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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Outcomes | SECONDARY | In this post-hoc analysis, patients were grouped by the NED at study drug initiation into low (≤ 0.25 µg/kg/min) and high (> 0.25 µg/kg/min) subgroups. This cut-off was established on the basis of post-marketing observational studies demonstrating that 0.2–0.3 µg/kg/min NED is a common criterion in local hospital proto... | PMC10163684 | |
Statistical methods | Categorical data were reported as counts with percentages and analyzed with chi-square or Fisher exact test in univariate analysis, as appropriate. Continuous data were reported as medians with interquartile ranges and analyzed with Wilcoxon rank sum test in univariate analysis. Kaplan–Meier analyses were used to descr... | PMC10163684 | ||
Results | PMC10163684 | |||
Renal recovery of patients on RRT | Within the low-NED subgroup, renal recovery (defined as cumulative incidence of discontinuing RRT) at day 7 in patients receiving RRT at randomization in the AT II group was 59% compared to 33% in the placebo group (HR 1.99; 95% CI: 0.55–7.24; | PMC10163684 | ||
Sensitivity analysis | SENSITIVITY | Sensitivity Analysis of the primary outcomes was performed at a NED threshold of 0.2 µg/kg/min and 0.3 µg/kg/min. At a threshold of 0.2 µg/kg/min, there were only 27 patients in the low-NED AT II group and 18 patients in the low-NED placebo group. Overall, with a sample size this low, there was not enough power to dete... | PMC10163684 | |
Discussion | Sepsis, shock, vasoplegic syndrome, hypotension, septic shock | SEPSIS, SHOCK, DISEASE, VASODILATORY SHOCK, SEPTIC SHOCK, DISEASE | This exploratory post-hoc analysis of the phase 3 ATHOS-3 clinical trial was undertaken to determine whether there is a signal for benefit of intervening with AT II at lower doses of other vasopressor agents. While this analysis is only hypothesis-generating in nature, we found a narrow window of low background vasopre... | PMC10163684 |
Conclusions | This exploratory post-hoc analysis of a phase 3 clinical trial suggests that the introduction of AT II therapy at lower doses of vasopressor therapy may be associated with benefit. Prospective randomized trials of AT II infusion in lower NED patients may be both desirable and justified. While the data presented herein ... | PMC10163684 | ||
Acknowledgements | None. | PMC10163684 | ||
Author contributions | Conception and design of the study: PMW, CRG, TH, JHC. Acquisition of data: All authors. Analysis and interpretation of data: All authors. Drafted or provided critical revisions: All authors. Provided final approval of manuscript: All authors. All authors read and approved the final manuscript. | PMC10163684 | ||
Funding | The primary study and the present post-hoc analysis were supported by La Jolla Pharmaceutical Company. The work is the authors’ own and no payments were made to the authors for participating in or writing the paper. | PMC10163684 | ||
Availability of data and materials | The data supporting the findings of this study are available from La Jolla Pharmaceutical Company. However, restrictions apply to the availability of these data, which were used under license for the current study and so are not publicly available. However, data are available from the authors upon reasonable request an... | PMC10163684 | ||
Declarations | PMC10163684 | |||
Ethics approval and consent to participate | ATHOS-3 was sponsored by La Jolla Pharmaceutical Company and conducted under full oversight of site-level or central institutional review boards and ethics committees, per regional requirement. Written informed consent was obtained from all patients or their legal surrogates prior to inclusion. | PMC10163684 | ||
Consent for publication | Not applicable. | PMC10163684 | ||
Competing interests | AMD, Hypertension | HYPERTENSION, SEPTIC SHOCK | RB, KRH, and AMD, report no conflicts of interest. JHC, PMW, AKK, RGW, and DWB have previously served on a scientific advisory board for La Jolla Pharmaceutical Company. JHC, LWB, AKK, and DWB have served on the Speaker’s Bureau for La Jolla Pharmaceutical Company. AZ and JHC have received consultant fees from La Jolla... | PMC10163684 |
References | PMC10163684 | |||
Background | anxiety | DENTAL CARIES, DISEASE | People with dental phobia often present with more active dental caries and fewer teeth. Minimally Intervention oral Healthcare offers a possible solution to address the high care needs of this group. The aim was to determine this patient group’s eligibility and willingness to participate and the effect of MIOC, compare... | PMC10391962 |
Methods | This two-arm randomised feasibility trial ( | PMC10391962 | ||
Results | Forty-four people diagnosed with dental phobia were allocated randomly to the two study arms. At the six-month recall after completed care, the outcome of each study arm was assessed. It was feasible to conduct a clinical trial (eligibility rate [56%], completion rate [81%], declined to participate [12%]). The interven... | PMC10391962 | ||
Conclusion | phobia | A clinical trial of MIOC vs TAU in people with dental phobia is feasible. Preliminary findings suggest that patients in the MIOC arm are more likely to successfully complete their course of treatment. The study was ‘retrospectively registered’ on 02/05/2018 (ISRCT15294714) with the International Standard Randomised Con... | PMC10391962 | |
Keywords | PMC10391962 | |||
Background | phobia, anxiety, ’, phobic, caries | DENTAL CARIES, INFLAMMATION, DISEASE, CARIES, DISEASES | Dental phobia has been defined “as a persistent fear of situation disproportional to the actual danger posed to the affected person where many will go to great lengths to avoid it. If the feared object or situation cannot be avoided entirely, the affected person will endure it with marked distress and significant inter... | PMC10391962 |
Methods | PMC10391962 | |||
Trial design | A two-arm feasibility trial (Fig. Flow diagram for the feasibility study according to CONSORT 2010The following three feasibility outcomes: the proportion of patients presenting for treatment who met the eligibility criteria (Table
Dentist adherence to intervention.Patient adherence with behaviour required by interven... | PMC10391962 | ||
Setting and location | The department of Sedation and Special Care Dentistry (SSCD) is based in Guy's Dental Hospital as part of Faculty of Dentistry, Oral & Craniofacial Sciences, King’s College London (KCL) and Guy's and St Thomas' Hospitals Foundation Trust (GSTT). Patients are referred from primary care for treatment by specialists when ... | PMC10391962 | ||
Randomisations | Patients were allocated to condition at random, following a simple random allocation sequence created independently of the treating clinician. The allocation sequence was concealed in an opaque envelop, opened after the participant consented. | PMC10391962 | ||
Intervention (T3) | The intervention group was treated according to the MIOC patient management pathway [ | PMC10391962 | ||
Description of treatment as usual arm (TAU) | Participants in the standard (control, TAU) care arm were offered conventional treatment. Upon completion of dental care, at the recall appointment that marked the end of the study, participants’ oral health outcome was documented by SSCD staff (Table The trial’s data collection information | PMC10391962 | ||
Validation of the intervention | In order to validate the independent variable (testing if MIOC was delivered as per protocol design), one of the authors (AB) reviewed 11 randomised patients’ records to assess if treatment was provided per feasibility and MIOC protocol. | PMC10391962 | ||
Measures | Information was collected (Table | PMC10391962 | ||
Screening measures | Anxiety, anxiety, tooth, depression, Depression | Participants completed a questionnaire set comprising Demographic data, Modified Dental Anxiety Score (MDAS) and Hospital Anxiety & Depression Scale (HADS) information. MDAS consists of five-items related to the dentist’s waiting room, tooth drilling and scaling in addition to local anaesthetic injection. The 5-point s... | PMC10391962 | |
Measures for eligible patients | OHR | The eligible participants filled in the questionnaire (part A and part B). Part B of the questionnaire (with questions based on ADHS, 2009) [At the recall appointment, in the post completion of care (≥ 6 months), in addition to part A of the questionnaire (patients’ demographic, MDAS and HADS), part B (patients’ OHR be... | PMC10391962 | |
Outcome measures (baseline and completed care) | PLAQUE | The clinical data compromised of collecting data on total number of teeth present, DMFS, BPE and plaque scores based on the UK ADHS 2009 methodology [ | PMC10391962 | |
Statistics | For outcome measures, the statistical analysis consisted of descriptive statistics (means, proportions, standard deviations [SD]). No changes to the trial protocol or trial measures were made after the commencement of the trial. | PMC10391962 | ||
Results | Figure In addition, the study sought to determine a preliminary estimate of the following potential outcome variables (e.g., patient satisfaction with care provided) (Table The data form the trial’s data collection information | PMC10391962 | ||
Validation of the intervention | One of the authors (AB) reviewed independently a random sample of 11 participants case records in the intervention arm and was satisfied that dentist (EH) had adhered to the defined specific behaviours in the MIOC pathway. | PMC10391962 | ||
Patient’s demographic | OHR, ’ | Most of the respondents were female (32, 72%) and between the ages of 45 to 54 (13, 30%). The average age for completing full-time education was 16 and 18 in the experimental respective control arm at the baseline. Majority of the respondents (33, 75%) only attended when they had trouble with their teeth/dentures.In MI... | PMC10391962 | |
Recall rates within the trial | In the MIOC (intervention arm) group, there were 4 dropouts whilst in the TAU group, the number was 19 (Fig. | PMC10391962 | ||
Discussion | phobic, OHR, phobia, caries | SECONDARY, RECRUITMENT, CARIES, DECAYED TEETH | This feasibility study highlighted that a trial seeking to determine the effects of providing MIOC to patients with dental phobia is possible within a secondary care setting that is a major national provider of conscious sedation and CBT services. The recruitment process to identify eligible patients and acceptability ... | PMC10391962 |
Acknowledgements | The authors would like to thank all the participants for taking part in this research, the department of Sedation and Special Care Dentistry and Faculty of Dentistry, Oral & Craniofacial Sciences (FoDOCS) for the support for this study. | PMC10391962 | ||
Authors’ contributions | The correspondence author has contributed in all following mentioned elements (the conception, design of the work, the acquisition, analysis interpretation of data, have drafted the work, revised it and approved the submitted version). The other authors (TN and AB) have contributed to all mentioned elements (the concep... | PMC10391962 | ||
Funding | “Not applicable”. | PMC10391962 | ||
Availability of data and materials | All data generated or analysed during this study are included in this published article. | PMC10391962 | ||
Declarations | PMC10391962 | |||
Ethics approval and consent to participate | Approval was obtained from East of Scotland Research Ethics Service (EoSRES) and Health Research Authority (REC:17/ES/0067).All methods were carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from all participants for all forms of personally identifiable data including cli... | PMC10391962 | ||
Consent for publication | “Not applicable”. | PMC10391962 | ||
Competing interests | The authors declare no competing interests. | PMC10391962 | ||
References | PMC10391962 | |||
Background | inflammation, infections | INFLAMMATION, INFECTIONS | Preterm children with their aberrant gut microbiota and susceptibility to infections and inflammation constitute a considerable target group for probiotic therapy to generate the age-appropriate healthy microbiota. | PMC10589095 |
Methods | 68 preterm neonates were randomized into five intervention groups: Beginning from the median age of 3 days, 13 children received | PMC10589095 | ||
Results | The gut microbiota compositions of the children directly receiving the probiotic combination (LGG + Bb12) were significantly different from those of the children receiving the other intervention modes or placebo ( | PMC10589095 | ||
Conclusion | DISEASES | The connection between aberrant primary gut microbiota and a heightened risk of infectious and non-communicable diseases invites effective microbiota modulation. We show that the direct, early, and brief probiotic intervention of LGG + Bb12 10 | PMC10589095 | |
Impact | breast milk |
Preterm children have a higher risk of several health problems partly due to their aberrant gut microbiota.More research is needed to find a safe probiotic intervention to modify the gut microbiota of preterm children. The maternal administration route via breast milk might be safer for the newborn.In our study, the e... | PMC10589095 | |
Introduction | prematurity, breast-fed | NECROTIZING ENTEROCOLITIS, SEQUELAE | The gut microbiota of healthy term vaginally delivered breast-fed children is rich in bifidobacteria.The establishment of the gut microbiota guides the maturation of key regulatory systems during the critical period of developmental plasticity.The use of specific probiotics has received considerable attention, particul... | PMC10589095 |
Methods | SEVERE BIRTH ASPHYXIA | A randomized, double-blind, placebo-controlled clinical trial recruited preterm neonates and their mothers at the Turku University Central Hospital from April 2014 to March 2018. The trial was registered in October 2011 (ClinicalTrials.gov Identifier NCT01454661). Children born during a 25–35-week gestational period, y... | PMC10589095 | |
The progress of the study. | MP | -11, DISEASE, ADVERSE EVENT, LYSIS | Initially, 65 mothers with their 79 newborn children were randomized into five intervention groups. Eventually, 68 mother-child pairs were eligible for the study. The abbreviations of the intervention groups are described in figure.The intervention strains were -Placebo: both the mother and the child received placebo-C... | PMC10589095 |
Statistics | The data was stored as a TreeSummarizedExperiment | PMC10589095 | ||
Results | The clinical characteristics of the study population are summarized in Table Characteristics of the children at birth by intervention group. Median with range or number with percentage. | PMC10589095 | ||
A heatmap of the gut microbiota of the preterm children receiving placebo. | breast milk | The counts of the bacterial groups have been converted into relative abundances, then CLR-transformed for the samples, and Z-transformed for the features (taxa) so that the heatmap is distributed around 0. The The effect of possible confounding factors on the gut microbiota.The R2 values that describe to what extent th... | PMC10589095 | |
Discussion | breast-fed | ACUTE INFECTIONS, ADVERSE EFFECTS | In early life, the profile of the gut microbiota of a full-term, vaginally delivered, breast-fed infant is considered the gold standard.Our study has a number of limitations. The intervention groups were small because several different interventions were included. Nevertheless, our study is of importance for future res... | PMC10589095 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41390-023-02560-y. | PMC10589095 | ||
Acknowledgements | We warmly thank Prof. Maria Carmen Collado (Institute of Agrochemistry and Food Technology, Valencia, Spain) for the sequencing analyses of the faecal samples and Ms Satu Tölkkö (Functional Foods Forum, University of Turku, Finland) for processing these samples. | PMC10589095 | ||
Author contributions | S.R. designed the study. H.H. performed the microbiological analyses. The statistical analyses were performed by C.R. and L.L. All authors participated in analyzing and interpreting the data. The first draft of the manuscript was written by E.-N.R.; all authors contributed to writing and revising the manuscript, have s... | PMC10589095 | ||
Funding | This trial was partly financed by the Finnish Foundation for Paediatric Research and The Academy of Finland, project 26081142. Open Access funding provided by University of Turku (UTU) including Turku University Central Hospital. | PMC10589095 | ||
Data availability | The datasets generated and analysed during the current study are available from the corresponding author on reasonable request. Source code for the analyses is available online [10.5281/zenodo.6674816]. | PMC10589095 | ||
Competing interests | The authors declare no competing interests. | PMC10589095 | ||
Informed consent | Written informed consent was obtained from the children’s parents. | PMC10589095 | ||
References | PMC10589095 | |||
1. Introduction | metabolic syndrome, MetS, premature death, T2DM | EVENT, SECONDARY, METABOLIC SYNDROME, TYPE 2 DIABETES, TYPE 2 DIABETES MELLITUS, METABOLIC SYNDROME, COMPLICATIONS | There is a high prevalence of metabolic syndrome (MetS) among people with type 2 diabetes mellitus (T2DM). Physical activity has the potential to improve health outcomes for individuals with type 2 diabetes. Our study aim was to determine the effect of a 12-week culturally appropriate home-based physical activity progr... | PMC10138586 |
2. Materials and Methods | PMC10138586 | |||
2.1. Study Design | MAY, RECRUITMENT | This study is a single-site parallel feasibility randomised controlled trial (RCT). The study design has the potential to provide information on intervention compliance, retention, adherence, recruitment, and safety [Ethics approvals were obtained in May 2022 from the Deakin University Human Research Ethics Committee (... | PMC10138586 | |
2.2. Participants | abdominal obesity, MetS, Diabetes, T2DM, Metabolic syndrome | RECRUITMENT, RECRUITMENT, METABOLIC SYNDROME, DIABETES | Between June and August 2022, 134 patients with T2DM and MetS who routinely reported to the National Diabetes Management and Research Centre (NDMRC) of the Korle-Bu Teaching Hospital (KBTH) were screened for possible recruitment into the study. A diagnosis of T2DM was confirmed by an NDMRC nurse or physician based on d... | PMC10138586 |
2.3. Study Interventions | PMC10138586 | |||
2.3.1. Control Group (Usual Diabetes Care in Ghana) | diabetes | DIABETES | Usual diabetes care in Ghana involves routine follow-up visits to the diabetes clinic. Depending on the patient’s glycaemic control, this visit may occur every 1 to 6 months. During these visits, the patient undergoes routine medical assessment (e.g., weight, BP, urine analysis, and blood tests such as Hb1Ac, FBG, and ... | PMC10138586 |
2.3.2. Intervention Group (PA Program) | diabetes | DIABETES | Participants engaged in a structured 12-week PA program in addition to their usual diabetes care. In total, participants engaged in 36 exercise sessions, involving three sessions per week with no more than two days without exercise. With each session lasting 45 min, participants performed three minutes of stretching ex... | PMC10138586 |
2.4. Outcome Measures | TG, pain | ADVERSE EVENTS, SECONDARY, BLOOD, PATHOLOGY, CREST | The primary outcome measure was a change in MetS markers (BP, TG, WC, FBG, and HDL) in the IG, compared to those in the CG. Secondary outcomes included: (1) a change in QoL in the IG, compared to the CG; and (2) feasibility of implementing the PA program determined by measures of participation and safety. Except for me... | PMC10138586 |
2.5. Data Analysis | Data were analysed using STATA (version 17). Continuous data are reported as means +/− SD and categorical data are reported using frequencies and percentages. Baseline comparisons between the control group and the intervention group were analysed using two sample t-tests or chi-squared tests for continuous and categori... | PMC10138586 | ||
3. Results | PMC10138586 | |||
3.1. Sample Characteristics | ±, T2DM | RECRUITMENT | A total of 87 out of 134 patients screened for eligibility were included in the study, indicating a recruitment rate of 64.9%. Reasons for exclusion included poor ECG results (Forty-four patients were randomly allocated to the IG (mean age 56.2 ± 8.3 years) and 43 were assigned to the CG (mean age 56.5 ± 8.5 years). Mo... | PMC10138586 |
3.2. Physical Activity Program Participation | Thirty-two (72.7%) participants in the IG completed the 12-week program (all 36 sessions at home and facility) and the remaining eleven (25%) participants completed 80% of the exercise sessions. The average number of sessions completed was 29 ± 5.4 (mean ± SD) out of 36 sessions. This indicates high feasibility. Reason... | PMC10138586 | ||
3.3. Effect of Physical Activity on Metabolic Syndrome Markers | Following the 12-week PA program, participants in the IG had significant improvement (Correlation analyses showed no significant difference between groups for oral glycaemic medication use and insulin use ( | PMC10138586 | ||
3.4. Effect of Physical Activity on Quality of Life | Comparing the IG to the CG, our results show that QoL generally improved in some dimensions of the SF-12, in favour of the IG, as shown in | PMC10138586 | ||
4. Discussion | MetS, T2DM, diabetes | ADVERSE EVENTS, PATHOLOGY, RECRUITMENT, DIABETES | The findings of this study show that the culturally appropriate 12-week PA program designed specifically for Ghanaian adults with T2DM improved three MetS markers (FBG, SBP, and WC). This is likely to have contributed to the reclassification of 48.8% of participants in the IG as no longer having MetS after completion o... | PMC10138586 |
5. Conclusions | MetS, T2DM, diabetes | DIABETES | Overall, our findings suggest that the PA program implemented in this study has the potential to improve MetS and QoL in Ghanaian adults with T2DM. Further, the PA program was feasible and safe. With a signification proportion of Ghanaians with T2DM resorting to alternative diabetes treatment, coupled with barriers to ... | PMC10138586 |
Author Contributions | Conceptualization, M.A.; methodology, M.A., D.K., Y.A., M.M.S. and A.D.; software, M.A. and M.M.S.; validation, M.A., D.K., Y.A. and A.D.; formal analysis, M.A., D.K. and A.D.; investigation, M.A., Y.A. and M.M.S.; resources, M.A., D.K., Y.A., M.M.S. and A.D.; data curation, M.A. and M.M.S.; writing—original draft prep... | PMC10138586 | ||
Institutional Review Board Statement | MAY | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Korle-Bu Teaching Hospital (protocol code KBTH-IRB/00011/2022; date of approval 24 May 2022) and the Deakin University Human Research Ethics Committee (protocol code 2022-041; date of approval 13 May... | PMC10138586 | |
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10138586 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10138586 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10138586 | ||
Objective: | To evaluate the impact of a menu box delivery service tailored to the long-day care (LDC) setting on improving menu compliance with recommendations, children’s diet quality and dietary intake while in care. | PMC10755420 | ||
Design: | A cluster randomised controlled trial in LDC centres randomly assigned to an intervention (menu box delivery) or comparison (menu planning training) group. The primary outcome was child food provision and dietary intake. Secondary outcomes include menu compliance and process evaluation, including acceptability, fidelit... | PMC10755420 | ||
Setting: | South Australian LDC centres. | PMC10755420 | ||
Participants: | Eight LDC centres ( | PMC10755420 | ||
Results: | No differences were observed in serves/d between intervention and comparison centres, for provision (intervention, 0·9 inter-quartile range (IQR) 0·7–1·2; comparison, 0·8 IQR 0·5–1·3) or consumption (intervention, 0·5 IQR 0·2–0·8; comparison, 0·5 IQR 0·3–0·9) of vegetables. Child food provision and dietary intake were ... | PMC10755420 | ||
Conclusions: | Menu compliance can be improved via a menu delivery service, delivering equivalent impacts on child food provision and dietary intake compared with an online training programme. Further exploration of cooks acceptability and cost is essential before scaling up to implementation. | PMC10755420 | ||
Keywords | chronic disease | DISEASE, SECONDARY, CHRONIC DISEASE | A nutritious diet supports health, growth and development. Diet is a modifiable risk factor for chronic disease and can prevent the burden of disease later in life. Early intervention is key to developing healthy habits, especially as behaviours developed in childhood often carry through to adolescence and adulthoodIn ... | PMC10755420 |
Methods | PMC10755420 | |||
Study design | A cluster randomised controlled trial design in South Australian LDC centres. Centres were randomly allocated to one of two study groups over the 12-week study period. Intervention centres received a weekly menu box delivery service to provide a predetermined menu compliant with the Victorian Menu Planning Guidelines, ... | PMC10755420 | ||
Study participants | Study participants are reported in detail in the published protocol paper | PMC10755420 | ||
Recruitment | As detailed in the protocol paper, eligible centres were recruited in partnership with a local childcare service provider and stratified by socio-economic status | PMC10755420 |
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