Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial
Postprandial distress syndrome (PDS) has a considerable impact on quality of life. Our previous pilot trial suggested that acupuncture might be a potential treatment option for PDS. We will conduct this large ... (Source: Trials)
Source: Trials - January 18, 2019 Category: General Medicine Authors: Ya-Quan Hou, Xin Zhang, Jian-Feng Tu, Yang Zheng, Jing-Wen Yang, Mirim Kim, Hui Hu, Li-Qiong Wang, Jing-Jie Zhao, Wei Zhou, Jun Wang, Xuan Zou, Yu Wang, Guang-Xia Shi and Cun-Zhi Liu Tags: Study protocol Source Type: research

Introducing the new CONSORT extension for stepped-wedge cluster randomised trials
The use of the stepped-wedge cluster randomised trial (SW-CRT) is on the increase, and although there are still relatively few SW-CRTs currently published its use is bound to show an increase in the near futur... (Source: Trials)
Source: Trials - January 18, 2019 Category: General Medicine Authors: Karla Hemming, Monica Taljaard and Jeremy Grimshaw Tags: Commentary Source Type: research

Enteral Nutrition Tolerance And REspiratory Support (ENTARES) Study in preterm infants: study protocol for a randomized controlled trial
Respiratory distress syndrome (RDS) and feeding intolerance are common conditions in preterm infants and among the major causes of neonatal mortality and morbidity. (Source: Trials)
Source: Trials - January 18, 2019 Category: General Medicine Authors: Francesco Cresi, Elena Maggiora, Silvia Maria Borgione, Elena Spada, Alessandra Coscia, Enrico Bertino, Fabio Meneghin, Luigi Tommaso Corvaglia, Maria Luisa Ventura and Gianluca Lista Tags: Study protocol Source Type: research

A phase III wait-listed randomised controlled trial of novel targeted inter-professional clinical education intervention to improve cancer patients ’ reported pain outcomes (The Cancer Pain Assessment (CPAS) Trial): study protocol
Variations in care models contribute to cancer pain being under-recognised and under-treated in half of all patients with cancer. International and national cancer pain management guidelines are achievable wit... (Source: Trials)
Source: Trials - January 18, 2019 Category: General Medicine Authors: Jane L. Phillips, Nicole Heneka, Melanie Lovell, Lawrence Lam, Patricia Davidson, Frances Boyle, Nikki McCaffrey, Sally Fielding and Tim Shaw Tags: Study protocol Source Type: research

School-based mental health promotion in children and adolescents with StresSOS using online or face-to-face interventions: study protocol for a randomized controlled trial within the ProHEAD Consortium
Schools are an ideal setting in which to promote health. However, empirical data on the effectiveness of school-based mental health promotion programs are rare, and research on universal Internet-based prevent... (Source: Trials)
Source: Trials - January 18, 2019 Category: General Medicine Authors: Heike Eschenbeck, Laya Lehner, Hanna Hofmann, Stephanie Bauer, Katja Becker, Silke Diestelkamp, Michael Kaess, Markus Moessner, Christine Rummel-Kluge and Hans-Joachim Salize Tags: Study protocol Source Type: research

Chinese herbal medicine bi min fang for allergic rhinitis: protocol for a double-blind, double-dummy, randomized controlled trial
This study will be the first to explore the mechanism of action of Chinese herbal medicine on the gut microbiota in AR.Trial registrationChinese Clinical Trial Registry,ChiCTR-IPR-17010970. Registered on 23 March 2017. (Source: Trials)
Source: Trials - January 18, 2019 Category: Research Source Type: clinical trials

Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial
AbstractBackgroundAt birth, the majority of neonates born at
Source: Trials - January 18, 2019 Category: Research Source Type: clinical trials

School-based mental health promotion in children and adolescents with StresSOS using online or face-to-face interventions: study protocol for a randomized controlled trial within the ProHEAD Consortium
This study represents the first adequately powered non-inferiority trial in the area of school-based mental health promotion. If onlineStresSOS proves efficacious and non-inferior to face-to-face delivery, this offers great potential for health promotion in youths, both in and outside the school environment.Trial registrationGerman Clinical Trials Register,DRKS00014693. Registered on 14 May 2018. (Source: Trials)
Source: Trials - January 18, 2019 Category: Research Source Type: clinical trials

A phase III wait-listed randomised controlled trial of novel targeted inter-professional clinical education intervention to improve cancer patients ’ reported pain outcomes (The Cancer Pain Assessment (CPAS) Trial): study protocol
DiscussionIf this mHealth intervention is found to be effective, in addition to improving cancer pain assessment practices, it will provide a readily transferable evidence-based framework that could readily be applied to other evidence practice gaps and a scalable intervention that could be administered simultaneously to multiple clinicians across diverse geographical locations. Moreover, if found to be cost-effective, it will help transform clinical continuing professional development. In summary, this mHealth intervention will provide health services with an opportunity to offer an evidence-based, pedagogically robust, c...
Source: Trials - January 18, 2019 Category: Research Source Type: clinical trials

Enteral Nutrition Tolerance And REspiratory Support (ENTARES) Study in preterm infants: study protocol for a randomized controlled trial
DiscussionThe identification of the most suitable technique (NCPAP vs HHHFNC) for preterm infants with feeding intolerance could reduce gastrointestinal complications, improve growth, and reduce hospital length of stay, thus improving clinical outcomes and reducing health costs. The evaluation of the timing of oral feeding could be useful in understanding the influence that these techniques could have on the development of sucking-swallow coordination. Moreover, the evaluation of the response to NCPAP and HHHFNC could clarify their efficacy as a treatment for RDS in extremely preterm infants.Trial registrationClinicalTrial...
Source: Trials - January 18, 2019 Category: Research Source Type: clinical trials

Introducing the new CONSORT extension for stepped-wedge cluster randomised trials
AbstractThe use of the stepped-wedge cluster randomised trial (SW-CRT) is on the increase, and although there are still relatively few SW-CRTs currently published its use is bound to show an increase in the near future. An extension of the CONSORT reporting guideline for SW-CRTs has recently been developed. By making reporting guidelines for this innovative design available relatively early in its development, it is possible that the methodological conduct and reporting of future SW-CRTs will not be at the same risk of low-quality of reporting as is the case with many other study designs. We provide a brief overview of thi...
Source: Trials - January 18, 2019 Category: Research Source Type: clinical trials

Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial
DiscussionThe finding of this trial will provide high-quality evidence on the efficacy of acupuncture for treatment of PDS. Results of this research will be published in peer-reviewed journals.Trial registrationISRCTN Registry,ISRCTN12511434. Registered on 31 March 2017. (Source: Trials)
Source: Trials - January 18, 2019 Category: Research Source Type: clinical trials

Efficacy and safety of exogenous ketone bodies for preventive treatment of migraine: A study protocol for a single-centred, randomised, placebo-controlled, double-blind crossover trial
Currently available prophylactic migraine treatment options are limited and are associated with many, often intolerable, side-effects. Various lines of research suggest that abnormalities in energy metabolism ... (Source: Trials)
Source: Trials - January 17, 2019 Category: General Medicine Authors: Elena Gross, Niveditha Putananickal, Anna-Lena Orsini, Simone Schmidt, Deborah R. Vogt, Sven Cichon, Peter Sandor and Dirk Fischer Tags: Study protocol Source Type: research

Efficacy of tuina in patients with chronic neck pain: study protocol for a randomized controlled trial
Chronic neck pain (CNP) is a common and disabling musculoskeletal disorder in developing and developed countries. Previous studies have shown that tuina and traditional Chinese massage are effective treatments fo... (Source: Trials)
Source: Trials - January 17, 2019 Category: General Medicine Authors: Zhiwei Wu, Lingjun Kong, Qingguang Zhu, Pengfei Song, Min Fang, Wuquan Sun, Hao Zhang, Yanbin Cheng, Shanda Xu, Guangxin Guo, Xin Zhou and Zhizhen Lv Tags: Study protocol Source Type: research

Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial
Mechanical ventilation (MV) is a life-saving technology that restores or assists breathing. Like any treatment, MV has side effects. In some patients it can cause diaphragmatic atrophy, injury, and dysfunction... (Source: Trials)
Source: Trials - January 17, 2019 Category: General Medicine Authors: Douglas Evans, Deborah Shure, Linda Clark, Gerard J. Criner, Martin Dres, Marcelo Gama de Abreu, Franco Laghi, David McDonagh, Basil Petrof, Teresa Nelson and Thomas Similowski Tags: Study protocol Source Type: research

Efficacy and safety of exogenous ketone bodies for preventive treatment of migraine: A study protocol for a single-centred, randomised, placebo-controlled, double-blind crossover trial
DiscussionA crossover design was chosen as it greatly improves statistical power and participation rates, without increasing costs. To our knowledge this is the first RCT using βHB salts worldwide. If proven effective and safe, βHB might not only offer a new prophylactic treatment option for migraine patients, but might additionally pave the way for clinical trials assessing its use in related diseases.Trial registrationClinicalTrials.gov,NCT03132233. Registered on 27 April 2017. (Source: Trials)
Source: Trials - January 17, 2019 Category: Research Source Type: clinical trials

Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial
This study is the first large-scale clinical trial of a novel technology (TTVDP) aimed at accelerating difficult weaning from MV. The technology tested provides the first therapy directed specifically at VIDD, an important cause of delayed weaning from MV. Its results will help delineate the place of this therapeutic approach in clinical practice and help design future studies aimed at defining the indications and benefits of TTVDP.Trial registrationClinicalTrials.gov,NCT03096639. Registered on 30 March 2017. (Source: Trials)
Source: Trials - January 17, 2019 Category: Research Source Type: clinical trials

Efficacy of tuina in patients with chronic neck pain: study protocol for a randomized controlled trial
DiscussionThe purpose of this trial is to determine whethertuina is more effective than traditional Chinese massage in adults with CNP. This trial will, therefore, contribute to providing a solid foundation for clinical treatment of CNP, as well as future research in massage therapy.Trial registrationChinese Clinical Trial Registry,ChiCTR-INR-17013763. Registered 8 December 2017. (Source: Trials)
Source: Trials - January 17, 2019 Category: Research Source Type: clinical trials

BIOLAP: biological versus synthetic mesh in laparo-endoscopic inguinal hernia repair: study protocol for a randomized, multicenter, self-controlled clinical trial
Inguinal hernia repair is one of the most common surgical operations globally; more than 20 million groin herniae are repaired annually worldwide. Recurrence after an inguinal hernia operation is a considerabl... (Source: Trials)
Source: Trials - January 16, 2019 Category: General Medicine Authors: C. S. Seefeldt, J. S. Meyer, J. Knievel, A. Rieger, R. Gei ßen, R. Lefering and M. M. Heiss Tags: Study protocol Source Type: research

Cerebral mechanism of celecoxib for treating knee pain: study protocol for a randomized controlled parallel trial
Celecoxib is frequently prescribed to treat knee osteoarthritis (KOA), but how celecoxib influences the activity of the central nervous system to alleviate chronic pain remains unclear. (Source: Trials)
Source: Trials - January 16, 2019 Category: General Medicine Authors: Chenjian Tang, Xiaohui Dong, Wenhua He, Shirui Cheng, Yang Chen, Yong Huang, Bao Yin, Yu Sheng, Jun Zhou, Xiaoli Wu, Fang Zeng, Zhengjie Li and Fanrong Liang Tags: Study protocol Source Type: research

Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
Sciatica is a relatively frequent illness that easily becomes a chronic and relapsing condition. Although numerous systematic reviews have analyzed various therapies for sciatica, the validity of their include... (Source: Trials)
Source: Trials - January 16, 2019 Category: General Medicine Authors: Koh-Woon Kim, Kyungmo Park, Hi-Joon Park, Geon-Ho Jahng, Dae-Jean Jo, Jae-Heung Cho, Eun-Mo Song, Woo-Chul Shin, Ye-Ji Yoon, Soo-Jeon Kim, Seulgi Eun and Mi-Yeon Song Tags: Study protocol Source Type: research

Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial
Treatment success rates of multidrug-resistant tuberculosis (MDR-TB) remain unsatisfactory, and long-term use of second-line anti-TB drugs is accompanied by the frequent occurrence of adverse events, low treat... (Source: Trials)
Source: Trials - January 16, 2019 Category: General Medicine Authors: Myungsun Lee, Jeongha Mok, Deog Kyeom Kim, Tae Sun Shim, Won-Jung Koh, Doosoo Jeon, Taehoon Lee, Seung Heon Lee, Ju Sang Kim, Jae Seuk Park, Ji Yeon Lee, Song Yee Kim, Jae Ho Lee, Kyung-Wook Jo, Byung Woo Jhun, Young Ae Kang & hellip; Tags: Study protocol Source Type: research

Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial
This study is a phase II/III, multicenter, randomized, open-label clinical trial of non-inferiority design comparing a new regimen to the World Health Organization-endorsed conventional regimen for fluoroquinolone-sensitive MDR-TB. The control arm uses a conventional treatment regimen with second-line drugs including injectables for 20 –24 months. The investigational arm uses a new shorter regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for 9 or 12 months depending on time to sputum culture conversion. The primary outcome is the treatment success rate at 24 months after tre...
Source: Trials - January 16, 2019 Category: Research Source Type: clinical trials

Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
This study is a randomized, patient-assessor blind, two-arm, parallel, non-penetrating, sham-controlled clinical trial. Eligible participants will include adults (aged 19 –70 years old) with a clinical diagnosis of chronic sciatica (40 mm or more of a 100-mm visual analog scale (VAS) for bothersomeness) blinded to the treatment received. Patients will be randomly allocated into the acupuncture treatment group (manual acupuncture plus electroacupuncture (EA),n = 34) or the sham acupuncture control group (sham acupuncture plus placebo EA without electrical stimulation,n = 34). Grou...
Source: Trials - January 16, 2019 Category: Research Source Type: clinical trials

Cerebral mechanism of celecoxib for treating knee pain: study protocol for a randomized controlled parallel trial
DiscussionThe results will investigate the influence of celecoxib treatment on cerebral activity of patients with KOA and the possible relationship between the cerebral activity changes and improvement of clinical variables so as to explore the central mechanism of celecoxib in treating knee pain.Trial registrationChiCTR-IOR-17012365. Registered on August 14, 2017. (Source: Trials)
Source: Trials - January 16, 2019 Category: Research Source Type: clinical trials

BIOLAP: biological versus synthetic mesh in laparo-endoscopic inguinal hernia repair: study protocol for a randomized, multicenter, self-controlled clinical trial
DiscussionThere is no reasonably sized trial that assesses the use of biological meshes in laparo-endoscopic inguinal hernia repair.Our self-controlled trial design allows a direct comparison of the two meshes with very few confounding factors as well as minimizing the exclusion criteria. As we compare CE-certified medical devices in their designated indication the medical risk is not different compared to routine clinical care. Due to the common nature of bilateral inguinal hernia, a high recruitment rate is achievable. Because guidelines for hernia repair have stressed the need for reliable data on the already frequent u...
Source: Trials - January 16, 2019 Category: Research Source Type: clinical trials

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial
Social isolation potentiates the risk of death by cancer in the older cancer patient population. The PREDOMOS study investigates the impact of establishing a Program of Social intervention associated with tech... (Source: Trials)
Source: Trials - January 15, 2019 Category: General Medicine Authors: Anne-Laure Couderc, Emilie Nouguer ède, Karine Baumstarck, Sandrine Loubière, Hervé Le Caer, Olivier Guillem, Frédérique Rousseau, Laurent Greillier, Emmanuelle Norguet-Monnereau, Maud Cecile, Rabia Boulahssass, Françoise Le Caer, Sandrine Tournier, Tags: Update Source Type: research

Comparing the placement of a left-sided double-lumen tube via fiberoptic bronchoscopy guidance versus conventional intubation using a Macintosh laryngoscope, to reduce the incidence of malpositioning: study protocol for a randomized controlled pilot trial
A fiberoptic bronchoscope (FOB) is commonly used to identify the proper placement of a double-lumen endotracheal tube (DLT) for good lung isolation during thoracic surgery. We hypothesized that the FOB-guided ... (Source: Trials)
Source: Trials - January 15, 2019 Category: General Medicine Authors: Taeha Ryu, Eugene Kim, Jong Hae Kim, Seong Jun Woo, Woon Seok Roh and Sung Hye Byun Tags: Study protocol Source Type: research

Effect of preconceptional DHEA treatment on in vitro fertilization outcome in poor ovarian respond women: study protocol for a randomized controlled trial
Women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with poor ovarian respond (POR) always have very low clinical pregnancy rates. In previous data, dehydroepiandrosterone ... (Source: Trials)
Source: Trials - January 15, 2019 Category: General Medicine Authors: Wei Wang, Hong Liu, Jing Li, Daimin Wei, Jiangtao Zhang, Jianfeng Wang, Jinlong Ma, Yuhua Shi and Zi-Jiang Chen Tags: Study protocol Source Type: research

Nurse-led, telephone-based secondary preventive follow-up benefits stroke/TIA patients with low education: a randomized controlled trial sub-study
The objective of this study was to analyze the impact of two forms of secondary preventive follow-up on the association between education level and levels of blood pressure (BP) and low-density lipoprotein cho... (Source: Trials)
Source: Trials - January 15, 2019 Category: General Medicine Authors: Anna-Lotta Irewall, Joachim Ögren, Lisa Bergström, Katarina Laurell, Lars Söderström and Thomas Mooe Tags: Research Source Type: research

Efficacy and cost-effectiveness of two online interventions for children and adolescents at risk for depression (E.motion trial): study protocol for a randomized controlled trial within the ProHEAD consortium
Depression is a serious mental health problem and is common in children and adolescents. Online interventions are promising in overcoming the widespread undertreatment of depression and in improving the help-s... (Source: Trials)
Source: Trials - January 15, 2019 Category: General Medicine Authors: Sabrina Baldofski, Elisabeth Kohls, Stephanie Bauer, Katja Becker, Sally Bilic, Heike Eschenbeck, Michael Kaess, Markus Moessner, Hans Joachim Salize, Silke Diestelkamp, Elke Vo ß and Christine Rummel-Kluge Tags: Study protocol Source Type: research

Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3  months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial
DiscussionWe hope to provide evidence that the combination of morphine and gabapentin will provide better analgesia than morphine alone and will be safe. We also aim to obtain confirmation of the recommended pediatric dose.Trial registrationEudractCT,2014-004897-40. Registered on 7 September 2017.ClinicalTrials.gov,NCT03275012. Registered on 7 September 2017. (Source: Trials)
Source: Trials - January 15, 2019 Category: Research Source Type: clinical trials

Efficacy and cost-effectiveness of two online interventions for children and adolescents at risk for depression (E.motion trial): study protocol for a randomized controlled trial within the ProHEAD consortium
This study represents the first randomized controlled trial (RCT) investigating efficacy and cost-effectiveness of two online interventions in children and adolescents aged ≥ 12 years at risk for depression. It aims to provide a better understanding of the help-seeking behavior of children and adolescents, potential benefits of E-mental health interventions for this age group, and new insights into so far understudied aspects of E-mental health programs, such as potential negative effects of online interventions. This knowledge will be used to tailor and improve future help offers and programs for children...
Source: Trials - January 15, 2019 Category: Research Source Type: clinical trials

Nurse-led, telephone-based secondary preventive follow-up benefits stroke/TIA patients with low education: a randomized controlled trial sub-study
ConclusionsNurse-led, telephone-based secondary preventive follow-up led to comparable improvements in BP across education groups, while routine follow-up disfavored those with low education.Trial registrationISRCTN RegistryISRCTN23868518, June 19, 2012 - Retrospectively registered. (Source: Trials)
Source: Trials - January 15, 2019 Category: Research Source Type: clinical trials

Effect of preconceptional DHEA treatment on in vitro fertilization outcome in poor ovarian respond women: study protocol for a randomized controlled trial
DiscussionThe results of this study will provide evidence for the effect of preconceptional DHEA treatment on IVF outcome in POR.Trial registrationChinese Clinical Trial Registry,ChiCTR-IPR-15006909. Registered on November 9, 2015. (Source: Trials)
Source: Trials - January 15, 2019 Category: Research Source Type: clinical trials

Comparing the placement of a left-sided double-lumen tube via fiberoptic bronchoscopy guidance versus conventional intubation using a Macintosh laryngoscope, to reduce the incidence of malpositioning: study protocol for a randomized controlled pilot trial
DiscussionThis pilot study was designed as the first randomized controlled trial to confirm our hypothesis. This should provide information for a further full-scale trial, and the outcomes of the study should provide clinical evidence on the usefulness of the FOB-guided method for DLT placement, in comparison to the conventional method.Trial registrationClinical Research Information Service; CRIS, ID:KCT0002663. Retrospectively registered on 24 January 2018. (Source: Trials)
Source: Trials - January 15, 2019 Category: Research Source Type: clinical trials

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial
AbstractBackgroundSocial isolation potentiates the risk of death by cancer in the older cancer patient population. The PREDOMOS study investigates the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance on the improvement of quality of life of older isolated patients, treated for locally advanced or metastatic cancer. This paper updates the pilot trial protocol.Methods/designThe original protocol was published in Trials, accessible athttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1894-7.This update reports on the eligibility criteria expan...
Source: Trials - January 15, 2019 Category: Research Source Type: clinical trials

Correction to: AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial
Following publication of the original article [1], we have been notified that one of the author names was listed incorrectly. Both incorrect and correct author names are presented below. The original publicati... (Source: Trials)
Source: Trials - January 14, 2019 Category: General Medicine Authors: David S. Lawrence, Nabila Youssouf, S íle F. Molloy, Alexandre Alanio, Melanie Alufandika, David R. Boulware, Timothée Boyer-Chammard, Tao Chen, Francoise Dromer, Admire Hlupeni, William Hope, Mina C. Hosseinipour, Cecilia Kanyama, Oliver Lortholary, An Tags: Correction Source Type: research

Process evaluation of the context, reach and recruitment of participants and delivery of dementia-specific case conferences (WELCOME-IdA) in nursing homes (FallDem): a mixed-methods study
A system of dementia-specific case conferences (WELCOME-IdA) was evaluated using a stepped-wedge design in six nursing homes (NHs) to enable nursing staff to analyse properly the behavioural and psychological ... (Source: Trials)
Source: Trials - January 14, 2019 Category: General Medicine Authors: Daniela Holle, Rene M üller-Widmer, Sven Reuther, Ute Rosier-Segschneider, Rabea Graf, Martina Roes and Margareta Halek Tags: Research Source Type: research

Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6  years of age: study protocol for a double-blind, randomized control trial
Recent clinical observations have reported the potential benefit of vagus nerve stimulation (VNS) as an adjunctive therapy for pediatric epilepsy. Preliminary evidence suggests that VNS treatment is effective ... (Source: Trials)
Source: Trials - January 14, 2019 Category: General Medicine Authors: Taoyun Ji, Zhao Yang, Qingzhu Liu, Jianxiang Liao, Fei Yin, Yanhui Chen, Liping Zou, Baomin Li, Yuxing Gao, Xiaomei Shu, Shaoping Huang, Feng Gao, Jianmin Liang, Su Fang Lin, Jing Peng, Shiwei Song & hellip; Tags: Study protocol Source Type: research

Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
There is an increased risk of premature death in people with severe mental illness (SMI). Respiratory disorders and cardiovascular disease are leading causes of increased mortality rates in these patients, and... (Source: Trials)
Source: Trials - January 14, 2019 Category: General Medicine Authors: Mar ía José Jaén-Moreno, Nuria Feu, Justa Redondo-Écija, Francisco Javier Montiel, Cristina Gómez, Gloria I. del Pozo, Jose Ángel Alcalá, Luis Gutiérrez-Rojas, Vicente Balanzá-Martinez, Geli Marie Chauca, Laura Carrión, Maria Isabel Osuna, Marí Tags: Study protocol Source Type: research

Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial
Axial spondyloarthritis (AxSpA) is a chronic disease which results in fatigue, pain, and reduced quality of life (QoL). Traditional Chinese medicine (TCM), especially acupuncture, has shown promise in managing... (Source: Trials)
Source: Trials - January 14, 2019 Category: General Medicine Authors: Yu Heng Kwan, Warren Fong, Xiang Ling Ang, Chuen Seng Tan, Bee Choo Tai, Youyi Huang, Marcel Bilger, Jie Kie Phang, Hui Chin Tan, Jia Ven Lee, Limin Sun, Choy Tip Tan, Bao Qiang Dong, Hwee Ling Koh, Ying Ying Leung, Nai Lee Lui & hellip; Tags: Study protocol Source Type: research

Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial
DiscussionThis trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of a TCMCMC for patients with AxSpA.Trial registrationClinicalTrials.gov,NCT03420404. Registered on 14 February 2018. (Source: Trials)
Source: Trials - January 14, 2019 Category: Research Source Type: clinical trials

Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
This article describes in detail a protocol developed to evaluate an intensive motivational tool, based on the individual risks of pulmonary damage and prevention opportunities. It is designed as a randomized, 12-month, follow-up, multicenter study. A minimum of 204 smokers will be included, aged 40  years and older, all of whom are patients diagnosed with either schizophrenia or bipolar disorder (BD). Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry, and the diagnosis will then be validated by a pneumologist and the lung age estimated. Based on this value, a mo tivational message abou...
Source: Trials - January 14, 2019 Category: Research Source Type: clinical trials

Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6  years of age: study protocol for a double-blind, randomized control trial
DiscussionThis trial will evaluate quantitative differences in efficacy and safety with/without VNS treatment for pediatric participants aged between 3 to 6  years with intractable epilepsy and will explore whether the current age range of VNS therapy can be expanded.Trial registrationClinicalTrials.gov, ID:NCT03062514, Registered on 23 February 2017. (Source: Trials)
Source: Trials - January 14, 2019 Category: Research Source Type: clinical trials

Process evaluation of the context, reach and recruitment of participants and delivery of dementia-specific case conferences (WELCOME-IdA) in nursing homes (FallDem): a mixed-methods study
ConclusionAn analysis of the process evaluation data indicated that there were inaccuracies in the implementation of WELCOME-IdA and there were methodological limitations within the design of the effectiveness trial, both of which could explain the lack of effectiveness of WELCOME-IdA. To optimise the process structure of WELCOME-IdA, an assessment of BPSD and a pre-selection of possible domains for the behavioural analysis could be conducted prior to a dementia-specific case conference.Trial registrationISRCTN20203855. Registered on 10 July 2013. (Source: Trials)
Source: Trials - January 14, 2019 Category: Research Source Type: clinical trials

Correction to: AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial
Following publication of the original article [1], we have been notified that one of the author names was listed incorrectly. Both incorrect and correct author names are presented below. The original publication has been corrected. (Source: Trials)
Source: Trials - January 14, 2019 Category: Research Source Type: clinical trials

The correlation between baseline score and post-intervention score, and its implications for statistical analysis
When using a continuous outcome measure in a randomised controlled trial (RCT), the baseline score should be measured in addition to the post-intervention score, and it should be analysed using the appropriate... (Source: Trials)
Source: Trials - January 11, 2019 Category: General Medicine Authors: Lei Clifton and David A. Clifton Tags: Methodology Source Type: research

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial
Transcutaneous electrical acupoint stimulation (TEAS), which is also known as acupuncture-like transcutaneous electrical nerve stimulation (TENS), has been widely used in acute or chronic pain. However, previo... (Source: Trials)
Source: Trials - January 11, 2019 Category: General Medicine Authors: Yi Liang, Guanai Bao, Liyan Gong, Jie Zhou, Xiangming Kong, Ran Ran, Xiaomei Shao, Yongliang Jiang, Weiping Zhang, Boyi Liu, Junying Du, Junfan Fang, Na Nie, Conghua Ji and Jianqiao Fang Tags: Study protocol Source Type: research

Effects of home-based prescribed pulmonary exercise by patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial
Chronic obstructive pulmonary disease (COPD) not only affects pulmonary function but also leads to skeletal muscle dysfunction. The various characteristics of different forms of traditional Chinese exercise le... (Source: Trials)
Source: Trials - January 11, 2019 Category: General Medicine Authors: Xiaodan Liu, Peijun Li, Lu Xiao, Yufan Lu, Ning Li, Zhengrong Wang, Hongxia Duan, Jian Li and Weibing Wu Tags: Study protocol Source Type: research