scholarly journals Randomized, double-blinded, controlled non-inferiority trials evaluating the immunogenicity and safety of fractional doses of Yellow Fever vaccines in Kenya and Uganda

2019 ◽  
Vol 4 ◽  
pp. 182 ◽  
Author(s):  
Derick Kimathi ◽  
Aitana Juan ◽  
Philip Bejon ◽  
Rebecca F. Grais ◽  
George M. Warimwe ◽  
...  
Keyword(s):  
Immune Response ◽  
Randomized Controlled Trials ◽  
Yellow Fever ◽  
Vaccine Dose ◽  
World Health ◽  
Yellow Fever Vaccine ◽  
Controlled Trials ◽  
Post Vaccination ◽  
Randomized Controlled ◽  
Link Type

Introduction: Yellow fever is endemic in specific regions of sub-Saharan Africa and the Americas, with recent epidemics occurring on both continents. The yellow fever vaccine is effective, affordable and safe, providing life-long immunity following a single dose vaccination. However, the vaccine production process is slow and cannot be readily scaled up during epidemics. This has led the World Health Organization (WHO) to recommend the use of fractional doses as a dose-sparing strategy during epidemics, but there are no randomized controlled trials of fractional yellow fever vaccine doses in Africa. Methods and analysis: We will recruit healthy adult volunteers, adults living with HIV, and children to a series of randomized controlled trials aiming to determine the immunogenicity and safety of fractional vaccine doses in comparison to the standard vaccine dose. The trials will be conducted across two sites; Kilifi, Kenya and Mbarara, Uganda. Recruited participants will be randomized to receive fractional or standard doses of yellow fever vaccine. Scheduled visits will include blood collection for serum and peripheral blood mononuclear cells (PBMCs) before vaccination and on various days – up to 2 years – post-vaccination. The primary outcome is the rate of seroconversion as measured by the plaque reduction neutralization test (PRNT50) at 28 days post-vaccination. Secondary outcomes include antibody titre changes, longevity of the immune response, safety assessment using clinical data, the nature and magnitude of the cellular immune response and post-vaccination control of viremia by vaccine dose. Ethics and dissemination: The clinical trial protocols have received approval from the relevant institutional ethics and regulatory review committees in Kenya and Uganda, and the WHO Ethics Review Committee. The research findings will be disseminated through open-access publications and presented at relevant conferences and workshops. Registration: ClinicalTrials.gov NCT02991495 (registered on 13 December 2016) and NCT04059471 (registered on 15 August 2019).

Interventions to Reduce Alcohol Harms in Low and Middle Income Countries: a Systematic Review and Meta Analysis

2018 ◽  
Author(s):  
Joao Ricardo Nickenig Vissoci
Keyword(s):  
Systematic Review ◽  
Alcohol Use ◽  
Randomized Controlled Trials ◽  
Brain Stimulation ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
Middle Income ◽  
Brief Motivational Intervention ◽  
Randomized Controlled

BackgroundHarmful alcohol use leads to a large burden of disease and disability which disportionately impacts LMICs. The World Health Organization and the Lancet have issued calls for this burden to be addressed, but issues remain, primarily due to gaps in information. While a variety of interventions have been shown to be effective at reducing alcohol use in HICs, their efficacy in LMICs have yet to be assessed. This systematic review describes the current published literature on alcohol interventions in LMICs and conducts a meta analysis of clinical trials evaluating interventions to reduce alcohol use and harms in LMICs.MethodsIn accordance with PRISMA guidelines we searched the electronic databases Pubmed, EMBASE, Scopus,Web of Science, Cochrane, and Psych Info. Articles were eligible if they evaluated an intervention targeting alcohol-related harm in LMICs. After a reference and citation analysis, we conducted a quality assessment per PRISMA protocol. A meta-analysis was performed on the 39 randomized controlled trials that evaluated an alcohol-related outcome.ResultsOf the 3,801 articles from the literature search, 87 articles from 25 LMICs fit the eligibility and inclusion criteria. Of these studies, 39 randomized controlled trials were included in the meta-analysis. Nine of these studies focused specifically on medication, while the others focused on brief motivational intervention, brain stimulation, AUDIT-based brief interventions, WHO ASSIST-based interventions, group based education, basic screening and interventions, brief psychological or counseling, dyadic relapse prevention, group counseling, CBT, motivational + PTSD based interview, and health promotion/awareness. Conclusion Issues in determining feasible options specific to LMICs arise from unstandardized interventions, unequal geographic distribution of intervention implementation, and uncertain effectiveness over time. Current research shows that brain stimulation, psychotherapy, and brief motivational interviews have the potential to be effective in LMIC settings, but further feasibility testing and efforts to standardize results are necessary to accurately assess their effectiveness.

scholarly journals Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-21
Author(s):  
Meng-Qi Yang ◽  
Yong-Mei Song ◽  
Huan-Yu Gao ◽  
Yi-Tao Xue
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
High Quality ◽  
Randomized Controlled ◽  
Link Type

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.

scholarly journals Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257843
Author(s):  
Kae Ling Cheah ◽  
Mohd Noor Norhayati ◽  
Lili Husniati Yaacob ◽  
Razlina Abdul Rahman
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Safety Data ◽  
Anxiety Level ◽  
World Health ◽  
Controlled Trials ◽  
Clinical Trial Registry ◽  
Randomized Controlled

Objective To determine the effect of Ashwagandha extract on sleep. Methods A comprehensive search was conducted in CENTRAL, MEDLINE, SCOPUS, Google Scholars, World Health Organization Trials Portal, ClinicalTrials.gov, Clinical Trial Registry of India, and AYUSH Research Portal for all appropriate trials. Randomized controlled trials that examined the effect of Ashwagandha extract versus placebo on sleep in human participants 18 years old and above were considered. Two authors independently read all trials and independently extracted all relevant data. The primary outcomes were sleep quantity and sleep quality. The secondary outcomes were mental alertness on rising, anxiety level, and quality of life. Results A total of five randomized controlled trials containing 400 participants were analyzed. Ashwagandha extract exhibited a small but significant effect on overall sleep (Standardized Mean Difference -0.59; 95% Confidence Interval -0.75 to -0.42; I2 =  62%). The effects on sleep were more prominent in the subgroup of adults diagnosed with insomnia, treatment dosage ≥600 mg/day, and treatment duration ≥8 weeks. Ashwagandha extract was also found to improve mental alertness on rising and anxiety level, but no significant effect on quality of life. No serious side effects were reported. Conclusion Ashwagandha extract appears to has a beneficial effect in improving sleep in adults. However, data on the serious adverse effects of Ashwagandha extract are limited, and more safety data would be needed to assess whether it would be safe for long-term use.

scholarly journals A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy

2020 ◽  
Author(s):  
Seema Mihrshahi ◽  
Danielle Jawad ◽  
Louise A. Richards ◽  
Kylie Hunter ◽  
Mahalakshmi Ekambareshwar ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Overweight And Obesity ◽  
World Health ◽  
Public Health Issue ◽  
Published Data ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Child Weight ◽  
Health Organization

Childhood overweight and obesity is a worldwide public health issue. Our objective was to describe planned, ongoing and completed randomized controlled trials (RCTs) designed for the prevention of obesity in early childhood. Two databases (World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov) were searched to identify RCTs with the primary aim of preventing childhood obesity and at least one outcome related to child weight. Interventions needed to start in the first two years of childhood or earlier, continue for at least 6 months postnatally, include a component related to lifestyle or behaviors, and have a follow up time of at least 2 years. We identified 29 unique RCTs, implemented since 2008, with most being undertaken in high income countries. Interventions ranged from advice on diet, activity, sleep, emotion regulation and parenting education through individual home visits, clinic-based consultations or group education sessions. Eleven trials have published data on child weight related outcomes to date, though most were not sufficiently powered to detect significant effects. Many trials detected improvements in practices such as breastfeeding, screen time and physical activity in the intervention groups compared to the control groups. Further follow-up of ongoing trials is needed to assess longer-term effects.

scholarly journals Tocilizumab may slow radiographic progression in patients with systemic or polyarticular-course juvenile idiopathic arthritis: post hoc radiographic analysis from two randomized controlled trials

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Clara Malattia ◽  
◽  
Nicolino Ruperto ◽  
Silvia Pederzoli ◽  
Elena Palmisani ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Randomized Controlled Trials ◽  
Bone Growth ◽  
Radiographic Progression ◽  
Systemic Juvenile Idiopathic Arthritis ◽  
Joint Damage ◽  
Trial Registration ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Few clinical trials have investigated the prevention of radiographic progression in children with juvenile idiopathic arthritis treated with antirheumatic drugs. This study aimed to investigate radiographic progression in patients with systemic juvenile idiopathic arthritis (sJIA) and patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with the anti–interleukin-6 receptor antibody tocilizumab for 2 years in the TENDER and CHERISH randomized controlled trials, respectively. Methods Standard radiographs of both wrists and both hands in the posteroanterior view were obtained within 4 weeks of baseline and were repeated at weeks 52 ± 4 and 104 ± 4 in both trials. All films were scored by two independent readers using the adapted Sharp–van der Heijde (aSH) and Poznanski scoring methods. Although the Poznanski score indicates bone growth limitation or cartilage growth decrease, which are not the same as joint space narrowing in rheumatoid arthritis, its change reflects damage to cartilage. Therefore, impairment in the Poznanski score as well as the aSH score was considered as a measure of structural joint damage. Radiographic progression was defined as worsening of radiographic scores beyond the smallest detectable difference. Results Poznanski and aSH scores were available at baseline and at one or more postbaseline time points for 33 and 47 of 112 sJIA patients and 61 and 87 of 188 pcJIA patients, respectively, providing a representative subset of the study populations. The inter-reader and intra-reader agreement intra-class correlation coefficient was > 0.8. Median baseline Poznanski and aSH scores, respectively, were − 2.4 and 24.6 for sJIA patients and − 1.5 and 8.0 for pcJIA patients. Compared with baseline, aSH scores remained stable for all sJIA patients at week 52, whereas 9.4% of sJIA patients had radiographic progression according to Poznanski scores at week 52; at 104 weeks, radiographic progression according to aSH and Poznanski scores was observed in 5.4% and 11.5%, respectively. In pcJIA patients, radiographic progression from baseline at 52 weeks and at 104 weeks was 12.5% and 2.9%, respectively, using aSH scoring and 6.5% and 4%, respectively, using Poznanski scoring. Conclusion Tocilizumab may delay radiographic progression in children with sJIA and children with pcJIA. Trial registration Trial registration numbers and dates: TENDER, NCT00642460 (March 19, 2008); CHERISH, NCT00988221 (October 1, 2009)

scholarly journals Randomized controlled trials in neurosurgery: an observational analysis of trial discontinuation and publication outcome

2017 ◽  
Vol 127 (4) ◽  
pp. 857-866 ◽  
Author(s):  
Aimun A. B. Jamjoom ◽  
Angus B. Gane ◽  
Andreas K. Demetriades
Keyword(s):  
Randomized Controlled Trials ◽  
Outcome Measures ◽  
Publication Rate ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Start Date ◽  
Randomized Controlled ◽  
Link Type ◽  
Unknown Status ◽  
Trial Discontinuation

OBJECTIVEThis study aimed to determine the trial discontinuation and publication rate of randomized controlled trials (RCTs) in neurosurgery.METHODSTrials registered from 2000 to 2012 were identified on the website clinicaltrials.gov using a range of key words related to neurosurgery. Any trials that were actively recruiting or had unknown status were excluded. Included trials were assessed for whether they were discontinued early on the clinicaltrials.gov database; this included trials identified as withdrawn, suspended, or terminated in the database. For included trials, a range of parameters was identified including the subspecialty, primary country, study start date, type of intervention, number of centers, and funding status. Subsequently, a systematic search for published peer-reviewed articles was undertaken. For trials that were discontinued early or were found to be unpublished, principal investigators were sent a querying email.RESULTSSixty-four neurosurgical trials fulfilled our inclusion criteria. Of these 64, 26.6% were discontinued early, with slow or insufficient recruitment cited as the major reason (57%). Of the 47 completed trials, 14 (30%) remained unpublished. Discontinued trials showed a statistically significant higher chance of remaining unpublished (88%) compared with completed trials (p = 0.0002). Industry-funded trials had a higher discontinuation rate (31%) compared with non–industry-funded trials (23%), but this result did not reach significance (p = 0.57). Reporting of primary outcome measures was complete in 20 (61%) of 33 trials. For secondary outcome measures, complete reporting occurred in only 11 (33.3%) of 33.CONCLUSIONSMore than a fifth (26.6%) of neurosurgical RCTs are discontinued early and almost a third of those that are completed remain unpublished. This result highlights significant waste of financial resources and clinical data.

scholarly journals A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy

2021 ◽  
Vol 18 (5) ◽  
pp. 2444
Author(s):  
Seema Mihrshahi ◽  
Danielle Jawad ◽  
Louise Richards ◽  
Kylie E. Hunter ◽  
Mahalakshmi Ekambareshwar ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Overweight And Obesity ◽  
World Health ◽  
Public Health Issue ◽  
Published Data ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Child Weight ◽  
Health Organization

Childhood overweight and obesity is a worldwide public health issue. Our objective was to describe planned, ongoing and completed randomized controlled trials (RCTs) designed for the prevention of obesity in early childhood. Two databases (World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov) were searched to identify RCTs with the primary aim of preventing childhood obesity and at least one outcome related to child weight. Interventions needed to start in the first two years of childhood or earlier, continue for at least 6 months postnatally, include a component related to lifestyle or behaviours, and have a follow up time of at least 2 years. We identified 29 unique RCTs, implemented since 2008, with most being undertaken in high income countries. Interventions ranged from advice on diet, activity, sleep, emotion regulation, and parenting education through to individual home visits, clinic-based consultations, or group education sessions. Eleven trials published data on child weight-related outcomes to date, though most were not sufficiently powered to detect significant effects. Many trials detected improvements in practices such as breastfeeding, screen time, and physical activity in the intervention groups compared to the control groups. Further follow-up of ongoing trials is needed to assess longer-term effects.

scholarly journals Reducing Salt Intake in China with “Action on Salt China” (ASC): Protocol for Campaigns and Randomized Controlled Trials (Preprint)

2019 ◽  
Author(s):  
Puhong Zhang ◽  
Feng J He ◽  
Yuan Li ◽  
Changning Li ◽  
Jing Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
School Children ◽  
Intervention Study ◽  
Salt Intake ◽  
Mobile App ◽  
World Health ◽  
Controlled Trials ◽  
Processed Foods ◽  
Salt Reduction ◽  
Randomized Controlled

BACKGROUND Salt intake in China is over twice the maximum recommendation of the World Health Organization. Unlike most developed countries where salt intake is mainly derived from prepackaged foods, around 80% of the salt consumed in China is added during cooking. OBJECTIVE Action on Salt China (ASC), initiated in 2017, aims to develop, implement, and evaluate a comprehensive and tailored salt reduction program for national scaling-up. METHODS ASC consists of six programs working in synergy to increase salt awareness and to reduce the amount of salt used during cooking at home and in restaurants, as well as in processed foods. Since September 2018, two health campaigns on health education and processed foods have respectively started, in parallel with four open-label cluster randomized controlled trials (RCTs) in six provinces across China: (1) app-based intervention study (AIS), in which a mobile app is used to achieve and sustain salt reduction in school children and their families; (2) home cook-based intervention study (HIS), in which family cooks receive support in using less salt; (3) restaurant-based intervention study (RIS) targeting restaurant consumers, cooks, and managers; and (4) comprehensive intervention study (CIS), which is a real-world implementation and evaluation of all available interventions in the three other RCTs. To explore the barriers, facilitators, and effectiveness of delivering a comprehensive salt reduction intervention, these RCTs will last for 1 year (stage 1), followed by nationwide implementation (stage 2). In AIS, HIS, and CIS, the primary outcome of salt reduction will be evaluated by 24-hour urinary sodium excretion in 6030 participants, including 5436 adults and 594 school children around 8-9 years old. In RIS, the salt content of meals will be measured by laboratory food analysis of the 5 best-selling dishes from 192 restaurants. Secondary outcomes will include process evaluation; changes in knowledge, attitude, and practice on salt intake; and economic evaluation. RESULTS All RCTs have been approved by Queen Mary Research Ethics Committee and the Institutional Review Boards of leading institutes in China. The research started in June 2017 and is expected to be completed around March 2021. The baseline investigations of the four RCTs were completed in May 2019. CONCLUSIONS The ASC project is progressing smoothly. The intervention packages and tailored components will be promoted for salt reduction in China, and could be adopted by other countries. CLINICALTRIAL Chinese Clinical Trial Registry. AIS: ChiCTR1800017553; https://tinyurl.com/vdr8rpr. HIS: ChiCTR1800016804; https://tinyurl.com/w8c7x3w. RIS: ChiCTR1800019694; https://tinyurl.com/uqkjgfw. CIS: ChiCTR1800018119; https://tinyurl.com/s3ajldw. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15933

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