bluuebunny/crossref_metadata_2025_split huggingface dataset:
Improving the efficiency of clinical trials in multiple sclerosis
Authors: Marrie Ruth Ann , Sormani Maria Pia , Apap Mangion Sean , Bovis Francesca , Cheung Winson Y , Cutter Gary R , Feys Peter , Hill Michael D , Koch Marcus Werner , McCreary Morgan , Mowry Ellen M , Park Jay JH , Piehl Fredrik , Salter Amber , Chataway Jeremy 
Published: August 2023

Background: Phase 3 clinical trials for disease-modifying therapies in relapsing-remitting multiple sclerosis (RRMS) have utilized a limited number of conventional designs with a high degree of success. However, these designs limit the types of questions that can be addressed, and the time and cost required. Moreover, trials involving people with progressive multiple sclerosis (MS) have been less successful. Objective: The objective of this paper is to discuss complex innovative trial designs, intermediate and composite outcomes and to improve the efficiency of trial design in MS and broaden questions that can be addressed, particularly as applied to progressive MS. Methods: We held an international workshop with experts in clinical trial design. Results: Recommendations include increasing the use of complex innovative designs, developing biomarkers to enrich progressive MS trial populations, prioritize intermediate outcomes for further development that target therapeutic mechanisms of action other than peripherally mediated inflammation, investigate acceptability to people with MS of data linkage for studying long-term outcomes of clinical trials, use Bayesian designs to potentially reduce sample sizes required for pediatric trials, and provide sustained funding for platform trials and registries that can support pragmatic trials. Conclusion: Novel trial designs and further development of intermediate outcomes may improve clinical trial efficiency in MS and address novel therapeutic questions.
Enhancing diversity of clinical trial populations in multiple sclerosis
Authors: Marrie Ruth Ann , Chataway Jeremy , Bierer Barbara E , Finlayson Marcia , Martinez-Lapiscina Elena H , Panagoulias Jennifer , Sormani Maria Pia , Williams Mitzi Joi , Amezcua Lilyana 
Published: August 2023

Background: Demographic characteristics, social determinants of health (SDoH), health inequities, and health disparities substantially influence the general and disease-specific health outcomes of people with multiple sclerosis (MS). Participants in clinical trials do not represent all people with MS treated in practice. Objective: To provide recommendations for enhancing diversity and inclusion in clinical trials in MS. Methods: We held an international workshop under the Auspices of the International Advisory Committee on Clinical Trials in MS (the “Committee”) to develop recommendations regarding diversity and inclusivity of participants of clinical trials in MS. Workshop attendees included members of the Committee as well as external participants. External participants were selected based on expertise in trials, SDoH, health equity and regulatory science, and diversity with respect to gender, race, ethnicity, and geography. Results: Recommendations include use of diversity plans, community engagement and education, cultural competency training, biologically justified rather than templated eligibility criteria, adaptive designs that allow broadening of eligibility criteria over the course of a trial, and logistical and practical adjustments to reduce study participant burden. Investigators should report demographic and SDoH characteristics of participants. Conclusion: These recommendations provide sponsors and investigators with methods of improving diversity and inclusivity of clinical trial populations in MS.
Fostering equitable change in health services: Using critical reflexivity to challenge dominant discourses in low back pain care in Australia
Authors: Mescouto Karime , Olson Rebecca E , Costa Nathalia , Evans Kerrie , Dillon Miriam , Walsh Kelly , Jensen Niamh , Hodges Paul W , Lonergan Kathryn , Weier Megan , Setchell Jenny 
Published: August 2023

Objectives Justice and equity-focused practices in health services play a critical but overlooked role in low back pain (LBP) care. Critical reflexivity – the ability to examine and challenge power relations, and broader social issues embedded in everyday life – can be a useful tool to foster practices that are more socially just. No research has yet explored this approach in back pain health services. This study sought to understand how clinicians construct LBP in relation to broader socio-cultural-political aspects of care and explore if those constructions changed when clinicians engaged with critically reflexive dialogues with researchers. Methods Using critical discourse analysis methods, this qualitative study explored institutionalised patterns of knowledge in the construction of LBP care. We conducted 22 critically reflexive dialogues with 29 clinicians from two health services in Australia – a private physiotherapy clinic and a public multidisciplinary pain clinic. Results Our analyses suggested that clinicians and services often constructed LBP care at an individual level. This dominant individualistic discourse constrained consideration of justice-oriented practices in the care of people with LBP. Through dialogues, discursive constructions of LBP care expanded to incorporate systems and health service workplace practices. This expansion fostered more equitable clinical and service practices – such as assisting patients to navigate health care systems, considering patients’ socioeconomic circumstances when developing treatment plans, encouraging staff discussion of possible systemic changes to enhance justice, and fostering a more inclusive workplace culture. Although such expansions faced challenges, incorporating broader discourses enabled recommendations to address LBP care inequities. Conclusions Critical reflexivity can be a tool to foster greater social justice within health services. By expanding constructions of LBP care beyond individuals, critical reflexive dialogues can foster discussion and actions towards more equitable workplace cultures, services and systems.
Comparative effects of mindfulness-based stress reduction and psychoeducational support on parenting stress in families of autistic preschoolers
Authors: Neece Cameron L , Fenning Rachel M , Morrell Holly ER , Benjamin Laurel R 
Published: August 2023

Relative to parents of children with neurotypical development and other developmental disabilities, parents of autistic children experience higher levels of parenting stress, which are associated with deleterious consequences for parents’ mental and physical health and child functioning. Despite urgent calls to action, parenting stress is rarely addressed directly in interventions for families of autistic children, and less so in underserved and racial/ethnic minority populations where clinical needs are greater. This study tested the efficacy of mindfulness-based stress reduction, compared to a psychoeducation and support intervention, in reducing parenting stress among diverse families of autistic preschoolers. Participants ( N = 117) were randomly assigned to the mindfulness-based stress reduction or psychoeducation and support groups; assessments were conducted at baseline, immediately postintervention, and 6 and 12 months postintervention. Results indicated significant reductions in parenting stress across both the mindfulness-based stress reduction and psychoeducation and support intervention conditions; however, reductions in parenting stress were greater for parents in mindfulness-based stress reduction than in psychoeducation and support. Furthermore, the benefit of mindfulness-based stress reduction relative to psychoeducation and support increased over time, with significant group differences in parenting stress detected at 12-month follow-up. Lay abstract Parents of autistic children often experience high levels of parenting stress, which can have negative mental and physical effects on both the parent and child. This study tested the efficacy of mindfulness-based stress reduction in reducing parenting stress in parents of preschool-aged autistic children compared to a psychoeducation and support intervention. We assessed parenting stress before and after the interventions and at 6- and 12-month follow-up. Both interventions significantly decreased parenting stress, but mindfulness-based stress reduction reduced stress more than did psychoeducation and support, with the strongest effect observed 1 year later. This suggests that the stress-reducing benefits of mindfulness-based stress reduction persist and may increase over time.
Retrograde tibial access for revascularization of chronic total occlusions in patients with chronic limb-threatening ischemia
Authors: Raskin Daniel , Barash Yiftach , Silverberg Daniel , Halak Moshe , Hater Hatem , Khaitovich Boris 
Published: August 2023

Purpose To evaluate tibial single access in treatment of chronic total occlusions (CTO) in patients with ipsilateral chronic-limb ischemia (CLTI). Materials and Methods In this retrospective study, data was collected on patients treated for ipsilateral CTO via a tibial artery access between March 2017 and March 2021. Fifty-nine limbs in 57 patients, (42 men, average age 73 years; range 47–96) were treated. Patient's symptoms were classified in accordance with the Rutherford category. The end points were freedom from major amputation and the need for reintervention up to 1 year of follow up. Results Out of the 59 treated limbs, technical success was achieved in 57 (97%). The treated multilevel segments involved 5 common and 12 external iliac arteries, 23 common and 37 superficial femoral arteries, 23 femoropopliteal segments, 14 popliteal arteries, and 4 bypasses. Mean length of occlusion was 186 mm (range 7–670). Rutherford classification of the treated limbs was category 5 and 6 in 45 patients and category 4 in 14 patients. Three procedural complications occurred and were successfully treated during the same procedure. No immediate post-procedural complication was encountered. Median follow-up was 13 months (range 1–45.3). Reintervention was required in 9 limbs, after an average of 6 months. One year free from amputation rate was 91.2%. Conclusions Single access via the ipsilateral tibial artery can be a useful, effective, and safe approach for treating CTO in CLTI patients.
Migraine and the risk of cervical artery dissection: A systematic review and meta-analysis
Authors: Sun Zihan , Kleine-Borgmann Julian , Suh Joome , McDermott Gregory C , Vishnevetsky Anastasia , Rist Pamela M 
Published: August 2023

Introduction: Migraine is a common, disabling chronic pain condition possibly related to changes in endothelial and vascular structure and function. Several observational studies have suggested an elevated risk of cervical artery dissection (CeAD) in patients with a history of migraine. We aimed to investigate this potential association using systematic review and meta-analytic methods. Patients and methods: We utilized a pre-defined search protocol to identify and screen studies related to migraine and CeAD in PubMed, Embase, and the Web of Science Core Collection. We assessed the risk of bias and performed a meta-analysis of selected studies to assess the association between migraine and CeAD. We also performed subgroup analyses by migraine subtype, biological sex, and the use of stroke versus non-stroke controls. Results: We identified 11 studies ( N = 9857 patients) for inclusion in the meta-analysis. Meta-analysis showed an association between migraine and CeAD with an odds ratio of 1.74 (95%CI 1.38–2.19). There was high heterogeneity among the included studies ( I2 = 61%). Publication bias was present but the Trim-Fill imputation suggested that the impact on results was likely minimal. Subgroup analyses revealed an association between migraine without aura and CeAD (OR 1.86, 95%CI 1.55–2.24) but not migraine with aura and CeAD (OR 1.15, 95%CI 0.71–1.88). There was no difference in the association between migraine and CeAD in men compared to women. Discussion and conclusion: A history of migraine is associated with an increased risk of CeAD. Further studies are needed to elucidate the potential pathophysiologic mechanisms underlying this association.
Clay mineralogical evidence of near-equatorial Palaeocene–Eocene Thermal Maximum in Barmer Basin, India
Authors: Kumar Rohit , Hameed Abdul , Srivastava Pankaj 
Published: August 2023

AbstractThe Palaeocene–Eocene Thermal Maximum (PETM) was a global extreme climatic event, but it is relatively unknown from lower latitudes or equatorial regions in comparison to mid- and high latitudes. The present study provides the first clay mineralogical evidence of the PETM and subsequent hyperthermal events in a near-equatorial region represented by the Akli Formation in the Barmer Basin, India. The 32 m-thick succession of the Akli Formation shows abrupt changes in smectite and kaolin abundances preceding, during and succeeding the PETM event. Within the studied section, the kaolin content increases from 5–8% pre-PETM to 30–35% during the PETM, and then again decreases to 5–6% during the post-PETM period. The smectite, however, is marked by a corresponding decrease and its transformation into kaolin in acid weathering conditions. The transformation of the smectite is first marked by hydroxy interlayering and then transformation into kaolin during the PETM. The transformation of smectite into kaolin also resulted in extensive precipitation of iron oxide in sediments. The clay mineralogical changes in the Palaeocene–Eocene transition sediments of the Akli Formation were caused by 3–5°C warming and a 25–50% increase in rainfall during the hyperthermal events. Unusually high charcoal (~20%) fragments during the Palaeocene–Eocene transition also suggest warming and widespread biomass burning during the PETM in the lower latitudes.
Chronic kidney disease following nephrectomy for renal tumours: retrospective analysis risk factors
Authors: Can Osman , Sabuncu Kenan , Erkoç Mustafa , Bozkurt Muammer , Danış Eyyüp , Degirmentepe Recep Burak , Ötünçtemur Alper 
Published: August 2023

Abstract
Objective
We aimed to determine factors responsible for chronic kidney disease (CKD) following nephrectomy for renal tumours.

Methods
A retrospective study was undertaken in patients underwent partial or radical nephrectomy due to kidney tumour between January 2015 and June 2020. Patients with eGFR above 60 ml/min/1.73m2 were included in the study. Demographic information, surgical features, eGFR values and some comorbidities of patients were recorded. The patients were evaluated for the development of CKD according to the CKD-EPI equation postoperatively.

Results
One hundred and sixty-six patients who underwent radical (n = 125) or partial (n = 41) nephrectomy were included to study. According to the logistic regression analysis, radical nephrectomy (adjusted OR 0.139 (95% CI 0.038–0.507), p = 0.003), age (adjusted OR 1.037 (95% CI 1.001–1.074), p = 0.045), preoperative proteinuria (adjusted OR 0.251 (95% CI 0.084–0.750) p = 0.013) and preoperative lower eGFR (adjusted OR 0.943 (95% CI 0.917–0.969) p < 0.001) were determined as independent predictor for development of CKD.

Conclusions
CKD is an important disease that causes morbidity and mortality. Age, type of surgery and preoperative eGFR and preoperative proteinuria are an independent risk factor for CKD development. Patients should be informed about this problem before surgery.
Testicular sperm aspiration has a poor effect in predicting micro-TESE outcomes in NOA patients with AZFc deletion
Authors: Deng Chenyao , Mao Jiaming , Zhao Lianming , Liu Defeng , Lin Haocheng , Zhang Zhe , Yang Yuzhuo , Zhang Haitao , Hong Kai , Jiang Hui 
Published: August 2023

Abstract
Background
Testicular sperm aspiration (TESA) is widely used in the diagnosis and management of nonobstructive azoospermia. However, its ability for predicting microdissection testicular sperm extraction in nonobstructive azoospermia (NOA) patients with AZFc deletion remains uncertain. To investigate whether TESA affected the sperm retrieval rate (SRR) in NOA patients with AZFc deletion, a retrospective analysis of the clinical data of NOA patients with AZFc deletion who underwent microdissection testicular sperm extraction (micro-TESE) was conducted. The effects of age, testicular volume, follicle-stimulating hormone (FSH) levels, luteinizing hormone (LH) levels, testosterone (T) levels and TESA on the SRR were analyzed in this group of patients.

Results
A total of 181 individuals had their sperm successfully collected and underwent micro-TESE, with an SRR of 67.4%. The patients were separated into two groups based on their micro-TESE results (sperm acquisition and nonsperm acquisition), with no significant variations in age, testicular volume, FSH levels, LH levels, or T levels between the two groups. There was no significant difference in the SRR between any of the groups into which patients were classified based on reproductive hormone reference value ranges. Binary logistic regression was used to explore the absence of significant effects of age, testicular volume, FSH levels, LH levels, and T levels on sperm acquisition in patients undergoing micro-TESE. In the preoperative testicular diagnostic biopsy group, the sperm acquisition and nonsperm acquisition groups had SRRs of 90.1% and 65.1%, respectively. More significantly, there was no significant difference in the SRR between the negative preoperative testicular diagnostic biopsy group and the nonpreoperative testicular diagnostic biopsy group (65.1 vs. 63.8%, p = 0.855).

Conclusion
There is a high probability of successful sperm acquisition in the testis of men undergoing micro-TESE. In this group of patients, age, testicular volume, FSH levels, LH levels, and T levels may have little bearing on the micro-TESE outcome. In patients whose preoperative TESA revealed the absence of sperm, the probability of obtaining sperm by micro-TESE remained high (65.1%); negative TESA results appeared to not influence the SRR (63.8%) in patients undergoing micro-TESE.
Impact of total intravenous anesthesia and total inhalation anesthesia as the anesthesia maintenance approaches on blood glucose level and postoperative complications in patients with type 2 diabetes mellitus: a double-blind, randomized controlled trial
Authors: Xiong Xinghui , He Yong , Zhou Cheng , Zheng Qin , Chen Chan , Liang Peng 
Published: August 2023

Abstract
Background
Diabetes mellitus is a prevalent metabolic disease in the world. Previous studies have shown that anesthetics can affect perioperative blood glucose levels which related to adverse clinical outcomes. Few studies have explored the choice of general anesthetic protocol on perioperative glucose metabolism in diabetes patients. We aimed to compare total intravenous anesthesia (TIVA) with total inhalation anesthesia (TIHA) on blood glucose level and complications in type 2 diabetic patients undergoing general surgery.

Methods
In this double-blind controlled trial, 116 type 2 diabetic patients scheduled for general surgery were randomly assigned to either the TIVA group or TIHA group (n = 56 and n = 60, respectively). The blood glucose level at different time points were measured and analyzed by the repeated-measures analysis of variance. The serum insulin and cortisol levels were measured and analyzed with t-test. The incidence of complications was followed up and analyzed with chi-square test or Fisher’s exact test as appropriate. The risk factors for complications were analyzed using the logistic stepwise regression.

Results
The blood glucose levels were higher in TIHA group than that in TIVA group at the time points of extubation, 1 and 2 h after the operation, 1 and 2 days after the operation, and were significantly higher at 1 day after the operation (10.4 ± 2.8 vs. 8.1 ± 2.1 mmol/L; P < 0.01). The postoperative insulin level was higher in TIVA group than that in TIHA group (8.9 ± 2.9 vs. 7.6 ± 2.4 IU/mL; P = 0.011). The postoperative cortisol level was higher in TIHA group than that in TIVA group (15.3 ± 4.8 vs. 12.2 ± 8.9 ug/dL ; P = 0.031). No significant difference regarding the incidence of complications between the two groups was found based on the current samples. Blood glucose level on postoperative day 1 was a risk factor for postoperative complications (OR: 1.779, 95%CI: 1.009 ~ 3.138).

Conclusions
TIVA has less impact on perioperative blood glucose level and a better inhibition of cortisol release in type 2 diabetic patients compared to TIHA. A future large trial may be conducted to find the difference of complications between the two groups.

Trial registration
The protocol registered on the Chinese Clinical Trials Registry on 20/01/2020 (ChiCTR2000029247).
Diagnostic accuracy of the BioFire® FilmArray® pneumonia panel in COVID-19 patients with ventilator-associated pneumonia
Authors: Cojuc-Konigsberg Gabriel , Moscona-Nissan Alberto , Guijosa Alberto , Mireles Dávalos Christian D. , Martínez María E. Jiménez , Mújica Sánchez Mario A. , Hernández Huizar Víctor F. , Durán Barrón Martha A. , Gómez Karen Villarreal , Andrade-Galindo Regina , Ordóñez-Oviedo Montserrat , Brito Grecia Deloya , Vargas Eduardo Becerril 
Published: August 2023

Abstract
Background
Ventilator-Associated pneumonia (VAP) is one of the leading causes of morbidity and mortality in critically ill COVID-19 patients in lower-and-middle-income settings, where timely access to emergency care and accurate diagnostic testing is not widely available. Therefore, rapid microbiological diagnosis is essential to improve effective therapy delivery to affected individuals, preventing adverse outcomes and reducing antimicrobial resistance.

Methods
We conducted a cross-sectional study of patients with suspected VAP and COVID-19, evaluating the diagnostic performance of the BioFire® FilmArray® Pneumonia Panel (FA-PP). Respiratory secretion samples underwent standard microbiological culture and FA-PP assays, and the results were compared.

Results
We included 252 samples. The traditional culture method detected 141 microorganisms, and FA-PP detected 277, resulting in a sensitivity of 95% and specificity of 60%, with a positive predictive value of 68% and negative predictive value of 93%. In samples with high levels of genetic material (> 10^5 copies/mL), the panel had a sensitivity of 94% and specificity of 86%. In addition, 40% of the culture-negative samples had positive FA-PP® results, of which 35% had > 10^5 copies/mL of genetic material. The most prevalent bacteria were Gram-negative bacilli, followed by Gram-positive cocci. The panel identified 98 genes associated with antimicrobial resistance, predominantly extended-spectrum beta-lactamases (28%).

Conclusion
The FA-PP is a sensitive assay for identifying bacteria causing VAP in patients with COVID-19, with a greater capacity to detect bacteria than the conventional method. The timely microbiological recognition offered by this panel could lead to optimized decision-making processes, earlier tailored treatment initiation, and improved antibiotic stewardship practices.