scholarly journals Levofloxacin versus placebo for the treatment of latent tuberculosis among contacts of patients with multidrug-resistant tuberculosis (the VQUIN MDR trial): a protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e033945 ◽  
Author(s):  
Greg J Fox ◽  
Cam Binh Nguyen ◽  
Thu Anh Nguyen ◽  
Phuong Thuy Tran ◽  
Ben J Marais ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Latent Tuberculosis ◽  
Multidrug Resistant ◽  
Preventive Therapy ◽  
Positive Tuberculin Skin Test ◽  
Primary Study ◽  
Double Blind ◽  
Mdr Tb ◽  
Randomised Controlled

IntroductionTreatment of latent tuberculosis infection (LTBI) plays a substantial role in the prevention of drug-susceptible tuberculosis (TB). However, clinical trials to evaluate the efficacy of preventive therapy for presumed multidrug-resistant (MDR) LTBI are lacking. This trial aims to evaluate the efficacy of the antibiotic levofloxacin in preventing the development of active TB among latently infected contacts of index patients with MDR-TB.Methods and analysisA double-blind placebo-controlled parallel group randomised controlled trial will be conducted in 10 provinces of Vietnam. Household contacts living with patients with bacteriologically confirmed rifampicin-resistant or MDR-TB will be eligible for recruitment if they have a positive tuberculin skin test or are known to be immunosuppressed, and do not have active TB. Participants will be randomised to receive either levofloxacin or placebo tablets once per day for 6 months. Screening for incident TB will be performed at 6 months intervals. The primary study outcome is the incidence of bacteriologically confirmed TB within 30 months after randomisation. Analysis will be by intention to treat, using Poisson regression.EthicsEthical approval from the University of Sydney Human Research Ethics Committee was obtained on 29 April 2015 (2014/929), and from the Vietnam Ministry of Health Institutional Review Board on 30 September 2015 (4040/QD-BYT).DisseminationFindings of the study will be published in peer-reviewed publications and conference presentations.Trial registration numberACTRN12616000215426.

scholarly journals Patient-specific instrumentation (PSI) Referencing High Tibial Osteotomy Technological Transfer and Education: protocol for a double-blind, randomised controlled trial (PROTECTED HTO Trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041129
Author(s):  
Lawrence Chun Man Lau ◽  
Elvis Chun Sing Chui ◽  
Jason Chi Ho Fan ◽  
Gene Chi Wai Man ◽  
Yuk Wah Hung ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
High Tibial Osteotomy ◽  
Controlled Trial ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Double Blind ◽  
Patient Specific Instrumentation ◽  
3D Printed ◽  
Randomised Controlled

IntroductionHigh tibial osteotomy (HTO) is a treatment of choice for active adult with knee osteoarthritis. With advancement in CT imaging with three-dimensional (3D) model reconstruction, virtual planning and 3D printing, patient-specific instrumentation (PSI) in form of cutting jigs is employed to improve surgical accuracy and outcome of HTO. The aim of this randomised controlled trial (RCT) is to explore the surgical outcomes of HTO for the treatment of medial compartment knee osteoarthritis with or without a 3D printed patient-specific jig.Methods and analysisA double-blind RCT will be conducted with patients and outcome assessors blinded to treatment allocation. This meant that neither the patients nor the outcome assessors would know the actual treatment allocated during the trial. Thirty-six patients with symptomatic medial compartment knee osteoarthritis fulfilling our inclusion criteria will be invited to participate the study. Participants will be randomly allocated to one of two groups (1:1 ratio): operation with 3D printed patient-specific jig or operation without jig. Measurements will be taken before surgery (baseline) and at postoperatively (6, 12 and 24 months). The primary outcome includes radiological accuracy of osteotomy. Secondary outcomes include a change in knee function from baseline to postoperatively as measured by three questionnaires: Knee Society Scores (Knee Scores and Functional Scores), Oxford Knee Scores and pain visual analogue scale (VAS) score.Ethics and disseminationEthical approval has been obtained from the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (CREC no. 2019.050), in accordance with the Declaration of Helsinki. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numberNCT04000672; Pre-results.

scholarly journals The effect of sertraline on emotional processing: secondary analyses of the PANDA randomised controlled trial

2021 ◽  
pp. 1-8
Author(s):  
Norin Ahmed ◽  
Jessica K. Bone ◽  
Gemma Lewis ◽  
Nick Freemantle ◽  
Catherine J. Harmer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Emotional Processing ◽  
Statistical Power ◽  
Controlled Trial ◽  
Negative Information ◽  
Small Samples ◽  
Double Blind ◽  
Treatment Allocation ◽  
Randomised Controlled ◽  
Cognitive Neuropsychological

Abstract Background According to the cognitive neuropsychological model, antidepressants reduce symptoms of depression and anxiety by increasing positive relative to negative information processing. Most studies of whether antidepressants alter emotional processing use small samples of healthy individuals, which lead to low statistical power and selection bias and are difficult to generalise to clinical practice. We tested whether the selective serotonin reuptake inhibitor (SSRI) sertraline altered recall of positive and negative information in a large randomised controlled trial (RCT) of patients with depressive symptoms recruited from primary care. Methods The PANDA trial was a pragmatic multicentre double-blind RCT comparing sertraline with placebo. Memory for personality descriptors was tested at baseline and 2 and 6 weeks after randomisation using a computerised emotional categorisation task followed by a free recall. We measured the number of positive and negative words correctly recalled (hits). Poisson mixed models were used to analyse longitudinal associations between treatment allocation and hits. Results A total of 576 participants (88% of those randomised) completed the recall task at 2 and 6 weeks. We found no evidence that positive or negative hits differed according to treatment allocation at 2 or 6 weeks (adjusted positive hits ratio = 0.97, 95% CI 0.90–1.05, p = 0.52; adjusted negative hits ratio = 0.99, 95% CI 0.90–1.08, p = 0.76). Conclusions In the largest individual placebo-controlled trial of an antidepressant not funded by the pharmaceutical industry, we found no evidence that sertraline altered positive or negative recall early in treatment. These findings challenge some assumptions of the cognitive neuropsychological model of antidepressant action.

Sign in / Sign up

Export Citation Format

Share Document