bluuebunny/crossref_metadata_2025_split huggingface dataset:
Heterogeneity and Gaps in Reporting Primary Outcomes From Neonatal Trials
Authors: Baba Ami , Webbe James , Butcher Nancy J. , Rodrigues Craig , Stallwood Emma , Goren Katherine , Monsour Andrea , Chang Alvin S.M. , Trivedi Amit , Manley Brett J. , McCall Emma , Bogossian Fiona , Namba Fumihiko , Schmölzer Georg M. , Harding Jane , Nguyen Kim An , Doyle Lex W. , Jardine Luke , Rysavy Matthew A. , Konstantinidis Menelaos , Meyer Michael , Helmi Muhd Alwi Muhd , Lai Nai Ming , Hay Susanne , Onland Wes , Choo Yao Mun , Gale Chris , Soll Roger F. , Offringa Martin ,   Core Outcome Reporting in Neonatal Trials Study Group
Published: August 2023

OBJECTIVES
Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials.

METHODS
Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials’ primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed.

RESULTS
Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity.

CONCLUSIONS
Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.
Strengthening Reporting of Neonatal Trials
Authors: Webbe James , Baba Ami , Butcher Nancy J. , Rodrigues Craig , Stallwood Emma , Goren Katherine , Monsour Andrea , Chang Alvin S. M. , Trivedi Amit , Manley Brett J. , McCall Emma , Bogossian Fiona , Namba Fumihiko , Schmölzer Georg M. , Popat Himanshu , Nguyen Kim An , Doyle Lex W. , Jardine Luke , Rysavy Matthew A. , Konstantinidis Menelaos , Muhd Helmi Muhd Alwi , Lai Nai Ming , Hay Susanne , Onland Wes , Choo Yao Mun , Gale Chris , Soll Roger F. , Offringa Martin ,   CORE OUTCOME REPORTING IN NEONATAL TRIALS (CORINT) STUDY GROUP
Published: August 2023

BACKGROUND AND OBJECTIVES
There is variability in the selection and reporting of outcomes in neonatal trials with key information frequently omitted. This can impact applicability of trial findings to clinicians, families, and caregivers, and impair evidence synthesis. The Neonatal Core Outcomes Set describes outcomes agreed as clinically important that should be assessed in all neonatal trials, and Consolidated Standards of Reporting Trials (CONSORT)-Outcomes 2022 is a new, harmonized, evidence-based reporting guideline for trial outcomes. We reviewed published trials using CONSORT-Outcomes 2022 guidance to identify exemplars of neonatal core outcome reporting to strengthen description of outcomes in future trial publications.

METHODS
Neonatal trials including &gt;100 participants per arm published between 2015 to 2020 with a primary outcome included in the Neonatal Core Outcome Set were identified. Primary outcome reporting was reviewed using CONSORT 2010 and CONSORT-Outcomes 2022 guidelines by assessors recruited from Cochrane Neonatal. Examples of clear and complete outcome reporting were identified with verbatim text extracted from trial reports.

RESULTS
Thirty-six trials were reviewed by 39 assessors. Examples of good reporting for CONSORT 2010 and CONSORT-Outcomes 2022 criteria were identified and subdivided into 3 outcome categories: “survival,” “short-term neonatal complications,” and “long-term developmental outcomes” depending on the core outcomes to which they relate. These examples are presented to strengthen future research reporting.

CONCLUSIONS
We have identified examples of good trial outcome reporting. These illustrate how important neonatal outcomes should be reported to meet the CONSORT 2010 and CONSORT-Outcomes 2022 guidelines. Emulating these examples will improve the transmission of information relating to outcomes and reduce associated research waste.
Recommendations for Prevention and Control of Influenza in Children, 2023–2024
Authors:   COMMITTEE ON INFECTIOUS DISEASES, O’Leary Sean T. , Campbell James D. , Ardura Monica I. , Banerjee Ritu , Bryant Kristina A. , Caserta Mary T. , Frenck Robert W. , Gerber Jeffrey S. , John Chandy C. , Kourtis Athena P. , Myers Angela , Pannaraj Pia , Ratner Adam J. , Shah Samir S. , Bryant Kristina A. , Hofstetter Annika M. , Chaparro Juan D. , Michel Jeremy J. , Kimberlin David W. , Barnett Elizabeth D. , Lynfield Ruth , Sawyer Mark H. , Bernstein Henry H. , Cardemil Cristina V. , Farizo Karen M. , Kafer Lisa M. , Kim David , López Medina Eduardo , Moore Denee , Panagiotakopoulos Lakshmi , Romero José R. , Sauvé Laura , Starke Jeffrey R. , Thompson Jennifer , Wharton Melinda , Woods Charles R. , Frantz Jennifer M. , Gibbs Gillian 
Published: August 2023

This statement updates the recommendations of the American Academy of Pediatrics for the routine use of influenza vaccine and antiviral medications in the prevention and treatment of influenza in children during the 2023–2024 influenza season. A detailed review of the evidence supporting these recommendations is published in the accompanying technical report (www.pediatrics.org/cgi/doi/10.1542/peds.2023-063773). The American Academy of Pediatrics recommends annual influenza vaccination of all children without medical contraindications starting at 6 months of age. Children are at risk for hospitalization and death from influenza. Influenza vaccination is an important strategy for protecting children and the broader community, as well as reducing the overall burden of respiratory illnesses when other viruses are cocirculating. Any licensed influenza vaccine appropriate for age and health status can be administered, ideally as soon as possible in the season, without preference for one product or formulation over another.
Antiviral treatment of influenza is recommended for children with suspected (eg, influenza-like illness [fever with either cough or sore throat]) or confirmed influenza who are hospitalized, have severe or progressive disease, or have underlying conditions that increase their risk of complications of influenza, regardless of duration of illness. Antiviral treatment should be initiated as soon as possible. Antiviral treatment may be considered in the outpatient setting for symptomatic children with suspected or confirmed influenza disease who are not at high risk for influenza complications, if treatment can be initiated within 48 hours of illness onset. Antiviral treatment may also be considered for children with suspected or confirmed influenza disease whose siblings or household contacts either are younger than 6 months or have a high-risk condition that predisposes them to complications of influenza. Antiviral chemoprophylaxis is recommended for the prevention of influenza virus infection as an adjunct to vaccination in certain individuals, especially exposed children who are at high risk for influenza complications but have not yet been immunized or those who are not expected to mount an effective immune response.
Quality and stability of different seafood products treated with high hydrostatic pressure (HPP) intended for raw consumption
Authors: Saldanha Pinheiro Ana Cristina de Aguiar , Tappi Silvia , Braschi Giacomo , Genovese Jessica , Patrignani Francesca , Rocculi Pietro 
Published: August 2023

The consumption of raw fish has rapidly increased in recent years, but being a highly perishable product, it is characterised by a very short microbiological shelf life. High hydrostatic pressure (HPP) processing is a non-thermal technology has emerged recently as a promising alternative to thermal processing for food pasteurization capable of maintaining fresh-like characteristics and nutritional value. However, the induced changes in product quality should be assessed carefully. The present research aimed to investigate the effect of HPP on different seafood products, namely grey mullet, tiger prawn and rose shrimp, intended for raw consumption. Three pressure levels (400, 500 and 600 MPa) were applied for 10 min. During refrigerated storage, microbiological quality, chemical parameters, colour and texture and fat oxidation were analysed. Results showed that the application of lower pressure was able to inactivate E. coli, pseudomonas and/or positive coagulase staphylococci; however, they were able to recover during storage. In addition, the application of 600-MPa pressure extended the microbiological shelf life by up to 30 days. For all samples, general whitening occurred while the texture was affected in a different way for the three considered species. Fat oxidation was only minimally affected and remained quite low during storage.
Certified Athletic Trainers’ Fight for State Regulation in California
Authors: Greicar Margo , Abdenour Tom , Post Eric 
Published: August 2023

California remains the only state in the nation without regulation in the form of licensure, registration or title protection for the athletic training profession. Athletic Trainers (AT) have advocated vigorously since the mid-1980s to have legislation vetoed by two separate governors on six different occasions. A total of 307 (14.6%) of 2100 current National Athletic Trainers Association (NATA) members were surveyed regarding this lack of regulation in California. Virtually all, (98%) supported the need for state regulation and the preponderance (93%) believed it should consist of licensure. Many respondents (78%) also indicated that the lack of regulation negatively impacts the public’s perception of the athletic training profession across the United States. Sixty-eight percent of respondents agreed that the lack of regulation negatively impacts ATs accepting employment in the state of California. Lastly, 87% agreed that the lack of regulation negatively impacted the safety of physically active individuals in California. Since 2002, ATs in California have attempted to have eight bills related to athletic training regulation with no success of being enacted. It is the perception of the NATA members surveyed in this study, that California needs state regulation, preferably in the form of licensure, for the protection of the health, safety, and wellbeing of physically active individuals and a better public understanding of the critical public health role and contributions of an ATs.
Recommendations for Cultural Competence Educational by Practicing Athletic Trainers
Authors: Strong Lorna 
Published: August 2023

Athletic trainers are allied health professionals providing healthcare to individuals from diverse personal and ethnic backgrounds in various of practices settings. The purpose of this phenomenological case study was to explore cultural competence of practicing athletic trainers, credentialed to practice between one and three years, having graduated from one accredited athletic training program in Texas. The guided protocol included five research questions to assess knowledge and skills of the participants in provision of culturally competent strategies used in clinical practice. Eleven athletic trainers were interviewed to assess the ability to define cultural competence and enumerate experiences of implementation of effective patient care. The findings revealed the participants of this study provided culturally competent care to diverse patient groups. Additional findings included the ability to recognize the importance of effective communication, sociocultural considerations, and expanded needs for educational content for professional preparation. Findings in study suggested the following implications: athletic trainers must be aware of patient diversity, the relationships between athletic trainer and patient are important for assisting patient outcomes, effective use of appropriate communication techniques are paramount to patient outcomes, and athletic training curricula need to provide a foundation of cultural competence with expanded content on patient diversity and treatment methods for enhanced preparation of future athletic training professionals to provide effective culturally competent care.
Complement inhibition in Myasthenia – from basics to RCT data
Authors: Jacob Saiju 
Published: August 2023

Myasthenia gravis (MG) is the prototypic autoimmune neurological disorder causing fatiguable muscle weakness either limited to the ocular muscles or becoming generalised involving the limb and bulbar muscles. Nine out of 10 generalised MG patients have IgG1 or IgG3 antibodies against the acetylcholine receptor (AChR). AChR antibodies cause neuromuscular weakness by internalisation of AChR, receptor blockade and by activating the complement pathway. Complement activation causes formation of the membrane attack complex (MAC) leading to degradation of the neuromuscular junction (NMJ). Several animal models have confirmed the role of complement in the pathogenesis of MG, with the experimental models (EAMG) often needing complement inhibitory therapies to prevent or reverse the disease. Various molecules that target the complement system have now been developed to treat myasthenia gravis. The vast majority of the currently studied molecules target the C5 protein, thereby preventing the formation of MAC and subsequent NMJ destruction. The currently studied anti-complement therapies for MG include Eculizumab, Zilucoplan, Ravulizumab, Pozelimab, Cemdisiran, Gefurilimab, Danicopan and few others in the pipeline. Eculizumab has been shown in clinical trials to be effective in the treatment of refractory MG, but further sub-group analysis and real-life experience have shown that this can be beneficial in various patients including those receiving regular IVIG, plasma exchange or Rituximab. It was approved for use by FDA in Oct 2017. Ravulizumab is a long-acting monoclonal antibody which has similar mechanism of action to Eculizumab and was approved for use in MG by FDA in April 2022. Zilucoplan is a macrocyclic peptide which binds to C5 and C5b thus preventing terminal complement activation, which can be given subcutaneously (FDA new drug application accepted in Nov 2022). Many of these have also been shown to have long term benefit in different sub-groups of patients with MG. Patients would need to be vaccinated against Neisseria meningitidis because of the risk of Gram-negative septicaemia, although no major safety signatures have been noted in the studies so far. Future studies may be able to identify specific biomarkers which might aid in selecting the most appropriate patients who might respond to these therapies.
Pharmacological treatment of Lambert-Eaton Myasthenic Syndrome
Authors: Bakker Wisse Roelof , Remijn-Nelissen Linda , Schimmel Kirsten , Tannemaat Martijn , Verschuuren Jan , Van Gelder Teun 
Published: August 2023

Lambert-Eaton myasthenic syndrome (LEMS) is a very rare antibody-mediated autoimmune disease of the neuromuscular junction. Therapy can be divided in symptomatic treatment and immunosuppressive treatment. Symptomatic treatment with amifampridine is the only therapy currently authorized for use in LEMS patients. In the Netherlands the first choice drug is amifampridine base in an extended release formulation instead of the currently authorized amifampridine phosphate. This formulation has lower costs and is possibly safer due to lower peak concentrations. Other therapy used in LEMS patients is prescribed off-label and is based on experience in patients with myasthenia gravis. In many cases pyridostigmine is added as symptomatic treatment. In almost half of patients immunosuppressive therapy is started, mostly corticosteroids with or without azathioprine. Intravenous immunoglobulins and plasma exchange are used as emergency treatment.
Currently no randomized clinical trials with new therapies are ongoing or announced in patients with LEMS, although multiple new therapies for myasthenia gravis are being investigated. These future therapies can be differentiated in symptomatic and immunomodulating drugs. The immunomodulating drugs can be further differentiated in early stage drugs which target the B-cell, later stage drugs which target the circulating antibodies and targeted therapy which have a disease-specific target. Some early and later stage immunomodulating drugs show promising results in myasthenia gravis although high cost and uncertain long term safety may be limiting for incorporating these drugs in LEMS treatment guidelines.
Clinical trials in LEMS patients are lacking due to the rarity of the disease and we suggest the following requirements for future trials of potential new treatments: Sufficient power by performing multicenter or n-of-1 trials when appropriate, a cross-over design to reduce the number of patients and using a LEMS-specific quantitative primary outcome measure like the 3TUG score.
Congenital myasthenic syndromes: beta adrenergic receptor agonist treatment
Authors: Beeson David 
Published: August 2023

Acetylcholinesterase inhibitors, such as pyridostigmine, are the standard symptomatic treatment for myasthenia gravis, and so have naturally been applied to the genetic forms of myasthenia, termed congenital myasthenic syndromes (CMS). Although effective for many CMS in others there was no clear response and in some it was positively harmful. Now, with greater understanding of the mutations and molecular mechanisms underlying CMS, treatments can be tailored for the specific syndrome and depending on diseases severity and patient response this can include utilizing different combinations of the drugs. In CMS, over the last 15-20 years b2-adrenergic receptor agonists have moved from occasional use to a mainstream medication. Many cases show life-transforming improvement both when the b2-adrenergic receptor agonists are used alone or in combination. Here we feature how the identification of DOK7-CMS first highlighted the consistent benefit of b2-adrenergic receptor agonists as medication and how it’s application to many different CMS subtypes evolved. The molecular pathogenic mechanisms for many CMS subtypes are now established and this report will also discuss a hypothetical rationale for which forms of CMS are likely to benefit from the b2-adrenergic receptor agonists.
Perfil de dor e cinesiofobia em atletas de judô da categoria master
Authors: Sestelo Enzo Seixas , Ribeiro Gabriel Ledo , Dos Santos Clarcson Plácido Conceição , Goes Bruno Teixeira 
Published: August 2023

INTRODUÇÃO: Atletas de contato estão sujeitos a lesões musculoesqueléticas devido às técnicas repetitivas aplicadas durante treinos e campeonatos. Isso pode levá-los a apresentar dores agudas e crônicas, e, a depender da técnica aplicada, diferentes regiões do corpo podem ser acometidas. Estudos nesta área focam na descrição da lesão ou trauma, no entanto, a presença de cinesiofobia nesta população é uma lacuna a ser investigada. OBJETIVO: Descrever o perfil de dor e cinesiofobia em atletas de Judô da categoria master. MÉTODO: Estudo observacional, descritivo, de corte transversal, realizado com 29 atletas de judô master inscritos na Federação Baiana. Para descrição da dor, foram utilizados o Inventário Breve de Dor (IBD) e Doleur Neuropathique Questionnaire (DN4) e a Escala de Cinesiofobia de Tampa (ECT). Os dados foram tabulados e analisados descritivamente através do software Excel for Windows® utilizando valor absoluto ou média (desvio padrão). RESULTADOS: Os dados do IBD mostraram que a média geral de dor foi de 5,1 ± 1,8, o tratamento optado foi majoritariamente o farmacológico e a região mais acometida foi a face anterior do joelho. Dos 29 participantes, 9 (31%) apresentavam o escore ≥3, indicando presença de dor neuropática e cinesiofobia leve com média geral de 33,8 ± 6,7 no escore da ECT. CONSIDERAÇÕES FINAIS: Os atletas apresentaram dor moderada com pouco impacto na vida pessoal e as regiões com maior incidência foram os joelhos. Cinesiofobia leve esteve presente em mais da metade dos participantes e um terço apresentou dor neuropática.
Refining PD-1/PD-L1 assessment for biomarker-guided immunotherapy - a review
Authors: Zdrenka Marek , Kowalewski Adam , Ahmadi Navid , Sidiqi Rizwanullah , Chmura Łukasz , Borowczak Jędrzej , Maniewski Mateusz , Szylberg Łukasz 
Published: August 2023

Anti-programmed cell death ligand 1 (Anti-PD-L1) immunotherapy is an increasingly crucial in cancer treatment. To date, the Federal Drug Administration has approved four PD-L1 immunohistochemistry (IHC) staining protocols, commercially available in the form of "kits", facilitating testing for PD-L1 expression. These kits comprise four PD-L1 antibodies on two separate IHC platforms, each utilizing distinct, non-interchangeable scoring systems. Several factors, including tumor heterogeneity and the size of the tissue specimens assessed, can lead to PD-L1 status misclassification, potentially hindering the initiation of therapy. Therefore, the development of more accurate predictive biomarkers to distinguish between responders and non-responders prior to anti-PD-1/PD-L1 therapy warrants further research. Achieving this goal necessitates refining sampling criteria, enhancing current methods of PD-L1 detection, and deepening our understanding of the impact of additional biomarkers. In this article, we review potential solutions to improve the predictive accuracy of PD-L1 assessment in order to more precisely anticipate patients' responses to anti-PD-1/PD-L1 therapy, monitor disease progression and predict clinical outcomes.