scholarly journals Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-6
Author(s):  
Jimin Park ◽  
Hyun Soo Kim ◽  
Seung Min Lee ◽  
Kanghyun Yoon ◽  
Woo-shik Kim ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Study Protocol ◽  
Controlled Trial ◽  
Persistent Atrial Fibrillation ◽  
Sham Acupuncture ◽  
University Hospital ◽  
Institutional Review Boards ◽  
Controlled Clinical Trial ◽  
Inflammatory Biomarker ◽  
Institutional Review

Background.Atrial fibrillation (AF) is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF).Methods.A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA) and left atrial appendage (LAA) changes in function and volume, and inflammatory biomarker changes.Ethics.This study protocol was approved by the institutional review boards (IRBs) of Kyung Hee University Hospital (number 1335-04). This trial is registered with clinicaltrials.govNCT02110537.

scholarly journals Effectiveness and organizational conditions of effectiveness of telemedicine in nursing homes. A study protocol of a comparative prospective cohort (EFFORT study)

2021 ◽  
Vol 7 ◽  
pp. 205520762098242
Author(s):  
Nathalie Salles ◽  
Florence Saillour-Glénisson ◽  
Matthieu Sibe ◽  
Emmanuel Langlois ◽  
Marion Kret ◽  
...  
Keyword(s):  
Study Protocol ◽  
Controlled Trial ◽  
University Hospital ◽  
Control Group ◽  
Organizational Conditions ◽  
Institutional Review ◽  
Ethical Approval ◽  
Registration Number ◽  
Unplanned Hospitalizations ◽  
The Impact

Introduction The profile of nursing home (NH) residents has changed over the past decade with more dependency, more severe chronic diseases and more treatments prescribed. For residents, the major consequence is the higher risk of unplanned hospitalization. French guidelines recommend the development of interactive telemedicine (InT) in NHs in order to improve access to care, and to decrease the rate of avoidable unplanned hospitalizations. Methods and analysis: The aim of this study is to analyze the impact of an InT protocol delivered in NHs on the rate of unplanned hospitalizations, and on the quality of life at work and the organizational conditions of effectiveness of telemedicine in NHs. We will perform a mixed methods study combining a cluster non-randomized controlled trial in two matched parallel arms (telemedicine group and control group) and qualitative analysis of the evolution of organizational and professional contexts in NHs. Ethics and dissemination: The study protocol was approved and sponsored by the French Ministry of Health. The study received ethical approval from the Bordeaux University Hospital Institutional Review Board. We will communicate the final results to the public via conferences and results will also be submitted for publication in international peer-reviewed scientific journals. Trial registration number NCT03486977

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 Staged transthoracic approach to persistent atrial fibrillation (TOP-AF): study protocol for a randomized trial

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Claudio Pragliola ◽  
Pasquale Mastroroberto ◽  
Mario Gaudino ◽  
Massimo Chello ◽  
Elvio Covino
Keyword(s):  
Atrial Fibrillation ◽  
Randomized Trial ◽  
Study Protocol ◽  
Persistent Atrial Fibrillation ◽  
Transthoracic Approach

Abstract WP229: Randomised Clinical Trial of Early Prolonged Ambulatory Cardiac monitoring After Stroke (EPACS): Interim Analysis

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
James T Teo ◽  
Judith Lenane ◽  
Laszlo Sztriha ◽  
Fong K Chan ◽  
John Aeron-Thomas ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Paroxysmal Atrial Fibrillation ◽  
Interim Analysis ◽  
Controlled Trial ◽  
Significant Proportion ◽  
University Hospital ◽  
Cardiac Monitoring ◽  
Serious Adverse Events ◽  
Index Event

Introduction: Cardioembolism in paroxysmal atrial fibrillation (PAF) is a preventable cause of ischaemic stroke or transient ischaemic attack (TIA), but the transient nature of PAF means that a short-duration Holter monitor misses a significant proportion of cases. Systems for recording beyond 3-7 days have significant limitations: event-triggered loop recorders are cumbersome while implanted loop recorders require a minor surgical procedure. There is a need for a patient-friendly long-duration cardiac monitoring system for stroke patients which can be performed without significant delay from the index event and with superior yield to Holter ECG’s. Methods: We conducted a pragmatic randomised controlled trial of cardiac monitoring after an ischaemic stroke or TIA to increase detection of paroxysmal atrial fibrillation (recruited within 72 hours of index event) using a wearable water-proof adhesive cardiac monitoring patch (Zio® Patch, iRhythm Technologies) that can be fitted immediately by the clinician early after the index event for up to 14 days or a standard Holter ECG. The trial aimed to recruit 120 patients across two locations - urban teaching hospital (Kings College Hospital, London) and suburban district hospital (Princess Royal University Hospital, Orpington). ISCRTN Registration 50253271. Results: In August 2016, the interim analysis detected PAF in 4/17 cases in the active arm and 0/16 cases in the control arm. The commonest arrhythmias detected were atrial tachyarrhythmias followed by PAF. Those in the control arm of Holter ECG’s had significant delays to initiate cardiac monitoring due to scheduling delays and patient non-attendance. There were no device-attributable serious adverse events. Further late-breaking results will be available in February 2017. Conclusion: The convenience of the Zio® Patch cardiac monitor substantially increased the uptake and efficiency of cardiac monitoring early after ischaemic strokes and TIA.

Relief of Low Back Pain Immediately after Acupuncture Treatment – a Randomised, Placebo Controlled Trial

2006 ◽  
Vol 24 (3) ◽  
pp. 103-108 ◽  
Author(s):  
Motohiro Inoue ◽  
Hiroshi Kitakoji ◽  
Naoto Ishizaki ◽  
Munenori Tawa ◽  
Tadashi Yano ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Sham Group ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Controlled Clinical Trial ◽  
Guide Tube ◽  
Low Back ◽  
Stainless Steel Needle

Background The purpose of this study was to examine the immediate effect of single acupuncture stimulation to the most painful point in patients with low back pain. Method A randomised, evaluator-blinded, sham controlled clinical trial was conducted in which 31 patients with low back pain were randomly allocated to either an acupuncture group (n=15) or a sham acupuncture group (n=16). Both acupuncture and sham acupuncture were performed at the most painful point on the lower back of the subjects. For the acupuncture group, a stainless steel needle was inserted to a depth of 20mm and manually stimulated (sparrow pecking method) for 20 seconds, while for the sham treatment a guide tube without a needle was placed at the point and tapped on the skin. Changes in low back pain were evaluated with a visual analogue scale (VAS) and the Schober test. Participants were also asked if they felt the needling sensation or not. The therapy and the evaluation were independently performed by two different acupuncturists. Results VAS score and the Schober test score showed significant improvement after treatment as compared with the sham group (P=0.02, 0.001, respectively). There were no significant differences in the needling sensation between the acupuncture and sham group. Conclusion These results suggest that acupuncture at the most painful point gives immediate relief of low back pain.

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