Long-term Outcomes and Patterns of Relapse Following High-dose Elective Salvage Radiotherapy and Hormone Therapy in Oligorecurrent Pelvic Nodes in Prostate Cancer: OLIGOPELVIS (GETUG-P07).

Androgen deprivation therapy (ADT) is a mainstay of treatment for metastatic prostate cancer, while additional salvage radiotherapy may offer prolonged remission for patients with regional node relapses. We report 5-yr outcomes from OLIGOPELVIS (GETUG-P07), an open-label phase 2 trial assessing long-term outcomes and patterns of relapse after 6-mo ADT and elective nodal radiotherapy (ENRT) in men with pelvic nodal oligorecurrence (<6 lesions) of prostate cancer. Progression was defined as two consecutive prostate-specific antigen (PSA) levels above the level at inclusion and/or clinical progression according to Response Evaluation Criteria in Solid Tumors v1.1 and/or death from any cause. Sixty-seven patients were recruited. Median follow-up was 6.1 yr (95% confidence interval 5.9-6.3). Rates of grade 2+ toxicities among patients without progression at 3, 4, and 5 yr were 15%, 9%, and 4% for genitourinary toxicities, and 2%, 3%, and 4% for gastrointestinal toxicities, respectively. The 5-yr progression-free, biochemical relapse-free, and ADT-free survival rates were 39%, 31%, and 64%, respectively. In total, 45 patients experienced progression, which was PSA-only progression in seven cases. Among the other 38 patients, local clinical progression occurred in 18%, progression to N1 stage in 29%, to M1a stage in 50%, to M1b stage in 32%, and to M1c stage in 11%. Finally, combined ENRT and ADT appeared to prolong tumor control with limited toxicity. At 5 yr, one-third of the patients had not experienced biochemical relapse. The major site of relapse was the para-aortic lymph nodes. PATIENT SUMMARY: We evaluated long-term results for high-dose radiotherapy in patients with recurrence of prostate cancer in pelvic lymph nodes. We found that this treatment provided prolonged tumor control without significant toxicity. One-third of the patients were still in complete remission after 5 years.

Cuidados prestados ao portador de úlcera venosa que auxiliam a cicatrização da ferida / Care provided to patients with venous ulcers to help the wound heal

Objetivo: Identificar na literatura quais são as mais recentes práticas assistenciais prestadas ao paciente portador de úlcera visando a cicatrização da ferida. Método: trata-se de uma revisão integrativa da literatura realizada no período de novembro e dezembro de 2022 indexados nos portais LILACS e MEDLINE, os descritores usados na busca foram "Úlcera varicosa" OR "Insuficiência venosa'' AND "cicatrização" AND "Assistência ao paciente". Resultados: foram incluídos 8 artigos, como principais resultados observou-se que a enfermagem realiza várias intervenções para cicatrização das lesões sendo a mais utilizada é o tratamento com terapia compressiva, seguido do tratamento com hidrocoloide e tratamento com gel de plaquetas homólogo. No que tange a avaliação de lesões, prevalece o uso do instrumento PUSH. Considerações finais: faz-se necessário a avaliação adequada, orientação do paciente e cuidador, cuidado multidisciplinar e associação de novas tecnologias para o tratamento de úlceras venosas. A padronização da utilização de escalas como a PUSH na avaliação dos cuidados prestados é essencial para nortear o atendimento.(AU)

Objective: To identify in the literature which are the most recent care practices provided to patients with ulcers, aiming at wound healing. Method: this is an integrative literature review carried out in the period of November and December 2022 indexed in the LILACS and MEDLINE portals, the descriptors used in the search were "Varicose ulcer" OR "Venous insufficiency'' AND "healing" AND "Assistance to the patient". Results: 8 articles were included. With regard to the assessment of injuries, the use of the PUSH instrument prevails. Final considerations: proper assessment, patient and caregiver guidance, multidisciplinary care and association of new technologies for the treatment of venous ulcers are necessary. The standardization of the use of scales such as the PUSH in the assessment of the care provided is essential to guide care.(AU)

Objetivo: Identificar en la literatura cuáles son las prácticas más recientes de cuidados prestados a pacientes con úlceras visando la cicatrización de las heridas. Método: se trata de una revisión bibliográfica integradora realizada en el período de noviembre y diciembre de 2022 indexada en los portales LILACS y MEDLINE, los descriptores utilizados en la búsqueda fueron "Úlcera varicosa" O "Insuficiencia venosa" Y "cicatrización" Y "Cuidados del paciente". Resultados: Se incluyeron 8 artículos, como principales resultados se observó que enfermería realiza diversas intervenciones para la cicatrización de las lesiones, siendo la más utilizada el tratamiento con terapia compresiva, seguida del tratamiento con hidrocoloide y el tratamiento con gel de plaquetas homólogas. En cuanto a la valoración de las lesiones, prevalece el uso del instrumento PUSH. Consideraciones finales: son necesarias una evaluación adecuada, la orientación al paciente y al cuidador, la atención multidisciplinar y la asociación de nuevas tecnologías para el tratamiento de las úlceras venosas. La estandarización del uso de escalas como el PUSH en la evaluación de los cuidados prestados es esencial para orientar la asistencia.(AU)

Bibliometric analysis and description of research trends on transforaminal full-endoscopic approach on the spine for the last two-decades.

OBJECTIVE: The study aims to assess the current development status of transforaminal full-endoscopic spine surgery (TFES) by exploring and analyzing the published literature to obtain an overview of this field and discover the evolution and emerging topics that are underrepresented. METHODS: Using Bibliometrix, CiteSpace, and VOSviewer, we analyzed the bibliometric data selected from the Web of Science Core Collection between January 2002 and November 2022. The descriptive and evaluative analyses of authors, institutes, countries, journals, keywords, and references are compiled. The quantity of research productivity was measured by the number of publications that were published. A quality indicator was thought to be the number of citations. In the bibliometric analysis of authors, areas, institutes, and references, we calculated and ranked the research impact by various metrics, such as the h-index and m-index. RESULTS: A total of 628 articles were identified in the field of TFES by the 18.73% annual growth rate of research on the subject from 2002 to 2022, constituting the documents are by 1961 authors affiliated with 661 institutions in 42 countries or regions and published in 117 journals. The USA (n = 0.20) has the highest international collaboration rate, South Korea has the highest H-index value (h = 33), and China is ranked as the most productive country (n = 348). Brown univ., Tongji univ., and Wooridul Spine represented the most productive institutes ranked by the number of publications. Wooridul Spine Hospital demonstrated the highest quality of paper publication. The Pain Physician had the highest h-index (n = 18), and the most cited journal with the earliest publication year in the area of FEDS is Spine (t = 1855). CONCLUSION: The bibliometric study showed a growing trend of research on transforaminal full-endoscopic spine surgery over the past 20 years. It has shown a significant increase in the number of authors, institutions, and international collaborating countries. South Korea, the United States, and China dominate the related areas. A growing body of evidence has revealed that TFES has leapfrogged from its infancy stage and gradually entered a mature development stage.

Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design.

BACKGROUND: Current standard of care for metastatic castration-sensitive prostate cancer supplements androgen deprivation therapy with either docetaxel, second-generation hormonal therapy, or radiotherapy. We aimed to evaluate the efficacy and safety of abiraterone plus prednisone, with or without radiotherapy, in addition to standard of care. METHODS: We conducted an open-label, randomised, phase 3 study with a 2 × 2 factorial design (PEACE-1) at 77 hospitals across Belgium, France, Ireland, Italy, Romania, Spain, and Switzerland. Eligible patients were male, aged 18 years or older, with histologically confirmed or cytologically confirmed de novo metastatic prostate adenocarcinoma, and an Eastern Cooperative Oncology Group performance status of 0-1 (or 2 due to bone pain). Participants were randomly assigned (1:1:1:1) to standard of care (androgen deprivation therapy alone or with intravenous docetaxel 75 mg/m2 once every 3 weeks), standard of care plus radiotherapy, standard of care plus abiraterone (oral 1000 mg abiraterone once daily plus oral 5 mg prednisone twice daily), or standard of care plus radiotherapy plus abiraterone. Neither the investigators nor the patients were masked to treatment allocation. The coprimary endpoints were radiographic progression-free survival and overall survival. Abiraterone efficacy was first assessed in the overall population and then in the population who received androgen deprivation therapy with docetaxel as standard of care (population of interest). This study is ongoing and is registered with ClinicalTrials.gov, NCT01957436. FINDINGS: Between Nov 27, 2013, and Dec 20, 2018, 1173 patients were enrolled (one patient subsequently withdrew consent for analysis of his data) and assigned to receive standard of care (n=296), standard of care plus radiotherapy (n=293), standard of care plus abiraterone (n=292), or standard of care plus radiotherapy plus abiraterone (n=291). Median follow-up was 3·5 years (IQR 2·8-4·6) for radiographic progression-free survival and 4·4 years (3·5-5·4) for overall survival. Adjusted Cox regression modelling revealed no interaction between abiraterone and radiotherapy, enabling the pooled analysis of abiraterone efficacy. In the overall population, patients assigned to receive abiraterone (n=583) had longer radiographic progression-free survival (hazard ratio [HR] 0·54, 99·9% CI 0·41-0·71; p<0·0001) and overall survival (0·82, 95·1% CI 0·69-0·98; p=0·030) than patients who did not receive abiraterone (n=589). In the androgen deprivation therapy with docetaxel population (n=355 in both with abiraterone and without abiraterone groups), the HRs were consistent (radiographic progression-free survival 0·50, 99·9% CI 0·34-0·71; p<0·0001; overall survival 0·75, 95·1% CI 0·59-0·95; p=0·017). In the androgen deprivation therapy with docetaxel population, grade 3 or worse adverse events occurred in 217 (63%) of 347 patients who received abiraterone and 181 (52%) of 350 who did not; hypertension had the largest difference in occurrence (76 [22%] patients and 45 [13%], respectively). Addition of abiraterone to androgen deprivation therapy plus docetaxel did not increase the rates of neutropenia, febrile neutropenia, fatigue, or neuropathy compared with androgen deprivation therapy plus docetaxel alone. INTERPRETATION: Combining androgen deprivation therapy, docetaxel, and abiraterone in de novo metastatic castration-sensitive prostate cancer improved overall survival and radiographic progression-free survival with a modest increase in toxicity, mostly hypertension. This triplet therapy could become a standard of care for these patients. FUNDING: Janssen-Cilag, Ipsen, Sanofi, and the French Government.

Rapid Communication: oxidative stress induced by mixed exposure to glyphosate and silver nanoparticles.

The aim of this study was to examine oxidative stress induced by the binary mixture of silver nanoparticles (AgNP) and glyphosate (Gly) in Daphnia magna by measurement of reactive oxygen species (ROS) production, glutathione (GSH) levels, enzyme activities of catalase (CAT) and superoxide dismutase (SOD) as well as malondialdehyde (MDA) content. Acute exposure of Daphnia magna to binary mixture of AgNP and Gly resulted in significant biochemical responses indicative of oxidative damage. This response seemed to be related to imbalance in enzymatic/non-enzymatic antioxidant enzymes associated with intracellular overproduction of ROS and significant increase in MDA levels, indicating that the integrity and function of the cell membrane was damaged. These changes adversely affected the fitness and survival of Daphnia magna and negatively influenced offspring growth and reproduction.

Sociodemographic and pharmacoepidemiological profile of people on antiretroviral therapy in the coast of the state of Paraná

The aim of this study was to investigate possible factors related to antiretroviral therapy (ART) that contribute to the understanding of the highest rate of Aids detection on the coast of the state of Paraná, a port region identified administratively as the 1stRegional Health Division (1stHD) in the state of Paraná. Data on the sociodemographic profile of the population undergoing antiretroviral treatment (ART), medication changes, dropout of therapy, proportion of the population undergoing treatment and viral load were obtained through computerized systems. Between July 1, 2018 and June 31, 2019, 1,393 people were on ART in the 1stRS. Of these, 57.6% were male. During this period, 110 people started ART with a predominance of the age group between 30 and 39 years old. ART was switched for169 people and 211 patient dropouts were detected. The proportion of people diagnosed with HIV without treatment (gap) is still high, however 92.7% people on ART have suppressed viral load. It can be concluded that the lower educational level of the population undergoing treatment, the late diagnosis of those infected and the treatment gapprobably contribute to the highest rate of Aids detection in the 1stRS.

OLIGOPELVIS GETUG P07, a Multicenter Phase II Trial of Combined High-dose Salvage Radiotherapy and Hormone Therapy in Oligorecurrent Pelvic Node Relapses in Prostate Cancer.

BACKGROUND: Oligorecurrent pelvic nodal relapse in prostatic cancer is a challenge for regional salvage treatments. Androgen depriving therapies (ADTs) are a mainstay in metastatic prostate cancer, and salvage pelvic radiotherapy may offer long ADT-free intervals for patients harboring regional nodal relapses. OBJECTIVE: To assess the efficacy of the combination of ADT and salvage radiotherapy in men with oligorecurrent pelvic node relapses of prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: We performed an open-label, phase II trial of combined high-dose intensity-modulated radiotherapy and ADT (6 mo) in oligorecurrent (five or fewer) pelvic node relapses in prostate cancer, detected by fluorocholine positron-emission tomography computed tomography imaging. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was 2-yr progression-free survival defined as two consecutive prostate-specific antigen levels above the level at inclusion and/or clinical evidence of progression as per RECIST 1.1 and/or death from any cause. RESULTS AND LIMITATIONS: Between August 2014 and July 2016, 67 patients were recruited in 15 centers. Half of the patients had received prior prostatic irradiation. The median age was 67.7 yr. After a median follow-up of 49.4 mo, 2- and 3-yr progression-free survival rates were 81% and 58%, respectively. Median progression-free survival was 45.3 mo. The median biochemical relapse-free survival (BRFS) was 25.9 mo. At 2 and 3 yr, the BRFS rates were 58% and 46%, respectively. Grade 2 + 2-yr genitourinary and gastrointestinal toxicities were 10% and 2%, respectively. CONCLUSIONS: Combined high-dose salvage pelvic radiotherapy and ADT appeared to prolong tumor control in oligorecurrent pelvic node relapses in prostate cancer with limited toxicity. After 3 yr, nearly half of patients were in complete remission. Our study showed initial evidence of benefit, but a randomized trial is required to confirm this result. PATIENT SUMMARY: In this report, we looked at the outcomes of combined high-dose salvage pelvic radiotherapy and 6-mo-long hormone therapy in oligorecurrent pelvic nodal relapse in prostatic cancer. We found that 46% of patients presenting with oligorecurrent pelvic node relapses in prostate cancer were in complete remission after 3 yr following combined treatment at the cost of limited toxicity.

Dural Tears During Lumbar Spinal Endoscopy: Surgeon Skill, Training, Incidence, Risk Factors, and Management.

BACKGROUND: Incidental dural tears during lumbar endoscopy can be challenging to manage. There is limited literature on their appropriate management, risk factors, and the clinical consequences of this typically uncommon complication. MATERIALS AND METHODS: To improve the statistical power of studying durotomy with lumbar endoscopy, we performed a retrospective survey study among endoscopic spine surgeons by email and chat groups on social media networks, including WhatsApp and WeChat. Descriptive and correlative statistics were done on the surgeons' recorded responses to multiple-choice questions. Surgeons were asked about their clinical experience with spinal endoscopy, training background, the types of lumbar endoscopic decompression they perform by approach, the decompression instruments they use, and incidental durotomy incidence with routine lumbar endoscopy. RESULTS: There were 689 dural tears in 64 470 lumbar endoscopies, resulting in an incidental durotomy incidence of 1.07%. Seventy percent of the durotomies were reported by 20.4% of the surgeons. Eliminating these 19 outlier surgeons yielded an adjusted durotomy rate of 0.32. Endoscopic stenosis decompression (54.8%; P < .0001), rather than endoscopic discectomy (44.1%; 41/93), was significantly more associated with durotomy. Medium-sized dural tears (1-10 mm) were the most common (52.2%; 48/93). Small pinhole durotomies (less than 1 mm) were the second most common type (46.7%; 43/93). Rootlet herniations were seen by 46.2% (43/93) of responding surgeons. The posterior dural sac injury during the interlaminar approach (57%; 53/93) occurred more frequently than traversing nerve-root injuries (31.2%) or anterior dural sac (23.7%; 22/93). Exiting nerve-root injuries (10.8%;10/93) were less common. Over half of surgeons did not attempt any repair or closure (52.2%; 47/90). Forty percent (36/90) used sealants. Only 7.8% (7/90) of surgeons attempted an endoscopic repair or sutures (11.1%; 10/90). DuralSeal was the most commonly used brand of commercially available sealant used (42.7%; 35/82). However, other sealants such as Tisseal (15.9%; 13/82), Evicel (2.4%2/82), and additional no-brand sealants (38; 32/82) were also used. Nearly half of the patients (48.3%; 43/89) were treated with 24-48 hours of bed rest. The majority of participating surgeons (64%; 57/89) reported that the long-term outcome was unaffected. Only 18% of surgeons reported having seen the development of a postoperative cerebrospinal fluid (CSF)-fistula (18%;16/89). However, the absolute incidence of CSF fistula was only 0.025% (16/64 470). Severe radiculopathy with dysesthesia; sensory loss; and motor weakness in association with an incidental durotomy were reported by 12.4% (11/89), 3.4% (3/89), and 2.2% (2/89) of surgeons, respectively. CONCLUSIONS: The incidence of dural tears with lumbar endoscopy is about 1%. The incidence of durotomy is higher with the use of power drills and the interlaminar approach. Stenosis decompression that typically requires the more aggressive use of these power instruments has a slightly higher incidence of dural tears than does endoscopic decompression for a herniated disc. Most dural tears are small and can be successfully managed with mechanical compression with Gelfoam and sealants. Two-thirds of patients with incidental dural tears had an entirely uneventful postoperative course. The remaining one-third of patients may develop a persistent CSF leak, radiculopathy with dysesthesia, sensory loss, or motor function loss. Patients should be educated preoperatively and reassured. LEVEL OF EVIDENCE: 3.

Indication and Contraindication of Endoscopic Transforaminal Lumbar Decompression.

BACKGROUND: The indications and contraindications to the endoscopic transforaminal approach for lumbar spinal stenosis are not well defined. METHODS: We performed a Kaplan-Meier durability survival analysis of patients with the following types of spinal stenosis: type I, central canal; type II, lateral recess; type III, foraminal; and type IV, extraforaminal. The 304 patients comprised 140 men and 164 women, with an average age of 51.68 ± 15.78 years. The average follow-up was 45.3 years (range, 18-90 years). The primary clinical outcome measures were the Oswestry Disability Index, visual analog scale, and the modified Macnab criteria. RESULTS: Of 304 study patients, 70 had type I (23.0%) stenosis, 42 type II (13.7%), 151 type III (49.7%), and 41 type IV (13.5%). Excellent outcomes were obtained in 114 patients (37.5%), good in 152 (50.0%), fair in 33 (10.9%), and poor in 5 (1.6%). Kaplan-Meier durability analysis of the clinical treatment benefit with the endoscopic transforaminal decompression surgery showed statistically significance differences (P < 0.0001) on log-rank (Mantel-Cox) χ2 testing between the estimated median (50% percentile) survival times of type I (28 months), type II (53 months), type III (32 months), and type IV (66 months). CONCLUSIONS: We recommend stratifying patients based on the underlying compressive disease and the skill level of the endoscopic spine surgeon to decide preoperatively whether more difficult central or complex foraminal stenotic lesions should be considered for alternative endoscopic approaches.

Durability of Endoscopes Used During Routine Lumbar Endoscopy: An Analysis of Use Patterns, Common Failure Modes, Impact on Patient Care, and Contingency Plans.

BACKGROUND: Successful implementation of endoscopic spinal surgery programs hinges on reliable performance and case cost similar to traditional decompression surgeries of the lumbar spine. MATERIALS AND METHODS: To improve the statistical power of studying the durability of endoscopes with routine lumbar endoscopy, the authors performed a retrospective survey study among endoscopic spine surgeons by email and chat groups on social media networks WhatsApp and WeChat. Descriptive and correlative statistics were done on the surgeon's responses recorded in multiple-choice questions. Surgeons were asked about their clinical experience with spinal endoscopy, training background, the types of lumbar endoscopic decompression they perform by approach, their preferred decompression instruments, and their experience with endoscopic equipment failure. RESULTS: A total of 485 surgeons responded, of whom 85 submitted a valid survey recording, rendering a completion rate of 27.1%. These 85 respondents reported a case volume of 12,650 lumbar endoscopies within the past year and, to date, had performed a total of 120,150 spinal endoscopies over their collective career years. The majority of respondents performed endoscopic surgery for herniated disc (65.9%) vs spinal stenosis (34.1%) in a hospital setting, preferentially employing the transforaminal (76.5%), interlaminar (51.8%), and unilateral biportal endoscopic (UBE; 15.3%) approach technique. The most commonly used endoscopic spine systems were Wolf/Riwo Spine (38.8%), Joimax (36.5%), Storz (24.7%), unspecified Chinese brand (22.4%), Maxmore (15.3%), Spinendos (12.9%), Elliquence (10.6%), unspecified Korean brand (7.1%), and asap Endosystems GmbH (2.4%). The most frequent failure mode of the endoscope reported by survey respondents was a blurry image (71.8%), followed by the loss of focus (21.2%), the loss of illumination of the surgical site (18.8%), and the failure of the irrigation/suction system integrated into the endoscope (4.7%). Most respondents thought they had problems with the lens (67.1%), the fiberglass light conductor (23.5%), the prism (16.5%), or the rod system (4.7%). Motorized high-speed power burrs and hand reamers and trephines were the reported favorite decompression tools that were presumably associated with the endoscope's failure. The majority of respondents (49.5%) performed up to 50 endoscopies before the endoscope had to be either exchanged or repaired. Another 15.3% of respondents reported their endoscope lasted between 101 and 200 cases and only 12.9% reported more than 300 cases. Besides abuse during surgery (25.9%), bad handling by staff was the most common suspected reason (45.9%), followed by the wrong sterilization technique (21.2%). Some 23.5% of respondents noted that the endoscope failed during their surgery. In that case, 66.3% asked for a replacement endoscope, and 36.1% completed the surgery with the broken endoscope. However, 10.8% stopped and another 6% of respondents woke the patient up and rescheduled the surgery to complete the decompression at another time. CONCLUSIONS: Spinal endoscopes used during routine lumbar decompression surgeries for herniated disc and spinal stenosis have an estimated life cycle between 50 and 100 surgeries. Abusive use by surgeons, mishandling by staff, and deviation for prescribed cleaning and sterilization protocols may substantially shorten the life cycle. Contingency protocols should be in place to readily replace a broken spinal endoscope during surgery. More comprehensive implementation of endoscopic spine surgery techniques will hinge on technology advancements to make these hightech surgical instruments more resistant to the stress of daily use and abuse of expanded clinical indications' for surgery. The regulatory burden on endoscope makers is likely to increase, calling for increased reimbursement for facilities to cover the added expense for capital equipment purchase, disposables, and the endoscopic spine surgery program's maintenance. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: End user surgeon survey study.

Uma Experiência Estética e didática sobre ciência e tecnologia por meio da literatura / An Aesthetic and Didactic Experience on Science and Technology based on Literature

Resumo Introdução: Discutimos o Potencial Estético-Formativo da Literatura para uma Crítica Estética da tecnologia em seus diversos âmbitos entre estudante dos cursos superiores em Tecnologia em Saúde da UNIFESP. Objetivos: Verificar o potencial estético da literatura para pensar a tecnologia. Metodologia: Leitura de clássicos da literatura universal por meio da Metodologia do Laboratório de Humanidades e Tecnologia, atividade complementar oferecida aos estudantes dos cursos de tecnologia em saúde da UNIFESP. Para coleta dos dados usamos da Observação Participante e História Oral de Vida. Análise fundamentada na Fenomenologia Hermenêutica. Resultados: Com base em uma compreensão Estética da formação da Racionalidade humana, nossa atividade parece ser capaz de promover a análise crítica da tecnologia sob diversos âmbitos, tanto conceituais quanto para uma prática social e produtiva. Conclusão: Sugerimos a metodologia do LabHumTec como meio de possibilitar uma formação estética e humanística para produção e inovação tecnológica.

Abstract Introduction: This paper reflects the Aesthetic-Formative Potential of Literature, considering the various aspects of Aesthetic Criticism of technology, which were discussed among undergraduate students of Health Technology at UNIFESP. Objectives: Our aim is to analyze the aesthetic potential of literature to think about technology. Methodology: Reading and discussions based on classics from universal literature during the meetings of the Complementary Activity, named Methodology of the Humanities and Technology Laboratory, which was offered to students of Health Technology courses at UNIFESP. For data collection, we used Participant Observation and Oral History of Life methods. The analysis was based on Hermeneutic Phenomenology. Results: Based on an Aesthetic understanding of the formation of Human Rationality, our activity seems capable of promoting the critical analysis of science and technology in various areas, both conceptual and social and productive practice. Conclusion: This research suggests the LabHumTec methodology as a way to enable an aesthetic and humanistic formation for production and technological innovation.

Production, physicochemical quality and antioxidant capacity of 'Niagara Rosada' grape grafted on different rootstocks / Produção, qualidade físico-química e capacidade antioxidante da uva 'Niagara Rosada' sobre diferentes porta-enxertos

The objective of this study is to evaluate the effect of rootstocks on grape production, quality and antioxidant capacity of 'Niagara Rosada' grape in two productive cycles. The work was developed in Jundiaí-SP, Brazil (26° 06' S, 46° 55' W and an average altitude of 745 m). The experimental design was in randomized blocks with subdivided plots, the plots being represented by the rootstocks and the subplots by the production cycles, with four replications, each consisting of 6 plants. The treatments consisted of a combination of 'IAC 313 Tropical', 'IAC 572 Jales', 'IAC 571-6 Jundiaí', 'IAC 766 Campinas' and '106-8 Mgt' as rootstocks and 'Niagara Rosada' as graft, and the production cycles were 2013 and 2014. The number of bunches, production and productivity of the vines, the physical characteristics of bunches, berries and stalks and the physicochemical composition of the must (soluble solids content, titratable acidity, pH and the relation soluble solids/titratable acidity) were evaluated in production cycles of 2013 and 2014). The content of chlorophylls, anthocyanins, carotenoids, flavonoids and total phenolic compounds and the antioxidant activity of grapes were also evaluated in grape berries. The rootstocks did not influence the production and physical quality of 'Niagara Rosada' grapes. As for the chemical characteristics, rootstocks only had an effect on solids content, and 'IAC 766' and '106-8 Mgt' rootstocks promoted higher values of this characteristic. Likewise, the total phenolic compounds and the antioxidant activity of the grapes were not influenced by the studied rootstocks. The vines in 2013 presented higher production and better physical characteristics of the grapes, however, the soluble solids content in this cycle was lower than in 2014.

Objetivou-se avaliar a influência de porta-enxertos na produção da videira, na qualidade e capacidade antioxidante da uva 'Niagara Rosada' em dois ciclos produtivos. O trabalho foi realizado em Jundiaí-SP, Brasil (26° 06' S, 46° 55' W e uma altitude média de 745m). O delineamento experimental foi de blocos causalizados em parcelas subdivididas, as parcelas foram representas pelos porta-enxertos e as subparcelas pelos ciclos de produção, com quatro repetições, constituídas de 6 plantas. Os tratamentos consistiram na combinação entre os porta-enxertos 'IAC 313 Tropical', 'IAC 572 Jales', 'IAC 571-6 Jundiaí', 'IAC 766 Campinas' e '106-8 Mgt' e a variedade copa 'Niagara Rosada', e os ciclos produtivos de 2013 e 2014. O número de cachos, produção e produtividade das videiras, as características físicas de cachos, bagas e engaços e a composição físico-química do mosto (teor de sólidos solúveis, acidez titulável, pH e relação sólidos solúveis/acidez titulável) foram avaliados nos ciclos de produção de 2013 e 2014. Avaliou-se ainda nas bagas das uvas o conteúdo de clorofilas, antocianinas, carotenoides, flavonoides e compostos fenólicos totais e a atividade antioxidante. Os porta-enxertos não influenciaram a produção e a qualidade física da uva 'Niagara Rosada'. Quanto as características químicas houve efeito dos porta-enxertos apenas no teor de sólidos solúveis, sendo que os porta-enxertos 'IAC 766' e '106-8 Mgt' promoveram maiores valores dessa característica. Da mesma forma, os compostos fenólicos totais e a atividade antioxidante das uvas não foram influenciados pelos porta-enxertos estudados. As videiras, em 2013 apresentaram maior produção e melhores características físicas das uvas, no entanto, o teor de sólidos solúveis nesse ciclo foi inferior ao de 2014.

Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial.

BACKGROUND: Adjuvant radiotherapy reduces the risk of biochemical progression in prostate cancer patients after radical prostatectomy. We aimed to compare adjuvant versus early salvage radiotherapy after radical prostatectomy, combined with short-term hormonal therapy, in terms of oncological outcomes and tolerance. METHODS: GETUG-AFU 17 was a randomised, open-label, multicentre, phase 3 trial done at 46 French hospitals. Men aged at least 18 years who had an Eastern Cooperative Oncology Group performance status of 1 or less, localised adenocarcinoma of the prostate treated with radical prostatectomy, who had pathologically-staged pT3a, pT3b, or pT4a (with bladder neck invasion), pNx (without pelvic lymph nodes dissection), or pN0 (with negative lymph nodes dissection) disease, and who had positive surgical margins were eligible for inclusion in the study. Eligible patients were randomly assigned (1:1) to either immediate adjuvant radiotherapy or delayed salvage radiotherapy at the time of biochemical relapse. Random assignment, by minimisation, was done using web-based software and stratified by Gleason score, pT stage, and centre. All patients received 6 months of triptorelin (intramuscular injection every 3 months). The primary endpoint was event-free survival. Efficacy and safety analyses were done on the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT00667069. FINDINGS: Between March 7, 2008, and June 23, 2016, 424 patients were enrolled. We planned to enrol 718 patients, with 359 in each study group. However, on May 20, 2016, the independent data monitoring committee recommended early termination of enrolment because of unexpectedly low event rates. At database lock on Dec 19, 2019, the overall median follow-up time from random assignment was 75 months (IQR 50-100), 74 months (47-100) in the adjuvant radiotherapy group and 78 months (52-101) in the salvage radiotherapy group. In the salvage radiotherapy group, 115 (54%) of 212 patients initiated study treatment after biochemical relapse. 205 (97%) of 212 patients started treatment in the adjuvant group. 5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42). Acute grade 3 or worse toxic effects occurred in six (3%) of 212 patients in the adjuvant radiotherapy group and in four (2%) of 212 patients in the salvage radiotherapy group. Late grade 2 or worse genitourinary toxicities were reported in 125 (59%) of 212 patients in the adjuvant radiotherapy group and 46 (22%) of 212 patients in the salvage radiotherapy group. Late genitourinary adverse events of grade 2 or worse were reported in 58 (27%) of 212 patients in the adjuvant radiotherapy group versus 14 (7%) of 212 patients in the salvage radiotherapy group (p<0·0001). Late erectile dysfunction was grade 2 or worse in 60 (28%) of 212 in the adjuvant radiotherapy group and 17 (8%) of 212 in the salvage radiotherapy group (p<0·0001). INTERPRETATION: Although our analysis lacked statistical power, we found no benefit for event-free survival in patients assigned to adjuvant radiotherapy compared with patients assigned to salvage radiotherapy. Adjuvant radiotherapy increased the risk of genitourinary toxicity and erectile dysfunction. A policy of early salvage radiotherapy could spare men from overtreatment with radiotherapy and the associated adverse events. FUNDING: French Health Ministry and Ipsen.

Toxicity of binary mixtures of Al2O3 and ZnO nanoparticles toward fibroblast and bronchial epithelium cells.

The objective of this study was to examine the cytotoxic effects of binary mixtures of Al2O3 and ZnO NPs using mouse fibroblast cells (L929) and human bronchial epithelial cells (BEAS-2B) as biological test systems. The synergistic, additive, or antagonistic behavior of the binary mixture was also investigated. In toxicity experiments, cellular morphology, mitochondrial function (MTT assay), apoptosis, nuclear size and shape, clonogenic assays, and damage based upon oxidative stress parameters were assessed under control and NPs exposure conditions. Although Abbott modeling results provided no clear evidence of the binary mixture of Al2O3 and ZnO NPs exhibiting synergistic toxicity, some specific assays such as apoptosis, nuclear size and shape, clonogenic assay, activities of antioxidant enzymatic enzymes catalase, superoxide dismutase, and levels of glutathione resulted in enhanced toxicity for the mixtures with 1 and 1.75 toxic units (TU) toward both cell types. Data demonstrated that co-presence of Al2O3 and ZnO NPs in the same environment might lead to more realistic environmental conditions. Our findings indicate cytotoxicity of binary mixtures of Al2O3 and ZnO NPs produced greater effects compared to toxicity of either individual compound.

Outcomes with transforaminal endoscopic versus percutaneous laser decompression for contained lumbar herniated disc: a survival analysis of treatment benefit.

BACKGROUND: Contained lumbar disc herniations frequently cause back- and leg pain. Clinical outcomes with surgical treatment may be affected by the size and location of the disc herniation. The surgical directly visualized transforaminal endoscopic decompression has gained acceptance and popularity, while the simplified percutaneous laser disc decompression has fallen out of favor in spite of its initial success as a minimally invasive intervention. In an attempt to better understand the durability of both procedures, the authors performed a comparative analysis of clinical outcomes in patients with contained lumbar disc herniations. METHODS: The study population was comprised 248 patients consisting of 162 patients in the endoscopy group (group 1) and 86 patients in the laser group (group 2). Primary outcome measures were Macnab criteria. Herniations were classified as large or small. Additional parameters of advanced degeneration of the lumbar motion segment including posterior disc- and lateral recess height of <3 mm were recorded. IBM SPSS 25.0 was used for Kaplan-Meier survival analysis and cross-tabulation of these variables with statistical testing for significant associations. RESULTS: The mean follow-up was 43.5 months. The serial time recorded for Kaplan-Meier analysis ranged from 1.5 to 84 months. The mean age was 53.37 years (standard deviation =14.65 years). The majority of patients had Excellent and Good Macnab outcomes (212/248; 85.5%) regardless of treatment. Fair and Poor results were achieved in another 36 patients (14.5%). There was a higher percentage of Excellent Macnab outcomes in the endoscopy group (94/162; 58.0%) than in the laser group (38/86; 44.2%) at a statistical significant level (P<0.0001). There was a statistically significantly higher percentage of Excellent and Good Macnab outcomes with endoscopic decompression of small paracentral herniations (97.1%; P<0.0001). Percutaneous laser decompression of large central disc herniations was not statistically better than endoscopic surgical decompression (P=0.125). Endoscopic bony and soft tissue decompression was also better than laser at alleviating symptoms in patients with reduced posterior disc- and lateral recess height with 96.7% in patients with reduced disc height of <3 mm and 94% in patients with reduced lateral recess height of <3 mm (P=0.001). Kaplan-Meier (K-M) Survival time showed longer median survival of the treatment benefit for patients who underwent visualized endoscopic surgical decompression (66.0 months) compared to median K-M survival time for percutaneous laser decompression of 17 months (P<0.0001). CONCLUSIONS: Transforaminal endoscopic decompression for symptomatic herniated disc is an effective and durable surgical treatment to alleviate sciatica-type and back symptoms in the vast majority of patients with good long-term survival of pain relief for up to six years. Interventional percutaneous non-visualized laser decompression for the same condition may provide favorable outcomes in the short-term with soft protrusions. However, the treatment effect deteriorates much faster with a median survival of 17 months.

Surgeon training and clinical implementation of spinal endoscopy in routine practice: results of a global survey.

BACKGROUND: Training of spine surgeons may impact the availability of contemporary minimally invasive spinal surgery (MIS) to patients and drive spine surgeons' clinical decision-making when applying minimally invasive spinal surgery techniques (MISST) to the treatment of common degenerative conditions of the lumbar spine. Training requirements and implementation of privileges vary in different parts of the world. The purpose of this study was to analyze the training in relation to practice patterns of surgeons who perform lumbar endoscopic spinal surgery the world over. METHODS: The authors solicited responses to an online survey sent to spine surgeons by email, and chat groups in social media networks including Facebook, WeChat, WhatsApp, and Linkedin. Surgeons were asked the following questions: (I) please indicate your training? (II) What type of MISST spinal surgery do you perform? (III) How would you rate your experience in MIS lumbar spinal surgery and what percentage of your practice is MISST? And (IV) which avenue did you use to train for the MISST you currently employ in your clinical practice today? Descriptive statistics were applied to count responses and cross-tabulated them to the surgeon's training. Pearson Chi-square measures, kappa statistics, and linear regression analysis of agreement or disagreement were performed by analyzing the distribution of variances using statistical package SPSS version 25.0. RESULTS: A total of 430 surgeons accessed the survey. The completion rate was 67.4%. Analyzing the responses of 292 surveys submitted by 97 neurosurgeons (33.2%), 161 orthopaedic surgeons (55.1%), and 34 surgeons of other postgraduate training (11.6%) showed that only 14% (41/292) of surgeons had completed a fellowship. Surgeons rated their skill level 33.5% of the time as master and experienced surgeon, and 35.6% of the time as novice or surgeon with some experience. There were more master (64.6% versus 29.2%) and experienced (52% versus 40%) surgeons amongst orthopaedic surgeons than amongst neurosurgeons at a statistically significant level (P=0.11). There were near twice as many orthopaedic surgeons (54.3%) using endoscopic procedures in the lumbar spine as their favorite MISST than neurosurgeons (35.4%; P=0.096). Endoscopic spine surgeons' main sources of knowledge acquisition were (I) learning in small meetings (57.3%), (II) attending workshops (63.1%), and (III) national and international conferences (59.8%). CONCLUSIONS: The majority of spine surgeons reported more than half of their cases employing MISST at a high skill level. Very few MISST surgeons are fellowship trained but attend workshops and various meetings suggesting that many of them are self-thought. Orthopaedic surgeons were more likely to implement endoscopic spinal surgery into the routine clinical practice. As endoscopic spine surgery gains more traction and patient demand, minimal adequate training will be part of the ongoing debate.

Surgeon motivation, and obstacles to the implementation of minimally invasive spinal surgery techniques.

BACKGROUND: This study aimed to analyze the motivators and obstacles to the implementation of minimally invasive spinal surgery techniques (MISST) by spinal surgeons. Motivators and detractors may impact the availability of MISST to patients and drive spine surgeons' clinical decision-making in the treatment of common degenerative conditions of the lumbar spine. METHODS: The authors solicited responses to an online survey sent to spine surgeons by email, and chat groups in social media networks including Facebook, WeChat, WhatsApp, and Linkedin. Descriptive statistics were employed to count the responses and compared to the surgeon's training. Kappa statistics and linear regression analysis of agreement were performed. RESULTS: A total of 430 surgeons accessed the survey. The completion rate was 67.4%. A total of 292 surveys were submitted by 99 neurosurgeons (33.9%), 170 orthopaedic surgeons (58.2%), and 23 surgeons of other postgraduate training (7.9%). Personal interest (82.5%) and patient demand (48.6%) were the primary motivators for MISST implementation. High equipment (48.3%) and disposables (29.1%) cost were relevant obstacles to MISST implementation. Local workshops (47.6%) and meetings in small groups (31.8%) were listed as the primary knowledge sources. Only 12% of surgeons were fellowship trained, but 46.3% of surgeons employed MISST in over 25% of their cases. CONCLUSIONS: The rate of implementation of MISST reported by spine surgeons was found to be high but impeded by the high cost of equipment and disposables. The primary motivators for spine surgeons' desire to implement were personal interest and patient demand.

Regional variations in acceptance, and utilization of minimally invasive spinal surgery techniques among spine surgeons: results of a global survey.

BACKGROUND: Regional differences in acceptance and utilization of MISST by spine surgeons may have an impact on clinical decision-making and the surgical treatment of common degenerative conditions of the lumbar spine. The purpose of this study was to analyze the acceptance and utilization of various minimally invasive spinal surgery techniques (MISST) by spinal surgeons the world over. METHODS: The authors solicited responses to an online survey sent to spine surgeons by email, and chat groups in social media networks including Facebook, WeChat, WhatsApp, and Linkedin. Surgeons were asked the following questions: (I) Do you think minimally invasive spinal surgery is considered mainstream in your area and practice setting? (II) Do you perform minimally invasive spinal surgery? (III) What type of MIS spinal surgery do you perform? (IV) If you are performing endoscopic spinal decompression surgeries, which approach do you prefer? The responses were cross-tabulated by surgeons' demographic data, and their practice area using the following five global regions: Africa & Middle East, Asia, Europe, North America, and South America. Pearson Chi-Square measures, Kappa statistics, and linear regression analysis of agreement or disagreement were performed by analyzing the distribution of variances using statistical package SPSS Version 25.0. RESULTS: A total of 586 surgeons accessed the survey. Analyzing the responses of 292 submitted surveys regional differences in opinion amongst spine surgeons showed that the highest percentage of surgeons in Asia (72.8%) and South America (70.2%) thought that MISST was accepted into mainstream spinal surgery in their practice area (P=0.04) versus North America (62.8%), Europe (52.8%), and Africa & Middle East region (50%). The percentage of spine surgeons employing MISST was much higher per region than the rate of surgeons who thought it was mainstream: Asia (96.7%), Europe (88.9%), South America (88.9%), and Africa & Middle East (87.5%). Surgeons in North America reported the lowest rate of MISST implementation globally (P<0.000). Spinal endoscopy (59.9%) is currently the most commonly employed MISST globally followed by mini-open approaches (55.1%), and tubular retractor systems (41.8%). The most preferred endoscopic approach to the spine is the transforaminal technique (56.2%) followed by interlaminar (41.8%), full endoscopic (35.3%), and over the top MISST (13.7%). CONCLUSIONS: The rate of implementation of MISST into day-to-day clinical practice reported by spine surgeons was universally higher than the perceived acceptance rates of MISST into the mainstream by their peers in their practice area. The survey suggests that endoscopic spinal surgery is now the most commonly performed MISST.

Crystalline phase-dependent toxicity of aluminum oxide nanoparticles toward Daphnia magna and ecological risk assessment.

Aluminum oxide nanoparticles (Al2O3 NPs) can be found in different crystalline phases, and with the emergence of nanotechnology there has been a rapid increase in the demand for Al2O3 NPs in different engineering areas and for consumer products. However, a careful evaluation of the potential environmental and human health risks is required to assess the implications of the release of Al2O3 NPs into the environment. Thus, the objective of this study was to investigate the toxicity of two crystalline phases of Al2O3 NPs, alpha (α-Al2O3 NPs) and eta (η-Al2O3 NPs), toward Daphnia magna and evaluate the risk to the aquatic ecology of Al2O3 NPs with different crystalline phases, based on a probabilistic approach. Different techniques were used for the characterization of the Al2O3 NPs. The toxicity toward Daphnia magna was assessed based on multiple toxicological endpoints, and the probabilistic species sensitivity distribution (PSSD) was used to estimate the risk of Al2O3 NPs to the aquatic ecology. The results obtained verify the toxic potential of the NPs toward D. magna even in sublethal concentrations, with a more pronounced effect being observed for η-Al2O3 NPs. The toxicity is associated with an increase in the reactive oxygen species (ROS) content and deregulation of antioxidant enzymatic/non-enzymatic enzymes (CAT, SOD and GSH). In addition, changes in MDA levels were observed, indicating that D. magna was under oxidative stress. The most prominent chronic toxic effects were observed in the organisms exposed to η-Al2O3 NPs, since the lowest LOEC was 3.12 mg/L for all parameters, while for α-Al2O3 NPs the lowest LOEC was 6.25 mg/L for longevity, growth and reproduction. However, the risk assessment results indicate that, based on a probabilistic approach, Al2O3 NPs (alpha, gamma, delta, eta and theta) only a very limited risk to organisms in surface waters.

Impact of suboptimal tandem implantation on local control and complications in intracavitary brachytherapy for cervix cancer.

PURPOSE: Correct tandem implantation for cervix cancer intracavitary brachytherapy may be challenging. We investigated whether suboptimal implantation can be related to patient and disease characteristics and may result in subsequent underutilization of brachytherapy in cervical cancer. METHODS AND MATERIALS: Consecutive cervix cancer patients referred for intracavitary brachytherapy after external beam radiation therapy performed in several general hospitals from 2013 to 2017 were included. RESULTS: In 172 patients having 301 procedures, 95 implantations were suboptimal (15% inadequate tandem insertions, 10% subserosal insertion, and 6% uterine perforation on postimplant CT scan). Risk factors were age, myometrium invasion, and uterine retroversion. Median followup was 21 months. Three-year local control and survival rates were 72% and 85%, respectively. Forty-seven patients (27%) failed to receive brachytherapy. Failure to perform brachytherapy was associated with poorer local control (OR = 0.34 [0.17-0.67], p = 0.001). By contrast, suboptimal implantation did not increase local failure or toxicity rates in patients undergoing brachytherapy. No peritoneal carcinomatosis occurred after uterine perforation in our cohort. CONCLUSIONS: Suboptimal implantation was frequent. In the absence of image guidance during implantation, conversion to other treatment modalities (including external beam radiation therapy) due to insertion difficulties resulted in worse local control. With optimization, however, suboptimal brachytherapy implantation did not result in suboptimal dose coverage or poorer local control. Failure to perform a brachytherapy boost correlates with increased local failure risk in patients with cervix cancer, whereas tandem malposition does not. Real-time intraoperative ultrasound guidance may be useful to reduce uterine perforation rates and thus increase brachytherapy use.