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Strengths and Limitations | SECONDARY, BLIND | Strengths of our study include the use of between-group structural equivalence and blind assessment. Furthermore, outcomes of interest (methadone doses and number of treatment days) were based on objective measures, extracted from patient records.This trial has limitations. It was not powered to detect group difference... | PMC10099063 | |
Conclusions | OUD | To our knowledge, this is the first RCT to assess the efficacy of a harnessed placebo intervention in a clinical OUD treatment context. Our findings of C-OLP–enhanced treatment retention and ameliorated sleep merit further investigation, especially considering the unchecked OUD epidemic that continues in the US. | PMC10099063 | |
Background | depression, anxiety | Some studies indicate that more than 10% of pregnant women are affected by psychological problems. The current COVID‐19 pandemic has increased mental health problems in more than half of pregnant women. The present study compared the effectiveness of virtual (VSIT) and semi-attendance Stress Inoculation Training (SIT) ... | PMC10176276 | |
Methods | psychological distress | This study was conducted on 96 pregnant women with psychological distress in a 2-arm parallel-group, randomized control trial between November 2020 and January 2022. The semi-attendance SIT received treatment for six sessions, sessions 1, 3 and 5 as individual face-to-face and sessions 2, 4 and 6 as virtual once a week... | PMC10176276 | |
Results | depression, psychological distress, anxiety | The post-intervention results showed that the stress inoculation training technique in both VSIT and SIT interventions effectively reduced anxiety, depression, psychological distress, pregnancy-specific stress and general perceived stress [ | PMC10176276 | |
Conclusion | The semi-attendance SIT group has been a more effective and practical model than the VSIT group, for reducing psychological distress. Therefore, semi-attendance SIT is recommended for pregnant women. | PMC10176276 | ||
Keywords | PMC10176276 | |||
Introduction | infection, depression, sleep disorders, anxiety | INFECTION, MATERNAL DISTRESS, DISORDERS | Pregnancy, as a critical period of a woman’s life, can be affected by various psychological factors [Given the fundamental role of maternal health during pregnancy on the long-term health of the developing fetus, it is essential to identify prenatal interventions to reduce maternal distress [A study examining the effec... | PMC10176276 |
Materials and methods | PMC10176276 | |||
Design | The present study is a multicenter randomized clinical trial with two parallel intervention groups. It was registered in the Iranian Clinical Trial registry under the number IRCT.20200122046228N1. | PMC10176276 | ||
Participant recruitment | bleeding, psychiatric | PRETERM DELIVERY, BLEEDING, MISCARRIAGE, DISORDERS | The study population consisted of all pregnant women of 14–32 weeks’ gestation referred to selected hospitals. It was performed in two educational and therapeutic centers affiliated with the Babol University of Medical Sciences in Iran between November 2020 and January 2022.The sample consisted of women meeting the eli... | PMC10176276 |
Sample size calculation | The sample size was calculated at 48 participants for each group using G-Power and Mohammadi et al.’s article [First type errors (α):0.05 s type error (β): 0.1To implement the intervention, the researcher first provided the necessary explanations about the study objectives to the subjects and obtained their informed wr... | PMC10176276 | ||
Measurements | anxiety, infertility, psychological distress, depression, Prenatal Distress | SECONDARY | The demographic and fertility information questionnaire included the mother’s age, job, and education level, the father’s education level and job, the family’s economic status, place of residence, gestational age, number of pregnancies, number of living children and history of infertility.The primary outcome of this st... | PMC10176276 |
Interventions | The sessions are six consecutive sessions, one day a week. The content of the sessions is the same for both groups. The structure of SIT therapy sessions was described in Table Outline of the training sessions | PMC10176276 | ||
SIT group | The session outline for intervention group 1 was as follows: SIT technique was conducted by a female expert psychotherapist (author MF) who had a license in psychology. The psychologist and Perinatologist (author ZP) organized weekly 60-min face-to-face group sessions for a period of 6 weeks. A female assistant (author... | PMC10176276 | ||
VSIT group | depression, bleeding, anxiety, abortion | PRETERM DELIVERY, SECONDARY, BLEEDING | Intervention VSIT group subjects received six sessions of virtual SIT treatment simultaneously. Virtual group meetings were held on WhatsApp messenger through which podcasts [consultant’s voice messages], videos, similar examples in PDF format and relaxation audio files were sent. To receive a consultation, the first r... | PMC10176276 |
Data management and analysis | REGRESSION | The mean and the relevant standard deviation for presenting patients’ characteristics and the study outcomes were used as summary measures in tables and results. An intention-to-treat analysis was used to manage the missing outcomes. Multiple Imputation technique was applied for addressing the missing observations. MI ... | PMC10176276 | |
Ethical considerations | The trial was approved by the Ethics Committee of the National Institute [IR.MUBABOL. HIR.REC.1399.277] and registered in the IRCT | PMC10176276 | ||
Discussion | Anxiety, mental distress, anxiety, SIT, depression | The present study was conducted to compare the effectiveness of virtual and semi-attendance Stress Inoculation Training on improving the symptoms of anxiety, depression and stress in pregnant women with mental distress. So far, this method has not been used to compare groups virtually or as semi-attendance. The results... | PMC10176276 | |
Limitations of the study | depression, anxiety | SECONDARY | This study had strengths and limitations that should be noted. One of the main strengths is that the present study was the first randomized clinical trial to compare the effectiveness of Virtual with face-to-face Semi-Attendance SIT techniques in Pregnant Women with Psychological distress for improving the symptoms of ... | PMC10176276 |
Acknowledgements | We would like to thank the staff of Rouhani and Yaheinejad hospitals for their cooperation in the implementation of this study. Also, we thank Midwifes Ms. Shafirizi and Ms Mirtabar they helped with sampling, and the outcome assessor, as well as respected professors and all participating pregnant mothers. | PMC10176276 | ||
Authors’ contributions | A.F. and F.N.A wrote the main manuscript text and M.F. prepared Counseling sessions. M.C performed the statistical analysis. H.A.R and Z.P reviewed the literature and prepared the manuscript. All authors reviewed the manuscript. The authors read and approved the final manuscript. | PMC10176276 | ||
Funding | The article was funded by Babol University of Medical Sciences (Grant No. 724132937). | PMC10176276 | ||
Availability of data and materials | The data sets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10176276 | ||
Declarations | PMC10176276 | |||
Ethics approval and consent to participate | In order to do ethical consideration, this study followed the guidelines set by declaration of Helsinki and received ethical approval for human subject by the Ethics Committee of Babol University of Medical Science approved the study.[Code of Ethics: MUBABOL.HIR.REC. 1399.277]. The pregnant women all provided written i... | PMC10176276 | ||
Consent for publication | Not applicable. | PMC10176276 | ||
Competing interests | The authors declare no competing interests. | PMC10176276 | ||
References | PMC10176276 | |||
Objective | SE, Status epilepticus | STATUS EPILEPTICUS | Status epilepticus (SE) is an emergency condition for which rapid and secured cessation is crucial. Although fosphenytoin (FPHT) is recommended as a second-line treatment, levetiracetam (LEV) reportedly has similar efficacy, but higher safety. Therefore, we herein compared LEV with FPHT in adult SE. | PMC9763167 |
Methods | convulsive, seizure | We initiated a multicentre randomised control trial in emergency departments with adult patients with convulsive SE. Diazepam was initially administered, followed intravenously by FPHT at 22.5 mg/kg or LEV at 1000–3000 mg. The primary outcome was assigned as the seizure cessation rate within 30 min of the administratio... | PMC9763167 | |
Results | SE, Seizure, seizure | ADVERSE EVENTS, RECURRENCE | A total of 176 adult patients with SE were enrolled (82 FPHT and 94 LEV), and 3 were excluded from the full analysis set. Seizure cessation rates within 30 min were 83.8% (67/80) in the FPHT group and 89.2% (83/93) in the LEV group. The difference in these rates was 5.5% (95% CI −4.7 to 15.7, p=0.29). The non-inferiori... | PMC9763167 |
Conclusion | SE | The efficacy of LEV was similar to that of FPHT for adult SE following the administration of diazepam. LEV may be recommended as a second-line treatment for SE along with phenytoin/FPHT. | PMC9763167 | |
Trial registration number | jRCTs031190160. | PMC9763167 | ||
WHAT IS ALREADY KNOWN ON THIS TOPIC | STATUS EPILEPTICUS, ADVERSE EVENTS | Phenytoin/fosphenytoin are recommended as a second-line treatment for status epilepticus; however, these drugs are associated with serious adverse events. Levetiracetam is expected to be as effective, but with less serious adverse events because previous randomised control trials (RCTs) that compared them reported simi... | PMC9763167 | |
WHAT THIS STUDY ADDS | status epilepticus | STATUS EPILEPTICUS, ADVERSE EVENTS | There has yet to be a study with a positive result or non-inferiority designed RCT, particularly for adult status epilepticus. We herein conducted a multicentre non-inferiority designed RCT, in which adult patients with status epilepticus were randomised into levetiracetam and fosphenytoin groups as a second-line treat... | PMC9763167 |
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY | status epilepticus | STATUS EPILEPTICUS | Levetiracetam may be used as a second-line treatment for adult status epilepticus. Each guideline and clinical practice for status epilepticus may add it as an alternative to phenytoin/fosphenytoin. | PMC9763167 |
Background | SE, Status epilepticus, convulsive SE, cerebral damage | STATUS EPILEPTICUS | Status epilepticus (SE) is an emergency condition that is life-threatening with respiratory and circulatory system failure and may cause irreversible cerebral damage.Phenytoin is recommended as an effective second-line therapy for SE.Levetiracetam (LEV), which primarily binds to synaptic vesicle protein 2A and regulate... | PMC9763167 |
Materials and methods | PMC9763167 | |||
Design | SE | A multicentre, prospective and non-blinded RCT was conducted to compare the efficacy and safety of intravenous LEV and intravenous FPHT for the treatment of adult SE in the emergency room. The primary aim of the present study was to examine the non-inferiority of the efficacy of LEV to that of FPHT as a second-line tre... | PMC9763167 | |
Participants, setting | SE, convulsive SE, seizures | Between 23 December 2019 and 31 March 2022, 176 consecutive patients with convulsive SE transported to nine emergency departments were enrolled. We finished the study when 176 patients were enrolled, irrespective of the patient number in each group. Since scheduled enrolment was achieved earlier, patient registration w... | PMC9763167 | |
Interventions | SE, convulsions, seizures | Resuscitation and stabilisation were simultaneously performed. Diazepam was intravenously administered at 1–20 mg. The physician selected the dose of diazepam to stop seizures. Following the intravenous administration of diazepam, electronic data capturing (EDC) (TXP Medical) was registered using a smartphone or person... | PMC9763167 | |
Outcomes | convulsions, arrhythmia, seizure, respiratory arrest, Seizure, hypotension, SE | RECURRENCE, ARRHYTHMIA, RESPIRATORY ARREST, CARDIAC ARREST, LIVER DISEASE, ADVERSE EVENT | The primary outcome was the seizure cessation rate within 30 min of starting administration of the study drug. Seizure cessation in each patient was defined as the cessation of an apparent seizure 30 min after the administration of FPHT or LEV. Seizure cessation was not achieved when convulsions continued, convulsions ... | PMC9763167 |
Adverse events reporting, monitoring and interim analysis | ADVERSE EVENTS, ADVERSE EVENT | On-site monitoring was performed at each hospital by monitors appointed by the monitoring committee. Central monitoring was also conducted. Adverse events were reported on medical records and EDC, with causal associations with intervention drugs, dates, severity, with/without any treatments and outcomes. Serious advers... | PMC9763167 | |
Sample size estimation | SE | The rate of effectiveness of each AED for SE was not assessed, | PMC9763167 | |
Statistical analysis | SECONDARY | Statistical analyses were performed with a full analysis set (FAS) and safety analysis set (SAS). FAS was defined as all subjects without violations of the main eligibility criteria (selection and exclusion criteria) or conflicts with discontinuation and dropout criteria. SAS was defined as all subjects who received th... | PMC9763167 | |
Results | status epilepticus, pseudoseizures, Coma, seizure, Seizure, convulsive | STATUS EPILEPTICUS, ADVERSE EVENTS, COMA | Among the 176 adult patients with convulsive SE enrolled during the study period, 82 were assigned to the FPHT group and 94 to the LEV group. The protocol was performed and completed on all patients. We did not obtain consent from 13 patients because they were unconscious and there was no proxy during hospitalisation, ... | PMC9763167 |
Discussion | arrhythmia, seizure, epilepsy, hypotension, convulsive, SE, respiratory/circulatory arrest | ADVERSE EVENTS, ARRHYTHMIA, EPILEPSY | We compared the efficacies of intravenous LEV and intravenous FPHT as second-line treatments following the administration of diazepam for adult convulsive SE with a non-inferiority RCT. Similar efficacies for seizure cessation within 30 min were observed. No significant differences were noted in other efficacies and sa... | PMC9763167 |
Data availability statement | Data are available upon reasonable request. The data sets generated and/or analysed during the present study are available from the corresponding author upon reasonable request. | PMC9763167 | ||
Ethics statements | PMC9763167 | |||
Patient consent for publication | Consent obtained from parent(s)/guardian(s). | PMC9763167 | ||
Ethics approval | The Institutional Certified Review Board of Tsukuba University approved the present study (TCRB18-006). Participants gave informed consent to participate in the study before taking part. | PMC9763167 | ||
References | PMC9763167 | |||
Background | MetS, overweight, Metabolic Syndrome | METABOLIC SYNDROME | Metabolomic dysregulation following a meal in overweight individuals with the Metabolic Syndrome (MetS) involves multiple pathways of nutrient storage and oxidation. | PMC10349757 |
Objective | The aim of the current study was to perform an acute cross-over intervention to examine the interactive actions of meal glycaemic load (GL) on the dynamic responses of the plasma metabolome in overweight females. | PMC10349757 | ||
Methods | Postmenopausal women [63 ± 1.23y; Healthy ( | PMC10349757 | ||
Results | MetS | In the overweight women with MetS, there were suppressed postprandial responses for several amino acids (AAs), including phenylalanine, leucine, valine, and tryptophan, | PMC10349757 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00394-023-03151-7. | PMC10349757 | ||
Keywords | Open Access funding enabled and organized by CAUL and its Member Institutions | PMC10349757 | ||
Introduction | T2D, CVD, MetS, metabolic syndrome, type 2 diabetes | CVD, METABOLIC SYNDROME, TYPE 2 DIABETES, CARDIOVASCULAR DISEASE | The metabolic syndrome (MetS) is a cluster of conditions highly predictive for the subsequent development of type 2 diabetes (T2D) and cardiovascular disease (CVD) [Analysis of the metabolomic complexity of MetS is most frequently conducted on the fasting state, although it is apparent that disordered metabolic flux is... | PMC10349757 |
Methods | PMC10349757 | |||
Ethics | Written informed consent was obtained from all subjects. The experimental protocol was reviewed and approved by the University of Auckland Human Participants and Ethics Committee (Ref #014501). The trial was retrospectively registered at Australia New Zealand Clinical Trials Registry (ANZCTR; ACTRN12615001108505). | PMC10349757 | ||
Participants | The study recruited 40 postmenopausal Caucasian women from the Auckland region through newspaper advertisements and from the university community. Eligible subjects were required to have a BMI between 18 and 34 kg/mDue to the complexity of untargeted metabolomics, there remains no standard method for sample size estima... | PMC10349757 | ||
Metabolomic analysis | The extraction was performed using a slightly modified protocol based on the method used by [ | PMC10349757 | ||
Liquid chromatography–mass spectrometry | Plasma extracts and blanks were analysed through LC–MS streams using both positive and negative ionisation modes separately, as previously described [ | PMC10349757 | ||
Data integration | XCMS software [ | PMC10349757 | ||
Statistical analysis | Metabolomics data were analysed with a linear mixed-effects model (LMM) approach. Statistical analysis was performed using R (version 3.1.2) [ | PMC10349757 | ||
Compound identification | Annotation was performed on significant features generated from LMMs for each interaction by matching peak identification data (accurate mass and retention time) against a local library of authentic standards run under identical conditions. If no hit was obtained, significant features were searched against the public d... | PMC10349757 | ||
Discussion | MetS.Despite, generalised, MetS, diabetes | DIABETES, INSULIN RESISTANCE, LGL | The current study compares the plasma metabolomic responses in postmenopausal women with or without MetS to two carbohydrate-rich meals, differing on the basis of GL. Using an untargeted LC–MS strategy, the results demonstrate a predominance of differences in circulating AAs between the healthy and MetS women. There we... | PMC10349757 |
Conclusion | MetS, overweight | In summary, the use of an untargeted metabolomic analysis of plasma samples in postprandial women demonstrated small and transient differences in a range of AAs and several energy-related metabolites for overweight women, characterised as having the MetS, when compared to aged-matched leaner and metabolic healthier wom... | PMC10349757 | |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file 1 (DOCX 890 KB) | PMC10349757 | ||
Abbreviations | controlType 2 diabetes, Diabetes | DIABETES | Amino acidsAromatic amino acidArea under the curveBranched chain amino acidBody mass indexCardiovascular diseaseGlycaemic indexInternational Diabetes FederationLiquid chromatography–mass spectrometryLinear mixed-effects modelMetabolic syndromeOral glucose tolerance testQuality controlType 2 diabetes | PMC10349757 |
Acknowledgements | This work was funded by Agency for Science, Technology and Research (A*STAR), Singapore; Singapore-New Zealand Foods for Health Grant (BMRC grant 14/1/16/24/008), Ministry of Business, Innovation and Employment, New Zealand; Singapore–New Zealand Foods for Health Grant (MAUX1309), and AgResearch Limited through the Str... | PMC10349757 | ||
Funding | Open Access funding enabled and organized by CAUL and its Member Institutions. | PMC10349757 | ||
Data availability | The data that support the findings of this study are available from the corresponding author, [DCS], upon reasonable request. | PMC10349757 | ||
References | PMC10349757 | |||
1. Introduction | death, Stroke, stroke, AIS, disability, acute ischemic stroke | STROKE, STROKE, ISCHEMIC STROKE | The care model composed of a multidisciplinary team is the best model to promote stroke rehabilitation. The objective of this study was to explore the effect of nurse-led rapid rehabilitation on mechanical thrombectomy (MT) in patients with acute ischemic stroke (AIS). This study used a non-randomized, historically con... | PMC10344476 |
2. Methods | PMC10344476 | |||
2.1. Study design | ISCHEMIC STROKE | This study used a non-randomized, pre- and post-historical controlled clinical trial design to compare the efficacy of rapid and routine rehabilitation after thrombectomy in patients with ischemic stroke. Patients hospitalized from January 1 to December 31 2020, were included in the control group for regular rehabilita... | PMC10344476 | |
2.2. Target population | PMC10344476 | |||
2.2.1. Inclusion and exclusion criteria | organ dysfunction diseases | LUNG DISEASE, KIDNEY DISEASE, HEART DISEASE, LIVER DISEASE, MALIGNANT TUMORS | The inclusion criteria were as follows: AIS patients who met the relevant requirements for MT surgery during hospitalization and were selected according to AHA/ASA 2018 AIS Early Management Guidelines; over 18 years of age; signed informed consent for vascular interventional therapy by themselves or their representativ... | PMC10344476 |
2.3. Implementation plan of rapid rehabilitation | PMC10344476 | |||
2.3.1. Build multidisciplinary teams. | A multidisciplinary rehabilitation management team was established through group discussion, including nurses, neurologists, rehabilitation physicians, respiratory therapists, rehabilitation therapists, occupational therapists, speech therapists, and dietitians. After the formation of the protocol and before the formal... | PMC10344476 | ||
2.3.2. Responsibilities of team members. | ’ overall disease, pain | PAT, COMPLICATIONS | The nurse responsibility is to lead the whole process of rapid rehabilitation of patients during hospitalization, carry out targeted pain care, posture management, respiratory management, personalized health education, emotional, rollover, assessment and training of swallowing function, and pat the patient on the back ... | PMC10344476 |
2.3.3. Rapid recovery implementation process. | cough | RECRUITMENT | The nurses started the corresponding early rehabilitation program when the patient entered the ward. Through process optimization, all links are integrated and sorted, and the fast recovery standard and process of the whole process from postoperative to rehabilitation are established. When the patient is ready to be se... | PMC10344476 |
2.4. Data collection | Stroke | STROKE, SECONDARY, MRS, CHRONIC DISEASE | The primary outcome was disability status, measured by the MRS. The prognosis was the primary endpoint measure in this study and was evaluated using MRS scores.The following secondary outcomes were assessed:The nurse assessed the activities of daily living and MRS scores at discharge and 3 months after discharge. The M... | PMC10344476 |
2.5. Statistical methods | MRS | Continuous variables are expressed as the means and standard deviations or medians with the 25th and 75th percentiles. The compromise between the 2 groups was compared by The GEE model was used to compare the differential changes in each outcome (MRS) at the time point 3 months after discharge (T2) to the time point of... | PMC10344476 | |
2.6. Ethical considerations | WEST | The hospital ethics committee approved this study. This study was approved by the West China Hospital, Sichuan University ethics committee, number 2019 (728). All participants were thoroughly informed about the voluntary nature of their participation and their right to withdraw from the study at any time. Data collecti... | PMC10344476 | |
3. Results | PMC10344476 | |||
3.1. Description of the sample | death, ischemic stroke | ISCHEMIC STROKE | For the intervention group, 251 patients with ischemic stroke who underwent MT with admission dates 01/01/2021 to 12/31/2021 were identified as potentially eligible, of which 11 were subsequently classified as unsuitable. Among the 240 eligible patients, 211 enrolled, and 50 participants withdrew due to death, resultin... | PMC10344476 |
3.2. Comparison of outcomes between the 2 groups of stroke survivors | PMC10344476 | |||
3.2.1. Outcomes during hospitalization. | The length of hospital stay, hospitalization expense, mRS score, ADL score, and NIHSS score were compared between the 2 groups. Table The treatment outcomes of both groups (N = 285).IQR = interquartile range, M = mean, MED = median, SD = standard deviation. | PMC10344476 | ||
3.2.2. Outcomes of the 2 groups 3 months after discharge. | MRS | There was no significant difference in MRS score (The treatment outcomes of both groups (N = 285). | PMC10344476 | |
3.3. Effects of the Intervention on MRS | Table Generalized estimating equation model (N = 285).This parameter is set to zero because it is redundant. | PMC10344476 | ||
4. Discussion | stroke, AIS, ischemic stroke, ’ | STROKE, PERIOPERATIVE COMPLICATION, MRS, ISCHEMIC STROKE | Our study observed that stroke patients’ mortality rates within 3 months following thrombectomy were 20.0% in 2020 and 23.7% in 2021. However, the difference between the 2 years was not statistically significant. Similarly, the in-hospital mortality rates were 19.4% and 22.3%.Nonetheless, the clinical outcomes of these... | PMC10344476 |
5. Limitations | This study was historically controlled and non-randomized. Although the difference in baseline data was not statistically significant, the influence of individual differences and medical progress cannot be eliminated due to the limitation of the study type. This study was single-center, and patients’ subjective feeling... | PMC10344476 | ||
Acknowledgments | stroke | WEST, STROKE | Thanks to all medical staff of the Department of Neurology, West China Hospital, Sichuan University, for supporting this study. LF, the corresponding author, is the head nurse in the Department of Neurology. She has been in stroke nursing for over 20 years and has rich experience in stroke nursing management. | PMC10344476 |
Abbreviations: | acute ischemic stroke, Stroke | WEST, STROKE | acute ischemic strokegeneralized estimating equationmodified Barthel indexmodified Rankin scalemechanical thrombectomyNational Institutes of Health Stroke Scale scoreThis study was approved by the West China Hospital, Sichuan University ethics committee, number 2019 (728).Consent for publication: The participants were ... | PMC10344476 |
References | PMC10344476 | |||
Keywords | Single-parent adolescents are vulnerable individuals and it is necessary to improve their health, particularly during epidemics. This study aimed to investigate the effects of virtual logotherapy (VL) on health-promoting lifestyle (HPL) among single-parent adolescent girls during the COVID-19 pandemic. This single-blin... | PMC10198750 |
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