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Self-expanding nitinol stents of high versus low chronic outward force in de novo femoropopliteal occlusive arterial lesions (BIOFLEX-COF trial): study protocol for a randomized controlled trial
The objective of the BIOFLEX-COF trial is to prospectively investigate differences in formation of intimal hyperplasia at 1 and 2 years after implantation of nitinol stents with high versus low COF in de novo femoropopliteal occlusive arterial lesions.MethodsThe BIOFLEX-COF trial is a prospective, quantitative, randomized study. Eighty subjects with symptomatic peripheral arterial lesions eligible for endovascular stent implantation will be enrolled and randomly assigned to either a high COF group (LifeStent Flexstar, Bard Peripheral Vascular Inc., Tempe, AZ, USA) or low COF group (Pulsar, Biotronik AG, B ülach, Switz...
Source: Trials - December 14, 2017 Category: Research Source Type: clinical trials

Adolescent Coordinated Transition (ACT) to improve health outcomes among young people living with HIV in Nigeria: study protocol for a randomized controlled trial
This study will be conducted at 12 secondary and tertiary healthcare facilities (six intervention, six control) across all six of Nigeria ’s geopolitical zones. The study population is 13- to 17-year-old ALHIV (N = 216,n = 108 per study arm) on antiretroviral therapy. Study participants will be followed through a 12-month pre-transfer/transition period and for an additional 24 months post transfer/transition. The primary outcome measure is the proportion of ALHIV retained in care at 12 and 24 months post tran sfer. Secondary outcome measures are proportions of ALHIV achieving vir...
Source: Trials - December 14, 2017 Category: Research Source Type: clinical trials

Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial
DiscussionPOAF is associated with increased morbidity, prolonged hospital stay, and increased costs after cardiac surgery. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, all with suboptimal results. Posterior left pericardiotomy has been associated with a reduction of POAF in previous series. However, these studies had limited sample sizes and suboptimal methodology, so that the efficacy of posterior pericardiotomy in preventing POAF remains to be definitively proven. Our randomized trial aims to determine the effect of a posterior left p...
Source: Trials - December 13, 2017 Category: Research Source Type: clinical trials

An evidence-based gamified mHealth intervention for overweight young adults with maladaptive eating habits: study protocol for a randomized controlled trial
Cognitive behavior therapy (CBT) is the first-line of treatment for overweight and obesity patients whose problems originate in maladaptive eating habits (e.g., emotional eating). However, in-person CBT is cur... (Source: Trials)
Source: Trials - December 12, 2017 Category: General Medicine Authors: Ioana R. Podina, Liviu A. Fodor, Ana Cosmoiu and Rare ș Boian Tags: Study protocol Source Type: research

An evidence-based gamified mHealth intervention for overweight young adults with maladaptive eating habits: study protocol for a randomized controlled trial
DiscussionThrough an evidence-based cognitive behavioral approach and a user-friendly game interface, the SIGMA intervention offers a significant contribution to the development of a cost-effective and preventive self-help tool for young overweight adults with maladaptive eating habits.Trial registrationISRCTN, ID:70907354. Registered on 6 February 2017. The ISRCTN registration is in line with the World Health Organization Trial Registration Data Set. The present paper represents the original version of the protocol. Any changes to the protocol will be communicated to ISRCTN. (Source: Trials)
Source: Trials - December 12, 2017 Category: Research Source Type: clinical trials

A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials
The DAMOCLES project established a widely used Data Monitoring Committee (DMC) Charter for randomised controlled trials (RCTs). Typically, within the UK, the DMC is advisory and recommends to another executive... (Source: Trials)
Source: Trials - December 8, 2017 Category: General Medicine Authors: Elizabeth J. Conroy, Barbara Arch, Nicola L. Harman, J. Athene Lane, Steff C. Lewis, John Norrie, Matthew R. Sydes and Carrol Gamble Tags: Research Source Type: research

Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial
Uncontrolled active rheumatoid arthritis can lead to increasing disability and reduced quality of life over time. ‘Treating to target’ has been shown to be effective in active established disease and also in e... (Source: Trials)
Source: Trials - December 8, 2017 Category: General Medicine Authors: Naomi H. Martin, Fowzia Ibrahim, Brian Tom, James Galloway, Allan Wailoo, Jonathan Tosh, Heidi Lempp, Louise Prothero, Sofia Georgopoulou, Jackie Sturt and David L. Scott Tags: Study protocol Source Type: research

Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial
DiscussionThe trial will establish whether the known benefits of intensive treatment strategies in active rheumatoid arthritis are also seen in patients with established rheumatoid arthritis who have moderately active disease. It will evaluate both the clinical and cost-effectiveness of intensive treatment.Trial registrationCurrent Controlled Trials, ID:ISRCTN70160382. Registered on 16 January 2014. (Source: Trials)
Source: Trials - December 8, 2017 Category: Research Source Type: clinical trials

A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials
ConclusionsWe present the first review of reporting TSC activity in the published academic literature. An absence of reporting standards with regards to TSC constitution, activity and impact on trial conduct was identified which can influence transparency of reporting trial oversight. Consistent reporting is vital for the benefits and impact of the TSC role to be understood to support adoption of this oversight structure and reduce global variations in practice. (Source: Trials)
Source: Trials - December 8, 2017 Category: Research Source Type: clinical trials

Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial
The incidence of proximal humeral fractures increases with age. The functional recovery of the upper arm after such fractures is slow, and results are often disappointing. Treatment is associated with long imm... (Source: Trials)
Source: Trials - December 6, 2017 Category: General Medicine Authors: Corinna Nerz, Lars Schwickert, Clemens Becker, Stefan Studier-Fischer, Janina Anna M üßig and Peter Augat Tags: Study protocol Source Type: research

Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial
This study protocol describes a phase II, randomised, controlled, single-blind, multicentre intervention study. The results will guide and possibly improve methods of rehabilitation after proximal humeral fracture.Trial registrationClinicaltrials.gov,NCT03100201. Registered on 28 March 2017. (Source: Trials)
Source: Trials - December 6, 2017 Category: Research Source Type: clinical trials

Applying quantitative bias analysis to estimate the plausible effects of selection bias in a cluster randomised controlled trial: secondary analysis of the Primary care Osteoarthritis Screening Trial (POST)
Selection bias is a concern when designing cluster randomised controlled trials (c-RCT). Despite addressing potential issues at the design stage, bias cannot always be eradicated from a trial design. The appli... (Source: Trials)
Source: Trials - December 4, 2017 Category: General Medicine Authors: L. A. Barnett, M. Lewis, C. D. Mallen and G. Peat Tags: Research Source Type: research

Nutrition education for cardiovascular disease prevention in individuals with spinal cord injuries: study protocol for a randomized controlled trial
Individuals with chronic spinal cord injuries (SCIs) have an increased prevalence of cardiovascular disease (CVD) and associated risk factors compared with age-matched control subjects. Exercise has been shown... (Source: Trials)
Source: Trials - December 4, 2017 Category: General Medicine Authors: Jesse A. Lieberman, Jacquelyn W. McClelland, David C. Goff Jr., Elizabeth Racine, Michael F. Dulin, William A. Bauman, Janet Niemeier, Mark A. Hirsch, H. James Norton and Charity G. Moore Tags: Study protocol Source Type: research

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial
Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, fe... (Source: Trials)
Source: Trials - December 4, 2017 Category: General Medicine Authors: Mary Acri, Emily Hamovitch, Maria Mini, Elene Garay, Claire Connolly and Mary McKay Tags: Study protocol Source Type: research

A novel Family Dignity Intervention (FDI) for enhancing and informing holistic palliative care in Asia: study protocol for a randomized controlled trial
The lack of a holistic approach to palliative care can lead to a fractured sense of dignity at the end of life, resulting in depression, hopelessness, feelings of being a burden to others, and the loss of the ... (Source: Trials)
Source: Trials - December 4, 2017 Category: General Medicine Authors: Andy Hau Yan Ho, Josip Car, Moon-Ho Ringo Ho, Geraldine Tan-Ho, Ping Ying Choo, Paul Victor Patinadan, Poh Heng Chong, Wah Ying Ong, Gilbert Fan, Yee Pin Tan, Robert A. Neimeyer and Harvey M. Chochinov Tags: Study protocol Source Type: research

PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial
Health and social care provision for an ageing population is a global priority. Provision for those with dementia and hip fracture has specific and growing importance. Older people who break their hip are reco... (Source: Trials)
Source: Trials - December 4, 2017 Category: General Medicine Authors: Simon P. Hammond, Jane L. Cross, Lee Shepstone, Tamara Backhouse, Catherine Henderson, Fiona Poland, Erika Sims, Alasdair MacLullich, Bridget Penhale, Robert Howard, Nigel Lambert, Anna Varley, Toby O. Smith, Opinder Sahota, Simon Donell, Martyn Patel & h Tags: Study protocol Source Type: research

Coping with Unusual ExperienceS for 12 –18 year olds (CUES+): a transdiagnostic randomised controlled trial of the effectiveness of cognitive therapy in reducing distress associated with unusual experiences in adolescent mental health services: study protocol for a randomised controlled trial
DiscussionThe CUES+ study will contribute to the currently limited child-specific evidence base for psychological interventions for UEDs occurring in the context of psychosis or any other mental health presentation.Trial registrationInternational Standard Randomised Controlled Trials, ID:ISRCTN21802136. Prospectively registered on 12 January 2015. Protocol V3 31 August 2015 with screening amended. (Source: Trials)
Source: Trials - December 4, 2017 Category: Research Source Type: clinical trials

PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial
DiscussionThe trial will provide a preliminary estimate of potential efficacy of PERFECT-ER versus standard care; assess service delivery variation, inform primary and secondary outcome selection, generate estimates of recruitment and retention rates, data collection difficulties, and completeness of outcome data and provide an indication of potential economic benefits. The process evaluation will enhance knowledge of implementation delivery and receipt.Trial registrationISRCTN,99336264. Registered on 5 September 2016. (Source: Trials)
Source: Trials - December 4, 2017 Category: Research Source Type: clinical trials

A novel Family Dignity Intervention (FDI) for enhancing and informing holistic palliative care in Asia: study protocol for a randomized controlled trial
DiscussionTo date, there is no available palliative care intervention for dignity enhancement in Asia. This first-of-its-kind study develops and tests an evidence-based, family driven, psycho-socio-spiritual intervention for enhancing dignity and wellbeing among Asian patients and families facing mortality. It addresses a critical gap in the provision of holistic palliative care. The expected outcomes will contribute to advancements in both theories and practices of palliative care for Singapore and its neighboring regions while serving to inform similar developments in other Asian communities.Trial registrationClinicalTri...
Source: Trials - December 4, 2017 Category: Research Source Type: clinical trials

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial
This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a ...
Source: Trials - December 4, 2017 Category: Research Source Type: clinical trials

Nutrition education for cardiovascular disease prevention in individuals with spinal cord injuries: study protocol for a randomized controlled trial
DiscussionTo our knowledge, this will be the first reported study of nutrition education in individuals with SCI. The low cost and feasibility of the intervention, if shown to improve nutritional behavior, suggests that it could be implemented in rehabilitation facilities across the country. This has the potential of lowering the burden of CVD and CVD risk factors in this high-risk population.Trial registrationClinicalTrials.gov,NCT02368405. Registered on February 10, 2015. (Source: Trials)
Source: Trials - December 4, 2017 Category: Research Source Type: clinical trials

Applying quantitative bias analysis to estimate the plausible effects of selection bias in a cluster randomised controlled trial: secondary analysis of the Primary care Osteoarthritis Screening Trial (POST)
ConclusionsThe use of probabilistic bias analysis in this c-RCT suggested that worse outcomes observed in the intervention arm could plausibly be attributed to selection bias. A very large degree of selection of bias was needed to mask a beneficial effect of intervention making this interpretation less plausible. (Source: Trials)
Source: Trials - December 4, 2017 Category: Research Source Type: clinical trials

Timing of oral anticoagulant therapy in acute ischemic stroke with atrial fibrillation: study protocol for a registry-based randomised controlled trial
Oral anticoagulation therapy is recommended for the prevention of recurrent ischemic stroke in patients with atrial fibrillation (AF). Current guidelines do not provide evidence-based recommendations on optima... (Source: Trials)
Source: Trials - December 2, 2017 Category: General Medicine Authors: Signild Åsberg, Ziad Hijazi, Bo Norrving, Andreas Terént, Patrik Öhagen and Jonas Oldgren Tags: Study protocol Source Type: research

Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial
Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) d... (Source: Trials)
Source: Trials - December 2, 2017 Category: General Medicine Authors: Lee S. Nguyen, Messaouda Merzoug, Philippe Estagnasie, Alain Brusset, Jean-Dominique Law Koune, Stephane Aubert, Thierry Waldmann, Jean-Michel Grinda, Hadrien Gibert and Pierre Squara Tags: Study protocol Source Type: research

Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial
Common mental disorders are important contributors to the global burden of disease and cause negative effects on both the individual and society. Stress-related disorders influence the individual ’s workability... (Source: Trials)
Source: Trials - December 2, 2017 Category: General Medicine Authors: Rie Poulsen, Jonas Fisker, Andreas Hoff, Carsten Hjorth øj and Lene Falgaard Eplov Tags: Study protocol Source Type: research

Does motivation matter in upper-limb rehabilitation after stroke? ArmeoSenso-Reward: study protocol for a randomized controlled trial
Fifty percent of all stroke survivors remain with functional impairments of their upper limb. While there is a need to improve the effectiveness of rehabilitative training, so far no new training approach has ... (Source: Trials)
Source: Trials - December 2, 2017 Category: General Medicine Authors: Mario Widmer, Jeremia P. Held, Frieder Wittmann, Olivier Lambercy, Kai Lutz and Andreas R. Luft Tags: Study protocol Source Type: research

Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial
Depression and anxiety are among the largest contributors to the global burden of disease and have negative effects on both the individual and society. Depression and anxiety are very likely to influence the i... (Source: Trials)
Source: Trials - December 2, 2017 Category: General Medicine Authors: Rie Poulsen, Andreas Hoff, Jonas Fisker, Carsten Hjorth øj and Lene Falgaard Eplov Tags: Study protocol Source Type: research

Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial
This study will provide new knowledge on vocational recovery, integrated vocational and health care interventions, and prevention of recurrent sickness absence among people with depression and anxiety. If the effect on return to work is different in the intervention groups, this study can contribute to current knowledge on shared care models for health care and vocational rehabilitation services.Trial registrationClinicalTrials.gov,NCT02872051. Retrospectively registered on 15 August 2016. (Source: Trials)
Source: Trials - December 2, 2017 Category: Research Source Type: clinical trials

Does motivation matter in upper-limb rehabilitation after stroke? ArmeoSenso-Reward: study protocol for a randomized controlled trial
AbstractBackgroundFifty percent of all stroke survivors remain with functional impairments of their upper limb. While there is a need to improve the effectiveness of rehabilitative training, so far no new training approach has proven to be clearly superior to conventional therapy. As training with rewarding feedback has been shown to improve motor learning in humans, it is hypothesized that rehabilitative arm training could be enhanced by rewarding feedback. In this paper, we propose a trial protocol investigating rewards in the form of performance feedback and monetary gains as ways to improve effectiveness of rehabilitat...
Source: Trials - December 2, 2017 Category: Research Source Type: clinical trials

Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial
This study will contribute with knowledge on the consequence of the current organizational separation of health care interventions and vocational rehabilitation regarding the individual ’s process of returning to work after sick leave because of exhaustion disorder, adjustment disorder or distress. If the effect on return to work, symptom level, and recurrent sick leave is different in the intervention groups, this study can contribute with new knowledge on shared care models and the potential for preventing deterioration in stress symptoms, prolonged sick leave, and recurrent sick leave.Trial registrationClinicalTri...
Source: Trials - December 2, 2017 Category: Research Source Type: clinical trials

Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial
AbstractBackgroundPostoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) during surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain low tidal volume (LTV) ventilation. Indirect evidence points towards better pulmonary outcomes when LTV is performed but no large-scale prospective trial has yet been published in cardiac surgery.DesignThe MECANO trial is a single-center, double-blind, randomized, controlled trial comparing two mecha...
Source: Trials - December 2, 2017 Category: Research Source Type: clinical trials

Timing of oral anticoagulant therapy in acute ischemic stroke with atrial fibrillation: study protocol for a registry-based randomised controlled trial
ConclusionThe TIMING study addresses the ongoing clinical dilemma of when to start NOAC after an acute ischemic stroke in patients with AF. By the inclusion of a randomisation module within the Swedish Stroke Register, the advantages of a prospective randomised study design are combined with the strengths of a national clinical quality register in allowing simplified enrolment and follow-up of study patients. In addition, the register adds the possibility of directly assessing the external validity of the study findings.Trial registrationClinicalTrials.gov,NCT02961348. Registered on 8 November 2016. (Source: Trials)
Source: Trials - December 2, 2017 Category: Research Source Type: clinical trials

Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial
Loss to follow-up (LTFU) in clinical trials is an important source of bias that can affect statistical power and generalisability of findings. The aim of this paper is to assess factors associated with LTFU in... (Source: Trials)
Source: Trials - December 1, 2017 Category: General Medicine Authors: Chris Smith, Christopher Jarvis and Caroline Free Tags: Commentary Source Type: research

Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial
Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and volu... (Source: Trials)
Source: Trials - December 1, 2017 Category: General Medicine Authors: Katherine A. Pohlman, Linda Carroll, Ross T. Tsuyuki, Lisa Hartling and Sunita Vohra Tags: Study protocol Source Type: research

COSUMO: study protocol for the development of a core outcome set for efficacy and effectiveness trials in posterior segment-involving uveitis
Uveitis, a group of disorders characterised by intraocular inflammation, causes 10 –15% of total blindness in the developed world. The most sight-threatening uveitis affects the posterior segment of the eye (po... (Source: Trials)
Source: Trials - December 1, 2017 Category: General Medicine Authors: Mohammad O. Tallouzi, Jonathan M. Mathers, David J. Moore, Philip I. Murray, Nicholas Bucknall, Jane M. Blazeby, Melanie Calvert and Alastair K. Denniston Tags: Study protocol Source Type: research

COSUMO: study protocol for the development of a core outcome set for efficacy and effectiveness trials in posterior segment-involving uveitis
DiscussionThe development of an agreed COS for PSIU would help ensure that outcomes which matter to key stakeholders are captured and reported in a consistent way. A COS for PSIU would allow greater comparison and aggregation of data across trials for the better evaluation of established and emerging therapies through evidence synthesis and meta-analysis to inform clinical guidelines and health policy.Trial registrationCOMET.http://comet-initiative.org/studies/details/640. August 2015. (Source: Trials)
Source: Trials - December 1, 2017 Category: Research Source Type: clinical trials

Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial
This study will be the first direct comparison of adverse event reporting using passive versus active surveillance. It is also the largest prospective evaluation of adverse events reported after chiropractic manual therapy in children, identified as a major gap in the academic literature.Trial registrationClinicalTrials.gov, ID:NCT02268331. Registered on 10 October 2014. (Source: Trials)
Source: Trials - December 1, 2017 Category: Research Source Type: clinical trials

Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial
ConclusionFuture studies assessing contraception use might anticipate increased attrition amongst younger participants, those of lower socio-economic status or those who do not provide additional contact details. Attrition could be reduced by collecting as many contact details as possible, by providing incentives and possibly by enhanced counselling to groups at higher risk of LTFU on recruitment. Multiple imputation should be considered in addition to complete case analysis if LTFU not missing at random is expected or observed.Trial registrationClinicalTrials.gov,NCT01823861. Registered on 30 March 2013. (Source: Trials)
Source: Trials - December 1, 2017 Category: Research Source Type: clinical trials

Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial
Delirium is a highly prevalent and morbid syndrome in intensive care units (ICUs). Changing the stressful environment within the ICU via music may be an effective and a scalable way to reduce the burden of del... (Source: Trials)
Source: Trials - November 29, 2017 Category: General Medicine Authors: Sikandar H. Khan, Sophia Wang, Amanda Harrawood, Stephanie Martinez, Annie Heiderscheit, Linda Chlan, Anthony J. Perkins, Wanzhu Tu, Malaz Boustani and Babar Khan Tags: Study protocol Source Type: research

Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke
Cooling may reduce infarct size and improve neurological outcomes in patients with ischaemic stroke. In phase II trials, cooling awake patients with ischaemic stroke has been shown to be feasible and safe, but... (Source: Trials)
Source: Trials - November 29, 2017 Category: General Medicine Authors: Per Winkel, Philip M. Bath, Christian Gluud, Jane Lindschou, H. Bart van der Worp, Malcolm R. Macleod, Istvan Szabo, Isabelle Durand-Zaleski and Stefan Schwab Tags: Update Source Type: research

Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke
DiscussionMajor adjustments compared with the original statistical analysis plan encompass: (1) adjustment of analyses by nationality; (2) power calculations for the secondary outcomes; (3) to address the multiplicity problem using of a fixed-sequence testing procedure starting with the primary outcome followed by the secondary outcomes ordered according to falling power; (4) assignment of worst possible score to patients who are not alive at the planned date of measurement of the continuous scores; (5) improved imputations; (6) outline of a supplementary exploratory analysis of the temperature measurements and time to dea...
Source: Trials - November 29, 2017 Category: Research Source Type: clinical trials

Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial
DiscussionDDM is a feasibility trial to provide personalized and non-personalized music interventions for critically ill, mechanically ventilated patients. Our trial will also estimate the preliminary efficacy of music interventions on reducing delirium incidence and severity.Trial registrationClinicalTrials.gov, Identifier:NCT03095443. Registered on 23 March 2017. (Source: Trials)
Source: Trials - November 29, 2017 Category: Research Source Type: clinical trials

Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial
Postoperative pulmonary complications (PPCs) are major causes of morbidity, mortality, and prolonged hospital stay in patients after surgery. Using effective strategies to prevent its occurrence is essential t... (Source: Trials)
Source: Trials - November 28, 2017 Category: General Medicine Authors: Ting Yan, Xin-Quan Liang, Tong Wang, Wei-Ou Li, Hui-Juan Li, Sai-Nan Zhu and Dong-Xin Wang Tags: Study protocol Source Type: research

The effect of an intensive smoking cessation intervention on disease activity in patients with rheumatoid arthritis: study protocol for a randomised controlled trial
Rheumatoid arthritis (RA) is a chronic, inflammatory rheumatic disease with the potential to induce significant disability. Patients with RA are at increased risk of cardiovascular diseases (CVD). Smokers with... (Source: Trials)
Source: Trials - November 28, 2017 Category: General Medicine Authors: Ida Kristiane Roelsgaard, Thordis Thomsen, Mikkel Østergaard, Robin Christensen, Merete Lund Hetland, Søren Jacobsen, Lena Andersen, Hanne Tønnesen, Silvia Rollefstad, Anne Grete Semb and Bente Appel Esbensen Tags: Study protocol Source Type: research

Core Health Outcomes In Childhood Epilepsy (CHOICE): protocol for the selection of a core outcome set
There is increasing recognition that establishing a core set of outcomes to be evaluated and reported in trials of interventions for particular conditions will improve the usefulness of health research. There ... (Source: Trials)
Source: Trials - November 28, 2017 Category: General Medicine Authors: Christopher Morris, Colin Dunkley, Frances M. Gibbon, Janet Currier, Deborah Roberts, Morwenna Rogers, Holly Crudgington, Lucy Bray, Bernie Carter, Dyfrig Hughes, Catrin Tudur Smith, Paula R. Williamson, Paul Gringras and Deb K. Pal Tags: Study protocol Source Type: research

Core Health Outcomes In Childhood Epilepsy (CHOICE): protocol for the selection of a core outcome set
DiscussionOur methodology is a proportionate and pragmatic approach to expediently produce a core outcome set for evaluative research of interventions aiming to improve the health of children with epilepsy. A number of decisions have to be made when designing a study to develop a core outcome set including defining the scope, choosing which stakeholders to engage, most effective ways to elicit their views, especially children and a potential role for qualitative research. (Source: Trials)
Source: Trials - November 28, 2017 Category: Research Source Type: clinical trials

The effect of an intensive smoking cessation intervention on disease activity in patients with rheumatoid arthritis: study protocol for a randomised controlled trial
DiscussionThis trial will reveal whether intensive smoking cessation counselling helps smokers with RA to achieve continuous smoking cessation and whether, as a concomitant benefit, it will reduce their RA disease activity. The trial aims to generate high quality evidence for the feasibility of a health promotion intervention for smokers with RA.Trial registrationClinicalTrials.gov, identifier:NCT02901886. Registered on 10 September 2016. Recruitment status updated on 10th October 2016. (Source: Trials)
Source: Trials - November 28, 2017 Category: Research Source Type: clinical trials

Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial
DiscussionResults of the present study will provide evidence to guide clinical practice in using prophylactic inhalation of an anticholinergic to prevent PPCs in high-risk patients.Trial registrationThe study was registered prospectively in Chinese Clinical Trial Registry (www.chictr.org.cn,ChiCTR-IPC-15006603) on 14 May 2015 and retrospectively in ClinicalTrials.gov (NCT02644876) on 30 December 2015. (Source: Trials)
Source: Trials - November 28, 2017 Category: Research Source Type: clinical trials

Efficacy and safety of the “Xingnao Kaiqiao” acupuncture technique via intradermal needling to treat postoperative gastrointestinal dysfunction of laparoscopic surgery: study protocol for a randomized controlled trial
DiscussionThis upcoming randomized clinical trial was designed as a standardized method to assess the efficacy and safety ofXingnao Kaiqiao acupuncture using intradermal needles on PC6, DU26, and SP6 in the treatment of gastrointestinal dysfunction after laparoscopic surgery. We aim to provide evidence and thus improve the clinical application of this technique.Trial registrationChinese Clinical Trial Registry,ChiCTR-IOR-17010763. Registered on 2 March 2017. (Source: Trials)
Source: Trials - November 28, 2017 Category: Research Source Type: clinical trials

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial
This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) program and integrated text messaging (TXT) in a three-arm randomized trial with repeated measures at one, three, six, and 12  months post randomization. The primary outcome is biochemically confirmed abstinence at 12 months post randomization. We will randomize 1650 smokers who present for a clinical LCS to: (1) a usual care control condition (UC) which consists of Ask–Advise–Refer; (2) a digital (WEB + TXT) ces sation inte...
Source: Trials - November 28, 2017 Category: Research Source Type: clinical trials