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Declarations
PMC10303338
Ethics approval and consent to participate
Ethics approval for this study was provided by the St. Michael’s Hospital Research Ethics Board (Toronto, ON) and all participants provided informed consent.
PMC10303338
Consent for publication
Not applicable.
PMC10303338
Competing interests
HT
CDM has received advisory board honoraria/consulting fees from Amgen, AstraZeneca, BioAge, Boehringer Ingelheim, and PhaseBio, and honoraria for DSMB membership from Beth Israel Deaconess Medical Center, Cerus and Takeda. HT reports personal fees from the Canadian Medical and Surgical Knowledge Translation Research Gro...
PMC10303338
References
PMC10303338
Background
HDN
The mosquito landing rate measured by human landing catches (HLC) is the conventional endpoint used to evaluate the impact of vector control interventions on human-vector exposure. Non-exposure based alternatives to the HLC are desirable to minimize the risk of accidental mosquito bites. One such alternative is the hum...
PMC10318828
Methods
HDN
Two experiments to evaluate the protective efficacy of (1) a VPSR and (2) ITC, were performed. A block randomized cross-over design over 32 nights was carried out with both the HLC or HDN. Eight replicates per combination of collection method and intervention or control arm were conducted. For each replicate, 100
PMC10318828
Results
HDN
For the VPSR, the protective efficacy was similar for the two methods: 99.3%, 95% CI (99.5–99.0) when measured by HLC, and 100% (100, Inf) when measured by HDN where no mosquitoes were caught (interaction test p = 0.99). For the ITC, the protective efficacy was 70% (60–77%) measured by HLC but there was no evidence of ...
PMC10318828
Conclusions
bite, HDN
INTERACTIONS
Interactions between mosquitoes, bite prevention tools and the sampling method may impact the estimated intervention protective efficacy. Consequently, the sampling method must be considered when evaluating these interventions. The HDN is a valid alternative trapping method (relative to the HLC) for evaluating the impa...
PMC10318828
Keywords
PMC10318828
Background
malaria, HLCs, HDN
MALARIA, DISEASE, DISEASES
The human-mosquito contact rate is an essential parameter for determining disease risk in a given area and reducing human-mosquito exposure is essential for reducing the risk of diseases such as malaria [Human landing catch set-up in the temporary structureIn response to these challenges, a variety of possible alternat...
PMC10318828
Methods
PMC10318828
Study site
This evaluation was conducted in Kasetsart University’s SFS in Pu Teuy Village, Sai Yok District, Kanchanaburi Province, Thailand. Experimental chambers (9 × 4 × 3 m) of the SFS structure were positioned at least 20 m apart to minimize any spillover effect where the chamber containing the intervention impacts the behav...
PMC10318828
Mosquito bite prevention interventions
HDN
Two interventions were included in this evaluation. The first is a transfluthrin-based VPSR that was hung from the open structure’s eaves. For this evaluation, two units of this product were hung from two opposite sides of the open structure, per manufacturer’s instructions. Note, due to limited space in the chambers, ...
PMC10318828
Experimental design
The evaluation was conducted over 32 nights using a block randomized cross-over design with 16 nights of collection for each of the two interventions (Fig. Experimental design of the trap evaluation.
PMC10318828
Mosquitoes and mosquito collection
HDN, a mouth
KU’s HLCs were conducted for 45 min during each hour of the six-hour replicate, allowing for a 15-min break per collection hour. To conduct the HLCs, a collector sat on a chair in the centre of the temporary structure and collected mosquitoes with a mouth aspirator as mosquitoes landed on the lower leg between the knee...
PMC10318828
Data analysis
The OR of the released
PMC10318828
Discussion
HDN, bite
This study evaluated the performance of two different mosquito trapping methods, the HLC and the HDN, for estimating the effect on mosquito landing rates of two intervention types characterized by contrasting modes of action. The study results indicated that the primary mode of action of each intervention had a substan...
PMC10318828
Conclusion
bite, irritancy
This study indicates that HDNs may be a suitable replacement for HLC for evaluating VPSRs in the field. However, for evaluating ITCs and other similarly acting interventions that function through short range modes of action and tarsal contact (such as, topical repellents), there are no known, validated alternative trap...
PMC10318828
Acknowledgements
The authors thank the data collectors for their diligent work collecting mosquitoes throughout the study.
PMC10318828
Author contributions
Project conceptualization: SJM, NFL, TC; Project design: SJM, NFL, EV, AR, TC, DM; Project implementation and data collection: TC, MS; Data entry: MS; Data analysis: EV, AR, SJM; Drafting manuscript: EV; Revising and substantially contributing to manuscript: EV, AR, SJM, MS, TC, NFL, DM, AT.
PMC10318828
Funding
This study was funded by the Australia Department of Foreign Affairs and Trade (DFAT) through the Innovative Vector Control Consortium (IVCC), Liverpool, United Kingdom (Grant number A134328). The funding body had no role in the study design, collection, data analysis, data interpretation, or drafting of manuscript.
PMC10318828
Availability of data and materials
Data supporting the analysis, outcomes, and conclusions of this article are available upon request to the corresponding author.
PMC10318828
Declarations
PMC10318828
Ethics approval and consent to participate
Ethics approval for the study was approved by the Research Ethics Review Committee for Research Involving Human Research Participants, Kasetsart University (No. CAO63/035) and field research station was provided by the Royal Thai Armed Forces Development Command, Ministry of Defense and the Kasetsart University Researc...
PMC10318828
Consent for publication
Not applicable.
PMC10318828
Competing interests
The authors declare they have no competing interests.
PMC10318828
References
PMC10318828
2. Materials and Methods
PMC10255291
2.1. Participants
stroke, mental disorder, cardiac disease, diabetes
CHRONIC RENAL FAILURE, JOINT DISORDER, HYPERLIPIDEMIA, GYNECOLOGICAL DISEASE, STROKE, CARDIAC DISEASE, HYPERTENSION, DIABETES
We recruited middle-aged and elderly community-dwelling adults from Japan. Ninety-eight participants were recruited through advertisements published in the local press and posters at community health and recreation centers. Thirty-two individuals who were performing habitual exercise; were taking anti-hyperlipidemic, a...
PMC10255291
2.2. Study Design
After informed consent for participation in the study was obtained, allocation was performed using computer-generated random numbers for each sex. In this study, using a randomized controlled intervention trial with a double-blind study design, participants were randomly divided into four groups: the sedentary-control ...
PMC10255291
2.3. Resistance Training Intervention
Participants performed resistance training sessions using elastic bands (THERABAND, The Hygenic Corporation, Akron, OH, USA) in each participant’s home in the evening (7:00–8:00 p.m.); sessions took place 3 days per week on non-consecutive days for 12 weeks. Participants were supervised by experienced trainers in all t...
PMC10255291
2.5. Outcome Measures
PMC10255291
2.5.1. Body Composition
Body weight and height were measured to the nearest 0.1 cm and 0.1 kg, respectively. Body mass index (BMI; kg/m
PMC10255291
2.5.2. Physical Activity, Energy Intake, and Nutritional Status
The physical activity levels were assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF), as previously described [
PMC10255291
2.5.3. Muscle Quantity and Quality Indexes
To assess the muscle thicknesses of the anterior and posterior femoris muscles and the echo intensity of the rectus femoris muscle, we used a B-mode ultrasound device with 3.4–8.0 MHz linear-array probe (Vscan dual probe, GE Healthcare, Chicago, IL, USA). Ultrasound images consistently set the following parameters: fre...
PMC10255291
2.5.4. Cardiometabolic Parameters
DBP) blood pressures
All participants sat quietly for 30 min, and brachial systolic (SBP) and diastolic (DBP) blood pressures and heart rate (HR) were measured in duplicate in the sitting position at rest (HEM-7120, OMRON Healthcare, Kyoto, Japan).The sample in serum was immediately collected via centrifuge (1500×
PMC10255291
2.6. Statistical Analysis
All values were expressed as mean ± standard deviation (SD). Statistical analysis of each parameter was carried out using two-way analysis of variance (ANOVA) for repeated measures (time × group). One-way ANOVA was used to compare the differences in changes from baseline to 12 weeks among the four groups. A post hoc co...
PMC10255291
3. Results
PMC10255291
3.1. Participant Characteristics and Nutritional Status
The participant flowchart for this study is shown in No significant differences in age, height, body weight, BMI, percent body fat, daily physical activity, or daily total energy intake were observed among the four groups before and after the intervention (Additionally, no significant differences in the main nutritiona...
PMC10255291
3.2. Muscle Quantity and Quality Indices
No significant differences were observed in anterior and posterior femoris muscle thickness, echo intensity for the rectus femoris, normal walking speed, single-leg stance test, five times sit-to-stand test, and grip strength before and after the interventions among the four groups (Furthermore, changes in the posterio...
PMC10255291
3.3. Cardiometabolic Parameters
TG
No significant differences in SBP, DBP, HR, Total-Cho, HDL, TG, or HbA1c before and after the interventions were observed among the four groups (
PMC10255291
4. Discussion
fibrosis
FIBROSIS
Our main findings demonstrated that in healthy middle-aged and older adults, 12-week In the present study, 12-week Aging accelerates muscle fibrosis, which results in decreased muscle quality [This study revealed that, among the cardiometabolic risk factors, HbA1c decreased in the sedentary and low-intensity resistance...
PMC10255291
5. Conclusions
In this study, we revealed that 12-week
PMC10255291
Author Contributions
Conceptualization, M.I.; Data curation, K.I. (Keiko Iemitsu), S.F., M.U., K.I. (Kenichiro Inoue) and M.I.; Formal analysis, K.I. (Keiko Iemitsu), Y.S. and M.I.; Funding acquisition, M.I.; Investigation, K.I. (Keiko Iemitsu), S.F., M.U., K.I. (Kenichiro Inoue) and M.I.; Methodology, Y.S. and M.I.; Project administration...
PMC10255291
Institutional Review Board Statement
The present study was performed in accordance with the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of Ritsumeikan University (approval number: BKC-2021-006; approval date: 30 June 2021).
PMC10255291
Informed Consent Statement
Informed consent was obtained from all the subjects involved in the study.
PMC10255291
Data Availability Statement
The data presented in this study are available upon request from the corresponding author.
PMC10255291
Conflicts of Interest
The authors declare no conflict of interest.
PMC10255291
References
anterior femoris muscle thickness
Participant flow chart.Change in anterior femoris muscle thickness ((Comparison of subject characteristics before and after interventions.Data are means and SD. Sed+PL: sedentary-control and placebo intake group, Sed+Dio: sedentary-control and Nutritional status before and after interventions.Data are means and SD. Sed...
PMC10255291
Objective
EPITHELIAL OVARIAN CANCER
Academic Editor: Dawei Cui The aim of this study was to explore prognostic factors, develop and internally validate a prognostic nomogram model, and predict the cancer-specific survival (CCS) of epithelial ovarian cancer (EOC) patients with pelvic exenteration (PE) treatment.
PMC10449593
Methods
A total of 454 EOC patients from the Surveillance, Epidemiology, and End Results (SEER) database were collected according to the inclusion criteria and randomly divided into the training (
PMC10449593
Results
In the training cohort, age, histological type, Federation of Gynecology and Obstetrics (FIGO) stage, number of examined lymph nodes, and number of positive lymph nodes were found to be independent prognostic factors of postoperative CSS. A practical nomogram model of EOC patients with PE treatment was constructed bas...
PMC10449593
Conclusion
Our nomogram exhibited satisfactory survival prediction and prognostic discrimination. It is a user-friendly tool with high clinical pragmatism for estimating prognosis and guiding the long-term management of EOC patients with PE treatment.
PMC10449593
1. Introduction
Ovarian cancer, aggressive disease
OVARIAN CANCER, RECURRENCE, EPITHELIAL OVARIAN CANCER, METASTASES
Ovarian cancer (OC) is an aggressive disease characterized by its occult property and high rate of recurrence, making iterative cytoreduction a potentially beneficial approach. Among OC cases, epithelial ovarian cancer (EOC) accounts for approximately 90% of cases and represents the most prevalent histological type [Wh...
PMC10449593
2. Patients and Method
PMC10449593
2.1. Study Cohort Selection
Patient information was obtained using SEER 
PMC10449593
2.2. Variable Collection and Reclassification
tumor
TUMOR
The diagnosis and treatment process of EOC patients in the SEER database in the past period were reviewed to identify prognostic factors for CSS. We obtained the following variables of selected patients from the SEER database directly: age at diagnosis, race, year of diagnosis, marital status, histological type, tumor ...
PMC10449593
2.3. Statistical Analysis
All statistical analysis was performed using
PMC10449593
3. Results
PMC10449593
3.1. Demographic and Clinical Characteristics
The detailed process of patient selection is shown in
PMC10449593
3.2. Optimal Cutoff of Age, Lymph Nodes, and Tumor Size
Multicollinearity bias between the number of positive lymph nodes and lymph nodes examined was first evaluated by calculating the variance inflation factor (VIF). As is shown in Supplementary
PMC10449593
3.3. Independent Predictors Analysis for CSS of EOC Patients with PE Treatment
REGRESSION
The univariate and multivariate stepwise Cox regression models were performed in the training cohort (
PMC10449593
3.4. Development of a Nomogram of CSS in Training Cohort
The nomogram was constructed by incorporating the above-identified independent prognostic variables to predict the 3-, and 5-year CSS in EOC patients with PE treatment (
PMC10449593
3.5. Validation of Nomogram in Training Cohort and Validation Cohort
The discrimination of the nomogram was assessed by time-dependent ROC analysis in both the training cohort and validation cohort (Figures The discrimination of this nomogram was further assessed by the bootstrap validation with 1000 resamplings. The bootstrap-corrected Cindex of the nomogram was 0.72 (95% CI: (0.66, 0....
PMC10449593
4. Discussion
ovarian cancer, gynecologic malignancies, gynecological recurrent cancer
OVARIAN CANCER, ADVANCED CANCER
Clinical treatment of gynecological recurrent cancer and advanced cancer is very limited. Recently, with the deepening of collaboration of multidisciplinary technology, PE combined with organ function reconstruction has been gradually applied clinically by some doctors in gynecologic malignancies [It could be summarize...
PMC10449593
4.1. Limitations
tumor
TUMOR, COMPLICATIONS
First, the SEER database only provides a collection of patients in the United States, and the nomogram constructed in this study has not been demonstrated to be applicable to other regions. Meanwhile, this nomogram was only validated by dividing the total cases into training group and validation group. Therefore, furth...
PMC10449593
5. Conclusion
In summary, we found that age, histological type, FIGO stage, number of examined lymph nodes, and number of positive lymph nodes were independent prognostic factors of CSS in EOC patients with PE treatment. We successfully developed a predictive nomogram of 3-year and 5-year CSS which has been demonstrated to present l...
PMC10449593
Acknowledgments
This study was supported by grants from Young Scholars Fostering Fund of the First Affiliated Hospital of Nanjing Medical University (PY2022032), Special Fund project of Laboratory Medicine Research of Jiangsu Medical Association (SYH-3201160-0056), the National Natural Science Foundation of China (No. 82273199), Natur...
PMC10449593
Data Availability
The data supporting the findings of this study are available upon request from the corresponding author.
PMC10449593
Ethical Approval
This study was exempted by the Institutional Ethics Committee of the First Affiliated Hospital of Nanjing Medical University since data in the SEER database are anonymous and open access to the public.
PMC10449593
Consent
Written informed patient consent for participation was not needed for SEER database data in accordance with the national legislation and the institutional requirements.
PMC10449593
Disclosure
Xin Fu and Lei Zhang are co-first authors.
PMC10449593
Conflicts of Interest
The authors declare that there are no conflicts of interest.
PMC10449593
Authors' Contributions
Shuna
Ting Wang conceptualized and designed the research, analyzed data, and wrote the manuscript. Xin Fu and Lei Zhang curated data, investigated the study, and developed methodology. Shuna Liu and Ziqi Tao curated data and investigated the study. Fang Wang conceptualized and designed the research, supervised the study, and...
PMC10449593
Supplementary Materials
tumor
REGRESSION, TUMOR
Supplementary Table 1: Univariate and multivariable Cox regression analyses of CSS (Click here for additional data file.Patient selection flowchart.Optimal cutoff values determination of continuous variables and Kaplan–Meier curves stratified by the values using x-tile software. (a) Ages were split into two groups: ≤70...
PMC10449593
Abstract
ALS
Co‐first authors.Organizations within the Pooled Resource Open‐Access ALS Clinical Trials Consortium are listed in the Acknowledgments.
PMC10723227
Objective
death, ALS
AMYOTROPHIC LATERAL SCLEROSIS
Sodium phenylbutyrate and taurursodiol (PB and TURSO) was evaluated in amyotrophic lateral sclerosis (ALS) in the CENTAUR trial encompassing randomized placebo‐controlled and open‐label extension phases. On intent‐to‐treat (ITT) survival analysis, median overall survival (OS) was 4.8 months longer and risk of death 36%...
PMC10723227
Methods
ALS
Clinical trial control participants from the PRO‐ACT database who met prespecified eligibility criteria were propensity score matched 1:1 with PB and TURSO‐randomized CENTAUR participants using prognostically significant covariates in ALS.
PMC10723227
Results
Baseline characteristics including propensity score–matched covariates were generally well balanced between CENTAUR PB and TURSO (
PMC10723227
Interpretation
ALS
This analysis suggests potentially greater survival benefit with PB and TURSO in ALS without placebo‐to‐active crossover than seen on ITT analysis in CENTAUR. Analyses using well‐matched external controls may provide additional context for evaluating survival effects in future ALS trials.
PMC10723227
Introduction
ALS
The efficacy and safety of an oral, fixed‐dose combination of sodium phenylbutyrate and taurursodiol (PB and TURSO [RELYVRIOOLE phases provide an opportunity for longer‐term assessment of survival outcomes in trials with randomized placebo‐controlled phases of short duration in addition to increasing access to investig...
PMC10723227
Methods
PMC10723227
Analysis cohorts
ALS
AMYOTROPHIC LATERAL SCLEROSIS
During the conduct of the CENTAUR trial, eligible participants were in the randomized phase from June 2017 to September 2019 and in the OLE phase from March 2018 to March 2021. CENTAUR trial eligibility criteria allowed for the stable use of riluzole and edaravone before and during the trial. Survival results for the C...
PMC10723227
Standard protocol approvals, registrations, and participant consents
The clinical study protocol for CENTAUR was approved by a central institutional review board (the Partners Human Research Committee) for all trial sites, and participants provided written informed consent before entering each trial phase.
PMC10723227
Statistical analysis methods
death
SENSITIVITY
Overall survival analysis was conducted for 1:1 propensity score–matched individuals from the PRO‐ACT external control group and the CENTAUR PB and TURSO group. Overall survival (time to death) was defined as the time from date of randomization to date of death due to any cause. Median overall survival and IQRs were es...
PMC10723227
Results
SE, ALS
AMYOTROPHIC LATERAL SCLEROSIS, AMYOTROPHIC LATERAL SCLEROSIS
A total of 134 individuals in PRO‐ACT met inclusion criteria for this analysis and had known mortality information (full analysis set; Fig. Baseline characteristics.Data are presented as mean (SD), range unless otherwise noted.ALS, amyotrophic lateral sclerosis; ALSFRS‐R, Amyotrophic Lateral Sclerosis Functional Rating...
PMC10723227
Discussion
ALS
To estimate the treatment effect of PB and TURSO on survival in ALS in the absence of the placebo‐to‐active crossover that occurred in the OLE phase of the CENTAUR trial, we compared overall survival in those randomized to PB and TURSO with an external, PB and TURSO‐naïve control group from PRO‐ACT, the largest ALS cli...
PMC10723227
Funding information
ALS
Funding for the CENTAUR trial was provided by Amylyx Pharmaceuticals, Inc., ALS Finding a Cure
PMC10723227
Author Contributions
SP, MQ, AVS, MV, YW, JT, and MC contributed to the drafting and revision of the manuscript for content. All authors provided final approval of the manuscript for submission. SP, AVS, MC, and the PRO‐ACT Consortium played major roles in the acquisition of data. SP, MQ, AVS, MV, YW, JT, and MC analyzed and/or interpreted...
PMC10723227
Conflict of Interest
ALS
S. Paganoni reports research grants from the National Institutes of Health, Alector Therapeutics, Biohaven, Cytokinetics, Anelixis Pharmaceuticals, Revalesio Corporation, UCB, Clene, Prilenia, Seelos Therapeutics, Calico, and Denali Therapeutics unrelated to this manuscript; consulting fees from Amylyx Pharmaceuticals,...
PMC10723227
Supporting information
Table S1 Click here for additional data file.
PMC10723227
Acknowledgments
ALS
AMYOTROPHIC LATERAL SCLEROSIS 1
The authors wish to thank the individuals who participated in the CENTAUR trial, as well as their caregivers and families; the NEALS site staff and the staff at the Coordination Center at the NCRI, Healey & AMG Center for ALS, Massachusetts General Hospital, and Barrow Neurological Institute; and The ALS Association fo...
PMC10723227
References
PMC10723227
Subject terms
Cognitive Impairment, HAMD, Anxiety, anxiety, cognitive impairment, somatic pain, pain, depressive disorder, MDD, depression, Depression, NRS
CORTEX
This study aims to explore changes in depression and pain for major depressive disorder (MDD) patients with somatic pain after repetitive transcranial magnetic stimulation (rTMS) using the event-related potentials (ERPs) technique. Eighty MDD patients with somatic pain were randomly assigned to drug therapy (DT) and co...
PMC10589316
Introduction
cognitive impairment, Pain, pain, depressive disorder, cognitive dysfunction, depressive, MDD, depression
CORTEX
Pain is one of the most common symptoms in patients with major depressive disorder (MDD), being present in 65% of casesCognitive impairment is another common and often persistent symptom of MDD. Patients with pain and cognitive impairment are more challenging to treat and have longer treatment durations. Furthermore, c...
PMC10589316
Results
PMC10589316
Characteristics of participants
HAMD, Anxiety, pain, Depression, NRS
DISEASE
In total, 37 patients in the DT group and 38 in the CT group completed the study with a 92.5% and 95.0% completion rate, respectively. Three cases in the DT group were dropped after 3 weeks for taking other drugs. In the CT group, two cases were lost during the follow-up––one due to work and another who believed that t...
PMC10589316
Discussion
cognitive impairment, anxiety, somatic pain, pain, MDD, depression
REMISSION
To our knowledge, this was the first study examining the primary changes in ERPs, improvements and effects of a combination treatment with rTMS and antidepressants on depression, pain and cognitive function in untreated MDD patients with somatic pain. Our findings highlighted that rTMS combined with antidepressants led...
PMC10589316
Conclusion
MDD, somatic pain, cognitive impairment, anxiety
SECONDARY
Our results highlight that therapy involving rTMS in combination with antidepressants is an effective method for rapid symptom improvement in MDD patients with somatic pain. The combination therapy was helpful for many secondary symptoms such as cognitive impairment, and anxiety.
PMC10589316