Protecting Adolescents in Low- And Middle-Income Countries from Interpersonal Violence (PRO YOUTH TRIAL): Study Protocol for a Cluster Randomized Controlled Trial of the Strengthening Families Programme 10-14 ( “Familias Fuertes”) in Panama
Interpersonal violence can significantly reduce adolescents ’ opportunities for becoming happy and healthy adults. Central America is the most violent region in the world and it is estimated that adolescents ar... (Source: Trials)
Source: Trials - June 15, 2018 Category: General Medicine Authors: Anilena Mejia, Richard Emsley, Eleonora Fichera, Wadih Maalouf, Jeremy Segrott and Rachel Calam Tags: Study protocol Source Type: research

Protecting Adolescents in Low- And Middle-Income Countries from Interpersonal Violence (PRO YOUTH TRIAL): Study Protocol for a Cluster Randomized Controlled Trial of the Strengthening Families Programme 10-14 ( “ Familias Fuertes ”) in Panama
DiscussionThis trial will be the first to evaluate SFP 10 –14 in a LMIC. Results have the potential to guide public policies for the prevention of interpersonal violence in Central America and beyond.Trial registrationISRCTN Registry,14023111. Registered on 13 July 2017. (Source: Trials)
Source: Trials - June 15, 2018 Category: Research Source Type: clinical trials

Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: Study protocol for a multi-center prospective randomized controlled trial
Invasive mechanical ventilation (IMV) is associated with the development of adverse pulmonary and non-pulmonary outcomes in very premature infants. Various modes of non-invasive respiratory support are increas... (Source: Trials)
Source: Trials - June 14, 2018 Category: General Medicine Authors: Xing-Wang Zhu, Yuan Shi, Li-Ping Shi, Ling Liu, Jiang Xue and Rangasamy Ramanathan Tags: Study protocol Source Type: research

Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: Study protocol for a multi-center prospective randomized controlled trial
DiscussionIn recent decades, several observational studies have compared the effects of NHFOV and NCPAP in neonates as a rescue mode or during weaning from IMV. To our knowledge, this will be the first multi-center prospective, randomized controlled trial to evaluate NHFOV as a primary mode in preterm infants with RDS in China or any other part of the world. Our trial may help to establish guidelines for NHFOV in preterm infants with RDS to minimize the need for IMV, and to decrease the significant pulmonary and non-pulmonary morbidities associated with IMV.Trial registrationClinicalTrials.gov,NCT03099694. Registered on 4 ...
Source: Trials - June 14, 2018 Category: Research Source Type: clinical trials

Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants: a study protocol for a randomized controlled trial
Morphine is worldwide the analgesic of first choice after cardiac surgery in children. Morphine has unwanted hemodynamic and respiratory side effects. Therefore, post –cardiac surgery patients may potentially b... (Source: Trials)
Source: Trials - June 13, 2018 Category: General Medicine Authors: Gerdien A. Zeilmaker-Roest, Joost van Rosmalen, Monique van Dijk, Erik Koomen, Nicolaas J. G. Jansen, Martin C. J. Kneyber, Sofie Maebe, Greet van den Berghe, Dirk Vlasselaers, Ad J. J. C. Bogers, Dick Tibboel and Enno D. Wildschut Tags: Study protocol Source Type: research

Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants: a study protocol for a randomized controlled trial
This study will focus on the reduction, or replacement, of morphine by IV paracetamol in children (0 –36 months old) after cardiac surgery. The results of this study will form the basis of a new pain management algorithm and will be implemented at the participating ICUs, resulting in an evidence-based guideline on post-operative pain after cardiac surgery in infants who are 0–36 months old.Trial registrationDutch Trial Registry (www.trialregister.nl):NTR5448 on September 1, 2015. Institutional review board approval (MEC2015 –646), current protocol version: July 3, 2017 (Source: Trials)
Source: Trials - June 13, 2018 Category: Research Source Type: clinical trials

Augmentation effect of acupuncture on Bi ’nao for hypophasis in patients with Bell’s palsy: study protocol for a randomized controlled trial
DiscussionThis is the first study assessing the safety and efficiency of Bi ’nao in treating the hypophasis of patients with Bell’s palsy that might support the application of this acupuncture therapy. However, evaluating hypophasis is challenging, and, thus, ECWM and ESA were applied to measure the eyelid movement.Trial registrationChinese Clinical Trials Registry,ChiCTR-INR-17012955. Registered on 12 October 2017. (Source: Trials)
Source: Trials - June 11, 2018 Category: Research Source Type: clinical trials

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial
DiscussionThis feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention.Trial RegistrationISRCTN38920246. Registered 22 June 2016. (Source: Trials)
Source: Trials - June 11, 2018 Category: Research Source Type: clinical trials

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial
Despite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-b... (Source: Trials)
Source: Trials - June 11, 2018 Category: General Medicine Authors: Anne Forster, Suzanne Hartley, Lorna Barnard, Seline Ozer, Natasha Hardicre, Tom Crocker, Marie Fletcher, Lauren Moreau, Ross Atkinson, Claire Hulme, Ivana Holloway, Laetitia Schmitt, Allan House, Jenny Hewison, Gillian Richardson and Amanda Farrin Tags: Study protocol Source Type: research

Augmentation effect of acupuncture on Bi ’nao for hypophasis in patients with Bell’s palsy: study protocol for a randomized controlled trial
Hypophasis is one of the most frequently observed sequelae of patients with Bell ’s palsy, who have not recovered completely, creating a clinical difficulty for physicians. Acupuncture therapy has been widely u... (Source: Trials)
Source: Trials - June 11, 2018 Category: General Medicine Authors: Xiaoyan Li, Chunlan Chen, Chuang Zhao, Zunyuan Li, Wei Liang and Zhidan Liu Tags: Study protocol Source Type: research

The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial
Prior studies indicate that stratified care for low back pain results in better clinical outcome and reduced costs in healthcare compared to current practice. Stratified care may be associated with clinical be... (Source: Trials)
Source: Trials - June 8, 2018 Category: General Medicine Authors: Lars Morso, Berit Schi øttz-Christensen, Jens Søndergaard, Nils-Bo de Vos Andersen, Flemming Pedersen, Kim Rose Olsen, Morten Sall Jensen, Jonathan Hill and David Høyrup Christiansen Tags: Study protocol Source Type: research

The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial
DiscussionStratified care that effectively targets treatment to relevant sub-groups of patients has potentially great impact on the treatment pathways of low back pain. Thus, if effective, this could result in better patient outcomes and at the same time reduce the costs for treatment of low back pain.Trial registrationClinicalTrials.gov,NCT02612467. Registered on 16 November 2015. (Source: Trials)
Source: Trials - June 8, 2018 Category: Research Source Type: clinical trials

Efficacy of acupuncture on pelvic pain in patients with endometriosis: study protocol for a randomized, single-blind, multi-center, placebo-controlled trial
DiscussionThe study will compare the effectiveness and safety of acupuncture with comfort needles on pelvic pain related to endometriosis in the hope of providing significant evidence for using acupuncture on pelvic pain related to endometriosis.Trial registrationClinicalTrials.gov, ID:NCT03125304. Registered on 30 April 2017. (Source: Trials)
Source: Trials - June 7, 2018 Category: Research Source Type: clinical trials

Efficacy of acupuncture on pelvic pain in patients with endometriosis: study protocol for a randomized, single-blind, multi-center, placebo-controlled trial
Endometriosis is a chronic gynecological disease that is characterized by the presence of endometrial tissue outside the uterine cavity. The main symptoms include dysmenorrhea, dyspareunia, chronic pelvic pain... (Source: Trials)
Source: Trials - June 7, 2018 Category: General Medicine Authors: Ruining Liang, Peishuang Li, Xuemei Peng, Ling Xu, Pei Fan, Jiahua Peng, Xu Zhou, Chunlin Xiao and Miao Jiang Tags: Study protocol Source Type: research

‘Test n Treat (TnT)’– Rapid testing and same-day, on-site treatment to reduce rates of chlamydia in sexually active further education college students: study protocol for a cluster randomised feasibility trial
Sexually active young people attending London further education (FE) colleges have high rates of chlamydia, but screening rates are low. We will conduct a cluster randomised feasibility trial of frequent, rapi... (Source: Trials)
Source: Trials - June 5, 2018 Category: General Medicine Authors: Sarah Kerry-Barnard, Charlotte Fleming, Fiona Reid, Rachel Phillips, Vari M. Drennan, Elisabeth J. Adams, Wendy Majewska, Anjella Balendra, Emma Harding-Esch, Emma Cousins, S. Tariq Sadiq and Pippa Oakeshott Tags: Study protocol Source Type: research

Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial
Preterm birth (birth before 37 weeks of gestation) and its complications are the leading contributors to neonatal and under-5 mortality. The majority of neonatal deaths in Kenya and Uganda occur during the int... (Source: Trials)
Source: Trials - June 5, 2018 Category: General Medicine Authors: Phelgona Otieno, Peter Waiswa, Elizabeth Butrick, Gertrude Namazzi, Kevin Achola, Nicole Santos, Ryan Keating, Felicia Lester and Dilys Walker Tags: Study protocol Source Type: research

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
AbstractBackgroundAmidst the high disease burden, non-adherence to medications among patients with type 2 diabetes mellitus (T2DM) has been reported to be common and devastating. Sarawak Pharmaceutical Services Division has formulated a pharmacist-led, multiple-theoretical-grounding, culturally sensitive and structured group-based program, namely “Know Your Medicine – Take if for Health” (MEDIHEALTH), to improve medication adherence among Malay patients with T2DM. However, to date, little is known about the effectiveness and sustainability of the Program.Methods/designThis is a prospective, parallel-desig...
Source: Trials - June 5, 2018 Category: Research Source Type: clinical trials

Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial
DiscussionThe results of this study will inform interventions to improve personnel and facility capacity to respond to preterm labor and delivery, as well as care for the preterm infant.Trial registrationClinicalTrials.gov, ID:NCT03112018. Registered on 13 April 2017. (Source: Trials)
Source: Trials - June 5, 2018 Category: Research Source Type: clinical trials

‘Test n Treat (TnT)’: a cluster-randomised feasibility trial of frequent, rapid-testing and same-day, on-site treatment to reduce rates of chlamydia in high-risk further education college students: statistical analysis plan
AbstractBackgroundThere are high rates of sexually transmitted infections (STIs) in ethnically diverse, sexually active students aged 16 –24 years attending London further education (FE) colleges. However, uptake of chlamydia screening remains low. The TnT study aims to assess the feasibility of conducting a future trial in FE colleges to investigate if frequent, rapid, on-site testing and treatment (TnT) reduces chlamydia rates. T his article presents the statistical analysis plan for the main study publication as approved and signed off by the Trial Management Group prior to the first data extraction for the final ...
Source: Trials - June 5, 2018 Category: Research Source Type: clinical trials

‘ Test n Treat (TnT)’– Rapid testing and same-day, on-site treatment to reduce rates of chlamydia in sexually active further education college students: study protocol for a cluster randomised feasibility trial
DiscussionFindings will provide key values to inform feasibility, sample size and timescales of a future definitive trial of TnT in FE colleges, including:Recruitment ratesTnT uptake ratesFollow-up ratesPrevalence of chlamydia in participants at baseline and 7  monthsAcceptability of TnT to students and college staffEstimate of the cost per person screened/treated in TnT versus usual careTrial registrationInternational Standard Randomised Controlled Trials Registry, ID:ISRCTN58038795, Registered on 31 August 2016. (Source: Trials)
Source: Trials - June 5, 2018 Category: Research Source Type: clinical trials

‘Test n Treat (TnT)’: a cluster-randomised feasibility trial of frequent, rapid-testing and same-day, on-site treatment to reduce rates of chlamydia in high-risk further education college students: statistical analysis plan
There are high rates of sexually transmitted infections (STIs) in ethnically diverse, sexually active students aged 16 –24 years attending London further education (FE) colleges. However, uptake of chlamydia sc... (Source: Trials)
Source: Trials - June 5, 2018 Category: General Medicine Authors: Rachel Phillips, Pippa Oakeshott, Sarah Kerry-Barnard and Fiona Reid Tags: Update Source Type: research

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
Amidst the high disease burden, non-adherence to medications among patients with type 2 diabetes mellitus (T2DM) has been reported to be common and devastating. Sarawak Pharmaceutical Services Division has for... (Source: Trials)
Source: Trials - June 5, 2018 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: Study protocol Source Type: research

Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Sw.) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial
DiscussionBecause fatigue is one of the most common and disabling symptoms of MS, effective management and reduction of MS-related fatigue has the potential to increase quality of life in this population. The results of this study will add to the evidence base for providing dietary recommendations to treat MS-related fatigue and other symptoms associated with this disease.Trial registrationClinicalTrials.gov,NCT02914964. Registered on 24 August 2016. (Source: Trials)
Source: Trials - June 4, 2018 Category: Research Source Type: clinical trials

Comparing isolated soy protein with flaxseed oil vs isolated soy protein with corn oil and wheat flour with corn oil consumption on muscle catabolism, liver function, blood lipid, and sugar in burn patients: a randomized clinical trial
ConclusionISP and FO compared to WF and CO reduced muscle catabolism and increased body weight in burn patients.Trial registrationIranian Registry of Clinical Trials,IRCT2014051817740N1. Registered on 27 June 2014. (Source: Trials)
Source: Trials - June 4, 2018 Category: Research Source Type: clinical trials

Effects of dexmedetomidine on delirium duration of non-intubated ICU patients (4D trial): study protocol for a randomized trial
DiscussionThe 4D trial may provide important data on the safety of commonly used sedative dexmedetomidine and could have a significant impact on future treatment of non-intubated ICU patients presenting with agitated delirium.Trial registrationClinicalTrials.gov, ID:NCT 03317067. Registered on 23 October 2017. (Source: Trials)
Source: Trials - June 4, 2018 Category: Research Source Type: clinical trials

Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial
Low back pain is a common and costly condition. Spinal manipulative therapy (SMT) is a treatment supported in some guidelines, although most clinical trials examining SMT report small effect sizes. Enhancing t... (Source: Trials)
Source: Trials - June 4, 2018 Category: General Medicine Authors: Julie M. Fritz, Jason A. Sharpe, Elizabeth Lane, Doug Santillo, Tom Greene and Gregory Kawchuk Tags: Study protocol Source Type: research

Effects of dexmedetomidine on delirium duration of non-intubated ICU patients (4D trial): study protocol for a randomized trial
Delirium during intensive care unit (ICU) stay is frequent and associated with significant morbidity, mortality and healthcare-related costs. International guidelines suggest its prevention. However, curative ... (Source: Trials)
Source: Trials - June 4, 2018 Category: General Medicine Authors: Cl émence Louis, Thomas Godet, Gérald Chanques, Nathalie Bourguignon, Dominique Morand, Bruno Pereira and Jean-Michel Constantin Tags: Study protocol Source Type: research

Comparing isolated soy protein with flaxseed oil vs isolated soy protein with corn oil and wheat flour with corn oil consumption on muscle catabolism, liver function, blood lipid, and sugar in burn patients: a randomized clinical trial
There is controversy regarding whether increasing isolated soy protein (ISP) with or without flaxseed oil (FO), as functional foods, would lead to reduce muscle catabolism and cachexia in burn patients. (Source: Trials)
Source: Trials - June 4, 2018 Category: General Medicine Authors: Siavash Babajafari, Abdollah Hojhabrimanesh, Zahra Sohrabi, Mehdi Ayaz, Ali Noorafshan and Atefeh Akrami Tags: Research Source Type: research

Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Sw.) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial
Fatigue is one of the most disabling symptoms of multiple sclerosis (MS) and contributes to diminishing quality of life. Although currently available interventions have had limited success in relieving MS-rela... (Source: Trials)
Source: Trials - June 4, 2018 Category: General Medicine Authors: Terry Wahls, Maria O. Scott, Zaidoon Alshare, Linda Rubenstein, Warren Darling, Lucas Carr, Karen Smith, Catherine A. Chenard, Nicholas LaRocca and Linda Snetselaar Tags: Study protocol Source Type: research

Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial
DiscussionBuilding on preliminary findings identifying possible mechanisms of effects for SMT, this trial represents the next phase in a multiphase strategy towards the ultimate goal of developing an optimized protocol for providing SMT to patients with LBP. If successful, the results of this trial can be tested in future clinical trials in an effort to produce larger treatment benefits and improve patient-centered outcomes for individuals with LBP.Trial registrationClinicalTrials.gov,NCT02868034. Registered on 16 August 2016. (Source: Trials)
Source: Trials - June 4, 2018 Category: Research Source Type: clinical trials

A randomized phase 2B trial of vancomycin versus daptomycin for the treatment of methicillin-resistant Staphylococcus aureus bacteremia due to isolates with high vancomycin minimum inhibitory concentrations – results of a prematurely terminated study
Studies have suggested the reduced effectiveness of vancomycin against methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections with high vancomycin minimum inhibitory concentrations. Alternative... (Source: Trials)
Source: Trials - June 1, 2018 Category: General Medicine Authors: Shirin Kalimuddin, Yvonne F. Z. Chan, Rachel Phillips, Siew Pei Ong, Sophia Archuleta, David Chien Lye, Thuan Tong Tan and Jenny G. H. Low Tags: Research Source Type: research

A randomized phase 2B trial of vancomycin versus daptomycin for the treatment of methicillin-resistant Staphylococcus aureus bacteremia due to isolates with high vancomycin minimum inhibitory concentrations – results of a prematurely terminated study
ConclusionBased on the limited number of patients evaluated in this study, it remains unclear if alternative, more expensive agents such as daptomycin are superior to vancomycin in the treatment of high vancomycin minimum inhibitory concentration MRSA bloodstream infections. More studies are urgently needed but investigators may wish to consider employing novel, alternative trial methodologies to ensure a greater chance of success.Trial registrationClinicalTrials.gov,NCT01975662. Registered on 5 November 2013. (Source: Trials)
Source: Trials - June 1, 2018 Category: Research Source Type: clinical trials

Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial
DiscussionThe EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external validity. Accordingly, if significant clinical benefits and cost-effectiveness are de...
Source: Trials - May 31, 2018 Category: Research Source Type: clinical trials

Synergistic effect of acupuncture and mirror therapy on post-stroke upper limb dysfunction: a study protocol for a randomized controlled trial
DiscussionThe results of this trial will demonstrate the synergistic effect of acupuncture and MT on upper limb motor dysfunction after stroke. In addition, whether AT and MT, either combined or alone, are more effective than the conventional treatment in the management of post-stroke upper limb dysfunction will also be determined.Trial registrationChinese Clinical Trial Registry:ChiCTR-IOR-17011118. Registered on April 11, 2017. Version number: 01.2016.09.1. (Source: Trials)
Source: Trials - May 31, 2018 Category: Research Source Type: clinical trials

The AWED trial (Applying Wolbachia to Eliminate Dengue) to assess the efficacy of Wolbachia -infected mosquito deployments to reduce dengue incidence in Yogyakarta, Indonesia: study protocol for a cluster randomised controlled trial
This study protocol describes the first trial to measure the efficacy ofWolbachia in reducing dengue virus transmission in the field.Methods/designThe study is a parallel, two-arm, non-blinded cluster randomised controlled trial conducted in a single site in Yogyakarta, Indonesia. The aim is to determine whether large-scale deployment ofWolbachia-infectedAe. aegypti mosquitoes leads to a measurable reduction in dengue incidence in treated versus untreated areas. The primary endpoint is symptomatic, virologically confirmed dengue virus infection of any severity. The 26 km2 study area was subdivided into 24 contiguous cluste...
Source: Trials - May 31, 2018 Category: Research Source Type: clinical trials

The AWED trial (Applying Wolbachia to Eliminate Dengue) to assess the efficacy of Wolbachia-infected mosquito deployments to reduce dengue incidence in Yogyakarta, Indonesia: study protocol for a cluster randomised controlled trial
Dengue and other arboviruses transmitted by Aedes aegypti mosquitoes, including Zika and chikungunya, present an increasing public health challenge in tropical regions. Current vector control strategies have fail... (Source: Trials)
Source: Trials - May 31, 2018 Category: General Medicine Authors: Katherine L. Anders, Citra Indriani, Riris Andono Ahmad, Warsito Tantowijoyo, Eggi Arguni, Bekti Andari, Nicholas P. Jewell, Edwige Rances, Scott L. O ’Neill, Cameron P. Simmons and Adi Utarini Tags: Study protocol Source Type: research

Synergistic effect of acupuncture and mirror therapy on post-stroke upper limb dysfunction: a study protocol for a randomized controlled trial
Upper limb dysfunction is common after stroke, posing an important challenge for post-stroke rehabilitation. The clinical efficacy of acupuncture for the recovery of post-stroke upper limb function has been pr... (Source: Trials)
Source: Trials - May 31, 2018 Category: General Medicine Authors: Ying Xu, Shufang Lin, Cai Jiang, Xiaoqian Ye, Jing Tao, Schupp Wilfried, Alex W. K. Wong, Lidian Chen and Shanli Yang Tags: Study protocol Source Type: research

Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial
Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint s... (Source: Trials)
Source: Trials - May 31, 2018 Category: General Medicine Authors: Paul A. Matthews, Brigitte E. Scammell, Arfan Ali, Timothy Coughlin, Jessica Nightingale, Tanvir Khan and Ben J. Ollivere Tags: Study protocol Source Type: research

Music therapy versus treatment as usual for refugees diagnosed with posttraumatic stress disorder (PTSD): study protocol for a randomized controlled trial
DiscussionThe effect of music therapy can be explained by theories on affect regulation and social engagement, and the impact of music on brain regions affected by PTSD. The study will shed light on the role of therapy for the attainment of a safe attachment style, which recently has been shown to be impaired in traumatized refugees. The inclusion of music and imagery in the treatment of traumatized refugees hopefully will inform the choice of treatment method and expand the possibilities for improving refugee health and integration.Trial registrationClinicalTrials.gov ID number NCT03574228, registered retrospectively on 2...
Source: Trials - May 30, 2018 Category: Research Source Type: clinical trials

Sex and cardiovascular disease status differences in attitudes and willingness to participate in clinical research studies/clinical trials
While women are under-represented in research on cardiovascular disease (CVD), little is known about the attitudes of men and women with CVD regarding participation in clinical research studies/clinical trials. (Source: Trials)
Source: Trials - May 30, 2018 Category: General Medicine Authors: Thomas S. Gruca, Wesley J. Hottel, Janine Comstock, Anna Olson and Gary E. Rosenthal Tags: Research Source Type: research

Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial
Treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional su... (Source: Trials)
Source: Trials - May 30, 2018 Category: General Medicine Authors: Michael C. Tanner, Raban Heller, Fabian Westhauser, Matthias Miska, Thomas Ferbert, Christian Fischer, Simone Gantz, Gerhard Schmidmaier and Patrick Haubruck Tags: Study protocol Source Type: research

Music therapy versus treatment as usual for refugees diagnosed with posttraumatic stress disorder (PTSD): study protocol for a randomized controlled trial
Meta-analyses of studies on psychological treatment of refugees describe highly varying outcomes, and research on multi-facetted and personalized treatment of refugees with post-traumatic stress disorder (PTSD... (Source: Trials)
Source: Trials - May 30, 2018 Category: General Medicine Authors: Bolette Daniels Beck, Steen Teis Lund, Ulf S øgaard, Erik Simonsen, Thomas Christian Tellier, Torben Oluf Cordtz, Gunnar Hellmund Laier and Torben Moe Tags: Study protocol Source Type: research

Post-trial follow-up methodology in large randomised controlled trials: a systematic review
Randomised controlled clinical trials typically have a relatively brief in-trial follow-up period which can underestimate safety signals and fail to detect long-term hazards, which may take years to appear. Ex... (Source: Trials)
Source: Trials - May 30, 2018 Category: General Medicine Authors: Rebecca Llewellyn-Bennett, Danielle Edwards, Nia Roberts, Atticus H. Hainsworth, Richard Bulbulia and Louise Bowman Tags: Review Source Type: research

Post-trial follow-up methodology in large randomised controlled trials: a systematic review
DiscussionData captured during the post-trial follow-up period can add scientific value to a trial. However, there are logistical and financial barriers to overcome. Where available, data linkage via electronic registries and records is a cost-effective method which can provide data on a range of endpoints.Systematic review registrationNot applicable for PROSPERO registration. (Source: Trials)
Source: Trials - May 30, 2018 Category: Research Source Type: clinical trials

Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial
In this study, we plan to examine the clinical effectiveness of BaG as a bone graft substitute in Masquelet therapy in comparison with present standard Masquelet therapy using an ABG with tricalciumphosphate to fill the bone defect.Methods/designThis randomized controlled, clinical non-inferiority trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University. Patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2 –5 cm and who are receiving Masquelet treatment will be included in the study. The resulting bone defect will either be filled wit...
Source: Trials - May 30, 2018 Category: Research Source Type: clinical trials

Sex and cardiovascular disease status differences in attitudes and willingness to participate in clinical research studies/clinical trials
ConclusionsThe findings reported here suggest that the observed lower levels of participation by women are due to factors other than a lower WTP or to women having more negative attitudes towards aspects of study participation. Patients with CVD have similar attitudes and WTP as patients with other chronic conditions. (Source: Trials)
Source: Trials - May 30, 2018 Category: Research Source Type: clinical trials

Efficacy and safety of electro-acupuncture treatment in improving the consciousness of patients with traumatic brain injury: study protocol for a randomized controlled trial
Traumatic brain injury (TBI) has become a leading cause of death among young people worldwide. Survivors may live with a long-term TBI-related disability or even develop a disorder of consciousness resulting i... (Source: Trials)
Source: Trials - May 29, 2018 Category: General Medicine Authors: Jie Liu, Xinsheng Xue, Ying Wu, Chaohua Yang, Ning Li and Huiping Li Tags: Study protocol Source Type: research

Daptomycin versus placebo as an adjunct to beta-lactam therapy in the treatment of Staphylococcus aureus bacteremia: study protocol for a randomized controlled trial
AbstractBackgroundStaphylococcus aureus bacteremia is associated with significant morbidity and mortality. To treat this infection, the current standard of care includes intravenous anti-staphylococcal beta-lactam antibiotics and obtaining adequate source control. Combination therapy with an aminoglycoside or rifampin, despite early promise, can no longer be routinely recommended due to an absence of proven benefit and risk of harm. Daptomycin is a rapidly acting bactericidal antibiotic that is approved for the treatment ofStaphylococcus aureus bacteremia as monotherapy but has not been shown to be superior to the current ...
Source: Trials - May 29, 2018 Category: Research Source Type: clinical trials

Efficacy and safety of electro-acupuncture treatment in improving the consciousness of patients with traumatic brain injury: study protocol for a randomized controlled trial
DiscussionResults from this trial will significantly add to the current body of evidence on the role of electro-acupuncture in the consciousness recovery of patients with severe TBI. In addition, a more convenient and consistent electro-acupuncture method can be set up for clinical practice. If found to be effective and safe, electro-acupuncture will be a valuable complementary option for comatose patients with TBI.Trial registrationChinese Clinical Trial Registry:ChiCTR-INR-17011674. Registered on 16 June 2016. (Source: Trials)
Source: Trials - May 29, 2018 Category: Research Source Type: clinical trials

Daptomycin versus placebo as an adjunct to beta-lactam therapy in the treatment of Staphylococcus aureus bacteremia: study protocol for a randomized controlled trial
Staphylococcus aureus bacteremia is associated with significant morbidity and mortality. To treat this infection, the current standard of care includes intravenous anti-staphylococcal beta-lactam antibiotics and ... (Source: Trials)
Source: Trials - May 29, 2018 Category: General Medicine Authors: Matthew P. Cheng, Alexander Lawandi, Guillaume Butler-Laporte, Katryn Paquette and Todd C. Lee Tags: Study protocol Source Type: research