bluuebunny/crossref_metadata_2025_split huggingface dataset:
TEXT4myBACK: A Text Message Intervention to Improve Function in People With Low Back Pain—Protocol of a Randomized Controlled Trial
Authors: Fritsch Carolina G , Ferreira Paulo H , Prior Joanna L , Clavisi Ornella , Chow Clara K , Redfern Julie , Thiagalingam Aravinda , Lung Thomas , McLachlan Andrew J , Ferreira Manuela Loureiro 
Published: March 2021

Abstract

Objective
The authors sought to describe the protocol of a randomized controlled trial that will investigate the effects of the TEXT4myBACK self-management text message intervention compared with control in people with low back pain (LBP).

Methods
A single-blind (assessor and statistician), randomized controlled trial with economic analysis and process evaluation will be conducted. A total of 304 people with non-specific LBP of less than 12 weeks will be enrolled and randomly allocated either to TEXT4myBACK intervention or control groups. The TEXT4myBACK intervention group will receive 4 semi-personalized text messages per week providing advice, motivation, and information about LBP, physical activity, sleep, mood, use of care, and medication during 12 weeks. The control group will receive 1 text message with a link to a LBP and diet online information package. Outcomes will be assessed at baseline and 3, 6, and 12 months. The primary outcome will be function assessed with the Patient-Specific Functional Scale. Secondary outcomes will include pain intensity, physical activity participation, sedentary behavior, global impression of change, health-related quality of life, and eHealth literacy. Data on demographic characteristics, smallest worthwhile change (ie, smallest function scored needed to be achieved at the end of the intervention to consider it to be worthwhile), health care utilization, and adverse events (ie, any new health issue that occurs during participation in the study) will be collected. An economic and process evaluation will also be conducted.

Impact
This study will assess if a self-management text message intervention is effective and cost-effective in improving function of people with LBP. This study can inform clinical practice of a simple, scalable, and affordable intervention for managing LBP.
Suicide and mental health during the COVID-19 pandemic in Japan
Authors: Ueda Michiko , Nordström Robert , Matsubayashi Tetsuya 
Published: March 2021

Abstract

Background
The coronavirus disease (COVID-19) pandemic is an unprecedented public health crisis, but its effect on suicide deaths is little understood.

Methods
We analyzed data from monthly suicide statistics between January 2017 and October 2020 and from online surveys on mental health filled out by the general population in Japan.

Results
Compared to the 2017–19 period, the number of suicide deaths during the initial phase of the pandemic was lower than average but exceeded the past trend from July 2020. Female suicides, whose numbers increased by approximately 70% in October 2020 (incidence rate ratio: 1.695, 95% confidence interval: 1.558–1.843), were the main source of this increase. The largest increase was found among young women (less than 40 years of age). Our survey data indicated that the status of young women’s mental health has been deteriorating in recent months and that young female workers were more likely to have experienced a job or income loss than any other group, suggesting adverse economic conditions surrounding them.

Conclusions
Continuous monitoring of mental health, particularly that of the most vulnerable populations identified in this study, and appropriate suicide prevention efforts are necessary during the COVID-19 pandemic.
The Implications of Interrelated Assumptions on Estimates of Divergence Times and Rates of Diversification
Authors: Carruthers Tom , Scotland Robert W 
Published: March 2021

Abstract
Phylogenies are increasingly being used as a basis to provide insight into macroevolutionary history. Here, we use simulation experiments and empirical analyses to evaluate methods that use phylogenies as a basis to make estimates of divergence times and rates of diversification. This is the first study to present a comprehensive assessment of the key variables that underpin analyses in this field—including substitution rates, speciation rates, and extinction, plus character sampling and taxon sampling. We show that in unrealistically simplistic cases (where substitution rates and speciation rates are constant, and where there is no extinction), increased character and taxon sampling lead to more accurate and precise parameter estimates. By contrast, in more complex but realistic cases (where substitution rates, speciation rates, and extinction rates vary), gains in accuracy and precision from increased character and taxon sampling are far more limited. The lack of accuracy and precision even occurs when using methods that are designed to account for more complex cases, such as relaxed clocks, fossil calibrations, and models that allow speciation rates and extinction rates to vary. The problem also persists when analyzing genomic scale data sets. These results suggest two interrelated problems that occur when the processes that generated the data are more complex. First, methodological assumptions are more likely to be violated. Second, limitations in the information content of the data become more important.[Divergence time estimation; diversification rates; macroevolution; phylogeny.]
Community-Acquired Neonatal SARS-CoV-2 Infection Associated with Neurological Symptoms in Colombia
Authors: Alvarado-Socarras Jorge L , Theurel-Martin Delia , Cruz-Hernandez Monica , Rodriguez-Morales Alfonso J 
Published: March 2021

Abstract

Introduction
The SARS-CoV-2/COVID-19 may produce neurological manifestations, including its occurrence in children, and newborns, which has been little reported so far in newborns with COVID-19.

Case
We present a case in Colombia, of community-acquired neonatal infection of SARS-CoV-2, with suggestive symptoms, such as fever, and showing neurological findings, such as drowsiness, poor suction and mild hypotonia for a short time.

Discussion
The clinical manifestations of SARS-COV-2 in neonates are beginning to be described in detail. We report a case of SARS-COV-2-associated neurological compromise in a newborn, with features of drowsiness, poor suction and hypotonia.
The Long-term Costs and Effects of Tubal Flushing With Oil-Based Versus Water-Based Contrast During Hysterosalpingography
Authors: van Welie Nienke , Pham Clarabelle T. , van Rijswijk Joukje , Dreyer Kim , Verhoeve Harold R. , Hoek Annemieke , de Bruin Jan Peter , Nap Annemiek W. , van Hooff Machiel H. A. , Goddijn Mariëtte , Hooker Angelo B. , Gijsen Anna P. , Traas Maaike A. F. , Smeenk Jesper M. J. , Sluijmer Alexander V. , Lambers Marieke J. , van Unnik Gijsbertus A. , de Koning Cornelia H. , Mozes Alexander , Timmerman Catharina C. M. , Lambalk Cornelis B. , Karnon Jonathan D. , Mijatovic Velja , Mol Ben Willem J. 
Published: March 2021

(Abstracted from Reprod Biomed Online 2021;42(1):150–157)
Hypersalpingography (HSG) is a common outpatient clinical examination of the fallopian tubes and is an important part of the fertility workup in infertile women. Although introduced for diagnostic purposes, therapeutic benefits of tubal flushing and positive cost-benefit analyses have been presented in literature for several years.
Early Prophylactic Enoxaparin for the Prevention of Preeclampsia and Intrauterine Growth Restriction: A Randomized Trial
Authors: Llurba Elisa , Bella Miriam , Burgos Jorge , Mazarico Edurne , Gómez-Roig María Dolores , de Diego Raül , Martínez-Astorquiza Txanton , Alijotas-Reig Jaume , Sánchez-Durán María Ángeles , Sánchez Olga , Carreras Elena , Cabero Lluís 
Published: March 2021

(Abstracted from Fetal Diagn Ther 2020;47:824–833)
Preeclampsia (PE) and intrauterine growth restriction (IUGR) are among the many causes of maternal and perinatal morbidity and mortality. Prior studies have shown that introduction of low-dose aspirin before 16 weeks of gestation can lead to a reduction in the prevalence of preterm PE and IUGR.
Association Between Epidural Analgesia During Labor and Risk of Autism Spectrum Disorders in Offspring
Authors: Qiu Chunyuan , Lin Jane C. , Shi Jiaxiao M. , Chow Ting , Desai Vimal N. , Nguyen Vu T. , Riewerts Robert J. , Feldman R. Klara , Segal Scott , Xiang Anny H. 
Published: March 2021

(Abstracted from JAMA Pediatr 2020;174(12):1168–1175)
More than 70% of pregnant women receive neuraxial anesthesia to manage labor pain in the United States. However, its long-term effects on offspring are largely unknown.
Magnesium Sulphate for Fetal Neuroprotection at Imminent Risk for Preterm Delivery: A Systematic Review With Meta-analysis and Trial Sequential Analysis
Authors: Wolf H. T. , Huusom L. D. , Henriksen T. B. , Hegaard H. K. , Brok J. , Pinborg A. 
Published: March 2021

(Abstracted from BJOG 2020;127:1180–1188)
Preterm delivery puts infants at risk of developing cerebral palsy (CP). Conventional meta-analyses have shown that administering magnesium sulfate (MgSO4) at imminent preterm birth may help decrease this risk.
Characteristics and Outcome of Severe Mycoplasma pneumoniae Pneumonia Admitted to PICU in Shanghai: A Retrospective Cohort Study
Authors: Zhou Yiping , Shan Yijun , Cui Yun , Shi Jingyi , Wang Fei , Miao Huijie , Wang Chunxia , Zhang Yucai 
Published: March 2021

Objectives:
We aimed to describe the characteristics and outcome in children with severe Mycoplasma pneumoniae pneumonia in a Chinese PICU.

Design:
A retrospective observational study from 2017 to 2019.

Setting:
A 36-bed university tertiary PICU at Shanghai Children’s Hospital.

Patients:
Patients admitted to a tertiary PICU 29 days to 18 years old screened for laboratory-confirmed severe M. pneumoniae pneumonia.

Interventions:
None.

Measurements and Main Results:
Descriptive analysis of baseline characteristics for patients included hospital mortality, organ dysfunctions, use of mechanical ventilation, continuous renal replacement therapy, and/or extracorporeal membrane oxygenation. A total of 817 children with severe pneumonia were admitted to PICU, and 203 of 817 cases (24.8%) with severe M. pneumoniae pneumonia were included in this study. The median age was 41 months (interquartile range, 20–67 mo), of which 77.3% (157/203) were younger than 6 years old. Among 163 patients with the test for macrolide resistance, 90.2% cases (147/163) were macrolide-resistant M. pneumoniae. Severe M. pneumoniae pneumonia-associated organ dysfunction included acute respiratory failure (203 cases, 100%), followed by cardiovascular disorder (79/203, 38.9%), gastrointestinal dysfunction (24/203, 11.8%). The main complications were pleural effusion (79/203, 38.9%), capillary leak syndrome (58/203, 28.6%), and plastic bronchitis (20/203, 9.9%). All patients needed respiratory support, including 64.5% patients (131/203) who received mechanical ventilation and 35.5% patients (72/203) who received high-flow nasal oxygen. Twenty-five patients (12.3%) treated with continuous renal replacement therapy and nine cases (4.4%) received extracorporeal membrane oxygenation. The case fatality rate was 3.9% (8/203). Furthermore, cardiovascular dysfunction, liver injury, or multiple organ dysfunction syndrome were associated with longer mechanical ventilation duration, delayed PICU discharge, and high hospital mortality. Coinfection was a risk factor of delayed PICU discharge.

Conclusions:
Children with severe M. pneumoniae pneumonia mainly occur under the age of 6 years, showing a high proportion of extrapulmonary organ dysfunction and macrolide resistances. Extrapulmonary organ dysfunction and coinfection are associated with worse outcomes. The overall mortality is relatively low after treated with appreciate antibiotics, respiratory support, and extracorporeal life support.
Clinical study of Dendrobium Nobile Lindl intervention on patients with metabolic syndrome
Authors: Zhang Xiaoyan , Wang Miao , Zhang Chengbo , Liu Zhidong , Zhou Shigao 
Published: March 2021

Abstract

Background:
Metabolic syndrome (MS) is a common chronic disease in modern society, and the etiology and pathogenesis of it is still unknown. For its main symptoms: disorder of glucose and lipid metabolism, the usual treatment is applying statin and hypoglycemic drugs. Comparing to the long-term application of these drugs which may cost great side effects, Dendrobium Nobile Lindl (DN) has been proved for its hypoglycemic and lipid-lowering effects without obvious side effects. So this trial is aim to evaluate the efficacy and safety of DN-powder in intervention of MS, and to explore the mechanism of action of DN through multi-group correlation analysis.

Methods:
This clinical trial is a single-arm, non-randomized, open, exploratory trial. A total of 30 participants who are suffering from MS will be assigned into therapy group (n = 30). The treatment course will last for 8 weeks, and a follow-up period for 4 weeks. The participants will receive DN-powder for 6 g, twice a day during the study period. The primary outcome will be the change of lipid and glucose metabolism. Other outcomes will be the body weight and body mass index (BMI) which will be assessments record in every 2 weeks. Participants who quit the trial due to untolerable reactions or uncontrollable conditions will enter into a follow-up period after the last treatment. All participants will enter into a follow-up period for 4 weeks after the last treatment. Adverse events will be recorded during the whole study.

Discussion:
The results of the trial are aim to provide evidence of the safety and efficacy of DN-powder in intervention of MS which may be potential to become an important alternative therapy for certain patients.

Trial registration:
It has been registered at http://www.chictr.org.cn/showprojen.aspx?proj=55914. (Identifier: ChiCTR2000034550), Registered 9 July 2020.
Carcinosarcoma and sarcomatoid carcinoma of the stomach
Authors: Li Youpeng , Cui Li , Chen Ying , Wang Furong 
Published: March 2021

Abstract

Rationale:
Carcinosarcoma and sarcomatoid carcinoma of the stomach are rare, malignant, and biphasic tumors with high mortality. The differential diagnosis of these 2 diseases remains challenging. In the present study, we present 2 cases of carcinosarcoma and sarcomatoid carcinoma of the stomach.

Patient concerns:
A 54-year-old woman was admitted with complaints of epigastric pain for 4 months, but she became serious for 10 days accompanied by melena. A 75-year-old man was admitted with complaints of epigastric pain for 1 month.

Diagnosis:
The female had a Borrmann type III irregular ulcerative lesion (5.0 × 4.0 × 1.0 cm) originating from the gastric antrum. The male had Borrmann type I tumor polypoid exophytic (5.0 × 4.0 × 2.0 cm) in the fundus of stomach near the cardia. Both cases were identified as malignant neoplasms by endoscopic biopsy and further confirmed by performing laparoscopic proximal gastrectomy, esophagogastrostomy, and palliative distal subtotal gastrectomy. The postoperative histopathological morphology and immunohistochemistry studies revealed sarcomatoid carcinoma for the female and gastric carcinosarcoma for the male respectively.

Interventions:
The female patient subsequently underwent laparoscopy-assisted radical distal gastrectomy for gastric cancer followed by systemic chemotherapy with oxaliplatin plus tegafur. The male patient underwent laparoscopic proximal gastrectomy and esophagogastrostomy were performed.

Outcomes:
The female had a mixture of a little poorly-differentiated adenocarcinoma and abundant sarcomatoid spindle cell elements, and is still alive healthy up to date for 2 and a half years after surgery by phone follow-up. The male patient had both adenocarcinoma and fibrosarcoma in a single tumor, and died 1 month after the operation.

Lessons:
The present study provides insight into the clinical findings, differential diagnosis, and prognosis of carcinosarcomas and sarcomatoid carcinomas of the stomach. More cases are needed for further studies in the future.
Pharmaceutical company payments to authors of the Japanese guidelines for the management of hypertension
Authors: Senoo Yuki , Saito Hiroaki , Ozaki Akihiko , Sawano Toyoaki , Shimada Yuki , Yamamoto Kana , Suzuki Yosuke , Tanimoto Tetsuya 
Published: March 2021

Abstract
Antihypertensive drugs have been of significant interest to the pharmaceutical industry due to increasing sales opportunities in a global market. The financial relationships between pharmaceutical companies and the Japanese Society of Hypertension (JSH) have a possible influence on clinical practices in Japan. This study examined the distribution of pharmaceutical payments made to the authors of the revised Guidelines for the Management of Hypertension (JSH2019) and the transparency of the Conflict of Interest disclosure that each author made.
We retrospectively obtained publicly available data regarding payments made by Japanese pharmaceutical companies to all authors of the JSH2019 in 2016. We also collected data on individual financial disclosure of JSH2019 authors to investigate whether their self-reported financial relationship with companies were compliant to the financial disclosure policy of JSH2019.
The total and mean payment values reported by pharmaceutical companies were $4,246,436 and $21,447, respectively. Of the 198 authors, 171 (86.4%) authors received at least 1 payment. Of 74 authors required to disclose their conflict of interest (COI) the authors, one-third failed to follow the COI policy covering the clinical guidelines.
Major pharmaceutical companies selling antihypertensive drug products in the Japanese market had a significant financial connection with the JSH2019 authors. Financial relationships between pharmaceutical companies and authors or Japanese medical societies are raising significant concerns about the credibility of clinical guidelines and the potentially biases and undue influences that they may cause, especially with respect to adverse prescription patterns.
Effectiveness and safety of music-supported therapy on mood in post-stroke rehabilitation patients
Authors: Ding Jie , Xiao Yuanyi , Yuan Fuqiang , Luo Zhaona , Hu Jinyu 
Published: March 2021

Abstract

Background:
Music-supported therapy has been widely used clinically to relieve post-stroke rehabilitation. However, the efficacy of Music-supported therapy in the treatment of Mood in post-stroke rehabilitation Patients is uncertain. The purpose of this study is to determine the effectiveness and safety of Music-supported therapy in the treatment of Mood in post-stroke rehabilitation Patients.

Methods:
Search PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure Database, Wanfang Database, China Science and Technology Journal Database, China Biomedical Literature Database, and search related randomized controlled trials. Two reviewers will independently select studies, collect data, and evaluate methodological quality through the Cochrane Deviation Risk Tool. Revman V.5.3 will be used for meta-analysis.

Results:
This study will evaluate the current status of Music-supported therapy treatment for mood in post-stroke rehabilitation Patients, aiming to illustrate the effectiveness and safety of Music-supported therapy treatment.

Conclusion:
This study will provide a basis for judging whether Music-supported therapy is effective in treating mood in post-stroke rehabilitation Patients.

INPLASY registration number:
INPLASY202120011.
His bundle pacing therapy for patients with chronic heart failure
Authors: Zhang Yongzheng , Ding Mingwang , Pu Zhihong , Peng Wenjia 
Published: March 2021

Abstract

Introduction:
A considerable amount of studies have been published with the results of clinical benefit from his bundle pacing (HBP) for chronic heart failure (CHF) patients and these researches led a uncertain conclusion for clinics. Thus, we will conduct a meta-analysis to evaluate the effect of his bundle pacing therapy for chronic heart failure.

Methods:
Pubmed, EMBASE, the Cochrane Library, Web of Science and Chinese online databases including Chinese National Knowledge Infrastructure, China Biology Medicine disc, Chinese Scientifific Journals Database (VIP), and Wanfang Database will be searched from these databases construction to the end of November, 2020. The STATA 13.0 will be used for data synthesis and meta-analysis.

Results:
The outcome measures included QRS duration, left ventricular ejection fraction, pacing threshold, New York Heart Association (NYHA), left ventricular end-diastolic diameter, left ventricular end-systolic diameter, mitral regurgitation, tricuspid regurgitation, and BNP will be analyzed and synthesized.

Conclusion:
This meta-analysis will evaluate the effect of his bundle pacing therapy for chronic heart failure.

Registration number:
INPLASY202110109.
Comparison of efficacy and safety of complementary and alternative therapies for coronary heart disease complicated with anxiety or depression disorder
Authors: Han Xueyan , Liu Xinxin , Zhong Fengxing , Wang Yiguo , Guan Hui , Zhang Qiming 
Published: March 2021

Abstract

Background:
With the acceleration of the pace of life, the phenomenon of anxiety and depression in patients with coronary heart disease (CHD) is more and more common, and “psycho-cardiology” arises spontaneously. At present, the drug treatments of psycho-cardiology are difficult to achieve satisfactory results, and the side effects are obvious. Complementary and replacement therapies of CHD complicated with anxiety or depression disorder play an increasingly positive role, but there is a lack of comparison among different complementary and alternative therapies. In this study, Bayesian network meta-analysis (NMA) analysis method will be used for the first time to synthesize all the evidences of direct and indirect comparison among a variety of interventions, and rank their effectiveness and safety.

Methods:
Two independent researchers will search from the beginning to January 2021 mainly including randomized controlled trials (RCTs) and closely related ongoing RCTs of complementary and alternative therapies for CHD complicated with anxiety or depression disorder. And then identify, select and extract the data. The primary outcome measures are frequency of acute attack angina, severity of angina pectoris; the changed score in the validated scales, which can assess severity of anxiety or depression. Secondary outcomes include total efficacy rate, electrocardiogram improvement, traditional Chinese medicine symptoms score, changes of dosage of nitroglycerin and adverse effects. Using softwares WinBUGS 1.4.3 and STATA 16.0 for pairwise meta-analysis and NMA to comprehensively evaluate various interventions. The quality of evidences will be evaluated through the Grading of Recommendations Assessment, Development and Evaluation.

Results:
This NMA will comprehensively compare and rank the efficacy and safety of a series of complementary and alternative therapies in the treatment of CHD complicated with anxiety or depression disorder.

Conclusion:
Supplementary and replacement therapies play an essential role in improving CHD complicated with anxiety or depression disorder. We expect that the NMA will provide reliable evidences of evidence-based medicine for treatment of CHD complicated with anxiety or depression disorder.

Protocol registration number:
INPLASY202120046.

Ethical approval:
This review does not require ethical approval.