Controlled clinical trial

BACKGROUND: Considering the persistent nature and higher prevalence of insomnia in cancer patients and survivors compared to the general population, there is a need for effective management strategies. This systematic review and meta-analysis aimed to comprehensively evaluate the available evidence for the efficacy of pharmacological and non-pharmacological interventions for insomnia in adult cancer patients and survivors. METHODS: Following the PRISMA guidelines, we analyzed data from 61 randomized controlled trials involving 6528 participants...

CONTEXT: Nut-enriched diets have a positive impact on cardiovascular risk factors, such as body mass, blood pressure, and fasting blood glucose. However, studies in individuals undergoing secondary cardiovascular prevention show controversial results. OBJECTIVE: This systematic review with meta-analysis assessed the effect of nut supplementation on anthropometric, glycemic, and blood pressure indices in patients with atherosclerotic cardiovascular disease, as well as the frequency of adverse events...

The aim of this systematic review was to describe the efficacy and acceptability of natural products in the management of oral mucositis caused by radiation. From the day it started to August 7, 2023, a thorough search for randomized controlled trials (RCTs) was carried out among seven databases: the Web of Science, PubMed, Embase, OVID, Scopus, the Cochrane Library and the CINAHL database. Only English-language articles were identified during the search. Using the revised Cochrane risk-of-bias tool, version 2, two researchers screened the articles, collected information on study characteristics, and appraised risks of bias...

INTRODUCTION: There is high evidence that chronic exercise benefits overall depression severity in older adults. However, late-life depression is characterized by considerable heterogeneity in clinical manifestation emphasizing the need for more individualized exercise intervention programs. Therefore, the objective of the proposed review is to investigate the effects of chronic exercise on overall depression severity and on different symptoms of depression in randomized controlled trials (RCTs) including older adults with a mean age of at least 60 years, and by considering the moderating effects of intervention characteristics and individual characteristics...

Triple-masked three-armed feasibility parallel randomized controlled trial. Multimedia patient education materials are increasingly used in healthcare. While much research focuses on optimising their scientific content, research is equally needed to optimise design and implementation. This study aims to determine the feasibility of a study examining how the implementation of scientific advice on design affects patient outcomes. Participants aged 10-18 with radiographically confirmed adolescent idiopathic scoliosis will be recruited from community settings in Ireland and randomized into usual care or receiving multimedia educational videos with or without evidence-informed design principles...

Inhibitors of DNA-PK sensitize cancers to radiotherapy and DNA-damaging chemotherapies, with candidates in clinical trials. However, the degree to which DNA-PK inhibitors also sensitize normal tissues remains poorly characterized. In this study we compare tumor growth control and normal tissue sensitization following DNA-PK inhibitors in combination with radiation and etoposide. FaDu tumor xenografts implanted in mice were treated with 10 - 15Gy irradiation ± 3 - 100 mg/kg AZD7648. A dose-dependent increase in time to tumor volume doubling following AZD7648 was proportional to an increase in toxicity scores of the overlying skin...

Herpes zoster (HZ) is caused by reactivation of the varicella-zoster virus. The life-time risk of developing HZ is ~ 30%. Management of HZ can be challenging due to limited efficacy of oral antivirals on pain control, and neuropathic pain that may require aggressive management. Post-herpetic neuralgia (PHN) can cause substantial pain and occurs in up to one-quarter of patients with HZ. Up to 48,000 HZ cases are estimated to occur annually in Belgium, estimated to cost almost 7 million euros in treatment...

BACKGROUND: Up to 50% of antibiotic prescriptions for upper respiratory infections (URIs) are inappropriate. Clinical decision support (CDS) systems to mitigate unnecessary antibiotic prescriptions have been implemented into electronic health records, but their use by providers has been limited. OBJECTIVE: As a delegation protocol, we adapted a validated electronic health record-integrated clinical prediction rule (iCPR) CDS-based intervention for registered nurses (RNs), consisting of triage to identify patients with low-acuity URI followed by CDS-guided RN visits...

BACKGROUND: Prebiotics are nondigestible carbohydrates fermented by gut bacteria into metabolites that confer health benefits. However, evidence on their role for inflammatory bowel disease (IBD) is unclear. This study systematically evaluated the research on prebiotics for treatment of IBD. METHODS: A search was performed in PubMed, Embase, Cochrane, and Web of Science. Eligible articles included randomized controlled trials or prospective observational studies that compared a prebiotic with a placebo or lower-dose control in patients with IBD...

IMPORTANCE: Advance care planning (ACP) remains low among patients with advanced cancer. Multilevel interventions compared with clinician-level interventions may be more effective in improving ACP. OBJECTIVE: To evaluate whether a multilevel intervention could improve clinician-documented ACP compared with a clinician-level intervention alone. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial, performed from September 12, 2019, through May 12, 2021, included adults with advanced genitourinary cancers at an academic, tertiary hospital...

IMPORTANCE: Pain management following pediatric adenotonsillectomies is opioid-inclusive, leading to potential complications. OBJECTIVE: To investigate the use of suprazygomatic maxillary nerve (SZMN) blocks to reduce pain and opioid use after pediatric intracapsular adenotonsillectomy and to measure recovery duration and incidence of complications. DESIGN, SETTING, AND PARTICIPANTS: This was a randomized, blinded, prospective single-center tertiary pediatric hospital that included 60 pediatric patients (2-14 years old) scheduled for intracapsular adenotonsillectomy from November 2021 to March 2023...

IMPORTANCE: SARS-CoV-2 viral load (VL) in the nasopharynx is difficult to quantify and standardize across settings, but it may inform transmission potential and disease severity. OBJECTIVE: To characterize VL at COVID-19 diagnosis among previously uninfected and unvaccinated individuals by evaluating the association of demographic and clinical characteristics, viral variant, and trial with VL, as well as the ability of VL to predict severe disease. DESIGN, SETTING, AND PARTICIPANTS: This secondary cross-protocol analysis used individual-level data from placebo recipients from 4 harmonized, phase 3 COVID-19 vaccine efficacy trials sponsored by Moderna, AstraZeneca, Janssen, and Novavax...

OBJECTIVE: The objective of this review is to assess the effect of total maxillary arch distalization (TMAD) treatment on the dental, skeletal, soft tissues, and airways during non-extraction camouflage treatment of class II division 1 patients. METHODS: We performed a systematic review of the published data in four electronic databases up to April 2023. We considered studies for inclusion if they were examining the effects of TMAD during treatment of class II division 1 malocclusion in the permanent dentition...

BACKGROUND: The "PromeTheus" trial is evaluating a home-based, multifactorial, interdisciplinary prevention program for community-dwelling (pre-)frail older adults. These individuals often suffer from reduced participation, which can complicate the recruitment and enrollment in a clinical trial. AIMS: The aim of this study was to evaluate different recruitment strategies and differences in participant characteristics in relation to these strategies. METHODS: This cross-sectional study used baseline data from the randomized-controlled PromeTheus trial, in which community-dwelling (pre-)frail older persons (Clinical Frailty Scale [CFS] 4-6 pt...

OBJECTIVE: This study aimed to evaluate the impact of an intervention using the Treatment Summary and Survivorship Care Plan (TSSCP-P) on self-efficacy and quality of life (QoL) in breast cancer survivors. METHOD: A clinical study, randomized and controlled, conducted to assess self-efficacy and QOL in breast cancer survivors. The participants were randomly assigned to either an intervention group or a control group. The intervention group received individualized nursing consultations guided by the TSSCP-P, while the control group received standard care...

SIGNIFICANCE: This Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-compliant review focuses on the efficacy of cellular, acellular and matrix-like products (CAMPs) in the management of diabetic foot ulcers based on published randomized control trials (RCTs). RECENT ADVANCES: While CAMPs have been incorporated into the clinical algorithm for chronic wounds, evidence is lacking to comparatively evaluate the efficacy of these products. CRITICAL ISSUES: Level 1 RCT studies are the gold standard to evaluate efficacy of different treatment approaches, however, due to differences in surgical techniques, patient demographics and compliance, standard of care outcomes in the wound care space can vary significantly between different randomized controlled trials, making it difficult to compare them against each other...

Intramedullary nail fixation of intertrochanteric fractures assisted by orthopedic surgical robot navigation is a new surgical method, but there are few studies comparing its efficacy with traditional intramedullary nail fixation. We aimed to assess whether robot-assisted internal fixation confers certain surgical advantages through a literature review. PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure (CNKI) and Wan fang Data Knowledge service Platform were searched to collect randomized and non-randomized studies on patients with calcaneal fractures...

BACKGROUND: Excess intravenous fluid for women requiring an induction of labour may adversely affect the duration of labour and maternal/neonatal outcomes. AIMS: This study aimed to determine the difference in duration of labour and outcomes with a low background infusion rate, compared to liberal background intravenous fluid management. MATERIALS AND METHODS: A double blind randomised controlled pilot study was performed on 200 women who underwent induction of labour at a single institution...

BACKGROUND: The COVID-19 pandemic has posed unprecedented challenges to healthcare systems globally, necessitating innovative care models like hospital-at-home and virtual care programs. The Influenzer telemedicine program aims to deliver hospital-led monitoring and treatment to patients at home. Integrating telemedicine technology with domestic visits provides an alternative to traditional hospitalization, with the aim of easing the burden on healthcare facilities without compromising patient safety...

For a long time, the reliability of medical-scientific research was, without further verification, based on real data. It is becoming increasingly clear that this assumption is unjustified and that probably at least 25% of published randomized clinical trials are based on unreliable and sometimes even fabricated data. After giving a number of examples, it is discussed what the reader can do about this problem. More importantly, editors and publishers should no longer rely on whistle-blowers but take action themselves...