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
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: Research Source Type: clinical trials
RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial
This study aims to evaluate the scalability and adaptation of FICare across a broader range of geographical and sociocultural contexts and address its sustainability. Furthermore, it seeks to compare the RISEinFAMILY model with standard care, examining differences in short-term newborn outcomes, family mental health, and professional satisfaction.Trial registrationClinicalTrials.gov NCT06087666. Registered on 17 October 2023. Protocol version: 19 December 2022; version 2.2. (Source: Trials)
Source: Trials - April 10, 2024 Category: Research Source Type: clinical trials
Safety and efficacy of ketorolac in improving the prognosis of acute type A aortic dissection patients: a protocol of a randomized, double-blinded, and placebo-controlled study
This study is a single-center, randomized, double-blinded, and placebo-controlled study. A total of 120 patients with aTAAD will be recruited and will be randomized into the ketorolac group and placebo group with a ratio of 1:1. Ketorolac tromethamine 60 mg per 2 ml will be intramuscularly injected within 2 h before surgery, followed by intramuscular injections of 30 mg per 1 ml BID. on the first and second postoperative days in the Ketorolac group, while 0.9% saline will be administered at the same dose, dosage form, and time in the placebo g roup. This study aims to evaluate the safety and efficacy of ketorolac in ...
Source: Trials - April 10, 2024 Category: Research Source Type: clinical trials
Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters
DiscussionResults from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections.Ethics and disseminationSir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023. (Source: Trials)
Source: Trials - April 10, 2024 Category: Research Source Type: clinical trials
RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial
Family Integrated Care (FICare) has demonstrated positive outcomes for sick neonates and has alleviated the psychological burden faced by families. FICare involves structured training for professionals and car... (Source: Trials)
Source: Trials - April 10, 2024 Category: General Medicine Authors: M. T. Alferink, B. Moreno-Sanz, M. Cabrera-Lafuente, E. Ergenekon, T. R. de Haan, A. A. M. W. van Kempen, J. Lakhwani, H. Rabe, G. C. Zaharie and A. Pellicer Tags: Study protocol Source Type: research
Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters
Malignant pleural effusion (MPE) is a debilitating condition as it commonly causes disabling breathlessness and impairs quality of life (QoL). Indwelling pleural catheter (IPC) offers an effective alternative ... (Source: Trials)
Source: Trials - April 10, 2024 Category: General Medicine Authors: Estee P. M. Lau, Matthew Ing, Sona Vekaria, Ai Ling Tan, Chloe Charlesworth, Edward Fysh, Ranjan Shrestha, Elaine L. C. Yap, Nicola A. Smith, Benjamin C. H. Kwan, Tajalli Saghaie, Bapti Roy, John Goddard, Sanjeevan Muruganandan, Arash Badiei, Phan Nguyen Tags: Study protocol Source Type: research
Safety and efficacy of ketorolac in improving the prognosis of acute type A aortic dissection patients: a protocol of a randomized, double-blinded, and placebo-controlled study
Acute type A aortic dissection (aTAAD) is a critical and life-threatening condition. Previous research has demonstrated that the use of ketorolac not only reduces the progression, incidence, and severity of ao... (Source: Trials)
Source: Trials - April 10, 2024 Category: General Medicine Authors: Zhikang Lv, Tuo Pan, Haitao Zhang, Yapeng Wang, Yusanjian Matniyaz, Yuxian Tang, Lichong Lu and Dongjin Wang Tags: Study protocol Source Type: research
Nutrition and movement to improve quality of life in patients with knee osteoarthritis: the NUMOQUA study protocol for a randomised controlled trial
DiscussionThe prevalence of OA is expected to increase in the future due to ongoing demographic changes and rising obesity rates. The expected results will provide important evidence on whether this interdisciplinary therapeutic approach could be a new, cost-effective and sustainable strategy to address the disease process of OA without negative side effects.Trial registrationClinicalTrials.gov NCT05955300. Date of registration: 23rd of October 2023. (Source: Trials)
Source: Trials - April 9, 2024 Category: Research Source Type: clinical trials
Effects of cognitive behavioural therapy and bright light therapy for insomnia in youths with eveningness: study protocol for a randomised controlled trial
This study will be the first RCT to directly compare the effects of CBT-I and BLT in youths with insomnia and eveningness. Findings from the study will provide evidence to inform the clinical management of insomnia problems and eveningness in youths.Trial registrationClinicalTrials.gov NCT04256915. Registered on 5 February 2020. (Source: Trials)
Source: Trials - April 9, 2024 Category: Research Source Type: clinical trials
