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Objective To evaluate the number of patients with early-stage breast cancer who could benefit from the omission of axillary surgery following the application of the Alliance for Clinical Trials in Oncology (ACOSOG) Z0011 trial criteria. Methods A retrospective cohort study conducted in the Hospital da Mulher da Universidade Estadual de Campinas. The study population included 384 women diagnosed with early-stage invasive breast cancer, clinically negative axilla, treated with breast-conserving surgery and sentinel lymph node biopsy, radiation therapy, chemotherapy and/or endocrine therapy, from January 2005 to December 2010. The ACOSOG Z0011 trial criteria were applied to this population and a statistical analysis was performed to make a comparison between populations. Results A total of 384 patients underwent breast-conserving surgery and sentinel lymph node biopsy. Of the total number of patients, 86 women underwent axillary lymph node dissection for metastatic sentinel lymph nodes (SNLs). One patient underwent axillary node dissection due to a suspicious SLN intraoperatively, thus, she was excluded fromthe study. Among these patients, 82/86 (95.3%) had one to two involved sentinel lymph nodes andmet the criteria for the ACOSOG Z0011 trial with the omission of axillary lymph node dissection. Among the 82 eligible women, there were only 13 cases (15.9%) of lymphovascular invasion and 62 cases (75.6%) of tumors measuring up to 2 cm in diameter (T1). Conclusion The ACOSOG Z0011 trial criteria can be applied to a select group of SLNpositive patients, reducing the costs and morbidities of breast cancer surgery. Resumo Objetivo Avaliar o número de pacientes com câncer de mama em estágio inicial que se beneficiariam da omissão da linfadenectomia axilar segundo o protocolo Z0011 da Alliance for Clinical Trials in Oncology (ACOSOG). Métodos Estudo de coorte retrospectiva conduzido no Hospital da Mulher da Universidade Estadual de Campinas. Foram incluídas mulheres diagnosticadas com carcinoma invasivo de mama em estágio inicial, com axila clinicamente negativa, tratadas com cirurgia conservadora e biópsia do linfonodo sentinela, radioterapia, quimioterapia e/ou hormonioterapia, de janeiro de 2005 a dezembro de 2010. Os critérios do estudo da ACOSOG Z0011 foram aplicados a essas mulheres e foi realizada uma análise estatística que comparou ambas as populações dos estudos. Resultados Foram estudadas 384 mulheres submetidas a cirurgia conservadora de mama e biópsia do linfonodo sentinela. Entre elas, 86 mulheres foram submetidas a linfadenectomia axilar por metástase presente no linfonodo sentinela. Uma paciente foi submetida a linfadenectomia axilar por ter um linfonodo palpável suspeito no intraoperatório, não incluída no estudo. Entre essas 86 pacientes, 82 (95,3%) tiveram de 1 a 2 linfonodos sentinela comprometidos e seriam elegíveis para omissão da linfadenectomia axilar pelos critérios do ACOSOG Z0011. Entre as 82 pacientes elegíveis, apenas 13 (15,9%) delas apresentaram tumores com invasão angiolinfática, e 62 (75,6%) dos tumores mediram até 2 cm (T1). Conclusão Os critérios do estudo ACOZOG Z0011 podem ser aplicados a um seleto grupo de pacientes com linfonodo sentinela positivo reduzindo os custos e a morbidade cirúrgica do tratamento do câncer de mama.

Neurological dysfunction represents a significant clinical component of many of the mucopolysaccharidoses (also known as MPS disorders). The accurate and consistent assessment of neuropsychological function is essential to gain a greater understanding of the precise natural history of these conditions and to design effective clinical trials to evaluate the impact of therapies on the brain. In 2017, an International MPS Consensus Panel published recommendations for best practice in the design and conduct of clinical studies investigating the effects of therapies on cognitive function and adaptive behavior in patients with neuronopathic mucopolysaccharidoses. Based on an International MPS Consensus Conference held in February 2020, this article provides updated consensus recommendations and expands the objectives to include approaches for assessing behavioral and social-emotional state, caregiver burden and quality of life in patients with all mucopolysaccharidoses.

Introduction Fibromyalgia is a complex pain condition that affects mostly women. Given the disease's lack of understanding, patients report poor adherence to medication and mistrust of medical services. This study aims to describe the recruitment characteristics and non-adherence associated factors of fibromyalgia patients to an RCT. Methods We performed a retrospective longitudinal analysis with data from our ongoing RCT. We investigated characteristics of subjects recruited, consented, and randomized. Adherence was studied using survival analysis techniques, and its associated factors were identified using Cox proportional hazards regression model. Results 524 subjects were contacted, 269 were eligible, 61 consented and 40 subjects were randomized. Thirty-eight percent were non-adherent to the protocol with a median of visits of five. The recruitment survey reported that 90% would likely participate in RCTs, 52% had previous participation, and 19% were aware of RCTs by their physicians. Some barriers were investigator-related (staff's friendliness and receiving the results of their trial participation) and center-related (privacy-confidentiality issues and the institution's reputation), without difference between adherent and non-adherent participants. We report significant factors for non-adherence as VAS anxiety score of 5 or more (5.3 HR, p = 0.01), Body Mass Index (BMI) (0.91 HR, p = 0.041) and Quality of Life (QoL) – Personal development subdomain (0.89 HR, p = 0.046). Conclusion Recruitment and adherence of fibromyalgia patients is a challenge; however, they seem eager to participate in RCTs. We recommend creating a comfortable, friendly and trusting environment to increase the recruitment rate. Higher anxiety, lower BMI and lower quality of life were associated with a higher attrition rate.

Daily rhythm of melatonin synchronizes the body to the light/dark environmental cycle. Several hypotheses have been raised to understand the intersections between melatonin and depression, in which changes in rest-activity and sleep patterns are prominent. This review describes key experimental and clinical evidence that link melatonin with the etiopathology and symptomatology of depressive states, its role in the follow up of therapeutic response to antidepressants, as well as the clinical evidence of melatonin as MDD treatment. Melatonin, as an internal temporal cue contributing to circadian organization and best studied in the context of circadian misalignment, is also implicated in neuroplasticity. The monoaminergic systems that underly MDD and melatonin production overlap. In addition, the urinary metabolite 6-sulfatoxymelatonin (aMT6) has been proposed as biomarker for antidepressant responders, by revealing whether the blockage of noradrenaline uptake has taken place within 24 h from the first antidepressant dose. Even though animal models show benefits from melatonin supplementation on depressive-like behavior, clinical evidence is inconsistent vis-à-vis prophylactic or therapeutic benefits of melatonin or melatonin agonists in depression. We argue that the study of melatonin in MDD or other psychiatric disorders must take into account the specificities of melatonin as an integrating molecule, inextricably linked to entrainment, metabolism, immunity, neurotransmission, and cell homeostasis.

Introduction Gingivitis is a gingival inflammation which can often be treated with oral hygiene such as brushing, flossing, and an antiseptic mouthwash. Objective The aim of this randomized clinical trial was to clinically evaluate the effectiveness of 0.12% chlorhexidine (CHX) solution as an anti-inflammatory agent and for reducing the presence of plaque and inflammation in young adults. Material and method Thirty patients with gingivitis aged 18 to 30 years with a probing depth ≤ 3 mm and a minimum of 20 teeth in the whole mouth were selected and evaluated at baseline and 30 days after treatment. Periodontal clinical parameters were verified: plaque index (PI), gingival index (GI), Simplified Oral Hygiene Index (OHI-S), Simplified Debris Index (DI-S), and Simplified Calculus Index (CI-S) Patients were then randomly allocated into two groups: CHX Group, received chlorhexidine 0.12% labeled as solution 1, and Placebo Group, received saline solution labeled as solution 2. Both groups were included in a hygiene program and received mouthwash. Result Statistically significant differences between CHX and Placebo groups were observed for the variables PI, GI, DI-S, CI-S, and OHI-S (p

Introduction Understanding the effects of periodontal therapy is essential in performance and satisfaction of partially dentate patients. Objective To assess the effect of subgingival periodontal treatment in performance and masticatory satisfaction and ability as reported by partially dentate patients with untreated chronic periodontitis. Materials and method Patients were given nonsurgical periodontal treatment and masticatory satisfaction, ability, and performance were evaluated before and after treatment. Performance was assessed based on sieving chewed standardized chewable material, while satisfaction and ability were analyzed using a questionnaire based on OHIP-EDENT. Result Mean numbers of functional tooth units were 10.36 ± 1.43 anterior and 6.73 ± 0.79 posterior teeth. Masticatory performance did not vary significantly (p = 0.075), and mean particle sizes before and after treatment were 4.23 ± 1.84 mm and 3.90 ± 0.75 mm, respectively. Overall satisfaction and ability scores after treatment were higher (p > 0.05) compared with scores prior to the periodontal intervention. Conclusion Periodontal treatment improves masticatory satisfaction and ability with no effect on performance.

To determine whether the topical use of gentamicin reduces periprosthetic joint infection rates in primary total hip arthroplasty (THA).We retrospectively evaluated two cohorts of patients who underwent primary THA in a university hospital, with a minimum of 1-year postoperative follow-up and full clinical, laboratory, and radiological documentation. Patients who underwent operation in the first 59 months of the study period (263 hips) received only intravenous cefazolin as antibiotic prophylaxis (Cef group), and those who underwent operation in the following 43 months (170 hips) received intravenous cefazolin plus topical gentamicin directly applied on the wound as antibiotic prophylaxis (Cef + Gen group). For the diagnosis of periprosthetic joint infection, we used the criteria of the Centers for Disease Control and Prevention. Data were analyzed using the Fisher exact test, and p values of0.05 were considered significant.Thirteen hips (4.9%) in the Cef group and eight hips (4.7%) in the Cef + Gen group presented periprosthetic joint infection. Statistical analysis revealed no difference between the infection rates (p = 1.0).Topical gentamicin as used in this study did not reduce periprosthetic joint infection rates in primary THA.Determinar se o uso tópico de gentamicina reduz a taxa de infecção articular periprotética na artroplastia total primária do quadril.Avaliamos retrospectivamente dois coortes de pacientes submetidos à artroplastia total primária do quadril em um hospital universitário, com seguimento pós-operatório mínimo de 1 ano e completa documentação clínica, laboratorial e radiológica. Os casos operados nos primeiros 59 meses do período do estudo (263 quadris) utilizaram somente a cefazolina por via endovenosa como antibioticoprofilaxia (Grupo Cef). Os casos operados nos 43 meses seguintes (170 quadris) utilizaram a cefazolina por via endovenosa associada à gentamicina tópica aspergida diretamente na ferida operatória como antibioticoprofilaxia (Grupo Cef + Gen). Para o diagnóstico de infecção articular periprotética, utilizamos os critérios do Centers for Disease Control and Prevention. Os dados foram submetidos ao teste exato de Fisher, e valor de p menor que 0,05 foi considerado significativo.Treze quadris apresentaram infecção articular periprotética no Grupo Cef (4,9%) e oito quadris no Grupo Cef + Gen (4,7%). A análise estatística demonstrou não haver diferença entre estas taxas (p=1,0).O uso tópico da gentamicina, da maneira como utilizada neste estudo, não reduziu a taxa de infecção articular periprotética na artroplastia total primária do quadril.

PURPOSE: Outcomes in patients with Fabry disease receiving migalastat during the phase 3 FACETS trial (NCT00925301) were evaluated by phenotype. METHODS: Data were evaluated in two subgroups of patients with migalastat-amenable GLA variants: "classic phenotype" (n = 14; males with residual peripheral blood mononuclear cell α-galactosidase A

Background: Fifty-five percent of Americans aged 50-65 are submitted to colonoscopy. For over 65-year, this number increases to 64%. In Brazil, it is forecast that the population submitted to colonoscopy will grow, even though inadequate preparation is still a major problem. Aim: To analyze the quality of a new intestinal preparation technique, Aquanet EC-2000®, compared to oral Mannitol solution. Methods: This prospective longitudinal study enrolled 200 patients with indication for colonoscopy. The sample was randomly allocated to two groups of 100; one group received Aquanet EC-2000® to prepare for colonoscopy and the other Mannitol solution. The Boston scale was used to analyze the results. Results: As expected both preparations produced similar results with the bowel cleansing of the different regions of the colon being classified as Boston scale 3 (excellent) in most patients (p>0.05). Conclusion: The results of bowel preparation using Aquanet EC-2000® were similar to using Mannitol solution.

Background : : : : The canine osteosarcoma is characterized by being an aggressive bone tumor that affects mainly large dogs, middle-aged and male, accounting for 80-85% of bone tumors and 5-6% of all tumors. The risk of developing this tumor is, on average, 125 times greater in dogs weighing over 36 kg than in dogs weighing less than 9 kg. This cancer develops more frequently in the appendicular skeleton (75%), preferably the bones of the forelimbs, where approximately 60% of body weight are sustained. The canine osteosarcoma is very similar to human, in which the metaphyseal region of long bones is the most affected, causing lameness and swelling of the affected limb. The diagnosis is made from epidemiological data, history of the animal, X-rays and laboratory tests such as cytology fine-needle aspiration (FNAC) and measurement of the enzyme alkaline phosphatase (ALP). The staging of the disease becomes a major method for the treatment, whereas primary bone tumors are highly complex and end up interfering with the animal organism in whole. The objective of this study is to report a clinical study of 12 dogs with osteosarcoma, showing the procedures performed from diagnosis to treatment. Material, Methods and Results : Dogs were assisted at the Clinic of Small Animals VUH - UFSM and after the clinical examination were referred to the Department of Radiology. After the radiographic study, blood samples for biochemical and material for cytological analysis of the tumor were collected. After the confirmation of the neoplasm, the physician who prescribed the treatment, depending on the case, the accession to it was left to the owner. In this study, we observed the development of osteosarcoma in dogs from two to 14 years old. Furthermore, in 10 animals (83.3%) the tumor was located in one of the members and nine of these (75%) affected forelimbs. Still, eight dogs (66.7%) were males. The animals weighed on average, 30 kg and five were crossbreeds. Eight dogs (66.7%) had an elevation in enzyme ALP. In this study, five dogs (41%) received no treatment, four (33.3%) were killed and three (25.7%) had the treatment as prescribed by the clinician. Three of the dogs treated survived for a few weeks and two of those who received appropriate treatment survived more than a year. Discussion : The clinical and epidemiological findings of this study corroborate the literature, making them increasingly used in the auxiliary tests cited. For a proper diagnosis it is necessary for the veterinary practitioner to know which tests to determine use. Approximately 98% of the patients have micrometastases at diagnosis, however, only 5% of dogs with osteosarcoma have radiographic evidence of pulmonary metastasis. These will only cause clinical signs in advanced stages, leading the majority of dogs to euthanasia. Moreover, the appearance of bone thinning and explosion in the limb are strong indications of osteosarcoma. The FNAC is one of the main tests for diagnosing neoplastic, because the laboratory technician can visualize the tumor cells in proliferation and other features visible only under a microscope. The enzyme alkaline phosphatase is of great value in the diagnosis and prognosis of this tumor and may demonstrate metastases when elevated. Epidemiological data along with auxiliary tests make the diagnosis of this neoplasm safer, which assists the owner in the decision for the treatment of the affected animals. As there is still little understanding of the anticancer treatment by the owners, treatment schedules may not be implemented, which prolongs the disease and causes more suffering to the dogs.

OBJECTIVE: To assess skeletal and dental changes immediately after rapid maxillary expansion (RME) in Class II Division 1 malocclusion patients and after a retention period, using cone beam computed tomography (CBCT) imaging. METHODS: Seventeen children with Class II, Division 1 malocclusion and maxillary skeletal transverse deficiency underwent RME following the Haas protocol. CBCT were taken before treatment (T1), at the end of the active expansion phase (T2) and after a retention period of 6 months (T3). The scanned images were measured anteroposteriorly (SNA, SNB, ANB, overjet and MR) and vertically (N-ANS, ANS-Me, N-Me and overbite). RESULTS: Significant differences were identified immediately after RME as the maxilla moved forward, the mandible moved downward, overjet increased and overbite decreased. During the retention period, the maxilla relapsed backwards and the mandible was displaced forward, leaving patients with an overall increase in anterior facial height. CONCLUSION: RME treatment allowed more anterior than inferior positioning of the mandible during the retention period, thus significantly improving Class II dental relationship in 75% of the patients evaluated. OBJETIVO: avaliar, por meio de imagens de tomografia computadorizada de feixe cônico (TCFC), as mudanças esqueléticas e dentárias, imediatas e após 6 meses de contenção, causadas pela expansão rápida da maxila (ERM) em pacientes com má oclusão de Classe II, divisão 1. MÉTODOS: dezessete crianças com má oclusão de Classe II, divisão 1, e deficiência transversal da maxila, foram submetidas a ERM, de acordo com o protocolo proposto por Haas. TCFC foram realizadas antes da ERM (T1), imediatamente após a fase ativa (T2) e após 6 meses de contenção (T3). Alterações anteroposteriores (SNA, SNB, ANB, overjet e RM) e verticais (N-ANS, ANS-Me, N-Me e overbite) foram analisadas. RESULTADOS: imediatamente após a ERM, enquanto a maxila se deslocou para frente, a mandíbula se movimentou para frente e para baixo, aumentando o overjet e diminuindo o overbite. Durante o período de contenção, a maxila retornou para posterior e a mandíbula deslocou em direção anterior, aumentando a altura facial anterior. CONCLUSÃO: a realização da ERM permitiu que a mandíbula se posicionasse mais anteriormente do que inferior durante o período de contenção, melhorando a relação molar de Classe II em 75% dos pacientes avaliados.

The aim of the present study was to evaluate the clinical performance of two types of ceramics: a slurry-powder ceramic (Duceram Plus, Degussa) - D and a hot-pressed leucite-based glass-ceramic (IPS Empress, Ivoclar Vivadent) - IPS. Eighty-six restorations, 44 IPS and 42 D, were made by one operator. A total of 33 onlays and 53 inlays on twenty-seven premolars and 59 molars were cemented in 35 patients of both sexes, mean age 35 years. All restorations were cemented with the dual-resin cement (Variolink, Ivoclar-Vivadent) under rubber dam and were evaluated at the baseline and after six months, using the modified U.S.P.H.S. criteria for postoperative sensitivity, secondary caries, fracture, color match, marginal discoloration, marginal integrity and surface texture. Additionally radiographs and intraoral photographs were carried out. At baseline 86 restorations were analyzed and all of them received Alfa rating, except for the following that received Bravo rating for postoperative sensitivity - IPS (2.27%); D (7.14%); for color match - IPS (2.27%); D (2.38%) and for surface texture - IPS (2.27%); D (11.90%). After 6 months 100% of the restorations were analyzed and the following received Bravo rating: color match - IPS (4.55%) and D (9.52%); surface texture - IPS (2.27%) and D (11.9%); marginal discoloration - IPS (6.82%) and D (4.76%) and marginal integrity - IPS (4.55%) and D (7.14%). The results were submitted to the Fisher and McNemar Statistical Tests. No significant differences were noticed between the two ceramics. Both ceramics demonstrated satisfactory clinical performance after six months. Este trabalho se propôs a avaliar a performance clínica de dois tipos de cerâmica: IPS Empress, Ivoclar-Vivadent - IPS e Duceram Plus, Degussa - D. Foram realizadas 86 restaurações por apenas um operador, sendo 44 IPS e 42 D. Vinte e sete pré-molares e 59 molares, num total de 33 onlays e 53 inlays, foram cimentadas em 35 pacientes de ambos os sexos, com idade média de 35 anos. A cimentação das restaurações foi realizada com cimento resinoso dual (Variolink, Ivoclar-Vivadent) sob isolamento absoluto e avaliadas no baseline e após 06 meses, mediante o critério U.S.P.H.S. modificado, quanto à sensibilidade pulpar, reincidência de cárie, fratura, reprodução de cor, descoloração marginal, integridade marginal e textura superficial. Adicionalmente foram realizadas radiografias e fotografias. No baseline foi obtida a classificação Bravo nos itens sensibilidade pulpar - IPS (2,27%); D (7,14%); reprodução de cor - IPS (2,27%); D (2,38%) e textura superficial - IPS (2,27%); D (11,90%). Após 06 meses foram analisadas as 86 restaurações, nas quais foi constatada a classificação Bravo para os itens reprodução de cor - IPS (6,82%); D (2,38%); textura superficial - IPS (2,27%); D (9,52%); descoloração marginal - IPS (6,82%); D (4,76%) e integridade de superfície- IPS (4,55%); D (7,14%). Os resultados obtidos foram submetidos ao Teste Estatístico de Fisher e McNemar. Não houve diferença estatisticamente significante entre as cerâmicas. Pode-se concluir que os dois tipos de cerâmica demonstraram uma performance clínica satisfatória após 06 meses.