Evaluation of intensive community care services for young people with psychiatric emergencies: study protocol for a multi-centre parallel-group, single-blinded randomized controlled trial with an internal pilot phase
This study aims to evaluate the clinical effectiveness and cost-effectiveness of intensive community care service (ICCS) compared to treatment as usual (TAU) for young people with psychiatric emergencies.MethodsThis is a multicentre two-arm randomized controlled trial (RCT) with an internal pilot phase. Young people aged 12 to< 18 considered for admission at participating NHS organizations across the UK will be randomized 1:1 to either TAU or ICCS. The primary outcome is the time to return to or start education, employment, or training (EET) at 6 months post-randomization. Secondary outcomes will include evaluations of ...
Source: Trials - February 22, 2024 Category: Research Source Type: clinical trials
Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems in bariatric surgery: study protocol for a randomized controlled prospective trial
The objective is to provide clinical evidence for new laparoscopic imaging systems and to evaluate potential benefits.Trial registrationThis trial is registered at clinicaltrials.gov under the identifier NCT05895058. Registered 30 May 2023. BASEC2023-D0014 [Registry ID Swissethics, approved 3 May 2023]. SNCTP000005489 [SNCTP study register, last updated 13 July 2023]. (Source: Trials)
Source: Trials - February 22, 2024 Category: Research Source Type: clinical trials
Seroma control in axillary lymphadenectomy with Glubran 2 ® without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain)
DiscussionSeveral studies compare the use of sealant products in axillary lymphadenectomy but generally with drains. We would like to demonstrate that patients who underwent axillary lymphadenectomy could benefit from an axillary sealant without drains and reduce axillary discomfort while maintaining a good quality of life. Assessing the relationship between axillary volume, symptoms, and related risk factors can be of great help in the control of seroma in patients who received breast cancer surgery.Trial registrationClinicalTrials.gov, NCT05280353. Registration date 02 August 2022. (Source: Trials)
Source: Trials - February 22, 2024 Category: Research Source Type: clinical trials
Understanding implementation of findings from trial method research: a mixed methods study applying implementation frameworks and behaviour change models
ConclusionsSeveral key areas affecting implementation of trial method recommendations were identified. Potential methods to enhance facilitators and reduce obstacles are suggested. Future research is needed to refine these methods and assess their feasibility and acceptability. (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
The advantages of laparoscopic left-sided hepatectomy (LLH) for treating hepatolithiasis in terms of the time to postoperative length of hospital stay (LOS), morbidity, long-term abdominal wall hernias, hospit... (Source: Trials)
Source: Trials - February 22, 2024 Category: General Medicine Authors: Shu-bo Pan, Chun-li Wu, Da-chen Zhou, Qi-ru Xiong, Xiao-ping Geng and Hui Hou Tags: Study protocol Source Type: research
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
