bluuebunny/crossref_metadata_2025_split huggingface dataset:
Dose escalation of preoperative short-course radiotherapy followed by neoadjuvant chemotherapy in locally advanced rectal cancer: protocol for an open-label, single-centre, phase I clinical trial
Authors: Zhang Meng-xia , Li Xiao-bo , Guan Bing-jie , Guan Guo-xian , Lin Xiao-yan , Wu Xiao-dong , Chi Pan , Xu Ben-hua 
Published: March 2019

IntroductionPreoperative radiotherapy followed by total mesorectal excision with adjuvant chemotherapy has been recommended as the preferred treatment method for locally advanced rectal cancer (LARC). Similar rates of local control, survival and toxicity were observed in preoperative long-course chemoradiotherapy (LCRT) (45–50.4 Gy in 25–28 fractions) and in short-course radiotherapy (SCRT) with 25 Gy over five fractions. Both regimens lower the local recurrence rates compared with that of surgery followed by postoperative radiotherapy. With the simplicity and lower cost of SCRT, a growing number of patients have been receiving SCRT as preoperative radiotherapy. However, the currently established SCRT (25 Gy over five fractions) followed immediately by surgery resulted in poor downstaging and sphincter preservation rate. The pathological complete response (pCR) rate is also markedly lower with SCRT than with LCRT (0.7%vs16%). Several studies recommended SCRT with delayed surgery for more than 4 weeks with expectation of improved pathological outcomes and fewer postoperative complications. While a number of clinical trials demonstrated a persistently better overall local control with SCRT than with LCRT, overall survival advantage has not been observed. Since survival is mainly depended on distant metastases, efforts should be made towards more effective pathological response and systemic treatment. Given the apparent advantages of SCRT, we aimed to establish a dose escalation of SCRT and sequential modified FOLFOX6 (mFOLFOX6) as preoperative therapy for LARC with objectives of achieving an optimal balance of safety, cost effectiveness and clinical outcome, and to support further investigation of this regimen in a phase II/III setting.MethodsIn this phase I study, three dose levels (6Gy×5F, 7Gy×5F, 8Gy×5F to gross tumour volume, while keeping the rest of irradiated volume at 5Gy×5) of SCRT followed by four cycles of mFOLFOX6 chemotherapy as neoadjuvant therapy will be tested by using the traditional 3+3 design. The pCR rate, R0 resection rate, sphincter preservation rate and treatment related toxicity will be assessed.Ethics and disseminationThe study protocol was approved by the Ethics Committee of Fujian Medical University Union Hospital (No. 2017YF020-02) and all participants provided written informed consent. Results from our study will be disseminated in international peer-reviewed journals. All study procedures were developed in order to assure data protection and confidentiality.Trial registration numberNCT03466424; Pre-results.
Haemorheological and haemostatic alterations in coeliac disease and inflammatory bowel disease in comparison with non-coeliac, non-IBD subjects (HERMES): a case–control study protocol
Authors: Szakács Zsolt , Csiszár Beáta , Kenyeres Péter , Sarlós Patrícia , Erőss Bálint , Hussain Alizadeh , Nagy Ágnes , Kőszegi Balázs , Veczák Ibolya , Farkas Nelli , Bódis Emőke , Márta Katalin , Szentesi Andrea , Tőkés-Füzesi Margit , Berki Tímea , Vincze Áron , Tóth Kálmán , Hegyi Péter , Bajor Judit 
Published: March 2019

IntroductionHaemorheological and haemostatic changes predispose to the development of arterial and venous thrombotic events; however, limited information is available on the status of these changes in coeliac disease (CeD) and inflammatory bowel disease (IBD). In this study, we aim to describe the haemorheological and haemostatic profiles of CeD and IBD patients in a Hungarian cohort of patients to investigate whether any alterations contribute to elevated thrombotic risk.Methods and analysisThis is a case–control study involving newly diagnosed and followed CeD and IBD patients with age-matched and sex-matched non-CeD, non-IBD subjects with an allocation ratio of 1:1:1.After informed consent is obtained, a detailed medical history will be collected, including venous and arterial thrombotic risk factors and medications. Symptoms in CeD patients will be assessed with the Gastrointestinal Symptoms Rating Scale, and disease activity in IBD patients will be determined by disease-specific scores. Dietary adherence will be assessed among CeD patients with a thorough interview together with a measurement of self-reported adherence, dietary knowledge and urine analysis (detection of gluten immunogenic peptides). In addition to routine laboratory parameters, haemorheological (ie, erythrocyte deformability and aggregation, viscosity of whole blood and plasma) and haemostatic parameters (eg, protein C, protein S and antithrombin) with immunological indicators (ie, coeliac-specific serology and antiphospholipid antibodies) will be measured from venous blood for every participant.Primary and secondary outcomes will be haemorheological and haemostatic parameters, respectively. Univariate and multivariate statistics will be used to compare CeD and IBD patients to control subjects. Subgroup analysis will be performed by disease type in IBD, (Crohn’s disease and ulcerose colitis), dietary adherence in CeD, and disease activity in IBD and CeD.Ethics and disseminationThe study was approved by the Regional and Local Research Ethics Committee, University of Pécs (Ref. No. 6917). Findings will be disseminated at research conferences and in peer-reviewed journals.Trial registration numberISRCTN49677481.
Promoting physical activity in vulnerable adults ‘at risk’ of homelessness: a randomised controlled trial protocol
Authors: Stringer Charlotte , Loosemore Mike , Moller Eloise , Jackson Sarah E , López-Sánchez Guillermo Felipe , Firth Joseph , Johnstone James , Stubbs Brendon , Vancampfort Davy , Smith Lee 
Published: March 2019

IntroductionPeople who are homeless, or at risk of homelessness, have substantially poorer health. Sustained and regular participation in physical activity is beneficial for both mental and physical health. Limited data suggest that levels of physical activity in the homeless and those at risk of homelessness are low, and access to community-based exercise is limited or non-existent for this population. Nonetheless, exercise programmes for the homeless could provide a feasible and scalable intervention for providing beneficial effects on physical and mental health in this population. The primary aim of this study is to evaluate the impact of a group exercise intervention on activity levels in people who are homeless or at risk of homelessness in central London, UK. The secondary aim is to evaluate the impact of the intervention on mental and physical health outcomes.Method and analysisA 2-arm, individually randomised controlled trial in people who are homeless and those vulnerable and at risk of homelessness in central London, UK. Participants will be recruited through a London-based homeless charity, Single Homeless Project. Following baseline assessments and allocation to intervention (exercise classes) or control (usual care), participants will be followed up at 3, 6, 9 and 12 months. The primary outcomes will be change in objective physical activity. The secondary outcomes will include change in fitness assessments and mental health parameters. Changes in drug use and alcohol dependency will also be explored.Ethics and disseminationEthical approval to process and analyse data and disseminate findings was obtained through the Anglia Ruskin University Department of Sport and Exercise Sciences Research Ethics Committee. Results of this study will be disseminated through peer-reviewed publications and scientific presentations.
The influence of complexity: a bibliometric analysis of complexity science in healthcare
Authors: Churruca Kate , Pomare Chiara , Ellis Louise A , Long Janet C , Braithwaite Jeffrey 
Published: March 2019

ObjectivesTo analyse trends in the academic literature applying complexity science to healthcare, focusing specifically on bibliometric characteristics and indicators of influence.DesignThis study reports a bibliometric analysis via a systematic search of the academic literature applying complexity science to healthcare.MethodA search of four academic databases was performed on 19 April 2018. Article details were downloaded and screened against inclusion criteria (peer-reviewed journal articles applying complexity science to healthcare). Publication and content data were then collected from included articles, with analysis focusing on trends over time in the types and topics of articles, and where they are published. We also analysed the influence of this body of work through citation and network analyses.ResultsArticles on complexity science in healthcare were published in 268 journals, though a much smaller subset was responsible for a substantial proportion of this literature. USA contributed the largest number of articles, followed by the UK, Canada and Australia. Over time, the number of empirical and review articles increased, relative to non-empirical contributions. However, in general, non-empirical literature was more influential, with a series of introductory conceptual papers being the most influential based on both overall citations and their use as index references within a citation network. The most common topics of focus were health systems and organisations generally, and education, with recent uptake in research, policy, and change and improvement.ConclusionsThis study identified changes in the types of articles on complexity science in healthcare published over time, and their content. There was evidence to suggest a shift from conceptual work to the application of concrete improvement strategies and increasingly in-depth examination of complex healthcare systems. We also identified variation in the influence of this literature at article level, and to a lesser extent by topic of focus.
Standardising practice in cardiology: reducing clinical variation and cost at Ochsner Health System
Authors: Oravetz Phil , White Christopher J , Carmouche David , Swan Nicole , Donaldson Josh , Ruhl Russel , Valdenor Czarlota , Paculdo David , Tran Mary , Peabody John 
Published: March 2019

ObjectiveLow quality and unwarranted clinical variation harm patients and increase unnecessary costs. Effective approaches to improve clinical and economic value have been difficult. The Ochsner Health System looked to improve clinical care quality and reduce unnecessary costs in cardiology using active measurement and customised feedback.MethodsWe serially measured care decisions using online, simulated cases to capture clinical details of cardiology practice and provide individual feedback. Fifty cardiologists cared for two simulated patients in each of six assessment rounds occurring 4 months apart. Simulated patients presented with heart failure (HF), coronary artery disease (CAD), supraventricular tachyarrhythmia (SVT) or valvular heart disease. Using Ochsner’s patient-level data, we performed real-world pre–post analyses of physician practice changes, patient outcomes and costs.ResultsBetween baseline and final rounds, overall simulated quality-of-care scores improved 14.1% (p<0.001). In the same period, we found cost-of-care variation decreased in patient-level data, with larger decreases for more severely ill patients. The total per-patient direct costs decreased $493 in SVT, $305 in HF and $55 in CAD (p<0.05 for SVT and HF). Readmission rates fell significantly for HF (from 20.0% to 11.9%) and SVT (from 14.5% to 7.8%) (both p<0.001) and non-significantly for CAD (from 13.7% to 11.3%, p=0.112). The cost avoidance/revenue generation opportunity from reduced readmissions and direct costs amounted to annual savings of $4.34 million, with no significant changes to in-hospital mortality rates (p>0.05).ConclusionsUsing simulated patients to serially measure and provide individual feedback on clinical practice significantly raises quality and reduces practice variation and costs without negatively impacting outcomes.
Redefining Treatment Paradigms in First-line Advanced Non–Small-Cell Lung Cancer
Authors: Heigener David F. , Kerr Keith M. , Laing Gavin M. , Mok Tony S.K. , Moiseyenko Fedor V. , Reck Martin 
Published: March 2019

Abstract
Metastatic non–small-cell lung cancer is still a devastating disease; however, treatment options have diversified dramatically in the past two decades. From unselected platinum-based chemotherapy for all patients, several different treatment groups have evolved, that is, those with “druggable” targets, those with a promising immune signature, and those without any predicting factors outlined in this article. Challenge includes the intersections between these groups and the optimal treatment path. These issues will be addressed in this review.
Ефективність хірургічних методів лікування гастродуоденальних виразкових кровотеч на тлі коморбідного цукрового діабету
Authors: Samoylenko H. Ie. , Gmoshynsky M. V. , Syniachenko O. V. 
Published: March 2019

Мета роботи: проаналізувати результати різних методів хірургічного лікування гастродуоденальних кровотеч на тлі коморбідного цукрового діабету (ЦД), виділити прогностичні критерії.
Матеріали і методи. Прооперовано 319 хворих із виразковими гастродуоденальними кровотечами з подальшим проведенням гемостатичної медикаментозної терапії, які склали основну групу спостереження. В групу порівняння увійшли 623 хворих, що отримували тільки аналогічне медикаментозне лікування. Коморбідний ЦД діагностовано у 15 % з числа хворих основної групи і 18 % групи порівняння. 34 % прооперованих пацієнтів мали виразки шлунка, 58 % – виразки дванадцятипалої кишки, інші 9 % – їх поєднання. Середній вік хворих склав 49 років, тривалість маніфестації захворювання – 7 років, тривалість кровотечі – 44 години, індекс тяжкості хвороби – 6 в. о., тяжкість кровотечі – 2,5 бала.
Результати досліджень та їх обговорення. Коморбідний ЦД визначає більш виразну тяжкість виразкових гастродуоденальних кровотеч, більшу частоту його струминного характеру, постінкового підтікання крові з виразок та розвиток геморагічного шоку перед початком хірургічного лікування, є чинником ризику рецидивів кровотеч у післяопераційному періоді й значно погіршує виживаність хворих, а до операцій вибору у таких пацієнтів із ЦД належать вирізання виразок із паралельним застосуванням симпатичної проксимальної ваготонії, резекції за Більротом-1 і Баррі–Хіллом, причому початковий рівень глікозованого гемоглобіну більше 9 % має прогностичну значущість відносно недостатньої ефективності подальших хірургічних заходів. У контексті прогностичного критерію рецидивів гастродуоденальних виразкових кровотеч у хворих з коморбідним ЦД після виконаних хірургічних втручань рекомендується використовувати показник інсулінорезистентності понад 30 в. о., а прогнознегативним критерієм відносно життя хворих є рівень глікемії більше 17 ммоль/л.
Особливості ультраструктурної перебудови нейроцитів головного мозку після стенозу аорто-клубового сегмента в щурів
Authors: Havryshchuk Yu. M. , Herasymiuk I. Ye. , Genyk T. R. 
Published: March 2019

Мета работы: встановити особливості ультраструктурних змін у нейроцитах головного мозку щурів після стенозу аортоклубового сегмента.
Матеріали і методи. Експерименти проведено на 18 статевозрілих білих лабораторних щурах-самцях, з них 3 тварини склали контрольну групу а іншим 15 щурам під кетаміновим знеболенням здійснювали звуження черевного відділу аорти безпосередньо над її біфуркацією на 2/3 діаметра. Матеріал для електронно-мікроскопічних досліджень забирали через 1, 3, 7, 14 і 28 діб після операції згідно з загальноприйнятою методикою.
Результати дослідження та їх обговорення. Проведене електронно-мікроскопічне дослідження нейроцитів кори півкуль головного мозку щурів після експериментального стенозу каудального відділу черевної аорти свідчить про етапність їх морфофункціональної перебудови на тлі ремоделювання гемомікроциркуляторної ланки органного кровоносного русла у динаміці яких можна виділити такі періоди: альтерації (посилення інвагінацій каріолеми, локальні порушення чіткості структурної організації ядерних мембран, нерівномірне розширення і фрагментація канальців ендоплазматичної сітки, зменшення на її мембранах кількості рибосом, збільшення розмірів цистерн комплексу Гольджі, гіпертрофія мітохондрій з одночасним просвітлення матриксу та деструкцією їх крист) – безпосередньо після стенозування і до 3-ї доби спостереження; адаптаційно-компенсаторних змін – з 3-ї по 7-му добу експерименту із стабілізацією морфофункціонального стану гемомікроциркуляторного русла (на тлі зменшення повнокрів’я гемокапілярів покращення ультраструктурної організаціїї нейроцитів: конденсовані грудочки гетерохроматину розташовувалися у різних ділянках ядра, а також біля каріолеми, у нейроплазмі значна кількість рибосом і полісом, у цитоплазмі гіпертрофовані мітохондрії з чіткими кристами та вогнищево просвітленим матриксом, канальці ендоплазматичної сітки та цистерни комплексу Гольджі лише помірно розширеними; відновні – з 14-ї по 28-му добу спостереження із зворотним розвитком альтераційних змін і суттєвим, однак не повним відновленням вихідного стану структур головного мозку.
Early diagnosis of infected acute necrotising pancreatitis
Authors: Banadyga A. I. , Dzyubanovsky I. Ya. 
Published: March 2019

The aim of the work: to determine criteria for early diagnosis of infected acute necrotising pancreatitis.
Materials and Methods. The study was based on complex treatment of acute pancreatitis (AP) in 63 patients, who were divided into two groups: group I – with severe and critical AP (n=31) and group II – with light and medium severity rate of AP (n=32). All required laboratory and instrumental methods were made and some special, particularly the procalcitonin levels in the blood serum (group I). Determination of prognostic parameters was made through correlation analysis of all clinical parameters. The attention was paid to statistically significant factors that correlate ratio not lower than 0.7 (strong correlation).
Results and Discussion. The level of procalcitonin in blood > 3.7 ng/ml in first study group was those factor that showed the risk of developing more severe stage of pancreatitis with complications. Procalcitonin should be used as a marker of infected acute necrotic pancreatitis (ANP) in combination with other parameters of inflammation, which helps to choose the correct treatment.
Induction chemoradiation is associated with improved survival in chest wall invasion lung cancer
Authors: Muñoz-Largacha Juan A , Rao Sowmya R , Brinckerhoff Laurence H , Daly Benedict D , Fernando Hiran C , Litle Virginia R , Suzuki Kei 
Published: March 2019

Objective: To determine if induction chemotherapy with concurrent high-dose radiation followed by resection is associated with improved survival in patients with nonsuperior sulcus lung cancer with chest wall invasion. Methods: We performed a retrospective review of clinical T3 (chest wall invasion) N0/N1 patients with non-small cell lung cancer who underwent surgical resection between January 1, 1992, and January 31, 2017. Exclusion criteria included superior sulcus tumors and resection performed for palliation/recurrence. Patients undergoing induction chemoradiation followed by surgical resection were compared to those undergoing resection first or those receiving induction radiation followed by resection. Overall survival was calculated using the Kaplan-Meier method. Results: Thirty-four patients were included in the analysis, with 5-year overall survival (OS) of 30%. By clinical stage, 31 (91%) were IIB (T3N0) and 3 (9%) were IIIA (T3N1). Sixteen patients (47%) received induction chemoradiation before surgery. Of the remaining 18 patients, 5 (15%) received induction radiation followed by surgery, and 13 (38%) underwent surgery as the first treatment. Three patients belonging to the group not receiving induction chemoradiation died within 30 days after surgery and were excluded from survival analysis. In the remaining 31 patients, induction chemoradiation was associated with improved 5-year OS (53% for induction chemoradiation vs 7% for others; P<0.01). Disease recurrence was evident in 9 cases, 2 (12.5%) in the induction chemoradiation group and 7 (46.6%) in the others (median disease-free time 103.0 months for induction chemoradiation group vs 8.0 months for others; P<0.01). Conclusion: In patients with nonsuperior sulcus lung cancer with chest wall invasion, induction chemoradiation therapy followed by resection is associated with improved OS.
Deltoid-Spring Ligament Reconstruction in Adult Acquired Flatfoot Deformity With Medial Peritalar Instability
Authors: Brodell James D. , MacDonald Ashlee , Perkins James A. , Deland Jonathan T. , Oh Irvin 
Published: March 2019

Background: A spring ligament tear is commonly present in advanced stages of adult acquired flatfoot deformity (AAFD). Previous anatomic studies have demonstrated that the superficial deltoid ligament blends with the superomedial spring ligament, forming the tibiocalcaneonavicular ligament (TCNL). Adding allograft TCNL reconstruction to osseous correction has been suggested to augment medial peritalar stability in advanced AAFD with large spring ligament tears. We aimed to investigate the clinical and radiographic outcomes of TCNL reconstruction for flexible AAFD with medial peritalar instability. Methods: Fourteen feet in 12 patients who underwent osseous and TCNL reconstructions for advanced AAFD (stage IIB with large spring ligament tears or stage IV) were recruited for the study. The mean postoperative follow-up was 24 (range, 12-33) months. Pre- and postoperative clinical outcomes were assessed by the Foot and Ankle Ability Measure (FAAM), SF-36, and Patient-Reported Outcomes Measurement Information System (PROMIS). Correction of forefoot abduction and the sagittal arch were measured from pre- and postoperative weightbearing radiographs. Results: The FAAM Activities of Daily Living improved from 69.3 to 90.1 ( P = .001). The SF-36 Physical Function (PF) and Pain subscales both improved significantly (39.4 to 87.8 and 44.6 to 93.1, respectively, P < .001 for each). The PROMIS PF improved from 38.2 to 46.8 ( P = .002) and the PROMIS Pain Interference (PI) from 62.6 to 50.1 ( P = .003). Radiographic measures showed an improved anterior-posterior (AP) talo–first metatarsal angle of 24.7 to 11.8 degrees ( P < .001) and talonavicular coverage angle of 47.4 to 23.1 degrees ( P < .01). An improved Meary’s angle of 29.7 to 12.5 degrees ( P < .001) and a calcaneal pitch angle of 11.7 to 16.9 degrees ( P = .14) were noted in the lateral view. Conclusion: Considering the anatomic characteristics of the deltoid-spring ligament complex, TCNL reconstruction may play a significant role in maintaining peritalar stability when performed with osseous correction. Deltoid-spring ligament (TCNL) reconstruction is a viable surgical option for those with advanced stage AAFD with medial peritalar instability that leads to improved functional and radiographic outcomes. Level of Evidence: Level IV, retrospective case series.