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Participants and recruitment | RECRUITMENT, UPPER GASTROINTESTINAL BLEEDING | Participants who fulfil the following criteria are eligible:Inclusion criteriaAged ≥ 18 yearsAim to undergo screening, surveillance, and diagnosisUndergo sedated EGDAble to read, understand, and sign informed consentExclusion criteriaEGD contraindicationsNot suitable for sedated endoscopy after anaesthesia evaluationBi... | PMC10176798 | |
Interventions | PMC10176798 | |||
Procedures | nodularity, depression, upper gastrointestinal tract landmarks, upper gastrointestinal lesion | GASTRIC NEOPLASM, BLIND | The ENDOANGEL-GC is an AI system designed for assisting in EGD and possesses three functions in real time: (1) to time the entire procedure (from the endoscope intubating into the mouth to it being drawn out), (2) to record observed upper gastrointestinal tract landmarks and blind spots, and (3) to mark the upper gastr... | PMC10176798 |
Adherence and protocol deviations | PATHOLOGY, GASTRIC RETENTION, OESOPHAGEAL OBSTRUCTION | To enhance the validity of the data, face-to-face adherence reminder sessions and a pilot study will be conducted before enrolment at each study site. Additionally, a key method will be followed for assessing adherence. All raw videos of the examinations, with and without the ENDOANGEL-GC dashboard, will be recorded, s... | PMC10176798 | |
Recruited cases | PMC10176798 | |||
Consent | Patients eligible to participate in this study will be provided with further discussions and informed consent. Discussions may be completed by a local study coordinator or a staff member. Written informed consent will be obtained from all participants who agree and wish to take part in the study. | PMC10176798 | ||
Eligibility and baseline assessment | Once written informed consent is obtained, an eligibility assessment will be performed by the local study coordinator or staff, according to the inclusion/exclusion criteria. For each eligible participant, the following baseline characteristics will be collected: gender; age; weight; height; indications; education; nat... | PMC10176798 | ||
Recruited case management | All recruited participants will be assigned identifications (IDs) comprising eight codes in the EDC system. The first four codes represent different hospitals, whereas the last four codes represent the recruiting sequences. This ID will not be used repeatedly. | PMC10176798 | ||
Specimen management and pathological traceability | gastric cancers, neoplasia, gastric cancer, carcinoma, inflammation, atrophy, diganosis | GASTRIC CANCERS, NEOPLASIA, INFLAMMATION, CARCINOMA, INTESTINAL METAPLASIA, ATROPHY, PATHOLOGY, GASTRIC CANCER | After tissue sampling, the specimens that arrive in the pathology department will be dehydrated, embedded, sliced, and stained. Pathological results will be obtained from local study centres by expert pathologists at each centre. Regarding patients diagnosed with gastric cancers by biopsy and those highly suspected wit... | PMC10176798 |
Randomisation | Local study coordinators or staff accomplished randomisation using an EDC system. Participants were randomised into either the experimental or control group at a 1:1 ratio before the examinations. The randomisation results, time points, and case IDs will be stored online in the EDC system.Participants will be randomise... | PMC10176798 | ||
Blinding | ADVERSE EVENT | Patients, pathologists, and data analysts will be blinded to the randomisation. Masking of study group allocations will not attempted by the endoscopists. Randomisation results will be concealed in information brochures or other documents for the participants.The interventions in this study will not add additional risk... | PMC10176798 | |
Outcomes | premalignant gastric lesions, neoplasms, neoplasia, gastric neoplasm, gastric cancer | BLIND, NEOPLASMS, NEOPLASIA, GASTRIC NEOPLASM, GASTRIC NEOPLASMS, BLIND, GASTRIC CANCER | The primary outcome measures are detection rate of gastric neoplasms and EGC detection rate. The gastric neoplasm detection rate is defined as the ratio of patients with neoplasms to the recruited population. The EGC detection rate is defined as the ratio of patients with EGC to all patients with gastric cancer. EGC in... | PMC10176798 |
Study withdrawal | haemorrhage, allergy | HAEMORRHAGE, ALLERGY, GASTRIC RETENTION | Eligible participants will be included in this study after providing informed consent and undergoing randomisation. The participants can withdraw at any time during the study. Data collected prior to withdrawal can be used in this study if informed consent is obtained. Participants should be withdrawn in the following ... | PMC10176798 |
Safety evaluation | ADVERSE EVENT, ADVERSE EVENT | Adverse events are evaluated according to the Common Terminology Criteria for Adverse Events [ | PMC10176798 | |
Data analysis | PMC10176798 | |||
Sample size calculation | GASTRIC NEOPLASMS | The sample size is calculated on the basis of the primary outcomes.The detection rate of gastric neoplasms and EGC detection rate without AI assistance were determined by literature research. Zhang et al. reported an EGC detection rate of 20.0 to 20.9% [According to our previous study, the detection rate of gastric neo... | PMC10176798 | |
Data collection | Data will be collected in a standard case-report form through the EDC system and anonymised for further analysis. Data include baseline information, endoscopic reports, and pathological results. Data will be de-identified before being entered into the database. Regular quality monitoring and database checking will be p... | PMC10176798 | ||
Data analysis plan | GASTRIC NEOPLASMS | The analysis will use intention-to-treat (ITT) and PP approaches. The ITT population will include all patients who are randomised, whereas the PP population will include patients who undergo EGD in accordance with the assigned intervention. The null hypothesis is that the detection rates of gastric neoplasms and EGC in... | PMC10176798 | |
Dissemination of results | The data in this study are the properties of the chief investigator and the other co-investigators. This publication is the responsibility of the chief investigator. All co-investigators will have access to anonymised trial data for further analysis and publication of peer-reviewed journal articles. | PMC10176798 | ||
Study monitoring | Research assistants of chief investigating centre are responsible for regular study monitoring. | PMC10176798 | ||
Discussion | GASTRIC NEOPLASMS | This study will explore the effectiveness of the AI system ENDOANGEL-GC in improving the detection rate of gastric neoplasms and EGC detection rate. We plan to enrol 30,000 participants from > 20 large-scale primary digestive centres in China. Enrolment began in December 2021. At the time of manuscript preparation, mor... | PMC10176798 | |
Trial status | RECRUITMENT | The enrolment of this study is ongoing at the time of manuscript submission, adhering to the protocol with version 3.0 (July 5, 2021). Recruitment began on December 21, 2021, and is estimated to be completed on December 20, 2024. | PMC10176798 | |
Roles and responsibilities | The principal investigator and research physician have contributed the following: designing and conducting of the trial, preparation of the protocol and revisions, and publication of study reports.There were no trial steering committee or data monitoring committee in this trial. | PMC10176798 | ||
Acknowledgements | Not applicable. | PMC10176798 | ||
Authors’ contributions | HGY is the chief investigator; he conceived the study and led the proposal and protocol development. ZHD and LLW contributed to the study design and to the development of the proposal. YJZ, HLD, JXW, XQZ, XT, TY, JMW, MD, and JL contributed to the data collection and system construction. All authors read and approved t... | PMC10176798 | ||
Funding | 1. College-enterprise Deepening Reform Project of Wuhan University (to Honggang Yu) (Here the name of the funding was misrefered, we have corrected it to the correct name, which still refers to the same project.2. Artificial Intelligence Application Demonstration Scenario Project Wuhan (grant no.2022YYCJ01) (to Honggan... | PMC10176798 | ||
Availability of data and materials | All principal investigators will be given access to the cleaned datasets. All datasets will be password protected. Project principal investigators will have direct access to their own site’s datasets and will have access to other sites data by request. The data in this study are available from the corresponding author ... | PMC10176798 | ||
Declarations | PMC10176798 | |||
Ethics approval and consent to participate | Ethics approval has been sought from the Ethical Review Board of Renmin Hospital of Wuhan University (2019K-K068) and all participating centres. Written informed consent to participate will be obtained from all participants. | PMC10176798 | ||
Consent for publication | Not applicable. | PMC10176798 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10176798 | ||
References | PMC10176798 | |||
Introduction | There is growing evidence of a mental health crisis in graduate student populations [One of the contributing factors is the level of stress graduate students experience and the lack of coping skills, resulting in adverse emotional, academic and health outcomes [The impact of stress on the mental health is compounded by... | PMC10032494 | ||
Background | anxiety, eating disorders, psychosomatic, psychosis, psychiatric, depression | DISORDERS | “Mindfulness” refers to a process of relating to the present-moment experience in an open, non-judgmental, curious, and accepting manner [There is an accumulating body of scientific evidence that mindfulness training can provide numerous benefits associated with mental health and general well-being. In clinical populat... | PMC10032494 |
Methods | PMC10032494 | |||
Participants | bipolar disorders, schizophrenia, psychotic disorders | Our investigation comprises two distinct phases of studies: Phase 1 was conducted over the course of one academic year at a single large public university (University of Wisconsin-Madison, denoted as University A) with one intervention group and one wait-list control group. Phase 2 was conducted over the course of mult... | PMC10032494 | |
Timing of recruitment, training, and surveys for intervention and control groups. | RECRUITMENT, RECRUITMENT | After recruiting participants and assigning them to either the Intervention Group or Control Group, all participants completed the Pre-Test Survey. After training of the Intervention Group all participants completed the Post-test Survey. The Summative Survey was completed by all participants after the Control Group com... | PMC10032494 | |
Training | cognitive skills | SESSION | The “Cultivating Transformative Research Through Mindfulness” (or An introduction to and exploration of the six dimensions of emotional style–An overview of the neuroplasticity of the brain and how the brain can be trained to change responses to emotions;Training in mindfulness meditation and other contemplative practi... | PMC10032494 |
Measures | Pre-test, post-test, and summative surveys were administered following standard practices of the University of Wisconsin-Madison and with approval of the IRB of the University of Virginia. Participants completed all the measures on the online survey platform Qualtrics. We employed a variety of well-being-related measur... | PMC10032494 | ||
Emotional Style Questionnaire (ESQ) | We used the 48-item ESQ to investigate the changes in participants’ emotional lives as a result of the training. This was a revised version of the questionnaire found in | PMC10032494 | ||
Ten Item Personality Inventory (TIPI) | To capture participants’ personality, we used the TIPI, which has been validated as a brief measure of Big Five personality [ | PMC10032494 | ||
Positive and Negative Affect Schedule (PANAS) | Participants indicated to what extent they have been experiencing certain negative and positive emotions “during the past two weeks including today.” The scale consisted of 10 positive (e.g., attentive, enthusiastic) and 10 negative emotion words (e.g., upset, guilty). Responses could range from 1 ( | PMC10032494 | ||
Cohen-Hoberman Inventory of Physical Symptoms (CHIPS) | cough, nosebleed, acne, pain | NOSEBLEED, COLD, ACNE | CHIPS is a list of 39 common physical symptoms (e.g., back pain, cold or cough, acne, nosebleed) [ | PMC10032494 |
Mindful Attention and Awareness Scale (MAAS) | On a scale ranging from 1 ( | PMC10032494 | ||
Five Facet Mindfulness Questionnaire—Short Form (FFMQ-SF) | We employed the 24-item short version of the FFMQ to assess different aspects of mindfulness [ | PMC10032494 | ||
Research Satisfaction Scale | We developed eight face-valid items to measure participants’ satisfaction with their research and their ability to make progress in their research. These items tapped into participant perceptions of making progress (e.g., “I am satisfied with how my research is progressing”), ability to do creative research (e.g., “I f... | PMC10032494 | ||
Contributive desire scale | ’ desire | We developed five statements to evaluate participants’ desire to contribute to the well-being of other people and the betterment of society, particularly through conducting impactful research. Scale items included “I am motivated to use my knowledge and skills to make a difference in people’s lives” and “I feel a respo... | PMC10032494 | |
Summative and Final Summative Surveys | The summative survey included open-ended questions regarding the impact and value of the training related to participants’ professional work and personal life. Questions included “In what ways has the training impacted your research and other professional work?”, “In what ways has the training impacted your personal li... | PMC10032494 | ||
Results | PMC10032494 | |||
Phase 1: Quantitative measures | The data described below comes from participants who completed at least 75% of the training. Some attrition occurred prior to the start of and over the course of the study, and not all participants completed the eight-week training. Participants who did not attend the training or had poor attendance chose not to comple... | PMC10032494 | ||
Phase 1 significant effects. | Graphical representations of significant effects observed between pre- and post-test means in four measures for intervention and control groups. The vertical bars represent standard error of the mean. | PMC10032494 | ||
Phase 1 pre- and post-test Means ( | POSITIVE | ESQ = Emotional Style Questionnaire. TIPI = Ten Item Personality Inventory. PANAS = Positive and Negative Affect Schedule. CHIPS = Cohen-Hoberman Inventory of Physical Symptoms. MAAS = Mindful Attention and Awareness Scale. FFMQ-SF = Five Facet Mindfulness Questionnaire-Short Form. For each of the measures, the sample ... | PMC10032494 | |
Phase 1: Qualitative measures | anger, anxiety | The qualitative summative survey was conducted approximately five months after the intervention group and one month after the control group had completed the training. The assessment was completed by 35 participants. It posed several open-ended questions, including “In what ways has the training impacted your research ... | PMC10032494 | |
Phase 2: Quantitative measures | In Year 1 of Phase 2, a combined total of 90 participants completed both the pre- and post-test surveys and 89 passed built-in attention checks. The summative survey, conducted after the training had concluded for both the intervention and control groups, was completed by a combined total of 60 participants, and 44 wen... | PMC10032494 | ||
Phase 2 significant effects. | Graphical representations of eight significant effects observed between pre- and post-test means for intervention and control groups. The vertical bars represent standard error of the mean. Phase 2 Year 1 and Year 2 are combined. | PMC10032494 | ||
Phase 2 pre- and post-test Means ( | Neuroticism | POSITIVE | ESQ = Emotional Style Questionnaire. TIPI = Ten Item Personality Inventory. PANAS = Positive and Negative Affect Schedule. CHIPS = Cohen-Hoberman Inventory of Physical Symptoms. MAAS = Mindful Attention and Awareness Scale. FFMQ-SF = Five Facet Mindfulness Questionnaire-Short Form For each of the measures, the sample s... | PMC10032494 |
Phase 2: Qualitative measures | The qualitative summative survey was conducted approximately 5 months after the intervention group and 1 month after the control group had completed the training in Year 1 of Phase 2. The Summative Survey for Year 2 cohorts was impacted by the pandemic in two ways: the control group received a hybrid training experienc... | PMC10032494 | ||
Discussion | anxiety | POSITIVE, REGRESSION | The purpose of this research was to explore the impact of a mindfulness training on engineering graduate students, with a particular focus on how this training affected their well-being and capacity for research. During the course of the two studies comprising three years, where each group engaged in training for eight... | PMC10032494 |
Conclusion | anxiety | The eight-week mindfulness-based training program provided to engineering graduate student participants was well-received and produced measurable positive impacts on emotional well-being. The improvements in emotional health were highly meaningful for a graduate student sample, where high levels of stress and anxiety a... | PMC10032494 | |
Supporting information | PMC10032494 | |||
Supplementary methods. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Phase 1 supplementary results. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Additional supplementary results. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Additional summative survey findings. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Phase 2 supplementary results. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Supplementary references. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Outline of the training curriculum developed by Healthy Minds Innovations. | BRAIN | Page numbers refer to the relevant sections of The Emotional Life of Your Brain for each week of training (Davidson and Begley 2012).(DOCX)Click here for additional data file. | PMC10032494 | |
Intercorrelations between measures at pre-test for Phase 1. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Intercorrelations between measures at post-test for Phase 1. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Summative survey results and representative responses for Phase 1 (n = 35). | (DOCX)Click here for additional data file. | PMC10032494 | ||
Summary of participant and completion statistics for Phase 2—Year 1. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Summary of participant and completion statistics for Phase 2—Year 2. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Phase 2 Year 1 pre- and post-test Means (M), Standard Deviations (SD), between group effect sizes (d), and RMANOVA results (F-value, p-value) for intervention and control groups. | POSITIVE | ESQ = Emotional Style Questionnaire. TIPI = Ten Item Personality Inventory. PANAS = Positive and Negative Affect Schedule. CHIPS = Cohen-Hoberman Inventory of Physical Symptoms. MAAS = Mindful Attention and Awareness Scale. FFMQ-SF = Five Facet Mindfulness Questionnaire-Short Form. AUT = Alternate Uses Task. For each o... | PMC10032494 | |
Phase 2 Year 2 pre- and post-test Means (M), Standard Deviations (SD), between group effect sizes (d), and RMANOVA results (F-value, p-value) for intervention and control groups. | POSITIVE | ESQ = Emotional Style Questionnaire. TIPI = Ten Item Personality Inventory. PANAS = Positive and Negative Affect Schedule. CHIPS = Cohen-Hoberman Inventory of Physical Symptoms. MAAS = Mindful Attention and Awareness Scale. FFMQ-SF = Five Facet Mindfulness Questionnaire-Short Form. AUT = Alternate Uses Task. For each o... | PMC10032494 | |
Intercorrelations between measures at pre-test for Phase 2. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Intercorrelations between measures at post-test for Phase 2. | (DOCX)Click here for additional data file. | PMC10032494 | ||
Summative survey results and representative responses for Phase 2 Year 1 (n = 49). | (DOCX)Click here for additional data file. | PMC10032494 | ||
Summative survey results and representative responses for Phase 2 Year 2 (n = 43). | (DOCX)Click here for additional data file. | PMC10032494 | ||
Summative survey results and representative responses for phase 2 Year 1 final summative (n = 44). | (DOCX)Click here for additional data file. | PMC10032494 | ||
Impact on research. | POSITIVE | Summative Data Comparison Across Years for Positive, Negative and Neutral Responses to “In what ways has the training impacted your research and other professional work?”.(DOCX)Click here for additional data file. | PMC10032494 | |
Impact on personal life. | POSITIVE | Summative Data Comparison Across Years for Positive, Negative and Neutral Responses to “In what ways has the training impacted your personal life?”.(DOCX)Click here for additional data file. | PMC10032494 | |
Recommend training to others. | Summative Data Comparison across Years for Yes, Maybe, and No Responses to “Would you recommend this training to other engineering graduate students?”.(DOCX)Click here for additional data file.We would like to recognize and thank the following colleagues at the University of Virginia (UVA) for partnering with us to imp... | PMC10032494 | ||
References | PMC10032494 | |||
ABSTRACT | METABOLIC DISEASES, MICROBIAL COLONIZATION | The authors declare no conflict of interest.Children delivered by elective, prelabor Cesarean section (C-section) are not exposed to the birth canal microbiota and, in relation to vaginally delivered children, show altered microbiota development. Perturbed microbial colonization during critical early-life windows of de... | PMC10294643 | |
KEYWORDS | PMC10294643 | |||
INTRODUCTION | UTERUS | The microbes that first colonize a neonate at birth play a key role in metabolic programming and immune system development (Cesarean section (C-section)—31.8% of all births in the United States in 2020 (Neonates delivered by C-section bypass the vaginal canal and therefore miss out on the exposure to the first live mic... | PMC10294643 | |
RESULTS | PMC10294643 | |||
Subjects. | Twenty mother-child dyads were randomized to either vaginal seeding (Baseline characteristics of randomized infants and mothers. Download Vaginal seeding was performed immediately after delivery and before skin-to-skin contact with their mother, following the procedure performed in our previous observational studies of... | PMC10294643 | ||
The maternal microbiota. | As expected, there were no differences in the maternal vaginal microbiota (prior to randomization) in terms of bacterial DNA load (measured by quantitative PCR [qPCR]) or alpha diversity, when comparing mothers from the vaginal-seeding versus control groups (Differences in bacterial DNA load and composition between tre... | PMC10294643 | ||
Effect of vaginal seeding on the infant stool and skin microbiota. | Vaginal seeding significantly increased bacterial load in the skin (forearm; average, 32 copies/μL versus 14 copies/μL, in seeded and control babies, respectively; Compared with the control, vaginal seeding caused a significant reduction in alpha diversity (Shannon index) in the skin at day 1 (Treatment (seeding versus... | PMC10294643 | ||
Maternal sources of the infant microbiota. | VAGINA | Source tracking analyses revealed a significantly higher proportion of maternal vaginal microbiota in the skin of 1-day old neonates, relative to control infants (adjusted Proportion of maternal bacterial sources in infant and maternal body sites. (A) Contribution of maternal bacterial sources from different body sites... | PMC10294643 | |
DISCUSSION | Our study is the first double-blind, randomized, placebo-controlled trial to determine whether vaginal seeding causes differential engraftment of maternal bacteria in the skin and stool of neonates. The study has important limitations, such as a small sample size and only 2 time points until 30 days of life. Despite th... | PMC10294643 | ||
MATERIALS AND METHODS | PMC10294643 | |||
Study subjects. | infection | INFECTION | We performed this institutional review board (IRB)-approved study (WCG IRB number 1300043) at the Inova Health System in Northern Virginia under the US Food and Drug Administration (FDA) Investigational New Drug Application (IND) number 18076 (with an IND required by the FDA). We recruited pregnant women who were sched... | PMC10294643 |
Study procedure: randomization and vaginal seeding. | ’s mouth | STERILE, OBESE, VAGINA, BLIND | On the day of the scheduled C-section, a team member blind to treatments inserted a gauze moistened with sterile saline into the mother’s vagina. The gauze was incubated in the vagina for approximately 1 h and then removed and placed into a lidded sterile container prior to the mother receiving perioperative antibiotic... | PMC10294643 |
Data and samples. | ADVERSE EVENTS, STERILE | We collected detailed data on mothers, including demographics, medical history, anthropometrics, and medication use, including antibiotics during pregnancy. Data collected for the infants included demographics, method of first feeding and subsequent feedings, medication use, and adverse events. We collected and managed... | PMC10294643 | |
DNA extraction and sequencing. | We extracted microbial DNA using the Qiagen DNeasy PowerSoil HTP 96 kit (Hilden, Germany) following the manufacturer’s instructions. For 16S rRNA gene sequencing, we amplified the V4 region of 16S rRNA genes using the 515F/806R primers according to the Earth Microbiome Project protocol ( | PMC10294643 | ||
Determination of bacterial DNA load. | We determined bacterial copy number by qPCR using a Quantstudio 3 system (Thermo Fisher, Waltham, MA) with universal 16S gene primers (338F, | PMC10294643 | ||
Metadata analysis. | BLIND | All analyses were conducted by the statistical team in a blind manner. Select members of the statistical team were unblinded only after the final analysis of the data. Descriptive statistics (median with interquartile range and percentages) were presented on demographic and clinical characteristics for mothers and infa... | PMC10294643 | |
Microbiota analysis. | BLIND | The bioinformatics team conducted all microbiota analyses in a blind manner, and select members were unblinded only after the final analysis. | PMC10294643 |
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