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Methods | PMC10673712 | |||
Patients and tumor samples | tumor, PAOLA-1 BRCAwt tumors | TUMOR | The first cohort consisted of FFPE-derived DNA from 449 AOC samples from the PAOLA-1/ENGOT-ov25 trial in the frame of the EHEI. The procedure consisted in preliminary evaluation of the academic test performance on 85 PAOLA-1 BRCAwt tumors by comparing to the Myriad MyChoice diagnostics, followed by final PFS based test... | PMC10673712 |
Shallow WGS workflow | ® | Genomic DNA was extracted from the FFPE samples. 50 µl of DNA samples were mechanically sheared using Covaris ME220 Focused-ultrasonicator. Libraries were prepared from 100 ng of DNA using Agilent SureSelect XT HS and XT Low Input Library Preparation kit (Agilent, Santa Clara, CA, USA, ref: G9703A) according to the man... | PMC10673712 | |
ShallowHRDv2 bioinformatics pipeline | LGA, tumor, ±2 | TUMOR | After DNA extraction and whole genome sequencing at low coverage (~1X), read counts profile (bin size ~50 kb) normalized and corrected for GC-content was obtained by ControlFreec [Main steps of CNA processing (Supplementary Fig. Three-way sample quality attribution: CNA profile classification according to tumor content... | PMC10673712 |
Decision rules | LGA, tumor | TUMOR | Decision rules are multi-step, depend on sample quality attribution and include selection of the thresholds for LGA call. Two thresholds were utilized to call LGA at CNA breakpoint: stringent (implying simple genome) and soft (implying complex genome), which are applied in conservative manner for good quality cases (LG... | PMC10673712 |
Comprehensive output (report) | LGA | Final diagnosis is reported along with quality assessment and warning messages (Supplementary Fig. Circular binary segmentation of CNA profile has a stochastic component and can result in between-run variation in LGA-score, which may affect the diagnostics if close to the thresholds. Thus, LGA number is represented by ... | PMC10673712 | |
Statistical analysis | The Kaplan–Meier method was used to estimate the PFS and overall survival (OS), with the stratified log-rank test used to assess the difference between the ola+bev and bev arms [ | PMC10673712 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41388-023-02839-8. | PMC10673712 | ||
Acknowledgements | cancers | CANCERS | All investigators and operational staff of GINECO, MITO, GEICO, AGO-Austria, GOTIC, BGOG, MANGO, NSGO, and AGO study group who contributed to the PAOLA-1 trial. We thank Christine Montoto-Grillot, Deborah Cardoso, Alexandre Degnieau, Eloise Glais, and Bénédicte Votan from ARCAGY for their assistance for accesses to sam... | PMC10673712 |
Author contributions | MR | CC, MR, TP, MHS, EPL, and IRC made substantial contributions to conception and design, and revising the manuscript, and final approval for publication. CC, AB, MR, MHS, TP, AE, EF, and VR contributed to acquisition of data, analysis and interpretation of data, and drafted the manuscript. CC, MR, EF, VR, TP, and MHS par... | PMC10673712 | |
Data availability | sWGS | The raw data from sWGS have been deposited at ENA under accession PRJEB61549. | PMC10673712 | |
Competing interests | TUMORS | CC, TP, AE, and M-HS are co-inventors of the ShallowHRDv2 method (European Patent Application number EP23170829, filed on April 28th, 2023, and entitled “METHODS FOR DIAGNOSING A HOMOLOGOUS RECOMBINATION DEFICIENCY IN HUMAN TUMORS”). TP and M-HS are co-inventors of the LST method (US20170260588, US20150140122 and exclu... | PMC10673712 | |
References | PMC10673712 | |||
Subject terms | ® | There is an emergent need to develop functional cosmetic ingredients for the topical management of skin barrier function. This study aimed to investigate the efficacy of a lotion containing fermented lysates VHProbi® Mix R for enhancing the skin barrier. In vitro studies demonstrated that fermented cultures of both | PMC10558477 | |
Introduction | impairment of skin barrier | MALNUTRITION | As the largest organ of the body, skin serves as the interface between the body and the external environment, exerting multiple pivotal protective functions against exposome aggressions, e.g., air pollution, climate stimuli, solar radiation, lack of sleep, malnutrition, etc.The impairment of skin barrier has a huge inf... | PMC10558477 |
Materials and methods | PMC10558477 | |||
In vitro studies | PMC10558477 | |||
Bacterial strains and cells | The bacterial strains of E15and Y21 were isolated from kimchi. The bacterial strains of E06and E12 were isolated infant feces samples. All of strains were identified using the method described by Zhang and DuanTo obtain the fermented lysate, bacterial strains were inoculated in fermentation medium (2% molasses, 0.1% pe... | PMC10558477 | ||
Scavenging capability of E06 and E12 for 2,2-diphenyl-1-picryl-hydrazyl (DPPH) | The antioxidation assay was conducted using the method described by Sanchez-Moreno et al. with slight modification | PMC10558477 | ||
Proliferation assay for Lysate on HaCaT cells | HaCaT cells were plated at 2 × 10 | PMC10558477 | ||
Cell viability assay for protective effect of lysate | To evaluate the protection effect of E06 and E12 on HaCaT cell viability, For the HFor the UVB radiation-induced damage model, cells were treated with the lysates of E06 and E12 individually at a MOI of 100 and were incubated at 37 °C for 3 h. Next, the cells were treated with UVB radiation system (LONGPRO, Shanghai, C... | PMC10558477 | ||
Clinical studies | PMC10558477 | |||
Lotion formula | ® | The ingredients of the lotion were: 3% VHProbi® Mix R, 4% propylene glycol, 4% caprylic/capric triglyceride, 4% mineral oil, 3.5% cetearyl alcohol, 1.5% PEG-100 glyceryl stearate, 1.5% stearic acid, 0.6% glyceryl stearate, 0.5% 1,2-hexanediol, 0.3% phenoxyethanol, 0.2% xanthan gum, 0.15% chlorphenesin, % L-arginine, an... | PMC10558477 | |
Subjects | A total of 52 eligible adult subjects, including males and females, were enrolled after verification of the criteria (Table Inclusion/exclusion criteria for the clinical study. | PMC10558477 | ||
Study procedures and assessments | redness | The subjects applied an equal amount to 0.6–0.8 g per time of the investigational lotion twice daily to their face for 30 days. After 15 min of resting in a room, the subjects were asked to complete the BoSS questionnaire on the repairing effect of the sensitive skin barrier. The dermatology assessments, including tran... | PMC10558477 | |
Statistical analysis | Data were initially analyzed by EpiData ver3.1 and exported to SPSS ver26.0 (SPSS Inc., USA) for further analysis. Data distribution was assessed by the 1-sample Kolmogorov–Smirnov test. Parametric values are expressed as means ± standard deviations. The Wilcoxon test or paired samples t- test for paired samples was pe... | PMC10558477 | ||
Ethical statement | Ethics review and approval was not required for this study on the human participants in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate this study. Written informed consent was obtained from individuals for the publication of ... | PMC10558477 | ||
Results | PMC10558477 | |||
In vitro studies | PMC10558477 | |||
DPPH radical scavenging activity of E06 and E12 | The DPPH free radical scavenging activity of E06 and E12 is shown in Table DPPH radical scavenging activity.Means ± standard deviation. | PMC10558477 | ||
Antioxidant effect of E06 and E12 in C. elegans | Survival of Survival of | PMC10558477 | ||
Enhancing proliferation effect of lysate on keratinocytes | PROLIFERATION | The ability of E06 and E12 to enhance the proliferation of HaCaT cells is shown in Fig. Absorbance variations of HaCaT Cells treated with or without lysate. ( | PMC10558477 | |
Protective effect of lysate on HaCaT cells | To determine the protective effect of the lysates on the viabilities of HaCaT cells, three different stimulants, including Protection of the lysate on HaCaT cells against different stimulants. ( | PMC10558477 | ||
Clinical studies | PMC10558477 | |||
Detection of TEWL | Detailed scores on the TEWL indicator for individuals from baseline to the final visit are presented in Table Improvement of cutaneous statuses related to sensitive skin. ( | PMC10558477 | ||
Skin moisturization | Detailed scores on moisturization for individuals from baseline to the final visit are presented in Table | PMC10558477 | ||
Skin redness | skin redness | SKIN REDNESS | Detailed scores on skin redness for individuals from baseline to the final visit are presented in Table Microscopic and macroscopic images of skin redness area captured under cross-polarized light using CK and VISIA instruments. D0: day 0; D30: day 30. | PMC10558477 |
Skin redness profile | redness | Detailed scores on redness profile for individuals from baseline to the final visit are presented in Table | PMC10558477 | |
BoSS and self-assessment questionnaire | In terms of BoSS questionnaire (see Table BoSS questionnaire of skin parameters.D0: day 0; D30: day 30; SD: standard deviation; The self-assessment questionnaire also illustrated that the VHProbi® Mix R may play an important role in improving skin quality (see Table | PMC10558477 | ||
Discussion | impairment of skin barrier function, xerosis, cutaneous disorder | PROLIFERATION, XEROSIS | The impairment of skin barrier function is a common cutaneous disorder raising challenges for dermatologists, patients, and the cosmetic industry. Increasing advancements in elucidating the mechanism of action for strengthening skin barrier provide promising interventions for the management of these individualsIn this ... | PMC10558477 |
Conclusion | ® | The results from this study implied that the lotion containing VHProbi® Mix R fermented lysate is well tolerated in strengthening skin barrier and may be able to mitigate the severity of sensitive skin after 30 days of intervention. Detailed immunomodulatory studies are needed to determine whether the components of VHP... | PMC10558477 | |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-43336-y. | PMC10558477 | ||
Acknowledgements | We would like to thank the volunteers, investigators, and staff who were involved in this study. | PMC10558477 | ||
Author contributions | All authors have permitted the orders in this article. | PMC10558477 | ||
Funding | This study received funding from Qingdao Vland Biotech Co., Ltd. The funder was not involved in the study design, collection, analysis, data interpretation, the writing of this article and decision to submit this manuscript for publication. | PMC10558477 | ||
Data availability | The original contributions presented in this study are included in the article/supplementary materials, further inquiries can be directed to the corresponding author. | PMC10558477 | ||
Competing interests | Hongchang Cui, Congrui Feng, Tao Zhang, Sidao Cheng, Shumin Cheng, Zhi Duan1were employed by the Qingdao Vland Biotech Co., Ltd and declare no other competing interests. No other author has conflict of interest. | PMC10558477 | ||
References | PMC10558477 | |||
Key words | OBESE | The present study aimed to determine the effect of whole meat GSM powder on gut microbiota abundance, body composition and iron status markers in healthy overweight or obese postmenopausal women. This was a 3-months trial involving forty-nine healthy postmenopausal women with body mass index (BMI) between 25 and 35 kg/... | PMC10214140 | |
Method and materials | PMC10214140 | |||
Study participants | A total of forty-nine New Zealand women aged 55–75 years old who were at least 5 years post-menopause were included in the study. A further inclusion criterion was having a body mass index (BMI) of between 25 and 35 kg/mThis study was conducted according to the guidelines laid down in the Declaration of Helsinki and al... | PMC10214140 | ||
Study design | Nelson | NELSON, RECRUITMENT | Participants who met the inclusion criteria were randomly assigned to either the GSM or placebo group, stratified by age (55–64, 65–75 years) and BMI (25–29⋅9 kg/mBoth GSM powder and placebo were encapsulated in hard-shell capsules by a commercial facility (Alaron, Nelson, NZ) and stored under nitrogen in the dark at r... | PMC10214140 |
Demographic and anthropometric, and body composition measurements | The data on demographic characteristics were collected from participants at the baseline. The anthropometric measurements including body weight and standing height were measured using a beam balance to the nearest 0⋅2 kg and a stadiometer to the nearest 0⋅1 cm, respectively, at the baseline and the end of the study. BM... | PMC10214140 | ||
Assessment of physical activity | Physical activity was assessed by the New Zealand Physical Activity Questionnaire – Short Form (NZPAQ-SF)MET values and formula for calculation of MET-minutes were assessed and used as below:
Walking MET-minutes/week at work = 3⋅3 × walking minutes × walking days at work.Moderate MET-minutes/week at work = 4⋅0 × modera... | PMC10214140 | ||
Dietary intake assessment | Each participant's daily nutrient intake from the diet was measured using a 3-d food record including two weekdays and one weekend day at the midpoint of the trial. The 3-d food record has been recommended and considered the ‘gold standard’ for dietary assessment. Instructions on how to accurately complete the food rec... | PMC10214140 | ||
Faecal sample collection, DNA isolation and gut microbe quantification | LYSIS | Participants were provided with a stool sample collection kit at the baseline and the end of the study. Each kit contained a container, an anaerobic bag with anaerobic sachet plus a freezer pack. Samples were delivered to the HNRU and stored at −80 °C. Bacterial DNA was extracted using an Isolate Faecal DNA kit (Biolin... | PMC10214140 | |
Biochemical analysis | inflammation | INFLAMMATION | Non-fasted blood samples were collected at the baseline and the end of the study to measure iron status markers including serum iron, transferrin, ferritin, sTfR, iron saturation, iron binding as well as C-reactive protein (CRP) levels as a marker of inflammation. All biomarkers were analysed at Medlab Central-Palmerst... | PMC10214140 |
Compliance | Compliance was checked at week 6 and the end of the study by examining the participant's records of their daily intake of study supplements. Compliance was assessed using cumulative capsule counts at the completion of the study, and adherence was measured as a percentage: (number of capsules provided − number of unused... | PMC10214140 | ||
Statistical methods | SECONDARY | The microbial analyses were secondary objectives of the original trial, and the sample size calculation was not based on detecting significant changes in either gut microbiota abundance, body composition parameters or iron status markers. In brief, the sample size was based on urinary C-telopeptide of type II collagen ... | PMC10214140 | |
Results | PMC10214140 | |||
Baseline characteristics | ± | Out of fifty-five participants who enrolled in the study, six participants withdrew during the trial due to health issues or being non-compliant. A total of forty-nine participants (GSM, Baseline characteristics of participants who completed the study across the treatment groups (BMI, body mass index; MET, metabolic eq... | PMC10214140 | |
Evaluation of treatment on gut microbiota abundance | ± | The baseline abundance of each selected bacteria is demonstrated in The abundance (mean ± The abundance of bacteria at the baseline and the end of the study were measured by real-time PCR. Data are presented in log scale ng/g faeces (mean ± | PMC10214140 | |
Evaluation of treatment on iron markers and CRP level | The baseline, endpoint and % change from baseline in iron markers of study population across the treatment groups are presented in The baseline, endpoint and % change from the baseline of iron markers and CRP level over the 12 weeks of study across treatment groups (The difference between the groups was compared using ... | PMC10214140 | ||
Evaluation of treatment on body composition parameters | The baseline, endpoint and % change from baseline in body composition parameters across the treatment groups are shown in The baseline, endpoint and % change from the baseline in body composition parameters over the 12 weeks of study across treatment groups (The difference between the groups was compared using the Stud... | PMC10214140 | ||
Safety and adverse events | nausea, abdominal pain, reflux | ADVERSE EVENTS, REFLUX | There was no evidence of a change between groups for their lipid profile, liver enzymes and kidney function tests. The majority of participants were tolerant without any side effects. In contrast, five subjects in the GSM group and two subjects in the placebo group reported adverse events including moderate indigestion... | PMC10214140 |
Acknowledgements | INFLAMMATION | The authors thank Louise Shaw and Chris Kendrick (Massey University) for phlebotomy and Shampa De (Massey University) for supporting in DNA extraction, PCR analysis. Gabrielle Plimmer for operation of dual-energy X-ray absorptiometry scan.This study was funded by the National Science Challenge, High Value Nutrition (HV... | PMC10214140 | |
References | PMC10214140 | |||
Background | DIABETIC MACULAR EDEMA | To investigate the efficacy of injecting suprachoroidal triamcinolone acetonide (SCTA) plus intravitreal bevacizumab (IVB) into patients with center-involving diabetic macular edema (CI-DME). | PMC9881520 | |
Methods | In this phase 2/3 randomized controlled pilot trial, sixty-six eyes with CI-DME and best-corrected visual acuity (BCVA) of at most 20/50 Snellen chart were randomly assigned into two groups. Monotherapy arm received sham injection plus 3 monthly IVB doses and combination arm received a single dose of SCTA and 3 monthly... | PMC9881520 | ||
Results | The mean BCVA improvements were obtained respectively as − 0.20 ± 0.20 log [minimum angle of resolution (MAR)] ( | PMC9881520 | ||
Conclusion | Significant improvements in BCVA and retinal anatomical outcomes demonstrated the additive effects of SCTA to those of anti-vascular endothelial growth factors with no short-term side effects and this combination appears to be a promising option in the management of patients with CI-DME. | PMC9881520 | ||
Trial registration | The trial was registered in Iranian Registry of Clinical Trials (IRCT20200314046761N1). | PMC9881520 | ||
Keywords | PMC9881520 | |||
Background | diabetic retinopathy, Diabetes mellitus | DIABETIC RETINOPATHY, DIABETES MELLITUS | Diabetes mellitus is estimated to involve over 500 million individuals in upcoming decades. The highly-prevalent diabetic retinopathy should also be considered a threat to vision in human in the near future [Many studies have investigated the pharmacologic aspects of the suprachoroidal space (SCS) for delivering pharma... | PMC9881520 |
Methods | PMC9881520 | |||
Study design | This prospective phase 2/3 triple-blind, uni-center parallel-group randomized controlled pilot trial was conducted to investigate the efficacy of a combination of SCTA and IVB administered in patients with DME. The study designed as per the Declaration of Helsinki was approved by the Ethics Committee of Isfahan Univers... | PMC9881520 | ||
Participants | dystrophies, lens opacity, optic disc lesions, retinal or glaucoma, uveitis, Diabetic Retinopathy, retinal and macular dystrophies, corneal haziness, cataract, ocular pathologies, vitreous hemorrhage, hypersensitivity, vision loss | UNCONTROLLED HYPERTENSION, DYSTROPHIES, SCAR, UVEITIS, DIABETIC RETINOPATHY, RETINA, EYE, CATARACT, CHOROIDAL NEOVASCULARIZATION, DIABETIC MACULAR EDEMA, VITREOUS HEMORRHAGE, HYPERSENSITIVITY, TYPE 2 DIABETES MELLITUS | The present study population comprised patients aged at least 18 years with vision loss caused by type 2 diabetes mellitus presenting to the retina clinic of Feiz Eye Hospital affiliated to Isfahan University of Medical Sciences. The eligibility criteria consisted of having center-involving diabetic macular edema (CI-D... | PMC9881520 |
Sample size and randomization | The sample size was calculated as 30 per group with a test power of 80% and a type I (two-sided) error of 5% corresponding to a mean BCVA difference of 10 ± 15 as our primary outcome reported in ETDRS letter scores for two study arms [Randomized sequences generated using a random number generator in SPSS and permuted b... | PMC9881520 | ||
Intervention protocol | STERILE, ANTERIOR, SCLERA | Every participant received three consecutive anesthetic drops every five minutes before beginning the procedure. During the first injection session, after placing an eyelid speculum and disinfecting the ocular surface with a 10% povidone-iodine solution for 30 seconds in all study eyes, 0.1 ml (4 mg) of TA (Exir Pharma... | PMC9881520 | |
Outcomes | cataract, hemorrhage | CATARACT, HEMORRHAGE, BACTERIAL ENDOPHTHALMITIS, ADVERSE EVENTS | The superior efficacy of the combination of SCTA and IVB compared to that of IVB alone, was the primary outcome of this three-months, randomized pilot study which will be achieved through between group analysis of the mean BCVA changes after the study was completed. Secondary outcomes were obtained from comparing the f... | PMC9881520 |
Statistical analysis | SD | The continuous and categorical data were reported as mean ± SD and frequency and relative frequency. The normality of the continuous data was evaluated using the Kolmogorov-Smirnov test and Q-Q plots. The non-normal positively-skewed data underwent a logarithmic transform. Continuous, categorical, demographic and clini... | PMC9881520 | |
Results | PMC9881520 | |||
Efficacy | PMC9881520 | |||
Retinal thickness and volume | Significant reductions were observed in CST between baseline and the study endpoints in the monotherapy arm. The mean decrease in CST was 76 μm (95% CI 15 to 138, The graph showed mean values of central subfield thickness at baseline and the study endpoints in both study arms. CST: central subfield thickness, IVB: Intr... | PMC9881520 | ||
Adverse events | CAVITY, ACUTE ENDOPHTHALMITIS | Acute endophthalmitis was observed in none of the study eyes. TA was inadvertently injected into the vitreous cavity of 2.2% (There was no significant IOP rising which needed medical or surgical treatment (over 10, 25 or 30 mmHg) observed in any of the participants. The mean IOP respectively obtained as 14.9 ± 2.7, 15 ... | PMC9881520 | |
Discussion | diabetic retinopathy, retinal tumors, retinal diseases, hyperglycemia, diabetes | DIABETIC RETINOPATHY, AGE-RELATED MACULAR DEGENERATION, RETINAL VEIN OCCLUSION, RETINAL DISEASES, PATHOPHYSIOLOGY, HYPERGLYCEMIA, ADVERSE EFFECTS, RETINA, INFLAMMATIONS, SCLERA, MACULAR EDEMA, DIABETES | This two-arm randomized pilot trial was conducted to evaluate the efficiency of adding a single dose of SCTA to IVB, as a popular anti-VEGF agent especially in developing countries, in managing CI-DME in treatment-naive eyes. The findings showed significant clinical and statistical improvements in BCVA and retinal anat... | PMC9881520 |
Acknowledgements | The authors would like to express their special thanks to Tavangar H, MD, for his valuable assists for medical writing of this article. | PMC9881520 | ||
Authors’ contributions | F.F. and M.F. contributed to the design of the study. F.F. M.M. B.O. M.T. and M.F. contributed to the data gathering. A.F. and M.F. contributed to the data analysis. A. F and M.F. contributed to the writing of the manuscript. F.F. and M.M. contributed to the revising of the manuscript. All the authors read and approved... | PMC9881520 | ||
Funding | The study was supported by Vice Chancellery for Research and Technology, Isfahan University of Medical Sciences, Isfahan, Iran. Funding organization participated in ethical and scientific approval, before the study began. | PMC9881520 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC9881520 | ||
Declarations | PMC9881520 | |||
Ethics approval and consent to participate | The research was conducted in full compliance with ethical principles and in accordance with the World Medical Association Declaration of Helsinki and it was approved by the Ethics Committee of Isfahan University of Medical Sciences, Isfahan, Iran (IR.MUI.MED.REC.1398.410). The patients signed written informed consents... | PMC9881520 | ||
Consent for publication | The patients signed written informed consents for publication of their clinical information and photos. | PMC9881520 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9881520 | ||
References | PMC9881520 | |||
Objective | MALE SEXUAL DYSFUNCTION | Academic Editor: Samar Tharwat Female sexual dysfunction is a common distressing problem among women, which may result from reducing circulating endogenous estrogen. | PMC10125751 | |
Methods | In the current randomized clinical trial, study populations consisted of 63 postmenopausal women who were randomly categorized into two groups. In the hop group ( | PMC10125751 | ||
Results | sexual pain | No statistically significant differences in FSFI scores (sexual desire, sexual arousal, vaginal lubrication, satisfaction, orgasm, sexual pain, and total FSFI) ( | PMC10125751 | |
Conclusion | sexual dysfunction | ADVERSE EVENTS | Vaginal hop was as effective as estradiol in improving the sexual dysfunction among postmenopausal women with no adverse events. This trial is registered with | PMC10125751 |
1. Introduction | digestive disorders, Female sexual dysfunction, anxiety, Since sexual dysfunction, sexual dysfunction, insomnia, depression | MALE SEXUAL DYSFUNCTION, ESTROGEN DEFICIENCY, DIGESTIVE DISORDERS | Female sexual dysfunction is a common distressing problem among about 30 to 50% of women, which could have consequences on the couple's overall relationship [Humulus lupulus L., commonly known as hop, is a plant belonging to the Cannabaceae family, widely grown in Europe, Asia, and North America. Hop has traditionally ... | PMC10125751 |
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