bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment with the anti-IgE monoclonal antibody omalizumab in women with asthma undergoing fertility treatment: a proof-of-concept study—The PRO-ART study protocol
Authors: Tidemandsen Casper , Juul Gade Elisabeth , Ulrik Charlotte Suppli , Nielsen Henriette Svarre , Oxlund-Mariegaard Birgitte Sophie , Kristiansen Karsten , Freiesleben Nina La Cour , Nøhr Bugge , Udengaard Hanne , Backer Vibeke 
Published: November 2020

IntroductionAsthma is associated with prolonged time to pregnancy and a higher need for fertility treatment. However, the mechanism underlying this association remains incompletely understood. Previous research points to asthma-driven systemic inflammation also affecting the reproductive organs and thereby fertility. The aim of this study was to determine if treatment with omalizumab prior to fertility treatment will increase pregnancy rate among women with asthma by decreasing the systemic asthma-related inflammation and, by that, to provide insight into the underlying mechanisms.Methods and analysisThis is an ongoing prospective multicentre randomised controlled trial planned to enrol 180 women with asthma recruited from fertility clinics in Denmark. The patients are randomised 1:1 to either omalizumab or placebo. The primary endpoint is the difference in pregnancy rate confirmed with ultrasound at gestational week 7 of pregnancy. The secondary endpoints are change in sputum and blood eosinophil cell count, change in biomarkers, change in microbiota, together with rate of pregnancy loss, frequency of malformations, pre-eclampsia, preterm birth, birth weight, small for gestational age and perinatal death between groups.Ethics and disseminationThe methods used in this study are of low risk, but if successful, our findings will have a large impact on a large group of patients as infertility and asthma are the most common chronic diseases among the young population. The study has been approved by the Ethics Committee–Danish national research ethics committee (H-18016605) and the Danish Medicines Agency (EudraCT no: 2018-001137-41) and the Danish Data Protection Agency (journal number: VD-2018486 and I-Suite number 6745). The test results will be published regardless of whether they are positive, negative or inconclusive. Publication in international peer-reviewed scientific journals is planned.Trial registration numberNCT03727971.
Translating the Symptom Screening in Paediatrics Tool (SSPedi) into North American Spanish and Among Spanish-speaking children receiving cancer treatments: evaluating understandability and cultural relevance in a multiple-phase descriptive study
Authors: Plenert Erin , Grimes Allison , Sugalski Aaron , Langevin Anne-Marie , Nieto Dominica , Salaverria Carmen , Gomez Sergio , Gonzalez Gisela , D'Angelo Gisela , Dupuis Lee , Sung Lillian 
Published: November 2020

ObjectivesSymptom screening is important to achieving symptom control. Symptom Screening in Paediatrics Tool (SSPedi) is validated for English-speaking children. Objectives were to translate SSPedi into Spanish, and to evaluate the understandability and cultural relevance of the translated version among Spanish-speaking children with cancer and paediatric haematopoietic stem cell transplant recipients.MethodsWe conducted a multiphase, descriptive study to translate SSPedi into Spanish. The first step was to determine whether one Spanish version would be appropriate for both North America and Argentina. Once this decision was made, forward and backward translations were performed. The translated version was evaluated by Spanish-speaking children 8–18 years of age receiving cancer treatments.Primary and secondary outcome measuresPrimary outcome was child self-reported difficulty with understanding of the entire instrument and each symptom using a 5-point Likert scale. Secondary outcomes were incorrect understanding of SSPedi items identified by cognitive interviews with the children using a 4-point Likert scale and cultural relevance, which was assessed qualitatively.ResultsThis report focuses on North American Spanish as a separate version will be required for Argentinian Spanish SSPedi based on different common vocabulary and grammatical structure. There were 20 children from Toronto and San Antonio included in cognitive interviews. The most common types of Spanish spoken were Mexican (13, 65%), Central American (2, 10%) and South American (2, 10%). No child reported that it was hard or very hard to complete Spanish SSPedi. Changes to the instrument itself were not required based on understanding or cultural relevance.ConclusionsWe translated and finalised Spanish SSPedi appropriate for use in North America. Future research will translate and evaluate SSPedi for use in Argentina and other Spanish-speaking countries.
Which moral barriers and facilitators do physicians encounter in advance care planning conversations about the end of life of persons with dementia? A meta-review of systematic reviews and primary studies
Authors: Keijzer-van Laarhoven Angela JJM , Touwen Dorothea P , Tilburgs Bram , van Tilborg-den Boeft Madelon , Pees Claudia , Achterberg Wilco P , van der Steen Jenny T 
Published: November 2020

Importance and objectiveConducting advance care planning (ACP) conversations with people with dementia and their relatives contributes to providing care according to their preferences. In this review, we identify moral considerations which may hinder or facilitate physicians in conducting ACP in dementia.DesignFor this meta-review of systematic reviews and primary studies, we searched the PubMed, Web of Science and PsycINFO databases between 2005 and 30 August 2019. We included empirical studies concerning physicians’ moral barriers and facilitators of conversations about end-of-life preferences in dementia care. The protocol was registered at Prospero (CRD42019123308).Setting and participantsPhysicians and nurse practitioners providing medical care to people with dementia in long-term and primary care settings. We also include observations from patients or family caregivers witnessing physicians’ moral considerations.Main outcomesPhysicians’ moral considerations involving ethical dilemmas for ACP. We define moral considerations as the weighing by the professional caregiver of values and norms aimed at providing good care that promotes the fundamental interests of the people involved and which possibly ensues dilemmas.ResultsOf 1347 studies, we assessed 22 systematic reviews and 51 primary studies as full texts. We included 11 systematic reviews and 13 primary studies. Themes included: (1) beneficence and non-maleficence; (2) respecting dignity; (3) responsibility and ownership; (4) relationship and (5) courage. Moral dilemmas related to the physician as a professional and as a person. For most themes, there were considerations that either facilitated or hindered ACP, depending on physician’s interpretation or the context.ConclusionsPhysicians feel a responsibility to provide high-quality end-of-life care to patients with dementia. However, the moral dilemmas this may involve, can lead to avoidant behaviour concerning ACP. If these dilemmas are not recognised, discussed and taken into account, implementation of ACP as a process between physicians, persons with dementia and their family caregivers may fail.
Protocol for a case–control study of vitamin D status, adult multidrug-resistant tuberculosis disease and tuberculosis infection in Mumbai, India
Authors: Mistry Nerges , Hemler Elena C. , Dholakia Yatin , Bromage Sabri , Shukla Anupam , Dev Prachi , Govekar Laxmi , Tipre Pranita , Shah Daksha , Keshavjee Salmaan A. , Fawzi Wafaie W. 
Published: November 2020

IntroductionVitamin D status may be an important determinant of multidrug-resistant tuberculosis (MDR-TB) infection, progression to disease and treatment outcomes. Novel and potentially cost-effective therapies such as vitamin D supplementation are needed to stem the tide of TB and MDR-TB globally, particularly in India, a country that accounts for the largest fraction of the world’s TB incidence and MDR-TB incidence, and where vitamin D deficiency is endemic. While vitamin D has shown some promise in the treatment of MDR-TB, its role in the context of MDR-TB infection and progression to disease is largely unknown.Methods and analysisThrough a case–control study in Mumbai, India, we aim to examine associations between vitamin D status and active MDR-TB and to investigate vitamin D status and TB infection among controls. Cases are adult outpatient pulmonary patients with MDR-TB recruited from two public TB clinics. Controls are recruited from the cases’ household contacts and from non-respiratory departments of the facilities where cases were recruited. Cases and controls are assessed for serum 25-hydroxyvitamin D concentration, nutrient intake, diet quality, anthropometry and other relevant clinical and sociodemographic parameters. Controls undergo additional clinical assessments to rule out active TB and laboratory assessments to determine presence of TB infection. Statistical analysis investigates associations between vitamin D status and active MDR-TB and between vitamin D status and TB infection among controls, accounting for potential confounding effects of diet, anthropometry and other covariates.Ethics and disseminationThis study has been approved by Harvard T.H. Chan School of Public Health Institutional Review Board; Foundation for Medical Research Institutional Research Ethics Committee and Health Ministry’s Screening Committee of the Indian Council for Medical Research. Permission was granted by the Municipal Corporation of Greater Mumbai, India, a collaborating partner on this research. Outcomes will be disseminated through publication and scientific presentation.Trial registration numberNCT04342598.
Fibrosis-4 index as a predictor for mortality in hospitalised patients with COVID-19: a retrospective multicentre cohort study
Authors: Park Jung Gil , Kang Min Kyu , Lee Yu Rim , Song Jeong Eun , Kim Na Young , Kweon Young Oh , Tak Won Young , Jang Se Young , Lee Changhyeong , Kim Byung Seok , Hwang Jae Seok , Jang Byoung Kuk , Bae Jinmok , Lee Ji Yeon , Suh Jeong Ill , Park Soo Young , Chung Woo Jin 
Published: November 2020

ObjectiveThe reliable risk factors for mortality of COVID-19 has not evaluated in well-characterised cohort. This study aimed to identify risk factors for in-hospital mortality within 56 days in patients with severe infection of COVID-19.DesignRetrospective multicentre cohort study.SettingFive tertiary hospitals of Daegu, South Korea.Participants1005 participants over 19 years old confirmed COVID-19 using real-time PCR from nasopharyngeal and oropharyngeal swabs.MethodsThe clinical and laboratory features of patients with COVID-19 receiving respiratory support were analysed to ascertain the risk factors for mortality using the Cox proportional hazards regression model. The relationship between overall survival and risk factors was analysed using the Kaplan-Meier method.OutcomeIn-hospital mortality for any reason within 56 days.ResultsOf the 1005 patients, 289 (28.8%) received respiratory support, and of these, 70 patients (24.2%) died. In multivariate analysis, high fibrosis-4 index (FIB-4; HR 2.784), low lymphocyte count (HR 0.480), diabetes (HR 1.917) and systemic inflammatory response syndrome (HR 1.714) were found to be independent risk factors for mortality in patients with COVID-19 receiving respiratory support (all p<0.05). Regardless of respiratory support, survival in the high FIB-4 group was significantly lower than in the low FIB-4 group (28.8 days vs 44.0 days, respectively, p<0.001). A number of risk factors were also significantly related to survival in patients with COVID-19 regardless of respiratory support (0–4 risk factors, 50.2 days; 49.7 days; 44.4 days; 32.0 days; 25.0 days, respectively, p<0.001).ConclusionFIB-4 index is a useful predictive marker for mortality in patients with COVID-19 regardless of its severity.
Thromboelastography-guided blood transfusion during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy: study protocol for a prospective randomised controlled trial
Authors: Wang Shaoheng , Zhang Qing , Chen Linfeng , Liu Gang , Liu Peng fei 
Published: November 2020

IntroductionCytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) is a well-established treatment for peritoneal cancer (PC). However, this kind of combination therapy is associated with a high incidence of complications. Moreover, relative studies have indicated that traditional laboratory testing is insufficient to demonstrate the overall haemostatic physiology of CRS/HIPEC. Thromboelastography (TEG), administered by monitoring dynamic changes in haemostasis, has been shown to contribute to reducing transfusion requirements and improving survival. However, there is no evidence to verify whether TEG can be applied to guide transfusion strategies during CRS/HIPEC. Therefore, we aim to investigate whether TEG-guided blood product transfusion (TEG-BT) therapy is superior to traditional blood product transfusion (T-BT) therapy for guiding perioperative blood transfusion treatment and improving the prognosis of patients undergoing CRS/HIPEC.Methods and analysisThe TEG-BT versus T-BT study is a single-centre, randomised, blinded outcome assessment clinical trial of 162 patients with PC, aged 18–64 years and undergoing CRS/HIPEC. Participants will be randomly allocated to receive TEG-BT or T-BT. The primary outcome will be the evaluation of perioperative blood transfusion, which refers to the total amount of blood transfusion given from the time patients enter the operating room up to 72 hours postoperatively. The secondary outcomes will include the transfusion volume during surgery, total amount of intraoperative infusion, amount of blood lost during the operation, total blood transfusion between 0 and 72 hours after surgery, lowest haemoglobin level within 72 hours after surgery, intensive care unit duration, overall length of stay, total cost of hospitalisation and adverse events. Data will be analysed according to the intention-to-treat principle.Ethics and disseminationThe study protocol has been approved by the Scientific Research Ethics Committee of Beijing Shijitan Hospital Affiliated with Capital Medical University (Approval Number: sjtkyll-lx-2020-3). The results will be published in peer-reviewed journals.Trial registration numberChinese Clinical Trial Registry (ChiCTR2000028835).
Mapping mental health recovery tools developed by mental health service users and ex-users: protocol for a scoping review
Authors: Sampietro Hernán María , Carmona Viviana R , Rojo J Emilio , Gómez-Benito Juana 
Published: November 2020

IntroductionSince the emergence in 1997 of the Wellness Recovery Action Plan, a number of other tools developed by users and/or ex-users of mental health services have been published and implemented. All these tools aim to promote self-determination in mental health recovery processes. A scoping review will be carried out in order to (1) identify existing tools, (2) describe their distinctive characteristics and (3) examine how they have been implemented and evaluated.Methods and analysisThe scoping review will be guided by the methodological framework proposed by Arksey and O’Malley and expanded by Levacet al. It will involve, primarily, a literature search of the following electronic databases: Cochrane database, Cumulative Index to Nursing and Allied Health Literature, PsycInfo, PsycArticles, Scopus, PubMed and Web of Science. In addition, the search process will consider grey literature databases. Users, ex-users and survivors organisations and networks will be contacted in order to identify any relevant material. The reference lists of the articles identified through the literature search will be inspected. Finally, hand searches of journals will be conducted in order to increase the confidence in the search. Two main approaches will be used to present the charted data: a descriptive analysis and a thematic analysis. The study will be performed between April and December 2020. The results will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.Ethics and disseminationThis study does not require ethical approval because the data used are from publicly available materials. The study results will be disseminated through an article submitted for publication to a scientific journal and presented at relevant conferences. The results will also be shared in future workshops and seminars as part of continuing education programmes for mental health professionals.
Vaccination against RhoC induces long-lasting immune responses in patients with prostate cancer: results from a phase I/II clinical trial
Authors: Schuhmacher Juliane , Heidu Sonja , Balchen Torben , Richardson Jennifer Rebecca , Schmeltz Camilla , Sonne Jesper , Schweiker Jonas , Rammensee Hans-Georg , Thor Straten Per , Røder Martin Andreas , Brasso Klaus , Gouttefangeas Cécile 
Published: November 2020

BackgroundPeptide-based vaccination is a rational option for immunotherapy of prostate cancer. In this first-in-man phase I/II study, we assessed the safety, tolerability and immunological impact of a synthetic long peptide vaccine targeting Ras homolog gene family member C (RhoC) in patients with prostate cancer. RhoC is a small GTPase overexpressed in advanced solid cancers, metastases and cancer stem cells.MethodsTwenty-two patients who had previously undergone radical prostatectomy received subcutaneous injections of 0.1 mg of a single RhoC-derived 20mer peptide emulsified in Montanide ISA-51 every 2 weeks for the first six times, then five times every 4 weeks for a total treatment time of 30 weeks. The drug safety and vaccine-specific immune responses were assessed during treatment and thereafter within a 13-month follow-up period. Serum level of prostate-specific antigen was measured up to 26 months postvaccination.ResultsMost patients (18 of 21 evaluable) developed a strong CD4 T cell response against the vaccine, which lasted at least 10 months following the last vaccination. Three promiscuouslypresented HLA-class II epitopes were identified. Vaccine-specific CD4 T cells were polyfunctional and effector memory T cells that stably expressed PD-1 (CD279) and OX-40 (CD134), but not LAG-3 (CD223). One CD8 T cell response was detected in addition. The vaccine was well tolerated and no treatment-related adverse events of grade ≥3 were observed.ConclusionTargeting of RhoC induced a potent and long-lasting T cell immunity in the majority of the patients. The study demonstrates an excellent safety and tolerability profile. Vaccination against RhoC could potentially delay or prevent tumor recurrence and metastasis formation.Trial registration numberNCT03199872.
Racial and gender disparities in neurology
Authors: Saleem Sidra , Naveed Sadiq , Mohyud Din Chaudhary Amna , Zeshan Muhammad , Hafeez Dawood , Siddiqi Javed , Khosa Faisal 
Published: November 2020

ABSTRACTIntroductionThe USA is a diverse society with representation from different ethnic and racial backgrounds, resulting in under-represented minorities (URMs) in various specialties of medicine. Our objective was to find the statistical ratio of URMs in the academic faculty of neurology.MethodsThis was a retrospective analysis of the American Association of Medical College database. The database covered neurology faculty members from 2006 to 2017.ResultsThis study shows a significant change in racial representation in faculty ranks over the last 12 years. At chairperson rank, white people decreased from 86.4% to 79.8% whereas Asian, Hispanic and multiple races (non-Hispanic) simultaneously increased from 6.4% to 9.3%, 0.9% to 3.1% and 1.8% to 4.7%, respectively. At the professor rank, white people decreased from 87.4% to 81.6%, while Asians and Hispanics increased from 7.1% to 10.5% and from 0.7% to 2.1%, respectively. At the rank of associate professor, white people decreased from 81.1% to 68.3% whereas Asians, Hispanics and unknown races increased from 10.3% to 19.0%, 1.6% to 3.1% and from 2.1% to 3.5%, respectively. For the rank of assistant professor, white people decreased from 64.7% to 56.9% and Asians increased from 20.5% to 25.9%. Gender differences (men vs women) for the ranks of chairperson, professor, associate professor, assistant professor and instructors were 90.3% and 9.7%, 83.1% and 16.9%, 67.1% and 32.9%, 56.8% and 43.2%, and 48.1% and 51.9%, respectively.ConclusionOver a period of 12 years the racial proportion in academic neurology has changed, but it is not proportionate to their respective increase in the population of the USA. Moreover, the portion of female faculty increased, but they are still under-represented in leadership roles. This racial and gender disparity can be addressed by well-planned interventions.
Caudal inferior alveolar nerve block in a Bennett’s wallaby (Macropus rufogriseus)
Authors: Ho Nicola Tian Zhi , Morgan Rhiannon Emma , Bolt David M , Hawkins Alexander Eric , Veres‐Nyéki Kata Orsolya 
Published: November 2020

A Bennett’s wallaby (Macropus rufogriseus) was referred for diagnostic imaging and further investigation into suspected progressive pyogranulomatous osteomyelitis of the mandible. This diagnosis was confirmed via CT and CT‐guided fine‐needle biopsies of the right mandible, and surgery was performed to remove the affected teeth and treat the associated bone.The right inferior alveolar nerve was targeted using a lateral approach with the needle directed medially in a rostro‐ventral direction into the masseteric foramen using bupivacaine hydrochloride 0.6 mg/kg.To the authors’ knowledge, the inferior alveolar nerve block has never been reported in this species, and the lateral approach via the masseteric foramen is novel, considering that the nerve is usually targeted at the medial aspect of the mandible.Surgical treatment of pyogranulomatous osteomyelitis is likely to be associated with significant pain, and the use of a locoregional technique to provide regional anaesthesia would complement the provision of balanced, multimodal anaesthesia.