Effect and cerebral mechanism of acupuncture treatment for functional constipation: study protocol for a randomized controlled clinical trial
Acupuncture is effective in functional constipation (FC) treatment, but the central mechanism has not been well investigated. This trial will combine functional magnetic resonance imaging (fMRI) and positron e... (Source: Trials)
Source: Trials - May 24, 2019 Category: General Medicine Authors: Tao Yin, Zhaoxuan He, Peihong Ma, Likai Hou, Li Chen, Kunnan Xie, Zilei Tian, Fumin Wang, Jing Xiong, Yi Yang, Ruirui Sun and Fang Zeng Tags: Study protocol Source Type: research

Barriers to recruitment when conducting a commissioned randomised controlled trial of medication versus psychological therapy for generalised anxiety disorder: some lessons learned
Poor recruitment is the most common reason for premature discontinuation of randomised controlled trials (RCTs). An RCT of medication versus psychological therapy for generalised anxiety disorder (GAD) was dis... (Source: Trials)
Source: Trials - May 24, 2019 Category: General Medicine Authors: Anastasia K. Kalpakidou, John Cape, Tarun J. Limbachya, Irwin Nazareth and Marta Buszewicz Tags: Research Source Type: research

Effect and cerebral mechanism of acupuncture treatment for functional constipation: study protocol for a randomized controlled clinical trial
DiscussionWe hypothesize that acupuncture can treat FC through normalizing the pathological alteration of the cerebral activity. The results of this trial will allow us to re-testify the therapeutic effects of acupuncture treating for FC and to investigate the potential central mechanism of acupuncture treatment for FC from direct (cerebral glucose metabolism) and indirect (contrast of oxyhemoglobin and deoxyhemoglobin) approaches.Trial registrationChinese Clinical Trial Registry,ChiCTR1800016658. Registered on 14 June 2018. (Source: Trials)
Source: Trials - May 24, 2019 Category: Research Source Type: clinical trials

Barriers to recruitment when conducting a commissioned randomised controlled trial of medication versus psychological therapy for generalised anxiety disorder: some lessons learned
ConclusionsOur findings suggest that poor recruitment to RCTs can be significantly affected by participants ’ treatment preferences and by factors influencing the recruiting clinicians. It may also be important not to include too many restrictions on inclusion criteria for pragmatic trials aiming for generalisable results.Trial registrationISCRTN14845583. Registration date: 5 February 2015. (Source: Trials)
Source: Trials - May 24, 2019 Category: Research Source Type: clinical trials

FortiColos – a multicentre study using bovine colostrum as a fortifier to human milk in very preterm infants: study protocol for a randomised controlled pilot trial
Very preterm infants ( (Source: Trials)
Source: Trials - May 22, 2019 Category: General Medicine Authors: Agnethe M. Ahnfeldt, Nana Hyldig, Yanqi Li, Susanne Soendergaard Kappel, Lise Aunsholdt, Per T. Sangild and Gitte Zachariassen Tags: Study protocol Source Type: research

Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis
Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message ... (Source: Trials)
Source: Trials - May 22, 2019 Category: General Medicine Authors: Rachel Whitemore, Jo Leonardi-Bee, Felix Naughton, Stephen Sutton, Sue Cooper, Steve Parrott, Catherine Hewitt, Miranda Clark, Michael Ussher, Matthew Jones, David Torgerson and Tim Coleman Tags: Study protocol Source Type: research

Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial
Septic shock is a major public health problem that is associated with up to 50% mortality. Unfavorable outcomes are mainly attributed to multiple organ failure (MOF) resulting from an uncontrolled inflammatory... (Source: Trials)
Source: Trials - May 22, 2019 Category: General Medicine Authors: Martin Cour, Marielle Buisson, Kada Klouche, Radhia Bouzgarrou, Carole Schwebel, Jean-Pierre Quenot, Fabrice Zeni, Pascal Beuret, Michel Ovize and Laurent Argaud Tags: Study protocol Source Type: research

Rationale and protocol of the ENGAGE study: a double-blind randomized controlled preference trial using a comprehensive cohort design to measure the effect of a cognitive and leisure-based intervention in older adults with a memory complaint
Leisure activities can be both enjoyable and cognitively stimulating, and participation in such activities has been associated with reduced age-related cognitive decline. Thus, integrating stimulating leisure ... (Source: Trials)
Source: Trials - May 22, 2019 Category: General Medicine Authors: S. Belleville, A. Moussard, A. I. Ansaldo, P. Belchior, L. Bherer, N. Bier, V. D. Bohbot, M.-A. Bruneau, L. L. Cuddy, B. Gilbert, R. Jokel, K. Mahalingam, K. McGilton, K. J. Murphy, G. Naglie, E. Rochon & hellip; Tags: Study protocol Source Type: research

Rationale and protocol of the ENGAGE study: a double-blind randomized controlled preference trial using a comprehensive cohort design to measure the effect of a cognitive and leisure-based intervention in older adults with a memory complaint
This study will test whether a program combining cognitive training with stimulating leisure activities can increase cognition and reduce cognitive decline in persons at risk of dementia.Trial registrationNCT03271190. Registered on 5 September 2017. (Source: Trials)
Source: Trials - May 22, 2019 Category: Research Source Type: clinical trials

FortiColos – a multicentre study using bovine colostrum as a fortifier to human milk in very preterm infants: study protocol for a randomised controlled pilot trial
AbstractBackgroundVery preterm infants (
Source: Trials - May 22, 2019 Category: Research Source Type: clinical trials

Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis
AbstractBackgroundSmoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy.A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called ‘MiQuit’ to text SHS support to pregnant women wh...
Source: Trials - May 22, 2019 Category: Research Source Type: clinical trials

Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial
DiscussionResults of this proof-of-concept trial should provide information on the efficacy of RECO in patients with septic shock.Trial registrationClinicalTrials.gov, ID: identifier:NCT03201575. Registered on 28 June 2017. (Source: Trials)
Source: Trials - May 22, 2019 Category: Research Source Type: clinical trials

Effect of home-based transcranial direct current stimulation (tDCS) on cognitive function in patients with mild cognitive impairment: a study protocol for a randomized, double-blind, cross-over study
The possible effect of transcranial direct current stimulation (tDCS) in improving cognitive function is clear from studies involving pre-dementia stage mild cognitive impairment (MCI). However, the applicatio... (Source: Trials)
Source: Trials - May 21, 2019 Category: General Medicine Authors: Jaesub Park, Yoonkyung Oh, Kyungmi Chung, Kwang Joon Kim, Chang Oh Kim and Jin Young Park Tags: Study protocol Source Type: research

Effect of home-based transcranial direct current stimulation (tDCS) on cognitive function in patients with mild cognitive impairment: a study protocol for a randomized, double-blind, cross-over study
This study will be conducted in 20 elderly people aged 60 to 80  years with complaints of subjective memory impairment while maintaining general functions with limited activities of daily living. This study involves a cross-over design that will include 2-week active or sham stimulation of both dorsolateral prefrontal cortexes (left, anode; right, cathode) ran domly with a 2-week wash-out phase. Changes in cognitive function will be evaluated using visual recognition tasks and neuropsychological tests. In this study, tDCS will be carried out by each patient at his/her home and its safety and suitability will be eval...
Source: Trials - May 21, 2019 Category: Research Source Type: clinical trials

Correction to: Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
After publication of the original article [1], the authors have notified us that their originally submitted Table 1 was mistakenly replaced with Fig. 3 during editing. The original article has been corrected. (Source: Trials)
Source: Trials - May 20, 2019 Category: General Medicine Authors: Mike Ralf Langenbach and D örthe Seidel Tags: Correction Source Type: research

Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO2): study protocol for a cluster randomised trial
Inappropriate staff behaviour during surgical procedures may disrupt the surgical performance and compromise patient safety. We developed an innovative monitoring and feedback system combined with an adaptive ... (Source: Trials)
Source: Trials - May 20, 2019 Category: General Medicine Authors: Gabriel Birgand, Thomas Haudebourg, Leslie Grammatico-Guillon, L éa Ferrand, Leila Moret, François Gouin, Nicolas Mauduit, Christophe Leux, Yannick Le Manach, Didier Lepelletier, Elsa Tavernier, Jean-Christophe Lucet and Bruno Giraudeau Tags: Study protocol Source Type: research

Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
Quadratus lumborum block (QLB) is increasingly gaining popularity as a novel abdominal truncal block in abdominal surgery; however, the mechanism of QLB is not yet thoroughly illustrated. The focus of our stud... (Source: Trials)
Source: Trials - May 20, 2019 Category: General Medicine Authors: Qing Yuan, Xulei Cui, Yuda Fei, Zhonghuang Xu and Yuguang Huang Tags: Study protocol Source Type: research

Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial
The recommended psychological treatment of choice for obsessive-compulsive disorder (OCD) is exposure with response prevention (ERP). However, recovery rates are relatively modest, so better treatments are nee... (Source: Trials)
Source: Trials - May 20, 2019 Category: General Medicine Authors: Kim Melchior, Ingmar Franken, Mathijs Deen and Colin van der Heiden Tags: Study protocol Source Type: research

Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO 2 ): study protocol for a cluster randomised trial
DiscussionThe field of human factors and behaviour in the OR seems to offer potential room for improvement. An intervention providing goal-setting, monitoring, feedback and action planning may reduce the traffic flow and interruptions/distractions of the surgical team during procedures, preventing subsequent POCs. The results of this trial will provide important data on the impact of OR staff behaviour on patient safety, and promote best practice during surgical procedures.Trial registrationClinicalTrials.gov,NCT03158181. (Source: Trials)
Source: Trials - May 20, 2019 Category: Research Source Type: clinical trials

Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial
DiscussionBy comparing MCT with ERP we hope to provide an indication whether MCT is efficacious in the treatment of OCD and, if so, whether it has the potential to be more efficacious than the current “gold standard” psychological treatment for OCD, ERP.Trial registrationDutch Trial Register,NTR4855. Registered on 21 October 2014. (Source: Trials)
Source: Trials - May 20, 2019 Category: Research Source Type: clinical trials

Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
DiscussionThis will the first randomized controlled trial to compare TMQLB with TPVB for analgesia in laparoscopic surgery. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of TMQLB.Trial registrationClinicalTrials.gov,NCT03414281. Registered on 9 January 2018. (Source: Trials)
Source: Trials - May 20, 2019 Category: Research Source Type: clinical trials

Correction to: Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
After publication of the original article [1], the authors have notified us that their originally submitted Table  1 was mistakenly replaced with Fig. 3 during editing. The original article has been corrected.The publisher apologizes to the readers for the inconvenience caused. (Source: Trials)
Source: Trials - May 20, 2019 Category: Research Source Type: clinical trials

Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients ’ treatment adherence via electronic monitors and an app versus usual care in Tibet
In this study we will pilot and evaluate the effectiveness of using new electronic monitors (e-monitors) and a sm... (Source: Trials)
Source: Trials - May 16, 2019 Category: General Medicine Authors: Xiaolin Wei, Joseph Paul Hicks, Pande Pasang, Zhitong Zhang, Victoria Haldane, Xiaoqiu Liu, Tingting Yin, Lixia Wang, Dachun Shi, Shiliang Ge, John Walley, Ross Upshur and Jun Hu Tags: Study protocol Source Type: research

Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients ’ treatment adherence via electronic monitors and an app versus usual care in Tibet
In this study we will pilot and evaluate the effectiveness of using new electronic monitors (e-monitors) and a smartphone app to improve treatment adherence among new pulmonary TB patients in Tibet.MethodsWe will use a multicentre, parallel-group, individually randomised controlled, superiority trial with blinded outcome evaluation and unblinded treatment. We will randomise new pulmonary TB outpatients (aged ≥ 15 years old and free from communication impairment) from Shigatse, Tibet to either the intervention or control arm in a 1:1 ratio at the time of their diagnosis. All patients will be treated according to t...
Source: Trials - May 16, 2019 Category: Research Source Type: clinical trials

Are stage-based health information messages effective and good value for money in improving maternal newborn and child health outcomes in India? Protocol for an individually randomized controlled trial
Evidence is limited on the effectiveness of mobile health programs which provide stage-based health information messages to pregnant and postpartum women. Kilkari is an outbound service that delivers weekly, s... (Source: Trials)
Source: Trials - May 15, 2019 Category: General Medicine Authors: Amnesty LeFevre, Smisha Agarwal, Sara Chamberlain, Kerry Scott, Anna Godfrey, Rakesh Chandra, Aditya Singh, Neha Shah, Diva Dhar, Alain Labrique, Aarushi Bhatnagar and Diwakar Mohan Tags: Study protocol Source Type: research

Are stage-based health information messages effective and good value for money in improving maternal newborn and child health outcomes in India? Protocol for an individually randomized controlled trial
DiscussionKilkari is the largest maternal messaging program, in terms of absolute numbers, currently being implemented globally. Evaluations of similar initiatives elsewhere have been small in scale and focused on summative outcomes, presenting limited evidence on individual exposure to content. Drawing upon system-generated data, we explore linkages between successful receipt of calls, user engagement with calls, and reported outcomes. This is the first study of its kind in India and is anticipated to provide the most robust and comprehensive evidence to date on maternal messaging programs globally.Trial registrationClini...
Source: Trials - May 15, 2019 Category: Research Source Type: clinical trials

Video feedback intervention to enhance parental reflective functioning in primary caregivers of inpatient psychiatric children: protocol for a randomized feasibility trial
Children requiring hospitalization for psychiatric care have serious disorders, high use of psychotropic medication, and frequent readmissions. The development and implementation of therapies focused on incorp... (Source: Trials)
Source: Trials - May 14, 2019 Category: General Medicine Authors: Fanny Leyton, Marcia Olhaberry, Rub én Alvarado, Graciela Rojas, Luis Alberto Dueñas, George Downing and Howard Steele Tags: Study protocol Source Type: research

Efficacy of the In2Care ® auto-dissemination device for reducing dengue transmission: study protocol for a parallel, two-armed cluster randomised trial in the Philippines
Mosquito-borne viruses are imposing an ever increasing health burden worldwide. In addition to the recent Zika and chikungunya virus epidemics, dengue viruses have become the fastest growing problem with a 40-... (Source: Trials)
Source: Trials - May 14, 2019 Category: General Medicine Authors: Ferdinand Salazar, Jason Angeles, Ava Kristy Sy, Marianette T. Inobaya, Ariza Aguila, Tom Toner, Michael J. Bangs, Edward Thomsen and Richard E. Paul Tags: Study protocol Source Type: research

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asian women: study protocol for a cluster randomized wait-list controlled trial
Marked ethnic disparities on cervical cancer screening have been observed among South Asian women. Multiple barriers, such as language difficulties, poor access to screening services, values, and beliefs, were... (Source: Trials)
Source: Trials - May 14, 2019 Category: General Medicine Authors: Cho Lee Wong, Winnie Kwok Wei So, Dorothy Ngo Sheung Chan, Kai Chow Choi and Tika Rana Tags: Study protocol Source Type: research

POPPIE: protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth
High rates of preterm births remain a UK public health concern. Preterm birth is a major determinant of adverse infant and longer-term outcomes, including survival, quality of life, psychosocial effects on the... (Source: Trials)
Source: Trials - May 14, 2019 Category: General Medicine Authors: C. Fernandez Turienzo, D. Bick, M. Bollard, L. Brigante, A. Briley, K. Coxon, P. Cross, A. Healey, M. Mehta, A. Melaugh, J. Moulla, P. T. Seed, A. H. Shennan, C. Singh, R. M. Tribe and J. Sandall Tags: Study protocol Source Type: research

Video feedback intervention to enhance parental reflective functioning in primary caregivers of inpatient psychiatric children: protocol for a randomized feasibility trial
This study will contribute to the currently scarce evidence on how to provide family attachment-based interventions in a child inpatient psychiatric unit. It will also inform the design and implementation of a future randomized clinical trial.Trial registrationClinicalTrials.gov,NCT03374904. Registered on 14 December 2017 (retrospectively registered). (Source: Trials)
Source: Trials - May 14, 2019 Category: Research Source Type: clinical trials

Efficacy of the In2Care ® auto-dissemination device for reducing dengue transmission: study protocol for a parallel, two-armed cluster randomised trial in the Philippines
DiscussionFor decades, it has been commonly accepted that an integrated approach to mosquito control is required. The World Health Organization (WHO) Global Strategic Framework for Integrated Vector Management recommends a range of interventions, in combination, to increase control impact to reduce transmission. This efficacy trial of the first commercial product using the AD approach will be informative in assessing the general utility of AD in reducing not only adult vector densities but, more importantly, reducing the incidence of dengue. The AD technique may complement source reduction and larviciding campaigns by more...
Source: Trials - May 14, 2019 Category: Research Source Type: clinical trials

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asian women: study protocol for a cluster randomized wait-list controlled trial
This study aims to assess the effects of a CHW-led multimedia intervention on the uptake of cervical cancer screening among South Asian women.MethodsThis study is a cluster randomized wait-list controlled trial. A total of 408 South Asian women from Pakistan, India or Nepal will be recruited from six ethnic minority associations. Each association will be randomized to one of the two arms: an intervention arm (n = 3) that will undergo immediate treatment (CHW-led multimedia intervention) or a wait-list control arm (n = 3) that will receive delayed treatment. Each recruited CHW will be allocated t...
Source: Trials - May 14, 2019 Category: Research Source Type: clinical trials

POPPIE: protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth
DiscussionLittle is known about the underlying reasons why and how models of midwifery continuity of care are associated with fewer preterm births, better maternal and infant outcomes and more positive experiences; nor how these models of care can be implemented successfully in the health services. This will be the first study to provide direct evidence regarding the effectiveness, implementation and evaluation of a midwifery continuity of care model and rapid access to specialist obstetric services for women at increased risk of preterm birth.Trial registrationISRCTN37733900. Retrospectively registered on 21 August 2017. (Source: Trials)
Source: Trials - May 14, 2019 Category: Research Source Type: clinical trials

Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial
Home blood pressure (BP) and unattended automated BP (uAOBP) monitoring have been recommended by guidelines for the care of hypertensive subjects. However, BP measurements in the peripheral arteries cannot ser... (Source: Trials)
Source: Trials - May 10, 2019 Category: General Medicine Authors: Hao-Min Cheng, Shih-Hsien Sung, Chen-Huan Chen, Wen-Chung Yu, Shu-Mei Yang, Chao-Yu Guo, Shao-Yuan Chuang and Chern-En Chiang Tags: Study protocol Source Type: research

Factors associated with recruitment to randomised controlled trials in general practice: protocol for a systematic review
Randomised controlled trials (RCTs) are frequently unable to recruit sufficient numbers of participants. This affects the trial ’s ability to answer the proposed research question, wastes resources and can be u... (Source: Trials)
Source: Trials - May 10, 2019 Category: General Medicine Authors: Keith R. Moffat, Paul Cannon, Wen Shi and Frank Sullivan Tags: Study protocol Source Type: research

Correction to: Effectiveness and sustainability of a structured group-based educational program (MEDIHEALTH) in improving medication adherence among Malay patients with underlying type 2 diabetes mellitus in Sarawak State of Malaysia: study protocol of a randomized controlled trial
After publication of the original article [1], the authors have notified us that there are changes to the primary outcome of the study, instrument, subject ’s inclusion criteria, the funding and acknowledgement... (Source: Trials)
Source: Trials - May 10, 2019 Category: General Medicine Authors: Chuo Yew Ting, Shahren Ahmad Zaidi Adruce, Mohamed Azmi Hassali, Hiram Ting, Chien Joo Lim, Rachel Sing-Kiat Ting, Abu Hassan Alshaari Abd Jabar, Nor Anizah Osman, Izzul Syazwan Shuib, Shing Chyi Loo, Sui Theng Sim, Su Ee Lim and Donald E. Morisky Tags: Correction Source Type: research

Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial
DiscussionTo our knowledge, this is the first prospective double-blind randomized controlled trial to assess the optimal guiding strategy for hypertension. It will help to define which BP monitoring method is the most effective for guiding the clinical management of hypertension. It will provide good evidence to support future guideline recommendations for BP monitoring devices.Trial registrationClinicalTrials.gov,NCT03578848. Registered on 4 June 2018. (Source: Trials)
Source: Trials - May 10, 2019 Category: Research Source Type: clinical trials

Correction to: Effectiveness and sustainability of a structured group-based educational program (MEDIHEALTH) in improving medication adherence among Malay patients with underlying type 2 diabetes mellitus in Sarawak State of Malaysia: study protocol of a randomized controlled trial
After publication of the original article [1], the authors have notified us that there are changes to the primary outcome of the study, instrument, subject ’s inclusion criteria, the funding and acknowledgements. These changes were made during the recruitment of participants and after approved by the Medical Research and Ethics Committee (MREC), National Institutes of Health Malaysia, on 16th November 2018. (Source: Trials)
Source: Trials - May 10, 2019 Category: Research Source Type: clinical trials

Factors associated with recruitment to randomised controlled trials in general practice: protocol for a systematic review
DiscussionThe review will, for the first time, systematically synthesise existing research on factors associated with recruitment rates to RCTs in general practice. By identifying research gaps to be prioritised in further research, it will be of interest to academics. It will also be of value to clinical trialists who are involved in the complex task of improving trial recruitment. Our team will use the findings to inform a prediction model of trial recruitment using machine learning.Systematic review registrationPROSPERO,CRD42018100695. Registered on 03 July 2018. (Source: Trials)
Source: Trials - May 10, 2019 Category: Research Source Type: clinical trials

MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system with a degenerative component, leading to irreversible disability. Mesenchymal stem cells (MSC) have been shown to prevent infla... (Source: Trials)
Source: Trials - May 9, 2019 Category: General Medicine Authors: Antonio Uccelli, Alice Laroni, Lou Brundin, Michel Clanet, Oscar Fernandez, Seyed Massood Nabavi, Paolo A. Muraro, Roberto S. Oliveri, Ernst W. Radue, Johann Sellner, Per Soelberg Sorensen, Maria Pia Sormani, Jens Thomas Wuerfel, Mario A. Battaglia and Ma Tags: Study protocol Source Type: research

MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis
DiscussionResults will provide patients and the scientific community with data on the safety and efficacy of MSC for MS. The innovative approach utilized to obtain funds to support the MESEMS trial could represent a new model to circumvent limitation of funds encountered by academic trials.Trial registrationAndalusia:NCT01745783, registered on Dec 10, 2012.Badalona:NCT02035514 EudraCT, 2010 –024081–21. Registered on 2012.Canada: ClinicalTrials.gov,NCT02239393. Registered on September 12, 2014.Copenhagen: EudraCT,2012 –000518-13. Registered on June 21, 2012.Italy: EudraCT, 2011 –001295-19, and Clinic...
Source: Trials - May 9, 2019 Category: Research Source Type: clinical trials

Correction to: Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial
After publication of the original article [1], the authors have notified us that two of the collaborator first and last names have been inverted in the “PROTHOR Investigators” table. (Source: Trials)
Source: Trials - May 8, 2019 Category: General Medicine Authors: T. Kiss, J. Wittenstein, C. Becker, K. Birr, G. Cinnella, E. Cohen, M. R. El Tahan, L. F. Falc ão, C. Gregoretti, M. Granell, T. Hachenberg, M. W. Hollmann, R. Jankovic, W. Karzai, J. Krassler, T. Loop & hellip; Tags: Correction Source Type: research

Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial
With the increasing amount of geriatric surgery, it has become a great challenge for anesthesiologists to reduce the incidence of postoperative pulmonary complications (PPCs). The two most popular airway manag... (Source: Trials)
Source: Trials - May 8, 2019 Category: General Medicine Authors: Ling Zhu, Xiao Shi, Suqing Yin, Jiemin Yin, Ziyu Zhu, Xiong Gao, Yingfu Jiao, Weifeng Yu and Liqun Yang Tags: Study protocol Source Type: research

Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial
Data from a feasibility study suggest that the use of an inelastic, short-stretch compression bandage following total knee arthroplasty is a safe technique that may improve patient-reported health outcomes, an... (Source: Trials)
Source: Trials - May 8, 2019 Category: General Medicine Authors: Liz Cook, Matthew J. Northgraves, Caroline Fairhurst, Sarah Ronaldson, David J. Torgerson, Jonathan Kent and Mike Reed Tags: Study protocol Source Type: research

Partner-assisted cognitive behavioural therapy for insomnia versus cognitive behavioural therapy for insomnia: a randomised controlled trial
Insomnia is a prevalent sleep disorder associated with significant economic and personal burdens. Cognitive behavioural therapy for insomnia (CBTI) is considered the gold standard intervention for insomnia and... (Source: Trials)
Source: Trials - May 8, 2019 Category: General Medicine Authors: Alix Mellor, Kellie Hamill, Melissa M. Jenkins, Donald H. Baucom, Peter J. Norton and Sean P. A. Drummond Tags: Study protocol Source Type: research

Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial
DiscussionThe Knee Replacement Bandaging Study (KReBS) is a large study which aims to contribute to the evidence base for informing clinical decisions for the use of compression bandaging following knee arthroplasty.Trial registrationInternational Standard Randomised Controlled Trial Register,ISRCTN 87127065. Registered on 20 February 2017. (Source: Trials)
Source: Trials - May 8, 2019 Category: Research Source Type: clinical trials

Partner-assisted cognitive behavioural therapy for insomnia versus cognitive behavioural therapy for insomnia: a randomised controlled trial
This study is a mixed-effects randomised effectiveness trial of partner-assisted CBTI (PA-CBTI). It is an “effectiveness” (as opposed to “efficacy”) trial, due to the focus on “real world” clinic-based clients and adherence/attrition as outcomes. Participants will include 120 clients with insomnia who are randomly assigned, in equal numbers, to PA-CBTI, traditional individual CBTI (i-CBTI), or partner-assisted sleep management therapy (PA-SMT; which serves as the control group). All interventions consist of seven weekly 1-h sessions. Treatment outcome is evaluated using clinician-rated t...
Source: Trials - May 8, 2019 Category: Research Source Type: clinical trials

Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial
DiscussionThis trial will assess the possible benefits or disadvantages of perioperative LMA use in elderly patients compared with ETI regarding the occurrence of PPCs and clinical prognosis. We expect that this trial will also add to the current understanding of PPCs in geriatric populations and contribute to the international recommendations of geriatric surgery management.Trial registrationClinicalTrials.gov,NCT02240901. Registered on 16 September 2014. (Source: Trials)
Source: Trials - May 8, 2019 Category: Research Source Type: clinical trials

Correction to: Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial
After publication of the original article [1], the authors have notified us that two of the collaborator first and last names have been inverted in the “PROTHOR Investigators” table. (Source: Trials)
Source: Trials - May 8, 2019 Category: Research Source Type: clinical trials