bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of early administration of tetracosactide on mortality and host response in critically ill patients requiring rescue surgery: a sensitivity analysis of the STOPSHOCK phase 3 randomized controlled trial
Authors: Noera Giorgio , Bertolini Alfio , Calzà Laura , Gori Mercedes , Pitino Annalisa , D’Arrigo Graziella , Egan Colin Gerard , Tripepi Giovanni 
Published: August 2024

Abstract
Background
Undifferentiated shock is recognized as a criticality state that is transitional in immune-mediated topology for casual risk of lethal microcirculatory dysfunction. This was a sensitivity analysis of a drug (tetracosactide; TCS10) targeting melanocortin receptors (MCRs) in a phase 3 randomized controlled trial to improve cardiovascular surgical rescue outcome by reversing mortality and hemostatic disorders.

Methods
Sensitivity analysis was based on a randomized, two-arm, multicenter, double-blind, controlled trial. The Naïve Bayes classifier was performed by density-based sensitivity index for principal strata as proportional hazard model of 30-day surgical risk mortality according to European System for Cardiac Operative Risk Evaluation inputs-outputs in 100 consecutive cases (from August to September 2013 from Emilia Romagna region, Italy). Patients included an agent-based TCS10 group (10 mg, single intravenous bolus before surgery; n = 56) and control group (n = 44) and the association with cytokines, lactate, and bleeding-blood transfusion episodes with the prior-risk log-odds for mortality rate in time-to-event was analyzed.

Results
Thirty-day mortality was significantly improved in the TCS10 group vs. control group (0 vs. 8 deaths, P < 0.0001). Baseline levels of interleukin (IL)-6, IL-10, and lactate were associated with bleeding episodes, independent of TCS10 treatment [odds ratio (OR) = 1.90, 95% confidence interval (CI) 1.39–2.79; OR = 1.53, 95%CI 1.17–2.12; and OR = 2.92, 95%CI 1.40–6.66, respectively], while baseline level of Fms-like tyrosine kinase 3 ligand (Flt3L) was associated with lower bleeding rates in TCS10-treated patients (OR = 0.31, 95%CI 0.11–0.90, P = 0.03). For every 8 TCS10-treated patients, 1 bleeding case was avoided. Blood transfusion episodes were significantly reduced in the TCS10 group compared to the control group (OR = 0.32, 95%CI 0.14–0.73, P = 0.01). For every 4 TCS10-treated patients, 1 transfusion case was avoided.

Conclusions
Sensitivity index underlines the quality target product profile of TCS10 in the runway of emergency casualty care. To introduce the technology readiness level in real-life critically ill patients, further large-scale studies are required.

Trial registration
European Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2007-006445-41).
School-based intervention for anxiety using group cognitive behavior therapy in Pakistan: a feasibility randomized controlled trial
Authors: Ijaz Saman , Rohail Iffat , Irfan Shahid 
Published: August 2024

Abstract
Background
Anxiety and mood disorders are the main cause of illness in people under the age of 25, accounting for 45% of the global disease burden, whereas 4.6% of teenagers aged 15 to 19 are predicted to experience anxiety. Pakistan country, with a population of 200 million, has the worst mental health indicators and fewer than 500 psychiatrists. Despite the existence of various treatments for anxiety, this goes unrecognized and untreated. Due to a lack of awareness, evaluation, prevention, and interventional programs related to being implemented among adolescents in Pakistan, there is a rise in mental health issues in the earlier years of life. It calls for a critical need for indigenous, evidence-based interventions. The present study aimed to evaluate the feasibility of cognitive behavioral therapy (CBT)-based interventions to reduce anxiety symptoms among school children in Pakistan.

Methods
This study was a pre-post design, two-arm, single-blinded, feasibility, randomized controlled trial. Thirty-four participants (experimental group, n = 17; control group, n = 17) were recruited from four semi-government schools in Rawalpindi with a mean age of 15 (M = 15, SD = 0.73). Two instruments Beck Anxiety Inventory for Youth (BAI-Y II) and BASC-3 Behavioural and Emotional Screening System Student (BESS-SF) were used to assess the severity of symptoms. Participants in the intervention arm received eight-group therapy CBT sessions. A two-way factorial analysis was used to examine the efficacy of CBT in reducing symptom severity.

Results
This study’s findings showed that in comparison to the wait-list control group, CBT successfully improved anxiety symptoms among school children while enhancing their social skills.

Conclusion
This study will help improve the treatment for anxiety in Pakistan by prioritizing school-based intervention and group-based CBT intervention.

Trial registration
The trial has been registered at the American Economic Association’s registry for randomized controlled trials. RCT ID: AEARCTR-0009551. Registered 2022–07-04.
PSMA-PET/CT response after metastasis-directed radiotherapy of bone oligometastases in prostate cancer
Authors: Sheikh Gabriel T. , Trapp Christian , Schmidt-Hegemann Nina-Sophie , Buchner Alexander , Stief Christian G. , Unterrainer Marcus , Kunz Wolfgang G. , Cyran Clemens C. , Grawe Freba , Delker Astrid , Zacherl Mathias J. , Holzgreve Adrien , Unterrainer Lena M. , Brendel Matthias , Belka Claus , Li Minglun , Rogowski Paul 
Published: August 2024

Abstract
Objective
Bone metastases are very common in advanced prostate cancer and can sensitively be detected utilizing PSMA-PET/CT. Therefore, our goal was to evaluate the suitability of PSMA-PET/CT-guided metastasis-directed external beam radiotherapy (MDT) as treatment option for patients with biochemical recurrence and oligometastatic bone lesions.

Materials & methods
We retrospectively examined 32 prostate cancer patients with biochemical recurrence and PSMA-positive oligometastatic disease limited to the bone (n = 1–3). A total of 49 bone lesions were treated with MDT. All patients received a post-radiotherapy PSMA-PET/CT-Scan. Changes in SUVmax, PSMA-positive tumor volume per lesion and PSA, as well as the correlation between the PET/CT-interval and SUVmax response were calculated.

Results
MDT lead to a SUVmax decrease in 46/49 (94%) of the lesions. The median relative decline of SUVmax was 60.4%, respectively. Based on PSMA-positive lesion volume with a SUV cut-off of 4, 46/49 (94%) of lesions showed complete response, two (4%) partial response and one lesion (2%) was stable on PSMA-PET/CT after MDT. Most of the treated patients (56.3%) showed an initial PSA decline at three months and a PSA nadir of median 0.14 ng/ml after a median time of 3.6 months after MDT. The median relative PSA change at three months after MDT was 3.9%.

Conclusion
MDT is a very effective treatment modality for prostate cancer bone oligometastases and lesion response to MDT can be assessed using the (semi-)quantitative parameters SUVmax and PSMA-positive lesion volume with established SUV cut-offs.
Brazilian version of the “Primary Sjögren’s Syndrome - Quality of Life questionnaire (PSS-QoL)”: translation, cross-cultural adaptation and validation
Authors: Miyamoto Samira Tatiyama , Serrano Érica Vieira , Gianórdoli Ana Paula Espíndula , Altoé Lara Betini , Noronha Bianca Domingos , dos Santos Pedro Henrique Alves , Pedrini Ana Paula Truhlar , da Silva Nicole Reis Souza , Favarato Letícia Fonseca , Alochio Luíza Vallory , Tomé Weider Andrade , Lackner Angelika , Valim Valéria 
Published: August 2024

Abstract
Background
The Primary Sjögren’s Syndrome Quality of Life questionnaire (PSS-QoL) is the first specific instrument to assess health-related quality of life (HRQoL) in Sjögren’s disease (SjD). The aim is to translate and cross-culturally adapt the PSS-QoL into Brazilian Portuguese and to evaluate its psychometric properties.

Methods
The original English version was translated into Brazilian Portuguese by two native Brazilians who were proficient in the English language. The retranslation was conducted by two native Americans proficient in Brazilian Portuguese. A committee undertook an analysis of the translated and retranslated versions, resulting in the generation of the first Brazilian version, which was submitted to the cross-cultural adaptation phase. In this phase, 50 participants with SjD responded to the instrument in Stages I and II, resulting in the generation of the second and final Brazilian version. To assess the psychometric properties, demographic and clinical data were collected from 75 patients. The HRQoL questionnaires (final Brazilian version of the PSS-QoL, Short Form-36 Health Survey (SF-36) and EuroQoL-5 dimension (EQ-5D)) were completed. Construct validity was analyzed using the Pearson or Spearman correlation coefficient. Reliability was analyzed using Cronbach’s alpha and the intraclass correlation coefficient (ICC).

Results
Eight questions and one response item were revised due to an incomprehension rate of greater than 15% among the participants in the cross-cultural adaptation phase. The final Brazilian version of the PSS-QoL was validated, revealing a high correlation between the total score and functional capacity (r= −0.713, p < 0.001), and vitality (r= −0.770, p < 0. 001) and mental health (r= −0.742, p < 0.001) domains of the SF-36 and a moderate correlation with the other domains of the SF-36 and a moderate correlation with the EQ-5D-tto (r= −0.573, p < 0.001), and EQ-5D-VAS (r= −0.559, p < 0.001). The intraobserver (ICC = 0.939; Cronbach’s alpha = 0.964) and interobserver (ICC = 0.965; Cronbach’s alpha = 0.964) reliability of the total score showed very high consistency.

Conclusion
The Brazilian version of the PSS-QoL has been demonstrated to be a valid and reproducible instrument for the assessment of HRQoL in patients with SjD.
When concrete was considered sustainable: ecological crisis, technological transition and the prefabricated concrete rural houses in Jiangsu Province from 1961 to the 1980s
Authors: Chen Yichuan 
Published: August 2024

AbstractThis paper explores the creation, development, and dissemination of prefabricated concrete rural houses in Jiangsu Province in East China from 1961 to the 1980s, an example of the technological transition provoked by the depletion of forest and timber in China. Through archival research, fieldwork and interviews, the paper examines the two waves of design and dissemination of prefabricated concrete rural houses between 1961 and 1965 and their subsequent ‘vernacularisation’ in the 1970s and the 1980s. This research provides a twofold insight into the current scholarly debates surrounding built heritage and global climate change. On one hand, it addresses a historical context of concrete overuse in contemporary China, a matter of critical importance in relation to carbon emissions and global climate change. On the other hand, it offers a counter-argument to today's call for reintroducing timber structures in many places, as evidenced by the case of East China, where the widespread use of materials like concrete was primarily a consequence of the ecological crisis following decades of deforestation and timber resource depletion. In addition, the ‘vernacularisation’ of concrete structures manifested by this case still provides lessons for today’s efforts to popularise more eco-friendly construction materials and technologies, especially in rural areas, and the prefabricated concrete houses possess potential heritage values as trackers of ecological changes.
US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Locally Advanced or Metastatic Breast Cancer With
PIK3CA
/
AKT1
/
PTEN
Alterations
Authors: Dilawari Asma , Buturla James , Osgood Christy , Gao Xin , Chen Wei , Ricks Tiffany K. , Schaefer Timothy , Avasarala Sreedevi , Reyes Turcu Francisca , Pathak Anand , Kalavar Shyam , Bhatnagar Vishal , Collazo Justin , Rahman Nam Atiqur , Mixter Bronwyn , Tang Shenghui , Pazdur Richard , Kluetz Paul , Amiri-Kordestani Laleh 
Published: August 2024

PURPOSE

The US Food and Drug Administration (FDA) approved capivasertib in combination with fulvestrant for adult patients with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, locally advanced, or metastatic breast cancer (MBC) who have received at least one previous endocrine therapy and whose tumors harbor one or more phosphatidylinositol 3-kinase (
PIK3CA
)/AKT Serine/Threonine Kinase 1 (
AKT1
)/phosphatase and tensin homolog (
PTEN
) alterations, as detected by an FDA-approved test.

PATIENTS AND METHODS

Approval was based on CAPItello-291, a randomized, double-blind, multicenter trial of 708 patients with hormone receptor–positive, HER2-negative advanced or MBC, including 289 patients with
PIK3CA/AKT1/PTEN
tumor alterations. Patients were randomly assigned 1:1 to receive capivasertib 400 mg twice daily for 4 days per week with fulvestrant versus placebo with fulvestrant. Random assignment was stratified by presence of liver metastases, previous treatment with CDK4/6i, cyclin-dependent kinase four and six (CDK4/6) inhibitors, and geographical region.

RESULTS
A statistically significant progression-free survival (PFS) benefit was demonstrated in the overall population (hazard ratio [HR], 0.6 [95% CI, 0.51 to 0.71]); this result was driven by 289 patients in the biomarker-positive population (HR, 0.5 [95% CI, 0.37 to 0.68]). An exploratory analysis of investigator-assessed PFS in the 313 (44%) patients in the biomarker-negative population showed uncertain benefit (HR, 0.78 [95% CI, 0.60 to 1.01]). With capivasertib, more patients had Grade ≥3 toxicities. Key concerns included hyperglycemia (18% all-grade, 2.8% Grade ≥3), cutaneous toxicity (58% all-grade, 17% Grade ≥3), and diarrhea (72% all-grade, 9% Grade ≥3).

CONCLUSION

Capivasertib with fulvestrant was approved for patients whose tumors harbored
PIK3CA/AKT1/
PTEN
alterations. Benefit-risk assessment in this subgroup was favorable based on a statistically significant and clinically meaningful improvement in PFS in the context of an acceptable safety profile including no evidence of a potential detriment in overall survival. By contrast, the benefit-risk was unfavorable in the biomarker-negative population.
Include the females: morphology–performance relationships vary between sexes in lizards
Authors: Head Alyssa , Vaughn Princeton L. , Livingston Ethan H. , Colwell Cece , Muñoz Martha M. , Gangloff Eric J. 
Published: August 2024

ABSTRACT
An animal's morphology influences its ability to perform essential tasks, such as locomoting to obtain prey or escape predators. While morphology–performance relationships are well-studied in lizards, most conclusions have been based only on male study subjects, leaving unanswered questions about females. Sex-specific differences are important to understand because females carry the bulk of the physiological demands of reproduction. Consequently, their health and survival can determine the fate of the population as a whole. To address this knowledge gap, we sampled introduced populations of common wall lizards (Podarcis muralis) in Ohio, USA. We measured a complete suite of limb and body dimensions of both males and females, and we measured sprint speeds while following straight and curved paths on different substrates. Using a multivariate statistical approach, we identified that body dimensions relative to snout-to-vent length in males were much larger compared with females and that body dimensions of P. muralis have changed over time in both sexes. We found that sprint speed along curved paths increased with relative limb size in both males and females. When following straight paths, male speed similarly increased as body dimensions increased; conversely, female speed decreased as body dimensions increased. Female sprint speed was also found to have less variation than that of males and was less affected by changes in body size and hindfoot length compared with males. This study thus provides insights into how selective pressures might shape males and females differently and the functional implications of sexual dimorphism.
Stable isotopes reveal sex- and context-dependent amino acid routing in green anole lizards (Anolis carolinensis)
Authors: Husak Jerry F. , Lailvaux Simon P. 
Published: August 2024

ABSTRACT
Allocation of acquired resources to phenotypic traits is affected by resource availability and current selective context. While differential investment in traits is well documented, the mechanisms driving investment at lower levels of biological organization, which are not directly related to fitness, remain poorly understood. We supplemented adult male and female Anolis carolinensis lizards with an isotopically labelled essential amino acid (13C-leucine) to track routing in four tissues (muscle, liver, gonads and spleen) under different combinations of resource availability (high- and low-calorie diets) and exercise training (sprint training and endurance capacity). We predicted sprint training should drive routing to muscle, and endurance training to liver and spleen, and that investment in gonads should be of lower priority in each of the cases of energetic stress. We found complex interactions between training regime, diet and tissue type in females, and between tissue type and training, and tissue type and diet in males, suggesting that males and females adjust their 13C-leucine routing strategies differently in response to similar environmental challenges. Importantly, our data show evidence of increased 13C-leucine routing in training contexts not to muscle as we expected, but to the spleen, which turns over blood cells, and to the liver, which supports metabolism under differing energetic scenarios. Our results reveal the context-specific nature of long-term trade-offs associated with increased chronic activity. They also illustrate the importance of considering the costs of locomotion in studies of life-history strategies.
Compensation for Exercise Professional Services
Authors: Badaracco Christina , Durak Eric , Ward-Ritacco Christie L. , Ribley Douglas 
Published: August 2024

Apply It!• Consider preparing for a growing number of payment options for your patients and clients• Engage in cross-sector collaboration to advance payment and reimbursement options to maximize access for your patients and clients• Pursue professional certifications and document positive outcomes from your interventions to expand the evidence base for the value provided by our field of professionals
Small intestinal obstruction secondary to migrated intragastric balloon retrieved endoscopically from the jejunum
Authors: Bamakhrama Khaled , Riyaz Suhana , Musthafa Mizna 
Published: August 2024

Introduction: The intragastric balloon is a medical device inserted into the stomach endoscopically and filled with either air or more commonly, saline. Widely utilised since the 1980s, numerous studies have affirmed its safety and effectiveness as a temporary treatment for weight loss. Despite this, there have been reports of rare but severe complications associated with its usage. Case description: We report the case of a 33-year-old female presented with two-day history of epigastric pain, nausea and vomiting. This occurred after having a gastric balloon placed endoscopically two months earlier. A contrast-enhanced abdominal CT scan revealed a partially deflated and migrated intragastric balloon in the proximal jejunum, causing intestinal obstruction without any signs of bowel perforation. The diagnosis was established as intestinal obstruction due to the migrated intragastric balloon. An emergency endoscopic procedure was undertaken, successfully removing the balloon thus highlighting a unique attempt to endoscopically retrieve a migrated intragastric balloon from the jejunum. Conclusion: The efficacy of an intragastric balloon in reducing weight in a short time is gaining more popularity. The more common it becomes the more we must be vigilant about its complications. We advise regular follow-up of patients and emphasise patient education of possible signs and symptoms of intragastric balloon migration, which will avoid serious complications.
Community Perception of Effectiveness Climate Village Program Implementation in Overcoming Flood Problems in Surabaya City
Authors: Sari Ida Nur I. , Purnomo Jerry D. Trijoyo 
Published: August 2024

Surabaya city as the second metropolitan city cannot be separated from flood disaster. According to verification team PROKLIM Lestari 2022, Surabaya is one of the cities designated as a role model for other villages. The appointment of Surabaya city as a role model is not in line with the occurrence of the flood disaster. Studies need to be carried out to measure the effectiveness level of the program. This study aims to measure community perceptions in assessing the effectiveness level of Climate Village Program to overcome the flooding problem in Surabaya using PLS-SEM method. The object of the research is people who felt the effects of flooding in Surabaya. This study uses public perceptions as exogenous variables, while the endogenous variables used were the level of effectiveness and the implementation of PROKLIM. The results showed that the variable of public perception had an effect on the effectiveness and variable effectiveness had an effect on the PROKLIM implementation. So, it can be concluded that the government as a policy maker must always pay attention to the effectiveness of sustainability programs and the community can provide positive evaluations, program can run well, and the flood disaster can resolve.
Designing Data Governance With DAMA DMBOK Framework
Authors: Sigi Awit Lela 
Published: August 2024

The vitality of data in aiding companies to fulfill their organizational objectives is paramount, as it can shape decisions across a variety of business operations. Often, corporations overlook the significance of data management, which in fact demands serious consideration. Two key issues that are frequently neglected include the hazy assignment of data responsibilities and the lack of robust data governance. The absence of transparency in data sources can interfere with data analysis or processing, while insufficient data integration and synchronization can prolong report creation time up to three days, due to the need to accumulate data from diverse sources. Furthermore, the use of Enterprise Architecture and Data Integration technologies has not reached its peak efficiency. To rectify these issues, it is recommended that PT XYZ adopts the DAMA DMBOK Framework for Data Governance. This would result in a well-organized and comprehensible data management structure. The procedure initiates with literature studies, progressing to plan data governance maturity evaluation activities, assessing data maturity levels using the DAMA DMBOK, generating recommendations, and finally planning enhancement strategies for Data Governance in the company. The anticipated outcome of this study would be the provision of Data Governance recommendations utilizing the DAMA DMBOK framework