Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial
ConclusionIn this paper, we describe the detailed statistical analysis plan (SAP) for the TIPS trial, which was prepared prior to database lock. The SAP includes details of planned analyses and unpopulated tables, which will be reported in the publications. We plan to lock the database in July 2023 and publish the results later in the same year.SAP Version 0.1 (dated: 28 April 2023)Protocol version:2.0Trial registrationClinical Trial Registry of India CTRI/2019/02/017464. Registered on 5 February 2019;https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29764&EncHid=&userName=2019/02/017464 (Source: Trials)
Source: Trials - February 22, 2024 Category: Research Source Type: clinical trials

Total laparoscopic partial hepatectomy versus open partial hepatectomy for primary left-sided hepatolithiasis: study protocol for a randomized controlled trial
ConclusionsAlthough the outcomes of LLH have been proven to be comparable to those of OLH in retrospective studies, the use of LLH remains restricted, partly due to the lack of short- and long-term informative RCTs pertaining to patients with hepatolithiasis in ERAS programmes. To evaluate the surgical and long-term outcomes of LLH, we will perform a prospective RCT to compare LLH with OLH for hepatolithiasis within an ERAS programme.Trial registrationClinicalTrials.gov NCT03958825. Registered on 21 May 2019. (Source: Trials)
Source: Trials - February 22, 2024 Category: Research Source Type: clinical trials

Efficacy of functional magnetic resonance imaging-guided personalized repetitive transcranial magnetic stimulation (fMRI-rTMS) in depressive patients with emotional blunting: study protocol for a randomized controlled trial
Emotional blunting is a symptom that has always been present in depressed patients. Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective supplementary therapy for treating depression. Ho... (Source: Trials)
Source: Trials - February 21, 2024 Category: General Medicine Authors: Yuyu Zhang, Nailong Tang, Lei Lei, Runxin Lv, Yaochi Zhang, Nian Liu, Haixia Chen, Min Cai and Huaning Wang Tags: Study protocol Source Type: research

To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial)
Rotator cuff (RC) tendinopathy is the most reported shoulder disorder in the general population with highest prevalence in overhead athletes and adult working-age population. A growing body of evidence support... (Source: Trials)
Source: Trials - February 21, 2024 Category: General Medicine Authors: Birgitte Hougs Kj ær, Ann M. Cools, Finn E. Johannsen, Jeanette Trøstrup, Theresa Bieler, Volkert Siersma and Peter S. Magnusson Tags: Study protocol Source Type: research

Investigating the added effects of guidance in digital psychological self-care for alcohol problems (ALVA) —protocol for a randomized factorial optimization trial
The continual development and implementation of effective digital interventions is one important strategy that may serve to bridge the well-known treatment gap related to problematic alcohol use. Research sugg... (Source: Trials)
Source: Trials - February 21, 2024 Category: General Medicine Authors: Christopher Sundstr öm, Ekaterina Ivanova, Philip Lindner, Magnus Johansson and Martin Kraepelien Tags: Study protocol Source Type: research

Investigating the added effects of guidance in digital psychological self-care for alcohol problems (ALVA) —protocol for a randomized factorial optimization trial
This study will investigate the added benefit of different forms of guidance to DPSC for problematic alcohol use. These added effects will be compared to the added cost of guidance, according to pre-defined optimization criteria.Trial registrationClinicaltrials.gov: NCT05649982. Registered on 06 December 2022. Prospectively registered. (Source: Trials)
Source: Trials - February 21, 2024 Category: Research Source Type: clinical trials

Efficacy of functional magnetic resonance imaging-guided personalized repetitive transcranial magnetic stimulation (fMRI-rTMS) in depressive patients with emotional blunting: study protocol for a randomized controlled trial
This study is a randomized, controlled, double-blind, and single-center clinical trial in which 80 eligible depressed patients with emotional blunting will be randomly assigned to two groups: a functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) group and a control group. Individuals in the fMRI-rTMS group (n = 40) will receive high-frequency rTMS (10 Hz, 120% MT). The main target of stimulation will be the area most relevant to the functional connectivity of the right medial prefrontal cortex (mPFC) and amygdala. The control group (n = 40) will receive sham stimulation, with a coil flipped ...
Source: Trials - February 21, 2024 Category: Research Source Type: clinical trials

To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial)
DiscussionThe results of this study will contribute knowledge about the treatment strategies for patients with RC tendinopathy and help physiotherapists in clinical decision-making. This is the first randomized controlled trial comparing the effects of allowing pain versus avoiding pain during shoulder exercises in patients with chronic RC tendinopathy. If tolerating pain during and after exercise proves to be effective, it will potentially expand our understanding of “exercising into pain” for this patient group, as there is currently no consensus.Trial registrationClinicalTrials.gov NCT05124769. Registered on August ...
Source: Trials - February 21, 2024 Category: Research Source Type: clinical trials

The efficacy of virtual reality technology for the postoperative rehabilitation of patients with cervical spondylotic myelopathy (CSM): a study protocol for a randomized controlled trial
Patients with cervical spondylosis myelopathy (CSM) may experience severe neurological dysfunction due to untimely spinal cord compression after surgery. These disorders may lead to sensory and motion disorder... (Source: Trials)
Source: Trials - February 19, 2024 Category: General Medicine Authors: Jiajun Wu, Zhongchuan Sun, Zhichao Ge, Dong Zhang, Jianghan Xu, Rilin Zhang, Xuecheng Liu, Qing Zhao and Hao Sun Tags: Study protocol Source Type: research

The efficacy of virtual reality technology for the postoperative rehabilitation of patients with cervical spondylotic myelopathy (CSM): a study protocol for a randomized controlled trial
DiscussionThe aim of this trial is to investigate the effect of VR training on the postoperative rehabilitation of patients with CSM after 12 intervention treatments. Positive and negative outcomes will help us better understand the effectiveness of the intervention and its neural impact. If effective, this study could provide new options for the postoperative rehabilitation of patients with CSM.Trial registrationChinese Clinical Trial Registry (ChiCTR2300071544). Registered 17 May 2023,https://www.chictr.org.cn/. (Source: Trials)
Source: Trials - February 19, 2024 Category: Research Source Type: clinical trials

Application of the patient-reported outcome-based postoperative symptom management model in lung cancer: a multicenter randomized controlled trial protocol
Lung cancer is the most common cancer in China, with the highest mortality rate. Surgery is the primary treatment for early lung cancer. However, patients with lung cancer have a heavy burden of symptoms withi... (Source: Trials)
Source: Trials - February 17, 2024 Category: General Medicine Authors: Ying Liang, Pengyu Jing, Zhongping Gu, Lei Shang, Peng Ge, Yong Zhang, Lv Wang, Chun Qiu, Ximing Zhu and Zhijun Tan Tags: Study protocol Source Type: research

Exploring critical intervention features and trial processes in the evaluation of sensory integration therapy for autistic children
We evaluated the clinical and cost-effectiveness of manualised sensory integration therapy (SIT) for autistic children with sensory processing difficulties in a two-arm randomised controlled trial. Trial proce... (Source: Trials)
Source: Trials - February 17, 2024 Category: General Medicine Authors: Elizabeth Randell, Rachel McNamara, Monica Busse, Sue Delport, Rhys Williams-Thomas, Wakunyambo Maboshe, David Gillespie, Sarah Milosevic, Lucy Brookes-Howell, Melissa Wright, Richard P. Hastings, Anne Marie McKigney, Eleni Glarou and Alka Ahuja Tags: Research Source Type: research

Recurrences of advanced sessile and lateral spreading colorectal adenoma after endoscopic mucosal resection (EMR) thermal ablation versus no adjuvant therapy (RESPECT): a protocol of an international randomized controlled trial
Nowadays, large benign lateral spreading lesions (LSLs) and sessile polyps in the colorectum are mostly resected by endoscopic mucosal resection (EMR). A major drawback of EMR is the polyp recurrence rate of u... (Source: Trials)
Source: Trials - February 17, 2024 Category: General Medicine Authors: Gijs Kemper, Christian Gerges, Erik J. Schoon, Ramon-Michel Schreuder, Ruud R. W. Schrauwen, Ludger S. M. Epping, Torsten Beyna, Joost P. H. Drenth, Ufuk G ündug, Peter D. Siersema and Erwin J. M. van Geenen Tags: Study protocol Source Type: research

Recurrences of advanced sessile and lateral spreading colorectal adenoma after endoscopic mucosal resection (EMR) thermal ablation versus no adjuvant therapy (RESPECT): a protocol of an international randomized controlled trial
DiscussionThe RESPECT study will evaluate if STSC is effective in reducing recurrence rates after piecemeal EMR of large colorectal lesions in daily clinical practice performed by expert and non-expert endoscopists. Moreover, endoscopists will be allowed to use adjunctive techniques to remove remaining adenomatous tissue during the procedure. Finally, adenomatous polyp recurrence during follow-up will be defined by histologic identification.Trial registrationClinicalTrials.gov NCT05121805. Registered on 16 November 2021. Start recruitment: 17 March 2022. Planned completion of recruitment: 31 April 2025. (Source: Trials)
Source: Trials - February 17, 2024 Category: Research Source Type: clinical trials

Exploring critical intervention features and trial processes in the evaluation of sensory integration therapy for autistic children
ConclusionsThe process evaluation was highly valuable in identifying contextual factors that could impact the effectiveness of this individualised intervention. Rigorous evaluations of interventions for autistic children are important, especially given the limitations such as limited sample sizes and short-term follow-up as faced by previous research. One of the challenges lies in the variability of outcomes considered important by caregivers, as each autistic child faces unique challenges. It is crucial to consider the role of parents or other caregivers in facilitating access to these interventions and how this may impac...
Source: Trials - February 17, 2024 Category: Research Source Type: clinical trials