Randomised controlled trail

BACKGROUND: The superiority of balloon angioplasty plus aggressive medical management (AMM) to AMM alone for symptomatic intracranial artery stenosis (sICAS) on efficacy and safety profiles still lacks evidence from randomised controlled trials (RCTs). AIM: To demonstrate the design of an RCT on balloon angioplasty plus AMM for sICAS. DESIGN: Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS) trial is a multicentre, prospective, randomised, open-label, blinded end-point trial to investigate whether balloon angioplasty plus AMM could improve clinical outcome compared with AMM alone in patients with sICAS...

BACKGROUND: Major depressive disorder (MDD) is a significant cause of workforce loss, and is associated with cognitive impairments which can continue even after the elimination of mood and behavioural symptoms. The aim of this study was to investigate the benefit of transcranial magnetic stimulation (TMS) on cognitive functions in treatment resistant depression. METHODS: This randomised controlled clinical trial was conducted at a university hospital, department of psychiatry (tertiary centre) between October 2019 and July 2020...

OBJECTIVE: Test an intervention for individuals with schizophrenia at an Adult Inpatient Unit with employment and social inclusion goals, compared to treatment as usual. METHOD: A single-blind, randomised, controlled trial assigned 25 participants to treatment as usual and 26 participants to receive an Individual Placement and Support (IPS) Disability Employment Service (DES) information pack and an offer of support from a nurse. Outcomes were measured at 6 and 12 months using Job Acquisition, IPS DES employment provider, Activity Participation Questionnaire-Revised, Brief Psychiatric Rating Scale, and Adult Hope Scale questionnaires, and Digit Span and Trail Making tests...

INTRODUCTION: The current treatment for heart disease consists of exercise therapy in addition to pharmacotherapy, nutritional support and lifestyle guidance. In general, nutritional support focuses on protein, salt and energy restrictions, with no active protein or amino acid intake in cases involving moderate or higher renal failure. From this perspective, patients with cardiac disease are at high risk of frailty.Beta-hydroxy beta-methyl butyrate (HMB) is a metabolite of leucine. HMB is widely used for muscle strengthening and can be safely ingested even by patients with renal failure...

RATIONALE: Chronic cannabis use is associated with impaired cognitive function. Evidence indicates cannabidiol (CBD) might be beneficial for treating cannabis use disorder. CBD may also have pro-cognitive effects; however, its effect on cognition in people with cannabis use disorder is currently unclear. OBJECTIVES: We aimed to assess whether a 4-week CBD treatment impacted cognitive function. We hypothesised that CBD treatment would improve cognition from baseline to week 4, compared to placebo...

PURPOSE: The OPTIMISE study uses a Multiphase Optimisation Strategy (MOST) to identify the best combination of four interventions targeting key diabetes self-care behaviours for use in clinical practice to improve short-term glycaemic outcomes. METHODS: This 4-week intervention trial will recruit 80 young people (aged 13-20 years) with type 1 diabetes ≥ 6 months duration), and pre-enrolment HbA1c ≥ 58 mmol/mol (7.5%) in the prior 6 months...

Computerised cognitive remediation therapy (CCRT) and aerobic exercise are often used to rehabilitate social functioning in patients with schizophrenia. However, there is limited knowledge regarding the effects of CCRT combined with aerobic exercise on cognitive function and brain-derived neurotrophic factor (BDNF) levels in patients with schizophrenia and cognitive impairment. Ninety-six patients with schizophrenia and cognitive impairment were included in this study and randomly divided into control, aerobic exercise (AE), and CCRT combined with aerobic exercise (CAE) groups...

Visual and cognitive dysfunction are common in Parkinson's disease and relate to balance and gait impairment, as well as increased falls risk and reduced quality of life. Vision and cognition are interrelated (termed visuo-cognition) which makes intervention complex in people with Parkinson's (PwP). Non-pharmacological interventions for visuo-cognitive deficits are possible with modern technology, such as combined mobile applications and stroboscopic glasses, but evidence for their effectiveness in PwP is lacking...

BACKGROUND: motivating older people with cognitive impairment to remain physically active is challenging. OBJECTIVE: this study aimed to examine the effects of a peer-supported exercise intervention on the cognitive function and health-related quality of life (HRQoL) of persons with mild cognitive impairment (MCI). DESIGN: a two-arm randomised controlled trial. SETTING AND PARTICIPANTS: community-dwelling persons with MCI were recruited from community centres for older adults in Hong Kong...

Objective: To explore the feasibility of a randomised controlled trial of a multiple sclerosis online course (MSOC) via qualitative analysis of participant semi-structured interviews. Methods: The MSOC was developed in two arms: intervention arm which contained evidence-based lifestyle modification recommendations, and standard-care arm which delivered information from MS websites reflecting standard advice. Participants were recruited via online advertisements, completed a baseline questionnaire, and randomised...

PURPOSE: The aim of this systematic review was to update the knowledge on risk factors and prevention strategies for shoulder injuries in overhead sports with special emphasis on methodological quality. METHODS: All methodological procedures were performed in line with a previous systematic review by Asker et al. (2018). The literature search was conducted in the PubMed, Google Scholar, Cochrane, and SPORT-Discuss databases. Due to the risk of bias assessment, only studies with at least an acceptable methodological quality were included...

BACKGROUND: Guanfacine is a α2A adrenergic receptor agonist approved for treating attention deficit hyperactivity disorder (ADHD). It is thought to act via postsynaptic receptors in the prefrontal cortex, modulating executive functions including the regulation of attention. Attention is affected early in Alzheimer's disease (AD), and this may relate to pathological changes within the locus coeruleus, the main source of noradrenergic pathways within the brain. Given that cholinergic pathways, also involved in attention, are disrupted in AD, the combination of noradrenergic and cholinergic treatments may have a synergistic effect on symptomatic AD...

INTRODUCTION: The optimal timing of delivery for pregnancies complicated by foetal gastroschisis remains controversial. Therefore, the aim of this study is to find whether elective or expectant delivery is associated with improved neonatal outcome. MATERIALS AND METHODS: MEDLINE and Embase databases were searched for studies up to 2021 that reported timing of delivery for foetal gastroschisis. A systematic review and meta-analysis were then performed in group 1: moderately preterm (Gestational age, [GA] 34-35 weeks) elective delivery versus expectant management after GA 34-35 weeks; and group 2: near-term (GA 36-37 weeks) elective delivery versus expectant management after GA 36-37 weeks...

OBJECTIVE: To review the evidence on the economic evaluations of workplace-based interventions that are designed to reduce prolonged periods of occupational sitting. DESIGN: An integrative review. DATA SOURCES: The search was conducted in 11 databases, including PubMed, Scopus, PsychINFO, NHS-EED, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ProQuest, Cochrane library, Sportdiscus, Research Paper in Economics (RePeC), the International Health Economic Association (IHEA) and EconLit...

OBJECTIVES: The aim of this preplanned secondary analysis of a 12-month randomised controlled trial was to investigate the effects of a multicomponent exercise programme combined with daily whey protein, calcium and vitamin D supplementation on cognition in men with prostate cancer treated with androgen deprivation therapy (ADT). DESIGN: 12-month, two-arm, randomised controlled trial. SETTING: University clinical exercise centre. PARTICIPANTS: 70 ADT-treated men were randomised to exercise-training plus supplementation (Ex+ Suppl, n=34) or usual care (control, n=36)...

BACKGROUND: Hirschsprung-associated enterocolitis (HAEC) is a leading cause of serious morbidity and potential mortality in children with Hirschsprung's disease (HD). People with HAEC suffer from intestinal inflammation, and present with diarrhoea, explosive stools, and abdominal distension. Probiotics are live microorganisms with beneficial health effects, which can optimise gastrointestinal function and gut flora. However, the efficacy and safety of probiotic supplementation in the prevention of HAEC remains unclear...

INTRODUCTION: Existing studies have shown that mobile-based mindfulness meditation (MMM) can have a certain impact on nurses' mental health problems, but its specific effect and the effect on specific mental health problems such as stress, anxiety, depression, mindfulness, well-being and resilience are not clear. METHODS AND ANALYSIS: This study protocol follows the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols guidelines. Electronic search through PubMed, Web of Science, EBSCO, Cochrane Library, CINAHL, PsycINFO, ERIC, Embase and three Chinese databases namely CNKI, Wan Fang and Chinese Biology Medicine disc...

INTRODUCTION: Mechanical thrombectomy (MT) had been regarded as the first-line therapy for acute ischaemic stroke patients. The sex differences in post-MT treatment outcomes were analysed by randomised controlled trial (RCT) studies with inconsistent conclusions. We suggest the results from the real-world data may differ from RCT containing studies. Therefore, the sex difference in non-clinical trial populations needs to be clarified. METHODS AND ANALYSIS: In order to obtain relative studies comprehensively, we will search the main document databases, consisting of Web of Science, Medline in Ovid, Embase in Ovid and Cochrane Library, and trials registers, including Clinical Trails register...

Injection treatment is one of the most widely used methods for the conservative management of patellar tendinopathy. The objective of this systematic review was to synthesise data from randomised control trails on the effectiveness of various injections used in the management of patellar tendinopathy. An electronic search was conducted in the Web of Science, Scopus, PubMed, and SPORTDiscus databases. To be included in the current systematic review, the study had to be an RCT conducted on human participants that investigated the effect of at least one injection treatment on the management of patellar tendinopathy...

This systematic literature review examined whole food or whole diet interventions to treat depression. The inclusion criteria encompassed adults, depression, a recognized depression scale and a whole food or diet intervention. APA PsychINFO, CINAHL, the Cochrance Central Register of Controlled Trails, MEDLINE and Scopus were searched for original research addressing diet as a treatment for depression in adult populations. The quality of the study was assessed using the Academy of Nutrition and Dietetics Quality Criteria Checklist...