scholarly journals Efficacy of sofosbuvir as treatment for yellow fever: protocol for a randomised controlled trial in Brazil (SOFFA study)

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e027207 ◽  
Author(s):  
Claudia Figueiredo-Mello ◽  
Luciana Vilas Boas Casadio ◽  
Vivian Iida Avelino-Silva ◽  
Ho Yeh-Li ◽  
Jaques Sztajnbok ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Yellow Fever ◽  
Hepatitis Virus ◽  
Controlled Trial ◽  
Clinical Care ◽  
Specific Treatment ◽  
Viral Kinetics ◽  
Randomised Controlled ◽  
To Receive

IntroductionAn ongoing outbreak of yellow fever (YF) has been reported in Brazil with 1261 confirmed cases and 409 deaths since July 2017. To date, there is no specific treatment available for YF. Recently published papers describing in vitro and animal models suggest a potential effect of antiviral drugs (approved for the treatment of hepatitis virus) against flaviviruses, including YF. The primary aim of this study is to analyse the effect of sofosbuvir on viral kinetics and clinical outcomes among patients presenting with YF. This is a multicentre open-label randomised controlled trial with 1:1 individual allocation, stratified by severity and by recruiting centre.Methods and analysisAdults with suspected or confirmed YF infection and symptoms lasting up to 15 days are screened. Eligible and consenting patients are randomised to receive oral sofosbuvir 400 mg daily for 10 days or to receive standard clinical care. Viral kinetics are measured daily and the reduction in YF plasma viral load from the sample at inclusion to 72 hours after randomisation will be compared between active and control groups. Clinical outcomes include severity meeting criteria for intensive care support, liver transplantation, in-hospital mortality and mortality within 60 days.Ethics and disseminationEthics approval was obtained at the participating sites and at the national research ethics committee (CAAE 82673018.6.1001.0068). The trial has been submitted for ethical approval at additional potential recruiting centres. Results of the study will be published in journals and presented at scientific meetings.Trial registrationBrazilian Clinical Trials Registry (RBR-93dp9n).

scholarly journals Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034987
Author(s):  
Jitender Nagpal ◽  
Manu Raj Mathur ◽  
Swapnil Rawat ◽  
Deepti Nagrath ◽  
Charlotte Lee ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Post Partum ◽  
Controlled Trial ◽  
Clinical Care ◽  
First Trimester ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Study Results ◽  
Randomised Controlled ◽  
To Receive

IntroductionVitamin B12 deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B12 deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.Methods and analysisThis double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring’s neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant’s biochemical B12 status at age 9 months and maternal biochemical B12 status in the first and third trimesters. Maternal biochemical B12 status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.Ethical considerations and disseminationThe study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits.Trial registration numberCTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov)

scholarly journals Home interventions and light therapy for the treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (4) ◽  
pp. e018649
Author(s):  
Rachel H Haines ◽  
Kim S Thomas ◽  
Alan A Montgomery ◽  
Jane C Ravenscroft ◽  
Perways Akram ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Clinical Care ◽  
Treatment Success ◽  
Mometasone Furoate ◽  
Body Region ◽  
Psychological Disturbance ◽  
Randomised Controlled

Introduction Vitiligo is a condition resulting in white patches on the skin. People with vitiligo can suffer from low self-esteem, psychological disturbance and diminished quality of life. Vitiligo is often poorly managed, partly due to lack of high-quality evidence to inform clinical care. We describe here a large, independent, randomised controlled trial (RCT) assessing the comparative effectiveness of potent topical corticosteroid, home-based hand-held narrowband ultraviolet B-light (NB-UVB) or combination of the two, for the management of vitiligo. Methods and analysis The HI-Light Vitiligo Trial is a multicentre, three-arm, parallel group, pragmatic, placebo-controlled RCT. 516 adults and children with actively spreading, but limited, vitiligo are randomised (1:1:1) to one of three groups: mometasone furoate 0.1% ointment plus dummy NB-UVB light, vehicle ointment plus NB-UVB light or mometasone furoate 0.1% ointment plus NB-UVB light. Treatment of up to three patches of vitiligo is continued for up to 9 months with clinic visits at baseline, 3, 6 and 9 months and four post-treatment questionnaires. The HI-Light Vitiligo Trial assesses outcomes included in the vitiligo core outcome set and places emphasis on participants’ views of treatment success. The primary outcome is proportion of participants achieving treatment success (patient-rated Vitiligo Noticeability Scale) for a target patch of vitiligo at 9 months with further independent blinded assessment using digital images of the target lesion before and after treatment. Secondary outcomes include time to onset of treatment response, treatment success by body region, percentage repigmentation, quality of life, time-burden of treatment, maintenance of response, safety and within-trial cost-effectiveness. Ethics and dissemination Approvals were granted by East Midlands—Derby Research Ethics Committee (14/EM/1173) and the MHRA (EudraCT 2014-003473-42). The trial was registered 8 January 2015 ISRCTN (17160087). Results will be published in full as open access in the NIHR Journal library and elsewhere. Trial registration number ISRCTN17160087.

scholarly journals Music to prevent deliriUm during neuroSurgerY (MUSYC) Clinical trial: a study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e048270
Author(s):  
Pablo Kappen ◽  
Johannes Jeekel ◽  
Clemens M F Dirven ◽  
M Klimek ◽  
Steven Kushner ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Randomised Controlled Trial ◽  
Medical Center ◽  
Controlled Trial ◽  
Clinical Care ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Neurosurgical Procedures ◽  
Depth Of Anaesthesia ◽  
Randomised Controlled

IntroductionDelirium is a neurocognitive disorder characterised by an acute and temporary decline of mental status affecting attention, awareness, cognition, language and visuospatial ability. The underlying pathophysiology is driven by neuroinflammation and cellular oxidative stress.Delirium is a serious complication following neurosurgical procedures with a reported incidence varying between 4% and 44% and has been associated with increased length of hospital stay, increased amount of reoperations, increased costs and mortality.Perioperative music has been reported to reduce preoperative anxiety, postoperative pain and opioid usage, and attenuates stress response caused by surgery. We hypothesize that this beneficial effect of music on a combination of delirium eliciting factors might reduce delirium incidence following neurosurgery and subsequently improve clinical outcomes.MethodsThis protocol concerns a single-centred prospective randomised controlled trial with 6 months follow-up. All adult patients undergoing a craniotomy at the Erasmus Medical Center in Rotterdam are eligible. The music group will receive recorded music through an overear headphone before, during and after surgery until postoperative day 3. Patients can choose from music playlists, offered based on music importance questionnaires administered at baseline. The control group will receive standard of clinical careDelirium is assessed by the Delirium Observation Scale and confirmed by a delirium-expert psychiatrist according to the DSM-5 criteria. Risk factors correlated with the onset of delirium, such as cognitive function at baseline, preoperative anxiety, perioperative medication use, depth of anaesthesia and postoperative pain, and delirium-related health outcomes such as length of stay, daily function, quality of life (ie, EQ-5D, EORTC questionnaires), costs and cost-effectiveness are collected.Ethics and disseminationThis study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Center Rotterdam, The Netherlands, approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.Trial registration numbersNL8503 and NCT04649450.

Longer-Term Clinical and Economic Benefits of Offering Acupuncture to Patients with Chronic Low Back Pain Assessed as Suitable for Primary Care Management – 3 Month Clinical Outcomes from a Controlled Trial of 241 Patients

2002 ◽  
Vol 20 (2-3) ◽  
pp. 121-137
Author(s):  
H Macpherson ◽  
K Thomas ◽  
J Brazier ◽  
M Fitter ◽  
L Thorpe ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Bodily Pain ◽  
Control Group ◽  
Low Back ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Objectives To undertake a pragmatic randomised controlled trial to test the hypothesis that a population of patients with persistent low back pain, when given access to an acupuncture service, gain more relief from pain than those offered usual management only, for equal or less cost. Methods The study is a pragmatic randomised controlled trial (n=241). Suitable patients are identified by their general practitioners. Patients randomised to the experimental arm are offered the option of referral for up to 10 individualised treatments from one of six qualified acupuncture practitioners. The control group continues to receive usual management from their general practitioner. The primary scale used for measuring change is the Bodily Pain (SF–36) at 3 months and 12 months post randomisation. The main outcome is cost-effectiveness at 12 months. Results A total of 43 general practitioners participated in the trial and 241 patients were randomised. All patients randomised to the option of acupuncture chose to receive treatment. Clinical outcomes at 3 months show that the SF-36 Bodily Pain scores improved by 29.4 and 24.9 points in the acupuncture and normal management group respectively (p=0.125). Patients in the acupuncture group reported lower levels of worry at three months (p<0.001). Conclusions It is possible to conduct a large pragmatic randomised controlled trial of acupuncture in a primary care setting. Acupuncture is seen as an acceptable treatment by patients with low back pain. Clinical outcomes at three months suggest that the acupuncture group are in less pain than the control group.

scholarly journals Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular point-of-care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031674 ◽  
Author(s):  
Kate Beard ◽  
Nathan Brendish ◽  
Ahalya Malachira ◽  
Samuel Mills ◽  
Cathleen Chan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Point Of Care ◽  
Controlled Trial ◽  
Clinical Care ◽  
Respiratory Illness ◽  
Acute Respiratory Illness ◽  
National Guidelines ◽  
South Central ◽  
Randomised Controlled ◽  
The Impact

BackgroundInfluenza infections often remain undiagnosed in patients admitted to hospital due to lack of routine testing. When tested for, the diagnosis and treatment of influenza are often delayed due to the slow turnaround times of centralised laboratory PCR testing. Newer molecular systems, have comparable accuracy to laboratory PCR testing, and can generate a result in under 1 hour, making them potentially deployable as point-of-care tests (POCTs). High-quality evidence for the impact of routine POCT for influenza on clinical outcomes is, however, currently lacking. This large pragmatic multicentre randomised controlled trial aims to address this evidence gap.Methods and analysisThe FluPOC trial is a pragmatic, multicentre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England. Up to 840 patients will be recruited over up to three influenza seasons, and randomised (1:1) to receive either POCT using the FilmArray respiratory panel, or routine clinical care. Clinical and infection control teams will be informed of the results in real time and where influenza is detected clinical teams will be encouraged to offer neuraminidase inhibitor (NAI) treatment in accordance with national guidelines. Those allocated to standard clinical care will have a swab taken for later analysis to allow assessment of missed diagnoses. The outcomes assessment will be by retrospective case note analysis. The outcome measures include the proportion of influenza-positive patients detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality.Ethics and disseminationPrior to commencing the study, approval was obtained from the South Central Hampshire A Ethics Committee (reference 17/SC/0368, granted 7 September 2017). Results generated from this protocol will be published in peer-reviewed scientific journals and presented at national and international conferences.Trial registration numberISRCTN17197293

DHA supplementation in infants born preterm and the effect on attention at 18 months’ corrected age: follow-up of a subset of the N3RO randomised controlled trial

2020 ◽  
pp. 1-12 ◽  
Author(s):  
Erandi Hewawasam ◽  
Carmel T. Collins ◽  
Beverly S. Muhlhausler ◽  
Lisa N. Yelland ◽  
Lisa G. Smithers ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
High Dose ◽  
Peak Period ◽  
Soya Oil ◽  
Randomised Controlled ◽  
To Receive ◽  
The Brain

Abstract Infants born preterm miss out on the peak period of in utero DHA accretion to the brain during the last trimester of pregnancy which is hypothesised to contribute to the increased prevalence of neurodevelopmental deficits in this population. This study aimed to determine whether DHA supplementation in infants born preterm improves attention at 18 months’ corrected age. This is a follow-up of a subset of infants who participated in the N3RO randomised controlled trial. Infants were randomised to receive an enteral emulsion of high-dose DHA (60 mg/kg per d) or no DHA (soya oil – control) from within the first days of birth until 36 weeks’ post-menstrual age. The assessment of attention involved three tasks requiring the child to maintain attention on toy/s in either the presence or absence of competition or a distractor. The primary outcome was the child’s latency of distractibility when attention was focused on a toy. The primary outcome was available for seventy-three of the 120 infants that were eligible to participate. There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0·08 s, 95 % CI –0·81, 0·97; P = 0·86). Enteral DHA supplementation did not result in improved attention in infants born preterm at 18 months’ corrected age.

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