bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparing paediatric- and adult-onset linear morphoea in a large tertiary-referral scleroderma centre
Authors: Saracino Amanda M , George Christina , Nihtyanova Svetlana I , Denton Christopher P 
Published: June 2020

Background: Linear morphoea is a severe morphoea subtype associated with extracutaneous manifestations, potentially permanent disfigurement and functional impairment. Linear morphoea is more prevalent in paediatric patients, and knowledge of disease in adults is limited. The objective of this study was to compare paediatric- and adult-onset linear morphoea, in an exclusively adult population. Methodology: This was a retrospective cohort study of adult patients with linear morphoea seen over a 3-year period at a single-site adult tertiary-referral Connective Tissue Disease centre. Clinical markers of disease severity and course, including anatomical distribution, extracutaneous manifestations, cutaneous symptoms, associated autoimmunity, inflammatory blood parameters, Dermatology Life Quality Index scores, treatment requirements and modified Localised Scleroderma Activity Tool were assessed and compared in paediatric- and adult-onset linear morphoea. Results: Of 298 patients with morphoea seen during the study period, 135 had linear morphoea and 133 were included in the study. Most were female (78.9%), the mean age was 36.5 years and almost half (43.6%) had adult-onset disease. Disease was similarly severe between groups with regard to anatomical distribution, cutaneous symptoms (n = 89, 66.9%), extracutaneous manifestations (n = 76, 57.1%), antinuclear antibody–positivity (n = 40, 40.4%), raised erythrocyte sedimentation rate (n = 27, 25.0%) and associated autoimmune diagnoses (n = 15, 11.3%). Prescribed treatments were similar between groups; 73.7% receiving methotrexate and almost one-third (32.3%) requiring more than one steroid-sparing agent. Those with paediatric-onset had more disease-related damage, with a mean modified Localised Scleroderma Skin Damage Index score of 19.5 (95% confidence interval: 17.0–22.0) versus 8.1 (95% confidence interval: 4.4–11.8; p < 0.001). Significantly more patients with adult-onset linear morphoea had quiescent disease (p = 0.0332), and even after correcting for disease duration, paediatric-onset patients still had 2.6 times greater odds of active disease (odds ratio = 2.59, 95% confidence interval: 0.9–7.6; p = 0.083). Conclusion: Linear morphoea in adults can be a severe disease with extracutaneous, autoimmune and systemic features. Adults with paediatric-onset disease appear to have more severe cumulative damage, greater functional impairment and ongoing disease activity. This patient subgroup may require particularly close monitoring and more aggressive therapy.
Validation of an algorithm for automated classification of migraine and tension-type headache attacks in an electronic headache diary
Authors: Roesch Aaron , Dahlem Markus A , Neeb Lars , Kurth Tobias 
Published: June 2020

AbstractBackgroundThis study evaluates the accuracy of an automated classification tool of single attacks of the two major primary headache disorders migraine and tension-type headache used in an electronic headache diary.MethodsOne hundred two randomly selected reported headache attacks from an electronic headache-diary of patients using the medical app M-sense were classified by both a neurologist with specialisation in headache medicine and an algorithm, constructed based on the ICHD-3 criteria for migraine and tension-type headache. The level of agreement between the headache specialist and the algorithm was compared by using a kappa statistic. Cases of disagreement were analysed in a disagreement validity assessment.ResultThe neurologist and the algorithm classified migraines with aura (MA), migraines without aura (MO), tension-type headaches (TTH) and non-migraine or non-TTH events. Of the 102 headache reports, 86 cases were fully agreed on, and 16 cases not, making the level of agreement unweighted kappa 0.74 and representing a substantial level of agreement. Most cases of disagreement (12 out of 16) were due to inadvertent mistakes of the neurologist identified in the disagreement validity assessment. The second most common reason (3 out of 16) was insufficient information for classification by the neurologist.ConclusionsThe substantial level of agreement indicates that the classification tool is a valuable instrument for automated evaluation of electronic headache diaries, which can thereby support the diagnostic and therapeutic clinical processes. Based on this study’s results, additional diagnostic functionalities of primary headache management apps can be implemented. Finally, future research can use this classification algorithm for large scale database analysis for epidemiological studies.
Campylobacter bacteriophage DA10: an excised temperate bacteriophage targeted by CRISPR-cas
Authors: Hooton Steven , D’Angelantonio Daniela , Hu Yang , Connerton Phillippa L. , Aprea Giuseppe , Connerton Ian F. 
Published: June 2020

Abstract
Background
Lytic bacteriophages that infect Campylobacter spp. have been utilized to develop therapeutic/decontamination techniques. However, the association of Campylobacter spp. and bacteriophages has been the focus of several strands of research aimed at understanding the complex relationships that have developed between predators and prey over evolutionary time. The activities of endogenous temperate bacteriophages have been used to evaluate genomic rearrangements and differential protein expression in host cells, and mechanisms of resistance to bacteriophage infection in campylobacters such as phase variation and CRISPR-mediated immunity.

Results
Temperate bacteriophage DA10 represents a novel excised and infective virus capable of replication in a restricted set of C. jejuni and C. coli hosts. Whole genome sequencing reveals that DA10 (35,379 bp) forms part of a novel group of temperate bacteriophages that have limited distribution among database host genome sequences. Analysis of potential host genomes reveals a robust response against DA10 and DA10-like bacteriophages is driven by CRISPR-mediated immunity with 75% of DA10 ORFs represented as ~ 30 bp spacer sequences in numerous Campylobacter Type II-C CRISPR arrays. Several DA10-like homologues have been identified in a small sub-set of C. jejuni and C. coli genome sequences (ranging from near complete integrated prophage sequences to fragments recognisable in the sequence read archive).

Conclusions
A complete intact DA10-like prophage in C. jejuni CJ677CC520 provides evidence that the associations between host and DA10-like bacteriophages are long-standing in evolutionary timescales. Extensive nucleotide substitution and loss can be observed in the integrated DA10-like prophage of CJ677CC520 compared to other relatives as observed through pairwise genome comparisons. Examining factors that have limited the population expansion of the prophage, while others appear to have thrived and prospered (Mu-like, CJIE-like, and lytic Campylobacter bacteriophages) will assist in identifying the underlying evolutionary processes in the natural environment.
Population attributable risk estimates of risk factors for contrast-induced acute kidney injury following coronary angiography: a cohort study
Authors: Lei Li , Xue Yan , Guo Zhaodong , Liu Bowen , He Yibo , Song Feier , Liu Jin , Sun Guoli , Chen Liling , Chen Kaihong , Su Zhiqi , Pan Li , Huang Zhidong , Huang Yulu , Huang Xiuqiong , Chen Shiqun , Chen Jiyan , Liu Yong 
Published: June 2020

Abstract
Background
Contrast-induced acute kidney injury (CI-AKI) is a common complication with poor outcomes following coronary angiography (CAG) or percutaneous coronary intervention (PCI). However, no study has explored the population attributable risks (PARs) of the CI-AKI risk factors. Therefore, we aimed to identify the independent risk factors of CI-AKI and estimate their PARs.

Methods
We analyzed 3450 consecutive patients undergoing CAG/PCI from a prospective cohort in Guangdong Provincial People’s Hospital. CI-AKI was defined as a serum creatinine elevation ≥50% or 0.3 mg/dL from baseline within the first 48 to 72 h after the procedure. Independent risk factors for CI-AKI were evaluated through stepwise approach and multivariable logistic regression analysis, and those that are potentially modifiable were of interest. PARs of independent risk factors were calculated with their odds ratios and prevalence among our cohort.

Results
The overall incidence of CI-AKI was 7.19% (n = 248), which was associated with increased long-term mortality. Independent risk factors for CI-AKI included heart failure (HF) symptoms, hypoalbuminemia, high contrast volume, hypotension, hypertension, chronic kidney disease stages, acute myocardial infarction and age > 75 years. Among the four risk factors of interest, the PAR of HF symptoms was the highest (38.06%), followed by hypoalbuminemia (17.69%), high contrast volume (12.91%) and hypotension (4.21%).

Conclusions
These modifiable risk factors (e.g., HF symptoms, hypoalbuminemia) could be important and cost-effective targets for prevention and treatment strategies to reduce the risk of CI-AKI. Intervention studies targeting these risk factors are needed.
Incorporating the patient-centered approach into clinical practice helps improve quality of care in cases of hypertension: a retrospective cohort study
Authors: Buawangpong Nida , Pinyopornpanish Kanokporn , Jiraporncharoen Wichuda , Dejkriengkraikul Nisachol , Sagulkoo Pakorn , Pateekhum Chanapat , Angkurawaranon Chaisiri 
Published: June 2020

AbstractBackgroundTreating hypertensive patients by integrating the patient-centered approach would influence the practice and outcome of treatment. Our purpose was to determine whether the implementation of a patient-centered approach in health care delivery can improve adhering to guidelines and the quality-of-care.MethodsA retrospective study was conducted using secondary data from the electronic medical records of the patients treated in the two primary care outpatient settings at the Family Medicine (FM) and Social Security (SS) clinics. A key feature of the FM clinic is the incorporation of a patient-centered approach in its service delivery. Individual information regarding initial assessment and treatment at the follow-up visits was reviewed for 1 year. Comparison of adherence to treatment guidelines between the two primary care clinics was performed by using chi-square, Fisher’s exact test or a t-test. To explore the difference in blood pressure and BP control between the two clinics, linear and logistic regression analysis respectively were performed with an adjustment for CV risk score in 2016 as a key confounder.ResultsThe evidence included 100 records from each clinic, showed variation between the two primary care sites. The FM clinic had more complete records regarding family history of hypertension, assessment for secondary causes, prescription for lifestyle modification and appropriate adjustment of medication. Higher levels of blood pressure control were recorded in the FM clinic, specifically systolic pressure 2.92 mmHg (p = 0.073) and diastolic pressure 5.38 mmHg (p <  0.001) lower than those recorded in the SS clinic. There was a 2.96 times higher chance for BP goals to be achieved in patients in receipt of hypertensive care at the FM clinic (p = 0.004).ConclusionsAdopting a patient-centered approach in service delivery could improve the quality of care for hypertension patients in primary care in Thailand.
Weekly paclitaxel plus ramucirumab versus weekly nab-paclitaxel plus ramucirumab for unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy—the P-SELECT trial (WJOG10617G)—a randomised phase II trial by the West Japan Oncology Group
Authors: Hirata Kenro , Hamamoto Yasuo , Ando Masahiko , Imamura Chiyo K. , Yoshimura Kenichi , Yamazaki Kentaro , Hironaka Shuichi , Muro Kei 
Published: June 2020

Abstract
Background
Ramucirumab (RAM) with weekly paclitaxel (wPTX) is a standard second-line therapy for advanced or recurrent gastric cancer. Nanoparticle albumin-bound paclitaxel (nab-PTX), an albumin-bound form of PTX, was developed to improve the therapeutic index of taxane treatment. However, the ABSOLUTE trial showed the non-inferiority of weekly nab-PTX (w-nab-PTX) to wPTX with respect to overall survival (OS) as second-line therapy for advanced or recurrent gastric cancer, and subgroup analysis of patients with peritoneal dissemination showed favourable OS and progression-free survival (PFS) in the w-nab-PTX arm compared to those in the wPTX arm. This study evaluated whether w-nab-PTX plus RAM is more effective than wPTX plus RAM for patients with peritoneal dissemination.

Methods
The P-SELECT trial (WJOG10617G) is a prospective, open-label, multicentre, randomised phase II study evaluating wPTX plus RAM (arm A) versus w-nab-PTX plus RAM (arm B). Key eligibility criteria include the following: 1) histologically proven adenocarcinoma, 2) unresectable or recurrent gastric cancer, 3) peritoneal dissemination, 4) intolerance or refractory to first-line therapy including fluoropyrimidines, and 5) ECOG Performance Status (PS) 0–2. Patients are randomised to either arm at a 1:1 ratio stratified by institution, PS, and severity of ascites. PTX (80 mg/m2; days 1, 8, and 15) and RAM (8 mg/kg; days 1 and 15) are administered every 4 weeks in arm A, while nab-PTX (100 mg/m2; days 1, 8, and 15) instead of PTX is administered in arm B. The primary endpoint is OS, and the main secondary endpoints are PFS, objective response rate, safety, neuropathy-specific quality of life, and biomarkers. To maintain a probability of ≥70% to ensure the hazard ratio for OS in arm B is lower than 0.90, 105 subjects are required. The study was initiated in October 2018 and is being conducted in 58 centres of the West Japan Oncology Group.

Discussion
The results of this study will determine whether w-nab-PTX plus RAM has the potential to be a preferred therapeutic option for advanced and recurrent gastric cancer with peritoneal dissemination, compared to wPTX plus RAM.

Trial registration
This study was prospectively registered in the Japan Registry of Clinical Trials (jRCTs031180022, October 1, 2018).
Timing of rapid weight gain and its effect on subsequent overweight or obesity in childhood: findings from a longitudinal birth cohort study
Authors: Li Yi-Fan , Lin Shio-Jean , Chiang Tung-liang 
Published: June 2020

Abstract
Background
Rapid weight gain (RWG) has been recognized as an important determinant of childhood obesity. This study aims to explore the RWG distribution among children at six-month intervals from birth to two years old and to examine the association of RWG in each interval with overweight or obesity development in preschool- and school-aged children.

Methods
Data were obtained from the Taiwan Birth Cohort Study, which is a nationally representative sample of 24,200 children who participated in a face-to-face survey. A total of 17,002 children had complete data both for weight and height at each of the five measurement time periods. Multivariable logistic regression models quantified the relationship between RWG and childhood overweight or obesity.

Results
A total of 17.5% of children experienced rapid weight gain in the first six months of age, compared to only 1.8% of children from 18-24 months. RWG was significantly associated with an increased risk of developing overweight or obesity at 36 months (RWG birth-6 months: OR = 2.6, 95% CI: 2.3–2.8; RWG 18–24 months: OR = 3.7, 95% CI: 2.9–4.6), 66 months (RWG birth-6 months: OR = 2.2, 95% CI: 2.0–2.4; RWG 18–24 months: OR = 2.3, 95% CI: 1.8–2.8), and 8 years of age (RWG birth-6 months: OR = 1.7, 95% CI: 1.6–1.9; RWG 18–24 months: OR = 2.4, 95% CI: 2.0–3.0).

Conclusions
Childhood RWG increased the risk of subsequent overweight or obesity, regardless of the specific time interval at which RWG occurred before the age of two years. The results reinforce the importance of monitoring childhood RWG continuously and show the risks of childhood RWG with respect to the development of overweight or obesity at preschool and school ages.
The validity and reliability of the Patient Health Questionnaire-9 for screening depression in primary health care patients in Botswana
Authors: Molebatsi Keneilwe , Motlhatlhedi Keneilwe , Wambua Grace Nduku 
Published: June 2020

Abstract
Background
The lack of locally validated screening instruments contributes to poor detection of depression in primary care. The Patient Health Questionnaire-9 (PHQ-9) is a brief and freely available screening tool which was developed for primary care settings; however, its accuracy may be affected by the population in which it is administered. This study aimed to determine the validity and reliability of PHQ-9 for screening depression in a primary care population in Botswana.

Methods
Data was collected from a conveniently selected sample of 257 adult primary care attendants. The Mini International Neuropsychiatric Interview (MINI) depression module was used as a gold standard to assess criterion validity.

Results
Sensitivity and specificity of the PHQ-9 for screening for major depression were 72.4 and 76.3 respectively at a cut off score of nine or more. The area under the ROC curve was 0.808. The PHQ-9 demonstrated good internal consistency with a Cronbach alpha of 0.799. Criterion validity was demonstrated by significant correlation (r = 0.528, p < 0.001) between PHQ-9 and the MINI. Significant negative correlation between PHQ-9 scores and all four domains of the WHO quality of life questionnaire- brief version scores demonstrated good convergent validity.

Conclusions
The PHQ-9 is a reliable and valid instrument to screen for depression in primary care facilities in Botswana. Primary care clinicians in Botswana may use the PHQ-9 to screen for depression with a cut –off score of nine. Further studies should focus on integrating routine depression screening in primary care.
Monetary incentives and peer referral in promoting digital network-based secondary distribution of HIV self-testing among men who have sex with men in China: study protocol for a three-arm randomized controlled trial
Authors: Lu Ying , Ni Yuxin , Li Xiaofeng , He Xi , Huang Shanzi , Zhou Yi , Dai Wencan , Wu Dan , Tucker Joseph D. , Shen Guangquan , Sha Yongjie , Jiang Hongbo , Huang Liqun , Tang Weiming 
Published: June 2020

Abstract
Background
Human immunodeficiency virus (HIV) testing is a crucial strategy for HIV prevention. HIV testing rates remain low among men who have sex with men (MSM) in China. Digital network-based secondary distribution is considered as an effective model to enhance HIV self-testing (HIVST) among key populations. Digital platforms provide opportunities for testers to apply for HIVST kits by themselves, and secondary distribution allows them to apply for multiple kits to deliver to their sexual partners or members within their social network. We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China.

Methods
Three hundred MSM in China will be enrolled through a digital platform for data collection. The eligibility criteria include being biological male, 18 years of age or over, ever having had sex with another man, being able to apply for kits via the online platform, and being willing to provide personal telephone number for follow-up. Eligible participants will be randomly allocated into one of the three arms: standard secondary distribution arm, secondary distribution with monetary incentives arm, and secondary distribution with monetary incentives plus peer referral arm. Participants (defined as “index”) will distribute actual HIV self-test kits to members within their social network (defined as “alter”) or share referral links to encourage alters to apply HIV self-test kits by themselves. All index participants will be requested to complete a baseline survey and a 3-month follow-up survey. Both indexes and alters will complete a survey upon returning the results by taking a photo of the used kits with the unique identification number.

Discussion
HIV testing rates remain suboptimal among MSM in China. Innovative interventions are needed to further expand the uptake of HIV testing among key populations. The findings of the trial can provide scientific evidence and experience on promoting secondary distribution of HIVST to reach key populations who have not yet been covered by existing testing services.

Trial registration
The study was registered in the Chinese Clinical Trial Registry (ChiCTR1900025433) on 26, August 2019, http://www.chictr.org.cn/showproj.aspx?proj=42001. Prospectively registered.
An 8 week open-label interventional multicenter study to explore the lung clearance index as endpoint for clinical trials in cystic fibrosis patients ≥8 years of age, chronically infected with Pseudomonas aeruginosa
Authors: Sutharsan Sivagurunathan , Naehrig Susanne , Mellies Uwe , Sieder Christian , Ziegler Jörg 
Published: June 2020

Abstract
Background
Forced expiratory volume in 1 second (FEV1) is the only parameter currently recognized as a surrogate endpoint in cystic fibrosis (CF) trials. However, FEV1 is relatively insensitive to changes in the small airways of patients with milder lung disease. This pilot study aimed to explore the lung clearance index (LCI) as a marker for use in efficacy trials with inhaled antibiotics in CF.

Methods
This open-label, single-arm study enrolled CF patients with Pseudomonas aeruginosa infection, who were treated with tobramycin (28-day on/off regime). FEV1, LCI and bacterial load in sputum (CFU) were assessed at baseline, after 1, 4 and 8 weeks of treatment.

Results
All patients (n = 17) showed elevated LCI of > 11 despite 3 patients having normal FEV1 (> 90% predicted) at baseline. Overall, LCI improved in 8 (47%) patients and FEV1 in 9 (53%) patients. At week 4, LCI improved by 0.88, FEV1 increased by 0.52%, and P. aeruginosa reduced by 30,481.3 CFU/mL. These changes were however statistically non-significant. Six adverse events occurred in 5/17 (29.4%) patients, most of which were mild-to-moderate in severity.

Conclusions
Due to the low evaluable sample size, no specific trend was observed related to the changes between LCI, FEV1 and CFU. Based on the individual data from this study and from recently published literature, LCI has been shown to be a more sensitive parameter than FEV1 for lung function. LCI can be hypothesized to be an appropriate endpoint for efficacy trials in CF patients if the heterogeneity in lung function is limited by enrolling younger patients or patients with more milder lung disease and thus, limiting the ventilation inhomogeneities.

Trial registration
The study is registered with ClinicalTrials.gov, identifier: NCT02248922.