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
Validation of the predictive value of BDNF -87 methylation for antidepressant treatment success in severely depressed patients —a randomized rater-blinded trial
AbstractBackgroundBrain-derived neurotrophic factor (BDNF) is essential for antidepressant treatment of major depressive disorder (MDD). Our repeated studies suggest that DNA methylation of a specific CpG site in the promoter region of exon IV of the BDNF gene (CpG -87) might be predictive of the efficacy of monoaminergic antidepressants such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and others. This trial aims to evaluate whether knowing the biomarker is non-inferior to treatment-as-usual (TAU) regarding remission rates while exhibiting significantly fewer ad...
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
Insomnia and eveningness are common and often comorbid conditions in youths. While cognitive behavioural therapy for insomnia (CBT-I) has been suggested as a promising intervention, it remains unclear whether ... (Source: Trials)
Source: Trials - April 9, 2024 Category: General Medicine Authors: Shirley Xin Li, Forrest Tin Wai Cheung, Ngan Yin Chan, Joey Wing Yan Chan, Jihui Zhang, Albert Martin Li, Colin A. Espie, Michael Gradisar and Yun-Kwok Wing Tags: Study protocol Source Type: research
Validation of the predictive value of BDNF -87 methylation for antidepressant treatment success in severely depressed patients —a randomized rater-blinded trial
Brain-derived neurotrophic factor (BDNF) is essential for antidepressant treatment of major depressive disorder (MDD). Our repeated studies suggest that DNA methylation of a specific CpG site in the promoter r... (Source: Trials)
Source: Trials - April 9, 2024 Category: General Medicine Authors: Hannah Benedictine Maier, Alexandra Neyazi, Gabriel L. Bundies, Fiona Meyer-Bockenkamp, Stefan Bleich, Hansi Pathak, Yvonne Ziert, Barbara Neuhaus, Franz-Josef M üller, Iris Pollmann, Thomas Illig, Stefanie Mücke, Meike Müller, Brinja Kira Möller, Ste Tags: Study protocol Source Type: research
