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 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 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 Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006618 ◽  
Author(s):  
Bing Zhao ◽  
Yong Cao ◽  
Yuanli Zhao ◽  
Jun Wu ◽  
Shuo Wang
Keyword(s):  
Randomised Controlled Trial ◽  
Functional Mri ◽  
Study Protocol ◽  
Arteriovenous Malformations ◽  
Controlled Trial ◽  
Case Series ◽  
Controlled Clinical Trial ◽  
High Morbidity ◽  
Intracranial Arteriovenous Malformations ◽  
Randomised Controlled

IntroductionIntracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI (fMRI) has been reported to be used for the preoperative evaluation of AVMs in small case series. The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial.Methods and analysisThe study is a prospective, randomised controlled clinical trial. This study will enrol a total of 600 eligible patients. These eligible patients will be randomised to the standard microsurgery group and the fMRI-guided microsurgery group in a 1:1 ratio. Patient baseline characteristics and AVM architecture and characteristics will be described. In the fMRI-guided group, fMRI mapping of an eloquent cortex in all AVMs will be identified. Surgical complications and outcomes at pretreatment, post-treatment, at discharge and at 1-month, 3-month and 6-month follow-up intervals will be analysed using the modified Rankin Scale (mRS). This trial will determine whether fMRI-guided microsurgery could improve outcomes in patients with AVMs and also identify the safety and efficacy of fMRI-guided microsurgery.Ethics and disseminationThe study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (ky2012-016-02). Study findings will be disseminated in the printed media.Trial registration numberClinicalTrials.gov NCT01758211.

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 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.

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