Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial.

BACKGROUND: Pembrolizumab has shown efficacy in persistent, recurrent, or metastatic cervical cancer. The effect of chemoradiotherapy might be enhanced by immunotherapy. In this phase 3 trial, we assessed the efficacy and safety of adding pembrolizumab to chemoradiotherapy in locally advanced cervical cancer. METHODS: In this randomised, double-blind, placebo-controlled, phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 clinical trial, adults (age ≥18 years) at 176 medical centres in 30 countries with newly diagnosed, high-risk, locally advanced cervical cancer were randomly assigned (1:1) using an interactive voice-response system with integrated web response to receive 5 cycles of pembrolizumab (200 mg) or placebo every 3 weeks plus chemoradiotherapy, followed by 15 cycles of pembrolizumab (400 mg) or placebo every 6 weeks. Randomisation was stratified by planned external beam radiotherapy type (intensity-modulated radiotherapy or volumetric-modulated arc therapy vs non-intensity-modulated radiotherapy or non-volumetric-modulated arc therapy), cervical cancer stage at screening (International Federation of Gynecology and Obstetrics 2014 stage IB2-IIB node positive vs stage III-IVA), and planned total radiotherapy (external beam radiotherapy plus brachytherapy) dose (<70 Gy vs ≥70 Gy equivalent dose in 2 Gy fractions). Primary endpoints were progression-free survival per Response Evaluation Criteria in Solid Tumours version 1.1-by investigator or by histopathologic confirmation of suspected disease progression-and overall survival. Primary analysis was conducted in the intention-to-treat population, which included all randomly allocated participants. Safety was assessed in the as-treated population, which included all randomly allocated patients who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT04221945, and is closed to new participants. FINDINGS: Between June 9, 2020, and Dec 15, 2022, 1060 participants were randomly assigned to treatment, with 529 assigned to the pembrolizumab-chemoradiotherapy group and 531 to the placebo-chemoradiotherapy group. At data cutoff (Jan 9, 2023), median follow-up was 17·9 months (IQR 11·3-22·3) in both treatment groups. Median progression-free survival was not reached in either group; rates at 24 months were 68% in the pembrolizumab-chemoradiotherapy group versus 57% in the placebo-chemoradiotherapy group. The hazard ratio (HR) for disease progression or death was 0·70 (95% CI 0·55-0·89, p=0·0020), meeting the protocol-specified primary objective. Overall survival at 24 months was 87% in the pembrolizumab-chemoradiotherapy group and 81% in the placebo-chemoradiotherapy group (information fraction 42·9%). The HR for death was 0·73 (0·49-1·07); these data have not crossed the boundary of statistical significance. Grade 3 or higher adverse event rates were 75% in the pembrolizumab-chemoradiotherapy group and 69% in the placebo-chemoradiotherapy group. INTERPRETATION: Pembrolizumab plus chemoradiotherapy significantly improved progression-free survival in patients with newly diagnosed, high-risk, locally advanced cervical cancer. FUNDING: Merck Sharp & Dohme, a subsidiary of Merck & Co (MSD).

Prostate-specific antigen (PSA) decline with apalutamide therapy is associated with longer survival and improved outcomes in individuals with metastatic prostate cancer: a plain language summary of the TITAN study.

WHAT IS THIS SUMMARY ABOUT?: This summary describes the results from an additional (or post hoc) analysis of the TITAN study. The TITAN study looked at whether the prostate cancer treatment apalutamide could be used to treat individuals with metastatic castration-sensitive prostate cancer (or mCSPC). A total of 1052 participants with mCSPC were included in the TITAN study. Treatment with apalutamide was compared with treatment with placebo. All participants received androgen deprivation therapy (or ADT), which is a type of hormone therapy that has been part of the main treatment for mCSPC for many years. The results showed that apalutamide plus ADT increased the length of time that participants remained alive compared with placebo plus ADT. Apalutamide plus ADT also controlled the growth of the cancer for a longer length of time compared with placebo plus ADT. Additionally, participants who received apalutamide plus ADT experienced a greater reduction in the blood levels of prostate-specific antigen (or PSA), called a deep PSA decline, compared with those who received placebo plus ADT. An additional (or post hoc) analysis was carried out to understand whether a decrease in blood PSA levels, in response to treatment, was associated with improved outcomes, including longer survival time. WHAT WERE THE RESULTS OF THE ADDITIONAL ANALYSIS?: In participants who received apalutamide plus ADT, a deep PSA decline in response to treatment was associated with longer survival time and improved outcomes. WHAT DO THESE RESULTS MEAN FOR INDIVIDUALS WITH MCSPC?: These results demonstrate that individuals with mCSPC can benefit from treatment with apalutamide plus ADT. The association seen between deep PSA decline and the longer survival time and improved outcomes highlights how PSA measurements can be used to help monitor cancer disease evolution in response to treatment. Monitoring PSA levels will assist doctors and other healthcare professionals to understand how effectively a treatment is working for a patient and to tailor their treatment approach to improve PSA decline.

A utilização de torques resistentes ao movimento compensatório dos dentes anteriores no tratamento da Classe III no paciente adulto / The use of torques resistant to compensatory movement of anterior teeth in the treatment of Class III in adult patients

Este trabalho visou relatar o caso clínico de um paciente padrão III com mordida cruzada anterior, através de um tratamento compensatório com o uso de bráquetes que geram torques resistentes nos incisivos. O paciente JPCN, 42 anos, leucoderma, gênero masculino, procurou a clínica ortodôntica com a queixa principal de mordida cruzada anterior. Na análise extrabucal, observou-se a presença de padrão horizontal, simetria facial, maxila deficiente, ângulo nasolabial fechado, presença de selamento labial passivo e perfil côncavo com o lábio inferior à frente do superior. A prescrição utilizada foi a biofuncional, apresentado 0° de torque nos incisivos superiores e 10° nos incisivos inferiores. Foram realizados o alinhamento e nivelamento, mecânica de acentuação da curva de Spee no arco superior e reversão no arco inferior simultaneamente aos elásticos intermaxilares. Ao final do tratamento, foram observados correção da relação anteroposterior e intercuspidação dentária, trespasse horizontal e vertical normais, linhas médias coincidentes e selamento labial passivo. Concluiu-se que a utilização de torques resistentes nos incisivos gerados pelo uso de bráquetes da técnica biofuncional foi eficiente para manter uma boa inclinação desses dentes durante a correção damá oclusão de Classe III com o uso de elásticos intermaxilares (AU)

This study aimed to report the clinical case of a patient with pattern III with anterior crossbite, through a compensatory treatment with the use of brackets that generate resistant torques in the incisors. Patient JPCN, 42 years old, caucasian, male, came to the orthodontic clinic with the main complaint of anterior crossbite. In the extraoral analysis, it was observed the presence of a horizontal pattern, facial symmetry, deficient maxilla, closed nasolabial angle, presence of passive lip seal, and concave profile with the lower lip in front of the upper. The prescription used was the biofunctional, with 0° of torque on the upper incisors and 10° on the lower incisors. Alignment and leveling, orthodontic mechanics of Spee curve accentuation in the maxillary arch and reversal in the mandibular arch were performed simultaneously with intermaxillary elastics. At the end of the treatment, Class III correction, correction of the anteroposterior relationship and dental intercuspation, normal overbite and overjet, coinci-dent midlines and passive lip seal were observed. It was concluded that the use of resistant torques on the incisors promoted by the use of biofunctional technique brackets was efficient to maintain a good inclination of these teeth during the correction of Class III malocclusion with the use of intermaxillary elastics (AU)

Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: A subgroup analysis of the randomised clinical TITAN study.

BACKGROUND: Whether disease burden in patients with metastatic castration-sensitive prostate cancer (mCSPC) predicts treatment outcomes is unknown. We assessed apalutamide treatment effect in TITAN patients with mCSPC by disease volume, metastasis number and timing of metastasis presentation. METHODS: These protocol-defined and post hoc analyses of the phase III randomised TITAN study evaluated clinical outcomes in patients receiving 240 mg/day apalutamide (n = 525) or placebo (n = 527) plus androgen-deprivation therapy (ADT). Subgroups were defined by volume (high: visceral and ≥1 bone metastases or ≥4 bone lesions with ≥1 beyond vertebral column/pelvis), development of metastases per conventional imaging (synchronous: at initial diagnosis; metachronous: after localised disease) and oligometastases (≤5 bone-only metastases) or polymetastases (>5 in bone ± other locations or ≤5 in bone plus other locations). Overall survival (OS), radiographic or second progression-free survival, and time to prostate-specific antigen progression or castration resistance were assessed using Cox proportional hazards models. RESULTS: Of 1052 patients, 63%, 81%, 54%, 27%, 5.7%, and 8.0% had high-volume, synchronous, synchronous/high-volume, synchronous/low-volume, metachronous/high-volume, and metachronous/low-volume disease, respectively. The OS benefit favoured apalutamide plus ADT versus ADT alone in synchronous/high-volume (hazard ratio = 0.68 [95% confidence interval: 0.53-0.87]; p = 0.002), synchronous/low-volume (0.65 [0.40-1.05]; p = 0.08), metachronous/high-volume (0.69 [0.33-1.44]; p = 0.32) and metachronous/low-volume (0.22 [0.09-0.55]; p = 0.001) subgroups. Apalutamide improved other clinical outcomes regardless of subgroup, with similar safety profiles. Most favourable outcomes were observed in oligometastatic disease. CONCLUSION: TITAN patients derived a robust benefit with apalutamide plus ADT regardless of disease volume and timing of metastasis presentation without differences in safety, supporting early apalutamide intensification in mCSPC. CLINICAL TRIAL REGISTRATION: NCT02489318.

Effect of Photobiomodulation Combined with Physiotherapy on Functional Performance in Children with Myelomeningo-Cele-Randomized, Blind, Clinical Trial.

BACKGROUND: This study aimed to evaluate the electrical activity of the rectus femoris, tibialis anterior, and lateral gastrocnemius muscles during the sit-to-stand task and functional mobility after a neurofunctional physiotherapy protocol associated with PBM. METHODS: Twenty-five children were randomly allocated to either Active PBM + physiotherapy (n = 13) or PBM sham + physiotherapy (n = 12). PBM was carried out with a LED device (850 nm, 25 J, 50 s per point and 200 mW) at four points over the area with absence of a spiny process. Both groups completed a twelve-week supervised program with two weekly 45-60 min sessions. Pre-training and post-training assessments involved the Pediatric Evaluation of Disability Inventory (PEDI). Muscle activity was assessed using portable electromyography (BTS Engineering) and the electrodes were positioned on the lateral gastrocnemius, anterior tibialis, and rectus femoris muscles. The RMS data were recorded and analyzed. RESULTS: After 24 sessions of the treatment protocol, improvements were found in the PEDI score. The participants presented greater independence in performing the tasks, requiring less assistance from their caregivers. More significant electrical activity was found in the three muscles evaluated between the rest period and execution of the sit-to-stand tasks, both in the more compromised or less compromised lower limbs. CONCLUSION: Neurofunctional physiotherapy with or without PBM improved functional mobility and electrical muscle activity in children with myelomeningocele.

Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer.

PURPOSE: Metastatic castration-resistant prostate cancer (mCRPC) remains a lethal disease with current standard-of-care therapies. Homologous recombination repair (HRR) gene alterations, including BRCA1/2 alterations, can sensitize cancer cells to poly (ADP-ribose) polymerase inhibition, which may improve outcomes in treatment-naïve mCRPC when combined with androgen receptor signaling inhibition. METHODS: MAGNITUDE (ClinicalTrials.gov identifier: NCT03748641) is a phase III, randomized, double-blinded study that evaluates niraparib and abiraterone acetate plus prednisone (niraparib + AAP) in patients with (HRR+, n = 423) or without (HRR-, n = 247) HRR-associated gene alterations, as prospectively determined by tissue/plasma-based assays. Patients were assigned 1:1 to receive niraparib + AAP or placebo + AAP. The primary end point, radiographic progression-free survival (rPFS) assessed by central review, was evaluated first in the BRCA1/2 subgroup and then in the full HRR+ cohort, with secondary end points analyzed for the full HRR+ cohort if rPFS was statistically significant. A futility analysis was preplanned in the HRR- cohort. RESULTS: Median rPFS in the BRCA1/2 subgroup was significantly longer in the niraparib + AAP group compared with the placebo + AAP group (16.6 v 10.9 months; hazard ratio [HR], 0.53; 95% CI, 0.36 to 0.79; P = .001). In the overall HRR+ cohort, rPFS was significantly longer in the niraparib + AAP group compared with the placebo + AAP group (16.5 v 13.7 months; HR, 0.73; 95% CI, 0.56 to 0.96; P = .022). These findings were supported by improvement in the secondary end points of time to symptomatic progression and time to initiation of cytotoxic chemotherapy. In the HRR- cohort, futility was declared per the prespecified criteria. Treatment with niraparib + AAP was tolerable, with anemia and hypertension as the most reported grade ≥ 3 adverse events. CONCLUSION: Combination treatment with niraparib + AAP significantly lengthened rPFS in patients with HRR+ mCRPC compared with standard-of-care AAP.[Media: see text].

NEOTROPICAL FRESHWATER FISHES: A dataset of occurrence and abundance of freshwater fishes in the Neotropics.

The Neotropical region hosts 4225 freshwater fish species, ranking first among the world's most diverse regions for freshwater fishes. Our NEOTROPICAL FRESHWATER FISHES data set is the first to produce a large-scale Neotropical freshwater fish inventory, covering the entire Neotropical region from Mexico and the Caribbean in the north to the southern limits in Argentina, Paraguay, Chile, and Uruguay. We compiled 185,787 distribution records, with unique georeferenced coordinates, for the 4225 species, represented by occurrence and abundance data. The number of species for the most numerous orders are as follows: Characiformes (1289), Siluriformes (1384), Cichliformes (354), Cyprinodontiformes (245), and Gymnotiformes (135). The most recorded species was the characid Astyanax fasciatus (4696 records). We registered 116,802 distribution records for native species, compared to 1802 distribution records for nonnative species. The main aim of the NEOTROPICAL FRESHWATER FISHES data set was to make these occurrence and abundance data accessible for international researchers to develop ecological and macroecological studies, from local to regional scales, with focal fish species, families, or orders. We anticipate that the NEOTROPICAL FRESHWATER FISHES data set will be valuable for studies on a wide range of ecological processes, such as trophic cascades, fishery pressure, the effects of habitat loss and fragmentation, and the impacts of species invasion and climate change. There are no copyright restrictions on the data, and please cite this data paper when using the data in publications.

Enseñanza de la seguridad del paciente en el grado de enfermería / O ensino da segurança do paciente na graduação em enfermagem / Teaching Patient Safety in the Undergraduate Nursing Degree

Introducción: La importancia de utilizar metodologías/estrategias de enseñanza que incentiven la reflexión y la develación de nuevos conceptos se hace notar, así como la creación de problemas por parte del alumno, que tomen en cuenta no solo los conocimientos técnico-científicos, sino también los aspectos subjetivos del cuidado en salud. Objetivo: Identificar la evidencia en la literatura científica sobre los contenidos cubiertos y las metodologías/estrategias utilizadas para la enseñanza de la seguridad del paciente en los cursos de grado en enfermería. Métodos: Revisión de alcance, cuya recolección de datos se realizó en las bases de datos - Literatura Latino-americana e do Caribe em Ciências da Saúde, Catálogo de Teses e Dissertações da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, Repositório Científico de Acesso Aberto de Portugal, MEDLINE/ PubMed, Cumulative Index of Nursing and Allied Health, Scopus, Web of Science, Education Resources Information Center, The National Library of Australia's, Electronic Theses Online Service, National ETD Portal e Theses Canada. Los criterios de inclusión fueron: artículos científicos, disertaciones y tesis disponibles en su totalidad y que describieran los contenidos y estrategias/metodologías que se han abordado en la enseñanza de la seguridad del paciente en el grado en enfermería. Se excluyeron editoriales, artículos de opinión, ensayos teóricos/reflexivos y reseñas. Los resultados se sintetizaron y se presentaron en figuras y tablas. Conclusión: Los enfoques pedagógicos se mantuvieron centrados en el docente, valorando la transmisión de contenidos y el desarrollo de competencias como condición sine qua non para la formación de los estudiantes(AU)

Introdução: denota-se a importância da utilização de metodologias/estratégias de ensino que estimulem a reflexão e o desvelar de novos conceitos, assim como a criação de problemas pelo discente, que considerem não somente os conhecimentos técnico-científicos, mas também os aspectos subjetivos do cuidar em saúde. Objetivo: identificar as evidências na literatura científica sobre os conteúdos abordados e as metodologias/estratégias empregadas para o ensino da segurança do paciente em cursos de Graduação em Enfermagem. Métodos: revisão de escopo, cuja coleta de dados foi realizada nas bases de dados - Literatura Latino-americana e do Caribe em Ciências da Saúde, Catálogo de Teses e Dissertações da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, Repositório Científico de Acesso Aberto de Portugal, MEDLINE/ PubMed, Cumulative Index of Nursing and Allied Health, Scopus, Web of Science, Education Resources Information Center, The National Library of Australia's, Electronic Theses Online Service, National ETD Portal e Theses Canada. Os critérios de inclusão foram: artigos científicos, dissertações e teses disponíveis na íntegra e que descrevessem conteúdos e estratégias/metodologias que vêm sendo abordados no ensino da segurança do paciente na Graduação em Enfermagem. Foram excluídos editoriais, artigos de opinião, ensaios teóricos/reflexivos e revisões. Os resultados foram sintetizados de forma descritiva e apresentados em forma de figura e quadros. Conclusão: observou-se que as abordagens pedagógicas permaneceram centrada no docente, valorizando a transmissão de conteúdos e o desenvolvimento de competências como condição sine qua non para a formação do discente(AU)

Introduction: The importance of using teaching methodologies/strategies that encourage reflection and the unveiling of new concepts is noted, as well as the creation of problems by the student, which take into account not only technical-scientific knowledge, but also the subjective aspects of health care. Objective: To identify the evidence in the scientific literature on the contents covered and the methodologies/strategies used for teaching patient safety in undergraduate nursing courses. Methods: Scoping review, whose data collection was performed in the databases - Literatura Latino-americana e do Caribe em Ciências da Saúde, Catálogo de Teses e Dissertações da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, Repositório Científico de Acesso Aberto de Portugal, MEDLINE/ PubMed, Cumulative Index of Nursing and Allied Health, Scopus, Web of Science, Education Resources Information Center, The National Library of Australia's, Electronic Theses Online Service, National ETD Portal e Theses Canada. Inclusion criteria were: scientific articles, dissertations and theses available in their entirety and describing the content and strategies/methodologies that have been addressed in the teaching of patient safety in undergraduate nursing. Editorials, opinion pieces, theoretical/reflective essays, and reviews were excluded. Results were synthesized and presented in figures and tables. Conclusion: Pedagogical approaches remained teacher-centered, valuing the transmission of content and the development of competencies as a sine qua non condition for student training(AU)

Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial.

BACKGROUND: This study aims to verify if the use of intravascular laser irradiation of blood (ILIB) influences the reduction of pain and increases the range of motion in opening and closing of the mouth in children and adolescents with temporomandibular disorders (TMD). METHODS: This will be a blind, randomized, and controlled clinical trial, which will be carried out on children between 6 and 12 years of age who enter the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, for treatment. To be included, children must present temporomandibular disorders, based on the diagnostic criteria will be the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Forty-five participants will be randomized to three groups: Group 1-ILIB with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 2-Placebo laser application with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 3-Control with no treatment (n = 15). Irradiation will be performed by continuous and direct transcutaneous application to the radial artery, by means of a bracelet that inserts the laser beam. The laser to be used is infrared, power 100 mW ± 20%, wavelength 808 nm ± 10 nm, continuous application. RDC/TMD and pain evaluated through a visual analog scale will be the outcome measures. DISCUSSION: Due to the low level of evidence, new studies are needed on the effect of ILIB in children with TMD.

Supervisões clínicas: vivências emocionais dos psicoterapeutas-aprendizes / Clinical supervision: emotional experiences of apprentice psychotherapists

Considerando a supervisão clínica como um dos pilares da formação do psicólogo clínico, o presente estudo teve por objetivo investigar as emoções vivenciadas pelos psicoterapeutas-aprendizes durante as supervisões de estágio em psicoterapia psicanalítica. Realizou-se um estudo clínico-qualitativo por meio de entrevistas com 27 acadêmicos que realizavam estágios em psicoterapia psicanalítica, em quatro Instituições de Ensino Superior. Os dados coletados foram submetidos à análise de conteúdo e discutidos a partir do referencial psicanalítico. A análise dos resultados demonstrou que as vivências emocionais dos psicoterapeutas-aprendizes estavam relacionadas, preponderantemente: à aprendizagem de conteúdos teórico-metodológicos e à necessidade de ser acolhido e de compartilhar com o grupo de supervisão as intensidades emocionais vivenciadas na clínica. Finalmente, ressaltou-se a necessidade de acolher e compreender as experiências emocionais dos psicoterapeutas-aprendizes durante os estágios em psicoterapia psicanalítica.

AMAZONIA CAMTRAP: A data set of mammal, bird, and reptile species recorded with camera traps in the Amazon forest.

The Amazon forest has the highest biodiversity on Earth. However, information on Amazonian vertebrate diversity is still deficient and scattered across the published, peer-reviewed, and gray literature and in unpublished raw data. Camera traps are an effective non-invasive method of surveying vertebrates, applicable to different scales of time and space. In this study, we organized and standardized camera trap records from different Amazon regions to compile the most extensive data set of inventories of mammal, bird, and reptile species ever assembled for the area. The complete data set comprises 154,123 records of 317 species (185 birds, 119 mammals, and 13 reptiles) gathered from surveys from the Amazonian portion of eight countries (Brazil, Bolivia, Colombia, Ecuador, French Guiana, Peru, Suriname, and Venezuela). The most frequently recorded species per taxa were: mammals: Cuniculus paca (11,907 records); birds: Pauxi tuberosa (3713 records); and reptiles: Tupinambis teguixin (716 records). The information detailed in this data paper opens up opportunities for new ecological studies at different spatial and temporal scales, allowing for a more accurate evaluation of the effects of habitat loss, fragmentation, climate change, and other human-mediated defaunation processes in one of the most important and threatened tropical environments in the world. The data set is not copyright restricted; please cite this data paper when using its data in publications and we also request that researchers and educators inform us of how they are using these data.

Effect of photobiomodulation on fatigue in individuals with relapsing-remitting multiple sclerosis: a pilot study.

Multiple sclerosis is an autoimmune disease of the central nervous system characterized by inflammation and destruction of the myelin sheath. Fatigue is one of the main symptoms of this disease, with a negative impact on quality of life and few treatment options. Photobiomodulation is used for several inflammatory conditions and may be beneficial for the treatment of fatigue in individuals with multiple sclerosis. Conduct a pilot study to analyze the effect of photobiomodulation on fatigue in individuals with relapsing-remitting multiple sclerosis. The participants were recruited from the UNINOVE Integrated Health Clinic and randomly allocated to two groups: group 1, administration of photobiomodulation (808 nm, 36 J for 360 s) under the tongue and group 2, administration of photobiomodulation over the radial artery. Fatigue was measured using the Modified Fatigue Impact Scale (MFIS). No significant differences were found regarding the total MFIS score or subscale scores (p < 0.05, two-way ANOVA). Photobiomodulation with the parameters employed in the present study had no effect on fatigue in individuals with multiple sclerosis. ClinicalTrials.gov Identifier: NCT03360487.

Photobiomodulation for the Treatment of Primary Headache: Systematic Review of Randomized Clinical Trials.

The purpose of this study was to evaluate the efficacy and safety of photobiomodulation as an adjuvant treatment for primary headache. A systematic review of randomized clinical trials was performed. For such, electronic searches were performed in the MEDLINE, Embase, Cochrane Library, LILACS, PEDro, PsycInfo, Clinicaltrials.gov., and WHO/ICTRP databases, with no restrictions imposed regarding language or year of publication. We included studies that assessed any photobiomodulation therapy as an adjuvant treatment for primary headache compared to sham treatment, no treatment, or another intervention. The methodological assessment was conducted using the Cochrane Risk of Bias tool. The certainty of the evidence was classified using the GRADE approach. Four randomized clinical trials were included. Most of the included studies had an overall high risk of bias. Compared to sham treatment, photobiomodulation had a clinically important effect on pain in individuals with primary headache. Despite the benefits reported for other outcomes, the estimates were imprecise, and the certainty of the evidence was graded as low. These findings are considered insufficient to support the use of photobiomodulation in the treatment of primary headache. Randomized clinical trials, with higher methodological quality, are needed to enhance the reliability of the estimated effects.

Getting back on track: a group psychoeducational intervention for patients and families living with head and neck cancer.

PURPOSE: Head and neck cancer survivors are increasing in prevalence, and 60-70% still experience at least one unmet emotional and/or physical need after treatment has ended. The purpose of this study was to determine the efficacy of a brief post-treatment psychoeducational intervention on perceived preparedness for coping with recovery using post-session evaluations. METHODS: Between August 2013 and May 2018, a two-session, multidisciplinary "getting back on track" class was delivered to head and neck cancer patients approximately 2 months following radiation treatment at Princess Margaret Cancer Centre in Toronto, Canada. Three hundred and fifty attendees completed evaluations. Statistical analyses of the 310 patients surveyed measured change in level of preparedness to cope with recovery using the b-prepared scale. Qualitative analyses provided insight into potential benefits for future patients. RESULTS: Almost two-thirds (58%) of patients reported an increase in level of preparedness in post-intervention surveys. Comparing self-reported level of preparedness among patients from before to after the class showed an increase in feeling prepared from 50 to 58%, and of those feeling very prepared, from 6 to 34%. The proportion of patients who reported feeling unprepared (11%) or neutral (33%) before the class decreased post-intervention, with 0% feeling unprepared and 7% feeling neutral. There were statistically significant differences in the ideal timing of the class, but overall attendees agreed that the class is an essential part of their recovery. CONCLUSION: Results confirm the efficacy of this brief psychoeducational intervention to improve preparedness in head and neck cancer survivors following radiation treatment.

Effect of antimicrobial photodynamic therapy with red led and methylene blue on the reduction of halitosis: controlled microbiological clinical trial.

To determine the effect of antimicrobial photodynamic therapy (aPDT) using a red light-emitting diode (LED) on the reduction of halitosis and microbiological levels in the tongue coating immediately after irradiation, 7, 14, and 30 days after treatment. Forty-five young adults diagnosed with halitosis were allocated to three groups: G1, aPDT with 0.005% methylene blue and red LED (660 nm, four irradiation points, 90 s per point, power of 400 mW, 36 J per point, radiant exposure of 95 J/cm2, continuous wave); G2, tongue scraping; and G3, tongue scraping and aPDT. Gas chromatography was performed before and immediately after treatment, as well as at the different follow-up times. Microbiological samples were collected at the same times from the dorsum of the tongue, and bacteria were quantified in the samples using real-time PCRq. The Wilcoxon test was used for the intragroup analyses, and the Kruskal-Wallis test was used for the intergroup analyses. In the intragroup analyses, differences were found before and immediately after treatment in all groups (p < 0.05). The effect was maintained after 7 days only in the tongue scraping group (p < 0.05). In the intergroup analysis, no statistically significant differences were found among the groups (p > 0.05). For the microbiological analyses, no statistically significant differences were found in the groups/bacteria that were analyzed (p > 0.05). aPDT using a red LED and 0.005% methylene blue caused an immediate reduction in halitosis, but the effect was not maintained after 7, 14, or 30 days. No reduction occurred in the number of bacteria investigated or the quantification of universal 16S rRNA. ClinicalTrials.gov Identifier: NCT03656419.

Quantifying Neck Fibrosis and Its Functional Implications: Development of the Neck Fibrosis Scale.

OBJECTIVE: Despite increasing recognition of the importance of functional outcomes for patients with head and neck cancer, post-treatment neck fibrosis remains poorly understood. We sought to develop and validate a patient reported outcome measure for head and neck cancer patients with neck fibrosis. STUDY DESIGN: Prospective multiphase cross-sectional study. METHODS: To guide instrument development, we employed the World Health Organization International Classification of Functioning, Disability and Health as our conceptual framework. Items were generated using a composite strategy consisting of patient focus groups, literature review, and expert opinion from a multidisciplinary group. Candidate items were reduced through the item impact method. Preliminary psychometric properties of the finalized instrument were evaluated through measures of internal consistency, test-retest reliability, and construct validity. RESULTS: Four in person focus groups were held with 13 head and neck cancer patients. The process of item generation led to 221 relevant citations and 68 unique items. An additional 17 items were identified from review of existing neck disability questionnaires and expert opinion. A draft instrument with 25 candidate items was generated and reduced to its final 15-item scale using item impact method. Early psychometric testing revealed excellent internal consistency (Cronbach's alpha = 0.95) and test-retest reliability [ICC = 0.95]. Internal consistency at the item level was good (>0.7) for 11/15 individual items. Four separate constructs were evaluated. Three of the four constructs matched our a priori hypotheses. CONCLUSION: The Neck Fibrosis Scale demonstrates preliminary reliability and validity for discriminate use. Further research is needed to confirm dimensionality and assess responsiveness. LEVEL OF EVIDENCE: NA Laryngoscope, 132:1015-1021, 2022.

Emoções vivenciadas pelos psicoterapeutas-aprendizes nos serviços-escolas: uma leitura psicanalítica / Emociones vivenciadas por los psicoterapeutas-aprendices em las escuelas-clínicas: una lectura psicanalítica / Emotions experienced by apprentice psychotherapists at school-clinics: a psychoanalytic reading

RESUMO Os atendimentos clínicos realizados nos serviços-escolas são permeados por uma série de experiências emocionais vivenciadas pela díade psicoterapeuta-aprendiz/paciente. Diante das diversas nuances da clínica psicanalítica, o psicoterapeuta-aprendiz vivencia experiências que refletem em sua subjetividade. Este estudo teve como objetivo investigar as vivências emocionais dos estudantes de graduação em psicologia durante os estágios em clínica psicanalítica e analisar as emoções percebidas em si mesmos pelos psicoterapeutas-aprendizes nos atendimentos em psicoterapia psicanalítica. Trata-se de um estudo clínico-qualitativo, utilizando-se o referencial teórico psicanalítico. Participaram 27 estudantes de psicologia, que realizavam atendimentos nos serviços-escolas de quatro Instituições de Ensino Superior. A coleta de dados foi realizada através de entrevistas semidirigidas, as quais foram submetidas à análise de conteúdo. Nos resultados observou-se a presença das vivências de ansiedade, medo, insegurança e nervosismo, presentes no processo psicoterapêutico. A identificação com as vivências emocionais dos pacientes e as dúvidas referentes à percepção das próprias emoções, foram importantes aspectos encontrados neste estudo. Tais resultados podem contribuir para a reflexão sobre a vivência desta experiência para o psicoterapeuta-aprendiz, a fim de melhor prepará-lo para os desafios da prática clínica psicanalítica.

RESUMEN Los atendimientos clínicos realizados en las escuelas clínicas están impregnados por una serie de experiencias emocionales vivenciadas por la díada psicoterapeuta-aprendiz / paciente. Ante los diversos matices de la clínica psicoanalítica, el psicoterapeuta-aprendiz vivencia experiencias que reflejan en su subjetividad. Este estudio tuvo como objetivo investigar las vivencias emocionales de los estudiantes de graduación en psicología durante las etapas en clínica psicoanalítica y analizar las emociones percibidas en sí mismos por los psicoterapeutas-aprendices en las atenciones en psicoterapia psicoanalítica. Se trata de un estudio clínico-cualitativo, utilizando el referencial teórico psicoanalítico. Participaron veintisiete estudiantes de psicología, que realizaban atendimientos en las escuelas clínicas de cuatro Instituciones de Enseñanza Superior. La recolección de datos fue realizada a través de entrevistas semidirigidas las cuales fueron sometidas a análisis de contenido. En los resultados se observó la presencia de las vivencias de ansiedad, miedo, inseguridad y nerviosismo, presentes en el proceso psicoterapéutico. La identificación con las vivencias emocionales de los pacientes y las dudas referentes a la percepción de las propias emociones, fueron importantes aspectos encontrados en este estudio. Tales resultados pueden contribuir a la reflexión sobre la vivencia de esta experiencia para el psicoterapeuta-aprendiz, a fin de prepararlo mejor para los desafíos de la práctica clínica psicoanalítica.

ABSTRACT The psychotherapeutic clinic services in the school-clinics are permeated by a series of emotional experiences lived by the apprentice psychotherapist/patient dyad. In the light of the various nuances of the psychoanalytic practice, the apprentice psychotherapist goes through experiences that reflect on his subjectivity. This study aimed to investigate the emotional experiences of undergraduate psychology students during their stages in school-clinics and to analyze the emotions perceived in themselves in the attendance in psychoanalytic psychotherapy. This is a clinical-qualitative study using the psychoanalytic theoretical framework. Twenty-seven psychology students participated in this study who attended the school-clinics of four Higher Education Institutions. Data collection was carried out through semi-structured interviews, which were submitted to content analysis. The results showed the presence of anxiety, fear, insecurity and nervousness feelings in the psychotherapeutic process. Identification with the emotional experiences of patients and doubts regarding the perception of their own emotions were essential aspects found in this study. Such results may contribute to the reflection on the experience of the apprentice psychotherapist to better prepare him for the challenges of psychoanalytic clinical practice.

Não é somente sobre Kevin que precisamos falar / No es solo Kevin de quien tenemos que hablar / It's not just Kevin that we need to talk about / Il n'y a pas que Kevin dont nous devons parler

O objetivo deste estudo consiste em apresentar uma análise do filme Precisamos falar sobre Kevin, partindo das reflexões teóricas de Jean Laplanche sobre a teoria da sedução generalizada. O artigo apresenta as contribuições teóricas do autor e de seus seguidores, principalmente no que diz respeito às mensagens enigmáticas e à construção de um modelo tópico e unificado do aparelho psíquico. A análise do filme permitiu chamar a atenção para os efeitos das vicissitudes da sedução, explorando as especificidades presentes na comunicação entre o adulto e a criança que repercutem sobre as possibilidades de tradução das mensagens enigmáticas e seus efeitos na constituição do psiquismo. Verifica-se a fecundidade do aporte teórico na compreensão do trauma psíquico infantil, uma vez que as consequências deste encontro assimétrico podem ser devastadoras e desorganizadoras, conforme elucidado pela história de Kevin

El objetivo de este estudio es presentar un análisis de la película Necesitamos hablar de Kevin, a partir de las reflexiones teóricas de Jean Laplanche sobre la teoría de la seducción generalizada. El artículo presenta los aportes teóricos del autor y sus seguidores, principalmente en lo que se refiere a los mensajes enigmáticos y la construcción de un modelo tópico y unificado del aparato psíquico. El análisis de la película permitió llamar la atención sobre los efectos de las vicisitudes de la seducción, explorando las especificidades presentes en la comunicación entre el adulto y el niño que inciden en las possibilidades de traducción de los mensajes enigmáticos y sus efectos en la constitución de la psique. Se verifica la fecundidad del aporte teórico en la comprensión del trauma psíquico infantil, ya que las consecuencias de este encuentro asimétrico pueden ser devastadoras y desorganizadoras, conforme esclarecido por la historia de Kevin

The aim of this study is to present an analysis of the film We need to talk about Kevin, based on the Jean Laplanche's theoretical reflections on the theory of generalized seduction. The article presents the theoretical contributions of the author and his followers, mainly with regard to the enigmatic messages and in the construction of a topical and unified model of the psychic apparatus. The film's analysis allowed to draw attention to the vicissitudes's effects of seduction, exploring the specificities present in the communication between the adult and child that reflect on the translation's possibilities of the enigmatic messages and their effects on the constitution of the psyche. It is verified the fecundity of the theoretical contribution to the understanding of the childhood psychic trauma, since the consequences of this asymmetrical encounter can be devastating and disorganizing, as elucidated by Kevin's story

Le but de cette étude est de présenter une analyse du film Nous devons parler de Kevin, à partir des réflexions théoriques de Jean Laplanche sur la théorie de la séduction généralisée. L'article présente les contributions théoriques de l'auteur et de ses adeptes, principalement en ce qui concerne les messages énigmatiques et dans la construction d'un modèle d'actualité et unifié de l'appareil psychique. L'analyse du film permis d'attirer l'attention sur les effets des vicissitudes de la séduction, explorant les spécificités présentes dans la communication entre l'adulte et l'enfant qui réfléchissent sur les possibilités de traduction des messages énigmatiques et leurs effets sur la constitution de la psyché. La fécondité de l'apport théorique à la compréhension du traumatisme psychique infantile est vérifiée, puisque les conséquencesde cette rencontre asymétrique peuvent être dévastatrices et désorganisantes, comme l'elucide par l'histoire de Kevin

Evaluation of the effects of high-level laser and electrocautery in lingual frenectomy surgeries in infants: protocol for a blinded randomised controlled clinical trial.

INTRODUCTION: Ankyloglossia (tongue-tie) is an anomaly characterised by an abnormally short, thick or small lingual frenulum that restricts tongue movements. This condition is considered one of the factors that can interfere with breast feeding by diminishing the ability of the newborn to latch adequately. According to the Brazilian Health Ministry, the prevalence of this anomaly among newborns is 3%-16%. Frenectomy is the most suitable surgical procedure for the treatment of ankyloglossia. The aim of this study is to compare the performance of electrocautery and high-power diode laser as forms of frenectomy. METHODS AND ANALYSIS: The proposed study will be a randomised, controlled, blind clinical trial involving the participation of healthy infants 0-3 months of age with breastfeeding difficulty and a diagnosis of tongue-tie with an indication for lingual frenectomy. The guardians will receive clarifications regarding the procedures and will authorise the participation of the infants by signing a statement of informed consent. A non-blinded researcher will perform the screening and procedures and a blinded researcher will perform the postoperative evaluations. Fifty-six infants will be randomly allocated into two groups (n=28): the electrocautery group or the high-power laser group. The preparation of the patients, asepsis and infection control procedures will rigorously follow biosafety norms. For both groups, patient histories will be taken, clinical evaluations will be performed and a standardised photograph of the lingual frenulum will be taken before surgery. The Bristol Tongue Assessment Tool will be used. We will evaluate pain in the mother during breast feeding before, immediately after, and 15 days after surgery. ETHICS AND DISSEMINATION: This protocol was submitted to the Research Ethics Committee of Nove de Julho University, having been given a favourable opinion (Number: 4387769). Results will be submitted to international peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT04487418.

A phase 2 randomized clinical trial of abiraterone plus ADT, apalutamide, or abiraterone and apalutamide in patients with advanced prostate cancer with non-castrate testosterone levels (LACOG 0415).

BACKGROUND: Androgen deprivation therapy (ADT) combined with apalutamide, abiraterone acetate plus prednisone, enzalutamide, or docetaxel are the standard treatments for advanced castration-sensitive prostate cancer (CSPC). We investigated ADT-free alternatives for advanced CSPC. PATIENTS AND METHODS: LACOG 0415 is a phase 2, open-label, non-comparative, randomized trial. Patients with advanced CSPC were randomized (1:1:1) to receive goserelin plus abiraterone acetate and prednisone (ADT plus AAP arm), apalutamide (APA arm), or apalutamide plus abiraterone acetate and prednisone (APA plus AAP arm). The primary endpoint was the proportion of patients with PSA of ≤0.2 ng/mL at week 25 in the modified intention-to-treat population. Safety analyses were performed in all patients with at least one dose of the study drug. RESULTS: Of 128 randomized patients, 120 patients were evaluable for PSA response at week 25; 17.2% had a high-risk biochemical recurrence, 8.6% had locally advanced disease, and 74.2% had distant metastases. At week 25, PSA of ≤0.2 ng/mL was observed in 75.6% (95%CI 59.7%-87.6%), 60.0% (95%CI 43.3%-75.1%), and 79.5% (95%CI 63.5%-90.7%) of patients in ADT plus AAP, APA, and APA plus AAP arms, respectively. PSA decline of ≥80% was observed in 100%, 90.0%, and 97.4%, respectively. Grade 3-4 AEs were observed in 31.0%, 21.4% and 36.4%, respectively. Testosterone levels increased significantly in the APA arm and decreased significantly in ADT plus AAP and APA plus AAP arms. CONCLUSIONS: ADT-free alternatives provide a high PSA response in advanced CSPC, although the APA arm did not reach the expected rate of PSA of ≤0.2 ng/mL at week 25. These results warrant further investigation of ADT-free treatments as alternatives in advanced CSPC. SOURCE STUDY REGISTRATION: ClinicalTrials.govNCT02867020.