Early secondary outcome analysis in multi-phase randomised-controlled trials, a pragmatic approach: the Healthy Life Trajectories Initiative (HeLTI) [0.03%]
Kalyanaraman Kumaran,Jean-Patrice Baillargeon,Catherine S Birken et al.
Kalyanaraman Kumaran et al.
Background: The extended time frame of some trials can cause significant challenges in delaying all analyses until the primary outcome is attained. This may particularly affect any mechanistic studies linked to secondary ...
Efficacy of transcutaneous spinal cord stimulation combined with resistance training on motor function in motor-incomplete spinal cord injury: protocol for an open-label, single-blind randomized controlled trial [0.03%]
Jibao Chen,Xiaoming Luo,Yuxin Zhang et al.
Jibao Chen et al.
Background: Spinal cord injury (SCI) commonly results in substantial motor impairments, particularly in standing and walking abilities, due to the disruption of the sensory-motor circuits. Conventional rehabilitation appr...
Effectiveness and mechanisms of digital cognitive and physical function prehabilitation for improving prognosis in kidney transplant recipients: protocol for a randomised controlled trial [0.03%]
Xiaojie Ma,Jindong Ding Petersen,Bonuan Yao et al.
Xiaojie Ma et al.
Introduction: Frailty and cognitive impairment are highly prevalent among patients on the kidney transplant waitlist (KTWs), contributing to poor post-transplant outcomes. While digital health interventions have shown pro...
Transcutaneous tibial nerve stimulation versus sham stimulation for the treatment of catheter-related bladder discomfort in patients undergoing transurethral resection of the prostate: a prospective, randomized, placebo-controlled, double-blind trial [0.03%]
Yanwen Song,Xiangyu Sun,Ling Mei et al.
Yanwen Song et al.
Background: Catheter-related bladder discomfort (CRBD), characterized by urinary urgency, frequency, and suprapubic pain, is a clinically significant complication following transurethral resection of the prostate (TURP). ...
Treatment guided by cerebral oximetry monitoring in extremely preterm infants: a Bayesian analysis of the SafeBoosC-III randomised clinical trial [0.03%]
Mathias Lühr Hansen,Markus Harboe Olsen,Theis Lange et al.
Mathias Lühr Hansen et al.
Purpose: The SafeBoosC-III trial compared treatment guided by cerebral oximetry monitoring for the first 72 h after birth with usual care in 1601 extremely preterm infants. Incidence of death or severe brain injury at 36 ...
Comparison of anesthesia efficacy between subclavius muscle plane block and interscalene brachial plexus block for open reduction and internal fixation of clavicle fractures: study protocol for a randomized non-inferiority clinical trial [0.03%]
Chen-Guang Li,Wei Yuan,Jie Wei et al.
Chen-Guang Li et al.
Background: Interscalene brachial plexus block (ISBPB) combined with supraclavicular nerve block or superficial cervical plexus block has been reported to be a reliable, efficacious anesthesia technique for clavicle fract...
Digital tools for recruitment and retention of participants in paediatric clinical research: a scoping review [0.03%]
Eunicia Tan,Kate Loveys,William Ali et al.
Eunicia Tan et al.
Background: Digital tools are increasingly used to support recruitment and retention of participants in paediatric research, particularly since the COVID-19 pandemic. However, the extent of the evidence supporting this me...
Optimizing metabolic management on integrase-based ART (OPTIMAR): study protocol for a 2 × 2 factorial, randomised, double-blind placebo-controlled trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin plus ezetimibe versus pitavastatin, in people with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with [0.03%]
Phyo Pyae Nyein,Hila Haskelberg,Marianne Martinello et al.
Phyo Pyae Nyein et al.
Background: People with HIV have an increased cardiovascular disease (CVD) risk due to both HIV and adverse effects of treatments. The currently preferred class of anti-retroviral drugs, integrase strand transfer inhibito...
Effects of tDCS on brain function in patients with post-stroke cognitive impairment: a randomised controlled study protocol based on TMS and fNIRS [0.03%]
Yuan Zhu,Hongxia Duan,Qun Zhang et al.
Yuan Zhu et al.
Background: Transcranial direct current stimulation (tDCS) positively affects post-stroke cognitive impairment (PSCI). However, the optimal stimulation protocol remains unclear, possibly because of the lack of objective a...
Labelling of subpleural pulmonary nodules with blue dye and contrast agents under CT-guided control and subsequent video-assisted thoracoscopic resection: the BLUEPAT prospective randomised study [0.03%]
Zdeněk Chovanec,Vladimír Červeňák,Ivan Čundrle et al.
Zdeněk Chovanec et al.
Background: Colour marking of indicated nodules is an innovative, accurate, and gentle method that allows subsequent wedge resection of the marked tissue using a mini-invasive, video-assisted thoracoscopic (VATS) method w...