scholarly journals EFFICACY OF THE MEASLES-MUMPS-RUBELLA (MMR) VACCINE IN THE REDUCING THE SEVERITY OF COVID-19: AN INTERIM ANALYSIS OF A RANDOMISED CONTROLLED CLINICAL TRIAL

2021 ◽  
Author(s):  
EDISON Natal Fedrizzi ◽  
Juliana Balbinot Reis Girondi ◽  
Thiago Mamoru Sakae ◽  
Sergio Murilo Steffens ◽  
Aldanea Norma de Souza Silvestrin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Risk Reduction ◽  
Interim Analysis ◽  
Health Workers ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Mmr Vaccine ◽  
Efficacy Analysis ◽  
Randomised Controlled ◽  
To Receive

Background: COVID–19 is still a challenge, both with regard to its treatment and to the actual efficacy of the vaccines available to date, especially with the emergence of new variants. We evaluated the efficacy of the measles–mumps–rubella (MMR) vaccine in preventing SARS–CoV–2 infection and severity of COVID–19 in health workers. Methods: This analysis includes data from one ongoing blinded, randomized, placebo–controlled trial with participants aged 18–60 years were randomly assigned to receive the MMR vaccine or a placebo. The primary efficacy analysis included all participants with a positive nasopharyngeal RT–PCR test since their inclusion. Results: The MMR vaccine did not prevent the SARS–CoV–2 infection. Participants in the MMR group, compared with those in the placebo group, had a 48% risk reduction in symptomatic COVID–19 (RR = 0.52; 95% CI: 0.33-0.83; p=0.004) and a 76% risk reduction in COVID–19 treatment (RR = 0.24; 95% CI: 0.06-0.88; p = 0.020) with one dose and a 51% risk reduction in COVID–19 symptoms (RR = 0.49; 95% CI: 0.31 – 0.78; p = 0.001) and a 78% risk reduction in COVID–19 treatment (RR = 0.22; 95% CI: 0.06-0.82; p = 0.015) with two doses. Conclusions: This interim analysis of an ongoing clinical trial suggests that compared with a placebo, the vaccine reduces the risk of COVID–19 symptoms and reduces the need for COVID–19 treatment.

scholarly journals Gonadotropin-releasing hormone agonist versus expectant management for treating multiple leiomyomas after myomectomy: the study protocol for a multicentre, prospective, randomised controlled clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e044347
Author(s):  
Jia Wei ◽  
Xiangyi Ma ◽  
Wenwen Wang ◽  
Minli Zhang ◽  
Zhiying Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Expectant Management ◽  
Gonadotropin Releasing Hormone ◽  
Controlled Clinical Trial ◽  
Releasing Hormone ◽  
Gonadotropin Releasing Hormone Agonist ◽  
Pathological Result ◽  
Randomised Controlled

IntroductionLeiomyoma recurrence is a major concern for long-term myomectomy management, especially for multiple leiomyomas. Gonadotropin-releasing hormone agonist (GnRHa) is one of the most effective medications to reduce the volume of fibroids and the uterus. However, its role in preventing recurrence after conservative surgery remains unclear. At present, there is no randomised clinical trial determining the efficacy of GnRHa treatment for preventing multiple leiomyomas recurrence after myomectomy.Methods and analysisWe are conducting a phase IV randomised controlled trial in women aged 18–45 undergoing myomectomy for multiple leiomyomas. After surgery, women whose pathological result confirms multiple leiomyomas are randomised in a 1:1 ratio into an observation or GnRHa group. The primary outcome is the recurrence of either clinical symptoms or fibroids on imaging. Patients will be assessed for adverse events during the follow-up.Ethics and disseminationThe study was approved by the Medical Ethics Committee of the Tongji Hospital Affiliated with the Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20180311) according to the submitted study protocol (V.1.0, 10 November 2017) and informed consent (V.1.0, 10 November 2017). The results will be presented at domestic and international conferences and published in peer-reviewed journals.Trial registration numberChiCTR-IPR-17012992.

scholarly journals Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial

2019 ◽  
Vol 25 (3) ◽  
pp. 305-309 ◽  
Author(s):  
Robert Fahed ◽  
Tim E Darsaut ◽  
Charbel Mounayer ◽  
René Chapot ◽  
Michel Piotin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Arteriovenous Malformation ◽  
Arteriovenous Malformations ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Cerebral Arteriovenous Malformations ◽  
Clinical Trial Registration ◽  
Transarterial Embolisation ◽  
Randomised Controlled ◽  
Transvenous Approach

Background Transvenous embolisation is a promising technique but the benefits remain uncertain. We hypothesised that transvenous embolisation leads to a higher rate of arteriovenous malformation angiographic occlusion than transarterial embolisation. Methods The Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM) is an investigator initiated, multicentre, prospective, phase 2, randomised controlled clinical trial. To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm). The primary endpoint of the trial is complete arteriovenous malformation occlusion, assessed by catheter cerebral angiography. Complete occlusions will be confirmed at 3 months, while incompletely occluded arteriovenous malformations, considered treatment failures, will then be eligible for complementary treatments by surgery, radiation therapy, or even transvenous embolisation. Standard procedural safety outcomes will also be assessed. Patient selection will be validated by a case selection committee, and participating centres with limited experience in transvenous embolisation will be proctored. Discussion The TATAM trial is a transparent research framework designed to offer a promising but still unvalidated treatment to selected arteriovenous malformation patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03691870.

scholarly journals Comparison of regional with general anaesthesia on postoperative delirium (RAGA-delirium) in the older patients undergoing hip fracture surgery: study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016937 ◽  
Author(s):  
Ting Li ◽  
Joyce Yeung ◽  
Jun Li ◽  
Yan Zhang ◽  
Teresa Melody ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hip Fracture ◽  
General Anaesthesia ◽  
Older Patients ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Hip Fracture Surgery ◽  
Randomised Controlled ◽  
Fracture Surgery

IntroductionPostoperative delirium (POD) is a common serious postoperative complication especially in older people and is associated with increased mortality, morbidity and healthcare costs. There is no clear consensus which anaesthesia is associated with less incidence of POD for older patients. We aim to assess whether regional anaesthesia results in lower incidence of POD comparing with general anaesthesia (GA) among older patients undergoing hip fracture surgery.Methods and analysisRAGA-delirium is a pragmatic, multicentre, prospective, parallel grouped, randomised controlled clinical trial comparing RA or GA for hip fracture surgery. A total of 1000 patients who are 65 years or over and who are having planned hip fracture surgery in nine clinical trial centres of China will be randomised in a 1:1 ratio to receive either anaesthesia for the surgery. The primary endpoint will be the incidence of POD at day 7. The secondary endpoints will be the subtype, severity and duration of delirium, postoperative acute pain score, incidence of other postoperative non-delirium complications, quality of life and cost-effective outcomes. Randomisation will be performed at the patient level using computer-generated assignment. Outcome assessors will be blinded from intervention assignment. Assessments will be conducted before surgery, intraoperatively, postoperatively, during the hospital stay, at 30-day, 6-month and 1-year postoperative intervals.Potential impact of studyThis study will provide clinical evidence with a more robust methodology to help anaesthetists in selecting appropriate anaesthesia for older patients with high risk for POD. At the era of increasing emphasis on delirium prevention, this trial has the potential to inform the future national guideline to reduce POD.Ethics and disseminationEthical approved by the local institutional review board. Trial results will be presented at national and international academic conferences, and published in peer-reviewed journals.Trial registration numberClinicalTrials.gov (NCT02213380); pre-results.

scholarly journals Tackling frailty at primary care: evaluation of the effectiveness of a multicomponent intervention through a randomised controlled trial: study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034591
Author(s):  
Francisco Rivas-Ruiz ◽  
Mónica Machón ◽  
Maider Mateo-Abad ◽  
Eugenio Contreras-Fernández ◽  
Carolina Güell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Functional Capacity ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Scientific Journal ◽  
Controlled Clinical Trial ◽  
Multifactorial Intervention ◽  
Randomised Controlled

IntroductionThis project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty. The final evaluation will be made at 12 months’ follow-up.Methods and analysisPragmatic multicentre cluster randomised controlled clinical trial, single blind with two arms: multifactorial intervention in PHC versus usual follow-up. The randomisation unit is the patient list and the analysis unit is the patient. In addition, a cost-effectiveness study and a qualitative study will be carried out, the latter based on semistructured interviews and focus groups. Two hundred persons (100 per study branch) all aged ≥70 years, presenting frailty, but functionally independent and resident in the community, will be recruited. A baseline evaluation will be carried out prior to the intervention, with follow-up at 6 and 12 months. The main study variables considered will be functional capacity and incidence of adverse events; the secondary variables considered will be the patients’ sociodemographic characteristics, nutritional status, level of physical activity and drug consumption, together with data on comorbidity, cognitive and affective status and health-related quality of life. Data will be analysed according to the intention-to-treat principle using a 5% significance level.Ethics and disseminationThe study will at all times be conducted in strict accordance with the provisions of the Declaration of Helsinki and with the national legislation regulating patients’ autonomy. All patients recruited will be asked to provide written informed consent before taking part in the clinical trial. On completion of the study, the principal investigator expects to publish the results of this research in a peer-reviewed open access scientific journal.Trial registration numberISRCTN17143761.

The effect of Xuanbai Chengqi decoction on patients with pneumonia-derived sepsis: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Zhang Jun ◽  
Yi Yu ◽  
Bojun Zheng ◽  
Huang Jing
Keyword(s):  
Bronchoalveolar Lavage Fluid ◽  
Controlled Trial ◽  
Lavage Fluid ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled ◽  
To Receive ◽  
Single Blind ◽  
Pro Inflammatory Cytokines

Abstract INTRODUCTION We wish to investigate the efficacy of Xuanbai Chengqi decoction (XCD) on management of pneumonia-derived sepsis.METHODS AND ANALYSIS A single-blind, randomised controlled clinical trial will be conducted involving 90 patients with pneumonia-derived sepsis. Participants will be randomised at a 1:1 ratio to receive XCD (experimental arm) or the same amount of saline treatment (control arm). The intervention will comprise one session/day for 1 week. The primary outcomes will be 28-day mortality, and levels of pro-inflammatory cytokines in bronchoalveolar lavage fluid and serum 1, 3 and 7 days after treatment completion with respect to baseline levels. Secondary outcomes will be the symptom score of traditional Chinese medicine, duration of parenteral nutrition, and prevalence of complications. Measurements will be taken at baseline, 1, 3 and 7 days during the intervention, after 28 days after completing the intervention. Adverse events between arms will be evaluated.

scholarly journals A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Aliza Werner-Seidler ◽  
Kit Huckvale ◽  
Mark E. Larsen ◽  
Alison L. Calear ◽  
Kate Maston ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Trial Registration ◽  
Control Group ◽  
School Students ◽  
School Based ◽  
Randomised Controlled ◽  
To Receive

Abstract Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implementing and accessing these programmes remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programmes. The Future Proofing Study is a large-scale school-based trial investigating whether cognitive behaviour therapies (CBT) delivered by smartphone application can prevent depression. Methods A randomised controlled trial targeting up to 10,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression, and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur post intervention (both trial stages) and at 6, 12, 24, 36, 48 and 60 months post baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed-effect models. Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much-needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programmes should be deployed in school-based settings in Australia and beyond. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

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