A Mediterranean diet improves glycation markers in healthy people and in those with chronic diseases: a systematic review of clinical trials.

CONTEXT: Consumption of the Mediterranean diet (MedDiet) has beneficial effects on cardiometabolic health and aging. OBJECTIVE: This systematic review aimed to critically investigate the effect of the MedDiet on glycation markers in healthy or overweight individuals with type 2 diabetes or cardiovascular disease. DATA SOURCES: MEDLINE, EMBASE, Web of Science, and the Cochrane Library were searched, using the terms "Mediterranean diet" AND "glycation end products, advanced". DATA EXTRACTION: Three randomized and 3 nonrandomized clinical trials, containing data on 2935 adult and elderly individuals with normal weight or overweight, were included. All extracted data were compiled, compared, and critically analyzed. DATA ANALYSIS: The authors of most of the studies demonstrated a reduction in serum concentrations of advanced glycation end products (AGEs), such as εN-carboxymethyllysine and methylglyoxal, and in skin autofluorescence levels after at least 4 weeks of adherence to the MedDiet. The MedDiet also led to positive effects on gene expression of receptors for AGEs, as RAGE and AGER1, and an enzyme involved in detoxification (glyoxalase I). There is no evidence that short-term adherence affects glycation markers. CONCLUSIONS: Glycation markers improved in response to the MedDiet. The possible mechanisms involved may be related to the low AGE and refined sugars content of the diet, as well as its high monounsaturated fatty acid, phenolic compound, and dietary fiber contents. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42021284006.

Serosurvey of Coxiella burnetii in Police Officers and Working Dogs in Brazil: Case Report and One Health Implications.

BACKGROUND: Although the Coxiella burnetii infection has been investigated in dogs, its role in human transmission remains to be fully established, particularly in close and daily human-dog contact settings, such as in Police K-9 Units. METHODS: Accordingly, this study aimed to assess anti-C. burnetii antibodies in clinically healthy police officers by an in-house indirect immunofluorescence assay (IFA), and working dogs by a commercial IFA Kit, from the State Special Operations Battalion, Paraná, Southern Brazil. RESULTS: Overall, 1/18 (5.5%) police officers and 9/30 (30.0%; CI 95% 16.66-47.88) dogs tested seropositive to anti-C. burnetii IgG antibodies. CONCLUSIONS: To date, this is the highest prevalence of Q fever seropositivity among military dogs worldwide. Despite the low sampling rate, a statistically significant association was found between seropositivity and female dogs (p = 0.0492). Further studies with larger sample sizes should be conducted to establish the prevalence of Q Fever in other Brazilian K-9 Units. In summary, this study is the first to conduct a concomitant serosurvey of police officers and working dogs, and its findings should be considered a warning for cross-exposure and transmission of Coxiella burnetii among Police K-9 Units in Brazil and worldwide.

Spread and persistence of antimicrobial resistance genes in wastewater from human and animal sources in São Paulo, Brazil.

The spread of antimicrobial resistance (AMR) through multiple reservoirs is a global concern. Wastewater is a critical AMR dissemination source, so this study aimed to assess the persistence of resistance genetic markers in wastewater using a culture-independent approach. Raw and treated wastewater samples (n = 121) from a wastewater treatment plant (WWTP), a human hospital, a veterinary hospital, and a pig farm were monthly collected and concentrated by filtration. DNA was extracted directly from filter membranes, and PCR was used in the qualitative search of 32 antimicrobial resistance genes (ARGs). Selected genes (blaCTX-M, blaKPC, qnrB, and mcr-1) were enumerated by quantitative real-time PCR (qPCR). Twenty-six ARGs were detected in the qualitative ARGs search, while quantitative data showed a low variation of the ARG's relative abundance (RA) throughout the months, especially at the human hospital and the WWTP. At the WWTP, despite significantly reducing the absolute number of gene copies/L after each treatment stage (p < 0.05), slight increases (p > 0.05) in the RAs of genes blaCTX-M, qnrB, and mcr-1 were observed in reused water (tertiary treatment) when compared with secondary effluent. Although the increase is not statistically significant, it is worth noting that there was some level of ARGs concentration after the disinfection process. No significant absolute or relative after-treatment quantification reductions were observed for any ARGs at the veterinary hospital or the pig farm. The spread of ARGs through sewage needs to be continuously addressed, because their release into natural environments may pose potential risks of exposure to resistant bacteria and impact local ecosystems.

CORRELATION OF THE SAGITTAL BALANCE WITH POSTURAL ANALYSIS OF THE PELVIS AND LUMBAR SPINE.

Objective: Evaluate and correlate the sagittal balance parameters with the postural of the pelvis and lumbar spine. Methods: 80 individuals of both sexes, aged between 20 and 35 years, were evaluated. Biophotogrammetry was done with the SAPO software program. Measurements of the sagittal balance parameters were obtained by analyzing a lateral view panoramic radiography of the vertebral column, in which the anatomical points of reference were digitally marked. The calculation of the angles was done automatically by the Keops program. Results: In Keops assessment, 17.5% of the sample had high pelvic incidence angles (> 60°), 31.5% had low pelvic incidence angles (< 45°), and 51.2% had medium pelvic incidence angles (between 46° and 59°). SAPO showed 12,5% lordosis, 40% retroversion, and 47,5% normal curvature. In the right lateral view, pelvic incidence angle had a moderate and positive correlation with vertical alignment of the trunk and with vertical alignment of the body, and a negative and moderate correlation with horizontal alignment of the pelvis. Conclusion: Differences were found between vertical alignment measurements from the postural evaluation system (SAPO). A positive correlation was found between PI from Keops and pelvic anteversion from SAPO. Level of Evidence II; Prospective Study.

Objetivo: Avaliar e correlacionar o equilíbrio sagital com parâmetros posturais da pelve e coluna lombar. Métodos: Foram avaliados 80 indivíduos de ambos os sexos, com idade entre 20 e 35 anos. A biofotogrametria foi realizada com o software SAPO. As medidas dos parâmetros do equilíbrio sagital foram obtidas pela análise de uma radiografia panorâmica em perfil da coluna vertebral, na qual os pontos anatômicos de referência foram marcados digitalmente. O cálculo dos ângulos foi feito automaticamente pelo programa Keops. Resultados: Na avaliação Keops, 17,5% da amostra apresentavam ângulos de incidência pélvicos altos (> 60°), 31,5% tinham ângulos de incidência pélvicos baixos (< 45°) e 51,2% apresentavam ângulos de incidência pélvicos médios (entre 46° e 59°). O SAPO apresentou 12,5% de lordose, 40% de retroversão e 47,5% de curvatura normal. Na vista lateral direita, o ângulo de incidência da pelve apresentou correlação moderada e positiva com o alinhamento vertical do tronco e com o alinhamento vertical do corpo e negativa e moderada com o alinhamento horizontal da pelve. Conclusão: Foram encontradas diferenças entre as medidas de alinhamento vertical do sistema de avaliação postural (SAPO). Uma correlação positiva foi encontrada entre IP de Keops e anteversão pélvica de SAPO. Nível de Evidência II; Estudo Prospectivo.

Novel tetrapolar single-needle electrode for electrochemotherapy in bone cavities: Modeling, design and validation.

Electrochemotherapy is a cancer treatment in which local pulsed electric fields are delivered through electrodes. The effectiveness of the treatment depends on exposing the tumor to a threshold electric field. Electrode geometry plays an important role in the resulting electric field distribution, especially in hard-to-reach areas and deep-seated tumors. We designed and developed a novel tetrapolar single-needle electrode for proper treatment in bone cavities. In silico and in vitro experiments were performed to evaluate the electric field and electric current produced by the electrode. In addition, tomography images of a real case of nasal cavity tumor were segmented into a 3D simulation to evaluate the electrode performance in a bone cavity. The proposed electrode was validated and its operating range was set up to 650 V. In the nasal cavity tumor, we found that the electrode can produce a circular electric field of 3 mm with an electric current of 14.1 A at 500 V, which is compatible with electrochemotherapy standards and commercial equipment.

Development of nanostructured environmentally responsive system containing hydroxypropyl methylcellulose for nose-to-brain administration of meloxicam.

The intranasal administration of drugs using environmentally responsive formulations, employing a combination of hydroxypropyl methylcellulose (HPMC) and poloxamer 407 (P407), can result in release systems that may assist in the treatment of neurological diseases. Meloxicam, considered a potential adjuvant in the treatment of Alzheimer's disease, could be used in these platforms. The aim of this work was to develop a mucoadhesive, thermoresponsive, and nanostructured system containing HPMC for nose-to-brain administration of meloxicam. The initially selected systems were investigated for their rheological, mechanical, and micellar size characteristics. The systems were dilatant at 25 °C and pseudoplastic with a yield value at 37 °C, showing viscoelastic properties at both temperatures. The platform containing HPMC (0.1%, w/w) and P407 (17.5%, w/w) was selected and demonstrated good mucoadhesive properties, along with an appropriate in vitro release profile. HPMC could form a binary system with P407, displaying superior mucoadhesive and thermoresponsive properties for nose-to-brain meloxicam administration, indicating that the selected formulation is worthy of clinical studies.

A native strain of Bacillus subtilis increases lipid accumulation and modulates expression of genes related to digestion and amino acid metabolism in Litopenaeus vannamei.

In the field of shrimp aquaculture, the utilization of probiotics represents a promising avenue, due to the well-documented benefits conferred by these microorganisms. In the current study, a Bacillus subtilis strain, referred to as strain E, was isolated from the gastrointestinal tract of the shrimp Litopenaeus vannamei and subsequently identified via molecular methods and phylogeny. The probiotic potential of strain E was characterized, and its application as a feed shrimp additive was evaluated in a 45-day experiment. Several parameters were assessed, including zootechnical performance, muscle tissue proximate composition, hepatopancreas lipid concentration, and the expression of genes associated with digestion, amino acid metabolism, and antioxidant defense mechanisms in various shrimp tissues. Although no significant impact on zootechnical performance was observed, supplementation with strain E led to an increase in lipid concentration within both muscle and hepatopancreas tissues. Furthermore, a marked decrease in the expression of genes linked to digestion and amino acid metabolism was noted. These findings suggest that the addition of the B. subtilis strain E to shrimp feed may enhance nutrient absorption and modulate the expression of genes related to digestion and amino acid metabolism.

Reference genes for gene expression profiling in mouse models of Listeria monocytogenes infection.

RT-qPCR dissects transcription-based processes but requires reference genes (RGs) for data normalization. This study prospected RGs for mouse macrophages (pMØ) and spleen infected with Listeria monocytogenes. The pMØ were infected in vitro with L. monocytogenes or vehicle for 4 h. Mice were injected with L. monocytogenes (or vehicle) and euthanized 24 h post-injection. The RGs came from a multispecies primer set, from the literature or designed here. The RG ranking relied on GeNorm, NormFinder, BestKeeper, Delta-CT and RefFinder. B2m-H3f3a-Ppia were the most stable RGs for pMØ, albeit RG indexes fine-tuned estimations of cytokine relative expression. Actß-Ubc-Ppia were the best RGs for spleen but modestly impacted the cytokine relative expression. Hence, mouse models of L. monocytogenes require context-specific RGs for RT-qPCR, thus reinforcing its paramount contribution to accurate gene expression profiling.

Mapa de evidências: estratégias efetivas em programas e políticas de alimentação e nutrição / Evidence map: effective strategies in food and nutrition programs and policies

O mapa de evidências foi desenvolvido tendo como referência as nove diretrizes da Política Nacional de Alimentação e Nutrição (PNAN). O objetivo foi identificar intervenções efetivas para melhorar as condições de saúde, alimentação e nutrição da população. Foram analisadas 101 revisões sistemáticas. As intervenções foram classificadas em 5 categorias e 80 subcategorias. Os desfechos foram classificados em 8 categorias e 119 subcategorias. Foram relatados efeitos positivos de 71 subcategorias de intervenção para 94 subcategorias de desfecho. Lacunas: poucas revisões sistemáticas abordaram "Atenção Nutricional" e "Força de Trabalho". Não foram identificadas revisões sistemáticas sobre "Vigilância Alimentar e Nutricional", "Gestão das Ações de Alimentação e Nutrição", "Participação e Controle Social", "Pesquisa, Inovação e Conhecimento em Alimentação e Nutrição".

The evidence map was developed with reference to the nine guidelines of the National Food and Nutrition Policy (PNAN). The objective was to identify effective interventions to improve the health, food and nutrition conditions of the population. 101 systematic reviews were analyzed. Interventions were classified into 5 categories and 80 subcategories. Outcomes were classified into 8 categories and 119 subcategories. Positive effects of 71 intervention subcategories were reported for 94 outcome subcategories. Gaps: few systematic reviews addressed "Nutritional Care" and "Workforce". No systematic reviews were identified on "Food and Nutrition Surveillance", "Management of Food and Nutrition Actions", "Participation and Social Control", "Research, Innovation and Knowledge in Food and Nutrition".

Healing profiles in patients with a chronic diabetic foot ulcer: An exploratory study with machine learning.

Diabetic foot ulcers (DFU) are one of the most frequent and debilitating complications of diabetes. DFU wound healing is a highly complex process, resulting in significant medical, economic and social challenges. Therefore, early identification of patients with a high-risk profile would be important to adequate treatment and more successful health outcomes. This study explores risk assessment profiles for DFU healing and healing prognosis, using machine learning predictive approaches and decision tree algorithms. Patients were evaluated at baseline (T0; N = 158) and 2 months later (T1; N = 108) on sociodemographic, clinical, biochemical and psychological variables. The performance evaluation of the models comprised F1-score, accuracy, precision and recall. Only profiles with F1-score >0.7 were selected for analysis. According to the two profiles generated for DFU healing, the most important predictive factors were illness representations on T1 IPQ-B (IPQ-B ≤ 9.5 and < 10.5) and the DFU duration (≤ 13 weeks). The two predictive models for DFU healing prognosis suggest that biochemical factors are the best predictors of a favorable healing prognosis, namely IL-6, microRNA-146a-5p and PECAM-1 at T0 and angiopoietin-2 at T1. Illness perception at T0 (IPQ-B ≤ 39.5) also emerged as a relevant predictor for healing prognosis. The results emphasize the importance of DFU duration, illness perception and biochemical markers as predictors of  healing in chronic DFUs. Future research is needed to confirm and test the obtained predictive models.

MT1-MMP and TIMP-2 are first expressed in the colon glands after a single dose of azoxymethane (AOM).

Tissue inhibitor of metalloproteinase-2 (TIMP-2) and membrane-type 1-matrix metalloproteinase (MT1-MMP) are always expressed during the cancer process. The aim was to identify which regions of the colon mucosa MT1-MMP and TIMP-2 begin to express themselves, as well as to establish their expression in relation to cell proliferation and mucin production. After intraperitoneal injection of 15 mg/kg of azoxymethane (AOM) at 4, 12, and 20 weeks, histological sections of the middle segment of the rat colon mucosa were evaluated by immunohistochemistry for cell proliferation and expression of MT1-MMP and TIMP-2 and histochemistry for mucin. As a result, a single dose of AOM initially increased the intensity of MT1-MMP and TIMP-2 expression in the conjunctive cells and glands, concurrently with alterations in the distribution of the mucin produced in the gland of the large intestine mucosa and cell proliferation. As a result, at 4 and 12 weeks, a single dose of AOM initially stimulated the expression of MT1-MMP and TIMP-2 in the conjunctive cells and glands with greater intensity. Changes in the cell proliferation and distribution of the mucin produced in the large intestine mucosa gland were observed. We conclude that MT1-MMP and TIMP-2 were first and strongly expressed in all cells of the colon glands, concurrently with an increase in cell proliferation and a diffuse dispersion of mucin, indicating the onset of the dysplasia process following a single dosage of AOM.

Renocardiac Effects of p-Cresyl Sulfate Administration in Acute Kidney Injury Induced by Unilateral Ischemia and Reperfusion Injury In Vivo.

The precise mechanisms underlying the cardiovascular complications due to acute kidney injury (AKI) and the retention of uremic toxins like p-cresyl sulfate (PCS) remain incompletely understood. The objective of this study was to evaluate the renocardiac effects of PCS administration in animals subjected to AKI induced by ischemia and reperfusion (IR) injury. C57BL6 mice were subjected to distinct protocols: (i) administration with PCS (20, 40, or 60 mg/L/day) for 15 days and (ii) AKI due to unilateral IR injury associated with PCS administration for 15 days. The 20 mg/L dose of PCS led to a decrease in renal mass, an increase in the gene expression of Cystatin C and kidney injury molecule 1 (KIM-1), and a decrease in the α-actin in the heart. During AKI, PCS increased the renal injury biomarkers compared to control; however, it did not exacerbate these markers. Furthermore, PCS did not enhance the cardiac hypertrophy observed after 15 days of IR. An increase, but not potentialized, in the cardiac levels of interleukin (IL)-1ß and IL-6 in the IR group treated with PCS, as well as in the injured kidney, was also noticed. In short, PCS administration did not intensify kidney injury, inflammation, and cardiac outcomes after AKI.

Impact of Psychological Distress on Physiological Indicators of Healing Prognosis in Patients with Chronic Diabetic Foot Ulcers: A Longitudinal Study.

Objective: Diabetic foot ulcers (DFUs) are devastating complications of diabetes, responsible for a high number of amputations worldwide. Due to its impact on chronic inflammation, psychological distress may negatively impact the healing process. Thus, this study evaluated the influence of psychological distress on physiological indicators of healing prognosis and the potential of stress-reducing therapies for DFU healing. Approach: Patients with chronic DFU were recruited and assessed at enrollment and 2 months later. According to psychological scores at enrollment, participants were allocated into groups without (group 1) or with (group 3) psychological distress. Participants who reported clinical distress were then randomly allocated into a control (no stress-reducing intervention-group 4) or experimental (with stress-reducing interventions-group 5) group. Subsequently, indicators of healing prognosis were measured. Results: Groups 1 and 3 presented no differences in the Perfusion, Extent, Depth, Infection and Sensation score, glycated hemoglobin, or inflammatory and angiogenic markers. However, the immune cell ratio was increased by more than twofold in group 3, compared with group 1. Importantly, the expression of circulating microRNAs was significantly increased in group 3 (miR-21-5p, miR-155-5p, miR-146a-5p, and miR-221-3p [p < 0.05]), compared with group 1. Two months later, group 5 displayed a significant improvement in the Perceived Stress Scale and Hospital Anxiety and Depression Scale scores (p < 0.01), and the immune cell ratio was decreased by more than 2.5-fold. Innovation: This study helped to identify which variables and psychological interventions are more successful in promoting DFU healing. Conclusion: Psychological distress influenced clinical and physiological parameters, leading to compromised DFU healing and consequently underlining the potential of adjuvant stress-reducing approaches.

Metastasis-associated lung adenocarcinoma transcript 1 molecular mechanisms in gastric cancer progression.

Gastric cancer (GC) remains among the most common cancers worldwide with a high mortality-to-incidence ratio. Accumulated evidence suggests that long noncoding RNAs (lncRNAs) are involved in gastric carcinogenesis. These transcripts are longer than 200 nucleotides and modulate gene expression at multiple molecular levels, inducing or inhibiting biological processes and diseases. Metastasis-associated lung adenocarcinoma transcript 1 (MALAT1) is one of the best-studied lncRNAs with comprehensive actions contributing to cancer progression. This lncRNA regulates gene expression at the transcriptional and posttranscriptional levels through interactions with microRNAs and proteins. In the present review, we discussed the molecular mechanism of MALAT1 and summarized the current knowledge of its expression in GC. Moreover, we highlighted the potential use of MALAT1 as a biomarker, including liquid biopsy.

Genomic and proteomic characterization of vB_SauM-UFV_DC4, a novel Staphylococcus jumbo phage.

Staphylococcus aureus is one of the most relevant mastitis pathogens in dairy cattle, and the acquisition of antimicrobial resistance genes presents a significant health issue in both veterinary and human fields. Among the different strategies to tackle S. aureus infection in livestock, bacteriophages have been thoroughly investigated in the last decades; however, few specimens of the so-called jumbo phages capable of infecting S. aureus have been described. Herein, we report the biological, genomic, and structural proteomic features of the jumbo phage vB_SauM-UFV_DC4 (DC4). DC4 exhibited a remarkable killing activity against S. aureus isolated from the veterinary environment and stability at alkaline conditions (pH 4 to 12). The complete genome of DC4 is 263,185 bp (GC content: 25%), encodes 263 predicted CDSs (80% without an assigned function), 1 tRNA (Phe-tRNA), multisubunit RNA polymerase, and an RNA-dependent DNA polymerase. Moreover, comparative analysis revealed that DC4 can be considered a new viral species belonging to a new genus DC4 and showed a similar set of lytic proteins and depolymerase activity with closely related jumbo phages. The characterization of a new S. aureus jumbo phage increases our understanding of the diversity of this group and provides insights into the biotechnological potential of these viruses. KEY POINTS: • vB_SauM-UFV_DC4 is a new viral species belonging to a new genus within the class Caudoviricetes. • vB_SauM-UFV_DC4 carries a set of RNA polymerase subunits and an RNA-directed DNA polymerase. • vB_SauM-UFV_DC4 and closely related jumbo phages showed a similar set of lytic proteins.

Isolation and Characterization of the Acadevirus Members BigMira and MidiMira Infecting a Highly Pathogenic Proteus mirabilis Strain.

Proteus mirabilis is an opportunistic pathogen and is responsible for more than 40% of all cases of catheter-associated urinary tract infections (CAUTIs). Healthcare-associated infections have been aggravated by the constant emergence of antibiotic-resistant bacterial strains. Because of this, the use of phages to combat bacterial infections gained renewed interest. In this study, we describe the biological and genomic features of two P. mirabilis phages, named BigMira and MidiMira. These phages belong to the Acadevirus genus (family Autographiviridae). BigMira and MidiMira are highly similar, differing only in four missense mutations in their phage tail fiber. These mutations are sufficient to impact the phages' depolymerase activity. Subsequently, the comparative genomic analysis of ten clinical P. mirabilis strains revealed differences in their antibiotic resistance profiles and lipopolysaccharide locus, with the latter potentially explaining the host range data of the phages. The massive presence of antimicrobial resistance genes, especially in the phages' isolation strain P. mirabilis MCS, highlights the challenges in treating infections caused by multidrug-resistant bacteria. The findings reinforce BigMira and MidiMira phages as candidates for phage therapy purposes.

Beyond sleep duration: Sleep timing is associated with BMI among Brazilian adults.

Objectives: To examine the association of sleep duration and timing with BMI among adults. Also, to identify obesogenic and unhealthy behaviors (e.g.diet/sleep quality, physical activity, screen time, smoking) associated with short sleep duration and late bedtime. Participants: Participants (n=755) were part of exploratory, population-based research, with data collection in a virtual environment. Methods: For purposes of characterizing the population we considered short sleepers<7h/night, and the population bedtime median was used to stratify participants into early and late sleepers (before and after 23:08). Student's t-test and chi-square test were performed to assess differences in characteristics between groups. Linear regression analyses were conducted to determine the association of sleep duration, bedtime, and wake-up time with BMI. Quantile regression was estimated for the 25th, 50th, and 75th quantiles to identify the distributional correlations between BMI and sleep variables. Restricted cubic splines were also used to study the shape of the association between sleep-BMI. Analyses were adjusted for potential confounding variables. Results: BMI decreased by 0.40Kg/m2 for each additional hour of sleep duration [95%CI=-0.68,-0.12,p=0.005] and increased by 0.37 kg/m2 for each additional hour of bedtime [95%CI=0.12,0.61,p=0.003]. The association between bedtime and BMI remained even after adjustment for sleep duration. These effects were higher and stronger with higher BMI values (p75th). Wake-up time did not show statistically significant associations. Conclusions: Because we found that beyond sleep duration, bedtime was significantly associated with BMI, our data reflect the pertinence of assessing sleep timing patterns in disentangling sleep-obesity association. Insights into the characteristics, obesogenic and unhealthy behaviors related to short and late sleep may support specific strategies to prevent and treat excess body adiposity and other negative health outcomes.

Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial.

BACKGROUND: Lymphedema is a common complication following breast cancer treatment. The aim of this study is to evaluate the effectiveness of a self-adjusting compression garment (ReadyWrap®) in reducing (phase 1) and maintaining (phase 2) upper limb volume in women presenting breast cancer-related lymphedema. METHODS: This study will comprise a randomized, controlled, single-blind clinical trial concerning women with breast cancer-related lymphedema undergoing treatment at a public cancer treatment reference hospital in the city of Rio de Janeiro, Brazil. The intervention will be carried out by adapting self-dressing versus the standard treatment of compressive bandaging (phase 1) and compressive mesh (phase 2). Both groups will be assessed at the beginning and end of intensive treatment and followed up for up to 12 months to evaluate immediate and late outcomes. Assessments will be carried out by physical upper limb examination (inspection, palpation, volume, dynamometry, and thermography) and questionnaires application to assess patient's quality of life pertaining to the health, functionality, and symptoms of the affected upper limb, as well adverse effects and adherence to treatment. Data will be analyzed descriptively and analytically through univariate and multiple linear regressions. P values < 0.05 will be considered statistically significant. DISCUSSION: This study will evaluate the effectiveness of a self-adjustable garment (ReadyWrap®) in the treatment of lymphedema secondary to breast cancer in Brazilian women compared to the gold standard treatment for limb volume reduction (phase 1) and maintenance (phase 2) phases comprising, respectively, a compressive bandaging and a compressive mesh. The outcome results will provide data based on both quantitative responses and self-reported participant outcomes. The study will also assess the cost-effectiveness of the ReadyWrap® treatment versus standard care. Finally, we expect to reaffirm one more product/therapy as a treatment for this extremely complex and impactful condition following the data analysis. TRIAL REGISTRATION: NCT04934098 [Clinical trials phase 1]. Registered on June 22, 2021. NCT04881604 [Clinical trials phase 2]. Registered on May 11, 2021.

Effectiveness of individualized counseling on the duration of exclusive breastfeeding: study protocol for a multicenter, randomized, parallel, and open clinical trial.

BACKGROUND: Despite the benefits of breastfeeding, early weaning is a reality, so less than 50% of children worldwide and in Brazil are on exclusive breastfeeding in the sixth month of life. A strategy to counteract this scenario is breastfeeding counseling. This study aims to verify the effectiveness of individualized counseling by nurses trained in breastfeeding counseling, on the duration of exclusive breastfeeding, compared to standard care. METHODS: Multicenter, randomized, parallel, and open clinical trial, with primiparous women aged over 18 years, hospitalized in rooming-in wards at participating centers and hemodynamically stable, aware, and oriented, who had a single-fetus pregnancy and gave birth, regardless of the type of delivery, with live child, gestational age of 37 to 42 weeks and birth weight greater than 2500 g. The women will be initially approached in rooming-in wards and, upon consent to participate in the study, will be allocated through randomization by blocks composed of eight participants in two groups: intervention and control. The randomization lists will be organized by a central without involvement with the study, which will manage the allocation groups and be prepared in the Randon® program. Women allocated to the intervention group will receive breastfeeding counseling by trained nurses, and those in the control group will receive standard care at the center participating in the study. DISCUSSION: The results can contribute to breastfeeding by evidencing possible exclusivity and duration of the counseling trained nurses provide. TRIAL REGISTRATION: REBEC RBR-4w9v5rq (UTN: U1111-1284-3559) ( https://ensaiosclinicos.gov.br/rg/RBR-4w9v5rq ). Posted on March 20, 2023.

Boosting the photodynamic activity of erythrosine B by using thermoresponsive and adhesive systems containing cellulose derivatives for topical delivery.

Erythrosine displays potential photodynamic activity against microorganisms and unhealthy cells. However, erythrosine has high hydrophilicity, negatively impacting on permeation through biological membranes. Combining biological macromolecules and thermoresponsive polymers may overcome these erythrosine-related issues, enhancing retention of topically applied drugs. The aim of this work was to investigate the performance of adhesive and thermoresponsive micellar polymeric systems, containing erythrosine in neutral (ERI) or disodium salt (ERIs) states. Optimized combinations of poloxamer 407 (polox407) and sodium carboxymethylcellulose (NaCMC) or hydroxypropyl methylcellulose (HPMC) were used as platforms for ERI/ERIs delivery. The rheological and mechanical properties of the systems was explored. Most of the formulations were plastic, thixotropic and viscoelastic at 37 °C, with suitable gelation temperature for in situ gelation. Mechanical parameters were reduced in the presence of the photosensitizer, improving the softness index. Bioadhesion was efficient for all hydrogels, with improved parameters for mucosa in contrast to skin. Formulations composed of 17.5 % polox407 and 3 % HPMC or 1 % NaCMC with 1 % (w/w) ERI/ERIs could release the photosensitizer, reaching different layers of the skin/mucosa, ensuring enough production of cytotoxic species for photodynamic therapy. Functional micelles could boost the photodynamic activity of ERI and ERIs, improving their delivery and contact time with the cells.