METHODS: The 307 open-label extension (OLE) study (NCT03531255) is a non-randomized, multicenter extension study of long-term safety and efficacy of pegcetacoplan in adult patients with PNH who completed a pegcetacoplan parent study. All patients received pegcetacoplan. Outcomes at the 48-week data cutoff (week 48 of 307-OLE or August 27, 2021, whichever was earlier) are reported. Hemoglobin concentrations, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores, and transfusion avoidance were measured. Hemoglobin > 12 g/dL and sex-specific hemoglobin normalization (i.e., male, ≥ 13.6 g/dL; female, ≥ 12 g/dL) were assessed as percentage of patients with data available and no transfusions 60 days before data cutoff. Treatment-emergent adverse events, including hemolysis, were reported.
RESULTS: Data from 137 patients with at least one pegcetacoplan dose at data cutoff were analyzed. Mean (standard deviation [SD]) hemoglobin increased from 8.9 (1.22) g/dL at parent study baseline to 11.6 (2.17) g/dL at 307-OLE entry and 11.6 (1.94) g/dL at data cutoff. At parent study baseline, mean (SD) FACIT-Fatigue score of 34.1 (11.08) was below the general population norm of 43.6; scores improved to 42.8 (8.79) at 307-OLE entry and 42.4 (9.84) at data cutoff. In evaluable patients, hemoglobin > 12 g/dL occurred in 40.2% (43 of 107) and sex-specific hemoglobin normalization occurred in 31.8% (34 of 107) at data cutoff. Transfusion was not required for 114 of 137 patients (83.2%). Hemolysis was reported in 23 patients (16.8%). No thrombotic events or meningococcal infections occurred.
CONCLUSION: Pegcetacoplan sustained long-term improvements in hemoglobin concentrations, fatigue reduction, and transfusion burden. Long-term safety findings corroborate the favorable profile established for pegcetacoplan.
TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03531255.
MATERIALS AND METHODS: A cross-sectional study was conducted to evaluate the perceptions of nurses (n = 45) and students (n = 6) when performing patient transfers from bed to wheelchair and vice versa using the NEAR-1 compared to an existing floor lift, walking belt, and manual transfer. Participants filled out surveys evaluating the perceived task demands and usability of the NEAR-1, as well as open-ended interviews.
RESULTS: The use of the NEAR-1 significantly reduced the mean of all NASA-TLX constructs (p
METHODS: A mixed-method study was conducted among individuals with T2DM in Udupi taluk, India. A cross-sectional survey (n = 467) followed by an in-depth interview (n = 35) was performed. The data were analyzed using descriptive statistics and thematic analysis, respectively.
RESULTS: About half (48.8%) of the participants engaged in PA of which 28.3% had an adequate score in the practice of PA. Walking was the most preferred mode. Self-realization, Comprehension, perception, and source of information, PA training, Current PA practices, enablers and barriers for PA were 6 themes derived under knowledge, perception, and practice of PA.
CONCLUSION: Despite knowing the importance of PA, compliance with PA was poor. The personal/internal, societal, and external factors constituted the trinity of barriers and enablers in compliance with PA. Behavioral changes, societal changes, policy initiatives, and PA training in health care settings may enhance PA practice among individuals with T2DM.
METHODS: All new pharmaceutical products approved between January 2015 and March 2021 were examined (n = 136) using publicly available information. Factors associated with drug approval lag were determined using multiple linear regression.
RESULTS: The median drug approval lag was 855 days. Drug approval lag was associated with drug characteristics and regulatory factors. Median submission lag and median review time for products which fulfilled the requirement for the new regulations (Conditional Registration/ Facilitated Registration Pathway) were shorter compared to products which did not fulfil the requirement.
CONCLUSION: Drug approval lag may delay the access of innovative medicine to patients, and this may lead to an increase in morbidity, mortality and healthcare costs. Good Regulatory Practices ensure efficient and transparent regulatory system which support the public health policy objectives in the most efficient way. The new regulations in Malaysia reduced the median submission lag and review time. The findings may be useful for regulators to consider for future policy development for medication access.
DESIGN: A prospective cohort study.
SETTING: The study was conducted across 623 ICUs of 224 hospitals in 114 cities in 37 African, Asian, Eastern European, Latin American, and Middle Eastern countries.
PARTICIPANTS: The study included 169,036 patients, hospitalized for 1,166,593 patient days.
METHODS: Data collection took place from January 1, 2014, to February 12, 2022. We identified CAUTI rates per 1,000 UC days and UC device utilization (DU) ratios stratified by country, by ICU type, by facility ownership type, by World Bank country classification by income level, and by UC type. To estimate CAUTI risk factors, we analyzed 11 variables using multiple logistic regression.
RESULTS: Participant patients acquired 2,010 CAUTIs. The pooled CAUTI rate was 2.83 per 1,000 UC days. The highest CAUTI rate was associated with the use of suprapubic catheters (3.93 CAUTIs per 1,000 UC days); with patients hospitalized in Eastern Europe (14.03) and in Asia (6.28); with patients hospitalized in trauma (7.97), neurologic (6.28), and neurosurgical ICUs (4.95); with patients hospitalized in lower-middle-income countries (3.05); and with patients in public hospitals (5.89).The following variables were independently associated with CAUTI: Age (adjusted odds ratio [aOR], 1.01; P < .0001), female sex (aOR, 1.39; P < .0001), length of stay (LOS) before CAUTI-acquisition (aOR, 1.05; P < .0001), UC DU ratio (aOR, 1.09; P < .0001), public facilities (aOR, 2.24; P < .0001), and neurologic ICUs (aOR, 11.49; P < .0001).
CONCLUSIONS: CAUTI rates are higher in patients with suprapubic catheters, in middle-income countries, in public hospitals, in trauma and neurologic ICUs, and in Eastern European and Asian facilities.Based on findings regarding risk factors for CAUTI, focus on reducing LOS and UC utilization is warranted, as well as implementing evidence-based CAUTI-prevention recommendations.
METHODS: LB was extracted from Bacillus clausii isolate and the dry extract was diluted in deionized water. The antimicrobial effect of LB against planktonic E. faecalis was evaluated by determining the Minimal Inhibitory Concentration (MIC50). The anti-biofilm effect was evaluated by Minimal Biofilm Inhibitory Concentration (MBIC50) and Minimal Biofilm Eradication Concentration (MBEC50) assays on biofilm grown on dentin specimen surface. To evaluate the effectiveness of LB as a single irrigation solution and as a pre-irrigation prior to NaOCl, live and dead bacterial cells were quantified using Confocal Laser Scanning Microscopy (CLSM), and cell biomass was assessed.
RESULTS: LB exhibited an MIC50 and MBIC50 of 100 ppm, with an MBEC50 of 1000 ppm, resulting in 52.94 % biofilm inhibition and 60.95 % biofilm eradication on dentin specimens. The effectiveness was concentration-dependent, at 500 ppm, LB demonstrated comparable antimicrobial efficacy to 2.5 % NaOCl. Pre-irrigation with LB resulted in lower biofilm biomass compared to NaOCl alone.
CONCLUSION: Pre-irrigation with LB enhanced the antimicrobial effect when followed by NaOCl irrigation. Consequently, LB shows promise as both a standalone root canal irrigation solution and as an adjunct to NaOCl in root canal treatment.
CLINICAL SIGNIFICANCE: The study highlights the potential of Lipopeptide Biosurfactant (LB) as an environmentally friendly irrigation solution for root canal treatment, demonstrating potent antimicrobial and anti-biofilm properties against Enterococcus faecalis. LB exhibits concentration-dependent efficacy comparable to 2.5 % NaOCl and can be used as a standalone irrigation solution or in conjunction with NaOCl.
DESIGN AND MEASURES: Data were analysed from the Global School-Based Student Health Survey Timor-Leste (n = 3455). An ordered probit model was used to assess the effects of demographic, lifestyle, social, and psychological factors on different levels of worry-related sleep problems (i.e., no, mild and severe sleep problems).
RESULTS: School-going adolescents were more likely to face mild or severe worry-related sleep problems if they were older, passive smokers, alcohol drinkers and moderately active. School-going adolescents who sometimes or always went hungry were more likely to experience worry-related sleep problems than those who did not. Involvement in physical fights, being bullied, and loneliness were positively associated with the probability of having modest or severe worry-related sleep problems.
CONCLUSION: Age, exposure to second-hand smoke, alcohol consumption, physical activity, going hungry, physical fights, being bullied and loneliness are the important determining factors of adolescent worry-related sleep problems. Policymakers should pay special attention to these factors when formulating intervention measures.
AIMS: This study examined positive and negative caregiver feelings about parenting youth with DS and to what extent children's demographic, cognitive, behavioral characteristics, and co-occurring medical conditions are associated with those parental feelings. Specifically, the mediatory role of child behavioral challenges on the relationship between child executive functioning (EF) and parent feelings about parenting a child with DS was examined in a mediation analysis model.
METHODS AND PROCEDURES: Parents of 113 youth with DS aged 6 to 17 year rated their positive and negative feelings about parenting, and their child's behavioral challenges and EF.
OUTCOMES AND RESULTS: Externalizing and Internalizing behavioral challenges and emotional and behavioral regulations of EF were significantly associated with positive and negative parent feelings. Child behavioral challenges fully mediated the relationship between child EF and caregiver feelings about parenting, after controlling for identified covariates of child demographics.
CONCLUSIONS AND IMPLICATIONS: Findings have implications for understanding the role of EF, through its impact on behavioral challenges, on the feelings of caregivers about parenting a child with DS. These findings play a role in understanding outcomes of interventions targeted at EF and behavioral challenges, in the context of other child variables.
METHODS: A systematic literature search in eight databases from January 2000 to July 2023 focusing on RCTs that compared a pharmacological intervention with a placebo for enhancing sleep in people with AD. The authors registered the study protocol at Prospero, followed the PRISMA guidelines, and produced the pooled estimates using random-effect or IVhet models.
RESULTS: Eight different interventions and 29 different sleep outcomes were examined in 14 RCTs included in this review. Eszopiclone positively affected sleep efficiency, as did orexin antagonists. However, there was no difference when melatonin was used. The interventions demonstrated low discontinuation rates and a few adverse drug reactions.
CONCLUSION: Although melatonin was the most investigated intervention, the evidence for its efficacy is inconclusive. On the other hand, trazodone and orexin receptor antagonists showed promising results; however, more RCTs are needed for definite answers.
METHODS: Chi-square tests were used for initial screening to select only those variables which would show an initial significance. Risk Ratios (RR) were calculated, and a Multiple Backward Stepwise Linear Regression Analysis (MBSLRA) was followed with those variables given significant results at screening and with the presence of distress or depression or the lack of both of them.
RESULTS: The most important risk factors for depression were female (RR = 1.59-5.49) and non-binary gender (RR = 1.56-7.41), unemployment (RR = 1.41-6.57), not working during lockdowns (RR = 1.43-5.79), bad general health (RR = 2.74-9.98), chronic somatic disorder (RR = 1.22-5.57), history of mental disorders (depression RR = 2.31-9.47; suicide attempt RR = 2.33-9.75; psychosis RR = 2.14-10.08; Bipolar disorder RR = 2.75-12.86), smoking status (RR = 1.15-5.31) and substance use (RR = 1.77-8.01). The risk factors for distress or depression that survived MBSLRA were younger age, being widowed, living alone, bad general health, being a carer, chronic somatic disorder, not working during lockdowns, being single, self-reported history of depression, bipolar disorder, self-harm, suicide attempts and of other mental disorders, smoking, alcohol, and substance use.
CONCLUSIONS: Targeted preventive interventions are crucial to safeguard the mental health of vulnerable groups, emphasizing the importance of diverse samples in future research.
LIMITATIONS: Online data collection may have resulted in the underrepresentation of certain population groups.
METHODS: We collected data on pediatric patients with gastrointestinal perforation between 2017 and 2019, from the National Clinical Database. The surgical volumes of various institutions were classified into three groups: low (average number of surgeries for gastrointestinal perforation/year