Pilot scale production of high-content mycoprotein using Rhizopus microsporus var. oligosporus by submerged fermentation and agro-industrial by-products.

While mycoprotein has gained traction as a human food source, its potential as a nutrient for animals remains largely unexplored. The mycoprotein-producing Rhizopus microsporus var. oligosporus, a fungus traditionally used for human food in Indonesia, is promising. It could revolutionise animal nutrition once it is Generally Recognized as Safe (GRAS) and is a biosafety level 1 (BSL1) organism. To enhance sustainably, we propose using sugar cane molasses (SM) and corn steep liquor (CSL) as nutrient sources. Also, we investigated the growth of R. microsporus var. oligosporus in five 14 L external-loop airlift bioreactors using CSL as the sole nutrient source. After 96 h of fermentation, at 25 °C and 0.5 vvm, the mycelium produced had an average biomass yield of 38.34 g L-1, with 70.18 % (m v-1) crude protein (mycoprotein). This bioprocess, which is scalable and economically viable, produces high amounts of mycoprotein for animal feed using CSL, a cost-effective agro-industrial by-product, providing a practical solution to the growing demand for animal protein.

Infrared spectroscopy as a new approach for early fabry disease screening: a pilot study.

BACKGROUND: Fabry disease (FD) is a rare X-linked lysosomal storage disorder marked by alpha-galactosidase-A (α-Gal A) deficiency, caused by pathogenic mutations in the GLA gene, resulting in the accumulation of glycosphingolipids within lysosomes. The current screening test relies on measuring α-Gal A activity. However, this approach is limited to males. Infrared (IR) spectroscopy is a technique that can generate fingerprint spectra of a biofluid's molecular composition and has been successfully applied to screen numerous diseases. Herein, we investigate the discriminating vibration profile of plasma chemical bonds in patients with FD using attenuated total reflection Fourier-transform IR (ATR-FTIR) spectroscopy. RESULTS: The Fabry disease group (n = 47) and the healthy control group (n = 52) recruited were age-matched (39.2 ± 16.9 and 36.7 ± 10.9 years, respectively), and females were predominant in both groups (59.6% and 65.4%, respectively). All patients had the classic phenotype (100%), and no late-onset phenotype was detected. A generated partial least squares discriminant analysis (PLS-DA) classification model, independent of gender, allowed differentiation of samples from FD vs. control groups, reaching 100% sensitivity, specificity and accuracy. CONCLUSION: ATR-FTIR spectroscopy harnessed to pattern recognition algorithms can distinguish between FD patients and healthy control participants, offering the potential of a fast and inexpensive screening test.

Kinect-Based Gait Analysis System Design and Concurrent Validity in Persons with Anterolateral Shoulder Pain Syndrome, Results from a Pilot Study.

As part of an investigation to detect asymmetries in gait patterns in persons with shoulder injuries, the goal of the present study was to design and validate a Kinect-based motion capture system that would enable the extraction of joint kinematics curves during gait and to compare them with the data obtained through a commercial motion capture system. The study included eight male and two female participants, all diagnosed with anterolateral shoulder pain syndrome in their right upper extremity with a minimum 18 months of disorder evolution. The participants had an average age of 31.8 ± 9.8 years, a height of 173 ± 18 cm, and a weight of 81 ± 15 kg. The gait kinematics were sampled simultaneously with the new system and the Clinical 3DMA system. Shoulder, elbow, hip, and knee kinematics were compared between systems for the pathological and non-pathological sides using repeated measures ANOVA and 1D statistical parametric mapping. For most variables, no significant difference was found between systems. Evidence of a significant difference between the newly developed system and the commercial system was found for knee flexion-extension (p < 0.004, between 60 and 80% of the gait cycle), and for shoulder abduction-adduction. The good concurrent validity of the new Kinect-based motion analysis system found in this study opens promising perspectives for clinical motion tracking using an affordable and simple system.

Impact of different blood pressure targets on cerebral hemodynamics in septic shock: A prospective pilot study protocol-SEPSIS-BRAIN.

INTRODUCTION: Septic shock, a life-threatening condition, can result in cerebral dysfunction and heightened mortality rates. In these patients, disturbances in cerebral hemodynamics, as reflected by impairment of myogenic cerebral autoregulation (CA), metabolic regulation, expressed by critical closing pressure (CrCP) and reductions in intracranial compliance (ICC), can adversely impact septic shock outcomes. The general recommendation is to maintain a target mean arterial pressure (MAP) of 65 mmHg but the effect of different MAP targets on cerebral hemodynamics in these patients is not clear and optimal targets might be dependent on the status of CA. This protocol aims to assess the cerebral hemodynamics profile at different pressure targets in septic shock patients. METHODS: Prospective, non-randomized, single-center trial, which will study cerebral hemodynamics in patients with septic shock within 48 hours of its onset. Patients will be studied at their baseline MAP and at three MAP targets (T1: 65, T2: 75, T3: 85 mmHg). Cerebral hemodynamics will be assessed by transcranial Doppler (TCD) and a skull micro-deformation sensor (B4C). Dynamic CA will be expressed by the autoregulation index (ARI), calculated by transfer function analysis, using fluctuations of MAP as input and corresponding oscillations in cerebral blood velocity (CBv). The instantaneous relationship between arterial blood pressure and CBv will be used to estimate CrCP and resistance-area product (RAP) for each cardiac cycle using the first harmonic method. The B4C will access ICC by intracranial pressure waveforms (P2/P1). The primary aim is to assess cerebral hemodynamics (ARI, CrCP, RAP, and P2/P1) at different targets of MAP in septic shock patients. Our secondary objective is to assess cerebral hemodynamics at 65mmHg (target recommended by guidelines). In addition, we will assess the correlation between markers of organ dysfunction (such as lactate levels, vasoactive drugs usage, SOFA score, and delirium) and CA. ETHICS AND DISSEMINATION: The results of this study may help to understand the effect of the recommended MAP and variations in blood pressure in patients with septic shock and impaired CA and ICC. Furthermore, the results can assist large trials in establishing new hypotheses about neurological management in this group of patients. Approval was obtained from the local Ethics Committee (28134720.1.0000.0048). It is anticipated that the results of this study will be presented at national and international conferences and will be published in peer-reviewed journals in 2024 and 2025. TRIAL REGISTRATION: Trial registration number: NCT05833607. https://clinicaltrials.gov/study/NCT05833607.

Perceptions and attitudes about the contribution of the environment to childhood cancer: a pilot study in a medical guild and undergraduate students.

BACKGROUND: Identifying and recognizing environmental risk factors for childhood cancer is crucial to prevent it. Medical guild are the first contact to monitor children's health. Therefore, courses about the contribution of chemical toxins in the environment and health outcomes such as cancer should be included in their professional training. This study aimed to evaluate the perceptions and attitudes of a medical guild and undergraduate students in health sciences about the contribution of the environment to childhood cancer. METHODS: A pilot study was conducted, an online survey including thirteen questions was shared among medical guild members and undergraduate students in health sciences. Frequencies, percentages, and chi-square homogeneity tests were calculated to compare groups. RESULTS: Genetic factors ranked as the first possible cause of childhood cancer (88.2% medical guild and 97.7% undergraduate students). However, 70.6% of medical guild and 64.6% of undergraduate students reported that they have ever suspected that childhood cancer could be related to the environmental conditions in which children live. More than 95% of the participants reported that they would find it useful to have more knowledge about environmental risks and cancer. When data were analyzed by profession (medical guild) and academic year (undergraduate students), no significant differences were observed. Nonetheless, comparisons by academic discipline between undergraduate students, showed that a higher percentage of medicine and environmental sciences and health (over 98%) reported environmental exposure as risk factors associated with childhood cancer compared to 75% from physiotherapy, (p = 0.001). CONCLUSIONS: In this study, the environmental contribution to childhood cancer is not clear among the medical guild and undergraduate students. They should be trained on the topic of cancer and the environment.

Effect of three group interventions on psychosocial functioning in adolescents exposed to interpersonal violence in Chile: A pilot clinical trial.

BACKGROUND: In Chile demand for specialist care following exposure to interpersonal violence (IPV) in youth far exceeds capacity. Group interventions may improve access to care for youth. OBJECTIVE: To evaluate the effectiveness and acceptability of two low-intensity group interventions: Trama Focused Cognitive Behavioral Therapy (TF-CBT); Interpersonal Psychotherapy (IPT); and treatment as usual, Art therapy-based support (ATBS). Outcomes measured were post-traumatic stress symptoms, depression, interpersonal functioning and affect regulation. PARTICIPANTS AND SETTING: Participants were 67 Chilean youth aged 13-17 years, victims of IPV on a waiting list to receive specialist individual intervention. METHODS: Using a randomised controlled trial design, participants were randomly assigned to one of the interventions. Self-report measures were completed at 5 timepoints between baseline and follow up eight weeks after intervention ended. Dropout rates and attendance were also analysed. RESULTS: TF-CBT showed significant decreases for PTSD (d = 0.91) and depression (d = 0.77) symptoms, sustained at follow-up with affect regulation problems also showing significant decrease from baseline (d = 0.43). IPT showed significant decreases in PTSD symptoms (d = 0.64) and affect regulation problems (d = 0.66), both sustained at follow-up. ATBS showed statistically significant decrease for PTSD (d = 0.79) and interpersonal problems (d = 0.65) but only change in PTSD was sustained at follow-up. There were no significant differences in dropout or attendance between the interventions. CONCLUSION: Group interventions provide a viable and effective first-phase option for reducing psychological distress in IPV-exposed youth in high-demand contexts. Effectiveness may be further improved through the more active involvement of parents and carers.

Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mí, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial.

BACKGROUND: HIV disproportionately affects sexual minority men (SMM; eg, gay, bisexual, and other men who have sex with men) in Lima, Peru; epidemiological data estimate that 32% to 39% of new HIV infections occur among adult cisgender SMM within primary partnerships (ie, male couples). Most HIV prevention-care research in Lima, Peru, has focused on SMM as individuals and not couples. To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral intervention (DHI) for adult cisgender SMM couples in Lima, Peru. The P3 DHI is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention care plan that aligns with their explicit sexual agreement. The P3 DHI is theoretically informed, self-guided, directed, sequential, and fully automated. OBJECTIVE: This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples' formation and adherence to a detailed prevention care plan containing evidence-based strategies that also aligns with their explicit sexual agreement over time. In addition, the feasibility of enrollment and retention and couples' acceptability of P3 will be assessed. METHODS: The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. After baseline, 60 enrolled SMM couples will be randomized to 1 of 2 conditions. Couples randomized to the unmatched, delayed control condition will receive access to the P3 DHI to use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to the P3 DHI for 6 months. Study assessments will occur at baseline and months 3 and 6. Descriptive, comparative, qualitative, and longitudinal analyses using generalized linear mixed-effect, multilevel, and actor-partner interdependence models will be conducted to address the specific aims. RESULTS: The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and ended in April 2024. A total of 74 adult cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% (68/74) at month 6. Data are currently being analyzed to address the 3 specific aims regarding feasibility, acceptability, and preliminary efficacy. CONCLUSIONS: Findings from this research will reveal whether couples deemed the P3 DHI to be acceptable. Findings will also highlight the preliminary efficacy of the P3 DHI on couples managing their vulnerability to HIV and other sexually transmitted infections (STIs) over time via alignment of their prevention-care plan and sexual agreement. Trial findings will help shape the future direction of the P3 DHI while addressing the existing gap in prevention and care services for couples in the local context. TRIAL REGISTRATION: ClinicalTrials.gov NCT05873855; https://clinicaltrials.gov/study/NCT05873855. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63106.

Topical tacrolimus orabase versus topical clobetasol propionate orabase in the treatment of symptomatic oral lichen planus: a pilot randomized study.

OBJECTIVES: This pilot study aimed to compare the efficacy of 0.1% tacrolimus and 0.05% clobetasol propionate in orabase for treating symptomatic oral lichen planus (OLP). MATERIALS AND METHODS: Pilot, randomized, and controlled study conducted on 21 patients with symptomatic OLP, selected according to the clinical and histopathological criteria of Cheng et al. 2016. Twelve patients received 0.1% tacrolimus, and nine received 0.05% clobetasol, both in orabase for 30 days with a two-month follow-up. The patients were examined for scores of signs (ODSS), symptoms (VAS), quality of life (OHIP-14), anxiety (Beck Anxiety Scale), and treatment satisfaction (Hedonic Scale). RESULTS: Both treatments were effective in reducing ODSS, VAS, and Beck Anxiety Scale scores and performed well on the hedonic scale, yet without statistical difference between them. However, at the 1-month follow-up, patients in group Clobetasol showed a greater percentage reduction in ODSS score compared to baseline by 50% (p = 0.02) and significantly lower average values (p = 0.03) than those in group Tacrolimus. Longitudinal intragroup analysis revealed significant improvements over time in both groups for ODSS, and only in the tacrolimus group for OHIP-14 and Beck scores. CONCLUSIONS: Both tested protocols were effective over a three-month follow-up. However, due to the lower cost of clobetasol propionate it can be considered the first-choice option. Tacrolimus in orabase formulation may be a promising alternative for refractory lesions that do not respond to topical steroids. CLINICAL RELEVANCE: Managing symptomatic OLP is challenging. Comparisons between tacrolimus and clobetasol propionate in orabase formulations have not yet been thoroughly explored.

Nutraceutical Capsules LL1 and Silymarin Supplementation Act on Mood and Sleep Quality Perception by Microbiota-Gut-Brain Axis: A Pilot Clinical Study.

Stress, unhealthy lifestyle, and sleep disturbance worsen cognitive function in mood disorders, prompting a rise in the development of integrative health approaches. The recent investigations in the gut-brain axis field highlight the strong interplay among microbiota, inflammation, and mental health. Thus, this study aimed to investigate a new nutraceutical formulation comprising prebiotics, minerals, and silymarin's impact on microbiota, inflammation, mood, and sleep quality. The study evaluated the LL1 + silymarin capsule supplementation over 180 days in overweight adults. We analyzed the fecal gut microbiota using partial 16S rRNA sequences, measured cytokine expression via CBA, collected anthropometric data, quality of life, and sleep questionnaire responses, and obtained plasma samples for metabolic and hormonal analysis at baseline (T0) and 180 days (T180) post-supplementation. Our findings revealed significant reshaping in gut microbiota composition at the phylum, genus, and species levels, especially in the butyrate-producer bacteria post-supplementation. These changes in gut microbiota were linked to enhancements in sleep quality, mood perception, cytokine expression, and anthropometric measures which microbiota-derived short-chain fatty acids might enhance. The supplementation tested in this study seems to be able to improve microbiota composition, reflecting anthropometrics and inflammation, as well as sleep quality and mood improvement.

Confocal Laser Endomicroscopy as a method for assessing endometriosis: A pilot study.

OBJECTIVES: To validate probe-based Confocal Laser Endomicroscopy (pCLE) as a method in assessing endometriosis during conventional and robot-assisted laparoscopy. STUDY DESIGN: Pilot study, including five women in Hospital Moriah, São Paulo, Brazil. During laparoscopic procedures, pCLE was used to assess endometriosis lesions, complemented by subsequent histological evaluations. 214 optical biopsies were performed. These assessments contributed to the development of a comparative atlas, which was used by surgeons to respond to a questionnaire to identify specific cellular structures related to endometriosis in selected confocal images. RESULTS: The patients had an average age of 35, exhibiting predominant symptoms like dysmenorrhea and dyspareunia. Despite varied familiarity with pCLE, surgeons demonstrated positive acceptance of the method, with 63.1% recommending its use for intraoperative diagnosis. The technique was particularly noted for its ability to provide real-time, detailed images aiding the identification of endometriosis and associated structures like adipocytes and vascularization, with average evaluation scores exceeding 8 of 10. CONCLUSIONS: This study underscores pCLE's potential as a transformative diagnostic tool in minimally invasive gynecological surgery. It highlights the feasibility and initial acceptance among surgeons, emphasizing the need for further improvements in device durability and cost-effectiveness. pCLE promises significant advancements in the diagnosis and management of endometriosis, suggesting a future direction for clinical applications and technological refinement.

Creatine Supplementation Prior to Strength Exercise Training Is Not Superior in Preventing Muscle Mass Loss Compared with Standard Nutritional Recommendations in Females After Bariatric Surgery: A Pilot Study.

BACKGROUND: This study examines whether creatine supplementation combined with strength training mitigates muscle mass loss in women during early rehabilitation post-bariatric surgery, as its effectiveness remains untested in this context. METHODS: Fifteen women (37.8 ± 9.6 years; BMI, 38.8 ± 5.6 kg/m2) completed the intervention (creatine group = 7; placebo group = 8). Both groups followed a strength training program three times a week for 8 weeks. The dosage for both the creatine and placebo was 8 g prior to each exercise session. Body weight, skeletal muscle mass, fat mass, handgrip strength, and physical activity levels were measured before and after the intervention. RESULTS: The creatine group showed a reduction of 9.5 ± 1.5 kg in body weight, with a 0.72 ± 0.6 kg decrease in muscle mass and an 8.64 ± 1.2 kg reduction in fat mass. The placebo group had a reduction of 9.6 ± 3.5 kg in body weight, with a 0.6 ± 1.2 kg decrease in muscle mass and an 8.88 ± 3.2 kg reduction in fat mass, without significant differences between groups (p > 0.05). CONCLUSION: The pre-session strength exercise training creatine supplementation is not superior to placebo regarding body weight and fat mass losses and the attenuation of muscle mass loss during the first weeks of rehabilitation following bariatric surgery.

The effectiveness of a contextually grounded social emotional learning program in Haiti: A pilot cluster randomized control trial.

Social emotional learning (SEL) has a robust evidence basis, but there remains a large gap in literature on the effectiveness of programs across educational settings in low- and middle-income countries and conflict-affected settings. The present study was a pilot trial aimed at evaluating the effects of a classroom based SEL program on dimensions of classroom climate and individual student social emotional skills. In the present study, fourth through sixth grade classrooms in 10 schools (N = 39 teachers, 75.68% female; N = 1048 students, 62.3% female) were randomly allocated to the SEL or wait-list control condition. The SEL program was associated with significant improvements in teacher reports of student achievement orientation (dr = 1.21) and responsible decision-making (dr = 0.49). There were no significant differences between conditions on peer sensitivity, teacher-pupil interactions, student interpersonal skills, or overall social emotional skills. Findings suggest that this community-developed, contextually relevant SEL curriculum may hold promise even in the context of ongoing adversity, including the COVID-19 pandemic and heightened insecurity due to political violence.

Pilot implementation of a telehealth course for health professions students.

OBJECTIVES: This study examined the level of technology proficiency amongst healthcare professions students. Additionally, the study provides an evaluation of the pilot implementation, as well as the effect of a 7-module telehealth course on the level of adoption and future use of telehealth amongst future Australian healthcare workforce. METHODS: Students from four health-sciences departments at the University of Melbourne, Australia, participated in this pilot study by completing the course and an online questionnaire, which included both structured and open-ended questions. The questionnaire included: 12-items on socio-demographic and Internet utilization; 34-items about acceptance and use of telehealth adapted from the Unified Theory of Acceptance and Use of Technology (UTAUT2) questionnaire; and 22-items about confidence in using the Internet and ICT, adapted from Technology Proficiency Self-Assessment Questionnaire for 21st Century Learning (TPSA-C-21). RESULTS: The evaluation included 26 students who expressed confidence in their Internet/ICT skills They showed enthusiasm for telehealth and recognized its potential benefits, but also emphasized the value of face-to-face interactions. They requested information on legal and aspects and additional learning. Post-test assessments indicated improvements in overall acceptance and use attitudes towards telehealth and on six dimensions of the UTAUT2 instrument. Participation in the course indicated improvements in students' overall acceptance and use attitudes and on six of the ten dimensions of the UTAUT2 instrument (p < 0.05). CONCLUSION: This preliminary evaluation indicated that the telehealth course was a positive and enjoyable learning experience for students with appropriate structure and information. The course was successful in improving students' acceptance and use of health technology. The study identified areas in which further development might be required. As such, the course represents a helpful approach for telehealth training among health professions students. Further evaluation with larger samples is required.

Can electroencephalography (EEG) identify the different dimensions of pain in fibromyalgia? A pilot study.

BACKGROUND: Electroencephalography (EEG) is a promising tool for identifying the physiological biomarkers of fibromyalgia (FM). Evidence suggests differences in power band and density between individuals with FM and healthy controls. EEG changes appear to be associated with pain intensity; however, their relationship with the quality of pain has not been examined. We aimed to investigate whether abnormal EEG in the frontal and central points of the 10-20 EEG system in individuals with FM is associated with pain's sensory-discriminative and affective-motivational dimensions. The association between EEG and the two dimensions of emotional disorders (depression and anxiety) was also investigated. METHODS: In this cross-sectional pilot study, pain experience (pain rating index [PRI]) and two dimensions of emotional disorders (depression and anxiety) were assessed using the McGill Pain Questionnaire (PRI-sensory and PRI-affective) and Hospital Anxiety and Depression Scale (HADS), respectively. In quantitative EEG analysis, the relative spectral power of each frequency band (delta, theta, alpha, and beta) was identified in the frontal and central points during rest. RESULTS: A negative correlation was found between the relative spectral power for the delta bands in the frontal (r= -0.656; p = 0.028) and central points (r= -0.624; p = 0.040) and the PRI-affective scores. A positive correlation was found between the alpha bands in the frontal (r = 0.642; p = 0.033) and central points (r = 0.642; p = 0.033) and the PRI-affective scores. A negative correlation between the delta bands in the central points and the anxiety subscale of the HADS (r = -0.648; p = 0.031) was detected. CONCLUSION: The affective-motivational dimension of pain and mood disorders may be related to abnormal patterns of electrical activity in patients with FM. TRIAL REGISTRATION: Retrospectively registered on ClinicalTrials.gov (NCT05962658).

Less experienced observers assess piglet castration-induced acute pain differently than experienced observers: A pilot study.

Behavioral pain scales have been helpful for standardized swine pain assessment. However, it is still unknown if observers' experience influences the scale score. We conducted a pilot study to investigate how three different levels of swine experience influenced how observers scored castration pain in piglets using Unesp-Botucatu Pig Composite Acute Pain Scale (UPAPS). We used a database from UPAPS scores from pigs undergoing surgical castration in a previous study. Scores were attributed by six observers with Little to no experience (n = 2), Some experience (n = 2) and Extensive experience (n = 2). Reliability was estimated using the intraclass correlation coefficient, agreement was investigated by Bland-Altman analysis, predictive capacity was estimated using the area under the curve (AUC), and statistical differences were tested using a regression model. We found that intra-experience levels reliability were satisfactory (Little to no: 0.72, Some: 0.81, Extensive: 0.84), but inter-experience reliability was lower (0.42). Little to no experience observers had poor agreement with other observers, with a bias toward underscoring UPAPS (bias of 0.94 vs. Some, 1.17 vs. Extensive). Predictive capacity was similar between all observers (AUC, Little to no: 71.94%, Some: 76.10%, Extensive: 79.09%, p > 0.05). Regression model confirmed underscoring of Little to no experience observers (mean ± standard error; Little to no: 1.09 ± 0.14; Some: 2.02 ± 0.23; Extensive: 2.25 ± 0.22; p < 0.05). We concluded that minimal experience, as Some experience observers have in the swine industry, is sufficient for them to score UPAPS in a similar way than more experienced observers. The present pilot study supports the enhancement and implementation of UPAPS on farm and laboratory settings by minimally qualified observers, improving swine welfare in the short and long term.

Cross-cultural adaptation of the Parent Hearing Aid Management Inventory into Brazilian Portuguese. / Adaptação transcultural do inventário Parent Hearing Aid Management Inventory para o Português Brasileiro.

PURPOSE: to translate and cross-culturally adapt the Parent Hearing Aid Management Inventory into Brazilian Portuguese. METHODS: study of the methodological type of cross-cultural adaptation, which followed the recommendations of the literature for its execution. Two steps and eight steps were performed to achieve the adaptation: obtaining permission from the authors; formation of a committee of specialists who acted in some of the steps for the validation of the translation, translation by 2 proficient translators, synthesis of the translations and evaluation of equivalences, reverse translation and synthesis of the same, pilot study with 10 families to verify the applicability of the instrument and synthesis of the final version of the instrument. RESULTS: Cohen's kappa analysis was applied for the inter-rater agreement analysis and Cronbach's alpha coefficient for the analysis of internal reliability of the instrument. After application with the families, the instrument was considered valid to assess the needs for guidance and support of families regarding the management of hearing devices in the population of children with hearing loss. CONCLUSION: the Inventory was translated and adapted into Brazilian Portuguese, under the name of Inventário de Manejo dos Aprendidos for the Family (IMAAF) and has the potential to help in clinical practice to achieve effective use of individual sound amplification devices in the population of children with hearing impairment, in a perspective centered on the needs of their families.

OBJETIVO: traduzir e adaptar transculturalmente o inventário Parent Hearing Aid Management Inventory para o português brasileiro. MÉTODO: estudo do tipo metodológico, de adaptação transcultural, que seguiu as recomendações da literatura para a sua execução. Foram realizadas duas etapas e oito passos para a consecução da adaptação: obtenção de permissão dos autores; formação de um comitê de especialistas que atuaram em alguns dos passos para a validação da tradução, tradução por 2 tradutores proficientes, síntese das traduções e avaliação das equivalências, tradução reversa e síntese das mesmas, estudo piloto com 10 famílias para verificar-se a aplicabilidade do instrumento e síntese da versão final do instrumento. RESULTADOS: foi aplicada a análise do kappa Cohen para a análise de concordância interavaliadores e o coeficiente de alfa de Cronbach para a análise de confiabilidade interna do instrumento. Após a aplicação com as famílias considerou-se o instrumento válido para avaliar as necessidades de orientação e apoio das famílias quanto ao manejo dos dispositivos auditivos na população de crianças com deficiência auditiva. CONCLUSÃO: o inventário foi traduzido e adaptado para o português brasileiro, sob o nome de Inventário de Manejo dos Aparelhos Auditivos pela Família (IMAAF) e tem o potencial de auxiliar na prática clínica para o alcance do uso efetivo dos aparelhos de amplificação sonora individual na população de crianças com deficiência auditiva, numa perspectiva centrada nas necessidades de suas famílias.

Safety and efficacy of topical testosterone in breast cancer patients receiving ovarian suppression and aromatase inhibitor therapy.

BACKGROUND: Premenopausal, high-risk, hormone receptor-positive breast cancer patients are often treated with ovarian suppression in combination with aromatase inhibitors (AI). This combination has important adverse effects, particularly in sexual function, such as vaginal dryness and loss of libido. There is no effective therapy for reduced sexual function in this setting. Our study aimed to determine the efficacy and safety, particularly regarding sexual function, of a low-dose, topical testosterone gel administration. METHODS: This is a pilot, single-center study, designed to evaluate the efficacy of topical testosterone gel (3 mg/day) in improving sexual function in 29 premenopausal patients on ovarian suppression in combination with an AI. The primary safety endpoint was to assess serum estradiol elevation. The primary efficacy endpoint was sexual function improvement, assessed by the Female Sexual Function Index questionnaire. RESULTS: We report the results on 29 patients. Twenty-two patients (75%) completed the 3-month treatment, and seven discontinued treatment before completion, mostly due to logistical difficulties related to the COVID-19 pandemic. All patients maintained the value of baseline mass spectrometry assay for estradiol of less than 2.7 pg/mL during the undertaken measurements. We observed a significant improvement in Female Sexual Function Index measures over the visits, with an increase from a mean of 11.7 at baseline to 19.1 in the third month (p < 0.001), with the greatest improvement observed between the second and third months. CONCLUSIONS: Our findings suggest that topical testosterone seems to be safe and may be effective in improving sexual function in patients on ovarian suppression and AI. TRIAL REGISTRATION: The project was submitted and approved through the hospital's SGPP platform in 11/26/2019 (Project No. SGPP 393819) and CAAE (Research Ethics Committee) (CAAE No 25609719.5.0000.007).

Salivary Molecular Spectroscopy with Machine Learning Algorithms for a Diagnostic Triage for Amelogenesis Imperfecta.

Amelogenesis imperfecta (AI) is a genetic disease characterized by poor formation of tooth enamel. AI occurs due to mutations, especially in AMEL, ENAM, KLK4, MMP20, and FAM83H, associated with changes in matrix proteins, matrix proteases, cell-matrix adhesion proteins, and transport proteins of enamel. Due to the wide variety of phenotypes, the diagnosis of AI is complex, requiring a genetic test to characterize it better. Thus, there is a demand for developing low-cost, noninvasive, and accurate platforms for AI diagnostics. This case-control pilot study aimed to test salivary vibrational modes obtained in attenuated total reflection fourier-transformed infrared (ATR-FTIR) together with machine learning algorithms: linear discriminant analysis (LDA), random forest, and support vector machine (SVM) could be used to discriminate AI from control subjects due to changes in salivary components. The best-performing SVM algorithm discriminates AI better than matched-control subjects with a sensitivity of 100%, specificity of 79%, and accuracy of 88%. The five main vibrational modes with higher feature importance in the Shapley Additive Explanations (SHAP) were 1010 cm-1, 1013 cm-1, 1002 cm-1, 1004 cm-1, and 1011 cm-1 in these best-performing SVM algorithms, suggesting these vibrational modes as a pre-validated salivary infrared spectral area as a potential biomarker for AI screening. In summary, ATR-FTIR spectroscopy and machine learning algorithms can be used on saliva samples to discriminate AI and are further explored as a screening tool.

Assessment of a Pilot Program for Remote Support on Mental Health for Young Physicians in Rural Settings in Peru: Mixed Methods Study.

BACKGROUND: Telemedicine-based interventions show promise in addressing mental health issues among rural populations, yet evidence regarding their impact among the health care workforce in these contexts remains limited. OBJECTIVE: This study aimed to evaluate the characteristics and the responses and perceptions of recently graduated physicians who work in rural areas of Peru as part of the Servicio Rural Urbano Marginal en Salud (Rural-Urban Marginal Health Service [SERUMS], in Spanish) toward a telehealth intervention to provide remote orientation and accompaniment in mental health. METHODS: A mixed methods study was carried out involving physicians who graduated from the Universidad Nacional Mayor de San Marcos and participated in the Mental Health Accompaniment Program (MHAP) from August 2022 to February 2023. This program included the assessment of mental health conditions via online forms, the dissemination of informational materials through a website, and, for those with moderate or high levels of mental health issues, the provision of personalized follow-up by trained personnel. Quantitative analysis explored the mental health issues identified among physicians, while qualitative analysis, using semistructured interviews, examined their perceptions of the services provided. RESULTS: Of 75 physicians initially enrolled to the MHAP, 30 (41.6%) opted to undergo assessment and use the services. The average age of the participants was 26.8 (SD 1.9) years, with 17 (56.7%) being female. About 11 (36.7%) reported have current or previous mental health issues, 17 (56.7%) indicating some level of depression, 14 (46.7%) indicated some level of anxiety, 5 (16.6%) presenting a suicidal risk, and 2 (6.7%) attempted suicide during the program. Physicians who did not use the program services reported a lack of advertising and related information, reliance on personal mental health resources, or neglect of symptoms. Those who used the program expressed a positive perception regarding the services, including evaluation and follow-up, although some faced challenges accessing the website. CONCLUSIONS: The MHAP has been effective in identifying and managing mental health problems among SERUMS physicians in rural Peru, although it faced challenges related to access and participation. The importance of mental health interventions in this context is highlighted, with recommendations to improve accessibility and promote self-care among participants.

68 Ga-DOTATATE PET/CT Versus 18 F-FDG PET/CT in TENIS Syndrome: A Head-to-Head Comparison With Elevated and Suppressed TSH Levels in Papillary Thyroid Carcinoma-A Pilot Study.

BACKGROUND: TENIS syndrome is characterized by reduced expression of sodium-iodine symporter, rising serum thyroglobulin (Tg) levels, and negative whole-body 131 I scans. In such patients, somatostatin receptor imaging with 68 Ga-DOTATATE PET/CT (somatostatin receptor [SSR] PET/CT) and 18 F-FDG PET/CT (FDG PET/CT) can identify metastases and were compared under 2 conditions: elevated (eTSH) and suppressed (sTSH) TSH serum levels. Potential candidates for peptide receptor radionuclide therapy (PRRNT) were identified in 15 patients prospectively enrolled. All patients underwent 4 examinations. Images were blindly evaluated for differences in SUV max values and lesion detectability. Reference standard consisted of neck ultrasound, CT, MRI, PET/CT, biopsy, and follow-up. Three patients were received PRRNT. RESULTS: sTSH SSR PET/CT detected a greater number of cervical ( P = 0.0253 and P = 0.0176) and distant LNs ( P = 0.0253 and P = 0.0391) when compared with sTSH FDG PET/CT, respectively, in a per-patient and on a per-lesion based analysis. Likewise, eTSH SSR PET/CT detected a greater number of patients with local recurrences ( P = 0.0455) and distant LN metastases ( P = 0.0143). Per-lesion analysis revealed greater number of cervical and distant LNs ( P = 0.0337 and P = 0.0039, respectively) when compared with eTSH FDG PET/CT. There was no difference in detection of distant metastases by both tracers for lung and bone metastases (κ = 1). Both skeletal and pulmonary lesions were also detected by conventional CT part of FDG or DOTATATE PET/CT scans. TSH stimulation had no additional value in a per-patient analysis for both FDG and DOTATATE PET scans (κ varying from 0.6087 to 1). However, TSH stimulation led to more lesion identifications in DOTATATE PET/CT; most of those metastases were not confirmed by the reference standard leading to a decrease in specificity (84% vs 74%). One of 3 patients submitted to 3 cycles of PRRNT presented with a visual partial response, a 20% reduction in quantitative analyses, and stable disease regarding Tg and TgAb levels. CONCLUSIONS: Patients with TENIS syndrome can be imaged with SSR PET/CT as well as FDG PET/CT with high overall accuracy regardless of TSH levels (86% to 92% and 92% to 85%, respectively, with eTSH and sTSH). SSR PET/CT detected a greater number of locoregional and distant LN metastases than FDG PET/CT with both sTSH and eTSH. One of 3 patients submitted to PRRNT presented a partial response to treatment. Our findings may impact in patient restaging, management, and theranostics strategies with radiolabeled somatostatin analogs.