bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial
Authors: Hansen Mathias Lühr , Pellicer Adelina , Gluud Christian , Dempsey Eugene , Mintzer Jonathan , Hyttel-Sørensen Simon , Heuchan Anne Marie , Hagmann Cornelia , Ergenekon Ebru , Dimitriou Gabriel , Pichler Gerhard , Naulaers Gunnar , Cheng Guoqiang , Guimarães Hercilia , Tkaczyk Jakub , Kreutzer Karen B. , Fumagalli Monica , Claris Olivier , Lemmers Petra , Fredly Siv , Szczapa Tomasz , Austin Topun , Jakobsen Janus Christian , Greisen Gorm 
Published: December 2019

AbstractBackgroundCerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.Methods/designSafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using ‘opt-out’ or deferred consent). Exclusion criteria will be no parental informed consent (or if ‘opt-out’ is used, lack of a record that clinical staff have explained the trial and the ‘opt-out’ consent process to parents and/or a record of the parents’ decision to opt-out in the infant’s clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants.DiscussionTreatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.Trial registrationClinicalTrial.gov,NCT03770741. Registered 10 December 2018.
Effects of acupuncture on the hypothalamus-pituitary-adrenal axis in chronic insomnia patients: a study protocol for a randomized controlled trial
Authors: Liu Chengyong , Zheng Shiyu , Wu Wenzhong , Wang Xiaoqiu , Qin Shan , Zhao Yanan , Xi Hanqing , Wan Qingyun 
Published: December 2019

Abstract
Background
Acupuncture, as an important component of traditional Chinese medicine (TCM), has been widely applied in the treatment of chronic insomnia in China, while there is no clinical study related to its therapeutic mechanism.

Methods/design
A single-center, single-blind, randomized, placebo-controlled trial will be conducted at Jiangsu Hospital of Traditional Chinese Medicine. A total of 60 patients will be registered. Eligible participants will be randomly divided into acupuncture group and sham acupuncture group (n = 30 cases in each group). Patients in both groups will be treated once every other day, three times per week for 4 weeks. The primary outcome measures are Pittsburgh Sleep Quality Index (PSQI) and concentrations of adrenocorticotropic hormone (ATCH), corticotrophin-releasing hormone (CRH), and cortisol (CORT). Secondary outcome measures are Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS).

Discussion
This study aims to evaluate the therapeutic effects of acupuncture on chronic insomnia by using PSQI, ISI, and FSS. The mechanism of acupuncture on CIPs will be preliminarily discussed by analyzing the changes in concentrations of CRH, ACTH, and CORT before and after treatment.

Trial registration
Chinese Clinical Trials Register, ChiCTR1800020298.
Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis – PROMETHEUS: a randomized controlled trial protocol
Authors:   On behalf of the Spanish Working Group on Pancreatic Collection Therapy, Gornals Joan B. , Perez-Miranda Manuel , Vazquez-Sequeiros Enrique , Vila Juan , Esteban José M. , Gonzalez-Huix Ferran , Guarner-Argente Carlos , Sanchez-Yague Andres , Teran Alvaro , Bas-Cutrina Francesc , De La Serna Carlos , De Paredes Ana Garcia , Ballester Raquel , Velasquez-Rodriguez Julio , Salord Silvia , Tebe Cristian , Hereu Pilar , Videla Sebas 
Published: December 2019

Abstract
Background
It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven.

Methods/design
This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences.

Discussion
The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.

Trial registration
ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home
Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial
Authors: Klek Stanislaw , Chambrier Cécile , Cooper Sheldon C. , Gabe Simon , Kunecki Marek , Pironi Loris , Rahman Farooq , Sobocki Jacek , Szczepanek Kinga , Wanten Geert , Lincke Nicole , Glotzbach Bernhard , Forbes Alastair 
Published: December 2019

AbstractBackgroundHome parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenously administered lipid emulsions (ILEs) are an essential component of HPN, providing energy and essential fatty acids, but can become a risk factor for intestinal-failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited.Methods/designThe HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG) for a projected period of 8 weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of the safety and tolerability as well as the efficacy of the ILEs.DiscussionCurrently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN.Trial registrationClinicalTrials.gov, ID:NCT03282955. Registered on 14 September 2017.
Efficacy of Actellic 300 CS-based indoor residual spraying on key entomological indicators of malaria transmission in Alibori and Donga, two regions of northern Benin
Authors: Salako Albert Sourou , Dagnon Fortune , Sovi Arthur , Padonou Gil Germain , Aïkpon Rock , Ahogni Idelphonse , Syme Thomas , Govoétchan Renaud , Sagbohan Herman , Sominahouin André Aimé , Akinro Bruno , Iyikirenga Laurent , Agossa Fiacre , Akogbeto Martin Codjo 
Published: December 2019

Abstract
Background
The current study shows the results of three years of IRS entomological monitoring (2016, before intervention; 2017 and 2018, after intervention) performed in Alibori and Donga, northern Benin.

Methods
Mosquito collections were performed on a monthly basis using human landing catches and pyrethrum spray catches in six districts including four treated with Actellic 300 CS (Kandi, Gogounou, Djougou and Copargo) and two untreated (Bembèrèkè and Kouandé) which served as control sites. Key transmission indicators of Anopheles gambiae (s.l.) as well as the residual activity of Actellic 300 CS assessed through WHO cone tests, were determined.

Results
The residual efficacy duration of Actellic 300 CS after the two IRS campaigns (2017 and 2018) was 4–5 months (May–September). The parity rate and the sporozoite index of An. gambiae (s.l.) were 36.62% and 0.71%, respectively, after the first spray round in treated areas compared to 57.24% and 3.7%, respectively, in the control areas (P < 0.0001). The same trend was observed after the second spray round. After the first spray round, each person received 1.6 infective bites/month (ib/m) in the treated areas against 12.11 ib/m in the control areas, resulting in a reduction rate of 86.78%. Similarly, the entomological inoculation rate was 1.5 ib/m after the second spray round in the treated areas vs 9.75 ib/m in the control areas, corresponding to a reduction of 84.61%. A decrease in the parity rate (46.26%), sporozoite index (85.75%) and EIR (87.27%) was observed for An. gambiae (s.l.) after the first round of IRS (June–October 2017) compared to the pre-intervention period (June–October 2016). The density of An. gambiae (s.l.) ranged between 0.38–0.48 per house in treated areas vs 1.53–1.76 An. gambiae (s.l.) per house respectively after the first and second IRS rounds.

Conclusions
This study showed the positive impact of IRS in reducing key entomological parameters of malaria transmission in Alibori and Donga. However, the considerable blood-feeding rate of An. gambiae (s.l.) in spray areas, stress the need for the population to sleep under long-lasting insecticidal nets (LLINs) in addition, to prevent from mosquito bites which did not succeed in resting on sprayed walls.
Molecular and physiological characterization of the chitin synthase B gene isolated from Culex pipiens pallens (Diptera: Culicidae)
Authors: Yang Xiaoshan , Yin Qi , Xu Yang , Li Xixi , Sun Yan , Ma Lei , Zhou Dan , Shen Bo 
Published: December 2019

Abstract
Background
The growth and development of insects is strictly dependent on the precise regulation of chitin synthase (CHS), which is absent in vertebrates and plants. Therefore, CHS represents an attractive target for insecticides. At present, the research on the CHS gene in mosquitoes, especially its biological functions, remains limited.

Results
The full-length cDNA of the chitin synthase B gene in Culex pipiens pallens (CpCHSB) was prepared and consists of 5158 nucleotides with an open reading frame (ORF) of 4722 nucleotides encoding a protein of 1573 amino acid residues. Among different tissues, CpCHSB gene is mainly expressed in the midgut tissue with the highest expression in adult mosquitoes. Knockdown of CpCHSB in the larval stage significantly lowered the chitin content (16.5%) decreased body size (reduced by 25.6% in the larval stage and by 25.6% in the adult stage), and diminished reproduction (20%). Injecting siCHSB into adult mosquito mainly decreased reproduction (27%).

Conclusions
CpCHSB plays essential roles in growth and development, by severely reducing larval chitin content, midgut permeability, and reducing the number of female mosquito offspring. These results indicate that CHSB may serve as a potential novel target for exploring biosafe insecticides.
Rule-based and machine learning algorithms identify patients with systemic sclerosis accurately in the electronic health record
Authors: Jamian Lia , Wheless Lee , Crofford Leslie J. , Barnado April 
Published: December 2019

Abstract
Background
Systemic sclerosis (SSc) is a rare disease with studies limited by small sample sizes. Electronic health records (EHRs) represent a powerful tool to study patients with rare diseases such as SSc, but validated methods are needed. We developed and validated EHR-based algorithms that incorporate billing codes and clinical data to identify SSc patients in the EHR.

Methods
We used a de-identified EHR with over 3 million subjects and identified 1899 potential SSc subjects with at least 1 count of the SSc ICD-9 (710.1) or ICD-10-CM (M34*) codes. We randomly selected 200 as a training set for chart review. A subject was a case if diagnosed with SSc by a rheumatologist, dermatologist, or pulmonologist. We selected the following algorithm components based on clinical knowledge and available data: SSc ICD-9 and ICD-10-CM codes, positive antinuclear antibody (ANA) (titer ≥ 1:80), and a keyword of Raynaud’s phenomenon (RP). We performed both rule-based and machine learning techniques for algorithm development. Positive predictive values (PPVs), sensitivities, and F-scores (which account for PPVs and sensitivities) were calculated for the algorithms.

Results
PPVs were low for algorithms using only 1 count of the SSc ICD-9 code. As code counts increased, the PPVs increased. PPVs were higher for algorithms using ICD-10-CM codes versus the ICD-9 code. Adding a positive ANA and RP keyword increased the PPVs of algorithms only using ICD billing codes. Algorithms using ≥ 3 or ≥ 4 counts of the SSc ICD-9 or ICD-10-CM codes and ANA positivity had the highest PPV at 100% but a low sensitivity at 50%. The algorithm with the highest F-score of 91% was ≥ 4 counts of the ICD-9 or ICD-10-CM codes with an internally validated PPV of 90%. A machine learning method using random forests yielded an algorithm with a PPV of 84%, sensitivity of 92%, and F-score of 88%. The most important feature was RP keyword.

Conclusions
Algorithms using only ICD-9 codes did not perform well to identify SSc patients. The highest performing algorithms incorporated clinical data with billing codes. EHR-based algorithms can identify SSc patients across a healthcare system, enabling researchers to examine important outcomes.
Train-the-Trainers in hand hygiene: a standardized approach to guide education in infection prevention and control
Authors: Tartari Ermira , Fankhauser Carolina , Masson-Roy Sarah , Márquez-Villarreal Hilda , Fernández Moreno Inmaculada , Rodriguez Navas Ma Luisa , Sarabia Odet , Bellissimo-Rodrigues Fernando , Hernández-de Mezerville Marcela , Lee Yew Fong , Aelami Mohammad Hassan , Mehtar Shaheen , Agostinho Américo , Camilleri Liberato , Allegranzi Benedetta , Pires Daniela , Pittet Didier 
Published: December 2019

Abstract
Background
Harmonization in hand hygiene training for infection prevention and control (IPC) professionals is lacking. We describe a standardized approach to training, using a “Train-the-Trainers” (TTT) concept for IPC professionals and assess its impact on hand hygiene knowledge in six countries.

Methods
We developed a three-day simulation-based TTT course based on the World Health Organization (WHO) Multimodal Hand Hygiene Improvement Strategy. To evaluate its impact, we have performed a pre-and post-course knowledge questionnaire. The Wilcoxon signed-rank test was used to compare the results before and after training.

Results
Between June 2016 and January 2018 we conducted seven TTT courses in six countries: Iran, Malaysia, Mexico, South Africa, Spain and Thailand. A total of 305 IPC professionals completed the programme. Participants included nurses (n = 196; 64.2%), physicians (n = 53; 17.3%) and other health professionals (n = 56; 18.3%). In total, participants from more than 20 countries were trained. A significant (p < 0.05) improvement in knowledge between the pre- and post-TTT training phases was observed in all countries. Puebla (Mexico) had the highest improvement (22.3%; p < 0.001), followed by Malaysia (21.2%; p < 0.001), Jalisco (Mexico; 20.2%; p < 0.001), Thailand (18.8%; p < 0.001), South Africa (18.3%; p < 0.001), Iran (17.5%; p < 0.001) and Spain (9.7%; p = 0.047). Spain had the highest overall test scores, while Thailand had the lowest pre- and post-scores. Positive aspects reported included: unique learning environment, sharing experiences, hands-on practices on a secure environment and networking among IPC professionals. Sustainability was assessed through follow-up evaluations conducted in three original TTT course sites in Mexico (Jalisco and Puebla) and in Spain: improvement was sustained in the last follow-up phase when assessed 5 months, 1 year and 2 years after the first TTT course, respectively.

Conclusions
The TTT in hand hygiene model proved to be effective in enhancing participant’s knowledge, sharing experiences and networking. IPC professionals can use this reference training method worldwide to further disseminate knowledge to other health care workers.
Bacterial pathogens and resistance causing community acquired paediatric bloodstream infections in low- and middle-income countries: a systematic review and meta-analysis
Authors: Droz Nina , Hsia Yingfen , Ellis Sally , Dramowski Angela , Sharland Mike , Basmaci Romain 
Published: December 2019

Abstract
Background
Despite a high mortality rate in childhood, there is limited evidence on the causes and outcomes of paediatric bloodstream infections from low- and middle-income countries (LMICs). We conducted a systematic review and meta-analysis to characterize the bacterial causes of paediatric bloodstream infections in LMICs and their resistance profile.

Methods
We searched Pubmed and Embase databases between January 1st 1990 and October 30th 2019, combining MeSH and free-text terms for “sepsis” and “low-middle-income countries” in children. Two reviewers screened articles and performed data extraction to identify studies investigating children (1 month-18 years), with at least one blood culture. The main outcomes of interests were the rate of positive blood cultures, the distribution of bacterial pathogens, the resistance patterns and the case-fatality rate. The proportions obtained from each study were pooled using the Freeman-Tukey double arcsine transformation, and a random-effect meta-analysis model was used.

Results
We identified 2403 eligible studies, 17 were included in the final review including 52,915 children (11 in Africa and 6 in Asia). The overall percentage of positive blood culture was 19.1% [95% CI: 12.0–27.5%]; 15.5% [8.4–24.4%] in Africa and 28.0% [13.2–45.8%] in Asia. A total of 4836 bacterial isolates were included in the studies; 2974 were Gram-negative (63.9% [52.2–74.9]) and 1858 were Gram-positive (35.8% [24.9–47.5]). In Asia, Salmonella typhi (26.2%) was the most commonly isolated pathogen, followed by Staphylococcus aureus (7.7%) whereas in Africa, S. aureus (17.8%) and Streptococcus pneumoniae (16.8%) were predominant followed by Escherichia coli (10.7%). S. aureus was more likely resistant to methicillin in Africa (29.5% vs. 7.9%), whereas E. coli was more frequently resistant to third-generation cephalosporins (31.2% vs. 21.2%), amikacin (29.6% vs. 0%) and ciprofloxacin (36.7% vs. 0%) in Asia. The overall estimate for case-fatality rate among 8 studies was 12.7% [6.6–20.2%]. Underlying conditions, such as malnutrition or HIV infection were assessed as a factor associated with bacteraemia in 4 studies each.

Conclusions
We observed a marked variation in pathogen distribution and their resistance profiles between Asia and Africa. Very limited data is available on underlying risk factors for bacteraemia, patterns of treatment of multidrug-resistant infections and predictors of adverse outcomes.
On the simple calculation of walking efficiency without kinematic information for its convenient use
Authors: Abe Daijiro , Fukuoka Yoshiyuki , Horiuchi Masahiro 
Published: December 2019

AbstractBackgroundSince walking is a daily activity not to require the maximal effort in healthy populations, a very few universal bio-parameters and/or methods have been defined to evaluate individual walking characteristics in those populations. A concept of “economy” is a potential candidate; however, walking economy highly depends on speed, so direct comparisons of economy values are difficult between studies. We investigated whether the vertical component of net walking “efficiency” (Effvert; %) is constant across speed. In that case, direct comparisons of Effvertwill be possible between studies or individuals at any voluntary speed.MethodsThirty young male participants walked at eight speeds on the level or ± 5% gradients, providing vertical speeds (vvert). Differences in energy expenditure between level and uphill or downhill gradients (ΔEE) were calculated. The metabolic rate for vertical component (MRvert) was calculated by multiplying ΔEE with body mass (BM). The mechanical power output for vertical component (Pmech) was calculated by multiplying BM, gravitational acceleration, andvvert. Effvertwas obtained from the ratio of Pmechto MRvertat eachvvert. Delta efficiency (Delta-E; %) was also calculated from the inverse slope of the regression line representing the relationship of Pmechto MRvert.ResultsUpward Effvertwas nearly constant at around 35% and downward Effvertranged widely (49–80%). No significant differences were observed between upward Delta-E (35.5 ± 8.8%) and Effvertat any speeds, but not between downward Delta-E (44.9 ± 12.8%) and Effvert.ConclusionsUpward ΔEE could be proportional tovvert. Upward, but not downward, Effvertshould be useful not only for healthy populations but also for clinical patients to evaluate individual gait characteristics, because it requires only two metabolic measurements on the level and uphill gradients without kinematic information at any voluntary speed.Trial registrationUMIN000017690 (R000020501; registered May 26th, 2015, before the first trial) and UMIN000031456 (R000035911; registered Feb. 23rd, 2018, before the first trial).