scholarly journals The DEXA-CORT trial: study protocol of a randomised placebo-controlled trial of hydrocortisone in patients with brain tumour on the prevention of neuropsychiatric adverse effects caused by perioperative dexamethasone

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e054405
Author(s):  
Anne-Sophie C A M Koning ◽  
Djaina D Satoer ◽  
Christiaan H Vinkers ◽  
Amir H Zamanipoor Najafabadi ◽  
Nienke R Biermasz ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Brain Tumour ◽  
Study Protocol ◽  
Rating Scale ◽  
Controlled Trial ◽  
Neuropsychiatric Symptoms ◽  
Primary Study ◽  
Dexamethasone Treatment ◽  
Neuropsychiatric Adverse Effects

IntroductionThe synthetic glucocorticoid dexamethasone can induce serious neuropsychiatric adverse effects. Dexamethasone activates the glucocorticoid receptor (GR) but, unlike endogenous cortisol, not the mineralocorticoid receptor (MR). Moreover, dexamethasone suppresses cortisol production, thereby eliminating its MR binding. Consequently, GR overactivation combined with MR underactivation may contribute to the neuropsychiatric adverse effects of dexamethasone. The DEXA-CORT trial aims to reactivate the MR using cortisol to reduce neuropsychiatric adverse effects of dexamethasone treatment.Methods and analysisThe DEXA-CORT study is a multicentre, randomised, double-blind, placebo-controlled trial in adult patients who undergo elective brain tumour resection treated perioperatively with high doses of dexamethasone to minimise cerebral oedema. 180 patients are randomised between treatment with either two times per day 10 mg hydrocortisone or placebo during dexamethasone treatment. The primary study outcome is the difference in proportion of patients scoring ≥3 points on at least one of the Brief Psychiatric Rating Scale (BPRS) questions 5 days postoperatively or earlier at discharge. Secondary outcomes are neuropsychiatric symptoms, quality of sleep, health-related quality of life and neurocognitive functioning at several time points postoperatively. Furthermore, neuropsychiatric history, serious adverse events, prescribed (psychiatric) medication and referrals or evaluations of psychiatrist/psychologist and laboratory measurements are assessed.Ethics and disseminationThe study protocol has been approved by the Medical Research Ethics Committee of the Leiden University Medical Center, and by the Dutch competent authority, and by the Institutional Review Boards of the participating sites. It is an investigator-initiated study with financial support by The Netherlands Organisation for Health Research and Development (ZonMw) and the Dutch Brain Foundation. Results of the study will be submitted for publication in a peer-reviewed journal.Trial registration numberNL6726 (Netherlands Trial Register); open for patient inclusion. EudraCT number 2017-003705-17.

scholarly journals Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD

2017 ◽  
Vol 23 (13) ◽  
pp. 1578-1591 ◽  
Author(s):  
David R. Coghill ◽  
Alain Joseph ◽  
Vanja Sikirica ◽  
Mark Kosinski ◽  
Caleb Bliss ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Children And Adolescents ◽  
Rating Scale ◽  
Controlled Trial ◽  
Pearson Correlation ◽  
Correlation Coefficients ◽  
Parent Report ◽  
Functional Impairments ◽  
Risk Avoidance

Objective: To assess relationships between treatment-associated changes in measures of ADHD symptoms, functional impairments, and health-related quality of life in children and adolescents with ADHD. Method: Pearson correlation coefficients were calculated post hoc for changes from baseline to endpoint in outcomes of one randomized, placebo- and active-controlled trial of lisdexamfetamine (osmotic-release methylphenidate reference) and one of guanfacine extended-release (atomoxetine reference). Results: Changes in ADHD Rating Scale IV (ADHD-RS-IV) total score generally correlated moderately with changes in Child Health and Illness Profile−Child Edition: Parent Report Form (CHIP-CE:PRF) Achievement and Risk Avoidance ( r ≈ .4), but weakly with Resilience, Satisfaction, and Comfort ( r ≈ .2); and moderately with Weiss Functional Impairment Rating Scale–Parent (WFIRS-P) total score ( r ≈ .5). CHIP-CE:PRF Achievement and Risk Avoidance correlated moderately to strongly with WFIRS-P total score ( r ≈ .6). Conclusion: The ADHD-RS-IV, CHIP-CE:PRF, and WFIRS-P capture distinct but interconnected aspects of treatment response in individuals with ADHD.

scholarly journals Assessment of neuropsychiatric symptoms in dementia: Toward improving accuracy

2013 ◽  
Vol 7 (3) ◽  
pp. 244-251 ◽  
Author(s):  
Florindo Stella
Keyword(s):  
Rating Scale ◽  
High Reliability ◽  
Neuropsychiatric Symptoms ◽  
Clinical Approach ◽  
Behavioral Disturbances ◽  
Versatile Tool ◽  
Clinician Rating ◽  
Improving Accuracy ◽  
Elderly Caregivers

ABSTRACT The issue of this article concerned the discussion about tools frequently used tools for assessing neuropsychiatric symptoms of patients with dementia, particularly Alzheimer's disease. The aims were to discuss the main tools for evaluating behavioral disturbances, and particularly the accuracy of the Neuropsychiatric Inventory - Clinician Rating Scale (NPI-C). The clinical approach to and diagnosis of neuropsychiatric syndromes in dementia require suitable accuracy. Advances in the recognition and early accurate diagnosis of psychopathological symptoms help guide appropriate pharmacological and non-pharmacological interventions. In addition, recommended standardized and validated measurements contribute to both scientific research and clinical practice. Emotional distress, caregiver burden, and cognitive impairment often experienced by elderly caregivers, may affect the quality of caregiver reports. The clinician rating approach helps attenuate these misinterpretations. In this scenario, the NPI-C is a promising and versatile tool for assessing neuropsychiatric syndromes in dementia, offering good accuracy and high reliability, mainly based on the diagnostic impression of the clinician. This tool can provide both strategies: a comprehensive assessment of neuropsychiatric symptoms in dementia or the investigation of specific psychopathological syndromes such as agitation, depression, anxiety, apathy, sleep disorders, and aberrant motor disorders, among others.

scholarly journals Efficacy of a Web-Enabled, School-Based, Preventative Intervention to Reduce Bullying and Improve Mental Health in Children and Adolescents: Study Protocol for a Cluster Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Covadonga M. Díaz-Caneja ◽  
Javier Martín-Babarro ◽  
Renzo Abregú-Crespo ◽  
Miguel Á. Huete-Diego ◽  
Marta Giménez-Dasí ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Bullying Victimization ◽  
Randomized Controlled ◽  
School Based ◽  
Cluster Randomized

Introduction: Bullying is a major preventable risk factor for mental disorders. Available evidence suggests school-based interventions reduce bullying prevalence rates. This study aims to test the efficacy of a web-enabled, school-based, multicomponent anti-bullying intervention to prevent school bullying and to assess its effects on mental health and quality of life.Methods and analysis: Cluster randomized controlled trial conducted in 20 publicly funded primary and secondary schools in Madrid, Spain. Schools are randomly allocated to either the intervention arm (n = 10) or conventional practices arm (n = 10). The web-enabled intervention (LINKlusive) lasts ~12 weeks and consists of three main components: (i) an online training program for teachers and parents, (ii) a web-guided educational program for students, focusing on promoting respect for diversity, empathy, and social skill development, and (iii) a web-guided, teacher-delivered, targeted intervention program for bullying situations identified based on peer-support strategies and individual intervention for those involved (i.e., bullying victims and perpetrators). The primary objective is to compare differences between peer-reported bullying victimization in the intervention and control arms at the end of the intervention. Secondary outcome measures are additional measures of bullying victimization and perpetration, mental health symptoms, self-esteem, and quality of life. A follow-up assessment is conducted 1 year after the end of the intervention. Treatment effects will be tested using multilevel mixed models, adjusting for school-, classroom-, and student-related covariates. Considering the increased bullying rates in children with special educational needs, a specific subgroup analysis will test the efficacy of the intervention on bullying prevalence, mental health, and quality of life in this particularly vulnerable population.Ethics and Dissemination: The Deontology Commission of the School of Psychology, Universidad Complutense in Madrid, Spain reviewed the study protocol and granted ethical approval on 21st January 2019. The results of the trial will be disseminated in relevant peer-reviewed journals and at conferences in the field.Trial Registration Number: ISRCTN15719015.

scholarly journals Effect of probiotics on nasal and intestinal microbiota in people with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yongcan Wu ◽  
Caixia Pei ◽  
Xiaomin Wang ◽  
Mingjie Wang ◽  
Demei Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intestinal Microbiota ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
High Exposure ◽  
Gastrointestinal Symptom Rating Scale ◽  
Probiotic Treatment ◽  
High Concentrations

Abstract Background Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5. Trial registration Chinese Clinical Trial Registry ChiCTR1900025469. Registered on 27 August 2019.

scholarly journals Astragalus polysaccharide (PG2) Ameliorates Cancer Symptom Clusters, as well as Improves Quality of Life in Patients with Metastatic Disease, through Modulation of the Inflammatory Cascade

Cancers ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1054 ◽  
Author(s):  
Wen-Chien Huang ◽  
Kuang-Tai Kuo ◽  
Oluwaseun Adebayo Bamodu ◽  
Yen-Kuang Lin ◽  
Chun-Hua Wang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Growth Factor ◽  
Adverse Effects ◽  
Metastatic Disease ◽  
Controlled Trial ◽  
High Dose ◽  
Advanced Stage ◽  
Gm Csf ◽  
Anti Inflammatory

Background: Improving patients’ quality of life (QoL) is a principal objective of all treatment in any clinical setting, including oncology practices. Cancer-associated inflammation is implicated in disease progression and worsening of patients’ QoL. Conventional anticancer therapeutics while selectively eliminating cancerous cells, are evaded by stem cell-like cells, and associated with varying degrees of adverse effects, thus reducing patients’ QoL. This necessitates novel therapeutic approaches with enhanced efficacy, minimal or no treatment-related adverse effects, and improved QoL in patients with cancer, especially those with metastatic/advance stage disease. Methods: Sequel to our team’s previous publication, the present study explores probable effects of Astragalus polysaccharides (PG2) on cancer-related inflammatory landscape and known determinants of QoL, as well as the probable link between the two to provide mechanistic insight. In an exploratory double blind randomized controlled trial using patients with metastatic disease (n = 23), we comparatively evaluated the therapeutic efficacy of high (500 mg) or low (250 mg) dose PG2 administered intravenously (i.v.), with particular focus on its suggested anti-inflammatory function and the probable effect of same on QoL indices at baseline, then at weeks 4 and 8 post-PG2 treatment. Results: All 23 patients with metastatic disease treated with either low or high PG2 experienced reduced pain, nausea, vomiting, and fatigue, as well as better appetite and sleep, culminating in improved global QoL. This was most apparent in the high dose group, with significant co-suppression of pro-inflammatory interleukin (IL)-1β, IL-4, IL-6, IL-13, IL-17, monocytes chemotactic protein (MCP)1, granulocyte-macrophage colony-stimulating factor (GM-CSF), vascular endothelial growth factor (VEGF), tumor growth factor (TGF)-β1, interferon (IFN)-γ, and immune suppressors IL-10 and IL-12. Univariate and multivariate analyses revealed that IL-1β, IL-13 and GM-CSF are independent prognosticators of improved QoL. Conclusion: This proof-of-concept study provides premier evidence of functional association between PG2 anti-inflammatory effects and improved QoL in patients with advanced stage cancers, laying the groundwork for future larger cohort blinded controlled trials to establish the efficacy of PG2 as adjuvant anticancer therapy in metastatic or advanced stage clinical settings.

Electroanalgesia during a carboxytherapy procedure for cellulite: a study protocol for a randomized controlled trial

2020 ◽  
Vol 10 (5) ◽  
pp. 283-290
Author(s):  
Adria Yared Sadala ◽  
Érika Patrícia Rampazo da Silva ◽  
Richard Eloin Liebano
Keyword(s):  
Pain Intensity ◽  
Study Protocol ◽  
Rating Scale ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Secondary Outcome ◽  
Electrical Currents ◽  
Electrical Nerve Stimulation ◽  
Interferential Current ◽  
Clinical Trials Registry

The aim of the present study is to describe a study protocol to compare different types of analgesic electrical currents on pain intensity and sensory comfort during the application of carboxytherapy for the treatment of cellulite. Seventy five women with the presence of moderate and/or severe gluteal cellulite will be randomly allocated into three groups: carboxytherapy plus transcutaneous electrical nerve stimulation, carboxytherapy plus interferential current or carboxytherapy plus Aussie current. Pain intensity, which is the primary outcome, will be measured by a numeric rating scale (0–10). The secondary outcome is sensory comfort, which will be measured using the visual analogue scale (0–10). Trial registration: Brazilian Clinical Trials Registry: ReBEC (RBR-6z82zb) www.ensaiosclinicos.gov.br/rg/RBR-6z82zb/

scholarly journals A Randomized, Placebo-Controlled Trial Evaluating Changes in Peripheral Neuropathy and Quality of Life by Using Low-Frequency Electrostimulation on Breast Cancer Patients Treated With Chemotherapy

2020 ◽  
Vol 19 ◽  
pp. 153473542092551
Author(s):  
Si-Yeon Song ◽  
Ji-Hye Park ◽  
Jin Sun Lee ◽  
Je Ryong Kim ◽  
Eun Hee Sohn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Low Frequency ◽  
Pharmacological Intervention ◽  
European Organization ◽  
Eortc Qlq

Background: This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer. Methods: A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN). Results: No differences in NRS scores were found between the patients in the ES and the SES group ( P = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES P < .001; SES P < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group ( P = .006). Conclusion: Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible.

Sign in / Sign up

Export Citation Format

Share Document