bluuebunny/crossref_metadata_2025_split huggingface dataset:
Neutral Polysaccharide from Panax notoginseng enhanced cyclophosphamide antitumor efficacy in hepatoma H22-bearing mice
Authors: Liu Yanhong , Qin Huayan , Zhong Yuanyuan , Li Shuang , Wang Huajing , Wang Hong , Chen Liling , Tang Xiang , Li Yalin , Qian Zhongyi , Li Huaiyu , Zhang Lei , Chen Tong 
Published: January 2021

Abstract
Background: Our previous studies demonstrated that the administration of crude Polysaccharide from Panax notoginseng (CPPN) can effectively prolong the lifespan of tumor-bearing mice via boosting the host immune system as well as weak cytotoxicity against hepatocellular carcinoma (HCC). In the present study, Neutral Polysaccharide (NPPN) were further purified from crude polysaccharide isolated from panax notoginseng. The effects of NPPN on the immune function and hematopoietic function of mice with low immunity and myelosuppression induced by cyclophosphamide (CTX) were investigated. The effect of NPPN combined with CTX on the tumor inhibition rate of the H22 tumor-bearing mice and the impact of NPPN on the proliferation of H22 liver cancer cells in vitro were investigated.Methods: CPPN was obtained by water extraction and alcohol precipitation method, and further purified by DEAE Sepharose Fast Flow ion exchange resin column. NPPN was added to the immunosuppressed with myelosuppression mice induced by CTX. Thymus index, spleen index, lymphocyte proliferation stimulation index by adding of concanavalin A, determination of serum hemolysin, NK cell activity assay, mice carbon clearance experiment, blood count tests were detected. The tumor inhibition rate of the H22 tumor-bearing mice treated with NPPN combined with CTX was recorded.Results: NPPN and 4 kinds of acid polysaccharide from Panax notoginseng (APPN) were successfully isolated from the CPPN by DEAE Sepharose Fast Flow ion exchange resin column. NPPN inhibited the growth of H22 cells and significantly increase the tumor inhibition rate of the H22 tumor-bearing mice combined with CTX. The elevation of the cellular and humoral immunity levels as well as a variety of blood count tests indicators of immunosuppressive with myelosuppression mice may contribute to the antitumor activity of NPPN.Conclusion: NPPN has a potential antitumor activity for the treatment of liver cancer combined with cyclophosphamide.
Short-term effectiveness of precise safety decompression via double percutaneous lumbar foraminoplasty and percutaneous endoscopic lumbar decompression for lateral lumbar spinal canal stenosis: a prospective cohort study
Authors: Wang Yu , Deng Mingyan , Wu Hao , Wu Ye , Guo Chuan , Zhang Dongfeng , Kong Qingquan 
Published: January 2021

Abstract
Purpose This prospective cohort study reports on a modified technique, namely precise safety decompression via double percutaneous lumbar foraminoplasty (DPLF) and percutaneous endoscopic lumbar decompression (PELD) for lateral lumbar spinal canal (LLSC) stenosis, and its short-term clinical outcomes.Methods The study analyzed 69 patients with single-level LLSC stenosis simultaneously occurring in both zones 1 and 2 (defined as retrodiscal space and upper bony lateral recess respectively by new LLSC classification) who underwent DPLF–PELD from November 2018 to April 2019. Clinical outcomes were evaluated according to preoperative, three months postoperatively, and last follow-up, via leg pain/low back pain (LBP) visual analog scale (VAS) scores, Oswestry disability index (ODI) scores, and the Macnab criteria. The postoperative MRI and CT were used to confirm the complete decompression, and flexion-extension x-rays at the last follow-up were used to observe lumbar stability.Results All patients successfully underwent DPLF–PELD, and the stenosis was completely decompressed, confirmed by postoperative MRI and CT. The mean follow-up duration was 13 months (range: 8–17 months). The mean preoperative leg pain VAS score is 7.05 ± 1.04 (range 5–9), which decreased to 1.03 ± 0.79(range: 0–3) at three months postoperatively and to 0.75 ± 0.63 (range: 0–2) by the last follow-up visit(p < 0.05). The mean preoperative ODI was 69.8 ± 9.05 (range: 52–85), which decreased to 20.3 ± 5.52 (range: 10–35) at the third month postoperatively and to 19.6 ± 5.21 (range: 10–34) by the final follow-up visit(p < 0.05). The satisfactory (excellent or good) results were 94.2%. There was one patient with aggravated symptoms, which were relieved after an open surgery. Two patients had a dural tear, and two patients suffered postoperative LBP. No recurrence or segmental instability was observed at the final follow-up.Conclusion DPLF–PELD could be a good alternative for the treatment of LLSC stenosis patients whose stenosis occurred in both zones 1 and 2.Trial registration Chinese Clinical Trial Registry (ChiCTR1800019551). Registered 18 November 2018.
Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project
Authors: Totton Nikki , Julious Steven , Hughes Dyfrig , Cook Jonathan , Biggs Katie , Coates Lizzie , Cook Andrew , Hewitt Catherine , Day Simon 
Published: January 2021

Abstract
Background: Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of: superiority; equivalence or non-inferiority. The design of the study is affected by many different elements including: the control treatment, the primary outcome and associated relationships. In some studies, there could be more than one outcome of interest. In these situations, benefit-risk methodologies could be used to assess the outcomes simultaneously and consider the trade-off between the benefits against the risks of a treatment. Benefit-risk is used within the regulatory industry but seldom included within publicly funded clinical trials within the UK. This project aims to gain an expert consensus on how to select the appropriate trial design (e.g. superiority) and when to consider including benefit-risk methods.Methods: The project will consist of four work packages:1. A web-based survey to elicit current experiences and opinions,2. A rapid literature review to assess any current recommendations,3. A two-day consensus workshop to gain agreement on the recommendations,4. Production of a guidance document.Discussion: The aim of the project is to provide a guideline for clinical researchers, grant funding bodies and reviewers for grant bodies for how to select the most appropriate trial design and when it is appropriate to consider using benefit-risk methods. The focus of the guideline will be on publicly funded trials, however, the vision is that the work will be applicable across research settings and we will connect with other organisations and committees as appropriate.
Determining sample size for progression criteria for pragmatic pilot RCTs: The Hypothesis test Strikes Back!
Authors: Lewis Martyn , Bromley Kieran , Sutton Christopher J , McCray Gareth , Myers Helen Lucy , Lancaster Gillian A 
Published: January 2021

Abstract
Background The current CONSORT guidelines for reporting pilot trials do not recommend hypothesis testing of clinical outcomes on the basis that a pilot trial is under-powered to detect such differences and this is the aim of the main trial. It states that primary evaluation should focus on descriptive analysis of feasibility/process outcomes (e.g. recruitment, adherence, treatment fidelity). Whilst the argument for not testing clinical outcomes is justifiable, the same does not necessarily apply to feasibility/process outcomes, where differences may be large and detectable with small samples. Moreover, there remains much ambiguity around sample size for pilot trials. Methods Many pilot trials adopt a ‘traffic light’ system for evaluating progression to the main trial determined by a set of criteria set up a priori. We construct a hypothesis-testing approach for binary feasibility outcomes focused around this system that tests against being in the RED zone (unacceptable outcome) based on an expectation of being in the GREEN zone (acceptable outcome) and choose the sample size to give high power to reject being in the RED zone if the GREEN zone holds true. Pilot point estimates falling in the RED zone will be statistically non-significant and in the GREEN zone will be significant; the AMBER zone designates potentially acceptable outcome and statistical tests may be significant or non-significant.Results For example, in relation to treatment fidelity, if we assume the upper boundary of the RED zone is 50% and the lower boundary of the GREEN zone is 75% (designating unacceptable and acceptable treatment fidelity, respectively), the sample size required for analysis given 90% power and one-sided 5% alpha would be around n=34 (intervention group alone). Observed treatment fidelity in the range of 0-17 participants (0-50%) will fall into the RED zone and be statistically non-significant; 18-25 (51-74%) fall into AMBER and may or may not be significant; 26-34 (75-100%) fall into GREEN and will be significant indicating acceptable fidelity.Discussion In general, several key process outcomes are assessed for progression to a main trial; a composite approach would require appraising the rules of progression across all these outcomes. This methodology provides a formal framework for hypothesis-testing and sample size indication around process outcome evaluation for pilot RCTs.
Reduced intensity of early intensification does not increase the risk of relapse in children with standard risk acute lymphoblastic leukemia - A multi-centric clinical study of GD-2008-ALL protocol
Authors: Li Xin-Yu , Li Jia-Qiang , Luo Xue-Qun , Wu Xue-Dong , Sun Xin , Xu Hong-Gui , Li Chang-Gang , Liu Ri-Yang , Sun Xiao-Fei , Chen Hui-Qin , Lin Yu-Deng , LI Chi-Kong , Fang Jian-Pei 
Published: January 2021

Abstract
Background The prognosis of childhood acute lymphoblastic leukemia (ALL) is optimistic with a 5-year event-free survival (EFS) rate of 70%-85%. However, the major causes of mortality are chemotherapy toxicity, infection and relapse. The Guangdong (GD)-2008-ALL collaborative protocol was carried out to study the effect of reduced intensity on treatment related mortality(TRM) based on Berlin-Frankfurt-Münster (BFM) 2002 backbone treatment. The study was designed to elucidate whether the reduced intensity is effective and safe for children with ALL. Methods The clinical data were obtained from February 28, 2008 to June 30, 2016. A total of 1,765 childhood ALL cases from 9 medical centers were collected and data were retrospectively analyzed. Patients were stratified into 3 groups according to bone marrow morphology, prednisone response, age, genotype, and karyotype information: standard risk (SR), intermediate risk (IR) and high risk (HR). For SR group, daunorubicin was decreased in induction IA while duration was reduced in Induction Ib (2 weeks in place of 4 weeks). Doses for CAM were same in all risk groups - SR patients received one CAM, others got two CAMs. Results The 5-year and 8-year overall survival (OS), event-free survival (EFS) and cumulative incidence of relapse (CIR) were 83.5±0.9% and 83.1±1.0%, 71.9±1.1% and 70.9±1.2%, and 19.5±1.0% and 20.5±1.1%, respectively. The 2-year treatment-related mortality (TRM) was 5.2±0.5%. The 5-year and 8-year OS were 90.7±1.4% and 89.6±1.6% in the SR group, while the 5-year and 8-year EFS were 81.5±1.8% and 80.0±2.0%. In the SR group, 74 (15.2 %) patients measured minimal residual disease (MRD) on Day 15 and Day 33 of induction therapy. Among them, 7 patients (9.46%) were MRD positive (≥ 0.01%) on Day 33. The incidence of relapse in the MRD Day33 positive group (n=7) was 28.6%, while in the MRD Day33 negative group (n=67) was 7.5% (p=0.129). Conclusions The results of GD-2008-ALL protocol are outstanding for reducing TRM in childhood ALL in China with excellent long term EFS. This protocol provided the evidence for further reducing intensity of induction therapy in the SR group according to the risk stratification. MRD levels on Day 15 and Day 33 are appropriate indexes for stratification.
Domestic Violence in Mozambique: From policy to practice
Authors: Jethá Eunice , Keygnaert Ines , Martins Emilia , Sidat Mohsin , Roelens Kristien 
Published: January 2021

Abstract
Background: To reduce the impact of domestic violence (DV), Mozambican governmental and non-governmental entities are making efforts to strengthen the legislative framework and improve the accessibility of care services for survivors of violence. Despite this remarkable commitment, the translation of policies and legislation into actions remains a huge challenge. Therefore, this paper aims to identify gaps in the implementation of existing national policies and laws for DV in the services providing care for survivors of DV.Methods: This study, using a qualitative approach had two components. The first was content analysis of guidelines and protocols for DV care provision. The second consisted of in-depth interviews with institutional gender focal points. The analysis of the document content was based on a framework developed according to key elements recommended by international agencies (PAHO and UN) for DV policies and strategies design. Data from the in-depth interviews, where analysed in accordance with study objectives.Results: Eleven (11) guidelines/protocols of care provision and innumerable brochures and pamphlets were identified and analysed. There is a standardised form highlighting the integrated approach incorporating fields for police and the health sector but excludes Civil Society Organisations. However, there is no national DV database specifically for DV. Although the focal points recognised the relevance of the reviewed documents, many identified gaps in implementation. This is related to the weaknesses of the offender’s penalisation and to the scarcity of care providers. And, many providers who do exist often lack appropriate training. They also recognised their performance is negatively influenced by socio-cultural factors.Conclusion: Within services providing care to survivors of DV, a scarcity of guidelines and protocols exist, compromising the quality and standardisation of care. Recognition of the relevance of care guidelines and protocols is a strength, there are challenges that governmental and non-governmental entities must address in order to ensure DV prevention and control strategies have the desired results.
Risk factors for recurrent wheezing after bronchiolitis in infants:2-year follow up in China
Authors: Chen Sainan , Gu Wenjing , Wu Min , Hao Chuangli , Zhu Canhong , Shao Xuejun , Wang Yuqing 
Published: January 2021

Abstract
Background: Infants with bronchiolitis have an increased risk of developing recurrent wheezing and asthma. However, the risk factors for the development of recurrent wheezing after bronchiolitis remains controversial.Objective: To investigate the incidence of post-bronchiolitis recurrent wheezing and associated risk factors.Methods: Infants with bronchiolitis were enrolled from November 2016 through March 2017. Nasopharyngeal aspirates were obtained for detection of respiratory viruses which were analyzed by reverse transcriptase polymerase chain reaction (RT-PCR) and direct immunofluorescent assay. Serum cytokines including TSLP, IL2, IL13, TIMP-1, MMP-9, IL33, IL5, IL4, IL25, TNF- α and MIP-1α were measured by flow cytometry. Patients were followed every 3 months for a duration of 2 years by telephone or at outpatient appointments.Results: We enrolled 89 infants, of which 81 patients were successfully followed up. In total, 22.2% of patients experienced recurrent wheezing episodes. The proportion of patients with history of eczema, systemic glucocorticoid use and patients with moderate-to-severe disease were significantly higher in the recurrent wheezing group than the non-recurrent wheezing group (83.3% vs 52.4%; 66.7% vs 36.5%; 61.1% vs 33.3%, respectively, all P<0.05); There were no significant differences between patients with and without recurrent wheezing episodes in the levels of TSLP, IL2, IL13, TIMP-1, MMP-9, IL33, IL5, IL4, IL25, TNF- α and MIP-1α (P>0.05). Logistic regression analysis showed that history of eczema was an independent risk factor for post-bronchiolitis recurrent wheezing (odds ratio [OR]=5.622; 95% confidence interval [CI], 1.3–24.9; P=0.023).Conclusion: The incidence of recurrent wheezing among infants after contracting bronchiolitis was 22.2% during a 2-year follow-up. History of eczema was the only independent risk factor identified and no correlation was found between the specific virus and disease severity in children with post-bronchiolitis recurrent wheezing.
Changes in the characteristics of dental emergencies under the influence of SARS-CoV-2 pandemic: A retrospective study
Authors: Wu Kan , Li Chunjie , Yang Zheng , Yang Shangchun , Yang Wenbin , Hua Chengge 
Published: January 2021

Abstract
Background Further understanding of the distribution and changing characteristics of dental diseases is of great significance for all dental emergency centers for strengthening the medical staff’s treatment abilities and effective use of emergency resources in the face of public health emergencies involving highly infectious respiratory diseases.Methods The medical records of 4158 cases of dental emergency patients from 2019 to 2020 were retrospectively analyzed, with patients divided into the pre-SARS-COV-2 group and the SARS-COV-2 group, according to the date of their admission to the dental emergency center. The dental emergency patients’ demographic data, date and time, diagnoses, and treatment approaches were compared before and during the SARS-COV-2 pandemic.Results During the SARS-COV-2 pandemic, the number of dental emergency visits increased by 29.7%. The peak of the number of patients at weekends and at night is not obvious compared with the pre-SARS-COV-2 group. During the pandemic, males (n=286, 58.1%) were more likely to visit dental emergency centers for trauma than females (n=206, 41.9%) (P<0.05); females (n=242, 60.8%) were more likely to visit dental emergency centers for acute gingivitis and acute pericoronitis than males (n=156, 39.2%) (P<0.05). A major change in diagnosis was related to acute pulpitis (K04.0) and acute apical periodontitis (K04.4), which increased by 9.2%; acute gingivitis (K05.0) and acute pericoronitis (K05.2) increased by 3.5%; open wound of the lip and oral cavity (S01.5) decreased by 17.9%; other conditions (non-emergency diseases) increased by 6.8%, compared with the pre-SARS-COV-2 period. Among the treatment modalities, during the pre-SARS-COV-2 period, 304 patients (17.7%) received a prescription for antibiotics and analgesics, and 1485 (86.5%) received a prescription for local treatment. During the SARS-COV-2 period, 958 (39.2%) received a prescription for antibiotics and analgesics, and 1636 (67.0%) received a prescription for local treatment.Conclusion SARS-COV-2 pandemic led to changes in the characteristics of dental emergency patients. Trauma, acute pulpitis, and acute periodontitis are the leading reasons patients refer to dental emergency centers. Dental emergency centers should optimize treatment procedures, optimize the staff, and reasonably allocate materials according to the changes to improve the on-site treatment capacity and provide adequate dental emergency care.
Demographic Features of Identified PLWHA Infected through Commercial and Nonmarital Noncommercial Heterosexual Contact in China from 2015 – 2018: A Retrospective Cross-Sectional Study
Authors: Dong Zhilong , Ma Liying , Cai Chang , Gao George Fu , Lyu Fan 
Published: January 2021

Abstract
Background:Understanding the demographic characteristics of people living with HIV/AIDS (PLWHA) infected through commercial heterosexual contact (CHC) or nonmarital noncommercial heterosexual contact (NMNCHC) is important for HIV/AIDS prevention and control.Methods:Cases reported through the Chinese HIV/AIDS Case Reporting System (CRS) from 2015 to 2018 were analyzed. A descriptive and preliminary inferential analysis were performed for those demographic characteristics deemed of interest.Results:Overall, 523,121 identified PLWHA between 2015 and 2018 in the CRS were analyzed. The constituent ratio of heterosexual transmission increased from 66.25% in 2015 to 71.48% in 2018. The proportion of CHC heterosexual transmission decreased from 40.18% in 2015 to 37.99% in 2018, while that of NMNCHC increased from 46.33% in 2015 to 49.02% in 2018. PLWHA infected through NMNCHC were significantly younger than those who were infected through CHC (Student’s t test, P<0.0001), with an average age gap ranging from 5.63 (2015) to 7.46 (2018) years, and the average age of both groups increased annually. The frequency of newly identified PLWHA who were infected through CHC had a remarkable increase among the ages of 65 and above. Gender distribution was significantly different between CHC and NMNCHC (χ2 = 8909.00(2015), 9941.90(2016), 11004.00 (2017), 12836.00(2018), all P < 0.0001), and the ratio of men to women in the NMCHC group was 1.50:1 (2015), 1.51:1 (2016), 1.54:1 (2017), and 1.52:1 (2018), while in the commercial heterosexual contact (CHC) group, these ratios were 11.45:1 (2015), 12.08:1 (2016), 12.53:1 (2017), and 13.28:1 (2018). Marital status was significantly different between CHC and NMNCHC (χ2 = 94.67 (2015), 109.88(2016), 58.18(2017), 152.38(2018), all P < 0.0001). As the educational level improved, the proportion of NMNCHC also increased (Cochran - Armitage test, P<0.0001).Conclusions:We found that heterosexual transmission was the primary mode of HIV transmission in China from 2015 to 2018. PLWHA infected through CHC and NMNCHC had different characteristics in age, gender, marital status, and educational level. The frequency of PLWHA infected through CHC increased substantially in the age group of 65 and above. This study provides useful baseline data for future studies on the heterosexual transmission of HIV in China.