bluuebunny/crossref_metadata_2025_split huggingface dataset:
The World of Clinical Trial Development Post COVID-19: Lessons Learned from a Global Pandemic
Authors: Karzai Fatima , Madan Ravi A. , Dahut William L. 
Published: June 2020

Abstract
The novel coronavirus disease-2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is a global health threat (1). Patients with cancer are one of the most vulnerable populations. During this pandemic, clinical trial accrual to NCI studies has fallen dramatically. Investigators quickly turned to regulatory bodies to simplify treatment schedules, facilitate telemedicine, and decrease required data collection. Going forward, the oncology research community must use the lessons learned to focus on redesigning studies to ensure that critical scientific questions are answered safely while expanding access and increasing partnerships with community physicians. These changes will accelerate clinical progress while protecting our patients.
Longitudinal Changes in Cardiac Structure and Function From Adolescence to Young Adulthood in Participants With Type 2 Diabetes Mellitus
Authors: Gidding Samuel S. , Braffett Barbara H. , Shah Rachana D. , Lima Joao , de Vasconcellos Henrique Doria , Shah Ravi , Nadeau Kristen J. , Tryggestad Jeanie B. , Hughan Kara S. , Dhaliwal Ruban , Levitt Katz Lorraine E. 
Published: June 2020

Background:
Heart failure is a prominent complication of type 2 diabetes mellitus (T2D). The goal of this study was to provide longitudinal data on cardiac structure and function (and cross-sectional comparison to normal-weight and obese controls without T2D) in individuals followed from adolescence with youth-onset T2D.

Methods:
In the TODAY study (Treatment Options for Type 2 Diabetes Mellitus in Adolescents and Youth), echocardiograms were performed at study years 4 to 5 and 9 to 10. Echocardiograms were also obtained at years 8 to 9 in a control population of age, race/ethnicity, and sex-matched normal-weight and obese individuals without diabetes mellitus. Study outcomes were measures of left ventricular structure and function. The cohort included 411 participants with T2D, 194 obese controls, and 51 normal-weight controls.

Results:

At follow-up, mean participant age was 23 years, 65% women, 20% non-Hispanic white, 35% non-Hispanic black, and 39% Hispanic. Ejection fraction was <52% in 11.7% of male participants with T2D. Diastolic function declined during follow-up in participants with T2D (mitral valve lateral E/Em increased 0.72±0.12 in women and 0.50±0.17 in men;
P
<0.01) and was significantly higher than obese controls (women, 6.65±1.89 versus 5.66±1.37; men, 6.15±1.90 versus 5.26±1.31;
P
<0.0001). Predictors of adverse changes included hypertension, obesity, female sex, Hispanic and non-Hispanic black ethnicity, worse glycemic control, and elevated heart rate. Cardiac structural abnormalities, left ventricular hypertrophy, or concentric geometry, were highest in those with T2D (15.8% versus 5.7% obese versus 0% normal weight).

Conclusions:
Adverse changes in cardiac structure and function changed significantly from adolescence to early adulthood in participants with youth-onset T2D.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT00081328.
Potassium Intake and Blood Pressure: A Dose‐Response Meta‐Analysis of Randomized Controlled Trials
Authors: Filippini Tommaso , Naska Androniki , Kasdagli Maria‐Iosifina , Torres Duarte , Lopes Carla , Carvalho Catarina , Moreira Pedro , Malavolti Marcella , Orsini Nicola , Whelton Paul K. , Vinceti Marco 
Published: June 2020

Background

Epidemiologic studies, including trials, suggest an association between potassium intake and blood pressure (
BP
). However, the strength and shape of this relationship is uncertain.

Methods and Results

We performed a meta‐analysis to explore the dose‐response relationship between potassium supplementation and
BP
in randomized‐controlled trials with a duration ≥4 weeks using the recently developed 1‐stage cubic spline regression model. This model allows use of trials with at least 2 exposure categories. We identified 32 eligible trials. Most were conducted in adults with hypertension using a crossover design and potassium supplementation doses that ranged from 30 to 140 mmol/d. We observed a U‐shaped relationship between 24‐hour active and control arm differences in potassium excretion and
BP
levels, with weakening of the
BP
reduction effect above differences of 30 mmol/d and a
BP
increase above differences ≈80 mmol/d. Achieved potassium excretion analysis also identified a U‐shaped relationship. The
BP
‐lowering effects of potassium supplementation were stronger in participants with hypertension and at higher levels of sodium intake. The
BP
increase with high potassium excretion was noted in participants with antihypertensive drug‐treated hypertension but not in their untreated counterparts.

Conclusions

We identified a nonlinear relationship between potassium intake and both systolic and diastolic
BP
, although estimates for
BP
effects of high potassium intakes should be interpreted with caution because of limited availability of trials. Our findings indicate an adequate intake of potassium is desirable to achieve a lower
BP
level but suggest excessive potassium supplementation should be avoided, particularly in specific subgroups.
Sex recognition and agonistic strategies of male and female crayfish
Authors: Oyama Taiga , Momohara Yuto , Yano Hirona , Kamio Michiya , Fujiyama Naoyuki , Nagayama Toshiki 
Published: June 2020

Abstract
Intraspecific communication is essential for agonistic and mating behaviours. Agonistic strategy of males must change according to the sex of opponents and that of females is also dependent on their physiological state as to whether they are brooding or not. We have analysed here the agonistic encounters between pairs of male and female crayfish in various combinations to reveal the interaction between agonistic and mating behaviours. After male crayfish became dominant, they aggressively chased subordinate males with attacks, while they did not attack female opponents. Furthermore, the agonistic behaviour of males changed depending on whether females were ovigerous or not. On the other hand, two females showed intense combats despite being ovigerous or not. Crayfish discriminated the sex of opponents via chemical signals in the urine. However, the dominant and subordinate social order of crayfish had no effect on selecting mating partners.
Pressure and flow properties of dual-lumen cannulae for extracorporeal membrane oxygenation
Authors: Broman Lars Mikael , Westlund C Jerker , Gilbers Martijn , Perry da Câmara Luisa , Prahl Wittberg Lisa , Taccone Fabio Silvio , Malfertheiner Maximilian V , Di Nardo Matteo , Swol Justyna , Vercaemst Leen , Barrett Nicholas A , Pappalardo Federico , Belohlavek Jan , Belliato Mirko , Lorusso Roberto 
Published: June 2020

Introduction: In the last decade, dual-lumen cannulae have been increasingly applied in patients undergoing extracorporeal life support. Well-performing vascular access is crucial for efficient extracorporeal membrane oxygenation support; thus, guidance for proper cannulae size is required. Pressure–flow charts provided by manufacturers are often based on tests performed using water, rarely blood. However, blood is a shear-thinning and viscoelastic fluid characterized by different flow properties than water. Methods: We performed a study evaluating pressure–flow curves during standardized conditions using human whole blood in two commonly available dual-lumen cannulae used in neonates, pediatric, and adult patients. Results were merged and compared with the manufacturer’s corresponding curves obtained from the public domain. Results: The results showed that using blood as compared with water predominantly influenced drainage flow. A 10-80% higher pressure-drop was needed to obtain same drainage flow (hematocrit of 26%) compared with manufacturer’s water charts in 13-31 Fr bi-caval dual-lumen cannulae. The same net difference was found in cavo-atrial cannulae (16-32 Fr), where a lower drainage pressure was required (Hct of 26%) compared with the manufacturer’s test using blood with an Hct of 33%. Return pressure–flow data were similar, independent whether pumping blood or water, to the data reported by manufacturers. Conclusion: Non-standardized testing of pressure–flow properties of extracorporeal membrane oxygenation dual-lumen cannulae prevents an adequate prediction of pressure–flow results when these cannulae are used in patients. Properties of dual-lumen cannulae may vary between sizes within same cannula family, in particular concerning the drainage flow.
Management of late hemorrhage after pancreatic surgery: treatment strategy and prognosis
Authors: Wu Xin , Chen Ge , Wu Wenming , Zhang Taiping , Liao Quan , Dai Menghua , Zhao Yupei 
Published: June 2020

Objective Postpancreatectomy hemorrhage is a life-threatening complication. Hemorrhage occurring >24 hours after the index operation is defined as late hemorrhage. This study was performed to analyze the therapeutic management and prognostic factors of late hemorrhage after pancreatectomy. Methods We identified 87 patients with late hemorrhage among 2031 patients who underwent pancreatic surgery from January 2013 to December 2017. The patients’ demographic characteristics, perioperative treatment, hemorrhage details, and prognosis were retrospectively analyzed. Results Of the 87 patients, 53 were men. Bleeding occurred at a mean of 8.9 ± 6.0 days postoperatively. Extraluminal and intraluminal hemorrhage occurred in 58 and 29 patients, respectively. The primary intervention was successful in 66 patients, and 16 patients required a secondary intervention. The primary and total recovery rates were 72.4% and 89.7%, respectively. Of the 87 patients, 9 died. Male sex, hemorrhage on a later postoperative day, a significantly decreased hemoglobin level, and pancreatic fistula showed statistical significance as possible risk factors for mortality. Conclusions Male sex, hemorrhage on a later postoperative day, a significantly decreased hemoglobin level, and pancreatic fistula are possible risk factors for mortality in patients with late hemorrhage after pancreatectomy. Hemorrhage is a dynamic process, and a secondary intervention may be necessary.
Effect of uric acid levels on mortality in Japanese peritoneal dialysis patients
Authors: Sugano Naoki , Maruyama Yukio , Ohno Iwao , Wada Atsushi , Shigematsu Takashi , Masakane Ikuto , Yokoo Takashi , Nitta Kosaku 
Published: June 2020

Background: Unlike the situation in the general population, most studies of patients receiving hemodialysis have reported lower uric acid (UA) as associated with higher mortality. However, the relationship between UA level and mortality remains unclear among patients receiving peritoneal dialysis (PD). Methods: We collected baseline data for 4742 prevalent PD patients (age, 63 ± 14 years; male, 61.5%; diabetes, 29.1%; median dialysis duration, 28 months) from a nationwide dialysis registry in Japan at the end of 2012. One-year all-cause and cardiovascular (CV) mortality and mortality caused by infectious disease were assessed using Cox regression analysis and competing-risks regression analysis, respectively. We used multiple imputation to deal with missing covariate data. Results: Within 1 year, 379 patients (8.0%) died, including 129 patients (2.7%) from CV causes and 95 patients (2.0%) from infectious disease. In multivariate analysis, serum UA, treated as a continuous variable, was not associated with any outcome. Conversely, both lower (<297 µmol/L) and higher (≥476 µmol/L) UA levels were independently associated with higher all-cause mortality compared to the reference group (416 to <446 µmol/L) in analyses where serum UA was treated as a categorical variable. Body mass index (BMI) affected the association between serum UA and all-cause mortality (interaction p = 0.049). Conclusions: A U-shaped relationship appears to exist between UA levels and all-cause mortality among Japanese PD patients. Additionally, lower BMI significantly enhanced the effect of UA levels on mortality.
What Is the Burden of Care of Nasoalveolar Molding?
Authors: Alfonso Allyson R. , Ramly Elie P. , Kantar Rami S. , Wang Maxime M. , Eisemann Bradley S. , Staffenberg David A. , Shetye Pradip R. , Flores Roberto L. 
Published: June 2020

Objective: This systematic review aims to evaluate nasoalveolar molding (NAM) in the context of burden of care defined as physical, psychosocial, or financial burden on caregivers. Search Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, 5 databases were searched from inception through December 24, 2019, for keywords and subject headings pertaining to cleft lip and/or palate and NAM. Eligibility Criteria: Clinical studies on NAM with reference to physical (access to care, number of visits, distance traveled), psychosocial (caregiver perceptions, family interactions, breast milk feeding), and financial (direct and indirect costs) burden were included. Data Collection and Analysis: Study selection was performed by 2 independent reviewers. Results: The search identified 1107 articles and 114 articles remained for qualitative synthesis. Burden of care domains were discussed but not measured in 43% of articles and only 25% assessed burden of care through a primary outcome. Of these, 20 articles reported on physical, 8 articles on psychosocial, and 12 articles on financial burden. Quality of evidence is limited by study design and risk of bias. Conclusion: Nasoalveolar molding has been indiscriminately associated with burden of care in the literature. Although NAM may not be the ideal treatment option for all patients and families, the physical considerations are limited when accounting for the observed psychosocial advantages. Financial burden appears to be offset, but further research is required. Teams should directly assess the impact of this early intervention on the well-being of caregivers and advance strategies that improve access to care.
Ten years experience of corneal collagen cross-linking
Authors: Elmassry Ahmed , Said Ahmed Osama Ibrahim , Abdalla Moones F , Gaballah Karim 
Published: June 2020

Purpose To study the effect of corneal collagen cross-linking (CXL) using riboflavin and ultraviolet rays on cases of corneal ectasia in keratoconus cases, post-laser–assisted in situ keratomileusis ectasia, and pellucid marginal degeneration and to present its long-term results over many years. Methods This study was conducted throughout 10 “years” experience in corneal collagen CXL, including 6120 cases. The study consists of two parts: a retrospective and a prospective part. All patients in the retrospective part were operated by epi-off, while in the prospective part, the epi-on procedure was used. Also, other machines were used as Peschke Vario, Peschke Phoenix, and different types of riboflavin. The results were analyzed using SPSS. Results The study showed stabilization ectasia in 95% of cases using our standard protocol, and this was proved by topography, pachymetry, refraction, and visual acuity. The effect of CXL was continued in 20% of cases, over a period of 3–5 years, some cases needed to repeat CXL due to the progression of corneal ectasia after cross-linking, in six eyes, that were rubbing their eyes and/or hormonal disturbance. Conclusion Corneal collagen cross-linking CXL is an effective method to prevent the progression of corneal ectasia, whether primary or post-laser–assisted in situ keratomileusis, and the effect was stable over the years of study.
“Chasing hope”: Parents’ perspectives on complementary and alternative interventions for children with autism in Kazakhstan
Authors: An Sofiya , Kanderzhanova Akbota , Akhmetova Assel , Foster Faye , Chan Chee Kai 
Published: June 2020

In post-Soviet Kazakhstan, the system of care for children with autism has been transforming over the past three decades. There is little known about the use of complementary and alternative medicine by families raising autistic children in the post-Soviet region. An exploratory qualitative focus group design was employed to study parents’ experiences of using complementary and alternative medicine focusing on the perceived factors driving the utilization of complementary and alternative medicine by families of autistic children and the availability of complementary and alternative medicine. Six focus groups were conducted in five cities of diverse geographical locations in Kazakhstan. Data were analyzed using a framework analysis. Two overarching themes and subthemes are developed. The first “unmet needs” relates to predisposing factors that motivate parents to complementary and alternative medicine uptake and the second “chasing hope” relates to enabling factors that facilitate parents’ uptake of complementary and alternative medicines. In summary, parents of autism spectrum disorder children in Kazakhstan face multiple challenges when seeking treatment for their children’s condition and implement whatever complementary and alternative medicine interventions available. A decision to use, and the choice of intervention, mainly comes from perceptions of having no other choice rather than from rational decisions based on efficacy of complementary and alternative medicines. This study provides the first empirical conceptualization of parents’ motives for choosing complementary and alternative medicine in Kazakhstan. Lay abstract The article reports the findings of a qualitative research study on how and why parents of autistic children in Kazakhstan utilize complementary and alternative medicine. We found that parents turn to complementary and alternative medicine because of the lack of professional care options available to them and in pursuit for hope and opportunities for their children with ASD.
NAD metabolism in aging and cancer
Authors: Kincaid John WR , Berger Nathan A 
Published: June 2020

NAD+and its derivatives NADH, NADP+, and NADPH are essential cofactors in redox reactions and electron transport pathways. NAD serves also as substrate for an extensive series of regulatory enzymes including cyclic ADP-ribose hydrolases, mono(ADP-ribosyl)transferases, poly(ADP-ribose) polymerases, and sirtuin deacetylases which are O-acetyl-ADP-ribosyltransferases. As a result of the numerous and diverse enzymes that utilize NAD as well as depend on its synthesis and concentration, significant interest has developed in its role in a variety of physiologic and pathologic processes, and therapeutic initiatives have focused both on augmenting its levels as well as inhibiting some of its pathways. In this article, we examine the biosynthesis of NAD, metabolic processes in which it is involved, and its role in aging, cancer, and other age-associated comorbidities including neurodegenerative, cardiovascular, and metabolic disorders. Therapeutic interventions to augment and/or inhibit these processes are also discussed.Impact statementNAD is a central metabolite connecting energy balance and organismal growth with genomic integrity and function. It is involved in the development of malignancy and has a regulatory role in the aging process. These processes are mediated by a diverse series of enzymes whose common focus is either NAD’s biosynthesis or its utilization as a redox cofactor or enzyme substrate. These enzymes include dehydrogenases, cyclic ADP-ribose hydrolases, mono(ADP-ribosyl)transferases, poly(ADP-ribose) polymerases, and sirtuin deacetylases. This article describes the manifold pathways that comprise NAD metabolism and promotes an increased awareness of how perturbations in these systems may be important in disease prevention and/or progression.
Incidence and mortality of cancer in the Volta Region of Ghana
Authors: Adadey Samuel M , Languon Sylvester , Ayee Richmond , Quansah Darius NK , Quaye Osbourne 
Published: June 2020

In Ghana, majority of cancer studies have focused on only two main teaching hospitals. However, there is the need to study the disease burden from other parts of the country. This study was designed to review cancer cases recorded in major hospitals in the Volta Region of Ghana, with the aim of determining the incidence of cancers and cancer-related mortalities, and contribute to cancer data in the country. In-patient diagnosis data from 2012 to 2014 were collected from 21 hospitals in the Volta Region of Ghana. The data were entered and structured in Microsoft Excel and analyzed with IBM SPSS Statistics 20 and GraphPad Prism 6. Cervical, breast, liver, soft tissue, and prostate cancer were identified as the commonly diagnosed cancers in the Region. Socioeconomic factors such as poor educational background and occupation were associated with incidence of cancer in the study area. The incidence of cancer was determined to be approximately 9, 11, and 6 morbidities per 100,000 people in the years 2012, 2013, and 2014, respectively, with liver cancer being the leading cause of deaths. Public awareness and screening efforts are thus needed to fight against cancer in the Volta Region, and Ghana as a whole. In addition, this study is an original report of cancers in the Volta Region of Ghana and underscores the need to report ethnic/population-specific frequencies to effectively evaluate the burden of cancer in the country. Impact statement Region-specific cancer reports are essential in knowing the common cancers in specific populations. This study reports all cancer types recorded in the major hospitals in the Volta Region of Ghana, a population that is sparsely captured in the national cancer registries. The study identified the common cancers as well as the death rates in the Volta Region, hence contributing to the national effort to report cancer data. Although not comprising all the elements of a cancer registry, our data will augment the effort of the two national cancer registries in Ghana to provide the national cancer reports.