scholarly journals Accuracy and consequences of usingtrial-of-antibioticsfor TB diagnosis (ACT-TB study): protocol for a randomised controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e033999
Author(s):  
Titus Henry Divala ◽  
Katherine L Fielding ◽  
Derek J Sloan ◽  
Neil French ◽  
Marriott Nliwasa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mycobacterium Tuberculosis ◽  
Research Ethics ◽  
Primary Outcome ◽  
Standard Of Care ◽  
Ethics Committee ◽  
Absolute Difference ◽  
Controlled Clinical Trial ◽  
London School ◽  
Randomised Controlled

IntroductionOver 40% of global tuberculosis case notifications are diagnosed clinically without mycobacteriological confirmation. Standard diagnostic algorithms include ‘trial-of-antibiotics’—empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a ‘rule-out’ diagnostic test for tuberculosis. Potentially 26.5 million such antibiotic courses/year are prescribed globally for the 5.3 million/year mycobacteriology-negative patients, making trial-of-antibiotics the most common tuberculosis diagnostic, and a global-scale risk for antimicrobial resistance (AMR). Our systematic review found no randomised controlled trial (RCT) to support use of trial-of-antibiotic. The RCT aims to determine the diagnostic and clinical value and AMR consequences of trial-of-antibiotics.Methods and analysisA three-arm, open-label, RCT randomising (1:1:1) Malawian adults (≥18 years) seeking primary care for cough into: (a) azithromycin 500 mg one time per day for 3 days or (b) amoxicillin 1 g three times per day for 5 days or (c) standard-of-care (no immediate antibiotic). We will perform mycobacteriology tests (microscopy, Xpert MTB/RIF (Mycobacterium tuberculosis/rifampicin) andMycobacterium tuberculosisculture) at baseline. We will use audiocomputer-assisted self-interview to assess clinical improvement at day 8. First primary outcome will be proportion of patients reporting day 8 improvement out of those with negative mycobacteriology (specificity). Second primary outcome will be day 29 incidence of a composite endpoint of either death or hospitalisation or missed tuberculosis diagnosis. To determine AMR impact we compare proportion of resistant nasopharyngealStreptococcus pneumoniaeisolates on day 29. 400 mycobacteriology-negative participants/arm will be required to detect a ≥10% absolute difference in diagnostic specificity with 80% power. We will estimate measures of effect by comparing outcomes in antibiotic arms (combined and individually) to standard-of-care.Ethics and disseminationThe study has been reviewed and approved by Malawi College of Medicine Research and Ethics Committee, London School of Hygiene & Tropical Medicine (LSHTM) Research Ethics Committee and Regional Committee for Health and Research Ethics – Norway, and Malawi Pharmacy, Medicines and Poisons Board. We will present abstracts at relevant conferences, and prepare a manuscript for publication in a peer-reviewed journal.Trial registration numberThe clinical trial is registered with ClinicalTrials.gov,NCT03545373

scholarly journals Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017550
Author(s):  
Hang Ding ◽  
Rajiv Jayasena ◽  
Andrew Maiorana ◽  
Alison Dowling ◽  
Sheau Huey Chen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Research Ethics ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Care Programme ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Randomised Controlled

IntroductionChronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients’ compliance, and associated health and economic outcomes.Methods and analysisAn open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits.Ethics and disseminationThe clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees.Trial registration numberRegistered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640).

scholarly journals Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e046830
Author(s):  
Peter G Enticott ◽  
Karen Barlow ◽  
Adam J Guastella ◽  
Melissa K Licari ◽  
Nigel C Rogasch ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Autism Spectrum Disorder ◽  
Transcranial Magnetic Stimulation ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Autism Spectrum ◽  
Spectrum Disorder ◽  
Controlled Clinical Trial ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled

IntroductionThere are no well-established biomedical treatments for the core symptoms of autism spectrum disorder (ASD). A small number of studies suggest that repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, may improve clinical and cognitive outcomes in ASD. We describe here the protocol for a funded multicentre randomised controlled clinical trial to investigate whether a course of rTMS to the right temporoparietal junction (rTPJ), which has demonstrated abnormal brain activation in ASD, can improve social communication in adolescents and young adults with ASD.Methods and analysisThis study will evaluate the safety and efficacy of a 4-week course of intermittent theta burst stimulation (iTBS, a variant of rTMS) in ASD. Participants meeting criteria for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ASD (n=150, aged 14–40 years) will receive 20 sessions of either active iTBS (600 pulses) or sham iTBS (in which a sham coil mimics the sensation of iTBS, but no active stimulation is delivered) to the rTPJ. Participants will undergo a range of clinical, cognitive, epi/genetic, and neurophysiological assessments before and at multiple time points up to 6 months after iTBS. Safety will be assessed via a structured questionnaire and adverse event reporting. The study will be conducted from November 2020 to October 2024.Ethics and disseminationThe study was approved by the Human Research Ethics Committee of Monash Health (Melbourne, Australia) under Australia’s National Mutual Acceptance scheme. The trial will be conducted according to Good Clinical Practice, and findings will be written up for scholarly publication.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12620000890932).

scholarly journals The control of pain due to dentin hypersensitivity in individuals with molar–incisor hypomineralisation: a protocol for a randomised controlled clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044653
Author(s):  
Ana Paula Taboada Sobral ◽  
Elaine Marcilio Santos ◽  
Ana Cecilia Aranha ◽  
Paulo Vinícius Soares ◽  
Caroline Moraes Moriyama ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tooth Enamel ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Dentin Hypersensitivity ◽  
Molar Incisor Hypomineralisation ◽  
Randomised Controlled Clinical Trial ◽  
Sensitive Teeth ◽  
Randomised Controlled ◽  
Incisor Hypomineralisation

IntroductionDentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: (1) the dentin must be exposed and (2) the dentinal tubules must be open and connected to the pulp. Molar–incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH. The aim of the proposed randomised, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.Methods and analysisOne hundred and forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with PermaSeal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL, AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, Brazil). In Group 4, sensitive teeth will be treated with both LLL and PermaSeal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment.Ethics and disseminationThis protocol has been ethically approved by the local medical ethical committee (protocol number: 4.020.261). Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration numberNCT04407702.

Moxibustion applied at home for non-vertex presentation: a multicentre randomised controlled clinical trial

2012 ◽  
Vol 4 ◽  
pp. 47
Author(s):  
Vas Jorge ◽  
Aranda-Regules José Manuel ◽  
Modesto Manuela ◽  
Barón Mercedes ◽  
Benítez-Parejo Nicolás ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Randomised Controlled Clinical Trial ◽  
Vertex Presentation ◽  
Randomised Controlled ◽  
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