title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Supporting information | PMC10619799 | |||
Protocol of the study. | (DOCX)Click here for additional data file. | PMC10619799 | ||
CONSORT checklist. | (DOC)Click here for additional data file. | PMC10619799 | ||
S1-S4 Tables. | (DOCX)Click here for additional data file.We wish to thank all the participants for generously contributing their time and experience to this study. We are grateful for the support received from all the members of the Obstetrics and Gynecology Department and Bahar clinic in Baharlou hospital. | PMC10619799 | ||
Background | SECONDARY | Primiparous women experience various challenges if not provided with social support in the early postpartum period. Support in form of postpartum education programs is needed to improve mental well-being in primiparous women. The aim of this study was to determine the effect of a postnatal supportive education program ... | PMC10045875 | |
Methods | This randomized clinical trial was performed on pregnant women referring to healthcare centers for routine care from September to November 2021 in Kermanshah, Iran. One hundred pregnant women were randomly divided in to intervention and control groups. Four 45–90 min online training sessions were held weekly for the hu... | PMC10045875 | ||
Results | In the control and intervention groups before the intervention, socio-demographic characteristics ( | PMC10045875 | ||
Conclusion | The postpartum supportive education program for husbands was effective in promoting social support for primiparous women. Thus it can be introduced as routine care in the postpartum period. | PMC10045875 | ||
Trial registration | Clinical trial registration Iranian Registry of Clinical Trials; | PMC10045875 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12905-023-02270-x. | PMC10045875 | ||
Keywords | PMC10045875 | |||
Introduction | depression, fatigue | SECONDARY | The early postpartum period is an exciting and joyful time for many parents, yet it is a stressful transient period during which most primiparous women face a variety of physical and emotional challenges, including fatigue and difficult responsibilities of caring for the baby and profound changes in the couple's roles ... | PMC10045875 |
Hypothesis of study | Education to the husbands of primiparous women will lead increased perceived social support and maternal self-efficacy and reduced stress of these women in the postpartum period. | PMC10045875 | ||
Primary aim | Determine the effect of a postnatal supportive education program for husbands on perceived social support of their primiparous wives. | PMC10045875 | ||
Secondary aim | Determine the effect of a postnatal supportive education program for husbands on stress and maternal self-efficacy of their primiparous wives. | PMC10045875 | ||
Methods | PMC10045875 | |||
Study design and participants | This randomized, controlled clinical trial study using two parallel groups was performed on 100 pregnant women referring to health centers in Kermanshah, Iran from September to November 2021. Figure CONSORT flowchart of the study | PMC10045875 | ||
Sample size calculation | The sample size was calculated based on the main variable of the study (social support) according to Khanzadeh and Moghaddam Tabrizi [
μ1: mean difference of the social support in the intervention group (11.25), μ2: mean difference of the social support in the control group (4.95), SD1: standard deviation of the social... | PMC10045875 | ||
Sampling and random allocation method | BLIND | The present study was approved by the committee of ethics of Ahvaz Jundishapur University of Medical Sciences (IR.AJUMS.REC.1399.401) and was registered in Iranian Registry of Clinical Trials (IRCT20160427027633N8). First, According to the information of Kermanshah health center, Kermanshah city was divided into 4 geog... | PMC10045875 | |
Intervention | Training was performed for intervention group in Skype. While the control group received only routine care. Training involved 4 online sessions of 45 to 90 min in Skype, held weekly (one session per week) by the researcher. Due to the different nature of education on natural childbirth and cesarean section, the women i... | PMC10045875 | ||
Study outcomes | SECONDARY | In this study, the study outcomes (primary outcome: social support and secondary outcome: maternal self-efficacy and stress) were measured at three time intervals: baseline or before intervention (third day after delivery), immediately after the intervention (fourth week after delivery), and one month after the interve... | PMC10045875 | |
Data collection tools | Data collection tools included socio-demographic questionnaire, Postpartum Partner Support Scale, Perceived Stress Scale, and Postpartum Parental Expectations Survey. | PMC10045875 | ||
Socio-demographic questionnaire | ’s disease | This questionnaire includes questions related to age, husband’s age, age gap with husband, educational of the woman and her husband, employment status of the woman and her husband, economic status, husband’s disease, weight at birth, type of baby feeding, breastfeeding problems, delivery method, pregnancy status, and b... | PMC10045875 | |
Primary outcome | PMC10045875 | |||
Postpartum Partner Support Scale (PPSS) | This scale was developed in 2017 by Dennis et al. This questionnaire has a four-point Likert scale (from | PMC10045875 | ||
Secondary outcome | PMC10045875 | |||
Postpartum Parental Expectations Survey (PPES) | This scale designed by Reese in 1992, was used to measure maternal self-efficacy. This questionnaire has 25 affirmatively worded items scored based on a 10-point Likert scale (from | PMC10045875 | ||
Perceived Stress Scale (PSS) | STRESSFUL EVENTS | Perceived Stress Scale was developed in 1983 by Cohen et al. to measure general perceived stress over the past month. Thoughts and feelings about stressful events, as well as controlling, overcoming, coping with stress. In the present study, the 14-item version was used which is answered based on a 5-point Likert scale... | PMC10045875 | |
Data analysis | The collected data were analyzed using descriptive statistics (frequency, percentage, mean and standard deviation) and inferential statistics using SPSS version 24. | PMC10045875 | ||
Discussion | depression, depressed | DISEASES, BLIND | The results of this study showed that the postnatal supportive education program for husbands enhanced the understanding of social support for their primiparous women in the fourth and eighth weeks after delivery. It can be argued that providing education and consultation services to husbands in order to increase their... | PMC10045875 |
Conclusion | This study demonstrated the effectiveness of a postnatal supportive education program for husbands (male partners) in improving perceived social support, maternal self-efficacy, and stress in primiparous women. Therefore, policymakers in postpartum care are advised to consider the participation of husbands in the postp... | PMC10045875 | ||
Acknowledgements | The authors would like to thank all the participants in this study. | PMC10045875 | ||
Authors’ contributions | All authors contributed to this study; F-SH, and ZA designed the study. F-SH, MJ, ZB and MN provided the training. F-SH and ZA collected the data, B-CH analyzed the data analysis, F-SH drafted the manuscript. All authors read and approved the final manuscript. | PMC10045875 | ||
Funding | The study is part of the results of the PhD dissertation of the first author in midwifery, which was financially supported by Ahvaz Jundishapur University of Medical Sciences (AJUMS) in Iran. | PMC10045875 | ||
Availability of data and materials | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10045875 | ||
Declarations | PMC10045875 | |||
Ethics approval and consent to participate | Ethical approval for this study was obtained from the research ethics committee of Ahvaz Jundishapur University of Medical Sciences with the ethics code of IR.AJUMS.REC.1399.401. In addition, this trial registered in Iranian registry of clinical trials; | PMC10045875 | ||
Consent for publication | Not applicable. | PMC10045875 | ||
Competing interests | The authors have no conflicts of interest to disclose. | PMC10045875 | ||
References | PMC10045875 | |||
1. Introduction | sepsis, groin, early-life | SKIN, SEPSIS, ADVERSE EFFECTS | The structure and function of infant skin is not fully developed until 34 weeks of gestation, and this immaturity is associated with risk of late-onset sepsis (LOS). Topical coconut oil improves preterm-infant skin integrity and may reduce LOS. However, data on early-life skin-microbiome succession and potential effect... | PMC10706365 |
2. Results | groin | We collected skin swabs from 72 very preterm infants from the axilla, ear, and groin on days 1, 7, 14, and 21 after birth. Microbiome analysis was performed on samples with sufficient DNA content from 672 swab samples, from a total of 56 infants (28 infants each in intervention and control arms, respectively). The demo... | PMC10706365 | |
2.1. Succession of the Skin Microbiota of Preterm Infants in Both Control and Intervention Infants | There were substantial changes in the composition of the skin microbiome over the first three weeks of life (The dissimilarity between microbial communities at different body sites and ages at sampling was assessed with non-metric multidimensional scaling (NMDS) using the Bray–Curtis dissimilarity index. Between-body-s... | PMC10706365 | ||
2.2. Factors Associated with Diversity of the Preterm-Infant Skin Microbiome | We tested the association between various participant-level factors and alpha diversity (within sample diversity) using linear mixed models. Bacterial richness (Chao1) in axilla samples was lower than that in groin samples (Bacterial richness was lower on day 7 (We also analyzed the association between the total durati... | PMC10706365 | ||
2.3. Effect of Topical Coconut Oil on the Skin Microbiome | We analyzed the effect of coconut oil emollient on within-sample diversity using a linear mixed model with participant ID as a random effect and with site and age as fixed effects. Compared to the control arm, there was a trend towards reduced microbiome richness in the intervention arm (beta = −9.97, 95% CI [−22.68, 2... | PMC10706365 | ||
3. Discussion | We investigated the effect of topical coconut oil emollient on the skin microbiome in preterm infants born <30 weeks of gestational age. Microbiome data were collected longitudinally from three body sites up to 21 days after birth. Overall, within-sample diversity was highest on day 1 after birth, with a subsequent dec... | PMC10706365 | ||
4. Materials and Methods | PMC10706365 | |||
4.1. Participant Recruitment and Sample Collection | congenital malformations | SKIN, SKIN CONDITION | This trial, conducted in the NICU at Edward Memorial Hospital, Perth, was approved by the institutional human research ethics committee (HREC2015191EW) and registered with the Australian Clinical Trial Registry (ACTRN12616000042448). Infants born <30 weeks’ gestational age without major congenital malformations or cong... | PMC10706365 |
4.2. DNA Extraction, PCR, and Amplicon Sequencing | BLOOD, STERILE | DNA was extracted from the eNAT tubes using the Qiagen Blood Mini Kit with several modifications. Briefly, 1 mL of sample was aliquoted in sterile 2 mL tubes containing 1.0 mm and 0.1 mm sized silicon beads. The tube was centrifuged at 10,000× The 16S rRNA gene V4 region was amplified using 515F and 806R primers with 5... | PMC10706365 | |
4.3. Bioinformatics and Statistical Analysis | Demultiplexed sequences were quality filtered using QIIME (Quantitative Insights into Microbial Ecology) version 2.2020.2 [To remove contaminants that were seen in sequenced controls, we used an in silico approach using the Decontam package in R software (v 4.3.2) [All univariate statistical analysis was carried out in... | PMC10706365 | ||
4.5. Quantification and Detection of Bifidobacterium | As per the NICU standard protocol at KEMH, all infants received oral supplementation with | PMC10706365 | ||
Supplementary Materials | The following supporting information can be downloaded at Click here for additional data file. | PMC10706365 | ||
Author Contributions | Conceptualization, T.S., A.C., M.P.N. and S.P.; Methodology, T.S., M.P.N., M.S.P. and N.-U.-H.G.; Formal analysis, N.-U.-H.G., C.A.M. and J.H.; Investigation, T.S., S.P. and J.H.; Resources, M.S.P., A.C. and T.S.; Data curation, T.S., S.P. and J.H.; Writing—original draft preparation, N.-U.-H.G., C.A.M. and M.P.N.; Wri... | PMC10706365 | ||
Institutional Review Board Statement | This study was approved by the institutional human research ethics committee (HREC2015191EW) of King Edward Memorial Hospital, Perth. | PMC10706365 | ||
Informed Consent Statement | Informed consent was obtained from the parents of all participants involved in the study prior to participation. | PMC10706365 | ||
Data Availability Statement | Data are unavailable due to privacy and ethical restrictions. | PMC10706365 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10706365 | ||
References | groin | Relative abundance of bacterial taxa in individual participants. Compositional bar plot shows the mean relative abundance at the genus level for each individual participant at axilla, ear, and groin sites for samples collected on days 1, 7, 14, and 21. Genera that had a relative abundance of <10% are listed as “other”.... | PMC10706365 | |
Background and aims | multiorgan failure, inflammation, death, ARDS | INFLAMMATION, CORONAVIRUS, MULTIORGAN FAILURE, ARDS, ACUTE RESPIRATORY DISTRESS SYNDROME | The main causes of death in patients with severe Coronavirus disease-2019 (COVID-19) are acute respiratory distress syndrome (ARDS) and multiorgan failure caused by a severe inflammatory cascade. Novel treatment strategies, such as stem-cell-based therapy and their derivatives can be used to relieve inflammation in the... | PMC10294333 |
Materials and methods | ARDS | ARDS | COVID-19 patients with ARDS were included in this study and allocated into two study and control groups using block randomization. While all patients received recommended treatment based on guidelines from the national advisory committee for COVID-19 pandemic, the two intervention groups received two consecutive inject... | PMC10294333 |
Results | A total number of 43 patients (the MSC alone group = 11, MSC plus EV group = 8, and control group = 24) were included in the final analysis. Mortality was reported in three patients in the MSC alone group (RR: 0.49; 95% CI 0.14–1.11; | PMC10294333 | ||
Keywords | PMC10294333 | |||
Introduction | CORONAVIRUS | Coronavirus disease-2019 (COVID-19), caused by severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), was first observed in December 2019 in Wuhan, Hubei province, China [SARS-CoV-2 could infect many organs, mainly through angiotensin-converting enzyme-2 receptor (ACE-2), and other potential receptors like gluco... | PMC10294333 | |
Materials and methods | PMC10294333 | |||
Study design | acute respiratory distress syndrome, ARDS | ARDS, SARS-COV-2 INFECTION, ACUTE RESPIRATORY DISTRESS SYNDROME | This phase II randomized, multicentric clinical trial was conducted on COVID-19 patients with acute respiratory distress syndrome referred to Masih Daneshvari and Shariati hospitals, two major referral centers for COVID-19 hospitalization in Tehran, Iran, during 2020. The inclusion criteria were: age between 18 and 65,... | PMC10294333 |
MSC and MSC-derived EVs | We used good manufacturing practice (GMP)-certified MSCs for this study, which underwent a panel of quality control tests as part of their certificate of analysis. The cell preparation protocol was previously described in our study [ | PMC10294333 | ||
Study endpoints | ADVERSE EVENTS | The primary endpoint in this study was assessment of adverse events, based on common terminology criteria for adverse events (CTCAE) version 4 [ | PMC10294333 | |
Statistical analysis | For statistical analysis, the data was entered into version 26 of the Statistical Package for the Social Sciences (SPSS | PMC10294333 | ||
Results | PMC10294333 | |||
General information | At baseline, 43 patients were enrolled in this study, of whom 24 were randomly placed in the control group, 11 were placed in the MSC alone group, and 8 were placed in the MSC plus EV group. The flowchart of the study is presented in Fig. Flowchart of the study | PMC10294333 | ||
Adverse events | ADVERSE EVENT | There was no adverse event (AE) or serious adverse event (SAE) linked to either type of intervention. Collectively, mortality occurred in three patients of the intervention groups (15.87%) and eight patients of the control group (33.4%). Mortality was reported in three patients of the MSC alone group (RR: 0.49; 95% CI ... | PMC10294333 | |
Clinical symptoms | cough, dyspnea, ARDS | ARDS | In this study, various clinical symptoms were evaluated before and after the intervention. Specifically, symptoms closely associated with ARDS were examined in detail. The cough symptom showed improvement in both intervention groups compared to the control group. Additionally, all patients in the MSC group and nearly 9... | PMC10294333 |
Inflammatory markers | The serum levels of inflammatory markers before and after intervention are presented in Table The inflammatory markers change in study groups. Red: MSC group; blue: MSC + EV group. Data is presented based on median and interquartile range and compared to the control group. *Refers to | PMC10294333 | ||
Discussion | Multiorgan failure, CRS, ARDS, extensive lung damage | SYSTEMIC INFLAMMATORY RESPONSE, SARS-COV-2 INFECTION, ADVERSE EVENTS, CYTOKINE RELEASE SYNDROME, MULTIORGAN FAILURE, ARDS, PATHOGENESIS | In this study, we administered allogenic MSCs to COVID-19 patients who were in the progressive phase of ARDS. We observed that systemic administration of MSC and local administration of MSC-EVs in COVID-19 patients is safe, with minimal adverse events. Furthermore, MSCs had significant effects on inflammatory markers c... | PMC10294333 |
Conclusion | The systemic administration of MSCs and respiratory inhalation of MSC-EVs in COVID-19 patients are safe and associated with improvement in inflammatory markers. The immune modulatory impact of MSCs and MSC-EVs can alleviate cytokine storm and its related consequences in COVID-19 patients. However, further studies with ... | PMC10294333 | ||
Acknowledgements | The authors deeply appreciate the efforts by their collaborators at Royan ATMP Technology Development Center (ATMP-TDC), Regenerative Medicine Department at Royan institute, QA, QC, and production departments at Cell Tech Pharmed Co., Royan Stem Cell Technology Co., and Royan Ati Tech Pharmed Co., clinicians and nurses... | PMC10294333 | ||
Author contributions | RA | MZ, MAS, MN, FS, and SHE contributed in drafting manuscript, data collection, and performing follow-up of the patients. SMH, RA, HJ, NK, HA, and HM contributed in the patient’s selection, conducting medical practice and follow-up. AN, AA, SNH, FA, NJ, NF, LT, and MG contributed in quality assurance, quality control, an... | PMC10294333 | |
Funding | Grants from the Royesh Venture Capital Fund and CellTech Pharmed supported this work. The funding resources provided cell products and covered the costs of hospitalization and laboratory parameters of patients. The funding sources had no responsibilities in the study design, data collection, analysis, and interpretatio... | PMC10294333 | ||
Availability of data and materials | The datasets generated and analyzed during the current study are available upon reasonable request from the corresponding author, after obtaining permission from the national institutional review board of COVID-19 in Iran. All materials used in this study are either commercially available or can be obtained from the co... | PMC10294333 | ||
Declarations | PMC10294333 | |||
Ethics approval and consent to participate | We conducted this study in accordance with the Helsinki declaration [ | PMC10294333 | ||
Consent for publication | Not applicable. | PMC10294333 | ||
Competing interests | EHS and MV were collaborating for the industrial manufacturing of the products used in this work, and they declare no financial interest that could have appeared to influence the data reported in this paper. The remaining authors have no conflicts of interest to declare. | PMC10294333 | ||
References | PMC10294333 | |||
1. Introduction | Attention deficit hyperactivity disorder, ADHD, attention deficit hyperactivity disorder | SECONDARY | Synbiotic 2000, a pre + probiotic, reduced comorbid autistic traits and emotion dysregulation in attention deficit hyperactivity disorder (ADHD) patients. Immune activity and bacteria-derived short-chain fatty acids (SCFAs) are microbiota–gut–brain axis mediators. The aim was to investigate Synbiotic 2000 effects on pl... | PMC10004766 |
2. Materials and Methods | PMC10004766 | |||
2.1. Participants | psychiatric, ADHD | All participants in this study, including ADHD patients and healthy controls, were recruited through a double-blind randomized controlled trial (ISRCTN57795429) of Synbiotic 2000 intervention performed between January 2016 and June 2018 at psychiatric clinics in Stockholm, Sweden, as previously described [ | PMC10004766 | |
2.2. Interventions | Synbiotic 2000, the active treatment provided by Synbiotics AB Sweden for free, consisted of lyophilized 4 × 10 | PMC10004766 | ||
2.3. Analysis of Plasma Immune Activity Markers | Peripheral blood was collected in tubes containing EDTA. Immediately after collection, the tubes were centrifuged at 1700× | PMC10004766 | ||
2.4. Analysis of Plasma Short-Chain Fatty Acids (SCFAs) | SCFAs (formic, acetic, propionic, butyric, isobutyric, succinic, valeric, isovaleric, and caproic acid) were analyzed in EDTA plasma by liquid chromatography–mass spectrometry (LC-MS) according to a method described previously [ | PMC10004766 | ||
2.5. Cell Culture | Human aortic vascular smooth muscle cell line (hAVSMCs), developed from a 23 years old African American healthy female, was purchased from (ATCC, Manassas, VA, USA, | PMC10004766 | ||
2.6. Statistical Analysis | ADHD | Analysis of differences in analyte levels between diagnosis groups (control versus ADHD patient), age groups (child versus adult), medication groups (yes versus no), and sexes (males versus females) was performed using Mann–Whitney U tests. Statistical relationships between two analytes were assessed by applying Spearm... | PMC10004766 | |
3. Results | PMC10004766 | |||
3.1. Baseline Levels of Immune Activity Markers in ADHD Patients | ADHD | Clinical characteristics of the study participants, being pediatric and adult ADHD patients and adult healthy controls, are summarized in The healthy controls included were from two categories, healthy family members and unrelated individuals. The baseline levels of eotaxin-1, fractalkine, MCP-1, TGF-β3, and TRAIL diff... | PMC10004766 | |
3.2. Effects of Synbiotic 2000 on Immune Activity Markers | ADHD | Children treated with Synbiotic 2000 showed a significant reduction of levels of IL-12/IL23p40, sICAM-1, and TGF-β3 from baseline to 9-week follow-up, while children treated with placebo did not show any level change of any immune activity marker over time (Among children with ADHD, pro-inflammatory cytokine IL-12/IL-2... | PMC10004766 | |
3.3. Baseline Levels of Short-Chain Fatty Acids (SCFAs) in ADHD Patients | ADHD | Plasma concentrations of six SCFAs were analyzed in the ADHD patients and the healthy controls. We found that the shorter SCFAs (formic acid, acetic acid, propionic acid, and succinic acid) were significantly correlated with each other in both controls and patients (Comparing levels between pediatric and adult ADHD pat... | PMC10004766 | |
3.4. Effects of Synbiotic 2000 on SCFAs | No significant changes in SCFA concentrations from baseline to follow-up were found neither for those on placebo nor those treated with Synbiotic 2000 for neither children nor adults (As shown in | PMC10004766 | ||
3.5. Associations between Immune Activity Markers and SCFAs | ADHD | Immune activity markers and SCFAs are both important components in the microbiota–gut–brain axis, and a small number of cellular in vitro studies have reported the effects of butyrate on a few immune activity markers. We performed a correlation analysis between plasma levels of the immune activity markers and concentra... | PMC10004766 | |
3.6. Effects of SCFAs on ICAM-1 Expression in Human Aortic Vascular Smooth Muscle Cells In Vitro | human aortic vascular smooth muscle | To further validate the negative correlations between SCFAs and sICAM-1, we did three independent in vitro experiments in human aortic vascular smooth muscle cells. Our results showed lower IL-1β-induced ICAM-1 expression when the cells were pre-incubated with formic acid, acetic acid, or propionic acid of the concentr... | PMC10004766 | |
4. Discussion | autistic traits, IBD, ADHD | PATHOLOGY, INFLAMMATORY BOWEL DISEASE | This study is the first to report the effects of a synbiotic intervention on plasma levels of immune activity markers and SCFAs in children and adults with ADHD. We previously reported that this intervention in an RCT design reduced autistic traits in children and improved emotion regulation in adults with ADHD [IL-12 ... | PMC10004766 |
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