps in the NPH insulin vial (71.9%), and not removing the insulin from the refrigerator between 15 and 30 minutes before injection (88.7%). No significant statistical differences were found among the exposure variables, though women, young individuals, those with 11 or more years of schooling, having the disease for more than ten years, and injecting insulin once or twice a day, more frequently made four or more management mistakes. Conclusion: A high prevalence of insulin management mistakes and considerable variability of practices were identified, reinforcing the importance of implementing a DM line of care at all healthcare system levels.

Multi-walled carbon nanotubes functionalized with pyrene-PEG via π-π interactions: toxicological assessment in zebrafish embryos.

Multi-walled carbon nanotubes (MWCNT) have many promising biological applications, even though functionalization is needed for better biocompatibility. Functionalization of MWCNT with polyethylene glycol (PEG) is a promising and widely studied approach, but the best PEGylation method is still under investigation. In this work, we have tested the biological implications of MWCNT functionalized via π-stacking with pyrene-PEG (MWCNT-Pyr-PEG) in zebrafish embryos. As Pyr toxicity is well documented and represents a major concern for the safety of the proposed approach, we have also tested the effects of the exposure to the isolated conjugate (Pyr-PEG). The resulting suspensions were stable in saline medium and well dispersed. Zebrafish embryos at 24 h post-fertilization (hpf) were dechorionated and randomly assigned to seven experimental groups (n = 50 per group): control, MWCNT-Pyr-PEG at 0.2, 2.0, and 20.0 mg l-1, and Pyr-PEG at the same concentrations, and exposures were performed in 96-well plates. Specimens were observed for heart rate, malformations, body length, mortality, traveled distance, and number of new movements. Heart rate was reduced in embryos exposed to any tested concentration of MWCNT-Pyr-PEG, while this effect was observed with Pyr-PEG from 2 mg l-1. The highest concentration of MWCNT-Pyr-PEG also led to increased occurrence of malformations, shortened body length and reduced traveled distance. The functionalization approach shows promise due to the stability in saline media, even though toxic effects were observed in the highest tested concentrations, being the MWCNT the main actors underlying these outcomes.

Assessment of the non-surgical treatment of patients with rectal cancer who underwent neoadjuvant treatment with chemotherapy and radiotherapy at the oncology department / Avaliação do tratamento não cirúrgico de pacientes com câncer de reto submetido ao tratamento neoadjuvante com quimioterapia e radioterapia no serviço de oncologia

ABSTRACT Objective: To describe the partial results of a study in patients with rectal cancer who underwent neoadjuvant treatment with chemotherapy and radiotherapy regarding the rate of complete clinical response, disease-free survival, anorectal function, and quality of life. Material and methods: This was a prospective study from June 2015 to June 2018, in patients with low- or mid-rectum adenocarcinoma and clinical stage II or III, treated with radiotherapy and chemotherapy (IMRT 54 Gy for six weeks) concomitant with 5-fluorouracil (5-FU) 380 mg/m2 and folinic acid (LV) 20 mg/m2 for five days in the first and fifth weeks and two cycles after radiotherapy (5-FU 400 mg/m2 and LV 20 mg/m2) every 28 days. After the treatment, clinical examination, rectosigmoidoscopy, pelvic magnetic resonance imaging, chest and upper abdomen computed tomography, and CEA testing were performed. Resection surgery was performed in those with incomplete clinical response (iCR). Those with complete clinical response (cCR) are under observation (wait-and-see policy). Manometry and scintigraphic function and quality of life scales were collected before treatment and at 30 and 90 days after the end of treatment. Results: As of June 2018, 11 patients were recruited. One was excluded from the analysis for presenting severe toxicity, suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency, after the first chemotherapy cycle. All others completed the treatment. Two patients presented toxicity grade 3/4 related to chemotherapy and had their doses reduced. Seven patients (70%) presented iRC; three underwent rectosigmoidectomy, and the anatomopathological evaluation indicated complete pathological response in two cases (28.5%). Three (30%) presented cCR and did not present evidence of disease after a mean follow-up of 19 months. Patients presented improvement of anorectal function and quality of life. Conclusions: Advances in the neoadjuvant treatment of rectal tumors contributed to better rates of complete pathological responses. New paradigms promote an increase in the complete clinical response rates, which would allow organ preservation and consequent reduction of surgical morbidity.

RESUMO Objetivo: Descrever os resultados parciais de estudo em pacientes com câncer de reto submetidos a tratamento neoadjuvante com quimioterapia e radioterapia quanto à taxa resposta clínica completa, sobrevida livre de doença, função anorretal e qualidade de vida. Material e métodos: Estudo prospectivo desde junho 2015 até junho de 2018, em paciente com adenocarcinoma de reto baixo ou médio e estadio clínico II ou III tratados com RT/QT (IMRT 54 Gy em 6 semanas) concomitante a 5-Fuorouracil (5-FU) 380 mg/m2 e ácido folínico (LV) 20 mg/m2 por 5 dias nas primeira e quinta semanas e dois ciclos após RT (5-FU 400 mg/m2 e LV 20 mg/m2) a cada 28 dias. Após o tratamento, realizou-se exame clínico, retossigmoidoscopia, RNM de pelve, TC de tórax e abdômen superior e dosagem de CEA. Naqueles com Resposta Clínica Incompleta (iRC) procedeu-se à cirurgia de ressecção. Aqueles com Resposta Completa (cRC) estão em observação (wait and see policy). Manometria e escalas de função esfincteriana e qualidade de vida foram obtidas antes e após 30 e 90 dias do término do tratamento. Resultados: Até junho de 2018, recrutaram-se 11 pacientes. Um foi excluído da análise, pois apresentou toxicidade severa sugestiva de deficiência de DPD após o primeiro ciclo de QT. Todos os demais concluíram o tratamento. Toxicidades graus 3/4 relacionadas à QT ocorreram dois pacientes, reduzindo-se sua dose. Sete (70%) apresentaram iRC, submetendo três à retossigmoidectomia cuja avaliação anatomopatológica evidenciou Resposta Completa (pRC) em dois casos (28,5%). Três (30%) apresentaram cRC e estão sem evidência de doença com seguimento médio de 19 meses. Houve melhora da função anorretal e da qualidade de vida. Conclusões: Avanços no tratamento neoadjuvante dos tumores de reto contribuíram para melhores taxas de pRC. Novos paradigmas promovem crescentes índices de cRC, o que possibilitaria a preservação do órgão e consequente redução da morbidade cirúrgica.

Toxicological assessment of PEGylated single-walled carbon nanotubes in early developing zebrafish.

Functionalization of single-walled carbon nanotubes (SWCNT) with polyethylene glycol (PEG) is among the most promising strategies to avoid SWCNT aggregation in aqueous media, improving its interactions with biological systems. However, the best molecular PEG weight and functionalization strategy remain under investigation. In this work we assessed the toxicological effects of SWCNT functionalized with PEG at 600 Da in zebrafish embryos. Embryos were exposed to SWCNT at 0.01, 0.1 and 1 mg/L from 3 to 96 h post-fertilization (hpf). At the highest concentration, SWCNT led to toxic effects at several endpoints, including mortality, delayed hatching, malformations, reduced body length, increased ROS production and DNA damage. Even with these effects, SWCNT could not be detected within the bodily tissues of the larvae. Our results give evidence that the tested PEGylation approach was unsuitable to avoid SWCNT aggregation in aqueous media, and that SWCNT can induce toxicity even without being absorbed by the organism by obstructing the chorion pores.

How effectively does medical care achieve its purposes? Evaluation of peer-reviewed literature in ophthalmology related to wellness.

PURPOSE: To get an idea of whether the issue of what makes people healthier is studied in ophthalmology by determining the proportion of articles dealing with that subject. METHODS: Prospective review of all articles published in 3 consecutive issues of 7 peer-reviewed ophthalmology journals, using a grading system in which A signified an article that clearly dealt with a subject expected to have an impact on health or quality of life, or that considered health or quality of life itself directly; B indicated an article similar to A, but not directly concerned with the issue of health; C signified an article similar to B but more distantly related to health or quality of life; and D was the grade given when there was no relationship at all to health or quality of life. Grading was done independently by 3 graders. A literature review on the subject was also performed. RESULTS: Thirty-three articles received a grade of A, 229 of B, 740 of C, and 81 of D. There were more articles that had no relationship at all to health or quality of life than there were articles dealing directly with those issues. CONCLUSIONS: On the basis of a review of the literature and of over 1000 articles, ophthalmologists do not appear to give much priority to issues of quality of life or health. How validly these conclusions can be generalized to general clinicians is not known.