bluuebunny/crossref_metadata_2025 huggingface dataset:
Perbandingan Peningkatan Hasil Belajar Kimia dan Biologi Melalui Penggunaan Alat Peraga di SMP Satu Atap Wasur Merauke
Authors: Asmaningrum Henie Poerwandar
Published: February 2019

Penelitian ini bertujuan untuk mengetahui perbandingan peningkatan hasil belajar kimia dan biologi melalui penggunaan alat peraga. Penelitian ini menggunakan metode penelitian eksperimen. Populasi dalam penelitian ini adalah semua siswa kelas VIII SMP Satu Atap Wasur Merauke. Teknik pengumpulan data dengan teknik tes, dokumentasi dan observasi. Teknik analisis data yang digunakan adalah uji korelasi. Hasil penelitian menunjukkan bahwa nilai rata-rata hasil belajar kimia setelah menggunakan alat peraga lebih baik daripada sebelum menggunakan alat peraga (74,6129 > 59,1290) dan nilai rata-rata hasil belajar biologi setelah menggunakan alat peraga lebih baik daripada sebelum menggunakan alat peraga (75,2903 > 59,4839). Hasil tersebut didukung oleh hasil uji t dua pihak dimana pada hasil belajar kimia harga thitung < ttabel (-59,144 < -2,04227) dan pada hasil belajar biologi harga thitung < ttabel (-86.802 < -2,04227). Kesimpulan dari penelitian ini adalah terdapat perbedaan hasil belajar kimia dan biologi melalui penggunaan alat peraga, dimana nilai rata-rata hasil belajar kimia dan biologi meningkat setelah menggunakan alat peraga.

Kata Kunci: Hasil belajar, alat peraga, kimia, biologi
Pengaruh Model Brain Based Learning (BBL) dan Regulasi Diri Terhadap Peningkatan Pemahaman Konsep Siswa Pada Materi Koloid
Authors: Hadis Siti Namiran , Muktiningsih Muktiningsih , Santoso Imam
Published: February 2019

Materi kimia yang sarat akan konsep dan perlu dipahami siswa salah satunya materi koloid. Berdasarkan hasil observasi yang dilakukan di beberapa sekolah menemukan 70% guru kimia mengemukakan bahwa materi koloid memiliki karakteristk seperti di atas, namun yang terjadi siswa kurang berminat mempelajarinya, hal ini mengakibatkan pemahaman konsepnya tidak maksimal. Dengan demikian diperlukan model pembelajaran yang memaksimalkan potensi otak baik aspek kognitif dan emosi. Salah satu pembelajaran yang mengoptimal potesi otak yaitu Brain Based Learning (BBL). Tujuan utama dari penelitian ini yaitu untuk mendapat informasi tentang pengaruh model pembelajaran (BBL dan TGT) dan regulasi diri terhadap pemahaman konsep koloid siswa. Subjek penelitian adalah siswa SMA Negeri di Tidore, dengan jumlah 60 siswa di kelas XI. Berdasarkan hasil analisis dengan ANAVA 2 jalur, menunjukan bahwa (1) pemhaman konsep koloid siswa lebih baik jika diajarkan dengan BBL daripada TGT, (2) Terdapat interaksi antara model pembelajaran dan regulasi diri terhadap pemahaman konsep siswa,(3) Pemahaman konsep siswa yang memiliki regulasi diri tinggi lebih baik jika diajarkan dengan BBL, karena siswa yang memiliki regulasi diri tinggi mempunyai motivasi dan kemandirian dalam menyelesaikan tantangan, (4) Sementara pemahaman konsep siswa dengan regulasi diri rendah lebih baik jika diajarkan dengan TGT, Karena dengan adanya kelompok yang heterogen dalam TGT mendukung siswa yang memiliki tregulasi diri rendah untuk berkolaborasi dengan anggota kelompoknya sehingga pemahaman pemahaman konsep dapat terjadi dengan baik. Berdasarkan hasil yang diperoleh disimpulkan bahwa terdapat pengaruh model BBL dan regulasi diri terhadap pemahamn konsep siswa.

Kata Kunci:   Brain Based Learning, Team Games Tournamen, Regulasi diri, Pemahaman Konsep, Koloid.
Pengaruh Metode Praktikum IPA Berbasis Science Writing Heuristic (SWH) dan Motivasi Berprestasi Terhadap Hasil Belajar Kognitif Peserta Didik
Authors: Retnosari Tri , Nurbaity Nurbaity , Paristiowati Maria
Published: February 2019

Penelitian ini bertujuan untuk menganalisis pengaruh metode praktikum IPA berbasis SWH dan motivasi berprestasi peserta didik terhadap hasil belajar IPA di kelas 7 pada materi Sifat dan Perubahan Fisika dan Kimia. Penerapan metode praktikum IPA berbasis Science Writing Heuristic (SWH) dan motivasi berprestasi merupakan pendekatan yang berperan dalam mendukung proses pembelajaran. Penelitian dilakukan pada bulan Oktober 2015-Juni tahun 2016 di salah satu SMP swasta yang ada di Bekasi. Metode penelitian yang digunakan adalah kuasi eksperimen dengan disain faktorial 2x2. Sampel terdiri atas 40 peserta didik yang diambil dengan diteknik simple random sampling. Data hasil belajar kognitif diukur menggunakan tes hasil belajar dan motivasi belajar ditentukan berdasarkan hasil kuesioner. Data yang diperoleh berdistribusi normal dan homogen. Hasil  analisis data menggunakan uji ANAVA 2 arah diperoleh hasil: 1) Penerapan metode praktikum SWH memberikan hasil belajar IPA yang lebih tinggi dibanding metode konvensional, 2) Penerapan metode praktikum SWH pada peserta didik dengan motivasi berprestasi tinggi memberikan hasil belajar IPA yang lebih tinggi dibanding metode konvensional; 3) Penerapan metode praktikum SWH pada peserta didik dengan motivasi berprestasi rendah tidak menghasilkan belajar IPA yang lebih tinggi dibanding metode konvensional; 4) Terdapat  interaksi metode praktikum dan motivasi berprestasi terhadap hasil belajar IPA.

Kata Kunci: Science Writing Heuristic, Motivasi Berprestasi, Hasil Belajar
Pengembangan Media Pembelajaran Mobile Learning Berbasis Android pada Materi Sifat Koligatif Larutan
Authors: Nurhalimah Septina Restu , Suhartono Suhartono , Cahyana Ucu
Published: February 2019

Penelitian ini bertujuan untuk mengembangkan media pembelajaran mobile learning untuk smartphone pada materi sifat koligatif larutan. Penelitian ini menggunakan pendekatan penelitian dan pengembangan model Borg & Gall yang telah diadaptasi. Tahapan penelitian terdiri atas analisis kebutuhan, pengembangan media, dan uji coba media. Hasil analisis kebutuhan menunjukan bahwa 91,7% siswa merasa perlu adanya pengembangan media pembelajaran mobile learning pada materi sifat koligatif larutan. Media yang dikembangkan ini berupa aplikasi khusus unuk android dengan ukuran 49,49MB. Hasil uji coba oleh ahli media diperoleh persentase kelayakan sebesar 87,2%. Hasil uji coba oleh ahli materi diperoleh persentase kelayakan sebesar 88%. Hasil uji coba kepada guru kimia diperoleh sebesar 94%. Hasil uji coba kepada siswa skala kecil diperoleh sebesar 79%. Hasil uji coba kepada siswa skala besar diperoleh sebesar 80%. Dari keseluruhan uji tersebut dapat disimpulkan bahwa Media Pembelajaran Mobile Learning Berbasis Android Pada Materi Sifat Koligatif Larutan telah sesuai dengan kebutuhan siswa dan guru dengan hasil interpretasi baik.

Kata Kunci: Media Pembelajaran Kimia, Mobile Learning, Android, Sifat Koligatif Larutan
Pengaruh Model Pembelajaran Problem Based Learning (PBL) Terhadap Kemampuan Berpikir Kritis Siswa pada Materi Sistem Koloid
Authors: Pusparini Septiwi Tri , Feronika Tonih , Bahriah Evi Sapinatul
Published: February 2019

Menurut beberapa penelitian terdahulu, kemampuan berpikir kritis siswa kurang terlatih dikarenakan pembelajaran lebih berpusat kepada guru (teacher center). Penelitian ini bertujuan untuk mengetahui pengaruh penerapan model pembelajaran Problem Based Learning (PBL) terhadap kemampuan berpikir kritis siswa pada materi sistem koloid. Penelitian ini dilaksanakan di SMAN 10 Kota Tangerang Selatan pada bulan Februari semester genap tahun ajaran 2016/2017. Metode penelitian yang digunakan dalam penelitian ini adalah quasi eksperimen. Sampel penelitian berjumlah masing-masing 30 orang siswa pada kelas kontrol maupun eksperimen. Teknik pengumpulan data yang digunakan yaitu purpossive sampling. Instrumen utama yang digunakan yaitu tes essay sebanyak 10 butir soal. Hasil uji hipotesis menggunakan bantuan software SPSS versi 22 diperoleh data bahwa sig < Î± yaitu 0,000 < 0,05 pada taraf signifikansi 5% sehingga H0 ditolak dan terima H1. Hal ini menunjukkan bahwa terdapat pengaruh model pembelajaran Problem Based Learning (PBL) terhadap kemampuan berpikir kritis siswa.

 

Kata kunci

Model Pembelajaran Problem Based Learning (PBL), Kemampuan Berpikir Kritis, Sistem Koloid.
A critical exploration of heritage language learners’ identities within Hellotalk
Authors: Teske Kaitlyn , Vollmer Rivera Alexis
Published: February 2019

There is a need for critical, inclusive analyses that uncover the constraints that reinforce monolingual ideologies and reject the expression of multilingual and multicultural identities that are evident in eTandem applications (ORTEGA, 2017; VOLLMER RIVERA, 2017; VOLLMER RIVERA; TESKE, 2018). One population that may be affected by these constraints are Heritage Language Learners (HLL), who make up a diverse group of learners that have varying linguistic and cultural knowledge stemming from language and cultural exposure generally stemming from a more familial and community context (POTOWSKI, 2005). Drawing on identity theory (CUMMINS, 2001, 2009), this study investigates how HLL (N = 11) construct their identities within the constraints of the dichotomous eTandem learning environment HelloTalk by examining participant-reported reflections. Vis-á-vis content analysis (KRIPPENDORF, 1989) informed by Critical Applied Linguistics (PENNYCOOK, 2001) the results showed that although some features promote collaborative relations of power, in general the design of the application fosters coercive relations of power.
Desenvolvimento da competência comunicativa oral em PLE: teletandem em foco
Authors: Lopes Messias Rozana Aparecida , Ferreira Michael J.
Published: February 2019

Tendo por base a modalidade Teletandem Institucional Integrado – na qual as interações ocorrem planejadas no currículo de uma disciplina (ARANHA; CAVALARI, 2014) – e buscando responder às questões: (a) em que medida a prática de teletandem institucional integrado influencia o desenvolvimento da competência comunicativa oral e (b) que aspectos da fala do interagente de teletandem evidenciam o desenvolvimento de sua produção oral, por um semestre letivo,  assistimos e assessoramos as aulas de Língua Estrangeira-PLE, analisamos documentos e acompanhamos o desenvolvimento das atividades de Teletandem de uma turma de uma universidade norte-americana. O estudo foi desenvolvido com base na metodologia qualitativa (ANDRÉ, 1984; FLICK, 2004); teorias que sustentam a ideia de competência comunicativa oral (CANALE; SWAIN, 1980) e, como parâmetro de proficiência, os descritores do Quadro Europeu Comum de Referência para Línguas (CONSELHO DA EUROPA, 2001). A partir da triangulação dos dados, em análise preliminar, elaboramos um quadro que demonstra a construção da proficiência oral de dois estudantes praticantes de teletandem, bem como expõe diferentes variáveis que podem impactar o desenvolvimento e a avaliação da proficiência em foco.
API Connection Leak Equation Extended with Dependence on Axial Force and Backup Pressure
Authors: Goodman Malcolm , Mitchell Robert , Kalil Issa
Published: February 2019

The existing API equation for internal leak predicts the internal pressure to overcome the pin-box contact pressure generated from the makeup interference plus the energizing effect of internal pressure which enhances the seal. For threaded connections, internal and external pressures close the connection and increase the leak resistance, whereas axial loads open the connection and decrease the leak resistance. These competing effects must be included to accurately assess the connection leak resistance under any combination of loads at any point in any string. Following the same approach used by API for internal leak, this paper obtains similar results for external leak. For API connections, the effects of combined axial force and backup pressure are then incorporated into the internal/external leak equations using results from the Mitchell and Goodman (2018) paper presented at the 2018 SPE-IADC Drilling Conference. Sensitivities of leak ratings to combined loads for API connections are presented for both tubing and casing sizes. An example design case shows the importance of considering combined loads.
Automated Drilling Narratives: A Scalable Workflow to Measure the Effectiveness of Drilling Procedures
Authors: Hamzah Mohammad , Erge Oney , Chambon Sylvain
Published: February 2019

Driller's instructions are written with the expectation that the specific procedures they contain will be followed by the driller during execution. Compliance with these instructions, such as connection practices, is rarely monitored as this would require either the company man to be next to the driller, or an interpretation engineer to examine multiple measurement curves remotely. This paper will present an automated system capable of generating narratives of the driller's action from real-time drilling data. These drilling narratives are intended to provide a consistent interpretation of the driller's actions in context, with a goal of improving the effectiveness of the procedures.

To avoid the need for intensive interpretation of multiple measurement curves, several algorithms are used to segment the drilling data into partitions that encompass the sequences of operations during drilling or tripping. In each of these partitions, surface measurements are used to infer the driller's actions. Different combinations of the actuation of the block, mud pumps, top drive rotation, and their corresponding responses, are assigned pre-defined labels such as taking a survey, working the pipe, or conducting a friction test. These labels are later combined sequentially to form the drilling narrative.

Automating the generation of the narratives allows the drilling engineer to quickly search, extract and load events of interest, making it easier to measure the effectiveness of the planned drilling procedures outlined in the drilling program. In addition, it will also allow driller's action to be translated from a set of real-time data curves to a structured narrative that could be understood and read as a quick summary of drilling events in real time.

This automated, scalable method should be beneficial to drilling engineers, who currently spend many hours on analyzing drilling operations data, allowing them to come up with better plans and procedures for the next well.
Combined Gyroscopic and Magnetic Surveys Provide Improved Magnetic Survey Data and Enhanced Survey Quality Control
Authors: Weston John , Ledroz Adrián
Published: February 2019

The use of advanced solid-state gyroscopic sensors has now become both a viable and practical option for high accuracy wellbore placement, with the potential to out-perform traditional mechanical gyroscopic systems. This paper describes how the contributions of the new gyroscope technology are causing service providers to reconsider current survey practices, and to examine how the new gyroscopic survey tools can be best used for wellbore surveying and real-time wellbore placement.

The simultaneous application of multiple survey tools, largely made possible as a result of the unique attributes of solid-state gyroscopic sensors (including small size and significant power reduction), has clear benefits in terms of enhanced well placement, reliability and the detection of gross errors in the survey process. Further benefits accrue through the combination of different, but complimentary survey methods. This paper focuses mainly on the benefits of combining gyroscopic and magnetic measurements to reduce or remove the known errors related to the Earth's magnetic field to which magnetic survey systems are susceptible; errors in total magnetic field, declination and dip angle.

In this context, the use of statistical estimation techniques based on performance models of the survey systems used is described. For post-drilling surveys (using drop survey tools or wireline-conveyed tools for example), post-run analysis of the data using least-squares estimation techniques is appropriate. Alternative methods capable of achieving real-time data correction during drilling are also described and results are presented to demonstrate the potential for enhanced magnetic survey performance.

The principles described may be used when running basic magnetic measurement while drilling (MWD) systems, and for systems that employ field correction methods, such as the various in-field referencing (IFR) techniques, that are frequently used. The proposed methodology is of particular benefit in the former case, allowing enhanced magnetic surveying to be achieved without the need for expensive and complex magnetic field correction procedures. The potential also exists either to identify or to correct possible errors in the IFR data when such methods are used. This information may be of great value for the safe drilling of additional wells in the same region.
Exceptional Flat Rheology Using a Synthetic Organic-Inorganic Hybrid in Oil-Based Muds Under High Pressure and High Temperature
Authors: Patel Hasmukh A. , Santra Ashok , Thaemlitz Carl J.
Published: February 2019

We developed a novel organic-inorganic hybrid that composed of various organic moieties covalently linked with nanometer thick inorganic platelets. The synthesized compounds are highly pure and have reproducible chemical compositions. These hybrids are employed as viscosifier in oil-based drilling fluids. The rheological behavior was studied at ambient condition as well as under high pressure and high temperature. A facile, one-pot synthetic route generate nanometer sized layered materials with covalently bound organic functionalities, as confirmed by X-ray powder diffraction and Infrared spectroscopy. An unprecedented improvement in flat rheology was observed under high pressure (10000 psi) and temperature up to 300°F as compared to commercial organoclays. The temperature dependent viscosity and viscoelastic properties of the fluids are also demonstrated. It has been challenging to obtain flat rheological behavior under high pressure and temperature by using commercial organoclays. A flat rheological behavior is achieved by incorporating organic-inorganic hybrids in drilling fluids.
Well Control and Temperature Modelling Facilitates the Effective Delivery of Challenging Shallow Water HPHT Exploration Well
Authors: Davis Mark , Selent Ivo , Duplessis Bertrand , Janisch Werner
Published: February 2019

Drilling operations in high-pressure/high-temperature (HP/HT) environments can be very challenging and costly. In an exploration well being drilled in a unique depositional environment, a rapid increase in pore pressure was anticipated, potentially reaching HP/HT conditions of up to 12,000 psi and over 180°C. The absence of close offset wells resulted in a large uncertainty in the magnitude of the pore pressure. This drove the planned casing design, which was limited by kick tolerance and potentially narrow margins between pore pressure and fracture gradient, resulting in planning for up to six casing strings.

To respond to this challenge, standard engineering practices were augmented with additional monitoring and predictive modelling solutions to improve well control and to predict and explain complex well behaviour and mitigate the associated drilling risks. The models were calibrated with measured mud properties and wellbore temperatures and pressures during operations. They were then used to simulate, explain, and predict variations in downhole pressures and surface mud volumes. Various innovative applications were used to guide safe operational decision-making. Where conventional practices would not have allowed, this modelling enabled total depth of the well to be reached while incurring minimal nonproductive time and no well control incidents.

By understanding wellbore conditions using advanced well control and temperature simulators, abnormalities normally failing the conventional practices could be detected and explained. This improved well control, safety, rig performance, and effective application of resources.
The Effect of Pipe Rotation on Dynamic Well Control Casing Pressure Using the Dispersed Bubble Model
Authors: Marhoon Zahrah Al , Ramis Hussain Al
Published: February 2019

Managed Pressure Drilling is a new technology that has recently emerged in the industry. It has special well control capabilities supported by the rotating control device to simultaneously provide the required pressure control on a certain volume gas influx and maintain the pipe rotation for drilling or any other operation. This paper examines the effect of pipe rotation on casing pressure profiles while circulating out the kick using MPD equipment.

The PERTT lab personnel conducted experiments during the 80s in a real scale well under controlled environment that mimicked downhole conditions with a gas influx entering the wellbore. The data experimental analysis was coupled with the effect of pipe rotation through the application of correlations. The correlations from literature show a change in the expected frictional pressure loss when comparing the rotating case to the non-rotating case. This change is then applied on the geometric configuration of the well to find the changein the surface casing pressure caused by rotation.This paper covers the developed dispersed bubble model in WBM. This model includes the effect of the bubble dispersing into smaller bubble size on surface casing pressure. The validity of the single bubble model was examined inthis paper. The results showed that the changes in surface pressure are considerable when the gas bubble is able to break down with a decrease of up to 30 %. These changes are only applicable to cases with similar mud properties and well design of the experiments. The practical outcome is to further the understanding of a gas bubble behavior in a wellbore experiencing an influx. Since new technologies allow for the rotation of the pipe during the kick circulation process, this paper helps in answering the question of whether or not the pipe rotation aids in overall expected surface pressure. Furthering the window of applicability of the MPD can possibly touch into its unexploited potential.
Safety and efficacy of Curcumin versus Diclofenac in Knee Osteoarthritis: a randomized open label parallel arm study
Authors: Shep Dhaneshwar , Khanwelkar Chitra , Gade Prakashchandra , Karad Satyanand
Published: February 2019

Background: To compare the efficacy and safety of curcumin with diclofenac in the treatment of knee osteoarthritis (OA).
Methods: In this randomized, open label, parallel, active controlled clinical study, 139 patients of knee OA were randomized to receive either Curcumin 500 mg (Curcugreen®) capsule thrice daily or diclofenac 50 mg tablet twice daily for 28 days. Patients underwent assessment at baseline, day 7, day 14 and day 28. Primary efficacy measures were severity of pain (Visual Analogue Scale) and the Knee injury and osteoarthritis outcome score (KOOS) subscale at day 14 and day 28. Anti-flatulent effect (at day 7), anti-ulcer effect, weight lowering effect, patient and physician’s global assessment of therapy at day 28 were included as secondary endpoints. Safety after treatment was evaluated by recording adverse events and laboratory investigation.
Results: Both treatment groups showed similar improvement in primary endpoints at day 14 and day 28. Patients receiving curcumin showed similar improvement in severity of pain and KOOS scale when compared to diclofenac, and the difference was not statistically significant (p>0.05). On day 7, the patients treated with curcumin experienced significantly greater reduction in number of episodes of flatulence compared with diclofenac (p<0.0001). Similar trend was observed at day 28 for weight lowering effect of curcumin (p<0.0001) and anti-ulcer effect. None of the patients required H2 Blockers in curcumin group and 19 patients required H2 blockers in diclofenac group (0% Vs 28%, respectively; p<0.00001). Adverse effects were significantly less in curcumin group (13% vs. 38% in diclofenac group; p=0.0015). Patient’s and physician’s global assessment of therapy was similar towards both the treatment.
Conclusion: Curcumin has similar efficacy, but better tolerated than diclofenac among patients with knee OA. Curcumin can be an alternative treatment option in the patients of knee OA who are intolerant to the side effects of NSAIDS.
Trial Registration: ISRCTN, ISRCTN10074826, Registered 21 November 2017 - Retrospectively registered, http://www.isrctn.com/ISRCTN10074826
Keywords: Knee osteoarthritis; Pain; Curcumin; Diclofenac; Anti-flatulent; Weight lowering; Anti-ulcer
3D- vs. 4K-Display System - Influence of "State-of-the-art"-Display Technique On Surgical Performance (IDOSP-Study) in minimal invasive surgery: protocol for a randomized cross-over trial
Authors: Wahba Roger , Datta Rabi R , Hedergott Andrea , Bußhoff Jana , Bruns Thomas , Kleinert Robert , Dieplinger Georg , Fuchs Hans , Giezelt Caroline , Möller Desdemona , Hellmich Martin , Bruns Christiane J , Stippel Dirk L
Published: February 2019

Abstract

Background
Three-dimensional (3D) stereoscopic vision is crucial to perform any kind of manual tasks. The reduction from real life 3D- to virtual two-dimensional (2D) sight is a major challenge in minimal invasive surgery (MIS). 3D-display technique has shown to reduce operation time, mistakes, and to improve the learning curve. Therefore it seems to optimize surgical performance for novice and experienced surgeons. Inspired by consumer electronics 4K-display technique was recently introduced to MIS. Due to its high resolution and zoom-effect surgeons should benefit from it. Aim of this study is to evaluate if “state-of-the-art” 3D- versus 4K- display techniques could influence surgical performance.

Methods
A randomized cross-over single-institution single-blinded trial is designed. It compares the primary outcome parameter “surgical performance”, represented by “performance time “ and “number of mistakes”, using a passive polarizing 3D- and a 4K-display system (2 arms) to perform different tasks in a minimal invasive/laparoscopic training parkour. Secondary outcome parameters are the mental stress load (NASA task load index) and the learning curve. Unexperienced novices (medical students), non-board certified and board-certified abdominal surgeons participate in the trial (i.e. level of experience, 3 strata). The parkour consists of 7 tasks (novices 5 tasks), which will be repeated 3 times. The 1st run of the parkour will be performed with the randomized display system, the 2nd run with the other one. After each run, the mental stress load is measured. After completion of the parkour, all participants are evaluated by an ophthalmologist for visual acuity and stereoscopic vision with five tests. A sample-size of 36 per stratum is required to detect a standardized effect of 1.0 (including additional 5% for a non-parametric approach) with a power of 80% at two-sided type I error of 5%. Thus, altogether 108 subjects need to be enrolled.

Discussion
Complex surgical procedures are performed in minimal invasive/laparoscopic technique. This study should provide some evidence to decide which display technique a surgeon could choose to optimize his performance.

Trial Registration
This trial is registered at clinicaltrials.gov (trial number: NCT 03445429, registered February 7, 2018, http://www.clinicaltrials.gov)
A Double-blind Randomized Comparative Clinical Trial to Evaluate the Safety and Efficacy of Dendritic Cell Vaccine Loaded with WT1 Peptides (TLP0-001) in Combination with S-1 in Patients with Advanced Pancreatic Cancer Refractory to Standard Chemotherapy
Authors: Katsuda Masahiro , Miyazawa Motoki , Ojima Toshiyasu , Katanuma Akio , Hakamada Kenichi , Sudo Kentaro , Asahara Shingo , Endo Itaru , Ueno Makoto , Hara Kazuo , Yamada Suguru , Fujii Tsutomu , Satoi Sohei , Ioka Tatsuya , Ohira Masaichi , Akahori Takahiro , Kitano Masayuki , Nagano Hiroaki , Furukawa Masayuki , Adachi Tomohiko , Yamaue Hiroki
Published: February 2019

Background: Pancreatic cancer is a refractory malignancy and the development of a new effective treatment strategy is needed. We generated a dendritic cell vaccine by culturing monocytes obtained by apheresis of blood from each patient, inducing their differentiation into dendritic cells, and pulsing with tumor antigen peptides. However, the clinical efficacy of the vaccine has not been established. We therefore decided to conduct an exploratory clinical trial of dendritic cell vaccine loaded with Wilms’ tumor gene 1 peptides (TLP0-001) as a potential new treatment for patients with advanced pancreatic cancer refractory to standard chemotherapy.
Methods: This is an investigator-initiated double-blind comparative trial. The patients were allocated to two groups in a 1:1 ratio through a central registration by dynamic allocation. A total of 185 patients with inoperable or metastatic pancreatic cancer who were refractory or intolerant to standard primary chemotherapy with gemcitabine plus nab-paclitaxel will be allocated to secondary treatment either with placebo in combination with S-1 (the control group) or TLP0-001 in combination with S-1 (the investigational product group). The primary objective of this trial is to evaluate the safety and efficacy (as measured by overall survival) of the investigational product by comparing the two groups. This clinical trial will be performed in accordance with Japanese Good Clinical Practice guidelines.
Discussion: Clinical trials of the standard regimen, including gemcitabine, for advanced pancreatic cancer are ongoing worldwide. However, a strategy for after the primary treatment has not been established. We therefore decided to conduct this study to evaluate the safety and efficacy of TLP0-001 as a secondary treatment for pancreatic cancer in anticipation of the approval of this new drug in Japan. This trial is conducted with full consideration of safety as it is the first-in-human clinical trial of TLP0-001; thus, the trial will be conducted only at the Second Department of Surgery at Wakayama Medical University until the safety is confirmed by interim analysis. We plan to conduct a multicenter trial at 18 institutions in Japan after confirmation of the safety.
Trial registration: University Hospital Medical Information Network Clinical Trials Registry, ID: UMIN000027179. Registered on 9 April 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000031102
Delayed-Onset Interface Fluid Syndrome After LASIK Following Phacotrabeculectomy
Authors: Kim Chung Young , Jung Young Ho , Lee Eun Ji , Hyon Joon Young , Park Kyu Hyung , Kim Tae Woo
Published: February 2019

Background
Interface fluid syndrome (IFS) is an unusual complication after laser-assisted in-situ keratomileusis (LASIK). We report the first case of IFS after uncomplicated phacotrabeculectomy in a patient who had undergone LASIK 10 years previously. This case emphasizes the importance of intraocular pressure (IOP) interpretation in eyes that have undergone LASIK.

Case presentation
A 30-year-old woman with a history of LASIK surgery presented to glaucoma clinic due to uncontrolled IOP despite of maximally tolerable medical treatment. After receiving phacotrabeculectomy, IOP decreased to 3mmHg on the first postoperative day, but again increased up to 21mmHg and a diffuse corneal edema with cloudy flap interface was demonstrated by slit-lamp microscopy. Corneal edema was sustained even after the IOP was lowered to 14 mmHg. Spectral-domain optical coherence tomography scanning of the cornea revealed a diffuse, thin fluid pocket in the corneal interface. After laser lysis of the scleral flap sutures, IOP was further decreased to 9mmHg and interface fluid was resolved.

Conclusion
IFS should be considered as a possible cause of postoperative corneal edema despite of low IOP in the eyes that underwent LASIK surgery. Additional IOP lowering may be helpful for resolving the corneal edema.
Fabry disease causes angiitis of the central nervous system:a case report
Authors: Kong De-Zheng , Lian Ya-Hui , Wang Lin-Jing , Wang Chun-Mei , Meng Yang-Yang , Zhou Hong-Wei
Published: February 2019

Background

Fabry disease is rare, and often the diagnosis is delayed. Here, we describe a case of Fabry disease resulting in vasculopathy of the central nervous system. Magnetic resonance (MR) black-blood sequence (three-dimensional T1 volumetric isotropic turbo spin echo acquisition), with a unique advantage of imaging the vascular wall, facilitated a clear identification of the vasculopathy.

Case presentation

A 27-year-old man visited our hospital for the treatment of " double vision 6d." After a series of examinations, the patient was diagnosed with Fabry disease, which caused vasculopathy of the central nervous system. Subsequently, the patient was treated with corticosteroids and his symptoms were attenuated. Two months after the initial treatment, the initial lesion formed in the vascular vessel disappeared, however, a new lesion appeared. Similarly, four months after the initial treatment, although the previous lesion disappeared, a new lesion appeared.

Conclusions

This case highlights that clinicians should use MR black-blood sequence scan in a timely manner in case of young patients with repeated strokes and migratory lesions. In case of detection of a vascular lesion in combination with other systemic lesions, the possibility of Fabry disease should be considered.
Views of healthcare professionals on recruiting to trials of psychosocial research: a qualitative study
Authors: Aspden Trefor , Armstrong Megan , Serfaty Marc
Published: February 2019

Background: Randomised controlled trials, and in particular those of psychosocial interventions, often fail to recruit to target, resulting in underpowered trials with poor generalisability of findings. The objectives of this study was to explore the views of healthcare professionals on recruiting to psychosocial research studies, and to explore their views on factors that may hinder or facilitate recruitment.

Methods: We conducted 14 semi-structured interviews, with healthcare professionals who had been involved in recruitment into a randomised controlled trial of a talking therapy for depression in patients with advanced cancer. Interviews were transcribed and analysed using thematic analysis.

Results: Six primary themes were identified, comprised of 15 subthemes. Attitudes towards research were largely positive. Health care professionals identified lack of time and narrow screening criteria as barriers to recruitment, and also noted the tendency to withhold participants from research for reasons other than eligibility (e.g., gatekeeping). The engagement of the study team with the clinical recruitment site, and the frequent presence of a researcher in clinics, were noted as facilitating recruitment.

Conclusions: Healthcare professionals involved in recruiting to trials of psychosocial interventions hold generally positive views of psychosocial research, but report that constraints limit their ability to recruit. The findings from this study can inform how best to design trials, and in particular trials of psychosocial interventions, and train health care professionals for the study, to maximise recruitment.

Trial registration: Controlled Trials ISRCTN07622709, registered 15 July 2011
The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
Authors: Salman Rustam Al-Shahi , Murray Gordon D. , Dennis Martin S. , Newby David E. , Sandercock Peter A.G. , Sprigg Nikola , Sudlow Cathie L.M. , Werring David J. , White Philip M. , Whiteley William N.
Published: February 2019

Background: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet drugs modifies the risks of recurrent ICH, haemorrhagic events, vaso-occlusive events, or a composite of all serious vascular events compared to avoiding antiplatelet drugs.
Methods/design: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, parallel group, open, assessor-blind, randomised trial comparing starting versus avoiding antiplatelet drugs for adults surviving antithrombotic-associated ICH. Recruitment began on 22 May 2013 and ended on 31 May 2018. Follow-up ended on 30 November 2018. This update to the protocol describes the statistical analysis plan (version 1.7, finalised on 25 January 2019). Database lock and un-blinding occured on 29 January 2019, after which the un-blinded trial statistician conducted the final analyses according to this statistical analysis plan.
Discussion: Final results of RESTART will be analysed and disseminated in May 2019.
Trial registration: ISRCTN registry 71907627. Prospectively registered on 25 April 2013.
The trial is funded by a British Heart Foundation special project grant (SP/12/2/29422) and a travel fellowship (FS/13/72/30531). The trial sponsor is the Academic and Clinical Central Office for Research and Development (ACCORD), which is a partnership between the University of Edinburgh and NHS Lothian Health Board.
Antithrombin Supplementation during Extracorporeal Membrane Oxygenation: Study Protocol for a Pilot Randomized Clinical Trial
Authors: Panigada Mauro , Spinelli Elena , Cucino Alberto , Cipriani Elisa , De Falco Stefano , Panarello Giovanna , Occhipinti Giovanna , Arcadipane Antonio , Sales Gabriele , Fanelli Vito , Brazzi Luca , Novembrino Cristina , Consonni Dario , Pesenti Antonio , Grasselli Giacomo
Published: February 2019

Background: Normal levels of plasma antithrombin (AT) activity might decrease heparin requirements to achieve an adequate level of anticoagulation during treatment with extracorporeal membrane oxygenation (ECMO). Acquired AT deficiency during ECMO is common, but formal recommendation on target, timing, and rate of AT supplementation is lacking. Thus, we conceived a pilot trial to evaluate the feasibility and safety of prolonged AT supplementation in patients requiring veno-venous ECMO for respiratory failure.
Methods: GATRA is a phase 3, prospective, randomized, single blinded multicenter controlled two-arm trial. Patients undergoing veno-venous ECMO will be randomized to either receive AT supplementation to maintain a functional AT level between 80%-120% (AT supplementation group) or not (control group) for the entire ECMO course. In both study groups anticoagulation will be provided with unfractionated heparin following a standardized protocol. The primary endpoint will be the dose of heparin required to maintain ratio of activated partial thromboplastin time between 1.5-2. Secondary endpoints will be the adequacy of anticoagulation and the incidence of hemorrhagic and thrombotic complications.
Discussion: GATRA is a pilot trial that will test the efficacy of a protocol of AT supplementation in decreasing the heparin dose and improving anticoagulation adequacy during ECMO. If positive, it might provide the basis for a future larger trial aimed at verifying the impact of AT supplementation on a composite outcome endpoint including hemorrhagic events, transfusion requirements and mortality.

Trial registration

ClinicalTrials.gov, NCT03208270. Registered on 5 July 2017.
Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme).
Authors: Vennik Jane , Blackshaw Helen , Philpott Carl , Thomas Mike , Eyles Caroline , Carpenter James , Clarke Caroline S , Morris Stephen , Schilder Anne , Lund Valerie , Little Paul , Durham Stephen , Denaxas Spiros , Williamson Elizabeth , Beard David , Cook Jonathan , Conte Steffi Le , Airey Kim , Boardman Jim , Hopkins Claire
Published: February 2019

Background

MACRO (Defining best Management for Adults with Chronic RhinOsinusitis) is an NIHR-funded programme of work designed to establish best practice for adults with chronic rhinosinusitis (CRS). The 7-year programme comprises three consecutive workstreams, designed to explore NHS care pathways through analysis of primary and secondary data sources, and to undertake a randomised controlled trial to evaluate a longer-term course of macrolide antibiotics and endoscopic sinus surgery for patients with CRS. A number of outstanding elements still required clarification at the funding stage. This paper reports an expert panel review process designed to agree and finalise the MACRO trial design, ensuring relevance to patients and clinicians whilst maximising trial recruitment and retention.

Methods

An expert panel consisting of the MACRO programme management group, independent advisors, and patient contributors, was convened to review current evidence and the mixed method data collected as part of the programme, and reach agreement on MACRO trial design. Specifically, agreement was sought for selection of macrolide antibiotic, use of oral steroids, inclusion of CRS phenotypes (with/without nasal polyps), and overall trial design.

Results

A 12-week course of clarithromycin was agreed as the main trial comparator, due to its increasing use as a first and second line treatment for patients with CRS, and the perceived need to establish its role in CRS management. Oral steroids will be used as a rescue medication during the trial, rather than routinely either pre or post trial randomisation, to limit any potential effects on surgical outcomes and better reflect current UK prescribing habits. Both CRS phenotypes will be included in a single trial to ensure the MACRO trial is both pragmatic and generalisable to primary care. A modified 3-arm trial design was agreed after intense discussions and further exploratory work. Inclusion criteria were amended to ensure that patients recruited would be considered eligible for the treatment offered in the trial, due to having already received appropriate medical therapy as deemed suitable by their ENT surgeon. A proposed 6-week run-in period prior to randomisation was removed due to the new criteria prior to randomisation.

Conclusion

The expert panel review process resulted in agreement on key elements and an optimal design for the MACRO trial, considered most likely to be successful in terms of both recruitment potential and ability to establish best management of patients with CRS.
A Predictive Model for the US Non-profit Market; A Macro to a Micro Perspective
Authors: Quevedo Francisco J , Quevedo-Prince Andrea Katherine
Published: February 2019

The Non-Profit Sector contributes almost $1 trillion to the US economy, representing 5.4% of GDP, and generating over 12 million jobs in 2017. Researchers suggest that a better understanding of the factors that affect fundraising would be of great interest to policy makers and fundraisers. However, the workings of the sector are subject of much debate. Some relate its size to the Theory of Government Failure, while others propose that government funding does have a positive effect on revenues. Some have suggested they swing with Gross Domestic Product (GDP), but others contradict this view and contend that macroeconomic variables do not affect short-run dynamics. Some research found that non-profit revenues react more to economic upswings than downturns, but nationwide organizations relate the ups-and-downs to certain events, as they influence public awareness. Predictive modeling overall has focused on big-donor analytics, aimed at identifying potential sponsors. Our research set out instead to define a working model for the US Non-Profit Sector. After an exhausting search, we located complete time series for an emblematic segment, the environmental cause, Factor Analysis allowed us to pinpoint the independent variables. We found that Non-Profit Revenues (NPR) depend largely on Public Awareness, as measured by TV coverage, and on Disposable Personal Income (DPI), specifically: NPR = -4401.542 + 528.327(DPI) +23.121(TVCoverage) + Ɛ We replicated prior research, which sought out relationships between macro-economic variables and NPR. That study had discarded the correlation between GDP and NPR as obvious, but did not explore DPI as the determining factor, and stuck to single variable searches, finding a correlation between the Standard & Poors index and lagged NPR figures, with a correlation coefficient of 0.636. Our model’s Pearson's R came up to 0.935, with perfect significance levels. Confirmatory Factor Analysis reaffirmed the fit of our equation, with an R² of 0.87.
Redesigning the ventilated improved pit latrine for use in built-up low-income settings
Authors: Obeng Peter A. , Oduro-Kwarteng Sampson , Keraita Bernard , Bregnhøj Henrik , Abaidoo Robert C. , Awuah Esi , Konradsen Flemming
Published: February 2019

The ventilated improved pit (VIP) latrine has the potential to address the challenge of access to improved sanitation in built-up low-income settings. However, its conventional technical design fails to address the needs and preferences of some users. The objective of this paper was to test the technical performance of modified engineering designs of the technology to respond to some preferences of toilet users. The entry of air from multiple windows in the superstructure and installation of insect screens in windows were tested in an experimental VIP latrine. The modified design achieved the recommended ventilation rate of 20 m3/h when a vent pipe diameter of 150 mm was used. The study concludes that adopting a multidirectional airflow design leads to a lower ventilation rate as compared to the conventional design. However, when fitted with the recommended size of vent pipe, this modified design achieves more than twice the recommended ventilation rate with or without an insect screen installed in the windows. Nevertheless, the practice in which 100 mm diameter vent pipes are used with insect screens installed in windows is likely to lead to odour problems due to inadequate ventilation through the vent pipe.
Flood disaster evaluation based on adaptive fuzzy clustering iterative model and hybrid differential evolution algorithm
Authors: Qiang Zou , Li Liao , Hui Qin
Published: February 2019

In order to reasonably and rapidly evaluate flood disaster, based on a fuzzy clustering iterative model (FCI) and differential evolution algorithm (DE), an adaptive fuzzy clustering iterative model using a hybrid differential evolution algorithm (AFCI-HDE) is proposed, which has three advantages: firstly, the decision-maker's subjective preference was considered to flexibly modify the objective function; secondly, HDE was introduced to optimize the index weight vector of AFCI; thirdly, the validity of its clustering effect was more credible than that of FCI. Finally, the case study revealed that AFCI-HDE is feasible and effective by comparing the optimal fitness and clustering validity values with other approaches, which could reflect various decision-maker's preferences by simple adaptive adjustments and rapidly obtain reasonable evaluation results, thus providing a new effective approach in flood risk management.
Nitrogen removal and responses of bacterial communities in activated sludge under different operational manipulations
Authors: Yasong Chen , Junling Lu , Zheng Zhao , Huiping Chen , Yuke Peng , Lin Xiao
Published: February 2019

Operational conditions are often manipulated to improve the nitrogen removal performance of wastewater treatment, yet the impacts of operational conditions on microbial communities were still not well understood. There is a pressing need to understand the microbial mechanisms that link operation manipulation and nitrogen removal performance. In this study, high-throughput analysis of 16S rDNA and quantitative polymerase chain reaction of functional genes were used to identify the microbial response to operational manipulations. The results showed that alteration of operational parameters could change the bacterial communities at the genera level and denitrification guild gradually dominated in the activated sludge bacterial communities. Heterotrophic Hyphomicrobium and Chromatiaceae drove the kinetic of dominant genera and denitrification guild. Carbon source supplement was the most efficient strategy for improving nitrogen removal, and greatly increased the abundance of denitrifiers and denitrification genes. However, carbon source supplement inhibited expression activities of denitrification genes, as well as the proliferation of autotrophic denitrifiers, and it was supposed to be unfavorable in terms of cost over the long term. The result should bring new inspiration for improving the effect of WWTP performance through the manipulation of operational parameters.