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Both groups will be followed up after their respective eye-drop application for 12 weeks according to the intervention regimens. Secondary outcome measures including meibomian gland function assessment, tear film break-up time, keratoconjunctival staining score, maximum blink interval and tear secretion volume using Schirmer’s test I will be assessed at 1, 5, 9, 13 and 25 weeks postoperatively.
This study has been approved by the Juntendo Hospital Certified Review Board, Tokyo, Japan (Approved protocol V.7.0 dated 7 May 2021. Approval number J20-018) and has been registered with the Japan Registry of Clinical Trials. Written informed consent will be collected from every patient prior to study participation. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.
jRCT1031210018.
jRCT1031210018.
Epilepsy is a neurological condition marked by recurring seizures. People with epilepsy, particularly in low-income and middle-income countries, are stigmatised due to a lack of understanding and a negative attitude towards the disease. Increased public awareness of epilepsy will aid in the search for therapy and the quality of life of the patients. The study aimed to assess knowledge about epilepsy and the associated factors among residents of Debub Bench District, Bench Sheko Zone, Southwest Ethiopia in 2020.
This community-based, cross-sectional study triangulated with qualitative method was conducted from 25 April 2020 to 20 May 2020. Multistage sampling technique was used to select 601 participants. A structured and interviewer-administered questionnaire was used to collect data. Data were entered in EpiData Manager V.4.0.2.101 and exported to SPSS V.23 for analyses. Multivariable logistic regression was carried out to identify the factors associated with knowledge of epilepsy. A p value of <0.05 atus, wealth index, occupation and residence.
Ageing in place, supported by formal home and community services and informal caregivers, is the most used long-term care option for people with dementia (PwD). Informal caregivers are inundated by their caregiving responsibilities and resultantly suffer consequences. Despite the multitude of clinical effectiveness studies on interventions that support informal caregivers, there is a paucity of information regarding their implementation process. This scoping review aims to identify the implementation strategies, implementation outcomes, and barriers and facilitators that impede or support the dissemination and uptake of interventions that support informal caregivers of PwD at home.
This protocol is guided by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Protocols, and the scoping review will follow the systematic steps of the PRISMA-Extension for Scoping Reviews guideline. The search strategy will include publications produced from inception to 8 March 2021 and will be cone to guide them in the effective implementation of caregiver-focused interventions in dementia support.
The review findings will be published in a peer-reviewed journal and disseminated at geriatric and implementation conferences to inform researchers, health service planners and practice professionals with an overview of the existing literature to guide them in the effective implementation of caregiver-focused interventions in dementia support.
Medical treatment is a less invasive alternative to surgical management of missed miscarriage. Studies have shown that pretreatment with mifepristone can increase the complete abortion rate in management of first-trimester missed miscarriage compared with misoprostol alone. Two studies have also shown that pretreatment with letrozole could increase the efficacy compared with misoprostol alone. So far, there is no trial comparing letrozole and mifepristone pretreatment for missed miscarriage. We designed this randomised controlled trial to test the hypothesis that for first-trimester missed miscarriage, letrozole pretreatment is non-inferior to mifepristone pretreatment followed by misoprostol in terms of complete abortion rate.
This is a prospective open-label non-inferiority randomised controlled trial conducted in a single centre. In total, 294 women diagnosed with first-trimester missed miscarriage opting for medical treatment is recruited with informed consent. They are randomly assigned to receive mi80.
Sciatica is one of the most common reasons for seeking healthcare for musculoskeletal pain. Sciatica is primarily considered as neuropathic in nature when neural tissue in the low back is compromised, but sometimes other non-neural structures may be involved. Appropriate assessment and management are important for patients with sciatica. Therapists use several outcome measures to assess patients to inform selection of the most suitable treatment. There is limited evidence for the best treatment of sciatica, and this is likely contributed to by having no reliable algorithm to categorise patients based on their clinical characteristics to inform physiotherapy treatment. The purpose of this study is to develop a clinical prediction model to categorise patients with sciatica, in terms of early clinical outcome, based on their initial clinical characteristics.
A prospective observational multicentre design will recruit consecutive patients (n=467) with sciatica referred for physiotherapy. Each patient will be tee of the University of West Attica, Athens, Greece, protocol number 38313-09/06/2020, 10226-10/02/2021. The study’s findings will be published in a peer-reviewed journal and disseminated at national and international conferences and through social media.
CRD42020168467.
CRD42020168467.
Autism spectrum disorder (ASD) is a complicated diffuse developmental disorder that commonly involves gastrointestinal distress and dysbacteriosis. Emerging lines of evidence have shown faecal microbiota transplantation (FMT) to be a potential therapeutic strategy for improving the clinical outcomes of patients with ASD by re-establishing their intestinal microflora. We are undertaking the first-ever multicentre, double-blind, randomised controlled trial of FMT for the treatment of children with both ASD and gastrointestinal symptoms and will assess the feasibility and efficacy outcomes of this strategy.
In total, 318 children with both ASD and gastrointestinal symptoms will be enrolled (from 15 hospitals in China) to receive either FMT intervention (n=212) or a placebo (control, n=106). Children aged 3-6 years will take two capsules two times a day, and those older than 6 years will take three capsules two times a day. Each patient will receive four treatment courses, with each 12-day course being repeated every month. Outcomes will be evaluated at baseline, throughout the period of intervention, and at subsequent follow-ups for 2 months. The primary trial objective is to investigate the remodelling effect of FMT on the intestinal microflora in patients with ASD. The secondary objective focuses on the clinical efficacy and safety of FMT, including its improvement of the clinical response and metabonomics.
Ethical approval was obtained from the hospital Ethics Committee of each Faecal Transfer for ASD China Multicenter Trial Working Group. The ongoing FMT clinical trial is intended to support the approval of the new technology and its administration. The results of this trial will provide high-quality evidence to inform the future clinical application of this new therapy.
ChiCTR2100043906; Pre-results.
ChiCTR2100043906; Pre-results.
Sri Lanka has a long history of armed conflict and natural disasters increasing the risk of mental health disorders in the population. Due to a lack of specialist services, there is a treatment gap between those seeking and those able to access mental health services. The aim of this research programme is to integrate mental health services into primary care to meet the needs of this postconflict population.
This is a stepped wedge cluster design randomised clinical trial of the WHO mental health Gap Action Programme primary care mental health training intervention. We will provide a 10-day training to primary care practitioners of 23 randomly selected primary care facilities aimed at increasing their ability to identify, treat and manage common mental health disorders. Public health professionals and community representatives will receive a tailored training intervention to increase mental health awareness. Refresher courses will occur at 3 and 6 months post training. Supervision and monitoring will occur for 1 month pre and post training. Target sample sizes have been calculated separately for each group of participants and for each outcome.
This trial has received ethical approval from the Faculty of Health, Education, Medicine and Social Care, Anglia Ruskin University, UK (SC/jc/FMFREP/16/17 076) and from the Faculty of Medicine, University of Jaffna, Sri Lanka (J/ERC/17/81/NDR/0170) and non-engagement approval has been received from the funding body, the Centers for Disease Control and Prevention (2018-015). GSK864 All participants gave written consent. Dissemination of study results will be completed through publication of academic articles, conference presentations, town hall meetings, written pamphlets in plain language, reports to Ministry of Health and other government organisations and through social media outlets.
ISRCTN registry ISRCTN62598070. SLCTR registration number SLCTR/2018/008.
ISRCTN registry ISRCTN62598070. SLCTR registration number SLCTR/2018/008.
Children with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) experience a higher prevalence of depression and anxiety compared with age-matched controls. Our previous systematic reviews in 2015/16 found little evidence for effective treatment for children with CFS/ME with comorbid depression and/or anxiety. This review updates these findings.
A systematic review. We searched Cochrane library, Medline, Embase and PsycINFO databases from 2015 to 2020. We combined the updated results with our previous reviews in a narrative synthesis.
Inclusion criteria <18 years old; diagnosed with CFS/ME (using Centers for Disease Control and Prevention, National Institute for Health and Care Excellence or Oxford criteria); validated measures of depression and/or anxiety.
Observational studies or randomised controlled trials.
Any or none.
Studies with outcome measures of anxiety, depression or fatigue.
The updated review identified two studies. This brings the total number of paediatric CFS/ME stu3488 and CRD42015016813.
The World Health Organization declared a Public Health Emergency of International Concern following the rapid emergence of neonatal microcephaly in Brazil during the 2015-2016 Zika virus (ZIKV) epidemic. In response, a national campaign sought to control
mosquito populations and reduce ZIKV transmission. Achieving adherence to vector control or mosquito-bite reduction behaviours, including the use of topical mosquito repellents, is challenging. Coproduction of research at the community level is needed to understand and mitigate social determinants of lower engagement with
preventive measures, particularly within disempowered groups.
In 2017, the Zika Preparedness Latin America Network (ZikaPLAN) conducted a qualitative study to understand individual and community level experiences of ZIKV and other mosquito-borne disease outbreaks. Presented here is a thematic analysis of 33 transcripts from community focus groups and semistructured interviews, applying the Health Belief Model (HBM) to elaborate knowledge, attitudes and perceptions of ZIKV and vector control strategies.