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Evaluating a multi-component, community-based program to improve adherence and retention in care among adolescents living with HIV in Zimbabwe: study protocol for a cluster randomized controlled trial
This study provides a unique opportunity to generate evidence of the impact of the on-going Zvandiri program, for adolescents living with HIV, on virological failure and psychosocial outcomes as delivered in a real-world setting. If found to reduce rates of treatment failure, this would strengthen support for further scale-up across Zimbabwe and likely the region more widely.Trial registrationPan African Clinical Trial Registry database, registration numberPACTR201609001767322 (the Zvandiri trial). Retrospectively registered on 5 September 2016. (Source: Trials)
Source: Trials - October 20, 2017 Category: Research Source Type: clinical trials

The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial
Cisplatin is a key drug in lung cancer therapy. However, cisplatin is also well known to induce gastrointestinal disorders, such as chemotherapy-induced nausea and vomiting, anorexia, and weight loss. These sy... (Source: Trials)
Source: Trials - October 18, 2017 Category: General Medicine Authors: Takuya Inoue, Hironori Takagi, Yuki Owada, Yuzuru Watanabe, Takumi Yamaura, Mitsuro Fukuhara, Satoshi Muto, Naoyuki Okabe, Yuki Matsumura, Takeo Hasegawa, Jun Osugi, Mika Hoshino, Mitsunori Higuchi, Yutaka Shio, Hiroshi Yokouchi, Kenya Kanazawa & hellip; Tags: Study protocol Source Type: research

iTACTIC – implementing Treatment Algorithms for the Correction of Trauma-Induced Coagulopathy: study protocol for a multicentre, randomised controlled trial
Traumatic injury is the fourth leading cause of death globally. Half of all trauma deaths are due to bleeding and most of these will occur within 6  h of injury. Haemorrhagic shock following injury has been sho... (Source: Trials)
Source: Trials - October 18, 2017 Category: General Medicine Authors: Kjersti Baksaas-Aasen, Lewis Gall, Simon Eaglestone, Claire Rourke, Nicole. P. Juffermans, J. Carel Goslings, Paal Aksel Naess, Susan van Dieren, Sisse Rye Ostrowski, Jakob Stensballe, Marc Maegele, Simon J. Stanworth, Christine Gaarder, Karim Brohi and P Tags: Study protocol Source Type: research

iTACTIC – implementing Treatment Algorithms for the Correction of Trauma-Induced Coagulopathy: study protocol for a multicentre, randomised controlled trial
DiscussionCCTs have traditionally been used to detect TIC and monitor response to treatment in traumatic major haemorrhage. The use of VHAs is increasing, but limited evidence exists to support the superiority of these technologies (or comparatively) for patient-centred outcomes. This knowledge gap will be addressed by this trial.Trial registrationClinicalTrials.gov, ID:NCT02593877. Registered on 15 October 2015.Trial sponsorQueen Mary University of LondonThe contact person of the above sponsor organisation is: Dr. Sally Burtles, Director of Research Services and Business Development, Joint Research Management Office, QM I...
Source: Trials - October 18, 2017 Category: Research Source Type: clinical trials

The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial
DiscussionThis trial is designed to examine the efficacy ofrikkunshito (TJ-43) for reducing anorexia and maintaining food intake caused by cisplatin-including chemotherapy in patients with lung cancer.Trial registrationJapan Pharmaceutical Information Center Clinical Trials Information (JAPIC CTI), trial registration: JAPICCTI-142747. Registered on 15 December 2014; the RICH trial. (Source: Trials)
Source: Trials - October 18, 2017 Category: Research Source Type: clinical trials

The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial
Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not be... (Source: Trials)
Source: Trials - October 17, 2017 Category: General Medicine Authors: Ben Darlow, James Stanley, Sarah Dean, J. Haxby Abbott, Sue Garrett, Fiona Mathieson and Anthony Dowell Tags: Study protocol Source Type: research

An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent
The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and impr... (Source: Trials)
Source: Trials - October 17, 2017 Category: General Medicine Authors: Sabine Bossert and Daniel Strech Tags: Research Source Type: research

Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial
A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW... (Source: Trials)
Source: Trials - October 17, 2017 Category: General Medicine Authors: Emilie I. Howe, Knut-Petter S. Langlo, Hans Christoffer Aargaard Terjesen, Cecilie R øe, Anne-Kristine Schanke, Helene L. Søberg, Unni Sveen, Eline Aas, Heidi Enehaug, Daniele E. Alves, Pål Klethagen, Kjersti Sagstad, Christine M. Moen, Karin Torsteins Tags: Study protocol Source Type: research

Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial
This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18 –60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcuss...
Source: Trials - October 17, 2017 Category: Research Source Type: clinical trials

An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent
ConclusionsIn most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges. (Source: Trials)
Source: Trials - October 17, 2017 Category: Research Source Type: clinical trials

The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial
DiscussionIn the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care.Trial registrationAustralian New Zealand Clinical Trials Registry,ACTRN12616000888460. Registered on 6 July 2016. (Source: Trials)
Source: Trials - October 17, 2017 Category: Research Source Type: clinical trials

Correction to: Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial
(Source: Trials)
Source: Trials - October 16, 2017 Category: General Medicine Authors: Seung-Yeon Cho, Seung-Bo Yang, Hee Sup Shin, Seung Hwan Lee, Jun Seok Koh, Seungwon Kwon, Woo-Sang Jung, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko and Seong-Uk Park Tags: Correction Source Type: research

Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS): study protocol for a randomized controlled trial
Xingnaojing injection (XNJ) is widely used for the treatment of stroke in China. However, there is currently a lack of high-quality evidence of its efficacy for acute ischemic stroke. ... (Source: Trials)
Source: Trials - October 16, 2017 Category: General Medicine Authors: Xinxing Lai, Kegang Cao, Lingbo Kong, Qiang Liu and Ying Gao Tags: Study protocol Source Type: research

The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial
This study was designed as a prospective, open-label, multicenter, randomized controlled study aimed at evaluating the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs. One hundred fourteen  KTRs registered throughout the year 2017 to 2018 are randomized into either the ICT-based centralized home monitoring system or to ambulatory follow-up. The planned follow-up duration is 6 months. The ICT-based centralized home monitoring system described consists of a smart pill box equipped wit h personal identification s...
Source: Trials - October 16, 2017 Category: Research Source Type: clinical trials

Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS): study protocol for a randomized controlled trial
DiscussionThe results of this trial will provide critical evidence for XNJ in the treatment of AIS as a complementary approach that can be initiated after reperfusion therapy or when the AIS is not eligible for thrombolytic treatment.Trial registrationClinical Trials.gov, ID:NCT02728180. Registered on 28 March 2016. (Source: Trials)
Source: Trials - October 16, 2017 Category: Research Source Type: clinical trials

Correction to: Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial
(Source: Trials)
Source: Trials - October 16, 2017 Category: Research Source Type: clinical trials

Efficacy differences of electroacupuncture with single acupoint or matching acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial
Previous studies have shown that acupuncture is beneficial for the alleviation of chemotherapy-induced nausea and vomiting. However, there is a lack of clinical evidence concerning the effects of acupoint-matc... (Source: Trials)
Source: Trials - October 13, 2017 Category: General Medicine Authors: Bo Chen, Yang Guo, Xue Zhao, Li-li Gao, Bo Li, Tian-yi Zhao, Qi-wen Zhang, Jin-xing Zou, Ming-yue Li, Yong-ming Guo, Yi Guo and Xing-fan Pan Tags: Study protocol Source Type: research

Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial
Requirements for frequent dispensing of antiretroviral therapy (ART) place demands on health systems and can lead to suboptimal adherence and disengagement in care for patients due to the time and cost of freq... (Source: Trials)
Source: Trials - October 13, 2017 Category: General Medicine Authors: Risa Hoffman, Ashley Bardon, Sydney Rosen, Matthew Fox, Thoko Kalua, Thembi Xulu, Angela Taylor and Ian Sanne Tags: Study protocol Source Type: research

Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial
This study will be an unblinded cluster-randomized, matched controlled trial conducted among 8200 stable, HIV-infected individuals age 18  years and older on ART in Malawi and Zambia, to compare three ART dispensing intervals on the outcomes of retention in care (primary outcome), virologic suppression, and cost-effectiveness. Thirty clusters will be matched according to country, facility type, and ART cohort size and randomized to o ne of three study arms: standard of care, 3-month dispensing, and 6-month dispensing. Study participants will be followed, and outcomes will be measured at 12, 24, and 36 months. A s...
Source: Trials - October 13, 2017 Category: Research Source Type: clinical trials

Efficacy differences of electroacupuncture with single acupoint or matching acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial
DiscussionThe results of this trial are expected to explore the effects of matching different acupoints and to offer biologic plausibility for the use of acupuncture in the treatment of chemotherapy-induced nausea and vomiting (CINV).Trial registrationThis trial is registered with clinicaltrials.govNCT02195921, The date of registration was 17 July 2014. (Source: Trials)
Source: Trials - October 13, 2017 Category: Research Source Type: clinical trials

Sedation with propofol during ERCP: is the combination with esketamine more effective and safer than with alfentanil? Study protocol for a randomized controlled trial
Endoscopic retrograde cholangiopancreatography (ERCP) is a gastrointestinal procedure that requires a relatively motionless patient during the intervention. Deep sedation by intravenous propofol combined with ... (Source: Trials)
Source: Trials - October 11, 2017 Category: General Medicine Authors: Susanne Eberl, Lena Koers, Jeanin E. van Hooft, Edwin de Jong, Thomas Schneider, Markus W. Hollmann and Benedikt Preckel Tags: Study protocol Source Type: research

The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial
Chronic subdural hematoma (cSDH) is one of the most common conditions encountered in neurosurgical practice. Recurrence, observed in 5 –30% of patients, is a major clinical problem. The temperature of the irrig... (Source: Trials)
Source: Trials - October 11, 2017 Category: General Medicine Authors: Andreas Bartley, Asgeir S. Jakola, Jiri Bartek Jr, Jimmy Sundblom, Petter F örander, Niklas Marklund and Magnus Tisell Tags: Study protocol Source Type: research

CXCR2 Inhibition – a novel approach to treating CoronAry heart DiseAse (CICADA): study protocol for a randomised controlled trial
There is emerging evidence of the central role of neutrophils in both atherosclerotic plaque formation and rupture. Patients with lower neutrophil counts following acute coronary syndromes tend to have a great... (Source: Trials)
Source: Trials - October 11, 2017 Category: General Medicine Authors: Jubin P. Joseph, Eliana Reyes, Josephine Guzman, Jim O ’Doherty, Hannah McConkey, Satpal Arri, Rahul Kakkar, Nicholas Beckley, Abdel Douiri, Sally F. Barrington, Simon R. Redwood and Albert Ferro Tags: Study protocol Source Type: research

The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates  of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial
There is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case ... (Source: Trials)
Source: Trials - October 11, 2017 Category: General Medicine Authors: Victoria Hardy, Yvonne O ’Connor, Ciara Heavin, Nikolaos Mastellos, Tammy Tran, John O’Donoghue, Annette L. Fitzpatrick, Nicole Ide, Tsung-Shu Joseph Wu, Griphin Baxter Chirambo, Adamson S. Muula, Moffat Nyirenda, Sven Carlsson, Bo Andersson and Matth Tags: Study protocol Source Type: research

Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
Pragmatic clinical trials embedded in routine delivery of clinical care can lead to improvements in quality of care, but often have design features that raise ethical concerns. (Source: Trials)
Source: Trials - October 11, 2017 Category: General Medicine Authors: Katherine R. Courtright, Scott D. Halpern, Steven Joffe, Susan S. Ellenberg, Jason Karlawish, Vanessa Madden, Nicole B. Gabler, Stephanie Szymanski, Kuldeep N. Yadav and Laura M. Dember Tags: Research Source Type: research

Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
AbstractBackgroundPragmatic clinical trials embedded in routine delivery of clinical care can lead to improvements in quality of care, but often have design features that raise ethical concerns.MethodsWe performed a discrete choice experiment and used conjoint analysis to assess how specific attributes of pragmatic dialysis trials influenced patients ’ and physicians’ willingness to have their dialysis facility participate in a hypothetical trial of hypertension management. Electronic survey data were collected from 200 patients enrolled from 11 outpatient hemodialysis units and from 203 nephrologists. The thre...
Source: Trials - October 11, 2017 Category: Research Source Type: clinical trials

The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates  of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial
DiscussionThis is the first large-scale trial evaluating the value of adding a mobile application of CCM to the assessment of children aged under 5  years. The trial will generate evidence on the potential use of mobile health for CCM in Malawi, and more widely in other low- and middle-income countries.Trial registrationClinicalTrials.gov, ID:NCT02763345. Registered on 3 May 2016. (Source: Trials)
Source: Trials - October 11, 2017 Category: Research Source Type: clinical trials

CXCR2 Inhibition – a novel approach to treating CoronAry heart DiseAse (CICADA): study protocol for a randomised controlled trial
DiscussionCardiovascular surrogate parameters, such as coronary flow reserve, may provide insights into the potential mechanisms of the cardiovascular effects of CXCR2 inhibitors. Currently, ongoing trials do not specifically focus on neutrophil function as a target of intervention, and we therefore believe that our study will contribute to a better understanding of the role of neutrophil-mediated inflammation in coronary artery disease.Trial registrationEudraCT,2016-000775-24. Registered on 22 July 2016.International Standard Randomised Controlled Trial Number,ISRCTN48328178. Registered on 25 February 2016. (Source: Trials)
Source: Trials - October 11, 2017 Category: Research Source Type: clinical trials

The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial
We present a study protocol for a multicenter randomized controlled trial investigating our hypothesis that irrigation fluid at body temperature is superior to room temperature in reducing recurrence rates following evacuation of cSDH.Trials registrationClinicalTrials.gov, ID:NCT02757235. Registered on 2 May 2016. (Source: Trials)
Source: Trials - October 11, 2017 Category: Research Source Type: clinical trials

Sedation with propofol during ERCP: is the combination with esketamine more effective and safer than with alfentanil? Study protocol for a randomized controlled trial
DiscussionEsketamine is known for its effective anesthetic and analgesic effects maintaining spontaneous breathing and airway reflexes. Due to an increase in sympathetic tone, hypotension and cardiac depression is less common. Unfortunately esketamine is also known for its psychotomimetic effects. We aim to demonstrate that the combination of esketamine with propofol for sedation in patients subjected to ERCP interventions is nevertheless superior to a combination of propofol with an opioid.Trial registrationNederland ’s Trial Register,NTR5486. Registered on 17 September 2015. (Source: Trials)
Source: Trials - October 11, 2017 Category: Research Source Type: clinical trials

The LeucoPatch ® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomised controlled trial
Diabetic foot ulcers are a common and severe complication of diabetes mellitus. Standard treatment includes debridement, offloading, management of infection and revascularisation where appropriate, although he... (Source: Trials)
Source: Trials - October 10, 2017 Category: General Medicine Authors: Frances Game, William Jeffcoate, Lise Tarnow, Florence Day, Deborah Fitzsimmons and Judith Jacobsen Tags: Study protocol Source Type: research

Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial
Chronic heart failure (CHF), the final stage of various cardiovascular diseases, is a major public health problem resulting in significant hospitalization rates, mortality, and huge health care costs despite a... (Source: Trials)
Source: Trials - October 10, 2017 Category: General Medicine Authors: Jinping Wang, Jun Shi, Jiawei Wei, Juan Wang, Kuo Gao, Xueli Li, Jianxin Chen, Shaojing Li, Huihui Zhao and Wei Wang Tags: Study protocol Source Type: research

A series of N-of-1 trials to assess the therapeutic interchangeability of two enalapril formulations in the treatment of hypertension in Addis Ababa, Ethiopia: study protocol for a randomized controlled trial
DiscussionThe number of locally produced products, such as enalapril, being approved without proof of bioequivalence is dramatically increasing. By bridging the information gap on bioequivalence, the trial will give rigorous evidence on therapeutic equivalence of locally produced enalapril in the treatment of hypertension. If there is no difference, the hypothesized result, then patients can take the local medicine with confidence. This trial will also will determine whether aggregated N-of-1 studies are feasible to evaluate untested generic drugs in resource-limited countries where bioequivalence testing centers are unava...
Source: Trials - October 10, 2017 Category: Research Source Type: clinical trials

COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial
DiscussionInformation about whether collaboration between orthodox and complementary health providers is feasible and can lead to improved outcome for patients is important to formulating policies designed to formally engage the services of traditional and faith healers within the public health system.Trial registrationNational Institutes of Health Clinical Trial registry, ID:NCT02895269. Registered on 30 July 2016 (Source: Trials)
Source: Trials - October 10, 2017 Category: Research Source Type: clinical trials

Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial
DiscussionResults of this pragmatic cRCT of FICare in Alberta Level  II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare.Trial registrationClinicalTrials.gov, ID:NCT02879799. Registered on 27 May 2016. Protocol version: 9 June 2016; version 2. (Source: Trials)
Source: Trials - October 10, 2017 Category: Research Source Type: clinical trials

Development of an infant feeding core outcome set for childhood obesity interventions: study protocol
This study aims to develop a core outcome set of infant feeding outcomes for randomised infant feeding studies to prevent childhood obesity. This research will improve examination and syntheses of the outcomes of such studies to prevent and reduce childhood obesity. (Source: Trials)
Source: Trials - October 10, 2017 Category: Research Source Type: clinical trials

Mechanical wrist traction as a non-invasive treatment for carpal tunnel syndrome: a randomized controlled trial
AbstractBackgroundCarpal tunnel syndrome (CTS) is a common, compressive nerve-entrapment disorder with symptoms of numbness, paresthesia, and pain. Carpal tunnel release surgery is the only known long-term effective treatment. However, surgery is invasive and up to 30% of patients report recurrence or persistence of symptoms or suffer from post-surgical complications. A promising non-surgical treatment for CTS is mechanical wrist traction. The purpose of this study was to evaluate clinical outcomes following mechanical traction in patients with CTS compared to care as usual.MethodsAdult patients (N = 181, mea...
Source: Trials - October 10, 2017 Category: Research Source Type: clinical trials

Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial
This study is designed as a randomized, placebo-controlled, multi-center, double-blind clinical trial with parallel groups. A total of 200 patients with CHF will be recruited and randomly allocated to either the QSG treatment group or the placebo group (in a 1:1 ratio). The patients will receive QSG or placebo granules twice a day for 12  weeks. The primary outcome is the proportion of patients in the QSG group, compared with the placebo group, demonstrating a more than 30% decrease in NT-proBNP level during 12 weeks of treatment. The secondary outcomes consist of composite cardiac events, New York Heart Associat...
Source: Trials - October 10, 2017 Category: Research Source Type: clinical trials

The LeucoPatch ® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomised controlled trial
DiscussionUlcers of the foot are a major source of morbidity to patients with diabetes and costs to health care economies. The study population is designed to be as inclusive as possible with the aim of maximising the external validity of any findings. The primary outcome measure is healing within 20  weeks of randomisation and the trial also includes a number of secondary outcome measures. Among these are rate of change in ulcer area as a predictor of the likelihood of eventual healing, minor and major amputation of the target limb, the incidence of infection and quality of life.Trial registrationInternational Standa...
Source: Trials - October 10, 2017 Category: Research Source Type: clinical trials

Current practice in methodology and reporting of the sample size calculation in randomised trials of hip and knee osteoarthritis: a protocol for a systematic review
DiscussionThe findings of this systematic review will summarise the current practice for sample size calculation in trials of hip and knee osteoarthritis. It will also provide evidence on the completeness of the reporting of the sample size calculation, reproducibility of the chosen sample size and the basis for the values used in the calculation.Trial registrationAs this review was not eligible to be registered on PROSPERO, the summary information was uploaded to Figshare to make it publicly accessible in order to avoid unnecessary duplication amongst other benefits (https://doi.org/10.6084/m9.figshare.5009027.v1); Regist...
Source: Trials - October 10, 2017 Category: Research Source Type: clinical trials

PANSAID —PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
DiscussionPANSAID will provide a large trial with low risk of bias regarding benefits and harms of the combination of paracetamol and ibuprofen used in a perioperative setting.Trial registrationClinicalTrials.org identifier:NCT02571361. Registered on 7 October 2015. (Source: Trials)
Source: Trials - October 10, 2017 Category: Research Source Type: clinical trials

PANSAID —PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
Effective postoperative pain management is essential for the rehabilitation of the surgical patient. The PANSAID trial evaluates the analgesic effects and safety of the combination of paracetamol and ibuprofen... (Source: Trials)
Source: Trials - October 10, 2017 Category: General Medicine Authors: Kasper H øjgaard Thybo, Janus Christian Jakobsen, Daniel Hägi-Pedersen, Niels Anker Pedersen, Jørgen Berg Dahl, Henrik Morville Schrøder, Hans Henrik Bülow, Jan Gottfrid Bjørck, Søren Overgaard, Ole Mathiesen and Jørn Wetterslev Tags: Update Source Type: research

Current practice in methodology and reporting of the sample size calculation in randomised trials of hip and knee osteoarthritis: a protocol for a systematic review
A key aspect of the design of randomised controlled trials (RCTs) is determining the sample size. It is important that the trial sample size is appropriately calculated. The required sample size will differ by... (Source: Trials)
Source: Trials - October 10, 2017 Category: General Medicine Authors: Bethan Copsey, Susan Dutton, Ray Fitzpatrick, Sarah E. Lamb and Jonathan A. Cook Tags: Study protocol Source Type: research

Mechanical wrist traction as a non-invasive treatment for carpal tunnel syndrome: a randomized controlled trial
Carpal tunnel syndrome (CTS) is a common, compressive nerve-entrapment disorder with symptoms of numbness, paresthesia, and pain. Carpal tunnel release surgery is the only known long-term effective treatment. ... (Source: Trials)
Source: Trials - October 10, 2017 Category: General Medicine Authors: Margreet Meems, Viola Spek, Willem J. Kop, Berend-Jan Meems, Leo H. Visser and Victor J. M. Pop Tags: Research Source Type: research

Development of an infant feeding core outcome set for childhood obesity interventions: study protocol
Childhood obesity is a significant public health challenge that affects approximately one in five children worldwide. Infant feeding practices are implicated in the aetiology of childhood obesity. Infant feedi... (Source: Trials)
Source: Trials - October 10, 2017 Category: General Medicine Authors: Karen Matvienko-Sikar, Molly Byrne, Colette Kelly, Elaine Toomey, Marita Hennessy, Declan Devane, Caroline Heary, Janas Harrington, Niamh McGrath, Michelle Queally and Patricia M. Kearney Tags: Study protocol Source Type: research

COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial
Psychotic disorders are a group of severe mental disorders that cause considerable disability to sufferers and a high level of burden to families. In many low- and middle-income countries (LMIC), traditional a... (Source: Trials)
Source: Trials - October 10, 2017 Category: General Medicine Authors: Oye Gureje, Victor Makanjuola, Lola Kola, Bidemi Yusuf, Leshawndra Price, Oluyomi Esan, Bibilola D. Oladeji, John Appiah-Poku, Benjamin Haris, Caleb Othieno and Soraya Seedat Tags: Study protocol Source Type: research

Effectiveness of the ‘Who’s Challenging Who’ support staff training intervention to improve attitudes and empathy towards adults with intellectual disability and challenging behaviours: study protocol for a cluster randomised controlled trial
Findings suggest approximately one in six people with intellectual disability engage in ‘challenging behaviours’, which include aggression towards others/property and self-injurious actions. In residential set... (Source: Trials)
Source: Trials - October 5, 2017 Category: General Medicine Authors: Elizabeth Randell, Richard P. Hastings, Rachel McNamara, Roseanna Knight, David Gillespie and Zachary Taylor Tags: Study protocol Source Type: research

Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial
Contrast-induced acute kidney injury (CI-AKI) is one of the most common causes of iatrogenic kidney injury and, therefore, its prevention is an important issue. However, whether the administration of 0.9% sali... (Source: Trials)
Source: Trials - October 5, 2017 Category: General Medicine Authors: Hyung Ah Jo, Sehoon Park, Chan-Duck Kim, Hee-Yeon Jung, Jang-Hee Cho, Ran-hui Cha, Ea Wha Kang, Tae Ik Chang, Sejoong Kim, Hyung-Jong Kim, Byung Ha Chung, Jung Pyo Lee, Jung Tak Park, Seung Hyeok Han, Tae-Hyun Yoo, Dong-Ryeol Ryu & hellip; Tags: Study protocol Source Type: research

Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial
This study will recruit patients who are scheduled for contrast-enhanced computed tomography (CT) scans with CI-AKI prophylaxis. In this study, participants will be randomized into two study arms; the study group will receive a balanced salt solution, and the control group will receive 0.9% saline. Fluids will be administered as designated in the protocol before and after the CT scan, and an evaluation of baseline clinical status will be performed by obtaining blood and urine samples. During the follow-up visits, the incidence of CI-AKI and long-term outcomes, including the start of renal replacement therapy or all-cause m...
Source: Trials - October 5, 2017 Category: Research Source Type: clinical trials

Effectiveness of the ‘Who’s Challenging Who’ support staff training intervention to improve attitudes and empathy towards adults with intellectual disability and challenging behaviours: study protocol for a cluster randomised controlled trial
DiscussionIf the results of the cluster randomised trial are positive, we will disseminate the findings widely and make all training manuals and materials freely available for anyone in intellectual disability services (and beyond) to use. Our training approach may have wider implications in other areas of social care. It may also provide a generally applicable model for how to train people with intellectual disability to act as co-trainers in intellectual disability social care settings. People with intellectual disability and challenging behaviour have already been involved centrally with the design, development and pilo...
Source: Trials - October 5, 2017 Category: Research Source Type: clinical trials