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Nevin Manimala Statistics

Trends in participant race and sex reporting in lung cancer phase III clinical trials

Cancer Rep (Hoboken). 2023 Jul 8:e1856. doi: 10.1002/cnr2.1856. Online ahead of print.

ABSTRACT

BACKGROUND: Clinical trials are an essential part of advancing care for cancer patients. Historically, however, racial minorities and females have been underrepresented in these trials. Efforts like the National Institute of Health Revitalization Act attempted to mitigate these disparities, but despite these efforts, they continue to exist. These disparities can subsequently lead to minorities and females receiving suboptimal care.

AIMS: The purpose of our study was to understand the changing trends in reporting of participant race and sex as a demographic variable in phase III lung cancer clinical trials published over the last 35 years given these consequences of poor representation.

METHODS AND RESULTS: A total of 426 articles reporting the results of phase III lung cancer clinical trials published from 1984 to 2019 were identified in PubMed. From these articles, data on participant sex and race were collected from the demographic tables to construct the database for this study. This database was subsequently used to determine the rate of reporting of demographic factors like race and sex and the participation trends over the time of minority and female participation in lung cancer phase III clinical trials. The SciPy Stats package for Python was used to calculate descriptive statistics, 95% confidence intervals, two sample t-test, one-way analysis of variance test, and Pearson’s correlation coefficients. The Matplotlib package for Python was used for figure generation. Only 137 (32.2%) of the 426 studies analyzed reported the race of participants. Among those studies, we found that the mean participation rate of White participants was significantly higher (82.65%; p < .001). We found a decrease in African American participants and an increase in Asian participants over time. When looking at sex, we found that although the rate of male participation (69.02%) was significantly higher than that of female participation (30.98%), female participation has improved with time at a rate of 0.65% per year.

CONCLUSION: We found that the reporting and participation of minority races continue to lag that of other demographic factors like sex in phase III clinical trials in lung cancer. Based on our analysis, we note a decline in participation of African Americans in lung cancer phase III clinical trials despite the rising incidence of lung cancer.

PMID:37421166 | DOI:10.1002/cnr2.1856

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Nevin Manimala Statistics

Comparison of fetal safety of vaginal Misoprostol tablet and Dinoprostone gel for induction of labor: An open-label randomized control trial

J Obstet Gynaecol Res. 2023 Jul 8. doi: 10.1111/jog.15737. Online ahead of print.

ABSTRACT

AIM: In modern obstetrics, need of labor induction is increasing along with increased caesarean deliveries. Major contributions for these operative deliveries are due to induction failure. This demands a potent labor-inducing agent. Dinoprostone gel is an established method but having some drawbacks. Misoprostol could be an effective alternative to Dinoprostone, but its fetal safety is not yet well established. This study aimed to evaluate the fetal safety of vaginal Misoprostol tablet by measuring fetal heart rate changes during induction of labor.

METHODS: This was a single-center randomized controlled trial incorporating 140 term women, equally randomized to get either tablet Misoprostol or Dinoprostone gel. Fetal heart rate patterns were compared in both the groups by continuous cardiotocographic tracing. All the data were analyzed on an intention-to-treat basis.

RESULTS: There were no statistically significant changes in fetal heart rate pattern in both Misoprostol and Dinoprostone groups. Vaginal deliveries were statistically higher in Misoprostol group. Neonatal parameters like 1 min Appearance, Pulse, Grimace, Activity, and Respiration score and neonatal intensive care unit admission were comparable, and there was no significant difference in terms of major adverse events and side effects.

CONCLUSIONS: Misoprostol is a safe alternative to Dinoprostone gel for induction of labor and found to be more effective labor-inducing agent. In the background of higher caesarean rate, vaginal Misoprostol can be a potential labor-inducing agent especially in a resource poor setting.

PMID:37421158 | DOI:10.1111/jog.15737

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Nevin Manimala Statistics

Diagnostic Value of Inflammation-Related Indicators in Distinguishing Early Colon Cancer and Adenomatous Polyps

Cancer Control. 2023 Jan-Dec;30:10732748231180745. doi: 10.1177/10732748231180745.

ABSTRACT

BACKGROUND: There are few clinical symptoms in early colorectal cancer, so it is necessary to find a simple and economical tumor detection index for auxiliary diagnosis. This study aims to explore the diagnostic value of preoperative inflammation-related indicators, such as neutrophil, lymphocyte, platelet count, platelet to lymphocyte ratio (PLA), neutrophil to lymphocyte ratio (NLR), and systemic immune-inflammation index (SII), for early colorectal cancer, and determine whether inflammation-related indicators can provide more accurate diagnostic judgment for patients.

METHODS: This study was a retrospective study. Patients who were first diagnosed with colorectal cancer or colorectal adenomatous polyp at Beijing Friendship Hospital from October 2016 to October 2017 were retrospectively collected. According to inclusion and exclusion criteria, a total of 342 patients were included, including 216 patients with colorectal cancer and 126 patients with colorectal adenomatous polyp. Fasting venous blood and other clinical features were collected to compare the differences between colorectal cancer and colorectal adenoma.

RESULTS: There were statistically significant differences in age, carcinoembryonic antigen, albumin, hemoglobin, mean platelet volume, lymphocyte, monocyte, NLR, PLA, SII, and mean platelet volume to platelet count ratio between colorectal cancer group and colorectal adenoma group (P < .05), and a Nomogram model was established. Using inflammatory markers to differentiate colorectal and colorectal polyps produced greater AUC than using tumor markers alone (.846 vs .695).

CONCLUSION: Inflammation-related indicators, such as lymphocyte, monocyte, and mean platelet volume, may serve as potential indicators to assist in the diagnosis of early colorectal cancer.

PMID:37421141 | DOI:10.1177/10732748231180745

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Nevin Manimala Statistics

Changes in lifestyle-related behaviour during the COVID-19 pandemic in Japan: a questionnaire survey for examinees who underwent an annual health check-up

J Int Med Res. 2023 Jul;51(7):3000605231184036. doi: 10.1177/03000605231184036.

ABSTRACT

OBJECTIVE: To investigate the effect of the coronavirus disease (COVID-19) pandemic on lifestyle behaviour and clinical data in a population who underwent an annual health check-up in Tokyo, Japan.

METHODS: A self-report questionnaire was completed regarding changes in their physical activities, diet, alcohol intake, smoking and mental stress. For those recommended to undergo further examination or treatment, their intention to do so was also questioned. The clinical results of the check-ups across three different periods (before and during the pandemic and survey period) were statistically compared.

RESULTS: During the survey period, 838 examinees responded. While physical activities decreased due to teleworking, changes in food intake and dietary patterns were varied. Furthermore, changes in mental stress were also diverse. As for the intention to undergo further clinical examination or treatment, 23.5% answered that they thought they would wait until the government lifted the state of emergency or the pandemic subsided. Compared with before the pandemic, diastolic blood pressure, liver function, kidney function and bone density tended to deteriorate.

CONCLUSIONS: The COVID-19 pandemic affected the lifestyle of the current study population. To prepare for future outbreaks, real-world information should be collected and shared so that effective measures for health promotion can be developed.

PMID:37421140 | DOI:10.1177/03000605231184036

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Nevin Manimala Statistics

Safety and effectiveness of IV Thrombolysis in retinal artery occlusion: A multicenter retrospective cohort study

Eur Stroke J. 2023 Jul 7:23969873231185895. doi: 10.1177/23969873231185895. Online ahead of print.

ABSTRACT

BACKGROUND: Retinal artery occlusion (RAO) may lead to irreversible blindness. For acute RAO, intravenous thrombolysis (IVT) can be considered as treatment. However, due to the rarity of RAO, data about IVT safety and effectiveness is limited.

METHODS: From the multicenter database ThRombolysis for Ischemic Stroke Patients (TRISP), we retrospectively analyzed visual acuity (VA) at baseline and within 3 months in IVT and non-IVT treated RAO patients. Primary outcome was difference of VA between baseline and follow up (∆VA). Secondary outcomes were rates of visual recovery (defined as improvement of VA ⩾ 0.3 logMAR), and safety (symptomatic intracranial hemorrhage (sICH) according to ECASS II criteria, asymptomatic intracranial hemorrhage (ICH) and major extracranial bleeding). Statistical analysis was performed using parametric tests and a linear regression model adjusted for age, sex and baseline VA.

RESULTS: We screened 200 patients with acute RAO and included 47 IVT and 34 non-IVT patients with complete information about recovery of vision. Visual Acuity at follow up significantly improved compared to baseline in IVT patients (∆VA 0.5 ± 0.8, p < 0.001) and non-IVT patients (∆VA 0.40 ± 1.1, p < 0.05). No significant differences in ∆VA and visual recovery rate were found between groups at follow up. Two asymptomatic ICH (4%) and one (2%) major extracranial bleeding (intraocular bleeding) occurred in the IVT group, while no bleeding events were reported in the non-IVT group.

CONCLUSION: Our study provides real-life data from the largest cohort of IVT treated RAO patients published so far. While there is no evidence for superiority of IVT compared to conservative treatment, bleeding rates were low. A randomized controlled trial and standardized outcome assessments in RAO patients are justified to assess the net benefit of IVT in RAO.

PMID:37421135 | DOI:10.1177/23969873231185895

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Nevin Manimala Statistics

Dimerization of iLID Optogenetic Proteins Observed Using 3D Single-Molecule Tracking in Live E.coli

Biophys J. 2023 Jul 6:S0006-3495(23)00430-7. doi: 10.1016/j.bpj.2023.07.003. Online ahead of print.

ABSTRACT

3D single molecule tracking microscopy has enabled measurements of protein diffusion in living cells, offering information about protein dynamics and cellular environments. For example, different diffusive states can be resolved and assigned to protein complexes of different size and composition. However, substantial statistical power and biological validation, often through genetic deletion of binding partners, are required to support diffusive state assignments. When investigating cellular processes, real-time perturbations to protein spatial distributions is preferable to permanent genetic deletion of an essential protein. For example, optogenetic dimerization systems can be used to manipulate protein spatial distributions which could offer a means to deplete specific diffusive states observed in single-molecule tracking experiments. Here, we evaluate the performance of the iLID optogenetic system in living E. coli cells using diffraction-limited microscopy and 3D single-molecule tracking. We observed a robust optogenetic response in protein spatial distributions after 488 nm laser activation. Surprisingly, 3D single-molecule tracking results indicate activation of the optogenetic response when illuminating with high intensity light with wavelengths at which there is minimal photon absorbance by the LOV2 domain. The pre-activation can be minimized through the use of iLID system mutants, and titration of protein expression levels.

PMID:37421134 | DOI:10.1016/j.bpj.2023.07.003

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Nevin Manimala Statistics

The Triglyceride Glucose (TyG) Index as a Sensible Marker for Identifying Insulin Resistance and Predicting Diabetic Kidney Disease

Med Sci Monit. 2023 Jul 8;29:e939482. doi: 10.12659/MSM.939482.

ABSTRACT

BACKGROUND Patients with insulin-resistant diabetes have the highest risk of kidney disease. The triglyceride glucose (TyG) index is considered a reliable and simple marker of insulin resistance. We studied the relationship between the TyG index, diabetic kidney disease (DKD), and related metabolic disorders in patients with type 2 diabetes. MATERIAL AND METHODS This retrospective study included a consecutive case series from January 2021 to October 2022 in the Department of Endocrinology at Hebei Yiling Hospital. In total, 673 patients with type 2 diabetes met the inclusion criteria. The TyG index was calculated by napierian logarithmic (ln) (fasting triglyceride×fasting glucose /2). Patient demographic and clinical indicators were obtained from medical records, and statistical analysis was conducted using SPSS version 23. RESULTS The TyG index was significantly related to metabolic indicators (low-density lipoprotein, high-density lipoprotein, alanine aminotransferase, plasma albumin, serum uric acid, triglyceride, and fasting glucose) and urine albumin (P<0.01) but not with serum creatinine and estimated glomerular filtration rate. In multiple regression analysis, an increase in the TyG index was revealed to be an independent risk factor for DKD (OR: 1.699, P<0.001). CONCLUSIONS The TyG index was independently related to DKD and related metabolic disorders; therefore, the TyG index can be used as an early sensitive target for clinical guidance in the treatment of DKD with insulin resistance.

PMID:37421131 | DOI:10.12659/MSM.939482

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Nevin Manimala Statistics

Design and Application of Near Infrared LED and Solenoid Magnetic Field Instrument to Inactivate Pathogenic Bacteria

Micromachines (Basel). 2023 Apr 14;14(4):848. doi: 10.3390/mi14040848.

ABSTRACT

PURPOSE: This study aims to evaluate the efficiency of infrared LEDs with a magnetic solenoid field in lowering the quantity of gram-positive Staphylococcus aureus and gram-negative Escherichia coli bacteria, as well as the best exposure period and energy dose for inactivating these bacteria.

METHOD: Research has been performed on a photodynamic therapy technique called photodynamic inactivation (PDI), which combines infrared LED light with a wavelength range of 951-952 nm and a solenoid magnetic field with a strength of 0-6 mT. The two, taken together, can potentially harm the target structure biologically. Infrared LED light and an AC-generated solenoid magnetic field are both applied to bacteria to measure the reduction in viability. Three different treatments infrared LED, solenoid magnetic field, and an amalgam of infrared LED and solenoid magnetic field, were used in this study. A factorial statistical ANOVA analysis was utilized in this investigation.

RESULTS: The maximum bacterial production was produced by irradiating a surface for 60 min at a dosage of 0.593 J/cm2, according to the data. The combined use of infrared LEDs and a magnetic field solenoid resulted in the highest percentage of fatalities for Staphylococcus aureus, which was 94.43 s. The highest percentage of inactivation for Escherichia coli occurred in the combination treatment of infrared LEDs and a magnetic field solenoid, namely, 72.47 ± 5.06%. In contrast, S. aureus occurred in the combined treatment of infrared LEDs and a magnetic field solenoid, 94.43 ± 6.63 percent.

CONCLUSION: Staphylococcus aureus and Escherichia coli germs are inactivated using infrared illumination and the best solenoid magnetic fields. This is evidenced by the rise in the proportion of bacteria that died in treatment group III, which used a magnetic solenoid field and infrared LEDs to deliver a dosage of 0.593 J/cm2 over 60 min. According to the research findings, the magnetic field of the solenoid and the infrared LED field significantly impact the gram-positive bacteria S. aureus and the gram-negative bacteria E. coli.

PMID:37421081 | DOI:10.3390/mi14040848

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Nevin Manimala Statistics

Simulations of the Rotor-Stator-Cavity Flow in Liquid-Floating Rotor Micro Gyroscope

Micromachines (Basel). 2023 Mar 31;14(4):793. doi: 10.3390/mi14040793.

ABSTRACT

When rotating at a high speed in a microscale flow field in confined spaces, rotors are subject to a complex flow due to the joint effect of the centrifugal force, hindering of the stationary cavity and the scale effect. In this paper, a rotor-stator-cavity (RSC) microscale flow field simulation model of liquid-floating rotor micro gyroscopes is built, which can be used to study the flow characteristics of fluids in confined spaces with different Reynolds numbers (Re) and gap-to-diameter ratios. The Reynolds stress model (RSM) is applied to solve the Reynolds averaged Navier-Stokes equation for the distribution laws of the mean flow, turbulence statistics and frictional resistance under different working conditions. The results show that as the Re increases, the rotational boundary layer gradually separates from the stationary boundary layer, and the local Re mainly affects the distribution of velocity at the stationary boundary, while the gap-to-diameter ratio mainly affects the distribution of velocity at the rotational boundary. The Reynolds stress is mainly distributed in boundary layers, and the Reynolds normal stress is slightly greater than the Reynolds shear stress. The turbulence is in the state of plane-strain limit. As the Re increases, the frictional resistance coefficient increases. When Re is within 104, the frictional resistance coefficient increases as the gap-to-diameter ratio decreases, while the frictional resistance coefficient drops to the minimum when the Re exceeds 105 and the gap-to-diameter ratio is 0.027. This study can enable a better understanding of the flow characteristics of microscale RSCs under different working conditions.

PMID:37421027 | DOI:10.3390/mi14040793

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Nevin Manimala Statistics

Single Cell Analysis of Inertial Migration by Circulating Tumor Cells and Clusters

Micromachines (Basel). 2023 Mar 31;14(4):787. doi: 10.3390/mi14040787.

ABSTRACT

Single-cell analysis provides a wealth of information regarding the molecular landscape of the tumor cells responding to extracellular stimulations, which has greatly advanced the research in cancer biology. In this work, we adapt such a concept for the analysis of inertial migration of cells and clusters, which is promising for cancer liquid biopsy, by isolation and detection of circulating tumor cells (CTCs) and CTC clusters. Using high-speed camera tracking live individual tumor cells and cell clusters, the behavior of inertial migration was profiled in unprecedented detail. We found that inertial migration is heterogeneous spatially, depending on the initial cross-sectional location. The lateral migration velocity peaks at about 25% of the channel width away from the sidewalls for both single cells and clusters. More importantly, while the doublets of the cell clusters migrate significantly faster than single cells (~two times faster), cell triplets unexpectedly have similar migration velocities to doublets, which seemingly disagrees with the size-dependent nature of inertial migration. Further analysis indicates that the cluster shape or format (for example, triplets can be in string format or triangle format) plays a significant role in the migration of more complex cell clusters. We found that the migration velocity of a string triplet is statistically comparable to that of a single cell while the triangle triplets can migrate slightly faster than doublets, suggesting that size-based sorting of cells and clusters can be challenging depending on the cluster format. Undoubtedly, these new findings need to be considered in the translation of inertial microfluidic technology for CTC cluster detection.

PMID:37421020 | DOI:10.3390/mi14040787