Probiotic supplementation and risk of necrotizing enterocolitis and mortality among extremely preterm infants —the Probiotics in Extreme Prematurity in Scandinavia (PEPS) trial: study protocol for a multicenter, double-blinded, placebo-controlled, and registry-based randomized controlled trial
Extremely preterm infants, defined as those born before 28 weeks ’ gestational age, are a very vulnerable patient group at high risk for adverse outcomes, such as necrotizing enterocolitis and death. Necrotizin... (Source: Trials)
Source: Trials - April 12, 2024 Category: General Medicine Authors: Sofia S öderquist Kruth, Carl Willers, Emma Persad, Elisabeth Stoltz Sjöström, Susanne Rautiainen Lagerström and Alexander Rakow Tags: Study protocol Source Type: research
How inclusive were UK-based randomised controlled trials of COVID-19 vaccines? A systematic review investigating enrolment of Black adults and adult ethnic minorities
To establish if Black adults and adult ethnic minorities, defined as any group except White British, were represented in UK-based COVID-19 vaccination randomised controlled trials (RCTs) when compared to corre... (Source: Trials)
Source: Trials - April 12, 2024 Category: General Medicine Authors: Hibba Herieka, Daphne Babalis, Evangelia Tzala, Shyam Budhathoki and Nicholas A. Johnson Tags: Review Source Type: research
Remote or in-clinic? The effect of service delivery mode on hearing aid output: study protocol for a double-blinded, randomised trial in adults with mild to moderate sensorineural hearing loss
Teleaudiology can potentially improve access to hearing healthcare services. Remote hearing aid fittings offer a new mode of service delivery that removes barriers of geography and access to an audiologist. Re... (Source: Trials)
Source: Trials - April 12, 2024 Category: General Medicine Authors: Craig Lett, David Welch and Rosie Dobson Tags: Study protocol Source Type: research
Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation
UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by t... (Source: Trials)
Source: Trials - April 12, 2024 Category: General Medicine Authors: Emma McNaught, Sophie Reale, Liam Bourke, Janet E. Brown, Michelle Collinson, Florence Day, Jenny Hewison, Amanda J. Farrin, Sa ïd Ibeggazene, Aidan Q. Innes, Ellen Mason, David Meads, Alison Scope, Chris Taylor, Steph JC. Taylor, Rebecca R. Turner & hel Tags: Study protocol Source Type: research
The World Health Organization Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns (ACTION-III) Trial: study protocol for a multi-country, multi-centre, double-blind, three-arm, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at high probability of late preterm birth in hospitals in low- resource countries
Preterm birth complications are the leading cause of newborn and under-5 mortality. Over 85% of all preterm births occur in the late preterm period, i.e. between 34 and (Source: Trials)
Source: Trials - April 12, 2024 Category: General Medicine Tags: Study protocol Source Type: research
Probiotic supplementation and risk of necrotizing enterocolitis and mortality among extremely preterm infants —the Probiotics in Extreme Prematurity in Scandinavia (PEPS) trial: study protocol for a multicenter, double-blinded, placebo-controlled, and registry-based randomized controlled trial
DiscussionCurrent recommendations for probiotic supplementation in Sweden and Denmark do not include extremely preterm infants due to lack of evidence in this population. However, this young subgroup is notably the most at risk for experiencing adverse outcomes. This trial aims to investigate the effects of probiotic supplementation on necrotizing enterocolitis, death, and other relevant outcomes to provide sufficiently powered, high-quality evidence to inform probiotic supplementation guidelines in this population. The results could have implications for clinical practice both in Sweden and Denmark and worldwide.Trial reg...
Source: Trials - April 12, 2024 Category: Research Source Type: clinical trials
The World Health Organization Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns (ACTION-III) Trial: study protocol for a multi-country, multi-centre, double-blind, three-arm, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at high probability of late preterm birth in hospitals in low- resource countries
DiscussionThis trial will evaluate the benefits and possible harms of ACS when used in women likely to have a late preterm birth. It will also evaluate a lower-dose ACS regimen based on literature from pharmacokinetic studies. The results of this trial will provide robust critical evidence on the safe and appropriate use of ACS in the late preterm period internationally.Trial registrationISRCTN11434567. Registered on 7 June 2021. (Source: Trials)
Source: Trials - April 12, 2024 Category: Research Source Type: clinical trials
How inclusive were UK-based randomised controlled trials of COVID-19 vaccines? A systematic review investigating enrolment of Black adults and adult ethnic minorities
ConclusionThe findings show that COVID-19 vaccine trials failed to adequately randomise proportionate numbers of Black adults and adult minority ethnicities. More inclusive practices must be developed and implemented in the recruitment of underserved groups to understand the true impact of COVID-19. (Source: Trials)
Source: Trials - April 12, 2024 Category: Research Source Type: clinical trials
Remote or in-clinic? The effect of service delivery mode on hearing aid output: study protocol for a double-blinded, randomised trial in adults with mild to moderate sensorineural hearing loss
ConclusionsThis study will inform the development of best practice guidelines for remote hearing aid fittings. If no clinically significant differences are found between in-clinic and remote fit hearing aids, it has the potential to expand teleaudiology initiatives.Trial registrationAustralian New Zealand Clinical Trial Registry,ACTRN12623000028606p. Date of registration: 12 January 2023. (Source: Trials)
Source: Trials - April 12, 2024 Category: Research Source Type: clinical trials
Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation
DiscussionThe STAMINA lifestyle intervention has the potential to improve quality of life and reduce fatigue in men on androgen deprivation therapy for prostate cancer. Embedding supervised exercise into prostate cancer care may also support long-term positive behaviour change and reduce adverse events caused by treatment. Findings will inform future clinical care and could provide a blueprint for the integration of supervised exercise and behavioural support into other cancer and/or clinical services.Trial registrationISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/...
Source: Trials - April 12, 2024 Category: Research Source Type: clinical trials
Correction: Engaging Black youth in depression and suicide prevention treatment within urban schools: study protocol for a randomized controlled pilot
(Source: Trials)
Source: Trials - April 11, 2024 Category: General Medicine Authors: Michael A. Lindsey, Laura Mufson, Carolina V élez‑Grau, Tracy Grogan, Damali M. Wilson, Aaron O. Reliford, Meredith Gunlicks‑Stoessel and James Jaccard Tags: Correction Source Type: research
Vitamin D as an intervention for improving quadriceps muscle strength in patients after anterior cruciate ligament reconstruction: study protocol for a randomized double-blinded, placebo-controlled clinical trial
The goal of anterior cruciate ligament reconstruction (ACLR) is to restore the preinjury level of knee function to return to play (RTP). However, even after completing the rehabilitation programme, some patien... (Source: Trials)
Source: Trials - April 11, 2024 Category: General Medicine Authors: Michael Tim-yun Ong, Xiaomin Lu, Ben Chi-yin Choi, Siu-Wai Wan, Qianwen Wang, Gene Chi-wai Man, Pauline Po-yee Lui, Daniel Tik-Pui Fong, Daniel Kam-wah Mok and Patrick Shu-hang Yung Tags: Study protocol Source Type: research
Effectiveness of personalized meal recommendation in improving dietary behaviors of Chinese community-dwelling elders: study protocol for a cluster randomized controlled trial
This study aims to examine the effectiveness, acceptability, and usability of a personalized meal recommendation system as a data-driven dietary intervention to benefit community-dwelling elders. The successful implementation will inform the future development and integration of digital health strategies in daily nutrition support for the elderly.Trial registrationChinese Clinical Trial Registry ChiCTR2300074912. Registered on August 20, 2023,https://www.chictr.org.cn/showproj.html?proj=127583 (Source: Trials)
Source: Trials - April 11, 2024 Category: Research Source Type: clinical trials
Vitamin D as an intervention for improving quadriceps muscle strength in patients after anterior cruciate ligament reconstruction: study protocol for a randomized double-blinded, placebo-controlled clinical trial
DiscussionPatients with low vitamin D levels had greater quadriceps fibre cross-sectional area loss and impaired muscle strength recovery after ACL. The proposed study will provide scientific support for using vitamin D supplementation to improve quadriceps strength recovery after ACLR.Trial registrationClinicalTrials.gov NCT05174611. Registered on 28 November 2021. (Source: Trials)
Source: Trials - April 11, 2024 Category: Research Source Type: clinical trials
Effects of task-based mirror therapy on upper limb motor function in hemiplegia: study protocol for a randomized controlled clinical trial
DiscussionThis trial will not only to establish that task-based mirror therapy (TBMT) could improve the recovery of hand function after stroke but also to explore the underlying mechanisms. We expect that this finding will clarify the brain activation and brain network mechanisms underlying the improvement of hand function with task-oriented mirror therapy and lead to new ideas for stroke hand function rehabilitation.Trial registrationURL:https://www.chictr.org.cn; Unique identifier: ChiCTR2300068855. Registered on March 1, 2023 (Source: Trials)
Source: Trials - April 11, 2024 Category: Research Source Type: clinical trials
