Shifting Sociodemographic Characteristics of a Phase I Clinical Trial Population at an NCI-Designated Comprehensive Cancer Center in the Southeast.

Racial and ethnic minority populations are consistently under-represented in oncology clinical trials despite comprising a disproportionate share of a cancer burden. Phase I oncology clinical trials pose a unique challenge and opportunity for minority inclusion. Here we compared the sociodemographic characteristics of patients participating in phase 1 clinical trials a National Cancer Institute ( NCI)-designated comprehensive center to all patients at the center, patients with new cancer diagnosis in metropolitan Atlanta and patients with new cancer diagnoses in the state of Georgia. From 2015 to 2020, 2325 patients (43.4% female, 56.6% male) consented to participate in a phase I trial. Grouped self-reported race distribution was 70.3% White, 26.2% Black, and 3.5% other. Of new patient registrations at Winship Cancer Institute (N = 107 497) (50% F, 50% M), grouped race distribution was 63.3% White, 32.0% Black, and 4.7% other. Patients with new cancer diagnoses in metro Atlanta from 2015 to 2016 (N = 31101) were 58.4% White, 37.2% Black, and 4.3% other. Race and sex distribution of phase I patients was significantly different than Winship patients (P < .001). Over time, percent of White patients decreased in both phase I and Winship groups (P = .009 and P < .001, respectively); percentage of females did not change in either group (P = .54 phase I, P = .063 Winship). Although phase I patients were more likely to be White, male, and privately ensured than the Winship cohort, from 2015 to 2020 the percentage of White patients in phase I trials and among all new patients treated at Winship decreased. The intent of characterizing existing disparities is to improve the representation of patients from racial and ethnic minority backgrounds in phase I clinical trials.

Efficacy of the Novel Formulation of Topical Liothyronine and Liothyronine-Insulin in Mild to Moderate Diabetic Foot Ulcer: A Randomized, Triple-blind Clinical Trial.

BACKGROUND: Diabetic foot ulcer (DFU) is one of the challenging complications of chronic diabetes. OBJECTIVE: The study aimed to investigate whether liothyronine (T3) and liothyronine-insulin (T3/Ins) topical preparations could significantly reduce the healing time of DFU. METHODS: A prospective, randomized, placebo-controlled, patient-blinded clinical trial was conducted on patients with mild to moderate DFU, over a lesion area of no greater than 100 cm2. The patients were randomized to receive T3, T3/Ins, or honey cream 10% as the routine of care twice a day. Patients were examined for tissue healing weekly for 4 weeks, or until the total lesion clearance was observed, whichever was earlier. RESULTS: Of 147 patients with DFUs, 78 patients (26 per group) completed the study and were included in the final evaluation. At the time of study termination, all participants in each of the T3 or T3/Ins groups were free of symptoms based on the REEDA score, while about 40% of participants in the control group were detected with each of grades 1, 2, or 3. A significant difference was observed on days 7, 14, and 21 of consumption of topical preparations (P-value < 0.001). The mean time to complete wound closure in the routine care group was about 60.6 days, while it was 15.9 and 16.4 days in T3 and T3/Ins groups, respectively. Within the T3 and T3/Ins groups, significant earlier wound closure was detected at day 28 (P-value < 0.001). CONCLUSION: T3 or T3/Ins topical preparations are effective for wound healing and acceleration of wound closure in mild to moderate DFUs.

Intervenciones para reducir el consumo de alcohol en jóvenes universitarios: una revisión integrativa / Interventions to Reduce University Students' Alcohol Consumption: Integrative Review / Intervenções para reduzir o consumo de álcool em universitários: uma revisão integrativa

Introducción: el consumo nocivo y excesivo de alcohol en los jóvenes ha sido reconocido como un comportamiento de riesgo significativo, por tanto, reducir el consumo y los problemas asociados es una prioridad entre los investigadores, educadores y profesionales de la salud que trabajan con esta población. Objetivo: examinar la evidencia actual sobre las intervenciones para reducir el consumo de alcohol de jóvenes universitarios. Método: se utilizó la metodología propuesta por Toronto y Remington. Para la evaluación y selección de los artículos cuantitativos se empleó el Instrumento de Criterios de Elegibilidad para la Selección de los Artículos de Investigación (ICrESAI) y para la evaluación de los ensayos clínicos aleatorizados se empleó la lista de verificación Estándares Consolidados de Informes de Ensayos (Consort). Resultados: se encontraron trece artículos, diez de ellos ensayos clínicos aleatorizados, dos cuantitativos longitudinales y un ensayo factorial. Conclusión: se encontró una gran variedad de diseños y propuestas de intervención, dentro de las cuales se demostró que las intervenciones breves entregadas de manera digital, tanto en la web, como en teléfonos inteligentes, son efectivas para reducir el consumo de riesgo de alcohol entre los jóvenes.

Introduction: Harmful and excessive alcohol consumption in young people has been recognized as a significant risk behavior, therefore, reducing consumption and associated problems is a priority among researchers, educators and health professionals who work with this population. Objective: To examine the current evidence on interventions to reduce alcohol consumption in university students. Method: The methodology proposed by Toronto and Remington was used. For the evaluation and selection of quantitative articles, the Instrument of Eligibility Criteria for the Selection of Research Articles (ICrESAI) was used, and for the evaluation of randomized clinical trials the Consolidated Standards of Trial Reporting (Consort) Checklist was applied. Results: A total of thirteen articles were found, ten of them randomized clinical trials, two quantitative longitudinal studies and one factorial trial. Conclusion: A wide variety of intervention designs and proposals were found, within which it was shown that brief interventions delivered digitally, both on the web and on smartphones, are effective for reducing alcohol risk consumption among youth.

Introdução: o consumo nocivo e excessivo de álcool em jovens tem sido reconhecido como um comportamento de risco significativo, portanto, reduzir o consumo e os problemas associados é uma prioridade entre pesquisadores, educadores e profissionais de saúde que trabalham com essa população. Objetivo: examinar as evidências atuais sobre intervenções para reduzir o consumo de álcool em estudantes universitários. Método: Utilizou-se a metodologia proposta por Toronto e Remington, para avaliação e seleção de artigos quantitativos utilizou-se o Instrumento de Critérios de Elegibilidade para Seleção de Artigos de Pesquisa (ICrESAI) e para avaliação de ensaios clínicos randomizados. Lista de verificação de Normas Consolidadas de Relatórios de Ensaios (CONSORT). Resultados: Foram encontrados 13 artigos, sendo dez ensaios clínicos randomizados, dois quantitativos longitudinais e um fatorial. Conclusão: Foi encontrada uma grande variedade de desenhos e propostas de intervenção, dentro dos quais foi demonstrado que intervenções breves entregues digitalmente, tanto na web como em smartphones, são eficazes na redução do consumo de risco de álcool entre os jovens.

The Effect of Intravenous Magnesium Sulphate as an Adjuvant in the Treatment of Acute Exacerbations of COPD in the Emergency Department: A Double-Blind Randomized Clinical Trial.

BACKGROUND: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are serious complications that often require immediate intervention in an emergency department (ED). The aim of this study was to investigate the effect of intravenous magnesium sulphate as an adjuvant in the treatment of AECOPD in the ED. METHODS: In a double-blind, randomized clinical trial, a total of 60 patients with AECOPD presenting to the ED of Imam Khomeini Hospital in Sari, Iran, were included. The study was conducted between September 2016 and February 2018. Eligible patients were randomly allocated into two groups of intervention and control. Patients in the intervention and control groups received intravenous infusion of magnesium sulfate (2 gr) or normal saline over 30 minutes, respectively. For all patients, Borgdyspnea score, forced expiratory volume in one second (FEV1) result and clinical variables of interest were evaluated before the beginning of the intervention, and also 45 minutes and 6 hours after the commencement of intervention. RESULTS: Regardless of time of evaluation, pulse rate (PR), respiratory rate (RR) and Borg score in intervention group was lower than control group. Also, FEV1 and SPO2 were greater in intervention group compared to control group. However, these differences were not statistically significant (between-subject differences or group effect) (p<0.001). The trends of FEV1, SPO2, PR, RR and Borg score were similar between two groups of study (no interaction effect; P>0.05). CONCLUSION: According to the results of this study, it seems that using intravenous magnesium sulfate has no significant effect on SPO2, FEV1, RR, and PR of patients with AECOPD who presented to ED.

Safety and efficacy of nusinersen in spinal muscular atrophy: The EMBRACE study.

INTRODUCTION: The EMBRACE study (Clinical Trials No. NCT02462759) evaluated nusinersen in infants/children with infantile- or later-onset spinal muscular atrophy (SMA) who were ineligible for the ENDEAR and CHERISH studies. METHODS: Participants were randomized to intrathecal nusinersen (12-mg scaled equivalent dose; n = 14) or sham procedure (n = 7) in part 1 (~14 months) and subsequently received open-label nusinersen for ~24 months in part 2 of the study. RESULTS: Part 1 was stopped early after the demonstration of motor function benefit with nusinersen in ENDEAR. There were no nusinersen-related adverse events (AEs) and no study discontinuations due to nusinersen-related AEs. The most common AEs included pyrexia, cough, pneumonia, and upper respiratory tract infections. Motor milestone responder rates were higher in those receiving nusinersen at last available assessment (93%) than in those receiving sham procedure in part 1 (29%) or transitioned from sham to nusinersen in part 2 (83%). This functional improvement was observed despite the small sample size and shortened part 1 trial duration that undermined the power of the study to demonstrate such treatment effects at a significant level. DISCUSSION: Nusinersen demonstrated a favorable long-term benefit-risk profile in this broad population of individuals with infantile- or later-onset SMA.

The effects of the Paleolithic Diet on obesity anthropometric measurements / Efeito da Dieta Paleolítica em medidas antropométricas de obesos

Abstract Comparing the effects of Paleolithic Diet (PD) and of a Guidelines Substantiated Diet (GSD) on anthropometric indicators of obese individuals. Randomized clinical trial. Obese patients were divided into two groups based on dietary prescription: PD and GSD. These diets encompassed 82 and 73 patients, respectively, who were followed-up for 60 days. Anthropometric measurements were taken before the beginning of the trial, at the 30th day of it and at the end of the experimental period. At the 60th experimental day, there was 26.8% treatment abandonment by individuals in group PD and 19.2% by the ones in group GSD; there was not difference between groups (p = 0.684). Weight and height measurements were taken in order to determine body mass index (BMI), waist circumference (WC) and hip circumference (HC), which allowed determining the waist/hip ratio (WHR). There was no initial difference between groups in demographic, socioeconomic, exercising and anthropometric variables (p > 0.05). Group PD recorded the highest weight (p = 0.003), BMI (p = 0.002) and WC (p = 0.033) values at the 30th experimental day. Group PD kept the highest weight loss at the 60th day (p < 0,001), as well as the highest BMI (p < 0.001), WC (p = 0.002) and WHR (p = 0.002) reduction. PD is a feasible option to treat obesity, it led to reduced anthropometric markers. Other studies are necessary to assure the safety of its use for longer periods of time.

Resumo Comparação do efeito da Dieta Paleolítica (DP) e da Dieta baseada em Diretrizes (DBD) em indicadores antropométricos de indivíduos obesos. Ensaio clínico randomizado. Pacientes obesos foram divididos em 2 grupos baseados na prescrição dietética: DP e DBD. Estas dietas abrageram 82 e 73 pacientes, respectivamente que foram acompanhados durante 60 dias. Medidas antropométricas foram aferidas anteriormente ao início da intervenção, no 30º dia e no fim da intervenção. No 60º dia de acompanhamento, houve 26,8% de desistência no grupo DP e 19,2% no grupo DBD , não havendo diferença entre os grupos (p= 0.684). Peso e estatura foram aferidas para determinar o Índice de Massa Corporal (IMC), circunferência da cintura (CC), circunferência do quadril (CQ), com os quais foi determinado a relação cintura-quadril (RCQ). Não houve diferença estatística inicial entre os grupos nas variáveis demográficas, socioeconômicas, atividade física e antropométricas (p > 0.05). O grupo DP registrou maior redução de peso (p = 0.003), IMC (p = 0.002) e CC (p = 0.033) no 30º dia de experimento. Grupo DP manteve maior redução de peso no 60º dia (p < 0,001), bem como maior redução de IMC (p < 0.001), CC (p = 0.002) e RCQ (p = 0.002). DP é uma possível opção de tratamento para a obesidade, a qual resultou na redução de marcadores antropométricos. Outros estudos são necessários para verificar seu uso por maiores períodos de tempo.