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Conclusions | T2DM | INSULIN RESISTANCE | FMT with or without metformin significantly improve insulin resistance and body mass index and gut microbial communities of T2DM patients by colonization of donor-derived microbiota. | PMC9872724 |
Introduction | metabolic disease, T2DM, fasting blood glucose, postprandial blood glucose | TYPE 2 DIABETES MELLITUS, METABOLIC DISEASE, SECONDARY, HIGH INSULIN, INSULIN SENSITIVITY | Type 2 diabetes mellitus (T2DM) is a metabolic disease characterized by a decrease in pancreatic β-cell mass and function, and represents a failure to compensate for the high insulin demand of homeostatic model assessment of insulin resistant (HOMA-IR) states (The human intestines harbor a complex community of intestin... | PMC9872724 |
Materials and methods | PMC9872724 | |||
Study population | gastrointestinal diseases, chronic infectious diseases, liver and kidney insufficiency, allergies, diabetic, Diabetes, cardiovascular and cerebrovascular diseases, 6)Leukopenia, T2DM | GASTROINTESTINAL DISEASES, VIRUS, HEART INSUFFICIENCY, ALLERGIES, HEPATITIS C, DIABETES, DISEASES, COMPLICATIONS | We recruited 29 adult T2DM patients, following the diagnostic criteria of the American Diabetes Association (ADA) for T2DM in 2019. We obtained written informed consent from all patients before screening. All patients volunteered to participate in the trial and exhibited good compliance and did not replace diabetic dru... | PMC9872724 |
Research plan and outcomes | T2DM | SECONDARY, INSULIN RESISTANCE | This study used FMT as an auxiliary method to compare the therapeutic effects of solely metformin, solely FMT and FMT combined with metformin onT2DM patients. Eight T2DM patients received FMT plus metformin treatment, 9 patients underwent FMT alone and 12 patients received solely metformin treatment. The primary resear... | PMC9872724 |
Intervention procedures | Screening of study donors was based on previous reports ( | PMC9872724 | ||
Fecal microbiota analysis by metagenomic sequencing | T2DM | Fecal samples from donor and T2DM patients were collected on the day of the medical examination and immediately frozen at −80°C. Fecal genomic DNA was extracted using the QIAamp Fast DNA Stool Mini Kit (Qiagen, CA, USA). DNA samples were stored at −20°C before use as templates for next-generation sequencing library pre... | PMC9872724 | |
Statistical analysis | Microbiota alpha diversity Shannon and Chao1 were calculated using the R program package ‘vegan’ (version 2.5.6). β-diversity metrics were obtained with rda and PERMANOVA with the adonis function. Principal Components analysis (PCA) was performed using the package vegan. Different analysis was performed to identify tax... | PMC9872724 | ||
Results | PMC9872724 | |||
Characteristics of the study population | T2DM | A total of 36 patients with T2DM were assessed for eligibility, of whom 31 were recruited and randomized to either FMT plus metformin, FMT alone, or metformin from July 2019 to Oct 2021. One of participants in both FMT plus metformin and FMT alone group withdraw after FMT infusion. Finally, 29 patients allocated to FMT... | PMC9872724 | |
Blood glucose, insulin resistance, and BMI improvement after intervention | fasting blood glucose, cholesterol;TP, T2DM | INSULIN RESISTANCE, PCP | Participants in the three treatment groups had significant (P<0.05) improvement in fasting blood glucose (FBG); postprandial blood glucose (PBG), hemoglobin A1c (HbA1c), and HOMA-HBCI at week 4 after intervention compared with the baseline (Clinical data included in this study.The data are shown as the mean±SD. N=12 in... | PMC9872724 |
Microbiota alterations associated with FMT intervention | T2DM | Microbial richness (observed taxa and Chao1) and Shannon diversity were obviously (P < 0.05) improved at week 4 after FMT compared with the baseline, although the significance is marginal. Moreover, the evenness was significantly (P<0.05) increased by FMT in FMT alone group at week 4 (Changes in gut microbiota between ... | PMC9872724 | |
β-diversity and microbial colonization | The results of β-diversity based on Euclidean distance showed that the intestinal microbiota changed at week 4 compared with week 0 with the three treatments. The gut microbial communities in FMT plus metformin group were significantly different (PERMANOVA, p < 0.05) between week 4 and week 0, while there was no signif... | PMC9872724 | ||
Taxa significantly associated with clinical improvements | T2D, T2DM | To explore the taxa associated with improvement in clinical efficacy, the differences between baseline and week 4 after intervention in FMT alone and FMT plus metformin groups were analyzed by Wilcoxon-rank sum test. A total of 7 phyla, 57 families, and 133 genera level were significantly (p < 0.05) different after int... | PMC9872724 | |
Discussion | diarrhea, cramps, constipation, hypoglycemia, abdominal distension, T2DM | HYPOGLYCEMIA, INSULIN RESISTANCE, DISEASES, SIDE EFFECTS | This study aimed to evaluate the improvements of T2DM patients and their gut microbiota by FMT alone and FMT plus metformin, compared with metformin. Results showed that FMT alone and FMT plus metformin significantly improved insulin resistance (HOMA-IR), HOMA-HBCI, BMI, FBG, and PBG within 4 weeks after intervention, ... | PMC9872724 |
Conclusion | T2DM | In conclusion, In conclusion, our study showed that FMT improved the BMI, PBG, HbA1c, FBG, HOMA-HBCI, and HOMA-IR of T2DM patients in 4 weeks and also promoted the engraftment of donor-associated microbiota in participants. Results from our trial will serve as a basis for the long-term intervention of FMT in T2DM patie... | PMC9872724 | |
Data availability statement | The datasets presented in this study can be found in online repositories. The names of the repository/repositories and accession number(s) can be found in the article/ | PMC9872724 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Longhu Hospital, The First Affiliated Hospital of Shantou University Medical College Ethics Committee in Shantou, China(Ethics number:LHLL2019001), and was registered at Chinses Clinical Trial Registry. (Registration number: ChiCTR1900024636).( | PMC9872724 | ||
Author contributions | ZW | ZW and BZ, conceptualization, investigation, methodology, and writing-original draft. RX and FC, conceptualization, investigation, methodology, writing-review and editing. DZ and BC, conceptualization, investigation, writing-review and editing. AL and CZ, conceptualization, supervision, writing-review and editing. DH, ... | PMC9872724 | |
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9872724 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC9872724 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Basic information and clinical data of participants.Click here for additional data file. | PMC9872724 | ||
References | PMC9872724 | |||
Purpose | mTNBC | TRIPLE-NEGATIVE BREAST CANCER | In a phase II trial in patients with metastatic triple-negative breast cancer (mTNBC; NCT02978716), administering trilaciclib prior to gemcitabine plus carboplatin (GCb) enhanced T-cell activation and improved overall survival versus GCb alone. The survival benefit was more pronounced in patients with higher immune-rel... | PMC10361859 |
Methods | TNBC, mTNBC, Tumor, tumor | TUMOR, INFLAMMATION, TUMOR | Patients with mTNBC and ≤ 2 prior chemotherapy regimens for locally recurrent TNBC or mTNBC were randomized 1:1:1 to GCb on days 1 and 8, trilaciclib prior to GCb on days 1 and 8, or trilaciclib alone on days 1 and 8, and prior to GCb on days 2 and 9. Gene expression, immune cell populations, and Tumor Inflammation Sig... | PMC10361859 |
Results | After two cycles, the trilaciclib plus GCb group ( | PMC10361859 | ||
Conclusion | TNBC | The results suggest that administering trilaciclib prior to GCb may modulate the composition and response of immune cell subsets to TNBC.
| PMC10361859 | |
Keywords | PMC10361859 | |||
Introduction | tumor, breast cancer, TNBC, mTNBC, chemotherapy-induced damage | TRIPLE-NEGATIVE BREAST CANCER, TUMOR, INVASIVE BREAST CANCER, BREAST CANCER | Triple-negative breast cancer (TNBC) is a specific subtype of breast cancer that is associated with high invasiveness, high metastatic potential, proneness to relapse, and poor prognosis. Patients with TNBC have fewer treatment options available to them than those with other types of invasive breast cancer [Trilaciclib... | PMC10361859 |
Materials and methods | PMC10361859 | |||
Study design and participants | TNBC, mTNBC, NCT02978716 | This analysis is based on data from a multicenter, randomized, open-label, phase II trial including patients aged ≥ 18 years with mTNBC who had received up to two prior chemotherapy regimens for locally recurrent TNBC or mTNBC (NCT02978716) [ | PMC10361859 | |
Antitumor efficacy endpoints and assessments | tumor, tumors, TNBC tumors | DISEASE PROGRESSION, TUMOR, MAY, SECONDARY, TUMORS | Efficacy and survival outcomes were analyzed as prespecified secondary endpoints and included objective response rate (confirmed complete or partial response) assessed in response-evaluable patients, and progression-free survival and OS, assessed in the intention-to-treat population. Objective response rate and progres... | PMC10361859 |
Peripheral immune cell population and function analysis | BLOOD | Peripheral blood was collected prior to and during treatment for flow cytometric analysis; for the purposes of this analysis, samples were collected prior to treatment on the first day of the first and third treatment cycles (C1D1 and C3D1, respectively). Blood was collected in Cyto-Chex | PMC10361859 | |
Tumor gene expression analysis | tumor | TUMOR | Genomic DNA and total RNA were simultaneously purified and sequenced as previously described from formalin-fixed, paraffin-embedded (FFPE) diagnostic tumor samples collected at baseline [ | PMC10361859 |
Tumor immune microenvironment analysis | Tumor | INFLAMMATION, TUMOR | The Tumor Inflammation Signature (TIS) [ | PMC10361859 |
Statistical methods | Statistical comparisons of cell numbers/ratios and TIS scores for different time points and patient groups were performed using the Wilcoxon signed-rank test. Plots were created using the ggplot2 and EnhancedVolcano R packages [ | PMC10361859 | ||
Results | PMC10361859 | |||
Participants and treatment | As of July 17, 2020, median (range) duration of follow-up was 8.4 (0.1–25.7) months for the 34 patients who received GCb alone, 14.0 (1.3–33.6) months for the 33 patients who received trilaciclib prior to GCb on days 1 and 8, and 15.3 (3.5–33.7) months for the 35 patients who received trilaciclib alone on days 1 and 8 ... | PMC10361859 | ||
Analysis of immune subsets and T-cell function at C1D1 versus C3D1 in patients receiving trilaciclib prior to GCb or GCb alone | Patients who received trilaciclib prior to GCb had fewer total T cells (Changes to | PMC10361859 | ||
Immune cell populations and T-cell function analysis among trilaciclib responders versus non-responders | To determine if the impact on T-cell effector function was attributable to clinical outcomes, data from responders and non‑responders who were treated with trilaciclib were compared. After two cycles, T-cell numbers were maintained in trilaciclib responders but significantly reduced in non‑responders (Changes to immune... | PMC10361859 | ||
Discussion | tumor, neutropenia, T-cell infiltration, mTNBC, chemotherapy-induced damage | TUMOR, NEUTROPENIA, BREAST CANCER, SECONDARY, ARREST | Data from this exploratory analysis provide further evidence of a trilaciclib-mediated antitumor immune response among patients with mTNBC [These findings support prior research indicating that, following transient G1 arrest, the proportion of immunosuppressive cells in the tumor microenvironment is decreased and effec... | PMC10361859 |
Acknowledgements | We acknowledge Aaron Stevens and Jessica Sorrentino, former employees of G1 Therapeutics, Inc., for their contributions toward this analysis and interpretation of data. We also thank all the patients, their families, and study personnel for participating in the study. | PMC10361859 | ||
Author contributions | ART and JOS contributed to the design and implementation of the clinical research and to the acquisition of data. SC, SA, and JSY conceived and designed the analysis. All authors were responsible for the analysis and interpretation of results; provided critical feedback and helped shape the research, analysis, and deve... | PMC10361859 | ||
Funding | This work was supported by G1 Therapeutics, Inc. The study sponsor was involved in the study design, in the collection, analysis, and interpretation of the data, in the writing of the report, and in the decision to submit the paper for publication. Medical writing assistance was provided by Alligent Europe (Envision Ph... | PMC10361859 | ||
Data availability | All data generated or analyzed during this study are included in this published article. | PMC10361859 | ||
Declarations | PMC10361859 | |||
Conflict of interest | Sarah Ahn | ONCOLOGY | Antoinette R. Tan reports institutional clinical trial support and personal fees from G1 Therapeutics, Inc.; outside of the submitted work, institutional clinical trial support from Arvinas, Genentech/Roche, Merck, and Pfizer, and personal fees from AstraZeneca, Genentech/Roche, Jazz Pharmaceuticals, Novartis, Puma, Se... | PMC10361859 |
Ethical approval | The study (NCT02978716) was designed and conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Council for Harmonisation. The protocol and all study-related materials were approved by the institutional review board or independent ethics committee of each... | PMC10361859 | ||
Consent to participate | Written informed consent was obtained from all individual participants included in the study. | PMC10361859 | ||
Consent to publish | Not applicable. | PMC10361859 | ||
References | PMC10361859 | |||
Subject terms | Our randomized controlled simulation study aimed to compare the CPR quality, time-related factors, attitude and self-assessment of non-healthcare university students (aged 18–25) compared video-assisted (V-CPR, n = 50) with telephone-assisted (T-CPR, n = 49) and unassisted (U-CPR, n = 48) CPR in a simulation setting. R... | PMC10495456 | ||
Introduction | death, Sudden cardiac arrest, OHCA, cardiac arrest, T-CPRThe, chest compression | CARDIAC ARREST | Sudden cardiac arrest is a major public health problem worldwide and it is one of the leading causes of death in industrialized countriesIn the majority of the cases, the bystanders who call the ambulance are laypeople, for whom the identification of OHCA is difficult without experience. Therefore, EMS dispatchers play... | PMC10495456 |
Methods | PMC10495456 | |||
Study design | A randomized controlled, superiority, simulation trial was performed. The Consolidated Standards of Reporting Trials (CONSORT) reporting guideline was followedOur study was registered at ClinicalTrials.gov (registration number: NCT05639868; date of first registration: 06/12/2022). | PMC10495456 | ||
Participants | University students from non-healthcare areas were recruited in our study from the Eötvös Lóránd University, Savaria University Centre, Szombathely, Hungary. The study was conducted between December 2022 and January 2023. Eligible for inclusion were university students. A written form was sent via email and students we... | PMC10495456 | ||
Randomization and blinding | Participants were randomly assigned into three different groups before the assessment: U-CPR; T-CPR; and V-CPR. During randomization, the permuted block technique was used with a 1:1:1 ratio. After randomization, study participants were informed about their allocated group, but were blinded to the purpose of the study.... | PMC10495456 | ||
Intervention | SE | Participants were accompanied into a room by a study operator who was equipped with a smartphone (iPhone 2013, Apple Inc., USA). Based on a prior study, video quality had no significant impact on the evaluation of CPR performanceDuring the scenario, the participants should perform the initial examinations (check the sa... | PMC10495456 | |
Data collection | cardiac arrest | CARDIAC ARREST | The quality of chest compressions (depth and rate) were measured by the AMBU CPR software and were analyzed retrospectively based on the recorded reports. For calculating proportions of correct chest compression parameters, software recorded data were dichotomized to „correct” (within the intervals described in the gui... | PMC10495456 |
Outcomes | SECONDARY | The primary outcome of the study was the quality of chest compressions, measured by the mean depth. The evaluation of data was based on the current ERC guidelines (depth of 50–60 mm)The secondary outcome of the study was chest compression quality expressed by rate (minFurthermore, the participant-centered secondary out... | PMC10495456 | |
Sample size calculation | Sample size was calculated to detect a 5 mm difference in chest compression depth between the groups based on prior studies | PMC10495456 | ||
Statistics | To describe the sample, descriptive statistics were used. Study parameters were assessed for normal distribution and reported as numbers (percentages) and means (SDs). Study parameters were assessed for normality by using Shapiro–Wilk test which indicated normal distribution. Continuous variables were compared using AN... | PMC10495456 | ||
Results | PMC10495456 | |||
Participants flow, recruitment, and baseline characteristics | SD | In total, 207 emails were sent to the university students (this was the total number of the students on the campus). One hundred and fifty of them responded that they would like to participate our study, so 150 participants were assessed for eligibility. None of the participants were excluded before the randomization. ... | PMC10495456 | |
Discussion | OHCA, cardiac arrest | CARDIAC ARREST | In this randomized controlled simulation study, we measured chest compression effectiveness (rate, depth and hand position) and time-related factors (time of check the breathing, time to call the ambulance, and time to the first chest compression) in a cardiac arrest scenario comparing V-CPR, T-CPR and U-CPR groups. In... | PMC10495456 |
Conclusion | We could not show any difference in chest compression depth comparing V-CPR with T-CPR and U-CPR groups in a simulation setting. However, V-CPR was superior to T-CPR and U-CPR in chest compression rate and correct hand position. | PMC10495456 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-42131-z. | PMC10495456 | ||
Acknowledgements | The authors would like to thank all the students who participated in the study. | PMC10495456 | ||
Author contributions | V.S., H.B. and B.B. participated in designing the study. H.B. obtained funding for the study. V.S. and H.B. were responsible for the data collection. V.S., D.N., H.B. and B.H. interpreted the data and performed statistical analyses. V.S., J.B., B.B. and H.B. participated in writing the manuscript. All authors reviewed ... | PMC10495456 | ||
Funding | Open access funding provided by University of Pécs. This study was supported by the ÚNKP-22-4-I New National Excellence Program of the Ministry for Culture and Innovation from the source of the National Research, Development and Innovation Fund. The funding agency had no role in the design of the study and collection, ... | PMC10495456 | ||
Data availability | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10495456 | ||
Competing interests | The authors declare no competing interests. | PMC10495456 | ||
References | PMC10495456 | |||
Background | High prevalence of excessive screen time among preschool children is attributable to certain parental factors such as lack of knowledge, false perception about screen time, and inadequate skills. Lack of strategies to implement screen time guidelines, in addition to multiple commitments that may hinder parents from fac... | PMC10196888 | ||
Objective | This study aims to develop, implement, and evaluate the effectiveness of | PMC10196888 | ||
Methods | SECONDARY | A single-blind, 2-arm cluster randomized controlled trial was conducted among 360 mother-child dyads attending government preschools in the Petaling district, who were randomly allocated into the intervention and waitlist control groups between March 2021 and December 2021. This 4-week intervention, developed using whi... | PMC10196888 | |
Results | A total of 352 dyads completed the study, giving an attrition rate of 2.2% (8/360). At 3 months after the intervention, the intervention group showed significantly reduced child’s screen time compared with the control group (β=−202.29, 95% CI −224.48 to −180.10; | PMC10196888 | ||
Conclusions | The | PMC10196888 | ||
Trial Registration | Thai Clinical Trial Registry (TCTR) TCTR20201010002; https://tinyurl.com/5frpma4b | PMC10196888 | ||
Introduction | PMC10196888 | |||
Background | Screen time is defined as the time occupied by screen-based activities on visual devices such as television, smartphones, computers, video games, tablets and iPads, and other handheld gadgets [Despite some reported advantages of screen time when digital devices are used in moderation under parental guidance, excessive ... | PMC10196888 | ||
Previous Studies | During the early childhood period of preschool years, parents play the most fundamental role in shaping a child’s habits [ | PMC10196888 | ||
Objectives | This study aimed to develop, implement, and evaluate the effectiveness of a parental digital health education intervention named | PMC10196888 | ||
Methods | PMC10196888 | |||
Study Design | RECRUITMENT | This study used a 2-arm, parallel, cluster randomized controlled trial (RCT) design based on the CONSORT (Consolidated Standards of Reporting Trials) guideline’s extension for clustered RCTs. The clusters in this RCT were government preschools under the Community Development Department that provided education to childr... | PMC10196888 | |
Study Setting and Recruitment | physical disabilities | RECRUITMENT, RECRUITMENT | Selangor is the most populated state in Malaysia, with the highest number of children (1.8 million children) [A total of 16 government preschools in the Petaling district were randomly selected. The operators of the preschools were then approached to participate in the study via phone calls and meetings. Recruitment of... | PMC10196888 |
Sample Size Calculation | The sample size was calculated based on the primary outcome of detecting the mean screen time differences between the intervention group and control group. To detect a reduction of 43.2 (SD 105) minutes of screen time per day [ | PMC10196888 | ||
Randomization and Blinding | Random sequence generation was conducted by a research assistant at the cluster level to avoid contamination. All eligible preschools were randomly allocated into the | PMC10196888 | ||
Intervention | As screen time was widely known to displace the time spent on physical activities, the term Following the COVID-19 pandemic, many health care professionals have strived to identify alternative evidence-based measures to deliver effective health education interventions at a time when face-to-face interactions were impos... | PMC10196888 | ||
Outcome | PMC10196888 | |||
Primary Outcome Measure | The primary outcome of this study was the average screen time per day of the child, obtained using the SCREENS questionnaire [The use of four types of devices at home was considered as screen time: (1) television (including DVD, video games, PlayStation, and Xbox), (2) computers (desktop, laptop, and Chromebook), (3) t... | PMC10196888 | ||
Secondary Outcome Measures | PMC10196888 | |||
Mother’s Knowledge | The items to measure parental knowledge were adapted from a previous study [ | PMC10196888 | ||
Mother’s Perception About the Influence of Screen Time on a Child’s Well-being | The total score for this outcome was calculated by averaging the responses to 11 items adapted from a previous study [ | PMC10196888 | ||
Mother’s Self-efficacy | Mother’s self-efficacy to reduce screen time was assessed using 9 items, 3 being adapted from the parenting self-efficacy scale used in the Infant Feeding Activity and Nutrition Trial [In addition, mothers’ self-efficacy to increase their child’s physical activity was measured using 8 items adapted from a previous stud... | PMC10196888 | ||
Mother’s Screen Time | Mothers’ weekday and weekend leisure screen time (excluding time spent on screen for work, school, or education purposes) was recorded in a way that is similar to recording the child’s screen time. | PMC10196888 | ||
Physical Household Environment | Parents were also required to report if digital devices were present in the child’s bedroom (“yes”=1 point and “no”=0 point) [ | PMC10196888 | ||
Data Collection | Data collection was performed between March 2021 and December 2021. Web links to self-administered questionnaires on Google Forms were disseminated through WhatsApp at 3 time points, namely, baseline, immediate after the intervention, and 3 months after the intervention. | PMC10196888 | ||
Data Analysis | Statistical analysis was conducted using SPSS software (version 27.0; IBM Corp). Normality was assessed using skewness and kurtosis. Mean and SD were calculated for continuous data, whereas frequency and percentage were computed for categorical data. The generalized linear mixed model (GLMM) was used to evaluate the ef... | PMC10196888 | ||
Ethics Approval | This study was approved by the Ethics Committee for Research Involving Human Subjects at University Putra Malaysia (JKEUPM-2020-284). Web-based consent was obtained from both representatives of the clusters (preschools) and individual participating mothers before randomization. All participants were free to withdraw fr... | PMC10196888 |
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