scholarly journals Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH)

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053190
Author(s):  
Paul Noel Brennan ◽  
Mark MacMillan ◽  
Thomas Manship ◽  
Francesca Moroni ◽  
Alison Glover ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Randomised Controlled Trial ◽  
Ex Vivo ◽  
Controlled Trial ◽  
Phase 2 ◽  
Open Label ◽  
Compensated Cirrhosis ◽  
Parallel Group ◽  
Liver Fibrogenesis ◽  
Randomised Controlled

IntroductionLiver cirrhosis is a growing global healthcare challenge. Cirrhosis is characterised by severe liver fibrosis, organ dysfunction and complications related to portal hypertension. There are no licensed antifibrotic or proregenerative medicines and liver transplantation is a scarce resource. Hepatic macrophages can promote both liver fibrogenesis and fibrosis regression. The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages in patients with compensated cirrhosis has been demonstrated.Methods and analysisThe efficacy of autologous macrophage therapy, compared with standard medical care, will be investigated in a cohort of adult patients with compensated cirrhosis in a multicentre, open-label, parallel-group, phase 2, randomised controlled trial. The primary outcome is the change in Model for End-Stage Liver Disease score at 90 days. The trial will provide the first high-quality examination of the efficacy of autologous macrophage therapy in improving liver function, non-invasive fibrosis markers and other clinical outcomes in patients with compensated cirrhosis.Ethics and disseminationThe trial will be conducted according to the ethical principles of the Declaration of Helsinki 2013 and has been approved by Scotland A Research Ethics Committee (reference 15/SS/0121), National Health Service Lothian Research and Development department and the Medicine and Health Care Regulatory Agency-UK. Final results will be presented in peer-reviewed journals and at relevant conferences.Trial registration numbersISRCTN10368050 and EudraCT; reference 2015-000963-15

Antimicrobial central venous catheters do not reduce infections in pre-term babies

BMJ ◽  
2019 ◽  
pp. l4993
Author(s):  
Rob Cook ◽  
Duncan Fortescue-Webb ◽  
Rosie Martin
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Technology ◽  
Central Venous Catheters ◽  
Central Venous ◽  
Open Label ◽  
Health Technology Assessment Programme ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

The studyGilbert R, Brown M, Rainford N et al. Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial. Lancet Child Adolesc Health 2019;3:381-90.The study was funded by the NIHR Health Technology Assessment programme (project number 12/167/02).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000782/antimicrobial-central-venous-catheters-for-pre-term-babies-do-not-reduce-infections

scholarly journals Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

2021 ◽  
Author(s):  
Jan Maláska ◽  
Jan Stašek ◽  
František Duška ◽  
Martin Balík ◽  
Jan Máca ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Objective ◽  
Efficacy And Safety ◽  
Open Label ◽  
Parallel Group ◽  
Secondary Objective ◽  
Randomised Controlled

Abstract ObjectivesThe primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.

scholarly journals An open-label, parallel-group, randomised controlled trial of antiseptic mouthwash versus antibiotics for oropharyngeal gonorrhoea treatment (OMEGA2)

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Eric P. F. Chow ◽  
Kate Maddaford ◽  
Jane S. Hocking ◽  
Catriona S. Bradshaw ◽  
Rebecca Wigan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Health Centre ◽  
Nucleic Acid Amplification ◽  
Open Label ◽  
Parallel Group ◽  
Randomised Controlled ◽  
New Treatments ◽  
Clinical Trials Registry

Abstract New treatments for oropharyngeal gonorrhoea are required to address rising antimicrobial resistance. We aimed to examine the efficacy of a 14-day course of mouthwash twice daily compared to standard treatment (antibiotic) for the treatment of oropharyngeal gonorrhoea. The OMEGA2 trial was a parallel-group and open-labelled randomised controlled trial among men with untreated oropharyngeal gonorrhoea that was conducted between September 2018 and February 2020 at Melbourne Sexual Health Centre in Australia. Men were randomised to the intervention (rinsing, gargling and spraying mouthwash twice daily for 14 days) or control (standard treatment) arm and followed for 28 days. Participants in both arms were advised to abstain from sex and kissing with anyone for 14 days after enrolment. Oropharyngeal swabs were collected at baseline, Day 14 and Day 28 and tested for Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) and culture. The primary outcome was the detection of oropharyngeal N. gonorrhoeae by NAAT at Day 14 after treatment. This trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12618001380280). This trial stopped early due to a high failure rate in the mouthwash arm. Twelve men were randomly assigned to either mouthwash (n = 6) or standard treatment (n = 6). Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1–72%; 1/5) and in the standard treatment arm was 100% (95% CI 54–100%; 6/6). A 14-day course of mouthwash failed to cure a high proportion of oropharyngeal gonorrhoea cases.

scholarly journals Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial

The Lancet ◽  
2017 ◽  
Vol 390 (10109) ◽  
pp. 2247-2255 ◽  
Author(s):  
Ashley Woodcock ◽  
Jørgen Vestbo ◽  
Nawar Diar Bakerly ◽  
John New ◽  
J Martin Gibson ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Fluticasone Furoate ◽  
Open Label ◽  
Parallel Group ◽  
Randomised Controlled
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