bluuebunny/crossref_metadata_2025_split huggingface dataset:
Statistical analysis plan for the randomized controlled trial CardioCare MV investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease
Authors: Ziegler Andreas , Mann Miriam , Brandewiede Bernard , Dittrich Hermann , Hintz Sissy , Krockenberger Katja , Öner Alper , de Sousa Marcos Oliviera , Schmidt Christian 
Published: February 2020

Abstract
Background
Cardiovascular diseases are the major cause of death globally and represent a major economic burden on health care systems. For patients with heart failure, atrial fibrillation or therapy-resistant hypertension, we have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a care center, including a call center, an integrated care network including inpatient and outpatient care providers and guideline therapy for patients (Schmidt et al. 2018 Trials 19:120). Here, we describe challenges and solutions in patient recruitment and provide the statistical analysis plan.

Methods
The study CardioCare MV is a prospective, randomized, controlled, parallel-group, open-label, bi-center trial with two groups for comparing NICC with standard of care (SoC). Because of issues with patient enrollment we adapted the study plan after consultation with the Ethics Committee and the funding agency. We altered the analysis strategy for the primary endpoints, which led to a change in the required sample size. We also changed the access points to patients from inpatient hospitals specialized in the treatment of patients with cardiovascular disease to specialized practices.

Results
Recruitment of patients started on 1 December 2017, and first patient in was on 4 December 2017. Recruitment was completed on 15 August 2019 as planned according to the amended study plan. The follow-up period will end in August 2020. A total of 964 patients was enrolled into the trial. The statistical analysis plan was finalized prior to last patient in. Results will be available by the end of 2020.

Discussion
The trial will inform care providers whether quality of care can be improved by an integrated care concept providing telemedicine through a round-the-clock call center approach. We expect that cost of the NICC will be lower than standard care because of reduced hospitalizations. The trial will guide additional research to disentangle the effects of this complex intervention.

Trial registration
DRKS, ID: DRKS00013124. Registered on 5 October 2017
ClinicalTrials.gov, ID: NCT03317951. Registered on 17 October 2017
Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial
Authors: Yang Weiqiang , Li Xiaoling , Zhong Jiatao , Mei Xueshuang , Liu Hongyu , Yang Le , Lu Liming , Hu Hongyi 
Published: February 2020

Abstract
Background
Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. The benefit of intratympanic compared to systemic treatment is the reduced systemic steroid exposure and associated systemic adverse effects. Intratympanic corticosteroid administration may have potential benefits over standard systemic therapies.

Methods/design
The proposed study is a prospective, randomized superiority trial. A total of 96 patients (48 in each group) will be randomized into the experimental or control group. Patients in the experimental group will receive four 1-mL doses of 40 mg/mL of methylprednisolone over a 1-week period, with a dose administered every 2 days via tympanic membrane injection into the middle ear. The control group will be administered intravenous methylprednisolone (1 mg/kg/day, maximal dose 60 mg/day) for 5 days. The primary outcome for this study is the change in hearing threshold from the first audiogram to the 30-day follow-up audiogram. Secondary outcome measures will include pure-tone average (PTA) at 90-day follow up, visual analog tinnitus scale, visual analog vertigo scale, visual analog aural fullness scale, fasting blood glucose and 2-h postprandial blood glucose during treatment, and the change in glycosylated hemoglobin (HbA1C) levels. Vital signs and otological physical examination will be performed at each follow-up visit.

Discussion
The efficacy and safety of intratympanic methylprednisolone compared to intravenous methylprednisolone will be investigated in patients with diabetes mellitus and SSNHL. This trial may provide strong evidence for the efficacy and safety of intratympanic corticosteroid treatment and important clinical information for the treatment of patients with diabetes mellitus and SSNHL.

Trial registration
ChiCTR, ChiCTR1800015954. Registered on 2 May 2018, Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=25326.
Does Bangkok have a central role in the dengue dynamics of Thailand?
Authors: Xu Zhiwei , Bambrick Hilary , Pongsumpun Puntani , Ming Tang I. , Yakob Laith , Devine Gregor , Frentiu Francesca D. , Williams Gail , Hu Wenbiao 
Published: February 2020

Abstract
Background
Bangkok plays a central role in the commerce of Thailand. This study aimed to characterize the district-level spatial-temporal patterns of dengue in Thailand and explore if a dengue peak in Bangkok led the peaks of dengue in other Thai provinces.

Methods
Monthly dengue data at district level in Thailand from January 2004 to December 2017 were obtained and used to assess the spatial and seasonal patterns of dengue in Thailand. As our seasonal decomposition and cross-correlation analyses showed that dengue in Bangkok peaked in November, which was a few months after the dengue peak in most other provinces, we used a time-series generalized linear model to explore if there was another province in which the dengue case number was most predictive of dengue case numbers in other Thai provinces.

Results
The highest district-level annual dengue incidence rates (per 10,000) in the three time periods (i.e. 2004–2008, 2009–2013 and 2014–2017) were 58.08 (Samphanthawong), 85.93 (Mueang Krabi), and 66.60 (Mae Sariang), respectively. Dengue incidence rates in the western part of Northern Thailand, southern part of Central Thailand, southern part of Eastern Thailand, and Southern Thailand were higher than in other regions. Dengue in most districts of Thailand peaked in June, July or August, but dengue peaks in all districts of Bangkok occurred in November. The number of dengue cases in Nakhon Ratchasima was most predictive of the number of dengue cases in other provinces in Thailand by a one-month lag.

Conclusions
Our results suggest that the dengue peak in Bangkok did not lead the peaks of dengue in other Thai provinces. Future research exploring how changes in socio-ecological factors (e.g. road network and climate factors) in Nakhon Ratchasima have affected the transmission of dengue in Thailand might shed some new light on the prevention and control of dengue.
Characterization of melanic and non-melanic forms in domestic and peridomestic populations of Triatoma infestans (Hemiptera: Reduviidae)
Authors: Nattero Julieta , Carbajal de la Fuente Ana Laura , Piccinali Romina Valeria , Cardozo Miriam , Rodríguez Claudia Susana , Crocco Liliana Beatriz 
Published: February 2020

AbstractBackgroundMelanic (dark) morphs have been barely reported in peridomestic and sylvatic conditions forTriatoma infestans, the most important vector of Chagas disease in the Southern Cone of South America. Adults with dark and small yellow markings on the connexivum were collected after manual searches conducted by technical personnel in 62 domiciliary units in Cruz del Eje, Córdoba Province, Argentina. The last community-wide insecticide spraying campaign before the study had been conducted three years earlier. We investigated if there was a measurable color morph variation (melanic and non-melanic) in wings and connexivum; we determined infestation, distribution of melanic and non-melanic forms, and correspondence of colorimetric variation with variations in morphology (wing size and shape and body length), development (wing fluctuating asymmetry), physiology (nutritional status) or behaviour (flight initiation).ResultsForty-nine females, 54 males and 217 nymphs were collected in 24 domiciliary units. House infestation and colonization were 53% and 47%, respectively. Most of theT. infestansindividuals (83.2%) were collected in chicken coops; intradomicile infestation was recorded in only one case. The chromatic cluster analysis showed two well-defined groups: melanic and non-melanic. The melanic group included 17 (35%) females and 25 (46%) males. Peridomestic infestation was lower for melanic than for non-melanic adults. Melanic morphs were collected in houses from several localities. Sexual dimorphisms were confirmed by morphometric measurements. Body length was large in melanic adults (P < 0.01 only for males). Differences between groups were significant for wing size and shape, but not for weight or weight/body length ratio. Melanic females and males showed significantly higher fluctuating asymmetry (FA) indices than their non-melanic counterparts.ConclusionsThis is the second report of melanic forms ofT. infestansin domestic and peridomestic habitats in the Dry Chaco region of Argentina. Although non-melanic adults exhibited a higher infestation rate, melanic adults were widespread in the area and were collected in the infested domicile and in most types of peridomestic annexes. Differences in morphometric variables between groups might be due to different ecological adaptations. The higher FA levels observed in melanic individuals suggest a higher developmental instability and a selective advantage of non-melanic individuals in domestic and peridomestic habitats.
Assessing structural damage progression in psoriatic arthritis and its role as an outcome in research
Authors: van der Heijde Désirée , Gladman Dafna D. , Kavanaugh Arthur , Mease Philip J. 
Published: February 2020

AbstractPsoriatic arthritis (PsA) is an immune-mediated, clinically heterogeneous disease characterized by arthritis, enthesitis, dactylitis, spondylitis, and psoriasis of the skin and nails. Persistent articular inflammation in patients with PsA can lead to structural damage, which can result in reduced physical function and quality of life. Structural damage can occur rapidly, and irreversible joint damage may be observed if patients are not treated promptly and appropriately. Therefore, evaluating therapeutic agents for their ability to inhibit structural progression has become increasingly important, with radiographic progression becoming a key efficacy outcome in clinical trials in PsA. Here, we review how structural damage and progression are assessed in clinical trials and the use of radiographic progression as a study outcome. We also discuss possible limitations in the current assessment of radiographic progression as well as areas of research that may improve the assessment of structural damage in clinical trials of PsA.
Adversarial attacks on fingerprint liveness detection
Authors: Fei Jianwei , Xia Zhihua , Yu Peipeng , Xiao Fengjun 
Published: February 2020

AbstractDeep neural networks are vulnerable to adversarial samples, posing potential threats to the applications deployed with deep learning models in practical conditions. A typical example is the fingerprint liveness detection module in fingerprint authentication systems. Inspired by great progress of deep learning, deep networks-based fingerprint liveness detection algorithms spring up and dominate the field. Thus, we investigate the feasibility of deceiving state-of-the-art deep networks-based fingerprint liveness detection schemes by leveraging this property in this paper. Extensive evaluations are made with three existing adversarial methods: FGSM, MI-FGSM, and Deepfool. We also proposed an adversarial attack method that enhances the robustness of adversarial fingerprint images to various transformations like rotations and flip. We demonstrate these outstanding schemes are likely to classify fake fingerprints as live fingerprints by adding tiny perturbations, even without internal details of their used model. The experimental results reveal a big loophole and threats for these schemes from a view of security, and enough attention is urgently needed to be paid on anti-adversarial not only in fingerprint liveness detection but also in all deep learning applications.
The prospective mathematical idea satisfying both radiation hormesis under low radiation doses and linear non-threshold theory under high radiation doses
Authors: Kino Katsuhito 
Published: February 2020

AbstractIt has yet to be determined whether or not the probability of developing cancer due to radiation exposure levels of low doses is proportional to the dose. Herein, for radiation hormesis occurring at low doses, mathematical models using functions that take a mountain-like shape having two inflection points are considered. The following perspectives were obtained: (i) When the probability of developing cancer decreases at radiation levels above the natural background dose, the radiation hormesis effect occurs up to ~ 12.4 mSv. (ii) When there is a proportional relationship at ≥750 mSv, the radiation hormesis effect occurs up to ~ 225 mSv. Thus, by performing studies at the molecular and cellular levels for radiation doses at ≤16.8 or 307 mSv, it is possible to investigate carcinogenesis resulting from low radiation doses.
Falls in systolic blood pressure during dialysis which require no nursing intervention are associated with increased patient intra-dialytic symptom self-reporting and prolonged post-dialysis recovery times
Authors: Yoowannakul Suree , Vongsanim Surachet , Tangvoraphonkchai Kamonwan , Mohamed Ahmed , Davenport Andrew 
Published: February 2020

Abstract
Background
Haemodialysis (HD) patients may suffer symptoms during dialysis and take time to recover post HD. We wished to determine whether patients with symptomatic intra-dialytic hypotension (IDH), requiring nursing interventions, or an asymptomatic fall in systolic blood pressure (SBP) reported more symptoms during dialysis.

Methods
Six hundred three HD patients completed self-reported intra-dialytic symptom questionnaires and recovery using a visual analogue scale, which were compared with their dialysis session records.

Results
Twenty-nine (4.8%) of patients suffered symptomatic IDH, and 187 (31.0%) had a fall in SBP of > 20 mmHg. Symptomatic patients had greater total symptom scores (30 (23–44) vs 23 (10–38), p < 0.05, versus asymptomatic patients, with increased low blood pressure, dizziness, cramps, palpitations and feeling cold reported (all p < 0.05). Patients with a SBP fall of > 20 mmHg had greater total scores compared with those with a SBP increase of > 10 mmHg (26 (13–38) vs 17 (7–34), p < 0.05), with more dizziness, cramps, backache, shortness of breath and headache reported (all p < 0.05). Although ultrafiltration rates were similar, HD weight loss was greater for patients with a SBP fall of > 20 mmHg (2.5 ± 1.1 vs 2.0 ± 1.3%, p < 0.05). Patients with highest symptoms scores (highest vs lowest quartile) had longer recovery times (40.3 vs 7.6% > 4 h), p < 0.001.
Multivariable analysis showed that patients reporting more intradialytic symptoms had higher psychological distress thermometer scores (odds ratio (OR) 1.34 (95% confidence limits 1.26–1.44)), systolic blood pressure < 100 mmHg (OR 2.53 (1.04–6.1)), whereas symptom scores were lower for male gender (OR 0.34 (0.22–0.51)), and with increasing age (OR 0.99 (0.97–0.99)).

Conclusion
Patients with both symptomatic and asymptomatic IDH, self-reported more symptoms during dialysis, and those patients reporting more symptoms had longer recovery times. We found that younger, female patients, those with greater psychological distress, and lower systolic blood pressure self-reported more intra-dialytic symptoms. More attention is required to prevent falls in intra-dialytic blood pressure to improve the patient experience of HD and shorten post-dialysis recovery times.
Deep learning and regression modelling of cloudless downward longwave radiation
Authors: Obot Nsikan I. , Humphrey Ibifubara , Chendo Michael A. C. , Udo Sunday O. 
Published: February 2020

Abstract
Background
Though downward longwave radiation (DLR) models curb the paucity of data, they are mostly location dependent. Therefore, there is a need to evaluate their relevance given the increasing use of machine learning techniques. In this study, cloudless DLR estimates from regression models and soft computing models of neural networks (NN), support vector regression (SVR) and adaptive neuro-fuzzy inference system (ANFIS) were compared. Clear days from September 1992 to August 1994 and July 1995 to March 1998 in Ilorin (8.50 °N, 4.55 °E), Nigeria were considered, while the predictors for the models were water vapour pressure, e and air temperature, T.

Results
A new regression model in relation to the Boltzmann constant, σ: $$ \left(1.014\left(\frac{1.0\times {10}^{30}\times e}{T^{13}}\right)+0.699\right)\sigma {T}^4 $$1.0141.0×1030×eT13+0.699σT4, was better than other regression models and applicable at another location. Between 1 and 8, the sixth degree was the best polynomial kernel function in SVR models’ estimations of cloudless DLR. Though the new regression model was comparable to expert systems, ANFIS was still the best model due to its consistent high correlations and lowest estimation errors.

Conclusions
Experience-based computational procedures that combine enough logics with neural networks respond effectively to other data. Furthermore, the analytical relationship between water vapour pressure and air temperature in DLR’s mechanism should be redefined accordingly, while the sixth polynomial should be used as the default setting in SVR systems.
Fluctuating capacity: the concept of micro- and macro-decisions
Authors: Curtice Martin 
Published: February 2020

SUMMARYThere is much Mental Capacity Act 2005 (MCA) case law emanating from the Court of Protection. This article reviews an important and unique case when the court specifically addressed for the first time the question of fluctuating capacity, a not uncommon clinical problem that can often be complex. It describes how the Court of Protection in Royal Borough of Greenwich v CDM [2019] legally approached an issue of fluctuating capacity in a 64-year-old woman with a personality disorder and chronic diabetes. In doing so it elucidates a new conceptual framework to apply when assessing fluctuating capacity in terms of considering micro- and macro-decisions which can be used in routine clinical practice.
Longitudinal Changes in the Relationship Between Hemoglobin A1c and Glucose Tolerance Across Pregnancy and Postpartum
Authors: Edelson P Kaitlyn , James Kaitlyn E , Leong Aaron , Arenas Juliana , Cayford Melody , Callahan Michael J , Bernstein Sarah N , Tangren Jessica Sheehan , Hivert Marie-France , Higgins John M , Nathan David M , Powe Camille E 
Published: February 2020

AbstractObjectiveTo characterize the relationship between hemoglobin A1c (HbA1c) levels and glucose tolerance across pregnancy and postpartum.Design and ParticipantsIn a longitudinal study of pregnant women with gestational diabetes risk factors (N = 102), we performed oral glucose tolerance testing (OGTT) and HbA1c measurements at 10–15 weeks of gestation, 24–30 weeks of gestation (N = 73), and 6–24 weeks postpartum (N = 42). Complete blood counts were obtained from clinical records. We calculated HbA1c-estimated average glucose levels and compared them with mean OGTT glucose levels (average of fasting, 1- and 2-hour glucose levels). Linear mixed effects models were used to test for longitudinal changes in measurements.ResultsMean OGTT glucose increased between 10–15 and 24–30 weeks of gestation (β = 8.1 mg/dL, P = .001), while HbA1c decreased during the same time period (β = –0.13%, P &lt; .001). At 10–15 weeks of gestation and postpartum the discrepancy between mean OGTT glucose and HbA1c-estimated average glucose was minimal (mean [standard deviation]: 1.2 [20.5] mg/dL and 0.16 [18.1] mg/dL). At 24–30 weeks of gestation, the discrepancy widened (13.2 [17.9] mg/dL, β = 12.7 mg/dL, P &lt; .001, compared to 10–15 weeks of gestation, with mean OGTT glucose being higher than HbA1c-estimated average glucose). Lower hemoglobin at 24–30 weeks of gestation was associated with a greater discrepancy (β = 6.4 mg/dL per 1 g/dL lower hemoglobin, P = .03 in an age- and gestational age-adjusted linear regression model).ConclusionsHbA1c accurately reflects glycemia in the 1st trimester, but underestimates glucose intolerance in the late 2nd trimester. Lower hemoglobin level is associated with greater underestimation. Accounting for gestational age and maternal hemoglobin may improve the clinical interpretation of HbA1c levels during pregnancy.
The dynamic nature and regulation of the root clock
Authors: Xuan Wei , De Gernier Hugues , Beeckman Tom 
Published: February 2020

ABSTRACT
Plants explore the soil by continuously expanding their root system, a process that depends on the production of lateral roots (LRs). Sites where LRs can be produced are specified in the primary root axis through a pre-patterning mechanism, determined by a biological clock that is coordinated by temporal signals and positional cues. This ‘root clock’ generates an oscillatory signal that is translated into a developmental cue to specify a set of founder cells for LR formation. In this Review, we summarize recent findings that shed light on the mechanisms underlying the oscillatory signal and discuss how a periodic signal contributes to the conversion of founder cells into LR primordia. We also provide an overview of the phases of the root clock that may be influenced by endogenous factors, such as the plant hormone auxin, and by exogenous environmental cues. Finally, we discuss additional aspects of the root-branching process that act independently of the root clock.
Cardiopharyngeal mesoderm origins of musculoskeletal and connective tissues in the mammalian pharynx
Authors: Adachi Noritaka , Bilio Marchesa , Baldini Antonio , Kelly Robert G. 
Published: February 2020

ABSTRACT
Cardiopharyngeal mesoderm (CPM) gives rise to muscles of the head and heart. Using genetic lineage analysis in mice, we show that CPM develops into a broad range of pharyngeal structures and cell types encompassing musculoskeletal and connective tissues. We demonstrate that CPM contributes to medial pharyngeal skeletal and connective tissues associated with both branchiomeric and somite-derived neck muscles. CPM and neural crest cells (NCC) make complementary mediolateral contributions to pharyngeal structures, in a distribution established in the early embryo. We further show that biallelic expression of the CPM regulatory gene Tbx1, haploinsufficient in 22q11.2 deletion syndrome patients, is required for the correct patterning of muscles with CPM-derived connective tissue. Our results suggest that CPM plays a patterning role during muscle development, similar to that of NCC during craniofacial myogenesis. The broad lineage contributions of CPM to pharyngeal structures provide new insights into congenital disorders and evolution of the mammalian pharynx.