bluuebunny/crossref_metadata_2025_split huggingface dataset:
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy
Authors: Suzman Daniel L. , Agrawal Sundeep , Ning Yang-min , Maher V. Ellen , Fernandes Laura L. , Karuri Stella , Tang Shenghui , Sridhara Rajeshwari , Schroeder Jason , Goldberg Kirsten B. , Ibrahim Amna , McKee Amy E. , Pazdur Richard , Beaver Julia A. 
Published: December 2018

Abstract

The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in April and May 2017, respectively, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. These approvals were based on efficacy and safety data demonstrated in the two single-arm trials, IMvigor210 (atezolizumab) and KEYNOTE-052 (pembrolizumab). The primary endpoint, confirmed objective response rate, was 23.5% (95% confidence interval [CI]: 16.2%–32.2%) in patients receiving atezolizumab and 28.6% (95% CI: 24.1%–33.5%) in patients receiving pembrolizumab. The median duration of response was not reached in either study and responses were seen regardless of PD-L1 status. The safety profiles of both drugs were generally consistent with approved agents targeting PD-1/PD-L1. Two ongoing trials (IMvigor130 and KEYNOTE-361) are verifying benefit of these drugs. Based on concerning preliminary reports from these trials, FDA revised the indications for both agents in cisplatin-ineligible patients. Both drugs are now indicated for patients not eligible for any platinum-containing chemotherapy or not eligible for cisplatin-containing chemotherapy and whose tumors/infiltrating immune cells express a high level of PD-L1. The indications for atezolizumab and pembrolizumab in patients who have received prior platinum-based therapy have not been changed. This article summarizes the FDA thought process and data supporting the accelerated approval of both agents and the subsequent revision of the indications.

Implications for Practice
The accelerated approvals of atezolizumab and pembrolizumab for cisplatin-ineligible patients with advanced urothelial carcinoma represent the first approved therapies for this patient population. These approvals were based on single-arm trials demonstrating reasonable objective response rates and favorable durations of response with an acceptable toxicity profile compared with available non-cisplatin-containing chemotherapy regimens. However, based on concerning preliminary reports from two ongoing phase III trials, the FDA revised the indication for both agents in cisplatin-ineligible patients. Both are now indicated either for patients not eligible for any platinum-containing chemotherapy or not eligible for cisplatin-containing chemotherapy and whose tumors have high expression of PD-L1.
Phase II Randomized Trial of Sequential or Concurrent FOLFOXIRI-Bevacizumab Versus FOLFOX-Bevacizumab for Metastatic Colorectal Cancer (STEAM)
Authors: Hurwitz Herbert I. , Tan Benjamin R. , Reeves James A. , Xiong Henry , Somer Brad , Lenz Heinz-Josef , Hochster Howard S. , Scappaticci Frank , Palma John F. , Price Richard , Lee John J. , Nicholas Alan , Sommer Nicolas , Bendell Johanna 
Published: December 2018

Abstract

Background
First-line treatment for metastatic colorectal cancer (mCRC) typically entails a biologic such as bevacizumab (BEV) with 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX) or 5-fluorouracil/leucovorin/irinotecan (FOLFIRI). STEAM (NCT01765582) assessed the efficacy of BEV plus FOLFOX/FOLFIRI (FOLFOXIRI), administered concurrently (cFOLFOXIRI-BEV) or sequentially (sFOLFOXIRI-BEV, FOLFOX-BEV alternating with FOLFIRI-BEV), versus FOLFOX-BEV for mCRC.

Patients and Methods
Patients with previously untreated mCRC (n = 280) were randomized 1:1:1 to cFOLFOXIRI-BEV, sFOLFOXIRI-BEV, or FOLFOX-BEV and treated with 4–6-month induction followed by maintenance. Coprimary objectives were overall response rate (ORR; first-line cFOLFOXIRI-BEV vs. FOLFOX-BEV) and progression-free survival (PFS; pooled first-line cFOLFOXIRI-BEV and sFOLFOXIRI-BEV vs. FOLFOX-BEV). Secondary/exploratory objectives included overall survival (OS), liver resection rates, biomarker analyses, and safety.

Results
ORR was 72.0%, 72.8%, and 62.1% and median PFS was 11.9, 11.4, and 9.5 months with cFOLFOXIRI-BEV, sFOLFOXIRI-BEV, and FOLFOX-BEV, respectively. OS was similar between arms. ORR between cFOLFOXIRI-BEV and FOLFOX-BEV did not significantly differ (p = .132); thus, the primary ORR endpoint was not met. cFOLFOXIRI-BEV and sFOLFOXIRI-BEV numerically improved ORR and PFS, regardless of RAS status. Median PFS was higher with pooled concurrent and sequential FOLFOXIRI-BEV versus FOLFOX-BEV (11.7 vs. 9.5 months; hazard ratio, 0.7; 90% confidence interval, 0.5–0.9; p &lt; .01). Liver resection rates were 17.2% (cFOLFOXIRI-BEV), 9.8% (sFOLFOXIRI-BEV), and 8.4% (FOLFOX-BEV). Grade ≥ 3 treatment-emergent adverse events (TEAEs) were observed in 91.2% (cFOLFOXIRI-BEV), 86.7% (sFOLFOXIRI-BEV), and 85.6% (FOLFOX-BEV) of patients, with no increase in serious chemotherapy-associated TEAEs.

Conclusion
cFOLFOXIRI-BEV and sFOLFOXIRI-BEV were well tolerated with numerically improved ORR, PFS, and liver resection rates versus FOLFOX-BEV, supporting triplet chemotherapy plus BEV as a first-line treatment option for mCRC.
Express diagnosis of connective tissue dysplasia in conditions of ambulatory-polyclinic service
Authors: Denisov A. S. , Zagorak D. P. 
Published: December 2018

Aim. To detect the most informative signs of connective tissue dysplasia (CTD) and develop the method for CTD express diagnosis in conditions of ambulatory and stationary traumatologo-orthopedic service.
Materials and methods. Sixty practically healthy persons were examined. To diagnose the connective tissue pathology, there were used the criteria developed by S.K. Evtushenko (2002), T.Yu. Smolnova (2003) and T.I. Kartunova (2006). Eighteen the most informative criteria were chosen.
Results. The paper is devoted to a widespread and yet not fully studied problem – the connective tissue dysplasia. The basic signs of this disease were analyzed. The most informative criteria of connective tissue dysplasia were singled out. Express test for primary diagnosis of this pathology in conditions of traumatologo-orthopedic service was offered.
Conclusions. Express test of the state of connective tissue structure is simple to perform. It can be used to improve surgical aids in connective tissue dysplasia, when additional stabilization of loco motor system is required.
Bir Hastanenin Aile Hekimliği Polikliniğine Başvuran Hastaların Sigara İçme Durumları: Ankara Örneği
Authors: UYSAL Zekai , HATİPOĞLU Ertuğrul 
Published: December 2018

Amaç:Aile Hekimliği Polikliniğine başvuran hastaların sigara içme durumları ve nikotin bağımlılık seviyelerinin sosyo-demografik değişkenlerle arasındaki ilişkinin incelenmesi amaçlanmıştır. Yöntem:Bu kesitsel, niceliksel araştırmada uygunluk örneklemi kullanılmıştır. Bu araştırma 01.02.2018-01.04.2018 tarihleri arasında Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi Aile Hekimliği Polikliniği’nde yürütülmüştür. Polikliniğe başvuran hastalar arasından, araştırmaya katılmayı kabul edenler ile görüşmeler yapılmıştır. Araştırmacılar verileri hastalarla yüz yüze görüşerek elde etmiştir. Verilerin toplanmasında demografik bilgi formu ve Fagerström Nikotin Bağımlılık Testi (FNBT) kullanılmıştır. Elde edilen veriler SPSS v. 20 programı ile araştırmanın amacı doğrultusunda incelenmiştir. Sürekli değişkenler ortalama ya da standart sapma, kategorik değişkenler ise sıklık, yüzdelik değerlerle ifade edilmiştir. Analizlerde p&lt;0.05 değeri anlamlılık sınırı olarak belirlenmiştir. Bulgular:177 hasta ile yapılan görüşmelerde; 97’si (%54,8) erkek, 80’i (%45,2) kadındır. Hastaların yaş ortalaması 39’dur ve cinsiyetler arasında anlamlı farklılık görülmemektedir. Hastaların 83’ü (%46,9) hiç sigara içmediğini, 26’sı (%14,7) daha önce sigara içmiş ancak bıraktığını, 66’sı (%37,3) aktif olarak sigara kullandığını ve 2 hasta ise pasif içici konumda olduğunu ifade etmiştir. Hastalarda sigaraya başlama yaşı ortalama 18’dir ve cinsiyetler arasında anlamlı bir fark bulunmamaktadır (p&gt;0.05). Kadınlar ve erkekler arasında bağımlılık derecesini gösteren nikotin bağımlılık puanları arasında anlamlı bir fark yoktur (p&gt;0.05). Sigara kullanan 66 hastanın %25’i hafif derecede nikotin bağımlısı, %36,4’ü orta derecede nikotin bağımlısı, %34,8’i şiddetli nikotin bağımlısı ve %3’ü çok şiddetli nikotin bağımlısıdır. Cinsiyetle sigara içme durumu arasında anlamlı bir ilişki tespit edilmiştir, erkeklerin sigara içme durumunun kadınlara göre daha sık olduğu bulunmuştur (p&lt;0,05). Günlük sigara kullanımı ile sigaraya başlama yaşı arasında pozitif bir korelasyon tespit edilmiştir. Günlük sigara kullanım miktarı ile cinsiyet arasında anlamlı bir ilişki yoktur (p&gt;0.05). Sigara kullananların %72’si sigarayı bırakmayı düşünürken, %28’i bırakmayı düşünmediğini ifade etmiştir. Sonuç:Hastaların sigara içme durumlarının incelendiği bu çalışmada bağımlılık düzeyi ile cinsiyet arasında anlamlı bir fark bulunmamıştır. Erkekler ile kadınlar arasında sigara içme yoğunluğuna bakıldığında, erkekler arasında sigara içme durumu daha sık karşılaşılan bir durumdur. Erkeklerin %60’ı sigara kullanırken kadınlarda bu oran %26’dır. Sigara içenlerin büyük çoğunluğu bırakmak istediğini ifade etmiştir.
Avaliação de parâmetros da laminação a quente no indicador de rendimento metálico de produção de tubos de aço sem costura
Authors: Cardoso Gabriela Rezende , Mapa Sílvia Maria Santana , Gomes Filipe José de Oliveira 
Published: December 2018

Para tornarem-se ou manterem-se competitivas diante da atual concorrência, as empresas têm utilizado técnicas estatísticas, como o experimento fatorial, que permitem avaliar processos produtivos de forma a melhorá-los, reduzindo, assim, a possibilidade de insucesso. A proposta deste trabalho é apresentar uma aplicação da técnica estatística Experimento Fatorial Completo 2K em um processo de produção de tubos de aço sem costura, com o objetivo de estudar especificidades do principal indicador de rendimento metálico, denominado VZ (Verbrauch Zieff), que descreve o rendimento do emprego de insumos sobre a produção de tubos. Foram definidos quatro fatores para a análise: tipo de aço, calibre, parede de laminação e tratamento térmico. Para a realização do presente estudo, a metodologia adotada é a pesquisa de natureza empírica e descritiva, por meio de abordagem combinada, qualitativa e quantitativa. A realização do experimento fatorial utilizando os fatores escolhidos proporcionou como resultado uma visão, até então desconhecida pela empresa, de como os fatores e suas interações influenciam o indicador estudado, sendo os fatores tipo de aço e calibre comprovados estatisticamente significativos, e, com isso, gerando maior assertividade no planejamento de matéria prima e reduzindo, assim, custos gerais dos produtos.
Modeling and control of an active knee orthosis using a computational model of the musculoskeletal system
Authors: Mosconi Denis , Nunes Polyana Ferreira , Siqueira Adriano Almeida Gonçalves 
Published: December 2018

One-third of the stroke survivors remain with some disability, needing assistance to perform the activities of daily life and therapy to recover the lost functions. The robotic rehabilitation is a promissed field in this context improving the effectiveness of the treatment. Many researches have focused on developing human-robot interaction control to ensure user safety and therapy efficiency, but the validation of these controllers often requires contact between humans and robots, which involves cost, time and risk of accidents. This work aims to present a computational model of an ideal active orthosis used to assist the knee movement as a tool for test and validate human-robot interaction controls. Three controllers were applied to make the orthosis move the knee tracking the desired trajectory: a PID controller, an Inverse Dynamics-Based controller, and a Feedback-Feedforward Controller. The model proved to be useful and the controller with the best performance was the Feedback-Feedforward one.
Zenlens scleral lenses for visual rehabilitation of patients with irregular cornea: a usage experience
Authors: Alyaeva O. O. , Ryabenko O. I. , Tananakina E. M. , Yushkova I. S. 
Published: December 2018

Scleral lenses improve visual acuity in patients with irregular corneal astigmatism, which is especially important when other methods of correction are ineffective.Purpose: to assess the efficiency of Zenlens scleral lenses in patients with irregular cornea.Material and methods. A total of 120 patients (164 eyes) were examined, including 86 males and 34 females, aged from 13 to 63 years (mean age 35 ± 12 years). The patients were divided into 4 groups. Group 1 consisted of patients with keratoconus, group 2 — postpenetrating keratoplasty, group 3 — keratoconus after cross-linking and/or corneal ring segment implantation, while group 4 consisted of patients with other diseases. The efficiency criteria included visual acuity before and after scleral lens fitting and wearing time (hours per day). To determine social significance of scleral lens wearing, we selected 30 patients (46 eyes) with average best-corrected visual acuity (BCVA) before fitting 0.21 ± 0.08 (0.1–0.3).Results. Average uncorrected visual acuity before fitting did not exceed 0.2 and average visual acuity after fitting was 0.8 ± 0.15. Average improvement in visual acuity after fitting compared to uncorrected visual acuity was at least six lines in all groups and average improvement of visual acuity was approximately three lines compared to BCVA before fitting. 74.4 % and 19.5 % of patients demonstrated long-term (> 10 hours per day) and partial (8–10 hours per day) wear, respectively. Short-term wear (< 8 hours per day) was noted in 6.1 % of patients. Visual acuity of patients with low BCVA (mean 0.21 ± 0.08) increased by 0.57 (271.4 %).Conclusion. Scleral lenses can be successfully used for visual acuity improvement and social rehabilitation of patients with irregular cornea when other methods of correction are ineffective.
Review on Seawater Greenhouse: Achievements and Future Development
Authors: Bait-Suwailam Tahani K. , Al-Ismaili Abdulrahim M. 
Published: December 2018

Background:Seawater greenhouse (SWGH) is a technology established to overcome issues related to open field cultivation in arid areas like high temperatures and freshwater shortage. So far, five pilot Seawater greenhouses were built around the world; in Spain, United Arab Emirates, Oman, Australia and Somaliland. All the patents related to the Seawater greenhouse components and designs mentioned were reviewed.Methods::The Seawater greenhouse adopts the humidification-dehumidification (HDH) concept where evaporated moisture from saline water source is condensed to produce freshwater within the greenhouse body. Many advancements have been made throughout the past 25 years to optimize the Seawater greenhouse by means of structural improvement, heat distribution, condenser design and material, source of feed water and the evaporator via both trial-and-error and simulation approaches. The latter included numerical, mathematical, analytical and artificial neural network simulations. Various condenser designs were adopted in order to increase freshwater production to meet the irrigation demand of the seawater greenhouse.Results and Conclusion:To make the Seawater greenhouse self-sufficient in terms of energy production, the use of renewable energies and nonconventional sources was also investigated like the use of geothermal, solar and wind energy to produce electricity for the greenhouse operation and for other requirements as well. The use of reverse osmosis along with reverse electro dialysis to produce freshwater and electricity in the seawater greenhouse, was also one of the ideas suggested to improve and solve the associated constraints. Direct contact dehumidification is another development suggested to improve the condensation rate. This new approach seems to be very promising as it involves low capital, operation and maintenance costs, high freshwater production, and fouling- and corrosion-free.
Spontaneous Neuronal Signaling is Inherently Musical and Mathematical: Insight into the Universal Human Affinity for Music
Authors: Shea Thomas B. , Remington Ruth 
Published: December 2018

Objective:Audio files of spontaneous signal streams generated byex vivoneuronal networks cultured on multi-electrode arrays generated an oscillating sine wave with an inherent musical quality. This was not anticipated considering that synaptic signals are “all - or – none”, and therefore digital, events.Methods:These findings may provide insight into why music can be perceived as pleasurable and invoke a calm mood despite that music is ultimately perceived and stored as a series of digital signals; it is speculated that music may reinforce and/or enhance this spontaneous digital stream.Results and Conclusion:These findings also support the relationship between music and mathematics.
Prevalence and Patterns of Antiretroviral Therapy Prescription in the United States
Authors: Tie Yunfeng , Skarbinski Jacek , Qin Gengsheng , Frazier Emma L 
Published: December 2018

Background:

The use of Antiretroviral Therapy (ART) in HIV-infected persons has proven to be effective in the reduction of risk of disease progression and prevention of HIV transmission.

Objective:
U.S. Antiretroviral Therapy (ART) guidelines specify recommended initial, alternative initial, and not-recommended regimens, but data on ART prescribing practices and real-world effectiveness are sparse.

Methods:
Nationally representative annual cross sectional survey of HIV-infected adults receiving medical care in the United States, 2009-2012 data cycles. Using data from 18,095 participants, we assessed percentages prescribed ART regimens based on medical record documentation and the associations between ART regimens and viral suppression (most recent viral load test <200 copies/ml in past year) and ART-related side effects.

Results:
Among HIV-infected adults receiving medical care in the United States, 91.8% were prescribed ART; median time since ART initiation to interview date was 9.8 years. The percentage prescribed ART was significantly higher in 2012 compared to 2009 (92.7% vs 88.7%; p < 0.001). Of those prescribed ART, 51.6% were prescribed recommended initial regimens, 6.1% alternative initial regimens, 29.0% not-recommended as initial regimens, and 13.4% other regimens. Overall, 79.5% achieved viral suppression and 15.7% reported side effects. Of those prescribed ART and initiated ART in the past year, 80.5% were prescribed recommended initial regimens.

Conclusion:
Among persons prescribed ART, the majority were prescribed recommended initial regimens. Monitoring of ART use should be continued to provide ongoing assessments of ART effectiveness and tolerability in the United States.
Kinetics, Thermodynamics, and Competitive Adsorption of Heavy Metals from Water Using Orange Biomass
Authors: Sandoval‐Flores G. , Alvarado‐Reyna S. , Elvir‐Padilla L.G. , Mendoza‐Castillo D.I. , Reynel‐Avila H.E. , Bonilla‐Petriciolet A. 
Published: December 2018

ABSTRACTAdsorption of heavy metals on modified orange biomass has been studied. This biomass was treated with NaOH and CaCl2 to improve its adsorption properties. Kinetic and thermodynamic studies of the adsorption of Cd2+, Ni2+, Cu2+, and Zn2+ were performed at different operating conditions, including competitive adsorption studies with binary metallic mixtures. Results show that this adsorption process was endothermic where an ion exchange mechanism played a relevant role. Adsorbent effectiveness decreased in binary solutions, indicating a strong antagonistic adsorption behavior caused by counter‐ions. This antagonistic adsorption was highly dependent on the counter‐ion type and its concentration. Multicomponent adsorption of Cu2+ ions was not significantly affected by the presence of other metallic counter‐ions, whereas the adsorption of Ni2+ could be totally suppressed by the other ions. The modeling of binary adsorption isotherms was successful using the modified Langmuir equation, which outperformed the Ideal Absorbed Solution Theory‐Sips and modified Redlich‐Peterson models.
Intenções podem salvar vidas? Motivações e dificuldades de potenciais doadores de sangue à luz do Marketing Social
Authors: Coelho Cássio Canuto , De Faria Marina Dias 
Published: December 2018

O cenário da doação de sangue no Brasil é marcado pela oferta abaixo dos padrões considerados ideiaspela Organização Mundial da Saúde, levando em conta que aproximadamente 1,78% da população é doadora desangue, sendo o índice ideal variando entre 3% e 5% da população. Diante do exposto, o objetivo geral destapesquisa foi identificar as principais motivações de jovens que têm intenção de doar sangue, mas que nuncadoaram. Metodologicamente, optou-se por utilizar uma pesquisa qualitativa, por meio de técnica projetiva eentrevistas individuais de roteiro semiaberto, realizadas com 19 jovens entre 18 e 29 anos. Como resultado daanálise, identificou-se que: os entrevistados justificam sua intenção como uma real possibilidade de salvar vidas;que não sentem pressão para doar por conta de pessoas próximas, apesar de alguns reconhecerem poderinfluenciar outras pessoas; e alguns são impossibilitados de doar sangue, principalmente por questões de saúde,entretanto, os outros parecem apenas não se mobilizar para doar, por questões diversas já abordadas em outrosestudos. O principal ponto de motivação identificado seria o da influência dos grupos de referência parafomentar o comportamento de doador.
PENGARUH PERMAINAN KARTU KASUGI TERHADAP PENINGKATAN PENGETAHUAN PERILAKU HIDUP BERSIH DAN SEHAT PADA SISWA
Authors: Sutriyanto Kristyawan , Raksanagara Ardini Septianingsih , Wijaya Merry 
Published: December 2018

Penyuluhan kesehatan dengan metode yang menarik dapat meningkatkan pengetahuan perilaku hidup bersih dan sehat. Penelitian ini bertujuan menganalisis pengaruh permainan kartu Kasugi terhadap peningkatan pengetahuan perilaku hidup bersih dan sehat pada siswa Sekolah Dasar. Metode penelitian menggunakan pendekatan Quasi Experimental dengan Non-Equivalent Control Group Design. Subyek penelitian adalah siswa kelas 5 sekolah dasar di Kabupaten Bandung Barat. Data kuantitatif diperoleh dari nilai pretest-posttest pada kelompok eksperimen yang mendapat permainan kartu Kasugi maupun kelompok kontrol dengan ceramah. Hasil analisis dengan uji Repeated Anova menunjukkan terdapat perbedaan bermakna nilai pretest dan posttest pengetahuan setelah siswa mendapat 1 kali permainan kartu Kasugi (p=0,021) dengan kenaikan sebesar 0,62, setelah 2 kali permainan kartu Kasugi (p=0,001) dengan kenaikan 22,24, dan setelah 3 kali permainan kartu Kasugi (p=0,001) dengan kenaikan 32,40. Tidak terdapat perbedaan bermakna peningkatan pengetahuan antara siswa yang mendapat 3 kali permainan kartu Kasugi dengan siswa yang mendapat 3 kali ceramah (p=0,831). Penyuluhan kesehatan melalui permainan kartu Kasugi sebanyak 1 kali atau lebih berpengaruh terhadap peningkatan pengetahuan perilaku hidup bersih dan sehat pada siswa. Penyuluhan kesehatan melalui permainan kartu Kasugi sebanyak 3 kali berpengaruh terhadap peningkatan pengetahuan perilaku hidup bersih dan sehat yang sama dengan siswa yang mendapatkan 3 kali penyuluhan kesehatan melalui metode ceramah.Kata Kunci: Kartu Kasugi, Pengetahuan, Permainan, PHBS