bluuebunny/crossref_metadata_2025 huggingface dataset:
Illicit Trade and Smuggling
Authors: Kemp Paul , Galemba Rebecca
Published: October 2020

In this article, illicit trade and smuggling refer to the unauthorized sale, purchase, exchange, or transport of goods, persons, animals, or technology across borders. Illicit trade across borders may entail goods considered dangerous, those that circumvent prohibitions in one or both countries, or mundane items and population movements that evade controls or regulations. However, smuggled goods may be produced, consumed, or recirculated legally, informally, or illegally. Lacking a universal, global set of norms and regulations across time, much of what is considered to be illicit trade may be legal in one place while prohibited in another, or tolerated in one time and banned in another. The forms smuggling takes and its profitability are shaped by regulations, their inconsistent application, and their differences across different regulatory spheres. Illicit trade often dovetails with legal global trade; forms of integration from below may proceed alongside, compete with, resist, or even complement and foster legal global economic flows. Power relations, within countries and wielded by more powerful nations with influence to shape trade agreements, trade policies, financial norms, and global prohibition regimes, normalize the kinds of international trade considered legal and beneficial and foster the criminalization of competing alternatives. Yet, such norms are not necessarily widely shared or consistently applied and implemented. Individuals engaging in forms of illicit trade and smuggling may not share the perspective of states or international organizations regarding the morality and legitimacy of their actions. Scholars contend that perceptions of illicit trade risk perpetuating seeing like a state, making historical and comparative perspectives paramount. Not everything the state does is moral and not every aspect of illicit trade is amoral. This may pertain especially with respect to the marginalized; extra-legal trade may provide a mode of subsistence, and state regulations may be experienced as selective, predatory, and protective of elite privilege and prevailing arrangements of inequality. States have the power to determine what is legal or criminal in the first place. Yet critical perspectives also point to how states and elite actors may benefit not only from forms of corruption, but also from illicit trade more broadly such that illicit trade is constitutive of state power, bureaucratic expansion, and international norms. Debate persists regarding whether illicit markets stabilize, build, compete with, or destabilize governance arrangements. Scholars also disagree whether illicit trade has grown, facilitated by globalization, or whether perceptions of this rising threat are shaped more by questionable numbers, state/private interests, and changing prohibitions.
Health-Care Politics in the United States
Authors: Peterson Lauren , Grogan Colleen
Published: October 2020

Comparative studies of health care in the United States and peer nations often highlight a number of distinct features of the American system including high costs, fragmentation, and health inequities. While unique political factors and institutions in the United States are prominent reasons for these disparities, there are also distinct interactions between American politics and cultural, economic, racial, and social factors. Many comprehensive overviews of American health politics and policy begin in the 20th century highlighting the important influence of global and national historical events, such as World Wars I and II, and social movements, including the civil rights movement. Yet, health-care politics in the United States also continues to be shaped by early American history, government institutions, and systems. To understand health-care policy in the United States, it is also necessary to consider the legacy of other non-health factors and their intersections with health politics, including slavery and ongoing racism, early Protestant notions of mortality and self-reliance, the localized nature of private charity and volunteerism, federalism, a public distrust of federal government, and the evolution of health professions, among other factors. Often these historical events and other cultural, economic, or social factors significantly shape public opinion, political participation, and health-care inequities, and in some cases, provide a window of opportunity to advance important health-care reforms. The structure of American government institutions, political parties and growing polarization, unique attributes of elected leaders or policy entrepreneurs, and the power of interest groups, particularly private actors in the health care delivery system, are all significant factors that shape health-care politics in the United States. Contemporary American public health policy literature focuses on efforts to reduce health inequities and improve access to health care as well as the politics of recent reform ideas that promote government regulation and investments in non-health factors such as the environment and social services to reduce population health inequities.
Referendums and Direct Democracy
Authors: Qvortrup Matt
Published: October 2020

Referendums have been defined as popular votes on bills before they become laws. However, referendums can also be held on existing laws or constitutions (as in the cases of the British referendum on membership in the European Union in 2016 or the Irish vote on abortion in 2017). In addition to these types, there are initiatives, defined as popular votes on laws proposed by the citizens, and plebiscites, which are votes by the whole population in authoritarian states. Scholars have sometimes disagreed as to the definition of referendums. Some have adopted the general umbrella term MDD (Mechanisms of Direct Democracy) to cover all these different types of institutionalized direct or semidirect democracy. But the word referendum has been used as the general signifier.
Education in New Spain
Authors: Tanck de Estrada Dorothy , Cid Víctor
Published: October 2020

New Spain, also known as Colonial Mexico, existed for three hundred years, from 1521 to 1821. These dates mark the defeat of the Aztecs and the inauguration of the first independent government of Mexico at the end of the war of independence. Hernán Cortés in 1520 proposed calling the land the “New Spain of the Ocean Sea” because of its similarity to Spain in its fertility, size, and climate. New Spain extended from Chihuahua in the north to Oaxaca and Yucatán in the south. In 1810, the total population was 6,111,915 inhabitants, made up of Indians (60 percent), Mestizos (22 percent), and Spaniards and Creoles (18 percent). Twenty Spanish cities were spread over the territory, Mexico City having in 1793 a population of 112,926 inhabitants and Puebla, 52,717. Most of the Indian population lived in 4,468 towns where the natives headed their municipal governments. For all groups primary education was very important as the means of religious instruction. Girls and boys were educated separately. Private teachers and religious orders headed primary schools during the first two centuries, while important changes occurred in the 18th century with legislation ordering cities and Indian towns to establish schools funded by the municipal treasuries. The Jesuits also had primary schools, while girls could receive early education in religious houses called “beaterios” where the teachers (“beatas”) were women with temporary vows of poverty, chastity, and obedience. The convents for nuns were all cloistered institutions without schools for girls, until the end of the 18th century when a newly established teaching order opened a large school. The Jesuit colleges located throughout New Spain offered the next level of education called “Artes,” which consisted of courses in Latin, rhetoric, logic, physics and metaphysics to prepare students for urban life or for university education. In the colonial period, the term “college” signified middle-level education between primary and university studies. The University of Mexico, founded in 1551, with degrees in medicine, civil law, canon law, and theology, was the only center of higher education in New Spain until the University of Guadalajara opened in 1792. New primary level textbooks written by local authors began to be used in schools late in the 18th century. The following sections present bibliographies related to the above topics.
Long-term changes of ichthyoplankton communities in an Iberian estuary are driven by varying hydrodynamic conditions
Authors: Monteiro M , Azeiteiro U M , Martinho F , Pardal M A , Primo A L
Published: October 2020

Ichthyoplankton assemblages are key components of estuaries worldwide, playing a vital role as nurseries for fish larvae. Nonetheless, estuaries can be highly affected by ongoing climate change. Impacts of climate variability on ichthyoplankton assemblages will have consequences for marine pelagic food webs and fish populations biology, namely recruitment. This study aims to investigate the influence of environmental variability on an interannual abundance of ichthyoplankton assemblages of the Mondego estuary (Portugal). For this, an ichthyoplankton sampling programme of 13 years (2003–2015) along six distinct sampling stations was analysed to evaluate spatial, seasonal and interannual changes of ichthyoplankton distribution over periods of wet, regular and dry conditions. The ichthyoplanktonic community was dominated by Pomatoschistus spp. across all seasons and conditions, with higher larval abundances during summer and spring. Main changes were related to species seasonality and phenology as well as an increase in the number of marine species during extreme events. The larval fish community showed a strong relationship with the regional and local environment over the study, presenting a distinct yet highly variable structure during the 2009–2013 period. Reported changes will likely trigger major changes in species dominance and abundance, with clear ecological and socio-economic implications.
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

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

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

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

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

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

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

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

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

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

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

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
Thoracic vertebral metastasis from progressive hepatocellular carcinoma following liver transplantation combined with resection of mesenteric and colonic metastases
Authors: Hu Jingen , Hu Caibao
Published: October 2020

Rationale:

Surgical treatment of spinal hepatocellular carcinoma metastasis after Liver transplantation (LT) is a clinical challenge. We herein report the clinical outcomes of the first case of a patient with T11 from hepatocellular carcinoma metastasis after systemic chemotherapy following LT combined with mesenteric resection and colectomy, who was successfully treated with En Bloc spondylectomy.

Patient concerns:

The patient with HCC was a 40-year-old man, who had received LT combined with mesenteric resection and colectomy 15 months before. His main symptom was progressive back pain because of T11 metastasis. PET examinations showed a solitary metastasis at T11 without recurrence in the liver and metastasis in the other organs.

Diagnosis:

The patient was diagnosed with the T11 vertebra HCC metastasis after LT combined with resection of HCC mesenteric metastasis and colon metastasis.

Interventions:

Five cycles of systemic chemotherapy following LT were performed for preventing HCC metastases. However, the right abdominal wall metastasis was found 9 months after LT, followed by T11 metastases thereafter. Immediate resection of the right abdominal wall metastasis was achieved. En Bloc spondylectomy of T11 vertebra was chosen as a treatment for metastasis to T11. After T11 surgery, the patient showed obvious pain relief. However, At 3 months after T11 surgery, a grafted liver metastasis and multiple nodules metastasis in the greater omentum region were revealed with CT imaging, At 5 months after T11 surgery, multiple lung metastases were discovered by MRI. The patient was performed 5 cycles of chemotherapy, 3 times of infusion of iodine [131I] meximab and 3 times of TACE after T11 surgery. Multiple bone metastases were treated with radiotherapy.

Outcomes:

The patient died 29 months after LT combined with mesenteric resection and colectomy because of recurrence in the liver and metastasis in the lung.

Lessons:

En Bloc spondylectomy may be a therapeutic choice for patients with progression after systemic chemotherapy for the solitary spinal metastases after LT combined with mesenteric resection and colectomy, which has a survival benefit without local recurrence at the surgical site. immunosuppressant after LT may result in worse immune function, which leads to HCC more prone to recurrence and bone metastasis.
Effect of herbal medicine Shenghua decoction on uterine bleeding after early medical abortion
Authors: Cheng Ran , Liu Shuhua , Gu Jianghong , Xu Lvyan
Published: October 2020

Background:

Excessive and prolonged uterine bleeding is an important obstacle for medical abortion to get popularized. Shenghua decoction (SHD) is widely used for treating uterine bleeding after early medical abortion. However, the clinical evidence is unclear.

Methods:

Two researchers will dependently search literatures of SHD for the treatment of uterine bleeding after medical abortion from Web of Science, PubMed, Embase, and The Cochrane Library; traditional Chinese medicine databases; China National Knowledge Infrastructure (CNKI); Chinese Scientific Journal Database (VIP database); and Wan-Fang Database. These inclusive data of included studies will be conducted by RevMan V5.3 software.

Results:

This systematic review and meta-analysis will provide a detailed summary of the current evidence related to the efficacy of SHD in treating uterine bleeding after early medical abortion, including the duration and volume of uterine bleeding, the medical abortion pain.

Conclusion:

This systematic review and meta-analysis will provide a detailed summary of the current evidence related to the efficacy of SHD in treating uterine bleeding after early medical abortion,

Registration Number:

PROSPERO CRD42020184465.
Effect of phenotypic detection of circulating tumor cells marked by epithelial-mesenchymal transformation on the prognosis of lung cancer
Authors: Ge Bin , Wang Yong , Lei Shaoqing , Zhang Jincao
Published: October 2020

Background:

To explore the significance of phenotype detection of circulating tumor cells (CTCs) based on epithelial-mesenchymal transition (EMT) labeling to evaluate the prognosis of lung cancer.

Methods:

Database was retrieved from China National Knowledge Infrastructure (CNKI), Chinese Biomedical literature Database (CBM), Chinese Scientific and Journal Database (VIP), Wan Fang database, PubMed, and EMBASE. Based on EMT on overall survival (OS) and disease-free survival (DFS), hazard ratios (HRs) and its 95% of confidence intervals (CIs) were applied to assess the prognostic effect of CTCs. RevMan 5.3 and STATA 16.0 software were adopted to perform the meta-analysis.

Results:

Based on EMT in terms of the prognosis of patients suffering from lung cancer, this study comprehensively reviewed and evaluated the available evidence of phenotype detection of CTCs.

Conclusion:

Based on EMT in the prognosis of patients who developed with lung cancer, our findings proved the effect of phenotype detection of CTCs. Such studies may reveal a new prognostic marker for lung cancer patients and help clinicians and health professionals make clinical decisions.

OSF Registration Number:

DOI 10.17605/OSF.IO/E7KAZ.
Efficacy of radial extracorporeal shock wave therapy for chronic prostatitis/chronic pelvic pain syndrome
Authors: Li Guangsen , Chang Degui , Chen Di’ang , Zhang Peihai , You Yaodong , Huang Xiaopeng , Cai Jian , Yang Xuesong
Published: October 2020

Background:

Prostatitis is a common urogenital system disease in men which affects 5% to 9% of adult men worldwide and accounts for approximately 8% of visits to urologists. In the past years, its pathogenesis is complicated and the classification of it is not clear, so the effect of treatment measures is not significant. Recently, the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) includes nonsteroidal anti-inflammatory drugs, phytotherapy, hormonal therapy, alpha-blockers, anti-anxiolytic, and acupuncture, which provide more choice for the urologist. But there still are some limitations. scholars. Many studies suggest radial extracorporeal shock wave therapy may be the better option in the treatment of CP/CPPS. However, the efficacy and safety of it still lack solid evidence.

Methods and analysis:

The electronic databases of MEDLINE, PubMed, Web of Science, EMBASE, Cochrane Library, Clinicaltrials.org, China National Knowledge Infrastructure Database, Wan fang Database, China Biology Medicine Database, VIP Science Technology Periodical Database, Chinese Clinical Trial Registry will be retrieved. All the randomized controlled trials of radial extracorporeal shock wave therapy (rESWT) for patients with CP/CPPS will be included. We will evaluate the outcomes including National Institutes of Health Chronic Prostatitis Symptom Index, visual analog scale, international prostate symptom score, international index of erectile function-5, and conduct this study strictly according to the Cochrane Handbook for Systematic Reviews of Interventions.

Results:

The current study is a protocol for systematic review and meta-analysis without results, and data analysis will be carried out after the protocol. We will share our findings on October 31st of 2021.

Conclusion:

rESWT as a noninvasive treatment with no pain, which will be accepted more easily. Although some studies have suggested that rESWT can relieve the symptoms of patients, the efficacy and safety of it still lack solid evidence. To address this limitation scientifically and systematically, this study will inspect the efficacy and safety of the rESWT treatment in patients with CP/CPPS by integrating various studies.

Ethics and dissemination:

Formal ethical approval is not required in this protocol. We will collect and analyze data based on published studies, and since there are no patients involved in this study, individual privacy will not be under concerns. The results of this review will be disseminated to peer-reviewed journals or submit to related conferences.

Protocol registration number:

INPLASY202090076
Treatment of atypical gouty arthritis of the hip using total hip arthroplasty
Authors: Huang Yuyang , Huang Jiongfeng , Luo Cheng , Chen Li’an , Huang Bingsheng
Published: October 2020

Rationale:

Gout and gouty arthritis typically involve peripheral and monoarticular joints, especially the first metatarsophalangeal joint and knees. Hip involvement in patients with gout is rare, and its diagnosis is very difficult, especially in the late stages of the disease. Total hip arthroplasty could be a surgical treatment for atypical gouty arthritis of the hip; however, few cases have been reported.

Patient concerns:

We reported an uncommon case of a 74-year-old man without typical symptoms of hip gout arthritis whom was misdiagnosed as having avascular necrosis of the femoral head.

Diagnoses:

Clinical examination and imaging revealed bilateral avascular necrosis of the femoral head. However, the final pathology report revealed left hip gout arthritis.

Interventions:

The patient underwent left total hip arthroplasty and was followed up for 3years.

Outcomes:

The outcome was favorable. The function of the left hip was almost normal.

Lessons:

Our case indicated the difficulty of the diagnosis of hip gout arthritis. Due to the lower rates of hip gout arthritis and lack of typical clinical examination, it is easy to misdiagnose. Furthermore, surgical treatment for the late stage of hip gout arthritis has not previously been reported. In our case, total hip arthroplasty proved to be a good option.
Metastasis of pulmonary adenocarcinoma to right occipital parafalcine meningioma
Authors: Hu Tianhao , Wang Run , Song Yifu , Yu Juanhan , Guo Zongze , Han Sheng
Published: October 2020

Rationale:

Tumor-to-tumor metastasis is a rare clinical phenomenon. Although meningioma is the most common intracranial recipient of cancer metastasis, only a few cases have been reported. We present a case of metastasis of lung adenocarcinoma into intracranial meningioma and review the published literature.

Patient concerns:

A 70-year-old woman was admitted to our hospital for a 1-month history of headache and pain in her lower extremities.

Diagnosis:

Brain and lumbar vertebral magnetic resonance imaging showed an intracranial space-occupying lesion in the right occipital region and spinal canal stenosis. Pulmonary computed tomography showed an irregular mass in the right upper lobe of the lung. The postoperative histological examination demonstrated adenocarcinoma metastasis to meningioma.

Intervention:

The patient underwent right occipital craniotomy for tumor removal and lumbar spinal canal decompression.

Outcomes:

There were no initial abnormal conditions after the operation. However, the patient died suddenly 7 days after surgery.

Lessons:

Tumor-to-meningioma metastasis is a rare but important phenomenon. According to previous reports, it is associated with rapid onset of symptoms and a poor prognosis. Histological examination is of great importance in diagnosis. The history and process of malignant carcinoma should be closely monitored.
Chronic myelomonocytic leukemia (CMML)-0 with pleural effusion as first manifestation
Authors: Hu Lianbo , Zheng Bingrong , Fu Lijuan , Hu Meiwei
Published: October 2020

Rationale:

Extramedullary invasion of chronic myelomonocytic leukemia (CMML) usually occurs in the liver, spleen, and lymph nodes, while the pleural infiltration of CMML is rare. The presence of pleural effusion is usually associated with uncontrolled leukocytosis and increased monocytes.

Patient concerns:

Here we reported a rare case of CMML-0 with pleural effusion as the first manifestation in a 44-year-old woman. The pleural effusion was caused by blasts infiltration confirmed by the flow cytometer and the pleural biopsy.

Diagnoses:

CMML with pleural invasion.

Interventions:

The patient was treated with azacitidine 75 mg/m2 d for 2 cycles, followed by daily oral intake of hydroxyurea (500 mg/d).

Outcomes:

Pleural effusion was resolved and chest pain was relieved.

Lessons:

The current case indicated that leukemic infiltration into pleura could occur despite mild leukocytes, while demethylation may be an effective therapy.