Open Study Research Articles

Moving from the Business Case Towards an Equity-Based Approach: Theorizing Diversity and Inclusion in Open Strategy

A growing number of organizations open their strategy processes by including a more diverse set of actors. This has drawn scholarly interest and led to a field of research known as open strategy. In this paper, we problematize how open strategy research deploys diversity and inclusion without engaging with the diversity and inclusion literature that offers a more differentiated understanding of these concepts. We build on this literature to elucidate how most open strategy studies follow a business case approach wherein inclusion, and implicitly also diversity, are theorized based on their impact on strategy outcomes. We show how engaging with the diversity and inclusion literature allows open strategy scholars to move from the business case towards an alternative, equity-based approach. Adopting an equity-based approach widens the themes addressed in open strategy research to the reproduction of power relations and sustained inequalities in strategy making and thus contributes to a more societally meaningful and relevant understanding of diversity and inclusion in the strategy field.

Long-Term Update of a Phase 3 Randomized Study Comparing Once-a-Week Versus Once-Every-3-Weeks Cisplatin Along With Radiation in Head and Neck Cancer

PurposeIn the weekly-3-weekly (W3W) study, cisplatin at 100 mg/m2 once-every-3-weeks led to superior locoregional control compared to cisplatin 30 mg/m2 once-a-week in combination with radical radiation for locally advanced head and neck squamous cell carcinoma (LAHNSCC). We report the updated analysis of the study. MethodsIn this phase III open label non-inferiority study conducted between 2013 and 2017, 300 patients with LAHNSCC were randomly assigned to receive cisplatin 100 mg/m2 once-in-3-weeks or cisplatin 30 mg/m2 once-a-week, concurrently with radiation. The primary endpoint was locoregional control (LRC). Secondary outcomes were overall survival (OS), progression free survival (PFS) and late adverse events. ResultsThe median follow-up was 6.91 years (95% CI, 6.12-7.36). The updated 2-year and 5-year LRC rates for the once-a-week cisplatin arm were 58.75% (95% CI, 51.08- 67.58) and 48.09% (95% CI, 40.26-57.43), while for the once-every-3-weeks cisplatin arm were 73.95% (95% CI, 66.93-81.70) and 56.76% (95% CI, 48.46-66.48), respectively; HR=1.44 (95% CI, 1.03-2.03), P=0.034. The 5-year OS was 43.60% (95% CI, 36.29-52.37) in the once-a-week cisplatin arm, and 50.55% (95% CI, 43.06-59.35) in the once-every-3-weeks cisplatin arm; P = 0.19. There was no difference in any grade or grade ≥ 3 late adverse events between the two arms, except for hearing dysfunction, which was significantly more common in patients who received high-dose cisplatin. ConclusionsLong term follow-up confirms that cisplatin at 100 mg/m2 administered once-every-3-weeks concurrently with radical radiation for LAHNSCC leads to superior locoregional control as compared to cisplatin 30 mg/m2 once-a-week and should remain one of the standard treatment options.

“Everybody looks at it as drug use instead of pain management”: Experiences of chronic pain and its management among older people living with HIV who use drugs in Vancouver, British Columbia

BackgroundChronic pain is a common comorbidity among people living with HIV (PLHIV) who use drugs. However, in-depth understanding of how chronic pain is managed among PLHIV who use drugs remains limited, especially in the aging population. We sought to explore how older PLHIV who use drugs manage chronic pain and situate these experiences within their social and structural contexts. MethodsThis study draws on semi-structured, in-depth interviews conducted with 27 PLHIV who use drugs and were living with chronic pain in Vancouver, Canada. Participants were recruited through outreach at an integrated HIV care facility and from an open prospective cohort study of PLHIV who use drugs. Interviews were audio-recorded, transcribed, and coded. Salient themes were identified using an inductive-deductive approach to coding. ResultsThree themes emerged from our data analysis. First, chronic pain influenced daily life and functioning, including ability to manage HIV and other health conditions. Second, provider-related barriers, including anti-drug stigma and discrimination, impeded access to pain management. Third, illicit drugs were often used to self-manage pain. ConclusionsThis study advances our understanding of the everyday experiences of living with chronic pain among older PLHIV who use drugs. Inadequately managed pain may contribute to an array of health- and drug-related harms among this population. Our findings underscore the need for equitable access to pain care, and safer alternatives to the toxic illicit drug supply in the context of the illicit drug poisoning epidemic, to relieve suffering and improve quality of life for older PLHIV who use drugs.

Open Parliament: Study from Indonesia and Philippines

This research aims to analyze the trend of open parliaments in Indonesia and the Philippines and the commitment of the parliaments of the two countries. This research uses a qualitative approach with bibliometric analysis and content analysis methods. The results of this research show that the Indonesian open parliament study has a higher number of publications, citations, h-index, and g-index, so that it has a greater impact and productivity. Even though Indonesian open parliament articles have higher total link strength and occurrences, the Philippine open parliament study is more focused on certain topics. There are more themes and clusters in the Indonesian open parliament study, and each cluster describes the relationship between certain themes and focuses. Network visualization, overlay visualization, and density visualization generate potential research themes regarding this study in the future. Even though the Indonesian and Philippine parliaments have stated their commitment to support open parliaments in both countries, the Indonesian parliament's commitment has a stronger influence through the formation of an open parliament institution.

The feasibility of allergen-specific immunotherapy for bronchial asthma in children with polysensitization

Relevance. There is a shortage of studies that would evaluate the effectiveness of allergen immunotherapy (AIT) in children with bronchial asthma (BA) and polysensitization.The aim of the study: to evaluate AIT effectiveness with house dust mite (HDM) allergens in the treatment of BA in children polysensitized to perennial allergens, based on the dynamics of the symptoms and medications score.Materials and methods. The open prospective controlled study included 36 children aged 9,6 [6,9; 12,3] years (from 6 years 1 months to 14 years 3 months) with moderate atopic asthma (21 children (58%) and mild asthma (15 children (42%) and polysensitization to household allergens. Each patient was observed in the study for 4 years: 1 year of preliminary observation and 3 years of sublingual AIT with D. pteronyssinus and D. farinae (Staloral, Stallergenes Greer, France). For each year of observation, asthma symptoms and medications used were assessed, and the combined Score was calculated. To confirm sensitization, a prick test was performed using a standard method with allergens: house dust, D. pteronyssinus, D. farinae, cat, dog, horse, pillow feather (Biomed, Russia).Results. Over 2 years of AIT, the decrease in the symptom and medication Score was 46,9%, and at the end of 3rd year of therapy, 59,8% (р = 0,0001 from baseline). A decrease in the combined Score exceeding 34.9% compared to baseline was noted in all patients in the study.Conclusion. Sublingual AIT with HDM allergens is highly effective in the treatment of asthma in children with domestic polysensitization, in terms of reducing symptoms of the disease, the need for pharmacotherapy and the combined Score of symptoms and medications. A significant positive effect was registered already from the first year of AIT and continues to increase over subsequent years of therapy.

Comparative effectiveness of clozapine and non-clozapine atypical antipsychotics provided by the Brazilian National Health System in adults with schizophrenia.

Currently, 21 million people live with the disease, mostly in low to middle-income countries. We aimed to assess the survival of patients with schizophrenia using clozapine compared with non-clozapine atypical antipsychotics provided by the Brazilian National Health System using real-world data. This is an open retrospective cohort study of patients diagnosed with schizophrenia to whom atypical antipsychotics were dispensed by the Brazilian National Health System between 2000 and 2015, based on deterministic-probabilistic pairing of administrative data records. The Kaplan-Meier method was used to estimate the cumulative probability of survival and the Cox proportional hazards model was adjusted to assess the risk factors for survival via the hazard ratio (HR). Participants were 375,352 adults with schizophrenia, with an overall survival rate of 76.0% (95%CI 75.0-76.0) at the end of the cohort. Multivariate analysis indicated a greater risk of death for men (HR=1.30; 95%CI 1.27-1.32), older adults (HR=17.05; 95%CI 16.52-17.60), and in the Southeast region of Brazil (HR=1.20; 95%CI 1.17-1.23). Patients who used non-clozapine atypical antipsychotics had a 21% greater risk of death when compared to those taking clozapine (HR=1.21; 95%CI 1.14-1.29). Additionally, a history of hospitalization for pneumonia (HR=2.17; 95%CI 2.11-2.23) was the main clinical variable associated with increased risk of death, followed by hospitalization for lung cancer (HR=1.82; 95%CI 1.58-2.08), cardiovascular diseases (HR=1.44; 95%CI 1.40-1.49) and any type of neoplasia (HR=1.29; 95%CI 1.19-1.40). This is the first published Brazilian cohort study that evaluated survival in people with schizophrenia, highlighting the impact of atypical antipsychotics. In this real-world analysis, the use of clozapine had a protective effect on survival when compared to olanzapine, risperidone, quetiapine, and ziprasidone.

Faculty-Student Mentorship Effects on Faith-Learning Integration: A Comparative Study of Residential and Open and Distance Learning Programs in Selected Christian Universities in Kenya

Being the organizing paradigm and the unique hallmark for the life and mission of Christian higher educational institutions, faith-learning integration (FLI) has dominated educational research for several decades, whilst, a limited body of empirical studies that focus on faculty and students’ perspectives on its implementation currently exists. What is more, most researches on FLI are skewed toward students in traditional residential studies programs (RSP). This situation exists against the backdrop of the phenomenal growth of Christian higher educational institutions offering their academic programs via open and distance learning programs (ODLP). Based on these issues, the present study was poised to investigate the extent to which faculty-student mentorship affects FLI in RSP compared to the effects of ODLP in selected Christian universities in Kenya. This comparison was analyzed based on Randall Lehmann Sorenson’s attachment theory with the view to addressing the problem of whether or not the extent of faculty-student mentorship effects on FLI in the two programs were similar. This study employed a cross-sectional survey research design. Three Christian universities in Kenya were purposely selected to participate in the study, namely: Africa Nazarene University, (ANU), Daystar University (DU), and Kenya Methodist University (KeMU). The target population was students enrolled in the Bachelor of Education Secondary Option (BEd SO) program and faculty members teaching in the program. A total of 613 residential and 113 ODL students were randomly sampled, whereas, 12 full-time faculty members were purposely selected to participate in the study. Mailed and self-administered questionnaires were used for data collection. Validation of the instruments was carried out before they were tested using the split-half technique for reliability. Data were analyzed using descriptive statistics aided by contingency tables, percentages, and a Chi-square test of independence with the view to responding to two research questions. One null hypothesis was tested using a Chi-square test of independence at 0.05 level of significance with 2 degrees of freedom. The result of this analysis revealed that faculty mentorship effects on students’ learning integration in RSP are significantly different from students’ learning integration in ODLP. Major recommendations included the need for faculty in the selected Christian universities to develop close and dynamic mentoring relationships with students both in RSP and ODLP equally. There was also a need for faculty to creatively adopt effective FLI strategies to have a positive and transformative impact on students’ learning integration in the ODLP.

ОСОБЕННОСТИ НУТРИТИВНОГО СТАТУСА ДЕТЕЙ С МУКОВИСЦИДОЗОМ РАЗЛИЧНЫХ ЭТНИЧЕСКИХ ГРУПП СЕВЕРНОГО КАВКАЗА

Adequate nutritional status in a patient with cystic fibrosis (CF) positively correlates with the normal function of the bronchopulmonary system. Many domestic and foreign studies have been conducted so far to assess the nutritional status of children and adults with CF. However, there is no data as yet on the phenotypic characteristics of children from different ethnic groups of the North Caucasus depending on their genotype. The purpose of this research was to study the peculiarities of nutritional status in children with CF of the following Russia’s North Caucasus ethnic groups: Chechen, Karachay-Circassian, Dagestani, Ingush and Ossetian-Alanian. Materials and methods used: a single-center open prospective study of 117 children with CF aged 2 months to 17 years old (Me 6 y/o) of various North Caucasus ethnic groups was conducted. All patients have undergone molecular diagnosis and assessment of both nutritional status and exocrine pancreatic function. Results: 50.4% of pediatric patients with CF in the Russia’s North Caucasus have had pathological mutations in c.1545_1546delTA, p.(Tyr515*) and c.3846G>A, p.(Trp1282*) in homozygous state. These mutations were most often found in the Ingush (100%) and Chechen (82%) ethnic groups and somewhat less frequently in the Dagestani (57.1%) and Karachay-Circassian (54%) ethnic groups. In the Chechen and Ossetian-Alanian ethnic groups, when these mutations were detected, severe pancreatic insufficiency was established in 40.5% and 100% of cases, respectively. Pseudo-Bartter syndrome was diagnosed in 60% of cases with this genetic variant in a homozygous or compound heterozygous states during the patients’ first years of life. Indicators for the nutritional status of children with CF from different ethnic groups were significantly lower compared to those recorded officially in the 2021 Russian National Register of Patients with CF. Conclusion: it is necessary to study the course of CF and the state of nutritional status separately in each population and its connection with the identified genetic characteristics of the Russia’s North Caucasus ethnic groups. The genotype and phenotype patterns for these patients were the reason for the development of disorders of the exocrine function of the pancreas and pseudo-Bartter syndrome at an early age, which in its turn could lead to further development of nutritional deficiency.

Topical treatment of pyoderma gangrenosum: A systematic review.

Systemic immunosuppressants are the mainstay of treatment for pyoderma gangrenosum (PG), but they generally have significant side effects which may be avoided by limiting treatment to topical therapy. This review aimed to assess the efficacy and safety of topical treatments for PG. An extensive literature search identified nineteen suitable publications for analysis, including two open cohort studies, five case series and twelve single case reports. The quality of evidence in the publications was graded and data relating to topical PG treatment was extracted. The lack of randomised clinical trials investigating topical monotherapy for PG means that robust statistical analysis was not possible. The greatest weight of the current evidence for topical therapy favours either corticosteroids or calcineurin inhibitors. According to our review, both these options appear well tolerated with a few side effects and may have similar efficacy in speeding up the resolution of PG ulcers. Topical therapy could be considered for use in combination with systemic treatment. There may also be a role for isolated topical monotherapy in selected patients with PG, especially those with early or mild disease and those with idiopathic PG. However further research is needed to confirm this and establish optimal treatment approaches for this condition.

Impact of coenzyme Q10 as an adjuvant therapy to letrozole on spermiogram results and sex hormone levels in Iraqi men with infertility; randomized open label comparative study.

Background: Worldwide, infertility affects about 15% of reproductive-age couples. In many cases, infertility can't be treated, however new treatment options with promising value have been involved in recent clinical trials. The aim of this clinical trial was to evaluate the impacts of adding coenzyme Q10 (CoQ10) to letrozole on the results of spermiogram and sex hormone tests in men diagnosed with idiopathic oligoasthenoteratozoospermia (iOAT) syndrome, which is a type of male defective spermatogenesis of unknown etiology. Methods: This randomized, open-label, parallel two-arm interventional study included 67 adult male patients aged 18-60 years with a confirmed diagnosis of iOAT syndrome recruited from The High Institute for Infertility Diagnosis & Assisted Reproduction Technologies/Nahrain University. Patients were randomly separated into two groups, Group A included 29 patients treated with letrozole 2.5 mg tablet orally twice a week, Group B included 38 patients treated with a combination of letrozole 2.5 mg tablet orally twice a week plus CoQ10 400 mg per day. Both groups completed treatment for three months. Semen samples, serum follicle-stimulating hormone (FSH), estradiol (E 2), and testosterone (T) were analyzed at day one, and at the end of month one, two and three. Results: Both groups showed that sperm concentration, normal morphology, total sperm count and motility, serum testosterone and FSH levels, and T/E 2 ratio were significantly increased, while estradiol levels significantly decreased after three months of treatment. Seminal fluid volume changed significantly in group A only. In comparing between the two groups, all measured parameters, apart from sperm motility and FSH level, demonstrated a significant difference after three months of treatment, while sperm volume reached significant value after only two months of therapy. Conclusions: CoQ10 as adjuvant treatment to letrozole effectively improved most of the tested sperm parameters in Iraqi men with iOAT. Registration: ClinicalTrials.gov ( NCT05847257, May 6, 2023).

Health care workers’ qualitative descriptions of ethically challenging situations evoking moral distress during Covid-19

Background: The high public demand for healthcare services during the COVID-19 pandemic and strict infection control measures, coupled with threat of severe illness and death, and limited resources, led to many healthcare workers (HCWs) experiencing ethically challenging situations (ECSs). Objective: To systematically explore first-hand accounts of ECS-evoking moral distress among HCWs during this public health emergency. Research design: This was an open cohort study. All participants were asked whether they had been in ECS-evoking moral distress during the pandemic. Those who had were asked to describe these situations. Answers were systematically analyzed according to three levels of root causes for ECSs, using thematic analysis. Participants and research context: In January 2022, 977 HCWs from four Norwegian university hospitals participated. Ethical considerations: The study received ethical approval from the Norwegian Ethical Review Authority (No. 130944). Results: In total, 508 participants (52%) reported that they had experienced ECS-evoking moral distress during the pandemic, whereof 323 provided a qualitative description. We found that while a few reported ECSs caused at the patient level, and some described situations at the unit/team level, the vast majority reported situations caused at the system level, predominantly related to resource scarcity, particularly poor staffing. Conclusion: Our findings strongly indicate that efforts to mitigate moral distress among HCWs should be targeted at the system level. More specifically, the study findings highlight resource limitations, particularly poor staffing, as a major cause of moral distress during the pandemic.

Cutaneous pharmacokinetics-based bioequivalence: A clinical dermal open flow microperfusion verification study using lidocaine and prilocaine combination topical products

BackgroundUsing accurate, sensitive, reproducible and efficient in vivo cutaneous pharmacokinetics (PK)-based bioequivalence (BE) approaches can promote the development of topical generic drug products. A clinical dermal open flow microperfusion (dOFM) study has previously demonstrated the BE of topical drug products containing a hydrophilic drug. However, the utility of dOFM to evaluate the topical BE of drug products containing moderately lipophilic drugs, more representative of most topical drugs, has not yet been established. ObjectiveTo evaluate the ability of a clinical dOFM study to assess BE of topical products containing two moderately lipophilic drugs that have only minor differences in chemical and physical properties. MethodsThe study included 20 healthy subjects. Four application sites on each thigh were treated with fixed dose lidocaine/prilocaine combination products, and dermal drug concentrations were monitored with two dOFM probes per application site for 12 h. A reference cream was compared to itself and to an approved generic cream (both serving as positive controls for BE), and to a gel (negative control). BE was established based on AUC0to12h and Cmax using the scaled-average-BE approach. Systemic exposure of both drugs was assessed throughout the study. ResultsBE was successfully demonstrated for the positive controls, and not for the negative control, for both drugs. The systemic exposure of both drugs was negligible. ConclusionsdOFM accurately demonstrated BE between bioequivalent topical creams, sensitively discriminated between different formulations and differentiated the cutaneous PK of both study drugs, even though they differ only slightly in chemical and physical properties. These results support the utility of dOFM as a cutaneous PK-based BE approach for topical lipophilic drugs, including lidocaine and prilocaine.

Affect labeling: a promising new neuroscience-based approach to treating combat-related PTSD in veterans.

A significant portion of individuals exposed to combat-related trauma will develop posttraumatic stress disorder (PTSD), a severe, debilitating disorder with adverse impacts on both mental and physical functioning. Current treatments are effective for many individuals, however, there is a need for new treatment approaches to improve outcomes in PTSD and address the many existing barriers to seeking or completing treatment. In this open trial pilot study, we tested a novel, brief, computer-based intervention for PTSD utilizing "affect labeling" that was inspired by recent advances in neuroscience with U.S. veterans. As expected, pre-intervention clinical and fMRI neuroimaging data indicated that U.S. veterans with combat-related PTSD (N = 20) had significantly higher PTSD symptoms, depression symptoms, and amygdala reactivity to trauma cues than trauma-exposed healthy control veterans (N = 20). Veterans with PTSD who completed the affect labeling intervention (N = 13) evidenced reduced PTSD symptoms and these reductions were correlated with reductions in amygdala reactivity. Results from this initial proof-of-concept study are intriguing and suggest that affect labeling training offers significant potential as a novel, cost-effective, computer-based intervention for PTSD. Implications and next steps for further developing affect labeling interventions for PTSD are discussed. https://clinicaltrials.gov/, identifier NCT05924399.

Disposition kinetics and tissue residues of tilmicosin following intravenous, subcutaneous, single and multiple oral dosing in geese (Anser anser domesticus)

AbstractTilmicosin (TMC), a semi‐synthetic macrolide antibiotic, is widely used in veterinary medicine due to its broad‐spectrum, bacteriostatic properties. Frequently administered in various birds species, it is likely used off‐label in geese as well. The study sought to investigate TMC's pharmacokinetics, tissue residues, in geese through in vivo experiments. The study involved longitudinal open studies on 15 healthy adult males, with three phases separated by one‐month washout periods. Geese were administered TMC through intravenous (IV, 5 mg/kg), subcutaneous (SC, 10 mg/kg), and oral (PO, 25 mg/kg for five consecutive days) routes, with blood samples drawn at specific intervals. Tissue samples were also collected for subsequent analysis at pre‐assigned times. TMC in goose plasma was quantified by a fully validated HPLC method. Plasma concentrations were quantified up to 4 hr for the PO and IV routes, and up to 10 hr in the SC route. Significant variations in bioavailability were observed between SC (87%) and PO (4%) routes. The body extraction ratio was low at 0.03, suggesting minimal ability of the liver and kidneys to eliminate TMC. Multiple oral doses showed no plasma accumulation, but tissue data revealed extensive distribution and prolonged residence, up to 120 h, suggesting a sustained therapeutic effect despite the brief plasma half‐life. Regarding the multiple PO doses, provisional withdrawal times of 6, 7.5, and 8 days were suggested for the liver, muscles, and kidneys, respectively, according to the MRL set for these matrices in chickens by EMA. In conclusion, while the practical oral administration is discouraged at the population level, SC administration of TMC may be appropriate for geese, albeit impractical for flock therapy.

Causal link between hypothyroidism and gastric cancer risk: insights gained through multivariable Mendelian randomization and mediation analysis.

Gastric cancer (GC) is the third leading cause of cancer death worldwide, and hypothyroidism has been identified as a potential influencing factor. Despite known associations between hypothyroidism and various cancers, the causal link between hypothyroidism and GC and potential mediators of this relationship remains unclear. This study aimed to clarify these relationships using Mendelian randomization (MR). Utilizing genetic variant information from the FinnGen and MRC Integrative Epidemiology Unit open genome-wide association studies (GWAS) databases, we conducted univariable and multivariable MR analyses to explore the causal relationship between hypothyroidism and GC risk. The analysis was adjusted for confounders such as BMI, smoking status, and alcohol intake, and included mediator MR analysis to examine the role of high cholesterol. We identified a significant inverse association between hypothyroidism and GC risk (OR = 0.93, 95% CI= 0.89-0.98, P = 0.003), with no evidence of reverse causation or pleiotropy. Adjustments for Helicobacter pylori infection weakened this association. Mediator analysis highlighted high cholesterol levels, chronic hepatitis B infection, and diabetes/endocrine disease status as significant mediators of the protective effect of hypothyroidism on GC risk. Our findings suggest that hypothyroidism may confer a protective effect against GC, mediated in part by high cholesterol and other factors. These results underscore the importance of thyroid function and metabolic health in GC risk, offering new insights for preventive strategies and highlighting the need for further research into these complex associations.

The role of short-chain fatty acids in the progression of non-alcoholic fatty liver disease

Introduction. Nowadays, a multifactorial model of the pathogenesis of NAFLD is recognized. It is interesting to study the contribution of changes in the composition of the intestinal microbiota and its metabolites in the development of the disease.Aim. To evaluate the contribution of research into the qualitative composition of the intestinal microbiota in relation to the risk of progression of NAFLD to reduce the loss of health- saving potential of the population.Materials and methods. An open comparative study of 83 mature-aged patients (56.6 years (46–63)) suffering from NAFLD was conducted. The levels of insulin, leptin, its receptor, adiponectin in blood serum, zonulin in feces were studied, and SCFA in feceswas determined. The analysis was carried out depending on the phenotypes of NAFLD: the degree of steatosis (1 – 40 patients, degree 2 – 18 and degree 3 – 25), the presence of NASH (43 patients), the presence of fibrosis (fibrosis was found in 35 patients). The degree of steatosis and fibrosis was assessed using elastometry. The results of the study were analyzed using the Microsoft Excel, STATISTICA 12.0 software package.Results. In patients with NAFLD, the absolute number of all SCFA in the feces was reduced. The anaerobic index was deviated towards sharply negative values (-0,711 (-0,576-(-0,830)). A high level of propionic acid was noted among the patients with fibrosis (p < 0.05). Anaerobic index, relative content of isoC4 + isoC5 + isoC6, relative content of butyric acid had a positive relationship with the St-index (rs = 0.254, rs = 0.269, rs = 0.240, p≤ 0.05). An increase in the relative amount of propionic acid was statistically significantly associated with a decrease of FLI (rs = -0.229, p ≤0.05). A positive correlation was found between the level of insulin and the absolute amount of butyric acid C4 (rs = 0.228, p ≤ 0.05). There was an inverse relationship of the absolute and relative amounts of isoC4+ isoC5 + isoC6 and Iso Cn/Cn with zonulin in the feces (rs = -0.231, p ≤ 0.05, rs = -0.380, p ≤ 0.05 and rs = -0.332, p ≤ 0.05, respectively).Conclusion. There is the anaerobic flora among the patients with NAFLD. Modification of the content of SCFA in feces may affect to the progression of NAFLD. The effect of SCFA on the development and progression of NAFLD may be mediated by the development of insulin and leptin resistance, as well as an integrity violation of the intestinal barrier.

Efficacy and Safety of Chidamide in Combination with PD-1 Inhibitor and Radiotherapy for HER2-Negative Advanced Breast Cancer: Study Protocol of a Single Arm Prospective Study.

As one of the most important breakthroughs in cancer therapy, immune checkpoint inhibitors have greatly prolonged survival of patients with breast cancer. However, their application and efficacy are limited, especially for advanced HER2-negative breast cancer. It has been reported that epigenetic modulation of the histone deacetylase (HDAC) inhibitor chidamide, as well as immune microenvironment modulation of radiotherapy are potentially synergistic with immunotherapy. Thus, the combination of chidamide, radiotherapy and immunotherapy is expected to improve prognosis of patients with advanced HER2-negative breast cancer. This is a single-arm, open, prospective clinical trial investigating the efficacy and safety of the combination of HDAC inhibitor chidamide, anti-PD-1 antibody sintilimab, and the novel immuno-radiotherapy, which aims to enhance efficacy of immunotherapy, in subsequent lines of therapy of HER2-negative breast cancer. Our study will include 35 patients with advanced breast cancer that has failed endocrine therapy and first-line chemotherapy. Participants will receive 30 mg of chidamide twice a week, 200 mg of sintilimab once every 3 weeks, combined with immuno-radiotherapy. Radiotherapy will be centrally 8 Gy for at least one lesion, and at least 1 Gy for the other lesions. We will complete three fractions of radiotherapy in one cycle. The primary endpoint is progression-free survival, and secondary endpoints are objective response rate, disease control rate and safety. Moreover, biomarkers including cytokines and lymphocyte subgroups will be explored. As a single-arm clinical trial, the analysis of the influence of each single treatment is limited. Besides, our study is an open study, which involves neither randomization nor blinding. In spite of the abovementioned limitations, this prospective clinical trial will give an insight into subsequent lines of therapy of HER2-negative advanced breast cancer, prolong the survival or achieve long remission for these participants, and identify potential responders.

Mental COP: Mental Health Cohort Of Police officers in Korea

PurposeThis cohort study addresses the need for comprehensive and longitudinal research on police officers’ mental health, focusing on the relationship between occupational factors, individual characteristics and mental health status or...

Effect of Jianpi Shengxue Tablet on Iron Metabolism and Nutritional Status in Patients with Renal Anemia: A Prospective, Randomized, Open, Parallel Controlled and Multicenter Clinical Study.

This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia. A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups. Patients in the control group were treated with polysaccharide-iron complex, and those in the experimental group were administered Jianpi Shengxue tablet. After 8 weeks of continuous treatment, the therapeutic outcomes regarding anemia were compared between the two groups. After treatment, the red blood cell (RBC) count, hematocrit (HCT), reticulocyte percentage (RET), ferritin (SF), serum iron (SI), transferrin saturation (TSAT), and serum albumin (ALB) all increased (P<0.01), and the clinical symptom score and total iron binding capacity decreased (P<0.01) in the experimental group. Moreover, the improvements in RBC, HCT, RET, SF, SI, TAST, ALB, and clinical symptoms (fatigue, anorexia, dull skin complexion, numbness of hands and feet) in the experimental group were significantly greater than those in the control group (P<0.05). The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group (P<0.01). The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia, leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.

MOVEMENT PATTERNS, HOME RANGE, AND MICROHABITAT USE OF ALLIGATOR SNAPPING TURTLES (MACROCHELYS TEMMINCKII) IN A SMALL EAST TEXAS STREAM SYSTEM

Abstract The alligator snapping turtle (Macrochelys temminckii), the largest freshwater turtle in North America, faces numerous threats, with population declines and range contractions suspected to have occurred across its historic range. Previous research studying movement patterns and microhabitat use of M. temminckii has mostly been conducted in large, open, lentic environments and few studies have been conducted in small, lotic habitats. We investigated the movement and microhabitat use of adult female and juvenile M. temminckii within Bonaldo Creek, a small tributary of the Angelina River in eastern Texas. Six M. temminckii were monitored (two or three relocations per week) via radiotelemetry from July 2008 to September 2009. We found that the linear home range for adult females (405.1–1395.5 m) was longer than that of the unsexed juveniles (439.7–996.9 m), although movement frequency was similar between groups. Juveniles utilized a smaller subset of microhabitats compared to adult females. Adult females utilized microhabitats with abundant submerged structure, while overhanging vegetation was an important microhabitat feature for juveniles. The broader microhabitat use we observed in adult females may have been influenced by seasonal factors, highlighting the need for more long-term, seasonal assessments of M. temminckii movement and microhabitat. Such investigations will bolster our understanding of the spatial and temporal factors that influence M. temminckii populations in different systems.