bluuebunny/crossref_metadata_2025_split huggingface dataset:
A phase III, randomized, open-label study of isatuximab (SAR650984) plus pomalidomide (Pom) and dexamethasone (Dex) versus Pom and Dex in relapsed/refractory multiple myeloma.
Authors: Richardson Paul G. , Attal Michel , San Miguel Jesus , Campana Frank , Le-Guennec Solenn , Hui Ai-Min , Risse Marie-Laure , Anderson Kenneth Carl 
Published: September 2018

TPS8057 Background: Treatment for refractory or relapsed and refractory multiple myeloma (MM) remains an unmet need. Isatuximab (ISA), an anti-CD38 monoclonal antibody with multiple mechanisms of tumor killing, has shown efficacy and an acceptable tolerability profile in Phase 1/2 studies in patients with refractory or relapsed and refractory MM (RRMM) (Richter et al. ASCO 2016; Vij et al. ASCO 2016). Methods: This Phase III, prospective, multicenter, randomized, open-label study (NCT02990338; ICARIA-MM) is being conducted to evaluate the clinical benefit of ISA in combination with Pom and low-dose Dex (Pom/Dex) versus Pom/Dex for the treatment of adult patients with RRMM and demonstrated disease progression within 60 days of the last therapy, and who have received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib) alone or in combination. Patients will be randomly assigned in a 1:1 ratio to either ISA (10 mg/kg IV on Days 1, 8, 15, and 22 in the 1st cycle; Days 1 and 15 in subsequent cycles) plus Pom (4 mg on Days 1–21) and Dex (40 mg for patients < 75 years of age and 20 mg for patients ≥75 years of age, on Days 1, 8, 15, and 22) or Pom and Dex. Treatment cycles will be 28 days each. Patients will continue therapy until disease progression, occurrence of unacceptable adverse events (AEs), or their decision to discontinue the study, whichever comes first. The primary endpoint is progression-free survival (PFS), i.e. time from randomization to progressive disease or death from any cause. Response will be determined by IMWG criteria (2016). Key secondary endpoints include overall response rate and overall survival (OS). Safety evaluations include treatment-emergent AEs/serious AEs (including infusion-associated reactions), laboratory parameters, vital signs and assessment of physical examination. Statistical analyses will be conducted according to a pre-specified plan; approximately 300 patients (150 in each arm) are expected to be enrolled in this study. The first patient was recruited in January 2017. Study funding: Sanofi. Clinical trial information: NCT02990338.
A phase II, noncomparative, open label, multicentre, study of AZD9291 in patients with locally advanced or metastatic EGFR mutated “T790M undetectable or unknown” non-small cell lung cancer (stage IIIB-IV) after no immediate prior EGFR TKI (OSIRIS study).
Authors: Soto Parra Hector J. , Noto Laura , Galetta Domenico , Ferraú Francesco , Gebbia Vittorio , Tassone Pierfrancesco , Verderame Francesco , Aiello Marco M. , Latteri Fiorenza , Novello Silvia 
Published: September 2018

TPS9107 Background: Osimertinib (OSI), is an oral, potent, irreversible inhibitor of both epidermal growth factor receptor (EGFR) sensitizing and resistance mutations (T790M) indicated for the treatment of pts with advanced EGFR T790M mutation-positive NSCLC. In the AURA study, OSI was associated with an ORR of 21% (13/61) among all patients with T790M negative mutation. Response rate broken down by immediate versus no immediate prior EGFR TKI was 11% (4/36 pts) versus 36% (9/25) respectively. This better activity with deferred OSI, drug able to inhibit also the EGFR sensitizing mutations, could be explained by a selection of sensitive tumor cells during chemotherapy (re-challenge strategy). Aim of the current study is prospective evaluate the efficacy of OSI in EGFR mutated, T790M “undetectable or unknown” patients as third-line therapy after a first-line EGFR TKI and a subsequent chemotherapy. Methods: OSIRIS study is a prospective single-arm, phase 2, open label, italian multicenter study. T790M “undetectable or unknown" is defined by the following conditions: inconclusive/negative tumor test result for T790M at the time of disease progression or medical inaccessible/contraindications/declined tumor biopsy or insufficient tumor tissue for testing. Pts are treated with OSI 80 mg once daily until disease progression or unacceptable toxicity. The single-arm design is appropriate, as there is no accepted standard therapy for these pts after chemotherapy. The primary endpoint is ORR according to RECIST version 1.1. The null hypothesis that the true response rate is 9% will be tested against a one-sided alternative. In the first stage, 32 pts will be accrued. If there are 3 or fewer responses in these 32 pts, the study will be stopped. Otherwise, 49 additional pts will be accrued for a total of 81. This design yields a type I error rate of 0.05 and power of 80% when the true response rate is 19%. Secondary endpoints are PFS, OS and safety. Exploratory: mutational analysis of a panel of genes involved in resistance to EGFR-TKIs is planned. Clinical trial information: 2016-002555-17.
Nephroprotective efficacy of Asparagus racemosus root extract on acetaminophen-induced renal injury in rats
Authors: Roy Suchismita , Pradhan Shrabani , Mandal Shreya , Das Koushik , Nandi Dilip Kumar 
Published: September 2018

Acetaminophen-induced renal necrosis and insufficiency occurs in patients with acetaminophen overdose. Renal failure is rapidly assuming epidemic proportions globally. In absence of reliable and effective nephroprotective drugs, strategies towards exploring alternative therapies for treatment of kidney diseases are essential. Asparagus racemosus is a medicinal plant used for treatment of various ailments. This research was undertaken to investigate the protective effect of ethanol fraction of A. racemosus roots extract in acetaminophen-induced uraemia and renal failure in rats. Rats were co-administered with acetaminophen injection and oral administration of A. racemosus roots extract in an attempt of protection against renal failure. Uremic biomarkers significantly decreased, and elevated levels of antioxidant enzymes were found, in the animals treated with ethanol fraction of A. racemosus when compared with acetaminophen treated uremic animals. Also, histology of kidneys showed control like structure in animals treated with this extract but severe damage in the uremic animals. HPLC analysis of the ethanol fraction of A. racemosus roots extract revealed eight compounds out of which one had a retention time near to the quercetin standard. It may be concluded that this extract of A. racemosus has therapeutically useful nephroprotective potential.
Vibrations Analysis of Rectangular Plates with Clamped Corners
Authors: Gharaibeh Mohammad A. , Obeidat Amr M. 
Published: September 2018

AbstractThis paper discusses the fundamental natural frequency of a thin elastic rectangular, isotropic and orthotropic, plates with clamped corners. Rayleigh’s method was used to analytically calculate the plate lowest natural frequency. In this solution, the vibration mode shape was assumed in a form that certifies the displacement as well as the rotational boundary conditions of the current problem. Finally, this paper provides useful information for evaluating the natural frequency of a plate with fixed corners with different mass attachments configurations.
Proline supplementation mitigates the early stage of liver injury in bile duct ligated rats
Authors: Heidari Reza , Mohammadi Hamidreza , Ghanbarinejad Vahid , Ahmadi Asrin , Ommati Mohammad Mehdi , Niknahad Hossein , Jamshidzadeh Akram , Azarpira Negar , Abdoli Narges 
Published: September 2018

Abstract

Background
Proline is a proteinogenic amino acid with multiple biological functions. Several investigations have been supposed that cellular proline accumulation is a stress response mechanism. This amino acid acts as an osmoregulator, scavenges free radical species, boosts cellular antioxidant defense mechanisms, protects mitochondria, and promotes energy production. The current study was designed to investigate the effect of proline treatment on the liver in bile duct ligated (BDL) rats as an animal model of cholestasis/cirrhosis.

Methods
BDL rats were supplemented with proline-containing drinking water (0.25% and 0.5% w:v), and samples were collected at scheduled time intervals (3, 7, 14, 28, and 42 days after BDL surgery).

Results
Drastic elevation in the serum level of liver injury biomarkers and significant tissue histopathological changes were evident in BDL rats. Markers of oxidative stress were also higher in the liver of BDL animals. It was found that proline supplementation attenuated BDL-induced alteration in serum biomarkers of liver injury, mitigated liver histopathological changes, and alleviated markers of oxidative stress at the early stage of BDL operation (3, 7, and 14 days after BDL surgery).

Conclusions
The hepatoprotection provided by proline in BDL animals might be associated with its ability to attenuate oxidative stress and its consequences.
Exposure to indoor radon can be a concern in studies on the role of short-term exposure to air pollution and mortality
Authors: Mortazavi S.M.J. 
Published: September 2018

Abstract
Recent studies show that short-term exposure to ambient particulate matter is associated with more emergency department visits and hospitalizations for pneumonia as well as increased mortality and increased health care costs among older adults. Moreover, exposure to ambient particulate matter is shown to be connected with an increased rate of daily mortality and hospitalizations due to cardiovascular diseases (CVDs). The association between short-term exposures to particulate matter with a diameter less than 2.5 µm (PM2.5) and ozone [at levels below the current daily National Ambient Air Quality Standards (NAAQS)] and mortality in the continental United States has been recently addressed by some researchers. Although exposure to radon is usually known to cause late health effects such as lung cancer, some studies show a significant association between radon exposure and cerebrovascular disease (CeVD) mortality. In some residential areas with high levels of radon, it has been found that the incidences of respiratory, nervous system and cardiovascular system diseases exceed the average. Studies that calculated the radiation dose to blood and the walls of coronary arteries from radon and progeny also indicate that exposure to radon can increase the incidence of CVDs. Based on the evidence provided in this short communication, it can be concluded that ignoring the key role of radon in non-cancer mortality can easily affect the validity of the studies aimed at investigating the association between exposure to ambient fine particulate matter and mortality.
Effects of stress on the auditory system: an approach to study a common origin for mood disorders and dementia
Authors: Pérez-Valenzuela Catherine , Terreros Gonzalo , Dagnino-Subiabre Alexies 
Published: September 2018

Abstract
The concept of stress is a fundamental piece to understand how organisms can adapt to the demands produced by a continuously changing environment. However, modern lifestyle subjects humans to high levels of negative stress or distress, which increases the prevalence of mental illnesses. Definitely, stress has become the pandemic of the 21st century, a fact that demands a great intellectual effort from scientists to understand the neurobiology of stress. This review proposes an innovative point of view to understand that mood disorders and dementia have a common etiology in a stressful environment. We propose that distress produces sensory deprivation, and this interferes with the connection between the brain and the environment in which the subject lives. The auditory system can serve as an example to understand this idea. In this sense, distress impairs the auditory system and induces hearing loss or presbycusis at an early age; this can increase the cognitive load in stressed people, which can stimulate the development of dementia in them. On the other hand, distress impairs the auditory system and increases the excitability of the amygdala, a limbic structure involved in the emotional processing of sounds. A consequence of these alterations could be the increase in the persistence of auditory fear memory, which could increase the development of mood disorders. Finally, it is important to emphasize that stress is an evolutionary issue that is necessary to understand the mental health of humans in these modern times. This article is a contribution to this discussion and will provide insights into the origin of stress-related neuropsychiatric disorders.
Plasmonic Cu/CuCl/Cu2S/Ag and Cu/CuCl/Cu2S/Au Supports with Peroxidase-Like Activity: Insights from Surface Enhanced Raman Spectroscopy
Authors: Song Wei , Hildebrandt Peter , Weidinger Inez M. 
Published: September 2018

Abstract
In the present study, we present nanostructured bimetallic Cu/CuCl/Cu2S/Au(Ag) supports that exhibit plasmonic electromagnetic field enhancement and peroxidase-like catalytic activity. The Cu2S component acts as the peroxidase-like catalyst, while the Au or Ag component provides the necessary light enhancement for surface enhanced Raman spectroscopic (SERS) studies of surface bound molecular reactants. As a test reaction the catalytic oxidation of 3,3′,5,5′-tetramethylbenzidine (TMB) in presence of H2O2 was investigated. The comparison of product evolution in solution measured by UV-Vis spectroscopy and on the surface measured via SERS is able to give more insight into the different steps involved in the overall catalysis.
Two New Factors Having Influence on Surface Cooling Rate of Quenched Workpiece
Authors: Zhang Ke Jian 
Published: September 2018

Abstract
The cooling processes of standard probes are observed directly, and it is found that all of the measured cooling characteristic curves cannot reflect the actual cooling condition of the probe surface. To know how the surface of a workpiece is cooled, the actual cooling process of the workpiece must be observed. The quench cooling processes of samples in different shapes and sizes are directly observed and video is recorded; the causes for the observed phenomena are discussed. Then, it is found that the flow of gas in the vapor blanket and the order of transition from vapor blanket cooling to boiling cooling at different parts have considerable influences on the surface cooling rate of the workpiece and cooling uniformity of the entire workpiece, in addition to the cooling capacity of the quenching medium and effective thickness of the workpiece. The fundamental rules of these two factors are tentatively revealed. Utilizing these rules, we can aspire to regulate and control the cooling rates on different surfaces of the same workpiece in the quench cooling process.
HBV Burden on Population, a Comparative Study between Two Districts Mardan and Charsadda of KPK, Pakistan
Authors: Shah Iftikhar Ali , Anwar Faheem , Haq Ihtesham Ul , Anwar Yasir , Ullah Faizan , Khan Khalid , Aizaz Muhammad , Ullah Noor 
Published: September 2018

The purpose of this study is to check out the spread rate of Hepatitis B Virus in the districts of Mardan and Charsadda, KPK Pakistan. As we know that Hepatitis results in damaging liver tissues, so it is one of the serious threats to the human health across the world. Hepatitis can give rise to acute and chronic infection which give rise to Liver cancer or Liver cirrhosis. It may be transfer from one person to another. Its transmission routs are oral, fecal and parental. The purpose of this paper is to check and judge health condition. Blood serum was collected from Mardan Medical Complex, Mardan and District Head Quarter, Charsadda. The paper was design to calculate anti-HBV antibody positive patients with ICT(immune-chromatography technique)based detection among various patients in MMC Mardan and DHQ hospital Charsada and from various regions of Mardan and Charsadda, KPK Pakistan. Total of 10852 patients of HBV in Charsadda and 14168 patients of HBV in Mardan. The blood samples were collected from Oct 2017 to May 2018 from both districts of KPK. The method for testing blood sample was ICT (immune chromatography technique). Our study about 10852 patients in district Charsadda who were at the risk of HBV infection, 103 were screened positive with the prevalence ratio of 0.949%. On the other hand, 14168 patients`s samples were collected in district Mardan, among them 149 were detected positive and ratio of prevalence is 1.051%. According to the above study the ratio of prevalence is lower in Charsadda as compare to Mardan
The Impact of Technology on the Innovation of Alumunium Products in Sawan District Buleleng Bali Indonesia
Authors: Widyani Anak Agung Dwi , Adnyana I Nyoman Kusuma , Sukawati Ni Ketut Astati 
Published: September 2018

Bali as a tourism area has craft centers scattered in various districts. One of the handicrafts that is the flagship product in Bali is aluminum craft based in Menyali Village, Sawan District, Buleleng Regency. Mr. Gex Aluminum and Candra Art are two groups of craftsmen who produce aluminum on a home industry basis. The existence of this business must get attention and support for the success of the people's economic program in order to improve the economy, the entrepreneurial spirit of the youth and to reduce the level of urbanization. The workforce used by this group is mostly students to fill their spare time (part time) and vacation. Despite having a high number of requests, these two business groups have not been able to produce optimally because the equipment used is still in limited space and the product processing process is still manual. In addition, the layout (layout) of the production process has not been arranged, accounting bookkeeping system has not been done regularly and regularly, the owner has not made payments and tax reporting, product marketing is still limited, the product does not have a name or logo. The main impact of all these problems is that the production process cannot be carried out effectively and efficiently, because products that are in accordance with standards cannot be maximally produced.
Based on the priority of the existing problems, the solution that can be offered through this program is to apply technology with the help of grinding, welding, cutting of NRT and concrete iron cutting tools for efficiency and creating molds to produce product innovations, rearranging production space and equipment , designing Standard Operating Procedures (SOPs), training in preparing financial reports, mentoring tax reporting, designing business card designs, websites and catalogs and designing product logos produced. With the implementation of this service program the expected output target is an increase in production according to the standard of 100%, lay out according to the production process, has two types of SOPs, is able to prepare financial statements, able to report tax on a self-assessment basis, has a business card, product catalog, and website and the product produced contains the business logo. In essence this service is expected to be able to improve the economy of the community and support the government's efforts to succeed in the people's economy program.
Minimal Increase in Survival Throughout the Years in Patients with Soft Tissue Sarcoma with Synchronous Metastases: Results of a Population-Based Study
Authors: Vos Melissa , Ho Vincent K. Y. , Oosten Astrid W. , Verhoef Cornelis , Sleijfer Stefan 
Published: September 2018

Abstract

Background
Treatment options for patients with metastatic soft tissue sarcoma (STS) have increased in the last decade. We aimed to examine whether this is associated with improved overall survival (OS) in patients with STS with synchronous metastases.

Patients and Methods
Patients diagnosed with STS and synchronous metastases from 1989 to 2014 were queried from The Netherlands Cancer Registry. Trends in OS were assessed by the Kaplan-Meier method and log-rank test in time intervals of 5 years, for the whole study population and in subgroups for liposarcomas, leiomyosarcoma, and other STS subtypes. A multivariable Cox regression analysis was performed to identify characteristics prognostic for OS.

Results
Median OS of the 1,393 identified patients did not improve significantly over the years from 5.8 months in 1989–1994 to 8.1 months in 2010–2014, but there was an evident trend. Median OS was prolonged in the subgroups of liposarcomas (3.6 to 9.3 months), leiomyosarcomas (11.3 to 14.6 months), and other STS subtypes (5.7 to 6.3 months), although there were no significant improvements in OS over the years. Primary tumor site in one of the extremities and surgery in an academic center had a favorable effect on OS, whereas significant negative predictors were no treatment, elderly age, STS subtype other than liposarcoma or leiomyosarcoma, high or unknown grade, and nodal involvement.

Conclusion
Although overall survival of patients with STS with synchronous metastases in this nationwide and “real-life” population has improved over the years, the improvement was not statistically significant, despite new treatment options.
TESETTÜR GİYİMİ ETKİLEYEN TÜKETİM KÜLTÜRÜ FAKTÖRLERİ ÜZERİNE UYGULAMALI BİR ARAŞTIRMA
Authors: Arslan Ali , Çaylak Melek 
Published: September 2018

Tesettür
kavramı temel mahiyeti ve amacı açısından İslam dini kapsamında
değerlendirilecek dini bir pratiktir. İslam’da kadının giyim konusundaki
sınırlarının belirlenmesi, bedenin gizlenmesi açısından tesettür kavramı önem
taşımaktadır. Fakat modernleşme ekseniyle değişme ve gelişmeler gösteren
tesettür anlayışının, tüketim kültürü ve moda ile birleşen, bu modern çağın
gereklerine ayak uyduran yeni bir tesettür anlayışı ve imajıyla karşı karşıya
kaldığı görülmektedir. Özellikle gençlerin giyim tercihlerinde tesettürün
modernleşme dinamiklerinden etkilenmesi söz konudur. Bu çalışmada tesettürlü
gençlerin giyim tercihlerinde tesettür algısının, tüketim kültürü ve moda ile
bütünleşmesi sonucu ortaya çıkan “tesettür modası” ile olan münasebeti ve
temelde tesettürün özsel ve şekilsel değişiklikleri ile bu değişikliklere sebep
olan faktörlerin etkisi ortaya konulmuştur. Teorik ve uygulamalı bir anket ile gençlerin
tesettür tercihi ve algısının değişim ve dönüşüm nedenleri, bu dönüşüme etki
eden unsurlar sorgulanmıştır.
SOSYAL BİLİMLERDE META-METODOLOJİK BİR UNSUR OLARAK ZAMAN
Authors: Yıldırım Yılmaz , Ertoy Muhammet 
Published: September 2018

Sosyal bilimsel yaklaşımlar önemli ölçüde kültürel
ayrımlara ve varsayımlara, kültürel ayrımlar ise örtük bir zaman tasavvuruna
bağlıdır. Kültürün bir bileşeni olan zaman, gerçekliğin toplumsal ve tarihsel
inşası sürecine dahildir. Toplumsal/tarihsel gerçekliğin incelenmesi adeta
toplumun kurumsallaşmış unsurlarından biri olan zamanın da incelenmesini gerekli
kılar. Kültürelci yaklaşımlarda zaman konusu bilhassa tarihselcilik ve
eleştirisi bağlamında ele alınmaktadır. Tarihselciliği eleştiren ve buna
alternatif teşkil eden yaklaşımlar da zaman tasavvuru ve bunun seçilen yönteme
etkisi bakımından tarihselciliğin bazı ön kabullerini paylaşmaktadır. Bu
alternatifler modernist sosyal bilimlerin zaman algısına yönelik esaslı bir
sorgulamadan uzaktır. Postmodernist sosyal bilimlerdeki mekân vurgusu ise
ötekini ortak bir insanlık zamanının dışında konumlandırmaya dönük modernist
varsayımın izlerini taşımaktadır. Bu çalışma zaman tasavvurunun sosyal
bilimsel yönteme yansımalarına ve kültürel taksonominin zamanla ilişkisine dair
eleştirel/anlayıcı bir perspektif sunmak ve yöntembilim tartışmalarında eksik
kalan bu boyuta katkı sağlamak amacındadır.