bluuebunny/crossref_metadata_2025_split huggingface dataset:
Innovative cardiovascular primary prevention population-based strategies: a 2-year hybrid type 1 implementation randomised control trial (RCT) which evaluates behavioural change conducted by community champions compared with brief advice only from the SPICES project (scaling-up packages of interventions for cardiovascular disease prevention in selected sites in Europe and sub-Saharan Africa)
Authors: Le Goff Delphine , Barais Marie , Perraud Gabriel , Derriennic Jeremy , Aujoulat Paul , Guillou-Landreat Morgane , Le Reste Jean Yves 
Published: July 2021

Abstract
Background
Cardiovascular diseases (CVD) caused 17.9 million deaths worldwide in 2016, being the world’s leading cause of death. Prevention of CVD in high-income countries is expensive and fails to reach the population at risk. In low-income countries, it is under-developed. The SPICES project implements a community-based program to improve CVD prevention in 3 European countries and 2 Sub-Saharan countries, based on using community champions to effect behavioural changes. In France, the project operates in “Pays Centre Ouest Bretagne” (COB) which is the Central West Brittany area, and a vulnerable, rural setting. The aim of this study is to assess this innovative prevention strategy versus brief advice.

Methods
A two-step RCT hybrid type 1 implementation study will first of all screen a population using the Non-Laboratory INTERHEART Score (NL-IHRS) and will involve health-care students at public events in the COB area until 1000 participants have been recruited. Second, a RCT will be carried out. The research team will contact each participant with an intermediate NL-IHRS in order to include them. Participants will be over 18 years of age and work or live in the COB area. Participants will be equally randomised in two groups. The intervention group will receive brief advice plus behavioural change guidance carried out by community champions. The control group will receive brief advice only. The main objective for the RCT is to assess a difference of at least 15% in the NL-IHRS between the two groups after 24 months. The primary outcome will be analysed with intention to treat. Secondary outcomes for the RCT will be assessed using validated questionnaires: the WHOQOL-BREF, the DASH Q questionnaire, the IPAQ-short; smoking level will be assessed according to the NL-IHRS scoring system; a modified self-declared alcohol consumption questionnaire has been developed and gauges will be used to assess BMI. The implementation strategy will use mixed methods: qualitative research methods and quantitative epidemiological studies.

Discussion
A difference in the mean NL-IHRS of 15% will provide an argument in favour of reorganising prevention policies. A substantial change would favour relocating primary prevention from healthcare professionals to lay people and the community.

Trial registration
Clinical Trials NCT03886064 - the study was recorded on ClinicalTrials.gov, the 22nd of March 2019.
Construct validity of the Suboptimal Health Status Questionnaire-25 in a Ghanaian population
Authors: Adua Eric , Afrifa-Yamoah Ebenezer , Frimpong Kwasi , Adama Esther , Karthigesu Shantha P. , Anto Enoch Odame , Aboagye Emmanuel , Yan Yuxiang , Wang Youxin , Tan Xuerui , Wang Wei 
Published: July 2021

AbstractBackgroundThe Suboptimal Health Status Questionnaire-25 (SHS-Q-25) developed to measure Suboptimal Health Status has been used worldwide, but its construct validity has only been tested in the Chinese population. Applying Structural Equation Modelling, we investigate aspects of the construct validity of the SHS-Q-25 to determine the interactions between SHS subscales in a Ghanaian population.MethodsThe study involved healthy Ghanaian participants (n = 263; aged 20–80 years; 63% female), who responded to the SHSQ-25. In an exploratory factor and parallel analysis, the study extracted a new domain structure and compared to the established five-domain structure of SHSQ-25. A confirmatory factor analysis (CFA) was conducted and the fit of the model further discussed. Invariance analysis was carried out to establish the consistency of the instrument across multi-groups.ResultsThe extracted domains were reliable with Cronbach’s$$\alpha$$αof 0.846, 0.820 and 0.864 respectively, for fatigue, immune-cardiovascular and cognitive. The CFA revealed that the model fit indices were excellent$$\left( {{\text{RMSEA}} = 0.049~ < ~0.08,\,{\text{CFI}} = 0.903 > 0.9,\,{\text{GFI}} = 0.880 < 0.9,\,{\text{TLI}} = 0.907 > 0.9} \right)$$RMSEA=0.049<0.08,CFI=0.903>0.9,GFI=0.880<0.9,TLI=0.907>0.9. The fit indices for the three-domain model were statistically superior to the five-domain model. There were, however, issues of insufficient discriminant validity as some average variance extracts were smaller than the corresponding maximum shared variance. The three-domain model was invariant for all constrained aspects of the structural model across age, which is an important risk factor for most chronic diseases.ConclusionThe validity tests suggest that the SHS-Q25 can measure SHS in a Ghanaian population. It can be recommended as a screening tool to early detect chronic diseases especially in developing countries where access to facilities is diminished.
Aiming for quality: a global compass for national learning systems
Authors: Sarakbi Diana , Mensah-Abrampah Nana , Kleine-Bingham Melissa , Syed Shams B. 
Published: July 2021

Abstract
Introduction
Transforming a health system into a learning one is increasingly recognized as necessary to support the implementation of a national strategic direction on quality with a focus on frontline experience. The approach to a learning system that bridges the gap between practice and policy requires active exploration.

Methods
This scoping review adapted the methodological framework for scoping studies from Arksey and O’Malley. The central research question focused on common themes for learning to improve the quality of health services at all levels of the national health system, from government policy to point-of-care delivery.

Results
A total of 3507 records were screened, resulting in 101 articles on strategic learning across the health system: health professional level (19%), health organizational level (15%), subnational/national level (26%), multiple levels (35%), and global level (6%). Thirty-five of these articles focused on learning systems at multiple levels of the health system. A national learning system requires attention at the organizational, subnational, and national levels guided by the needs of patients, families, and the community. The compass of the national learning system is centred on four cross-cutting themes across the health system: alignment of priorities, systemwide collaboration, transparency and accountability, and knowledge sharing of real-world evidence generated at the point of care.

Conclusion
This paper proposes an approach for building a national learning system to improve the quality of health services. Future research is needed to validate the application of these guiding principles and make improvements based on the findings.
Cost-effectiveness analysis of neoadjuvant versus adjuvant chemotherapy for cT2-4N0-1 non-small cell lung cancer patients during initial treatment phase
Authors: Wu Dongdong , Li Juan , Wang Yubo , Huang Hao , Huang Chunji 
Published: July 2021

AbstractObjectiveThe choice between neoadjuvant chemotherapy (NAC) and adjuvant chemotherapy (AC) remains controversial in the treatment of non-small cell lung cancer (NSCLC). There is no significant difference in NAC and AC’s effectiveness. We investigate the cost-effectiveness of NAC versus AC for NSCLC.MethodA decision tree model was designed from a payer perspective to compare NAC and AC treatments for NSCLC patients. Parameters included overall survival (OS), surgical complications, chemotherapy adverse events (AEs), treatment initiation probability, treatment time frame, treatment cost, and quality of life (QOL). Sensitivity analyses were performed to characterize model uncertainty in the base cases.ResultAC treatment strategy produced a cost saving of ¥3064.90 and incremental quality-adjusted life-years (QALY) of 0.10 years per patient with the same OS. NAC would be cost-effective at a ¥35,446/QALY threshold if the median OS of NAC were 2.3 months more than AC. The model was robust enough to handle variations to all input parameters except OS. In the probability sensitivity analysis, AC remained dominant in 54.4% of simulations.ConclusionThe model cost-effectiveness analysis indicates that with operable NSCLC, AC treatment is more cost-effective to NAC. If NAC provides a longer survival advantage, this treatment strategy may be cost-effective. The OS is the main factor that influences cost-effectiveness and should be considered in therapeutic regimes.
Construction of an infectious clone of Zika virus stably expressing an EGFP marker in a eukaryotic expression system
Authors: Gao Jing , Chen Jiayi , Lu Weizhi , Cai Jintai , Shi Linjuan , Zhao Wei , Zhang Bao 
Published: July 2021

Abstract
Background
Zika virus is becoming one of the most widely transmitted arboviruses in the world. Development of antiviral inhibitor and vaccine requires an experimental system that allows rapid monitoring of the virus infection. This is achievable with a reverse genetic system. In this study, we constructed an infectious clone for Zika virus that stably expressing EGFP.

Methods
A PCR-mediated recombination approach was used to assemble the full-length Zika virus genome containing the CMV promoter, intron, EGFP, hepatitis delta virus ribozyme, and SV40 terminator sequence for cloning into the pBAC11 vector to produce recombinant pBAC-ZIKA-EGFP. ZIKA-EGFP virus was rescued by transfection of pBAC-ZIKA-EGFP into 293T cells. The characterization of ZIKA-EGFP virus was determined by qPCR, plaque assay, CCK-8, and Western blot.

Results
Rescued ZIKA-EGFP virus exhibited stable replication for at least five generations in tissue culture. ZIKA-EGFP can effectively infect C6/36, SH-SY5Y and Vero cells, and cause cytopathic effects on SH-SY5Y and Vero cells. The inhibition of ZIKA-EGFP by NF-κB inhibitor, caffeic acid phenethyl ester was observed by fluorescence microscopy.

Conclusion
Our results suggested that Zika virus infectious clone with an EGFP marker retained it infectivity as wide-type Zika virus which could be used for drugs screening.
Large variations of oxygen delivery in self-inflating resuscitation bags used for preoxygenation - a mechanical simulation
Authors: Grauman Sven , Johansson Joakim , Drevhammar Thomas 
Published: July 2021

Abstract
Background
Self-Inflating Resuscitation Bags (SIRB) are common and essential tools in airway management and ventilation. They are often used in resuscitation and emergency anaesthesia outside the operating theatre. There is a common notion that all SIRBs applied with a tight sealed mask will deliver close to 100 % oxygen during spontaneous breathing. The aim of the study was to measure the oxygen delivery of six commonly used SIRBs in a mechanical spontaneous breathing adult in vitro model.

Methods
Three SIRBs of each of the six models were evaluated for oxygen delivery during simulated breathing with an adult mechanical lung. The test was repeated three times per device (54 tests in total). The breathing profile was fixed to a minute volume of 10 L/min, a tidal volume of 500 mL and the SIRBs supplied with an oxygen fresh gas flow of 15 L/min. The fraction of delivered oxygen (FDO2) was measured over a three-minute period. Average FDO2 was calculated and compared at 30, 60 and 90 s.

Results
At 90 s all models had reached a stable FDO2. Average FDO2 at 90 s; Ambu Oval Plus 99,5 %; Ambu Spur II 99,8 %; Intersurgical BVM Resuscitator 76,7 %; Laerdal Silicone 97,3 %; Laerdal The Bag II 94,5 % and the O-Two Smart Bag 39,0 %. All differences in FDO2 were significant apart from the two Ambu models.

Conclusions
In simulated spontaneous breathing, four out of six (by Ambu and Laerdal) Self-Inflating Resuscitation Bags delivered a high fraction of oxygen while two (Intersurgical and O-two) underperformed in oxygen delivery. These large variations confirm results reported in other studies. It is our opinion that underperforming Self-Inflating Resuscitation Bags might pose a serious threat to patients’ health if used in resuscitation and anaesthesia. Manufacturers of Self-Inflating Resuscitation Bags rarely provide information on performance for spontaneous breathing. This poses a challenge to all organizations that need their devices to deliver adequate oxygen during spontaneous breathing.
Emergency medical dispatchers’ ability to identify large vessel occlusion stroke during emergency calls
Authors: Vuorinen Pauli E. T. , Ollikainen Jyrki P. J. , Ketola Pasi A. , Vuorinen Riikka-Liisa K. , Setälä Piritta A. , Hoppu Sanna E. 
Published: July 2021

Abstract
Background
In acute ischemic stroke, conjugated eye deviation (CED) is an evident sign of cortical ischemia and large vessel occlusion (LVO). We aimed to determine if an emergency dispatcher can recognise LVO stroke during an emergency call by asking the caller a binary question regarding whether the patient’s head or gaze is away from the side of the hemiparesis or not. Further, we investigated if the paramedics can confirm this sign at the scene. In the group of positive CED answers to the emergency dispatcher, we investigated what diagnoses these patients received at the emergency department (ED). Among all patients brought to ED and subsequently treated with mechanical thrombectomy (MT) we tracked the proportion of patients with a positive CED answer during the emergency call.

Methods
We collected data on all stroke dispatches in the city of Tampere, Finland, from 13 February 2019 to 31 October 2020. We then reviewed all patient records from cases where the dispatcher had marked ‘yes’ to the question regarding patient CED in the computer-aided emergency response system. We also viewed all emergency department admissions to see how many patients in total were treated with MT during the period studied.

Results
Out of 1913 dispatches, we found 81 cases (4%) in which the caller had verified CED during the emergency call. Twenty-four of these patients were diagnosed with acute ischemic stroke. Paramedics confirmed CED in only 9 (11%) of these 81 patients. Two patients with positive CED answers during the emergency call and 19 other patients brought to the emergency department were treated with MT.

Conclusion
A small minority of stroke dispatches include a positive answer to the CED question but paramedics rarely confirm the emergency medical dispatcher’s suspicion of CED as a sign of LVO. Few patients in need of MT can be found this way. Stroke dispatch protocol with a CED question needs intensive implementation.
Effects of lower extremity constraint-induced movement therapy on gait and balance of chronic hemiparetic patients after stroke: description of a study protocol for a randomized controlled clinical trial
Authors: Menezes-Oliveira Elaine , da Silva Matuti Gabriela , de Oliveira Clarissa Barros , de Freitas Simone Ferreira , Kawamura Catia Miyuki , Lopes José Augusto Fernandes , Arida Ricardo Mario 
Published: July 2021

Abstract
Background
Protocols involving intensive practice have shown positive outcomes. Constraint induced movement therapy (CIT) appears to be one of the best options for better outcomes in upper limb rehabilitation, but we still have little data about lower extremity constraint-induced movement therapy (LE-CIT) and its effects on gait and balance.

Objective
To evaluate the effects of an LE-CIT protocol on gait functionality and balance in chronic hemiparetic patients following a stroke.

Methods
The study adopts a randomized, controlled, single-blinded study design. Forty-two patients, who suffered a stroke, who were in the chronic phase of recovery (>6 months), with gait disability (no community gait), and who were able to walk at least 10 m with or without the advice or support of 1 person, will be randomly allocated to 2 groups: the LE-CIT group or the control group (intensive conventional therapy). People will be excluded if they have speech deficits that render them unable to understand and/or answer properly to evaluation scales and exercises selected for the protocol and/or if they have suffered any clinical event between the screening and the beginning of the protocol. Outcome will be assessed at baseline (T0), immediately after the intervention (T1), and after 6 months (T2). The outcome measures chosen for this trial are as follows: 6-min walk test (6minWT), 10-m walk test (10mWT), timed up and go (TUG), 3-D gait analysis (3DGA), Mini Balance Evaluation Systems Test (Mini-BESTest), and as a secondary measure, Lower Extremity Motor Activity Log will be evaluated (LE-MAL). The participants in both groups will receive 15 consecutive days of daily exercise. The participants in the LE-CIT group will be submitted to this protocol 2.5 h/day for 15 consecutive days. It will include (1) intensive supervised training, (2) use of shaping as strategy for motor training, and (3) application of a transfer package (plus 30 min). The control group will receive conventional physiotherapy for 2.5 h/day over 15 consecutive days (the same period as the CIT intervention). Repeated measures analyses will be made to compare differences and define clinically relevant changes between groups.

Results
Data collection is currently on-going and results are expected in 2021.

Discussion
LE-CIT seems to be a good protocol for inclusion into stroke survivors’ rehabilitation as it has all the components needed for positive results, as well as intensity and transference of gains to daily life activities.

Trial registration
www.ensaiosclinicos.gov.brRBR-467cv6. Registered on 10 October 2017. “Effects of Lower Extremities - Constraint Induced Therapy on gait and balance function in chronic hemipretic post-stroke patients”.
Efficacy and safety of Suxiao Jiuxin Pill in the treatment of stable angina (Qi stagnation and blood stasis syndrome): study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial
Authors: Ruan Xiaofen , Li Yiping , Sun Yuanlong , Jia Meijun , Xu Xiaowen , Huo Li , Song Wei , Yao Yili , Wang Xiaolong 
Published: July 2021

AbstractBackgroundCoronary heart disease (CHD) has become one of the biggest health problems in the world. Stable angina is a common clinical type of CHD with poor prognosis and high mortality. Although there are various interventions for stable angina, none of them can significantly reduce mortality. Both basic and clinical research have shown that Suxiao Jiuxin Pill (SJP) can relieve the symptoms of angina pectoris and improve the clinical efficacy, but there is a lack of high-quality clinical research to provide research-based evidence. We design a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of SJP for stable angina.Methods/designThis is a prospective, randomized, double-blind, placebo-controlled, and multicenter trial. The trial will enroll 324 participants with chronic stable angina (Qi Stagnation and Blood Stasis syndrome). All participants will have received the conventional therapy of chronic stable angina. Participants will be randomized into two groups, conventional therapy plus SJP group and conventional therapy plus placebo group. Eligible participants will receive either SJP or placebo (five pills administered orally, three times daily) in addition to conventional treatment for 24 weeks. The primary outcomes are the symptom improvement rate of angina from baseline to 4 weeks after inclusion and major adverse cardiovascular events (MACE). The secondary outcomes are angina classification (CCS), improvement of traditional Chinese medicine (TCM) syndromes, Seattle Angina Scale score, the dosage of emergency drugs and the stopping rate, and electrocardiogram (EKG) efficacy. Adverse events will be monitored throughout the trial.DiscussionIntegrated traditional Chinese and Western Medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of SJP for angina. The results of the trial will provide high-level clinical research-based evidence for the application of SJP instable angina.Trial registrationThis study protocol was registered on 14 March 2019. The registration number isChiCTR1900021876on the Chinese Clinical Trial Registry.
Single-nucleus transcriptome analysis of human brain immune response in patients with severe COVID-19
Authors: Fullard John F. , Lee Hao-Chih , Voloudakis Georgios , Suo Shengbao , Javidfar Behnam , Shao Zhiping , Peter Cyril , Zhang Wen , Jiang Shan , Corvelo André , Wargnier Heather , Woodoff-Leith Emma , Purohit Dushyant P. , Ahuja Sadhna , Tsankova Nadejda M. , Jette Nathalie , Hoffman Gabriel E. , Akbarian Schahram , Fowkes Mary , Crary John F. , Yuan Guo-Cheng , Roussos Panos 
Published: July 2021

Abstract
Background
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has been associated with neurological and neuropsychiatric illness in many individuals. We sought to further our understanding of the relationship between brain tropism, neuro-inflammation, and host immune response in acute COVID-19 cases.

Methods
Three brain regions (dorsolateral prefrontal cortex, medulla oblongata, and choroid plexus) from 5 patients with severe COVID-19 and 4 controls were examined. The presence of the virus was assessed by western blot against viral spike protein, as well as viral transcriptome analysis covering > 99% of SARS-CoV-2 genome and all potential serotypes. Droplet-based single-nucleus RNA sequencing (snRNA-seq) was performed in the same samples to examine the impact of COVID-19 on transcription in individual cells of the brain.

Results
Quantification of viral spike S1 protein and viral transcripts did not detect SARS-CoV-2 in the postmortem brain tissue. However, analysis of 68,557 single-nucleus transcriptomes from three distinct regions of the brain identified an increased proportion of stromal cells, monocytes, and macrophages in the choroid plexus of COVID-19 patients. Furthermore, differential gene expression, pseudo-temporal trajectory, and gene regulatory network analyses revealed transcriptional changes in the cortical microglia associated with a range of biological processes, including cellular activation, mobility, and phagocytosis.

Conclusions
Despite the absence of detectable SARS-CoV-2 in the brain at the time of death, the findings suggest significant and persistent neuroinflammation in patients with acute COVID-19.