scholarly journals S50 A randomised clinical trial of azithromycin versus standard care in ambulatory COVID-19 – the ATOMIC2 trial

2021 ◽  
Author(s):  
TSC Hinks ◽  
L Cureton ◽  
R Knight ◽  
A Wang ◽  
JL Cane ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Care ◽  
Randomised Clinical Trial

scholarly journals Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial

2017 ◽  
Vol 31 (9) ◽  
pp. 814-824 ◽  
Author(s):  
Mogens Groenvold ◽  
Morten Aagaard Petersen ◽  
Anette Damkier ◽  
Mette Asbjoern Neergaard ◽  
Jan Bjoern Nielsen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Palliative Care ◽  
Advanced Cancer ◽  
Standard Care ◽  
Primary Outcome ◽  
Randomised Clinical Trial ◽  
Sensitivity Analyses ◽  
Specialist Palliative Care ◽  
Beneficial Effects ◽  
Secondary Outcomes

Background: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. Aim: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. Setting/participants: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient’s primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0–100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival. Results: Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (−4.9 points (95% confidence interval −11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect. Conclusion: We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.

scholarly journals Short-stay unit hospitalisation vs. standard care outcomes in older internal medicine patients—a randomised clinical trial

2018 ◽  
Vol 47 (6) ◽  
pp. 810-817 ◽  
Author(s):  
Camilla Strøm ◽  
Lars Simon Rasmussen ◽  
Anne-Sophie Löwe ◽  
Anne Kathrine Lorentzen ◽  
Nicolai Lohse ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Clinical Trial ◽  
Standard Care ◽  
Randomised Clinical Trial ◽  
Short Stay ◽  
Care Outcomes

scholarly journals A Randomised Clinical Trial of Azithromycin Versus Standard Care in Ambulatory COVID-19 – The ATOMIC2 Trial

2021 ◽  
Author(s):  
Timothy SC Hinks ◽  
Lucy Cureton ◽  
Ruth Knight ◽  
Ariel Wang ◽  
Jennifer L. Cane ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Care ◽  
Randomised Clinical Trial

scholarly journals COpenhagen Neuroplastic TRaining Against Contractures in Toddlers (CONTRACT): protocol of an open-label randomised clinical trial with blinded assessment for prevention of contractures in infants with high risk of cerebral palsy

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044674
Author(s):  
Maria Willerslev-Olsen ◽  
Jakob Lorentzen ◽  
Katrine Røhder ◽  
Anina Ritterband-Rosenbaum ◽  
Mikkel Justiniano ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cerebral Palsy ◽  
High Risk ◽  
Standard Care ◽  
Muscle Growth ◽  
Randomised Clinical Trial ◽  
Triceps Surae ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Open Label

IntroductionContractures are frequent causes of reduced mobility in children with cerebral palsy (CP) already at the age of 2–3 years. Reduced muscle use and muscle growth have been suggested as key factors in the development of contractures, suggesting that effective early prevention may have to involve stimuli that can facilitate muscle growth before the age of 1 year. The present study protocol was developed to assess the effectiveness of an early multicomponent intervention, CONTRACT, involving family-oriented and supervised home-based training, diet and electrical muscle stimulation directed at facilitating muscle growth and thus reduce the risk of contractures in children at high risk of CP compared with standard care.Methods and analysisA two-group, parallel, open-label randomised clinical trial with blinded assessment (n=50) will be conducted. Infants diagnosed with CP or designated at high risk of CP based on abnormal neuroimaging or absent fidgety movement determined as part of General Movement Assessment, age 9–17 weeks corrected age (CA) will be recruited. A balanced 1:1 randomisation will be made by a computer. The intervention will last for 6 months aiming to support parents in providing daily individualised, goal-directed activities and primarily in lower legs that may stimulate their child to move more and increase muscle growth. Guidance and education of the parents regarding the nutritional benefits of docosahexaenic acid (DHA) and vitamin D for the developing brain and muscle growth will be provided. Infants will receive DHA drops as nutritional supplements and neuromuscular stimulation to facilitate muscle growth. The control group will receive standard care as offered by their local hospital or community. Outcome measures will be taken at 9, 12, 18, 24, 36 and 48 months CA. Primary and secondary outcome measure will be lower leg muscle volume and stiffness of the triceps surae musculotendinous unit together with infant motor profile, respectively.Ethics and disseminationFull approval from the local ethics committee, Danish Committee System on Health Research Ethics, Region H (H-19041562). Experimental procedures conform with the Declaration of Helsinki.Trial registration numberNCT04250454.Expected recruitment period1 January 2021–1 January 2025.

Sign in / Sign up

Export Citation Format

Share Document