bluuebunny/crossref_metadata_2025_split huggingface dataset:
Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis
Authors: Dagenais Gilles R. , Rydén Lars , Leiter Lawrence A. , Lakshmanan Mark , Dyal Leanne , Probstfield Jeffrey L. , Atisso Charles Messan , Shaw Jonathan E. , Conget Ignacio , Cushman William C. , Lopez-Jaramillo Patricio , Lanas Fernando , Munoz Ernesto German Cordona , Pirags Valdis , Pogosova Nana , Basile Jan , Sheu Wayne H. H. , Temelkova-Kurktschiev Theodora , Raubenheimer Peter J. , Keltai Matyas , Hall Stephanie , Pais Prem , Colhoun Helen M. , Riddle Matthew C. , Gerstein Hertzel C. 
Published: November 2020

Abstract
Background
The Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) double blind randomized trial demonstrated that weekly subcutaneous dulaglutide 1.5 mg, a glucagon like peptide-1 receptor agonist, versus matched placebo reduced the first outcome of major adverse cardiovascular event (MACE), cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (594 versus 663 events) in 9901 persons with type 2 diabetes and either chronic cardiovascular disease or risk factors, and followed during 5.4 years. These findings were based on a time-to-first-event analysis and preclude relevant information on the burden of total major events occurring during the trial. This analysis reports on the total cardiovascular or fatal events in the REWIND participants

Methods
We compared the total incidence of MACE or non-cardiovascular deaths, and the total incidence of expanded MACE (MACE, unstable angina, heart failure or revascularization) or non-cardiovascular deaths between participants randomized to dulaglutide and those randomized to placebo. Incidences were expressed as number per 1000 person-years. Hazard ratios (HR) were calculated using the conditional time gap and proportional means models.

Results
Participants had a mean age of 66.2 years, 46.3% were women and 31% had previous cardiovascular disease. During the trial there were 1972 MACE or non-cardiovascular deaths and 3673 expanded MACE or non-cardiovascular deaths. The incidence of total MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 35.8 and 40.3 per 1000 person-years, respectively [absolute reduction = 4.5 per 1000 person-years; conditional time gap HR 0.90 (95% CI, 0.82–0.98) p = 0.020, and proportional means HR 0.89 (95% CI, 0.80–0.98) p = 0.022]. The incidence of total expanded MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 67.1 and 74.7 per 1000 person-years, respectively [absolute reduction = 7.6 per 1000 person-years; conditional time gap HR 0.93 (95% CI, 0.87–0.99) p = 0.023, and proportional means HR 0.90 (95% CI, 0.82–0.99) p = 0.028].

Conclusions
These findings suggest that weekly subcutaneous dulaglutide reduced total cardiovascular or fatal event burden in people with type 2 diabetes at moderate cardiovascular risk.
Clinical Trial Registration:https://www.clinicaltrials.gouv. Unique Identifier NCT01394952).
Intermittent screening and treatment with dihydroartemisinin-piperaquine for the prevention of malaria in pregnancy: implementation feasibility in a routine healthcare system setting in western Kenya
Authors: Hill Jenny , Ouma Peter , Oluoch Seth , Bruce Jane , Kariuki Simon , Desai Meghna , Webster Jayne 
Published: November 2020

Abstract
Background
Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended for preventing malaria in pregnancy in areas of moderate-to-high transmission in sub-Saharan Africa. However, due to increasing parasite resistance to SP, research on alternative strategies is a priority. The study assessed the implementation feasibility of intermittent screening and treatment (ISTp) in the second and third trimester at antenatal care (ANC) with malaria rapid diagnostic tests (RDTs) and treatment of positive cases with dihydroartemisinin-piperaquine (DP) compared to IPTp-SP in western Kenya.

Methods
A 10-month implementation study was conducted in 12 government health facilities in four sub-counties. Six health facilities were assigned to either ISTp-DP or IPTp-SP. Evaluation comprised of facility audits, ANC observations, and exit interviews. Intermediate and cumulative effectiveness analyses were performed on all processes involved in delivery of ISTp-DP including RDT proficiency and IPTp-SP ± directly observed therapy (DOT, standard of care). Logistic regression was used to identify predictors of receiving each intervention.

Results
A total of 388 and 389 women were recruited in the ISTp-DP and IPTp-SP arms, respectively. For ISTp-DP, 90% (289/320) of eligible women received an RDT. Of 11% (32/289) who tested positive, 71% received the correct dose of DP and 31% the first dose by DOT, and only 6% were counselled on subsequent doses. Women making a sick visit and being tested in a facility with a resident microscopist were more likely to receive ISTp-DP (AOR 1.78, 95% CI 1.31, 2.41; and AOR 3.75, 95% CI 1.31, 2.40, respectively). For IPTp-SP, only 57% received a dose of SP by DOT. Payment for a laboratory test was independently associated with receipt of SP by DOT (AOR 6.43, 95% CI 2.07, 19.98).

Conclusions
The findings indicate that the systems effectiveness of ANC clinics to deliver ISTp-DP under routine conditions was poor in comparison to IPTp-SP. Several challenges to integration of ISTp with ANC were identified that may need to be considered by countries that have introduced screening at first ANC visit and, potentially, for future adoption of ISTp with more sensitive RDTs. Understanding the effectiveness of ISTp-DP will require additional research on pregnant women’s adherence to ACT.
Digitalized mass distribution campaign of insecticide-treated nets (ITNs) in the particular context of Covid-19 pandemic in Benin: challenges and lessons learned
Authors: Aïkpon Rock , Affoukou Cyriaque , Hounpkatin Benjamin , Eclou Dieu-Donné , Cyaka Yves , Egwu Elijah , Agbessi Narcisse , Tokponnon Filémon , Salifou Sahidou , Salami Lamidhi , Hounto Aurore Ogouyemi 
Published: November 2020

Abstract
Background
In 2020, Benin has implemented a digitalized mass distribution campaign of insecticide-treated nets (ITNs) in the particular context of COVID-19 pandemic. This paper describes the implementation process as well as the challenges and lessons learned from this campaign.

Methods
A descriptive design was used for reporting the planning and implementation process of ITNs campaign. Moreover, the changes and adaptations related to COVID-19 pandemic are described.

Results
A total of 3,175,773 households were registered corresponding to a total of 14,423,998 persons (13.55% more from projection). Moreover, 94.16% (13,581,637 people) of enumerated population were protected. A total of 7,652,166 ITNs were distributed countrywide.

Conclusions
High political commitment, engagement and support add to the financial and technical supports from partners were the essential factors that make 2020 ITNs mass campaign success in Benin despite the particular context of COVID-19 pandemic. It is essential to maintain the prevention activities for malaria and this could substantially reduce the overall impact of the COVID-19 pandemic for the populations at malaria risk.
Molecular surveillance of anti-malarial resistance Pfdhfr and Pfdhps polymorphisms in African and Southeast Asia Plasmodium falciparum imported parasites to Wuhan, China
Authors: Jiang Tingting , Cheng Weijia , Yao Yi , Tan Huabing , Wu Kai , Li Jian 
Published: November 2020

Abstract
Background
Anti-malarial drug resistance is a severe challenge for eventual control and global elimination of malaria. Resistance to sulfadoxine-pyrimethamine (SP) increases as mutations accumulate in the Pfdhfr and Pfdhps genes. This study aimed to assess the polymorphisms and prevalence of mutation in these genes in the Plasmodium falciparum infecting migrant workers returning to Wuhan, China.

Methods
Blood samples were collected for 9 years (2011–2019). Parasite genomic DNA was extracted from blood spots on filter paper. The mutations were evaluated by nested PCR and sequencing. The single-nucleotide polymorphisms (SNPs) and haplotypes of the Pfdhfr and Pfdhps genes were analysed.

Results
Pfdhfr codon 108 showed a 94.7% mutation rate, while for Pfdhps, the rate for codon 437 was 79.0%. In total, five unique haplotypes at the Pfdhfr locus and 11 haplotypes at the Pfdhps locus were found while the Pfdhfr-Pfdhps combined loci revealed 28 unique haplotypes. A triple mutant (IRNI) of Pfdhfr was the most prevalent haplotype (84.4%). For Pfdhps, a single mutant (SGKAA) and a double mutant (SGEAA) were detected at frequencies of 37.8 and 22.3%, respectively. Among the combined haplotypes, a quadruple mutant (IRNI-SGKAA) was the most common, with a 30.0% frequency, followed by a quintuplet mutant (IRNI-SGEAA) with a frequency of 20.4%.

Conclusion
The high prevalence and saturation of Pfdhfr haplotypes and the medium prevalence of Pfdhps haplotypes demonstrated in the present data will provide support for predicting the status and progression of antifolate resistance in malaria-endemic regions and imported malaria in nonendemic areas. Additional interventions to evaluate and prevent SP resistance should be continuously considered.
Cultural respect in midwifery service provision for Aboriginal women: longitudinal follow-up reveals the enduring legacy of targeted program initiatives
Authors: Thackrah Rosalie D. , Wood Jennifer , Thompson Sandra C. 
Published: November 2020

Abstract
Background
Culturally competent maternity care provision to Aboriginal and Torres Strait Islander women was identified as a priority area by Australia’s National Maternity Services Plan in 2011. While midwifery programs responded by including core Indigenous content and community placements in curricula, little is known about whether knowledge learned, and insights gained in response to these initiatives have endured and been applied in clinical practice. This follow-up study explores the impact of a compulsory Indigenous unit and a remote clinical placement on two cohorts of non-Indigenous midwives who were participants in an earlier 2012–14 study.

Methods
Fourteen non-Indigenous participants who were either students or recent graduates in 2012–14 were located and re-interviewed in 2019–20. In-depth interviews based on a semi-structured interview guide were conducted by telephone or face-to face; recordings were transcribed and thematically analysed using standard qualitative procedures.

Results
Exposure to Indigenous content and settings during training had an enduring impact on participants’ midwifery practice; most felt better prepared to provide culturally safe care, build respectful relationships and advocate for improved services for Aboriginal women. Despite this positive legacy, they also expressed apprehension about causing offence and recognised their own knowledge deficits with regard to Aboriginal cultural practices. Organisational constraints, including restrictions on the number of family members accompanying a birthing mother were identified as barriers to optimal care; some positive organisational initiatives were also described.

Conclusions
This follow-up study provides encouraging evidence that well-designed and delivered Indigenous content and community placement opportunities in midwifery programs can have a lasting impact on service provision to Aboriginal women, contribute to a more informed, empathetic and culturally competent maternity workforce and help catalyse health service changes towards more culturally safe care.
Letter to the editor regarding “spatiotemporal association of low birth weight with Cs-137 deposition at the prefecture level in Japan after the Fukushima nuclear power plant accidents”
Authors: Soleman Sani Rachman , Fujitani Tomoko , Harada Kouji H. 
Published: November 2020

AbstractIn the previous report, association between increased low birth weight prevalence and radiocesium deposition after 2011 Fukushima nuclear disaster was found. However, the statistical analyses therein raised several questions. First, ecological variables are not justified enough to adjust potential confounding. Second, the spatiotemporal regression model does not consider temporal reduction in radiation dose rate. Third, dose-response plot between dose rates and odds ratios overestimates R2 and underestimates p value.
Association between the alanine aminotransferase/aspartate aminotransferase ratio and new-onset non-alcoholic fatty liver disease in a nonobese Chinese population: a population-based longitudinal study
Authors: Zou Yang , Zhong Ling , Hu Chong , Sheng Guotai 
Published: November 2020

Abstract
Background
The alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ratio has been considered an alternative marker for hepatic steatosis. However, few studies have investigated the association of the ALT/AST ratio with non-alcoholic fatty liver disease (NAFLD) in nonobese people.

Methods
A total of 12,127 nonobese participants who were free of NAFLD participated in this study. The participants were divided into quintiles of the ALT/AST ratio. Multiple Cox regression models were used to explore the association of the ALT/AST ratio with new-onset NAFLD.

Results
During the five-year follow-up period, 2147 individuals (17.7%) developed new-onset NAFLD.
After adjusting for all non-collinear covariates, the multiple Cox regression analysis results showed that a higher ALT/AST ratio was independently associated with new-onset NAFLD in nonobese Chinese (adjusted hazard ratios [aHRs]: 2.10, 95% confidence intervals: 1.88, 2.36). The aHRs for NAFLD across increasing quintiles of the ALT/AST ratio were 1, 1.63 (1.30, 2.04), 2.07 (1.65, 2.60), 2.84 (2.33, 3.48) and 3.49 (2.78, 4.39) (P for trend< 0.001). The positive association was more significant among people with high blood pressure, high blood lipids and hyperglycaemia, as well as in men. Additionally, the regression spline showed that the saturation effect of the ALT/AST ratio on NAFLD risk was at 0.93 in this study population, which was 1.22 in males and 0.89 in females.

Conclusions
In nonobese Chinese individuals without NAFLD at baseline, the increase in the ALT/AST ratio is closely associated with the risk of new-onset NAFLD.
Impact of previous abdominal surgery on robotic-assisted rectal surgery in patients with locally advanced rectal adenocarcinoma: a propensity score matching study
Authors: Huang Ching-Wen , Su Wei-Chih , Chang Tsung-Kun , Ma Cheng-Jen , Yin Tzu-Chieh , Tsai Hsiang-Lin , Chen Po-Jung , Chen Yen-Cheng , Li Ching-Chun , Hsieh Yi-Chien , Wang Jaw-Yuan 
Published: November 2020

Abstract
Background
The application of minimally invasive surgery in patients with colorectal cancer (CRC) and a history of previous abdominal surgery (PAS) remains controversial. This retrospective study with propensity score matching (PSM) investigated the impact of PAS on robotic-assisted rectal surgery outcomes in patients with locally advanced rectal adenocarcinoma undergoing preoperative concurrent chemoradiotherapy (CCRT).

Methods
In total, 203 patients with locally advanced rectal adenocarcinoma who underwent preoperative CCRT and robotic-assisted rectal surgery between May 2013 and December 2019 were enrolled. Patients were categorized into PAS and non-PAS groups based on the PAS history. The PSM caliper matching method with 1-to-3 matches was used to match PAS patients with non-PAS.

Results
Of the 203 enrolled patients, 35 were PAS patients and 168 were non-PAS patients. After PSM, 32 PAS patients and 96 non-PAS patients were included for analysis. No significant between-group differences were noted in the perioperative outcomes, including median console time (165 min (PAS) vs. 175 min (non-PAS), P = 0.4542) and median operation time (275 min (PAS) vs. 290 min (non-PAS), P = 0.5943) after PSM. Postoperative recovery and overall complication rates were also similar (all P > 0.05). Moreover, the between-group differences in pathological or short-term oncological outcomes were also nonsignificant (all P > 0.05). No 30-day postoperative deaths were observed in either group.

Conclusion
The current results indicate that robotic-assisted surgery is safe and feasible for PAS patients with locally advanced rectal adenocarcinoma undergoing preoperative CCRT. However, future prospective randomized clinical trials are required to verify these findings.
Thyroid autoimmunity and IVF/ICSI outcomes in euthyroid women: a systematic review and meta-analysis
Authors: Venables Ashley , Wong Wilbert , Way Mandy , Homer Hayden Anthony 
Published: November 2020

Abstract
Background
Thyroid autoimmunity (TAI) – the presence of anti-thyroid peroxidase and/or anti-thyroglobulin antibodies – affects 8–14% of reproductively-aged women. It is hotly debated whether TAI adversely affects IVF/ICSI outcomes. This systematic review and meta-analysis evaluated the relationship between thyroid autoimmunity (TAI) and IVF/ICSI outcomes, both overall and amongst euthyroid women of known age using strict criteria for grouping pregnancy outcomes.

Methods
The review was registered with PROSPERO: CRD42019120947. Searches were undertaken in MEDLINE, EMBASE, Web of Science and Cochrane Database from Inception-March 2020. Primary outcomes were clinical pregnancy rate, clinical miscarriage rate, biochemical pregnancy loss, livebirth rate per-cycle and live birth rate per clinical pregnancy (CP).

Results
14 studies were included in the meta-analysis. Compared with women who tested negative for thyroid autoantibodies (TAI-), there was no significant difference in clinical pregnancy rate overall (OR 0.86; 95%CI [0.70, 1.05]; P = 0.14; 11 studies; I2 = 29.0%), or in euthyroid women (OR 0.88; 95%CI [0.69, 1.12]; P = 0.29; 10 studies; I2 = 32.0%). There was also no significant difference in clinical miscarriage rate overall (OR 1.04; 95%CI [0.52, 2.07]; P = 0.908; 8 studies; I2 = 53%), or in euthyroid women (OR 1.18; 95%CI [0.52, 2.64]; P = 0.69; 7 studies; I2 = 54%). There was no significant difference in biochemical pregnancy loss (OR 1.14; 95%CI [0.48, 2.72]; P = 0.769; 4 studies; I2 = 0.0%), live birth rate per cycle (OR 0.84; 95%CI [0.67, 1.06]; P = 0.145; I2 = 1.7%), live birth rate per clinical pregnancy (OR 0.67; 95%CI [0.28, 1.60]; P = 0.369; I2 = 69.2%), both overall and in euthyroid women as all studies included consisted of euthyroid women only. There was also no significant difference in number of embryos transferred, number of oocytes retrieved, mean maternal age or TSH levels overall or in euthyroid women.

Conclusion
The findings of the present study suggest that thyroid autoimmunity has no effect on pregnancy outcomes in euthyroid women alone, or in euthyroid women and women with subclinical hypothyroidism.
Agnostic evaluation of ipilimumab and nivolumab association: a metanalysis
Authors: Marchetti Paolo , Botticelli Andrea , Ascierto Antonio Paolo , Curigliano Giuseppe , Giannarelli Diana 
Published: November 2020

Abstract
Background
Ipilimumab and Nivolumab, targeting the molecules CTLA-4, PD-1, respectively,have shown efficacy against several types of cancer. Despite these results, only a small percentage of patients maintains a long-lasting effect. Even Ipilimumab, in combination with nivolumab, has demonstrated a significant clinical benefit in multiple tumor types. However, no trial has been designed with the primary endpoint to compare the efficacy of nivolumab plus ipilimumab combined, compared to nivolumab alone. Hence, the added value of ipilimumab in the combination has not clearly been established yet. The aim of this study was to demonstrate the superiority of the combination strategy compared to the single agent therapy.

Materials and methods
We performed a meta-analysis of Phase I-II-III Clinical Trials, published from 2010 up to 2020, in which the combination of ipilimumab plus nivolumab was compared to nivolumab alone. We extracted ORR, OS and PFS HR on the basis of treatment from the subgroup analysis of each trial.

Results
A total of 7 trials were included in the present meta-analysis. Overall, 1313 patients were treated with the nivolumab plus ipilimumab combination compared to 1110 patients treated with nivolumabalone. All trials reported the Objective response rate(ORR), no heterogeneity was found among studies and the pooled Odds Ratio was highly in favor of the nivolumab plus ipilimumab combination with respect to nivolumab alone (1.683; 95% CI: 1.407–2.012; P < 0.0001). Three studies were considered for Progression free survival (PFS) analysis, and the pooled Hazard Ratio favored the combination of nivolumab plus ipilimumab with respect to nivolumab alone (0.807; 95% CI: 0.719–0.907; P < 0.0001). The Overall survival(OS) endpoint was considered only in 2 trials, and the pooled HR favored, also in this case, the combination of nivolumab plus ipilimumab with respect to nivolumab alone (0.87; 95% CI: 0.763–0.997; P = 0.045).

Conclusions
The combination of ipilimumab plus nivolumab seems to be superior to nivolumab alone in cancer patients, regardless of histology.
Early cases of SARS-CoV-2 infection in Uganda: epidemiology and lessons learned from risk-based testing approaches – March-April 2020
Authors: Migisha Richard , Kwesiga Benon , Mirembe Bernadette Basuta , Amanya Geofrey , Kabwama Steven N. , Kadobera Daniel , Bulage Lilian , Nsereko Godfrey , Wadunde Ignatius , Tindyebwa Tonny , Lubwama Bernard , Kagirita Atek A. , Kayiwa John T. , Lutwama Julius J. , Boore Amy L. , Harris Julie R. , Bosa Henry Kyobe , Ario Alex Riolexus 
Published: November 2020

Abstract
Background
On March 13, 2020, Uganda instituted COVID-19 symptom screening at its international airport, isolation and SARS-CoV-2 testing for symptomatic persons, and mandatory 14-day quarantine and testing of persons traveling through or from high-risk countries. On March 21, 2020, Uganda reported its first SARS-CoV-2 infection in a symptomatic traveler from Dubai. By April 12, 2020, 54 cases and 1257 contacts were identified. We describe the epidemiological, clinical, and transmission characteristics of these cases.

Methods
A confirmed case was laboratory-confirmed SARS-CoV-2 infection during March 21–April 12, 2020 in a resident of or traveler to Uganda. We reviewed case-person files and interviewed case-persons at isolation centers. We identified infected contacts from contact tracing records.

Results
Mean case-person age was 35 (±16) years; 34 (63%) were male. Forty-five (83%) had recently traveled internationally (‘imported cases’), five (9.3%) were known contacts of travelers, and four (7.4%) were community cases. Of the 45 imported cases, only one (2.2%) was symptomatic at entry. Among all case-persons, 29 (54%) were symptomatic at testing and five (9.3%) were pre-symptomatic. Among the 34 (63%) case-persons who were ever symptomatic, all had mild disease: 16 (47%) had fever, 13 (38%) reported headache, and 10 (29%) reported cough. Fifteen (28%) case-persons had underlying conditions, including three persons with HIV. An average of 31 contacts (range, 4–130) were identified per case-person. Five (10%) case-persons, all symptomatic, infected one contact each.

Conclusion
The first 54 case-persons with SARS-CoV-2 infection in Uganda primarily comprised incoming air travelers with asymptomatic or mild disease. Disease would likely not have been detected in these persons without the targeted testing interventions implemented in Uganda. Transmission was low among symptomatic persons and nonexistent from asymptomatic persons. Routine, systematic screening of travelers and at-risk persons, and thorough contact tracing will be needed for Uganda to maintain epidemic control.