bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-term assessment of crystalline lens transparency in eyes implanted with a central-hole phakic collamer lens developing low postoperative vault
Authors: Gonzalez-Lopez Felix , Bouza-Miguens Carmen , Tejerina Victor , Mompean Blas , Ortega-Usobiaga Julio , Bilbao-Calabuig Rafael 
Published: October 2020

Purpose:
To assess long-term crystalline lens transparency in eyes implanted with phakic collamer intraocular lens (pIOL) with a central port and low postoperative vault for correction of myopia.

Setting:
Clinica Baviera, Madrid, Spain.

Design:
Retrospective cross-sectional single-center study.

Methods:
Using a noninvasive Fourier-domain swept-source anterior segment optical coherence tomography system, shifts in myopic and astigmatic myopic eyes implanted with a pIOL with vaulting lower than 100 μm in miosis and more than 4 years of follow-up were dynamically evaluated. Main outcome measures were pIOL dynamic vault (vault interval and vault range [VR]), crystalline lens density, and anterior subcapsular lens opacities. Crystalline lenses were examined under slitlamp microscopy, and lens density was evaluated using quantitative Scheimpflug images. Scheimpflug images were compared with those of a control group comprising eyes that were candidates for pIOL implantation.

Results:
The study population comprised 24 eyes from 16 patients previously implanted with a pIOL (5.82 ± 0.9 years) with central vault lower than 100 μm under photopically induced miosis. The mean vault value was 52 ± 19 µm under photopic light conditions and 113 ± 37 µm under scotopic conditions. The mean VR was 58 ± 24 μm. Anterior subcapsular lens opacities were found in only 1 eye (4.17%). The mean lens density was 7.94 ± 0.43, and no statistically significant differences were observed compared with the control group.

Conclusions:
Long-term low vaulting in eyes implanted with a pIOL with a central port for correction of myopia was associated with a low risk for developing anterior crystalline lens opacities.
Recurrent trigeminocardiac reflex in percutaneous balloon compression for trigeminal neuralgia
Authors: Qin Qin , Wang Yaping 
Published: October 2020

Abstract

Rationale:
Trigeminocardiac reflex (TCR) sometimes occurs during the percutaneous balloon compression (PBC) procedure to treat trigeminal neuralgia (TN), and it manifests as transient bradycardia or sinus arrest. However, recurrent intraoperative TCR cases are rarely reported. Meanwhile, the treatment for recurrent TCR is still unclear.

Patient concerns:
A 74-year-old male with a 2-year TN history could no longer tolerate the side effects of carbamazepine and came to seek PBC treatment.

Diagnoses:
Bradycardia or sinus arrest occurred repeatedly during the operation, and the heart rate (HR) rapidly returned to normal when the operation was suspended. The C-arm image showed the puncture needle entering the foramen ovale.

Interventions:
First, 0.5 mg atropine was administered twice, and then 1 mL of 2% lidocaine was injected locally at the puncture site. Finally, isoproterenol was continuously pumped and dynamically adjusted to maintain the HR above 90 bpm.

Outcomes:
The use of atropine and lidocaine did not prevent the recurrence of TCR. The use of isoproterenol to maintain the HR enabled the successful completion of the operation. The patient recovered quickly after the operation and was discharged 2 days later. No complaints of discomfort were reported during the sixth-month follow-up.

Lessons:
The elimination of intraoperative TCR may be difficult. Maintaining a high HR intraoperatively by continuous isoproterenol infusion is effective for preventing or mitigating the onset of TCR.
The influence of hypoglycemia and hyperglycemia on the adverse outcome of COVID-19 combined with diabetes mellitus
Authors: Yang Yan , Chen Xiumei Fan Dongqiong , Chen Yalin , Xie Hongyan , Xie Chunguang , Ying Lipin 
Published: October 2020

Abstract

Background:
COVID-19 has become a global epidemic, causing huge loss of life and property. Diabetes will affect the prognosis of COVID-19 patients in many ways. Both hyperglycemia and hypoglycemia can affect oxidative stress and lead to the release of inflammatory mediators, leading to multiple organ damage and chronic inflammation. Here, we want to know whether hyperglycemia or hypoglycemia will adversely affect patients with diabetes and COVID-19 comorbidities. This has very important practical significance for the control of blood glucose in the treatment of diabetes combined with SARS-COV-2 infection.

Methods:
We will search electronic databases including PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), and Wanfang database using keywords related to COVID-19, diabetes mellitus, hyperglycemia and hypoglycemia. We will manually search gray literature, such as conference proceedings and academic degree dissertations, and trial registries. Two independent reviewers will screen studies, extract data, and evaluate risk of bias. Data analysis will be conducted using the Review Manager software version 5.3.5 and STATA4.0 software for Mac. The main outcome was the mortality of COVID-19 which was included in meta-analysis and subgroup analysis. The bias of the study was evaluated independently by NOS scale, and published by funnel chart. The sensitivity was analyzed row by row.

Results:
This study will provide a high-quality synthesis of hyperglycemia and hypoglycemia in patients with COVID-19 combined with diabetes mellitus. To provide evidence for clinical treatment of diabetes mellitus combined with COVID-19. And the results will be published at a peer-reviewed journal.
INPLASY registration number INPLASY 202080096.
Preferences in end of life care substantially differ between the Netherlands and Japan
Authors: Groenewoud A. Stef , Sasaki Noriko , Westert Gert P. , Imanaka Yuichi 
Published: October 2020

Abstract
Strategies to increase appropriateness of EoL care, such as shared decision making (SDM), and advance care planning (ACP) are internationally embraced, especially since the COVID-19 pandemic. However, individuals preferences regarding EoL care may differ internationally. Current literature lacks insight in how preferences in EoL care differ between countries and continents. This study's aim is to compare Dutch and Japanese general publics attitudes and preferences toward EoL care, and EoL decisions. Methods: a cross-sectional survey design was chosen. The survey was held among samples of the Dutch and Japanese general public, using a Nationwide social research panel of 220.000 registrants in the Netherlands and 1.200.000 in Japan. A quota sampling was done (age, gender, and living area). N = 1.040 in each country.
More Japanese than Dutch citizens tend to avoid thinking in advance about future situations of dependence (26.0% vs 9.4%; P = .000); say they would feel themselves a burden for relatives if they would become dependent in their last phase of life (79.3% vs 47.8%; P = .000); and choose the hospital as their preferred place of death (19.4% vs 3.6% P = .000). More Dutch than Japanese people say they would be happy with a proactive approach of their doctor regarding EoL issues (78.0% vs 65.1% JPN; P = .000).
Preferences in EoL care substantially differ between the Netherlands and Japan. These differences should be taken into account a) when interpreting geographical variation in EoL care, and b) if strategies such as SDM or ACP – are considered. Such strategies will fail if an international “one size fits all” approach would be followed.
Structural equation modeling test of the pre-intentional phase of the health action process approach (HAPA) model on condom use intention among senior high school students in Tianjin, China
Authors: Xu Fang , Bu Kai , Chen Fangfang , Jin Shanshan , Zhang Hanxi , Zhang Dong , Sun Caixia , Wang Ning , Han Mengjie , Wang Lu 
Published: October 2020

Abstract
Based on the Theory of Health Action Process Approach (HAPA) Model, this study aimed to investigate factors associated with condom use intention in Chinese adolescents.
In 2017, we conducted a cross-sectional study using stratified cluster, convenience sampling method to assess condom use intention among senior high school students in Tianjin, China. One thousand eighty two senior high school students were anonymously surveyed through self-administered questionnaires. Structural equation modelling was used to assess the pre-intentional phase of HAPA model.
Among the participants, 41.5% (449/1082) were male, 54.1% (585/1082) were female, 4.4% (48/1082) were gender-deficient. The average age was 16.7 years. The final pre-intentional phase of HAPA model was acceptable (CFI = 0.95; GFI = 0.94; RMSEA = 0.06). Action self-efficacy (r = 0.60) had a strong direct effect on condom use intention.
The pre-intentional phase of HAPA model is valid to assess condom use intention among Chinese senior high school students. The pre-intention phase of the HAPA model could be applied to guide AIDS health educations of students, and further research is needed to evaluate the effect.
Single versus bilateral internal thoracic artery grafting in patients with low ejection fraction
Authors: Farkash Ariel , Pevni Dmitri , Mohr Rephael , Kramer Amir , Ziv-Baran Tomer , Paz Yosef , Nesher Nahum , Ben-Gal Yanai 
Published: October 2020

Abstract
Coronary artery bypass grafting (CABG) is the standard of care for the treatment of complex coronary artery disease. However, the optimal surgical treatment for patients with reduced left ventricular function with low ejection fraction (EF) is inconclusive. In our center, left-sided coronary grafting with bilateral internal thoracic artery (BITA) is generally the preferred method for surgical revascularization, also for patients with low EF. We compared early and long-term outcomes between BITA grafting and single internal thoracic artery (SITA) grafting in patients with low EF.
We evaluated short- and long-term outcomes of all patients who underwent surgical revascularization in our center during 1996 to 2011, according to EF ≥30% and <30%. Univariate and multivariate analyses were performed. In addition, patients who underwent BITA and SITA grafting were matched using propensity score matching.
In total, 5337 patients with multivessel disease underwent surgical revascularization during the study period. Of them, 394 had low EF. Among these, 188 underwent SITA revascularization and 206 BITA grafting. Those who underwent SITA were more likely to have comorbidities such as chronic obstructive pulmonary disease, diabetes, congestive heart failure, chronic renal failure, and a critical preoperative condition including preoperative intra-aortic balloon pump insertion.
Statistically significant differences were not observed between the SITA and BITA groups in 30-day mortality (8.5% vs 6.8%, P = .55), sternal wound infection (2.7% vs 1.0%, P = .27), stroke (3.7% vs 6.3%, P = .24), and perioperative myocardial infarction (5.9% vs 2.9%, P = .15). Long-term survival (median follow up of 14 years, interquartile range, 11.2–18.9) was also similar between the groups. Propensity score matching (129 matched pairs) yielded similar early and long-term outcomes for the groups.
This study did not demonstrate any clinical benefit for BITA compared with SITA revascularization in individuals with low EF.
Effectiveness and safety of massage for knee osteoarthritis
Authors: Qin Siyu , Chi Zhenhai , Xiao Yuanyi , Zhu Daocheng , Zhong Genping , Xu Wei , Ouyang Xilin , Li Jun , Cheng Pan , Yu Ting , Li Haiyan , Jiao Lin 
Published: October 2020

Abstract

Background:
Knee osteoarthritis (KOA), a concerning public health problem, seriously threatens well being of human beings. At present, studies have shown that massage therapy is effective in relieving related symptoms of KOA. However, the evidence of massage for KOA has not been systematically evaluated. Therefore, the study is conducted to systematically assess the reliability of patients with KOA treated by massage.

Methods:
We will retrieve the relevant literature of massage for KOA from PubMed, Cochrane Library, EMBASE, Web of Science, Wanfang, Chongqing VIP, CNKI, and Chinese Biomedical Literature Database from the establishment of the databases to August 1, 2020. Two researchers will independently perform the screening of literature and extract the basic information of the data. In addition, RevMan V.5.3 software will be used for data analysis.

Results:
The study will comprehensively assess the effect of massage for KOA.

Conclusion:
The study will provide comprehensive evidence for evaluating whether massage therapy is useful in treating patients with KOA.

INPLASY registration number:
INPLASY202080115.
A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections
Authors: Sun Feng , Xu Xiao-Lei , Lu Yan-Qiu , Chen Yao-Kai 
Published: October 2020

Abstract

Background:
Asymptomatic cryptococcal antigenemia is a state of cryptococcal infection commonly seen in immunocompromised HIV-infected persons. Without early intervention, a proportion of HIV-infected persons with cryptococcal antigenemia may go on to develop cryptococcosis, especially cryptococcal meningitis, which is associated with high mortality. The benefits of antifungal intervention and optimal therapeutic intervention regimens for HIV-infected persons with cryptococcal antigenemia remain controversial. We therefore designed the present study in order to investigate the necessity of, and the optimal regimens for antifungal intervention in the clinical management of cryptococcal antigenemia in HIV-infected populations.

Methods/Design:
This study will be an open-labeled, multi-center, prospective, randomized controlled trial, and 450 eligible participants will be randomized into a control arm and 2 intervention arms at a 1:1:1 ratio, with 150 subjects in each arm. Participants in the control arm will not receive antifungal treatment during the study period. Participants in intervention arm 1 will receive oral fluconazole 800 mg/day for 2 weeks, followed by 400 mg/day for 8 weeks and 200 mg/day for 42 weeks, and participants in intervention arm 2 will receive oral fluconazole 400 mg/day for 52 weeks. The primary outcome is the incidence of CM among the 3 groups during the study period. The secondary outcomes include the differences in all-cause mortality, proportion of patients reverting to blood CrAg negativity, change of CrAg titers, and adverse events among the 3 groups during the follow-up period.

Discussion:
We envisage that the results of this study will reveal the necessity of, and the optimal therapeutic regimens for, antifungal intervention in clinical management of HIV-infected patients with cryptococcal antigenemia.

Trial registration:
The study was registered as one of the 12 clinical trials under a general project at the Chinese Clinical Trial Registry on February 1, 2019, and the registration number of the general project is ChiCTR1900021195.
Prevalence of and lifestyle factors associated with metabolic syndrome determined using multi-level models in Chinese adults from a cross-sectional survey
Authors: Xu Tao , Zhu Guangjin , Han Shaomei 
Published: October 2020

Abstract
People living in the same area are more likely to experience similar socioeconomic characteristics, which leads to cluster effect and influences the generalizability of data regarding metabolic syndrome (MetS). However, previous studies did not consider or adjust for the cluster effect of living circumstances. The aim of this study was to determine the prevalence of MetS and associated lifestyle factors in Chinese adults 18 to 80 years of age, using multi-level generalized estimation equation (GEE).
The participants came from a large-scale cross-sectional population survey. A total of 28,062 participants underwent all the blood tests. Participants meeting at least 3 of the 5 diagnostic criteria were defined as having MetS. Multi-level GEE was used to evaluate the relationship between MetS and lifestyle covariates to control the cluster effect of living circumstances. Odds ratios (ORs) and their 95% confidence intervals (CIs) were used to assess the strength of each relationship.
A total of 65.70% of the participants had at least 1 clinical feature of MetS, and 2926 were diagnosed with MetS (prevalence 14.03%). 32.74%, 18.93%, 10.25%, 3.25%, and 0.53% of the participants had 1, 2, 3, 4, and 5 components, respectively. The prevalence of MetS in men (12.31%) was lower than in women (15.57%). After controlling for the cluster effect of living circumstances, many demographic and lifestyle characteristics were associated with MetS. Overweight (OR = 1.670, 95%CI: 1.600–1.743), obesity (OR = 2.287, 95% CI: 2.136–2.449), current alcohol consumption (OR = 1.053, 95% CI: 1.020–1.086), physical labor (OR=1.070, 95% CI: 1.040–1.101), a high-salt diet (OR=1.040, 95% CI: 1.009–1.071), hyperuricemia (OR=1.264, 95% CI: 1.215–1.316), short sleep duration (OR=1.032, 95% CI: 1.009–1.055), and a family history of cardiovascular disease (OR=1.065, 95% CI: 1.019–1.113), or cerebrovascular disease (OR=1.055, 95% CI: 1.007–1.104) increased the risk of MetS. The risk of MetS increased 6.9% (OR = 1.069, 95% CI: 1.053–1.085) with each 5% increase in body fat percentage.
MetS has become a serious public health challenge in China. Many lifestyle factors have been found to be closely associated with MetS, including obesity, a high-salt diet, alcohol consumption, and short sleep duration. Therefore, changes in lifestyle are very important for adults to reduce the prevalence of MetS.
Disease duration before surgical resection for chronic pancreatitis impacts long-term outcome
Authors: Willner Antonie , Bogner Andreas , Müssle Benjamin , Teske Christian , Hempel Sebastian , Kahlert Christoph , Distler Marius , Weitz Jürgen , Welsch Thilo 
Published: October 2020

Abstract
Many patients with chronic pancreatitis (CP) undergo a step-up approach with interventional procedures as first-line treatment and resection reserved for later stages. The aim of this study was to identify predictive factors for a significant clinical improvement (SCI) after surgical treatment.
All patients operated for CP between September 2012 and June 2017 at our center was retrospectively reviewed. A prospective patient survey was conducted to measure patients postoperative outcome. The primary endpoint SCI was defined as stable health status, positive weight development and complete pain relief without routine pain medication. Additionally, risk factors for relaparotomy were analyzed.
A total of 89 patients with a median follow-up of 38 months were included. In most cases, a duodenum-preserving pancreatic head resection (n = 48) or pancreatoduodenectomy (n = 28) was performed. SCI was achieved in 65.3% (n = 47) of the patients after the final medium follow-up of 15.0 months (IQR: 7.0–35.0 months), respectively. Patients with a longer mean delay (7.7 vs 4 years) between diagnosis and surgical resection were less likely to achieve SCI (P = .02; OR .88; 95%CI .80–98). An endocrine insufficiency was a negative prognostic factor for SCI (P = .01; OR .15; 95%CI .04–68). In total, 96.2% of the patients had a complete or major postoperative relief with a mean pain intensity reduction from 8.1 to 1.9 on the visual analogue scale.
The results support that surgical resection for CP should be considered at early stages. Resection can effectively reduce postoperative pain intensity and improve long-term success.
Anti-PD-1 antibody therapy for epithelial skin malignancies
Authors: Ishii Maki , Hirai Ikuko , Tanese Keiji , Fusumae Takayuki , Nakamura Yoshio , Fukuda Keitaro , Uchi Hiroshi , Kabashima Kenji , Otsuka Atsushi , Yokota Kenji , Yamazaki Naoya , Namikawa Kenjiro , Fujimura Taku , Takenouchi Tatsuya , Yamamoto Yuki , Nishiguchi Mana , Sato Yasunori , Amagai Masayuki , Funakoshi Takeru 
Published: October 2020

Abstract

Introduction:
Malignant cutaneous epithelial tumors comprise various skin malignancies originating from the cutaneous epithelium, including cutaneous squamous cell carcinoma, basal cell carcinoma, and malignant cutaneous adnexal tumors. Treatment options are limited, as the rarity of these tumors, especially among Asians, renders well-controlled clinical trials extremely challenging to conduct. Thus, we designed a clinical trial to evaluate the efficacy and safety of the anti-programmed cell death-1 (PD-1) monoclonal antibody nivolumab in patients with metastatic cutaneous squamous cell carcinomas and other rare metastatic cutaneous epithelial tumors.

Methods and analysis:
This is an open-label, single-arm, multicenter, phase 2 clinical trial involving patients with metastatic malignant cutaneous epithelial tumors. Nivolumab (480 mg) will be administered intravenously every 4 weeks for a maximum of 26 doses. The primary outcome of the study will be the response rate based on response evaluation criteria in solid tumors, version 1.1. Assuming a null hypothesis of a response rate ≤5% and an alternative hypothesis of a 25% response rate, a minimum of 26 patients are required to achieve a 5% two-sided type I error and 80% power based on the exact binomial distribution. Finally, a target cohort size of 30 patients was determined as some patient dropout will be expected.

Discussion:
This is the first phase 2 clinical trial evaluating the efficacy and safety of the PD-1 inhibitor nivolumab in Asian patients with metastatic malignant cutaneous epithelial tumors. The findings of the study will contribute to the development of novel treatment approaches for patients with rare cutaneous malignancies, which remains an unmet clinical need.

Trial registration:
Registry number: jRCT 2031190048
Placebo use and outcome quality
Authors: da Silva Juliana C. R. Alves , de Azevedo Kesley Pablo Morais , Farinasso Cecília Menezes , da Silva Dayde Lane Mendonça , Stefani Cristine , Figueiredo Ana Cláudia Morais Godoy , de Souza Patrícia Medeiros , Piuvezam Grasiela , Capucho Helaine Carneiro 
Published: October 2020

Abstract

Background:
The Pharmaceutical industry sponsorship, research outcome and quality has been already evaluated for clinical trials in order to analyze if this kind of sponsorship affects the results of clinical trials. In this sense, this study has the aim to investigate whether placebo use allows positive outcomes regarding efficacy and safety compared to synthetic medicines.

Methods:
We designed and registered a study protocol for a systematic review for methodology data. We will only randomized clinical trials that use placebo as comparator. The main outcome will be the evaluation of placebo use regarding the tendency for positive results (efficacy and security) when comparing to synthetic medicines. PubMed, Cochrane, LILACS (BVS), Web of Science, Scopus, and Excerpta Medica dataBASE (EMBASE) databases will be searched. Gray literature will be identified through the databases Proquest (Dissertation and Theses), OpenGrey and Google Scholar. Two review authors will independently assess trial quality and will extract data in accordance with standard Cochrane methodology. If necessary, we will also contact authors for additional information. The Cochrane Collaboration's risk of bias tool will be used. If feasible, it means homogenous data, we will conduct random effects meta-analysis. Subgroup analyses will be conducted for different justifications for placebo use and for studies sponsored/not sponsored by the pharmaceutical industry.

Results:
Our present findings will indicate the effects of placebo use as comparator regarding efficacy and safety of the oral synthetic medicines.

Discussion:
This systematic review will identify, summarize, and analyze if there is a trend for positive efficacy and safety results for synthetic medicines in clinical trials when compared with placebo and if the justification for placebo use is considered ethically acceptable.

Systematic review registration:
PROSPERO CRD42018110829