Trials This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

A methodological review of randomised n-of-1 trials
n-of-1 trials are a type of crossover trial designed to optimise the evaluation of health technologies in individual patients. This trial design may be considered for the evaluation of health technologies in r... (Source: Trials)
Source: Trials - April 16, 2024 Category: General Medicine Authors: Olivia Hawksworth, Robin Chatters, Steven Julious, Andrew Cook, Katie Biggs, Kiera Solaiman, Michael C. H. Quah and Sxe Chang Cheong Tags: Review Source Type: research

Study protocol for a randomized controlled trial of the Parent –Child Assistance Program: a case management and home visiting program for people using substances during pregnancy
Perinatal substance use can have significant adverse effects on maternal and child health and family stability. Few interventions are specifically designed to address this significant public health problem. Th... (Source: Trials)
Source: Trials - April 16, 2024 Category: General Medicine Authors: Erin J. Maher, Susan A. Stoner, Julie Gerlinger, A. C. Ferraro and Heather Lepper-Pappan Tags: Study protocol Source Type: research

3D printing vs traditional workflow for the fabrication of mandibular implant overdentures: study protocol for a mixed-methods cross-over RCT
DiscussionThis mixed-methods RCT will explore patient experiences with 3D-printed IMOs, aiming to assess the potential for altering clinical practice and dental public health policies. Our results will inform policies by showing whether 3D printing offers comparable outcomes at lower costs, facilitating greater access to oral care for the elderly.Trial registrationClinicalTrials.gov, NCT06155630, Registered on 04 December 2023.https://classic.clinicaltrials.gov/ct2/show/NCT06155630 (Source: Trials)
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials

Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial
DiscussionThe BOPPP trial aims to investigate the clinical and cost-effectiveness of carvedilol in patients with cirrhosis and small oesophageal varices to determine whether this non-selective beta-blocker can prevent or reduce hepatic decompensation. There is clinical equipoise on whether intervening in cirrhosis, at an earlier stage of portal hypertension, with NSBB therapy is beneficial. Should the trial yield a positive result, we anticipate that the administration and use of carvedilol will become widespread with pathways developed to standardise the administration of the medication in primary care.Ethics and dissemin...
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials

Study protocol for a randomized controlled trial of the Parent –Child Assistance Program: a case management and home visiting program for people using substances during pregnancy
This study protocol describes a randomized controlled trial that aims to examine the effectiveness of the intervention compared to services as usual in affecting primary outcomes related to substance use and family planning. Secondary outcome s will concern connection to recovery support services and family preservation.MethodsUsing an intent-to-treat design, the study will recruit from two metro areas in Oklahoma and enroll 200 birthing individuals who are pregnant or up to 24 months postpartum with at-risk substance use during their current or most recent pregnancy. Participants will be randomly assigned, stratified by...
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials

A methodological review of randomised n-of-1 trials
Conclusionsn-of-1 trials are still underused and the application of the n-of-1 design for the evaluation of health technologies for rare diseases has been particularly limited. We have summarised the characteristics of randomised n-of-1 trials in rare and non-rare conditions. We hope that it can inform researchers in the design of future n-of-1 studies. Further work is required to provide guidance on specific design considerations, implementation, and statistical analysis of these studies.Trial registrationNot applicable. (Source: Trials)
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials

Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST)
DiscussionThis trial will provide evidence on the beneficial and harmful effects, as well as the cost-effectiveness of schema therapy versus treatment as usual for outpatients with difficult-to-treat depression. The results can potentially improve treatment for a large and understudied patient group.Trial registrationClinicalTrials.gov NCT05833087. Registered on 15th April 2023 (approved without prompts for revision on 27th April 2023). (Source: Trials)
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials

Designing greener participant-centred trials: an analysis of ‘carbon relevant’ factors within items that influence participants’ decisions about trial recruitment and retention
(Source: Trials)
Source: Trials - April 15, 2024 Category: General Medicine Authors: Emilia Piltonen, Beatriz Goulao and Katie Gillies Tags: Letter Source Type: research

The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol for a randomized controlled trial
Although clinical guidelines prioritize the treatment of depression and anxiety in young persons, there is accumulating evidence that the presence of symptoms of borderline personality disorder (BPD) is associ... (Source: Trials)
Source: Trials - April 15, 2024 Category: General Medicine Authors: Melissa G. A. Remeeus, Sharon L. Clarke, Dine J. Feenstra, Hester Van Eeren, Maaike L. Smits, Sara Debruyne, Mirjam E. J. Kouijzer, Patrick Luyten, Ron H. J. Scholte and Joost Hutsebaut Tags: Study protocol Source Type: research

Educational nutritional intervention to prevent loss of health-related quality of life among older adults after a surgical treatment: design of a randomised controlled trial
This study aims to develop and test the effectiveness of an educational video to prevent loss of health-related quality of life among live-at-home older adults after surgical treatment in a hospital.MethodThis randomised controlled trial will occur at a regional hospital in Norway. Participants will be live-at-home adults aged 65 years and older. They will be recruited from three different surgical departments after a surgical procedure. Individuals with a body mass index below 24 and a home address in one of nine selected municipalities will be eligible for inclusion. Participants will be randomly assigned to either the...
Source: Trials - April 15, 2024 Category: Research Source Type: clinical trials

The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol for a randomized controlled trial
This study is a multi-centre randomized controlled trial. A total of 132 adolescents, presenting with either depression, anxiety, or both and significant BPD features will be randomized to either MBT-early or CBT. The severity of BPD, symptoms of depression and anxiety, personality, social and academic functioning, and quality of life will be assessed at baseline, end of treatment, and at 12-, 18-, and 24-month follow-up, along with medical costs and costs of productivity losses for cost-effectiveness analyses.DiscussionThis study will provide an empirical evaluation of the potential surplus value of early intervention in ...
Source: Trials - April 15, 2024 Category: Research Source Type: clinical trials

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