bluuebunny/crossref_metadata_2025_split huggingface dataset:
Electronic Health Record Nested Pragmatic Randomized Controlled Trial of a Reminder System for Serum Lithium Level Monitoring in Patients with Mood Disorder: KONOTORI study protocol
Authors: Seki Tomotsugu , Aki Morio , Kawashima Hirotsugu , Miki Tomotaka , Tanaka Shiro , Kawakami Koji , Furukawa Toshi A. 
Published: July 2019

Abstract
Background: The weaknesses of classical explanatory randomized controlled trials (RCTs) include limited generalizability, high cost, and time burden. Pragmatic RCTs nested within electronic health records (EHRs) can be useful to overcome such limitations. Serum lithium level monitoring has often been underutilized in real-world practice in Japan. This trial aims to evaluate the effectiveness of the EHR-nested reminder system for serum lithium level monitoring in the maintenance of therapeutic lithium concentration and in the improvement of the quality of care for patients on lithium maintenance therapy.
Methods: The Kyoto tOyooka Nested cOntrolled Trial Of Reminders (KONOTORI trial) is an EHR-nested, parallel-group, stratified permuted block randomized controlled trial. Screening, random allocation, reminder output, and outcome collection will be conducted automatically by the EHR-nested trial program. Patients with a mood disorder taking lithium carbonate for maintenance therapy will be randomly allocated to the two-step reminder system for serum lithium level monitoring or to usual care. The primary outcome is achievement of therapeutic serum lithium concentration between 0.4 and 1.0 mEq/L after 18 months.
Discussion: The KONOTORI trial uses EHRs to enable the efficient conduct of a pragmatic trial of the reminder system for lithium monitoring. This may contribute to improved quality of care for patients on lithium maintenance therapy.
International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing Sarcoma Family of Tumours – EURO EWING 2012
Authors: Birmingham Jennifer Anne , Moroz Veronica , Marec-Berard Perrine , Gaspar Nathalie , Laurence Valerie , Martin-Broto Javier , Sastre Ana , Gelderblom Hans , Owens Cormac , kaiser Sophie , Fernández-Pinto Melissa , Fenwick Nicola , Evans Abigail , Strauss Sandra , Whelan Jeremy , Wheatley Keith , Brennan Bernadette 
Published: July 2019

Abstract
Abstract
Background Despite multiple randomised trials in newly diagnosed Ewing sarcoma family of tumours (ESFT), over many years, and involving many international co-operative groups, the outcomes for all stages of disease have plateaued. Internationally, the standard treatment of ESFT is not defined, and there is a need to add new agents other than conventional chemotherapy to improve outcomes. This trial will compare two different induction/consolidation chemotherapy regimens vincristine, ifosfamide, doxorubicin and etoposide (VIDE) induction and vincristine, actinomycin D, ifosfamide or cyclophosphamide, or Busulfan and Mephalan (VAI/VAC/BuMel) consolidation compared with vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide (VDC/IE) induction and ifosfamide and etoposide, vincristine and cyclophosphamide, vincristine, actinomycin D and ifosfamide, or Busulfan and Mephalan (IE/VC/VAI/ BuMel) consolidation- randomisation 1 (R1). A second randomisation (R2) will determine whether the addition of zoledronic acid to consolidation chemotherapy, as assigned at R1, is associated with improved clinical outcome.
Methods EURO EWING 2012 is an international, multicentre, phase III, open-label randomised controlled trial. There are two randomisations: R1 and R2. Patients are randomised at two different time points, at entry to the trial (R1) and following local control therapy (R2). The primary outcome measure is event-free survival. The secondary outcome measures include overall survival, adverse events and toxicity, histological response of the primary tumour, response of the primary tumour, regional lymph nodes and/or metastases, and achievement of local control at the end of treatment.
Discussion This study will establish which is the "standard regimen" of chemotherapy, taking into account both clinical outcomes and toxicity. This will form the chemotherapy backbone for future interventional studies where we may want to add new targeted agents. It will also determine the role of zoledronic acid, in conjunction with the separate EE2008 trial. Any trial in ESFT needs to take into account the rarity of the tumour and that international co-operation is needed to provide answers in a timely manner.
Trial registration Registered with EudraCT number 2012-002107-17 on 26th February 2012. Registered with ISRCTN number 54540667 on 4th November 2013.
Sensory processing of women diagnosed with genito-pelvic pain/penetration disorder: a research proposal
Authors: Labuschagne Elsie , Niekerk Matty van 
Published: July 2019

Abstract
Objectives: The study’s purpose is to investigate a possible link between Sensory Processing Disorder (SPD) and sexual pain in females diagnosed with genito-pelvic pain/penetration disorder (GPPPD). Study objectives are to determine sensory processing patterns of women diagnosed with GPPPD, to explore the level of anxiety when both GPPPD and SPD are present and to investigate participants’ perception of participating in a sensory-based home programme.

Methods: A sequential explanatory mixed method two-phased study design will be used. Phase one is a quantitative, cross sectional non-experimental descriptive study, using the Adolescent/Adult Sensory History (AASH) and Hospital Anxiety and Depression Scales (HADS) to obtain data from purposive sampling.
Phase two is an exploratory qualitative study involving participants who were identified with SPD in phase one. They will participate in a sensory based-home programme and their perception thereof will be established during semi-structured interviews.

Outcomes: This study could improve practitioners’ understanding of GPPPD and SPD and make alternative, non-invasive, non-pharmacological treatment options available to better assist these patients. The study could further clarify the role of the occupational therapist in sexuality. Exploring participants’ anxiety has important implications for treatment protocols in occupational therapy and assisting in describing the signs and symptoms of GPPPD.
Febrile neutropenia management in pediatric cancer patients at Ethiopian Tertiary Care Teaching Hospital
Authors: Bedewi Husnia , Berihun Malede , Mulu Atalay , Assefa Tamrat 
Published: July 2019

Abstract
Objective

This study aimed at assessing the management practice of febrile neutropenia (FN) in pediatric cancer patients at Tikur Anbessa Specialized Hospital (TASH), Ethiopia by reviewing patients’ charts from 135 participants retrospectively. Data was entered into Epi-info 7 and exported to SPSS 20 for analysis.

Results

Empiric antibiotics therapy (EAT) was given to all patients in which ceftriaxone with gentamycin constituted of 71.9% followed by ceftriaxone monotherapy. EATs were converted to others in 20 (14.8%) and 2(1.5%) patients for the first and second times respectively, mainly based on poor clinical response without conducting culture and sensitivity tests. These tests were done only for 13 (9.6%) participants and growth was seen in 5 patients; and definitive therapy was given for 2 patients. ANC value was above 500 cell/mm3 in 80.7% of patients and 98.5% of study participants were afebrile after completion FN treatment. Most of them (70.4%) were treated for FN and 7 of patients died due to all case mortality. The hospital should not rely mainly only on ceftriaxone with gentamycin as EAT and also should do culture and sensitivity test to optimize therapy based on susceptibility result before conversion and modification of therapy in management of FN.
The efficacy and safety of acupuncture for alleviating chemotherapy-induced peripheral neuropathy in colorectal cancer patients: study protocol for a pilot single-blinded, randomized sham-controlled trial
Authors: Chan Kaiyin , Lui Louisa , Yu Kaling , Lau Kwongwai , Lai Manchi , Lau Waiwai , Ng Bacon , Zhong Linda LD , Bian ZhaoXiang 
Published: July 2019

Abstract
Background: Colorectal cancer is the most common cancer in Hong Kong. Oxaliplatin based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer. However, oxaliplatin causes chemotherapy induced peripheral neuropathy (CIPN). Acupuncture has been recognized as one of the effective intervention for preventing CIPN. This study aims to examine the efficacy and safety of acupuncture for preventing CIPN in colorectal cancer patients in Hong Kong.
Methods/Design: This is a pilot single-blinded, randomized, sham- controlled trial. Eighty-four eligible patients, who are Hong Kong Chinese aged ≥18 years and are diagnosed as colorectal cancer undergoing oxaliplatin based chemotherapy, will be randomized in a ratio of 1:1 to acupuncture group and sham-controlled group. During 12-weektreatment period, patients in acupuncture group will undergo acupuncture once a week from the first cycle of chemotherapy, patients in control group will receive sham-acupuncture, and the patients in both groupswill be followed up for twelve weeks. The primary outcome measure is the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOC-Ntx) questionnaire. The secondary outcome measures include numerical rating scale (NRS), vibration and light touch sense test, quality of life questionnaire-C30 of European Organization for Research and Treatment of Cancer (EQRTC) (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ).
Discussion: The study will compare acupuncture with sham acupuncture and will obtain evidence for utilizing acupuncture for chemotherapy induced peripheral neuropathy.
Multimodal cardio protective strategy in cardiac surgery (The PROCCARD trial): Study protocol for a multicenter randomized controlled trial
Authors: Chiari Pascal , Durand Michel , Desebbe Olivier , Fischer Marc-Olivier , Lena-Quintard Diane , Palao Jean-Charles , Mercier Catherine , Samson Géraldine , Varillon Yvonne , Pozzi Matteo , Mewton Nathan , Maucort-Boulch Delphine , Ovize Michel , Fellahi Jean-Luc 
Published: July 2019

Abstract
Background

Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing either with preconditioning or postconditioning or assessing a single aspect of cardioprotection showed conflicting results. We tested the hypothesis that a multimodal approach would improve cardioprotection and limit myocardial damage following cardiac surgery with cardiopulmonary bypass.

Methods

This study is a pragmatic multicenter (six French institutions), prospective, randomized, single-blinded, controlled trial. The randomization is stratified by centers. 210 patients scheduled for aortic valve surgery with or without coronary artery bypass grafting will be assigned to a control or a treated group (105 patients in each group). In the control group, patients receive total intravenous anesthesia with propofol and liberal intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 60 min, is greater than 180 mg/dl), as a standard of care. The treated group receives a bundle of care combining five techniques of cardioprotection: (1) Remote ischemic preconditioning applied before aortic cross-clamping; (2) Maintenance of anesthesia with sevoflurane; (3) Tight intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 30 min, is greater than 140 mg/dl); (4) Moderate respiratory acidosis (pH: 7.30) at the end of cardiopulmonary bypass; and (5) A gentle reperfusion protocol following aortic unclamping. The primary outcome is the myocardial damage measured by postoperative 72-h area under the curve of high-sensitive cardiac troponin I.

Discussion

The ProCCard study will be the first multicenter randomized controlled trial aiming to assess the role of a bundle of care combining several cardio protective strategies to reduce myocardial damage in patients undergoing cardiac surgery with cardiopulmonary bypass.
Fast Track Recovery Surgery with A Whey Protein Infused Carbohydrate Loading Drink Pre-Operatively and Early Oral Feeding Post-Operatively among Surgical Gynaecologic Cancer Patients: Study Protocol of an Open Labelled Randomised Controlled Trial
Authors: Ho Chiou Yi , Ibrahim Zuriati , Zaid Zalina Abu , Daud Zulfitri 'Azuan Mat , Yu Nor Baizura Md 
Published: July 2019

Abstract
Introduction: There has been growing evidence on the favourable outcomes of fast tract recovery (FTR) surgery; expedite recovery, minimise complications, reduce length of hospital stay on surgical patients. However, there is lack of evidence on the effectiveness of FTR in surgical gynaecologic cancer patients. Most of previous study did not focus on feeding composition in FTR surgery protocol. This study aims to determine the effectiveness of FTR feeding with whey protein infused carbohydrate loading drink pre-operatively and early oral feeding post-operatively on post-operative outcomes among surgical gynaecologic cancer patients.

Methods and analysis: This open labelled RCT will randomly allocate patients into intervention and control group. Ambulated Malaysian aged over 18 years and scheduled for elective surgery for (suspected) GC, will be included in this study. Intervention group will be given whey protein infused carbohydrate loading drinks evening before operation and 3 hours before operation as well as started on early oral feeding 4 hours post-operatively. Control group will be fasted overnight pre-operation and only allowed plain water, and the diet transition fashion is followed when there is bowel sound post-operatively. Primary outcomes of study are length of post-operative hospital stay, length of clear fluid toleration, solid food toleration and bowel function. Additional outcome measures are changes in nutritional status, biochemical profile and functional status. Data will be analysed on an intention-to-treat basis.

Trial Registration Number: ClinicalTrials.gov, NCT03667755. Registered 12 September 2018 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03667755
Combined use of apatinib mesylate and vinorelbine versus single use of vinorelbine in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial
Authors: Wu Shuo , Zhang Liang , Li Huan , Xu Junnan , Jiang Cui , Sun Tao 
Published: July 2019

Abstract
Background: The emergence of new molecular targeted drugs provides new prospects for the treatment of advanced breast cancer; the future therapeutic trend includes chemotherapy combined with molecular targeted therapy. Apatinib mesylate, a novel small anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase. Apatinib mesylate also blocks the signaling of vascular endothelial growth factor binding to its receptor, thereby, strongly inhibiting tumor angiogenesis and exerting an anti-tumor effect. However, a randomized controlled clinical trial of apatinib combined with vinorelbine for triple-negative breast cancer (TNBC) has not been reported. We attempted to compare the therapeutic effect of vinorelbine alone or in combination with apatinib mesylate for patients with recurrent or metastatic TNBC who have received at least two drug treatments with anthracyclines and taxanes.
Methods/analysis: This study is a triple-blind, randomized, placebo-controlled, parallel-group clinical trial. We plan to include 184 female patients with locally recurrent or metastatic TNBC admitted at the Liaoning Cancer Hospital & Institute, in Northeast China. All enrolled patients will be randomized to orally take vinorelbine alone (40 mg orally, thrice a week (Mondays, Wednesdays, and Fridays) in each 3-week cycle) or combined with apatinib mesylate (500 mg orally, once daily of each 3-week cycle). Radiographic assessment will be performed every 6 weeks for 36 weeks, and every 9 weeks thereafter. The primary outcome is measurement of progression-free survival and secondary outcomes include overall survival, disease control rate, objective response rate, and incidence of adverse events at grades 3 and 4 as defined by the National Cancer Institute Common Toxicity Criteria [NCI-CTC] Version 4.0. Outcome measures will be evaluated at baseline (< 2 weeks before starting treatment), every 6 weeks during treatment, and at 4 weeks and every 3 months after treatment discontinuation.
Discussion: Based on the data from this trial, we hope to identify a treatment plan that is suitable for female TNBC patients in Northeast China who have been treated with anthracyclines and taxanes.
Trial registration: ClinicalTrials.gov (identifier: NCT03932526). Registered on April 30, 2019.
Anais VIII Encontro de Pós-Graduação e V Encontro de Egressos do Mestrado em Odontologia da Universidade Ibirapuera (UNIB)
Authors: Shinohara Elio Hitoshi , Moreira Maria Stella 
Published: July 2019

EditorialCaro(a) Leitor(a)Em 11 de abril de 2019, aconteceu o VIII Encontro de Pesquisa e Bioética e V Jornada de Egressos do Mestrado em Odontologia da Universidade Ibirapuera (UNIB), um evento que contou com especialistas que discutiram questões científicas, éticas e metodológicas pertinentes à pesquisa científica, promovendo a atualização e aprofundamento no conhecimento para o desenvolvimento de pesquisas clínicas e laboratoriais, de boas práticas clínicas e rigor no delineamento metodológico. Além disso, foram abordados temas de interesse direto ao Programa de Mestrado em Ciências Odontológicas, como produção científica e a internacionalizaçãoParticiparam alunos de graduação envolvidos em TCC e iniciação científica, alunos de pós-graduação/egressos (stricto e latu sensu), profissionais vinculados ao ensino e pesquisa, professores da pós-graduação e graduação (áreas de saúde, exata e humanas).Prof. Dr. Elio Hitoshi Shinohara - PresidenteVIII Encontro de Pesquisa e Bioética - V Jornada dos Egressos do Mestrado em Odontologia
Quadrinhos, leitura e discurso da interdição em espaços oficiais de educação
Authors: Costa Felipe de Souza 
Published: July 2019

Este artigo tem por objetivo analisar as estratégias linguístico-discursivas que legitimaram, em espaços oficiais de educação, a interdição dos quadrinhos como uma prática de leitura. Para tanto, foi selecionado um capítulo do livro “Literatura Infanto-Juvenil”, publicado no ano de 1969, para compor o corpus da pesquisa resultante deste artigo. Tal obra fez parte da “Coleção Didática do Brasil”, cujos objetivos eram difundir e, de algum modo, prescrever princípios e práticas relativos a diversos temas que envolvessem a educação. De posse desse corpus, orientamo-nos pelas contribuições advindas da análise do discurso de linha francesa, sobretudo tendo como exponentes os estudos de Michel Pêcheux (2009 e 2015) acerca de memória e discurso. Guia-nos, neste artigo, a seguinte questão de pesquisa: quais estratégias linguístico-discursivas articulam leitura, quadrinhos e sanção? Finalmente, encontramos as análises que demonstram as seguintes estratégias linguístico-discursivas, com vistas à interdição dos quadrinhos: memória, interdiscurso, argumentação por autoridade, discurso científico e discurso oficial.
Palavras-chave: Análise do discurso. Quadrinhos. Discurso da interdição. Educação.
Complete Unsteady One-Dimensional Model of the Net Aortic Pressure Drop
Authors: Susin Francesca M. 
Published: July 2019

Background:
A large amount of engineering and medical research has been devoted to the assessment of aortic valve stenosis severity in the past decades. The net transvalvular pressure drop has been recognized as one of the parameters that better reflect stenosis effects on left ventricle overload, and its adoption in clinical assessment of stenosis has been proposed. Flow unsteadiness has been shown to have a non-negligible impact on the net drop; however, a simple formulation for net drop calculation that includes not only flow pulsatility but also the effects of valve dynamics is still lacking.

Objective:
The present contribution is hence aimed at developing a complete unsteady one-dimensional model of the net aortic transvalvular pressure drop that just requires non-invasive data to be implemented.

Methods:
Transvalvular flow is described as a jet of incompressible viscous fluid through a circular orifice placed in a concentric rigid circular tube. The classical one-dimensional mass and total head conservation equations are applied. The effective orifice area and transvalvular flow rate are assumed to vary with time throughout the ejection period.

Results:
The model is found to capture pressure drop oscillations occurring when the valve opens/closes and/or leaflets flutter, thanks to the inclusion of valve dynamics effects. The model is also proposed as a numerical tool for the calculation of the instantaneous effective orifice area once net pressure drop and flow rate are known.

Conclusion:
The model may contribute to the improvement of non-invasive aortic stenosis assessment.
In vitro Micro Propagation of Soybean (Glycine max) BARI-5 Variety
Authors: Begum Nadira , Zenat Elina A. , Sarkar Mohammad K.I. , K. Roy Chapol , Munshi John L. , A. Jahan Miskat A. 
Published: July 2019

Introduction:The present research work was undertaken with a view to developing a suitable protocol forin vitroplant regeneration of economically important plant (Glycine max) (Bangladesh Agricultural Research Institute BARI- 5) variety,viaboth direct and indirect organogenesis fromin vitrogrown seedlings.Methods:For micropropagation explants were cultured on MS and half strength Murashige and Skoog (MS) medium supplemented with various plant growth regulators (cytokinins and auxins). In the present study for inducting of callus, among 3 different hormone combinations, the suitable medium was 3.32 mg/L 2, 4-D containing MS medium and the callus was deep green in color. Different type of media like MS, 1/2 MS and MS with different (6-Benzyl Amino Purine) BAP concentration was used for seed germination ofGlycine max. 100% of seed germination was observed in MS +1 mg/L BAP containing the medium.Results:In the present investigation, different concentration of cytokinins and auxins{BAP, 2, 4-D, and Naphthalene Acetic Acid (NAA)} were used individually or in combinations with MS medium to observe their effect on multiple shoot regeneration from the cotyledonary nodal segment. 100% shoot formation from cotyledonary nodal segment was recorded in 1.5 mg/L BAP and 0.15 mg/L BAP + 0.025 mg/L NAA containing MS medium, the best number of shoot was 10.9±2.0 found in MS + 1.5 mg/L BAP containing medium and highest length of shoot was 2 cm recorded in 1.5 mg/L BAP + 0.3 mg/L (different concentrations of Giberrellic acid) GA3containing MS medium. In addition, for root inductionin vitroraised well developed and elongated shoots were excised and cultured on MS and 1/2 MS medium supplemented with various concentration of Indole-3-Butyric acid (IBA). It was observed that MS medium containing 0.1 mg/L IBA and 1/2 MS medium containing 0.25 mg/L IBA was optimal for root induction. In which 100% shoots rooted well within 13 days of culture. The highest average number of roots per shoot was 6 recorded in MS +0.5 mg/L IBA containing the medium and highest average length of root was 8 cm recorded in 0.1 mg/L IBA containing MS medium.Conclusion:The most effective surface sterilization treatment for explants ofGlycine maxhas been found in 0.1% HgCl2solution for 15 minutes.