bluuebunny/crossref_metadata_2025_split huggingface dataset:
The whole is greater than the sum of its parts: profiles of multiple mental health risk factors using Latent class analysis
Authors: Göbel Kristin , Cohrdes Caroline 
Published: June 2021

AbstractBackgroundThe exposure to an accumulation of various risk factors during childhood and adolescence relative to a single risk is associated with poorer mental health. Identification of distinct constellations of risk factors is an essential step towards the development of effective prevention strategies of mental disorders. A Latent class analysis (LCA) extracts different combinations of risk factors or subgroups and examines the association between profiles of multiple risk and mental health outcomes.MethodsThe current study used longitudinal survey data (KiGGS) of 10,853 German children, adolescents and young adults. The LCA included 27 robust risk and protective factors across multiple domains for mental health.ResultsThe LCA identified four subgroups of individuals with different risk profiles: abasic-risk (51.4%), high-risk (23.4%), parental-risk (11.8%) and social-risk class (13.4%).Multiple risk factors of the family domain, in particular family instability were associated with negative mental health outcomes (e.g. mental health problems, depression, ADHD) and predominately comprised late adolescent girls. The social environment represented a more common risk domain for young males.ConclusionThe understanding of multiple risk and different risk “profiles” helps to understand and adjust targeted interventions with a focus on vulnerable groups.
Awake prone positioning in patients with hypoxemic respiratory failure due to COVID-19: the PROFLO multicenter randomized clinical trial
Authors: Rosén Jacob , von Oelreich Erik , Fors Diddi , Jonsson Fagerlund Malin , Taxbro Knut , Skorup Paul , Eby Ludvig , Campoccia Jalde Francesca , Johansson Niclas , Bergström Gustav , Frykholm Peter ,   the PROFLO Study Group, Gradin Anna , Ali Mustafa , Lennborn Ulrica , Bogdanovic Darko , Roos Andreas , Modie Matilda , Giesecke Julia 
Published: June 2021

AbstractBackgroundThe effect of awake prone positioning on intubation rates is not established. The aim of this trial was to investigate if a protocol for awake prone positioning reduces the rate of endotracheal intubation compared with standard care among patients with moderate to severe hypoxemic respiratory failure due to COVID-19.MethodsWe conducted a multicenter randomized clinical trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO2/FiO2ratio ≤ 20 kPa were randomly assigned to a protocol targeting 16 h prone positioning per day or standard care. The primary endpoint was intubation within 30 days. Secondary endpoints included duration of awake prone positioning, 30-day mortality, ventilator-free days, hospital and intensive care unit length of stay, use of noninvasive ventilation, organ support and adverse events. The trial was terminated early due to futility.ResultsOf 141 patients assessed for eligibility, 75 were randomized of whom 39 were allocated to the control group and 36 to the prone group. Within 30 days after enrollment, 13 patients (33%) were intubated in the control group versus 12 patients (33%) in the prone group (HR 1.01 (95% CI 0.46–2.21),P = 0.99). Median prone duration was 3.4 h [IQR 1.8–8.4] in the control group compared with 9.0 h per day [IQR 4.4–10.6] in the prone group (P = 0.014). Nine patients (23%) in the control group had pressure sores compared with two patients (6%) in the prone group (difference − 18% (95% CI − 2 to − 33%);P = 0.032). There were no other differences in secondary outcomes between groups.ConclusionsThe implemented protocol for awake prone positioning increased duration of prone positioning, but did not reduce the rate of intubation in patients with hypoxemic respiratory failure due to COVID-19 compared to standard care.Trial registrationISRCTN54917435. Registered 15 June 2020 (https://doi.org/10.1186/ISRCTN54917435).
Breath-holding as a novel approach to risk stratification in COVID-19
Authors: Messineo Ludovico , Perger Elisa , Corda Luciano , Joosten Simon A. , Fanfulla Francesco , Pedroni Leonardo , Terrill Philip I. , Lombardi Carolina , Wellman Andrew , Hamilton Garun S. , Malhotra Atul , Vailati Guido , Parati Gianfranco , Sands Scott A. 
Published: June 2021

Abstract
Background
Despite considerable progress, it remains unclear why some patients admitted for COVID-19 develop adverse outcomes while others recover spontaneously. Clues may lie with the predisposition to hypoxemia or unexpected absence of dyspnea (‘silent hypoxemia’) in some patients who later develop respiratory failure. Using a recently-validated breath-holding technique, we sought to test the hypothesis that gas exchange and ventilatory control deficits observed at admission are associated with subsequent adverse COVID-19 outcomes (composite primary outcome: non-invasive ventilatory support, intensive care admission, or death).

Methods
Patients with COVID-19 (N = 50) performed breath-holds to obtain measurements reflecting the predisposition to oxygen desaturation (mean desaturation after 20-s) and reduced chemosensitivity to hypoxic-hypercapnia (including maximal breath-hold duration). Associations with the primary composite outcome were modeled adjusting for baseline oxygen saturation, obesity, sex, age, and prior cardiovascular disease. Healthy controls (N = 23) provided a normative comparison.

Results
The adverse composite outcome (observed in N = 11/50) was associated with breath-holding measures at admission (likelihood ratio test, p = 0.020); specifically, greater mean desaturation (12-fold greater odds of adverse composite outcome with 4% compared with 2% desaturation, p = 0.002) and greater maximal breath-holding duration (2.7-fold greater odds per 10-s increase, p = 0.036). COVID-19 patients who did not develop the adverse composite outcome had similar mean desaturation to healthy controls.

Conclusions
Breath-holding offers a novel method to identify patients with high risk of respiratory failure in COVID-19. Greater breath-hold induced desaturation (gas exchange deficit) and greater breath-holding tolerance (ventilatory control deficit) may be independent harbingers of progression to severe disease.
Can patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design
Authors: Bhattacharya Indrani S. , Haviland Joanne S. , Turner Lesley , Stobart Hilary , Balasopoulou Ada , Stones Liba , Kirby Anna M. , Kirwan Cliona C. , Coles Charlotte E. , Bliss Judith M. ,   on behalf of the PRIMETIME Trialists
Published: June 2021

Abstract
Background
For patients with early breast cancer considered at very-low risk of local relapse, risks of radiotherapy may outweigh the benefits. Decisions regarding treatment omission can lead to patient uncertainty (decisional conflict), which may be lessened with patient decision aids (PDA). PRIMETIME (ISRCTN 41579286) is a UK-led biomarker-directed study evaluating omission of adjuvant radiotherapy in breast cancer; an embedded Study Within A Trial (SWAT) investigated whether PDA reduces decisional conflict using a cluster stepped-wedge trial design.

Methods
PDA diagrams and a video explaining risks and benefits of radiotherapy were developed in close collaboration between patient advocates and PRIMETIME trialists. The SWAT used a cluster stepped-wedge trial design, where each cluster represented the radiotherapy centre and referring peripheral centres. All clusters began in the standard information group (patient information and diagrams) and were randomised to cross-over to the enhanced information group (standard information plus video) at 2, 4 or 6 months. Primary endpoint was the decisional conflict scale (0–100, higher scores indicating greater conflict) which was assessed on an individual participant level. Multilevel mixed effects models used a random effect for cluster and a fixed effect for each step to adjust for calendar time and clustering. Robust standard errors were also adjusted for the clustering effect.

Results
Five hundred twenty-one evaluable questionnaires were returned from 809 eligible patients (64%) in 24 clusters between April 2018 and October 2019. Mean decisional conflict scores in the standard group (N = 184) were 10.88 (SD 11.82) and 8.99 (SD 11.82) in the enhanced group (N = 337), with no statistically significant difference [mean difference − 1.78, 95%CI − 3.82–0.25, p = 0.09]. Compliance with patient information and diagrams was high in both groups although in the enhanced group only 121/337 (36%) reported watching the video.

Conclusion
The low levels of decisional conflict in PRIMETIME are reassuring and may reflect the high-quality information provision, such that not everyone required the video. This reinforces the importance of working with patients as partners in clinical trials especially in the development of patient-centred information and decision aids.
Effects of seated lumbar rotation manipulation in treating degenerative lumbar instability: a protocol for a randomized controlled trial
Authors: Xie Rui , Liang Long , Li Kaiming , Yu Jie , Feng Minshan , Zhan Jiawen , Wei Xu , Yang Kexin , Jin Zhefeng , Yin He , Chen Xin , Yin Xunlu , Liu Zhiwei , Dai Wenkang , Zhu Liguo 
Published: June 2021

Abstract
Background
Degenerative lumbar instability (DLI) is a common disease that causes low back pain (LBP) in clinic. It is difficult to completely recover from DLI, and it occurs repeatedly, which seriously affects the quality of life of patients. The epidemiological survey showed that 20–30% of low back pain was related to lumbar instability. Increasing evidence shows that seated lumbar rotation manipulation can effectively improve the clinical symptoms of patients with low back pain. The primary aim of this clinical trial is to observe the intervention effect of seated lumbar rotation manipulation on DLI patients.

Method/design
A total of 60 participants with DLI will be recruited and randomly allocated into the seated lumbar rotation manipulation group (the intervention group) or lumbar traction in supine position group (the control group) in this prospective, outcome assessor-blind, two-arm randomized controlled clinical trial. The treatment of the two groups lasted for 3 weeks, and the manipulation of the intervention group would be carried out once every other day, three times a week, a total of 9 times; the control group would be given lumbar traction once a day, five times a week, a total of 15 times. JOA (Japanese Orthopaedic Association) and VAS (Visual Analogue Scales) scores will be recorded as the primary outcomes before the treatment and at the 1st, 3rd, 5th, 8th, 10th, 12th, 15th, 17th, and 19th days after treatment and follow-up visit at the first, third, and sixth months. JOA efficacy evaluation standard will be used to evaluate the overall efficacy as the secondary outcomes.

Discussion
The results of this prospective, randomized controlled trial will provide a clinical evidence for the treatment of DLI with seated lumbar rotation manipulation.

Trial registration
Chinese Clinical Trial Registry ChiCTR2000032017. Registered on 18 April 2020, Prospective registration.
Short-term effects of synchronized vs. non-synchronized NIPPV in preterm infants: study protocol for an unmasked randomized crossover trial
Authors: Cresi Francesco , Chiale Federica , Maggiora Elena , Borgione Silvia Maria , Ferroglio Mattia , Runfola Federica , Maiocco Giulia , Peila Chiara , Bertino Enrico , Coscia Alessandra 
Published: June 2021

Abstract
Background
Non-invasive ventilation (NIV) has been recommended as the best respiratory support for preterm infants with respiratory distress syndrome (RDS). However, the best NIV technique to be used as first intention in RDS management has not yet been established.
Nasal intermittent positive pressure ventilation (NIPPV) may be synchronized (SNIPPV) or non-synchronized to the infant’s breathing efforts.
The aim of the study is to evaluate the short-term effects of SNIPPV vs. NIPPV on the cardiorespiratory events, trying to identify the best ventilation modality for preterm infants at their first approach to NIV ventilation support.

Methods
An unmasked randomized crossover study with three treatment phases was designed. All newborn infants < 32 weeks of gestational age with RDS needing NIV ventilation as first intention or after extubation will be consecutively enrolled in the study and randomized to the NIPPV or SNIPPV arm. After stabilization, enrolled patients will be alternatively ventilated with two different techniques for two time frames of 4 h each. NIPPV and SNIPPV will be administered with the same ventilator and the same interface, maintaining continuous assisted ventilation without patient discomfort.
During the whole duration of the study, the patient’s cardiorespiratory data and data from the ventilator will be simultaneously recorded using a polygraph connected to a computer.
The primary outcome is the frequency of episodes of oxygen desaturation. Secondary outcomes are the number of the cardiorespiratory events, FiO2 necessity, newborn pain score evaluation, synchronization index, and thoracoabdominal asynchrony. The calculated sample size was of 30 patients.

Discussion
It is known that NIPPV produces a percentage of ineffective acts due to asynchronies between the ventilator and the infant’s breaths. On the other hand, an ineffective synchronization could increase work of breathing. Our hypothesis is that an efficient synchronization could reduce the respiratory work and increase the volume per minute exchanged without interfering with the natural respiratory rhythm of the patient with RDS. The results of this study will allow us to evaluate the effectiveness of the synchronization, demonstrating whether SNIPPV is the most effective non-invasive ventilation mode in preterm infants with RDS at their first approach to NIV ventilation.

Trial registration
ClinicalTrials.gov NCT03289936. Registered on September 21, 2017.
Metabolic profiling of liver and faeces in mice infected with echinococcosis
Authors: Zhu Mingxing , Du Xiancai , Xu Hongxia , Yang Songhao , Wang Chan , Zhu Yazhou , Zhang Tingrui , Zhao Wei 
Published: June 2021

Abstract
Background
Echinococcosis is a severe zoonotic parasitic disease which severely affects the health of the hosts. The diagnosis of echinococcosis depends mainly on imaging examination. However, the patient is often in the late stage of the disease when the symptoms appear, thus limiting the early diagnosis of echinococcosis. The treatment and prognosis of the patients are hampered because of long-term asymptomatic latency. Metabolomics is a new discipline developed in the late 1990s. It reflects a series of biological responses in pathophysiological processes by demonstrating the changes in metabolism under the influence of internal and external factors. When the organism is invaded by pathogens, the alteration in the characteristics of metabolites in cells becomes extremely sensitive. Here, we used a metabolomics approach involving liquid chromatography coupled with tandem mass spectrometry (LC–MS/MS) to determine the molecular mechanism of cystic echinococcosis (CE) and to develop an effective method for CE diagnosis.

Methods
Twenty 8-week-old female BALB/c mice were divided into normal and Echinococcus granulosus infection groups. To develop the E. granulosus infection model, mice were infected with protoscoleces. Six weeks later, the abdomens of the mice showed significant bulging. An LC–MS/MS system-based metabolomics approach was used to analyse the liver and faeces to reveal the metabolic profiles of mice with echinococcosis.

Results
We found that the metabolism of nucleotides, alkaloids, amino acids, amides, and organic acids in mice is closely interrelated with E. granulosus infection. In the liver, the metabolic pathways of tyrosine and tryptophan biosynthesis; phenylalanine, valine, leucine and isoleucine biosynthesis; and phenylalanine metabolism were notably associated with the occurrence and development of hydatid disease, and in the faeces, pantothenate and CoA biosynthesis are thought to be closely associated with the development of CE.

Conclusion
The metabolomics approach used in this study provides a reference for a highly sensitive and specific diagnostic and screening method for echinococcosis.

Graphical Abstract
Predictors of unacceptable pain with and without low inflammation over 5 years in early rheumatoid arthritis—an inception cohort study
Authors: Eberhard Anna , Bergman Stefan , Mandl Thomas , Olofsson Tor , Rydholm Maria , Jacobsson Lennart , Turesson Carl 
Published: June 2021

Abstract
Objectives
Pain is a major symptom in patients with rheumatoid arthritis (RA). In early RA, pain is usually due to synovitis, but can also persist despite effective anti-inflammatory treatment. The objective of this study was to investigate the pain course over time and predictors of unacceptable pain and unacceptable pain with low inflammation, in patients with early RA.

Methods
An inception cohort of 232 patients with early RA, recruited in 1995–2005, was followed in a structured programme for 5 years. Pain was assessed using a visual analogue scale (VAS; 0–100). Unacceptable pain was defined as VAS pain > 40 based on the patient acceptable symptom state (PASS) and low inflammation as CRP < 10 mg/l. Baseline predictors of unacceptable pain were evaluated using logistic regression analysis.

Results
Pain improved significantly during the first 6 months, but then remained basically unchanged. Thirty-four per cent of the patients had unacceptable pain 5 years after inclusion. Baseline predictors of unacceptable pain after 5 years were lower swollen joint counts [odds ratio (OR) 0.71 per standard deviation (95% confidence interval (CI) 0.51–0.99)] and higher VAS for pain and global assessment of disease activity. Unacceptable pain with low inflammation after 5 years was negatively associated with anti-CCP antibodies [OR 0.50 (95% CI 0.22–0.98)].

Conclusion
Over one third of the patients had unacceptable pain 5 years after inclusion. Lower swollen joint count was associated with unacceptable pain at 5 years. The results may be explained by the positive effects of treatment on pain related to inflammation. Non-inflammatory long-lasting pain appears to be a greater problem in anti-CCP-negative patients.
Impact of COVID-19 pandemic on athletes with disabilities preparing for the Paralympic Games in Tokyo
Authors: Urbański Piotr , Szeliga Łukasz , Tasiemski Tomasz 
Published: June 2021

Abstract
Objective
The main aim of the study was to assess the impact of COVID-19 pandemic on athletes preparing for the Tokyo 2021 Paralympic Games during 1 month of lockdown in Poland. The study involved 166 athletes (106 male, 66 female), members of either the Polish Paralympic Committee or the Polish Sports Association for the Disabled’Start’, two organizations responsible for managing and regulating sports played by persons with disabilities in Poland.

Results
Athletes with disabilities have been strongly affected by the pandemic and the resultant lockdown. The majority of respondents reported that they trained at home (88.6%), whereas 60.2% of athletes trained outdoors, and 12% suspended their training regimens altogether. Only 5.4% of athletes had some access to sport facilities. The athletes reduced their weekly training time by almost half (9.4 h/week vs. 5.3 h/week), a statistically significant difference (t = 16.261, p < 0.001).
Computer-aided clinical image analysis for non-invasive assessment of tumor thickness in cutaneous melanoma
Authors: Papadakis Marios , Paschos Alexandros , Manios Andreas , Lehmann Percy , Manios Georgios , Zirngibl Hubert 
Published: June 2021

Abstract
Objective
Computerized clinical image analysis is shown to improve diagnostic accuracy for cutaneous melanoma but its effectiveness in preoperative assessment of melanoma thickness has not been studied. The aim of this study, is to explore how melanoma thickness correlates with computer-assisted objectively obtained color and geometric variables. All patients diagnosed with cutaneous melanoma with available clinical images prior to tumor excision were included in the study. All images underwent digital processing with an automated non-commercial software. The software provided measurements for geometrical variables, i.e., overall lesion surface, maximum diameter, perimeter, circularity, eccentricity, mean radius, as well as for color variables, i.e., range, standard deviation, coefficient of variation and skewness in the red, green, and blue color space.

Results
One hundred fifty-six lesions were included in the final analysis. The mean tumor thickness was 1.84 mm (range 0.2–25). Melanoma thickness was strongly correlated with overall surface area, maximum diameter, perimeter and mean lesion radius. Thickness was moderately correlated with eccentricity, green color and blue color. We conclude that geometrical and color parameters, as objectively extracted by computer-aided clinical image processing, may correlate with tumor thickness in patients with cutaneous melanoma. However, these correlations are not strong enough to reliably predict tumor thickness.
Embryo transfer can be performed in either uterine horn. Two successive pregnancies in a patient with uterus didelphys: a case report
Authors: Khrait Zakwan 
Published: June 2021

Abstract
Background
Uterus didelphys results from a failure in Mullerian duct fusion and may be associated with complete or partial vaginal septa. Most cases of uterus didelphys are discovered incidentally during the workup of infertility or recurrent miscarriage. The incidence of uterus didelphys has been reported to be 0.2% in the infertile population.

Case presentation
A 35-year-old white Arab woman, gravida 0, parity 0, with a history of primary infertility of 8 years (a well-known male factor) presented to our infertility center. She was diagnosed as having uterus didelphys with severe male factor. The patient had three previous failed in vitro fertilization/intracytoplasmic sperm injection cycles outside our center.
This is a case report of an infertile woman with uterus didelphys who conceived twice following single embryo transfer in both uterine horns successively. After the first successful pregnancy in the left uterine horn, the initial decision was to transfer the embryo to the same horn (left) because of the previous successful transfer. The very deep and long vagina forced us to reach one of the cervices, in which the embryo was placed in the right uterine horn, followed by the second successful pregnancy in the other, smaller horn. The patient gave her informed consent, both verbal and written, to use her information and images for medical publication.

Conclusion
Pregnancy is possible in women with uterus didelphys using single embryo transfer in in vitro fertilization/intracytoplasmic sperm injection cycles. It is recommended that both horns be given a chance.