The effectiveness of relugolix compared with leuprorelin for preoperative therapy before laparoscopic myomectomy in premenopausal women, diagnosed with uterine fibroids: protocol for a randomized controlled study (MyLacR study)
DiscussionReal-world evidence will be collected in a clinical setting to use pre-treatment with an oral gonadotropin-releasing hormone antagonist to reduce intraoperative bleeding in women who undergo laparoscopic myomectomy.Trial registrationjRCTs031210564 was registered on 19 January 2022 in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp). (Source: Trials)
Source: Trials - May 24, 2024 Category: Research Source Type: clinical trials

Implementation of supplemental physiotherapy following hip fracture surgery: a protocol for the process evaluation of a randomised controlled trial
This study aims to complete a process evaluation to identify barriers and facilitators to implementation and explore the patient, carer and clinician experience of intensive therapy following hip fracture surgery.Methods and analysisThe process evaluation is embedded within a two-arm randomised, controlled, assessor-blinded trial recruiting 620 participants from eight Australian hospitals who have had surgery for a hip fracture sustained via a low-trauma injury. A theory-based mixed method process evaluation will be completed in tandem with the HIPSTER trial. Patient and carer semi-structured interviews will be completed a...
Source: Trials - May 24, 2024 Category: Research Source Type: clinical trials

Efficacy of heel lifts for mid-portion Achilles tendinopathy (the LIFT trial): study protocol for a randomised controlled trial
DiscussionThe LIFT trial (efficacy of heeL lIfts For mid-portion Achilles Tendinopathy) will be the first randomised trial to compare the efficacy of heel lifts to a sham intervention in reducing pain and disability in people with Achilles tendinopathy. The biomechanical analysis will provide useful insights into the mechanism of action of heel lifts.Trial registrationAustralian New Zealand Clinical Trials Registry,ACTRN12623000627651. Registered 7 June 2023. (Source: Trials)
Source: Trials - May 24, 2024 Category: Research Source Type: clinical trials

Study protocol: group-based psychoeducation for relatives of patients with bipolar disorder —a large scale real-world randomized controlled parallel group trial, the R-bipolar RCT
DiscussionThis protocol describes our currently ongoing randomized controlled trial (RCT) that aims at investigating group-based psychoeducation as an intervention for relatives of individuals diagnosed with bipolar disorder (BD). The study is the first large-scale real-world RCT to focus on a relatively short intervention of psychoeducation (6 sessions of 2  h each) in a large group of relatives (approximately 30 participants per group). With this focus, we wish to test an intervention that is feasible to implement in real-life psychiatric settings with limited budgets and time. It is also the first study to use mood ins...
Source: Trials - May 23, 2024 Category: Research Source Type: clinical trials

Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial
Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMP... (Source: Trials)
Source: Trials - May 22, 2024 Category: General Medicine Authors: James S. Khan, Ian Gilron, P. J. Devereaux, Hance Clarke, Nour Ayach, George Tomlinson, May Lynn Quan, Karim S. Ladha, Stephen Choi, Allana Munro, Richard Brull, David W. Lim, Sinziana Avramescu, Philippe Richeb é, Nicole Hodgson, James Paul & hellip; Tags: Study protocol Source Type: research

The impact of elder abuse training on subacute health providers and older adults: study protocol for a randomized control trial
Elder abuse often goes unreported and undetected. Older people may be ashamed, fearful, or otherwise reticent to disclose abuse, and many health providers are not confident in asking about it. In the No More Sham... (Source: Trials)
Source: Trials - May 22, 2024 Category: General Medicine Authors: Marina G. Cavuoto, Simona Markusevska, Catriona Stevens, Patricia Reyes, Gianna Renshaw, Micah D. J. Peters, Briony Dow, Peter Feldman, Andrew Gilbert, Elizabeth Manias, Duncan Mortimer, Joanne Enticott, Claudia Cooper, Josefine Antoniades, Brenda Appleto Tags: Study protocol Source Type: research

Patient information leaflets for placebo-controlled surgical trials: a review of current practice and recommendations for developers
Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information l... (Source: Trials)
Source: Trials - May 22, 2024 Category: General Medicine Authors: S. Cousins, M. Huttman, N. Blencowe, C. Tsang, D. Elliott, J. Blazeby, D. J. Beard, M. K. Campbell and K. Gillies Tags: Methodology Source Type: research

Virtual reality as a method of cognitive training of processing speed, working memory, and sustained attention in persons with acquired brain injury: a protocol for a randomized controlled trial
Acquired brain injury (ABI) often leads to persisting somatic, cognitive, and social impairments. Cognitive impairments of processing speed, sustained attention, and working memory are frequently reported and ... (Source: Trials)
Source: Trials - May 22, 2024 Category: General Medicine Authors: T. Johansen, M. Matre, M. L øvstad, A. Lund, A. C. Martinsen, A. Olsen, F. Becker, C. Brunborg, J. Ponsford, J. Spikman, D. Neumann and S. Tornås Tags: Study protocol Source Type: research

START NOW WebApp —promoting emotion regulation and resilience in residential youth care and correctional institutions: study protocol for a cluster randomized controlled trial
Adolescents and young adults in residential care and correctional institutions face various challenges, leading to negative life outcomes. Implementation barriers within these institutions, such as limited fin... (Source: Trials)
Source: Trials - May 22, 2024 Category: General Medicine Authors: Linda Kersten, Janine Alfano, Tobias E. Erlanger, Fabrice Helfenstein, Lelia Lanz, Stefan Weiss, Chiara Chilla, Beryll von Planta, Madlaina Kapoor, Nathalie Borel, Tabea Rocco, Andreas Papageorgiou, Catarina Fernandes De Brito, Arzie Bajrami, Valentine Sa Tags: Study protocol Source Type: research

The impact of elder abuse training on subacute health providers and older adults: study protocol for a randomized control trial
DiscussionThis will be one of the first trials in the world to evaluate a multi-component elder abuse intervention. If successful, it will provide the most robust evidence base to date for health providers to draw on to create a safe environment for reporting, response, and referral.Trial registrationANZCTR,ACTRN12623000676617p. Registered 22 June 2023. (Source: Trials)
Source: Trials - May 22, 2024 Category: Research Source Type: clinical trials

START NOW WebApp —promoting emotion regulation and resilience in residential youth care and correctional institutions: study protocol for a cluster randomized controlled trial
This study aims to assess the efficacy of a newly developed web-based version of the existing evidence-based START NOW skills training in fostering emotion regulation and resilience among institutionalized adolescents and young adults. We present the study protocol (Version 5, August 2023) of the trial titled “Implementation of an e-version of the skills training START NOW for promoting emotion regulation and resilience in residential youth care and correctional institutions”.MethodsThe study is a monocentric, prospective, confirmatory randomized controlled trial with 150 institutionalized adolescents and young adults ...
Source: Trials - May 22, 2024 Category: Research Source Type: clinical trials

Virtual reality as a method of cognitive training of processing speed, working memory, and sustained attention in persons with acquired brain injury: a protocol for a randomized controlled trial
This study will contribute to improve understanding of how VR is tolerated and experienced by the ABI population. If proven effective, the study can contribute to new rehabilitation methods that persons with ABI can utilize in a home setting, after the post-acute rehabilitation has ended. (Source: Trials)
Source: Trials - May 22, 2024 Category: Research Source Type: clinical trials

Patient information leaflets for placebo-controlled surgical trials: a review of current practice and recommendations for developers
ConclusionDevelopers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials. (Source: Trials)
Source: Trials - May 22, 2024 Category: Research Source Type: clinical trials

Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial
DiscussionThis trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients.Trial registrationThis trial has been registered on clinicalt...
Source: Trials - May 22, 2024 Category: Research Source Type: clinical trials

High-precision stereotactic irradiation for focal drug-resistant epilepsy versus standard treatment: a randomized waitlist-controlled trial (the PRECISION trial)
DiscussionThis is the first randomized trial comparing SRT with standard of care in patients with DRE, non-eligible for open surgery. The primary objective is to determine whether SRT significantly reduces the seizure frequency 2  years after treatment. The results of this trial can influence the current clinical practice and medical cost reimbursement in the Netherlands for patients with focal DRE who are not eligible for open surgery, providing a non-invasive curative treatment option.Trial registrationClinicaltrials.gov Identifier: NCT05182437. Registered on September 27, 2021. (Source: Trials)
Source: Trials - May 21, 2024 Category: Research Source Type: clinical trials