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https://www.readbyqxmd.com/read/27923407/nets-1hd-study-protocol-for-development-of-a-core-outcome-set-for-use-in-determining-the-overall-success-of-hirschsprung-s-disease-treatment
#1
Benjamin Allin, Timothy Bradnock, Simon Kenny, Gregor Walker, Marian Knight
BACKGROUND: Use of core outcome sets in research has been proposed as a method for countering the problems caused by heterogeneity of outcome measure reporting. Heterogeneity of outcome measure reporting occurs in Hirschsprung's disease (HD) research and is limiting the development of a robust evidence base to support clinical practice. METHODS: Candidate outcome measures have been identified through a systematic review. These outcome measures will form the starting point for a three-phase online Delphi process to be carried out in parallel by three panels of experts...
December 7, 2016: Trials
https://www.readbyqxmd.com/read/27923401/effectiveness-of-the-who-safe-childbirth-checklist-program-in-reducing-severe-maternal-fetal-and-newborn-harm-in-uttar-pradesh-india-study-protocol-for-a-matched-pair-cluster-randomized-controlled-trial
#2
Katherine E A Semrau, Lisa R Hirschhorn, Bhala Kodkany, Jonathan M Spector, Danielle E Tuller, Gary King, Stuart Lipsitz, Narender Sharma, Vinay Pratap Singh, Bharath Kumar, Neelam Dhingra-Kumar, Rebecca Firestone, Vishwajeet Kumar, Atul A Gawande
BACKGROUND: Effective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries. Building on the successes of previous checklist-based programs, the World Health Organization (WHO) and partners led the development of the Safe Childbirth Checklist (SCC), a 28-item list of evidence-based practices linked with improved maternal and newborn outcomes. Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practices (EBPs)...
December 7, 2016: Trials
https://www.readbyqxmd.com/read/27923390/the-rapid-ctca-trial-rapid-assessment-of-potential-ischaemic-heart-disease-with-ctca-a-multicentre-parallel-group-randomised-trial-to-compare-early-computerised-tomography-coronary-angiography-versus-standard-care-in-patients-presenting-with-suspected-or-confirmed
#3
Alasdair J Gray, Carl Roobottom, Jason E Smith, Steve Goodacre, Katherine Oatey, Rachel O'Brien, Robert F Storey, Lumine Na, Steff C Lewis, Praveen Thokala, David E Newby
BACKGROUND: Emergency department attendances with chest pain requiring assessment for acute coronary syndrome (ACS) are a major global health issue. Standard assessment includes history, examination, electrocardiogram (ECG) and serial troponin testing. Computerised tomography coronary angiography (CTCA) enables additional anatomical assessment of patients for coronary artery disease (CAD) but has only been studied in very low-risk patients. This trial aims to investigate the effect of early CTCA upon interventions, event rates and health care costs in patients with suspected/confirmed ACS who are at intermediate risk...
December 7, 2016: Trials
https://www.readbyqxmd.com/read/27923389/the-importance-of-albumin-infusion-rate-for-plasma-volume-expansion-following-major-abdominal-surgery-air-study-protocol-for-a-randomised-controlled-trial
#4
Svajunas Statkevicius, Johan Bonnevier, Björn P Bark, Erik Larsson, Carl M Öberg, Päivi Kannisto, Bobby Tingstedt, Peter Bentzer
BACKGROUND: Administration of fluids to restore normovolaemia is one of the most common therapeutic interventions performed peri-operatively and in the critically ill, but no study has evaluated the importance of infusion rate for the plasma volume-expanding effect of a resuscitation fluid. The present study is designed to test the hypothesis that a slow infusion of resuscitation fluid results in better plasma volume expansion than a rapid infusion. METHODS/DESIGN: The study is a single-centre, assessor-blinded, parallel-group, randomised prospective study...
December 7, 2016: Trials
https://www.readbyqxmd.com/read/27923384/the-quality-of-reporting-in-cluster-randomised-crossover-trials-proposal-for-reporting-items-and-an-assessment-of-reporting-quality
#5
Sarah J Arnup, Andrew B Forbes, Brennan C Kahan, Katy E Morgan, Joanne E McKenzie
BACKGROUND: The cluster randomised crossover (CRXO) design is gaining popularity in trial settings where individual randomisation or parallel group cluster randomisation is not feasible or practical. Our aim is to stimulate discussion on the content of a reporting guideline for CRXO trials and to assess the reporting quality of published CRXO trials. METHODS: We undertook a systematic review of CRXO trials. Searches of MEDLINE, EMBASE, and CINAHL Plus as well as citation searches of CRXO methodological articles were conducted to December 2014...
December 6, 2016: Trials
https://www.readbyqxmd.com/read/27919285/a-randomised-patient-assessor-blinded-sham-controlled-trial-of-external-non-invasive-peripheral-nerve-stimulation-for-chronic-neuropathic-pain-following-peripheral-nerve-injury-en-pens-trial-study-protocol-for-a-randomised-controlled-trial
#6
Selina Johnson, Andreas Goebel, Roberta Richey, Emily Holmes, Dyfrig Hughes
BACKGROUND: Eight percent of people in the UK are estimated to have persistent (chronic) neuropathic pain, and for many there is no effective treatment. Medications are the most common first-line treatment but often have limited benefit or adverse events. Surgical treatments, such as spinal cord stimulation, are then often considered. External non-invasive peripheral nerve stimulation (EN-PENS) is a form of electrical stimulation that involves placing a pen-shaped electrode onto the skin, which can be easily self-administered by patients...
December 6, 2016: Trials
https://www.readbyqxmd.com/read/27914473/effectiveness-of-enhanced-cognitive-behavioral-therapy-cbt-e-for-eating-disorders-study-protocol-for-a-randomized-controlled-trial
#7
Martie de Jong, Kees Korrelboom, Iris van der Meer, Mathijs Deen, Hans W Hoek, Philip Spinhoven
BACKGROUND: While eating disorder not otherwise specified (EDNOS) is the most common eating disorder (ED) diagnosis in routine clinical practice, no specific treatment methods for this diagnosis have yet been developed and studied. Enhanced cognitive behavioral therapy (CBT-E) has been described and put to the test as a transdiagnostic treatment protocol for all EDs, including EDNOS. Initial research in the UK suggests that CBT-E is more effective for EDs, especially bulimia nervosa (BN) and EDNOS, than the earlier version of CBT...
December 3, 2016: Trials
https://www.readbyqxmd.com/read/27906104/the-effects-of-computer-based-mindfulness-training-on-self-control-and-mindfulness-within-ambulatorily-assessed-network-systems-across-health-related-domains-in-a-healthy-student-population-smash-study-protocol-for-a-randomized-controlled-trial
#8
Zarah Rowland, Mario Wenzel, Thomas Kubiak
BACKGROUND: Self-control is an important ability in everyday life, showing associations with health-related outcomes. The aim of the Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains (SMASH) study is twofold: first, the effectiveness of a computer-based mindfulness training will be evaluated in a randomized controlled trial. Second, the SMASH study implements a novel network approach in order to investigate complex temporal interdependencies of self-control networks across several domains...
December 1, 2016: Trials
https://www.readbyqxmd.com/read/27906080/tonic-and-burst-spinal-cord-stimulation-waveforms-for-the-treatment-of-chronic-intractable-pain-study-protocol-for-a-randomized-controlled-trial
#9
Konstantin V Slavin, Richard B North, Timothy R Deer, Peter Staats, Kristina Davis, Roni Diaz
BACKGROUND: Burst stimulation is a novel form of neurostimulation for the treatment of chronic pain which has demonstrated promise in small uncontrolled studies, but has not yet gained approval for use in the U.S. We report the study methods for an ongoing multicenter, randomized, controlled, cross-over study designed to gain United States Food and Drug Administration (FDA) approval for burst stimulation. METHODS: Participants who are candidates for a currently approved neurostimulation device were enrolled and screened...
December 1, 2016: Trials
https://www.readbyqxmd.com/read/27906034/effect-on-attendance-by-including-focused-information-on-spirometry-in-preventive-health-checks-study-protocol-for-a-randomized-controlled-trial
#10
Lene Maria Ørts, Anders Løkke, Anne-Louise Bjerregaard, Helle Terkildsen Maindal, Annelli Sandbæk
BACKGROUND: Early detection of lung diseases can help to reduce their severity. Lung diseases are among the most frequently occurring and serious diseases worldwide; nonetheless, many patients remain undiagnosed. Preventive health checks including spirometry can detect lung diseases at early stages; however, recruitment for health checks remains a challenge, and little is known about what motivates the attendance. The aim of the study is to examine whether focused information on spirometry in the invitation compared to general information will impact the attendance rate in preventive health checks...
December 1, 2016: Trials
https://www.readbyqxmd.com/read/27903282/start-now-a-comprehensive-skills-training-programme-for-female-adolescents-with-oppositional-defiant-and-conduct-disorders-study-protocol-for-a-cluster-randomised-controlled-trial
#11
Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine M Freitag, Robert L Trestman, Christina Stadler
BACKGROUND: In Europe, the number of females exhibiting oppositional defiant disorder (ODD) and conduct disorder (CD) is growing. Many of these females live in youth welfare institutions. Consequently, there is a great need for evidence-based interventions within youth welfare settings. A recently developed approach targeting the specific needs of girls with ODD and CD in residential care is START NOW. The aim of this group-based behavioural skills training programme is to specifically enhance emotional regulation capacities to enable females with CD or ODD to appropriately deal with daily-life demands...
December 1, 2016: Trials
https://www.readbyqxmd.com/read/27899130/antibiotic-prophylaxis-in-reduction-mammaplasty-study-protocol-for-a-randomized-controlled-trial
#12
Edgard Silva Garcia, Daniela Francescato Veiga, Joel Veiga-Filho, Isaías Vieira Cabral, Natália Lana Larcher Pinto, Neil Ferreira Novo, Miguel Sabino Neto, Lydia Masako Ferreira
BACKGROUND: The role of antibiotics in surgical procedures where the risk of surgical site infection (SSI) is low remains uncertain. There is, to date, no evidence to justify the routine use of antibiotics in postoperative reduction mammaplasty. The aim of this study is to evaluate the effect of postoperative antibiotic treatment on the occurrence of SSI after breast reduction surgery. METHODS: This is a double-blind randomized clinical trial with 124 breast hypertrophy patients allocated to two treatment groups: antibiotic (n = 62) and placebo (n = 62)...
November 30, 2016: Trials
https://www.readbyqxmd.com/read/27899162/design-of-case-report-forms-based-on-a-public-metadata-registry-re-use-of-data-elements-to-improve-compatibility-of-data
#13
Martin Dugas
BACKGROUND: Clinical trials use many case report forms (CRFs) per patient. Because of the astronomical number of potential CRFs, data element re-use at the design stage is attractive to foster compatibility of data from different trials. The objective of this work is to assess the technical feasibility of a CRF editor with connection to a public metadata registry (MDR) to support data element re-use. RESULTS: Based on the Medical Data Models portal, an ISO/IEC 11179-compliant MDR was implemented and connected to a web-based CRF editor...
November 29, 2016: Trials
https://www.readbyqxmd.com/read/27894336/curcumin-and-long-chain-omega-3-polyunsaturated-fatty-acids-for-prevention-of-type-2-diabetes-cop-d-study-protocol-for-a-randomised-controlled-trial
#14
Rohith N Thota, Shamasunder H Acharya, Kylie A Abbott, Manohar L Garg
BACKGROUND: Lifestyle interventions, including increase in physical activity and dietary counselling, have shown the ability to prevent type 2 diabetes (T2D) in high-risk state individuals, but the prevalence is still skyrocketing in Australia, in line with global prevalence. Currently, no medicines are approved by the Therapeutic Goods Administration in Australia for the management of prediabetes. Therefore, there is a need of developing a safer, biologically efficacious and cost-effective alternative for delaying the transition of individual health state from prediabetes into T2D...
November 29, 2016: Trials
https://www.readbyqxmd.com/read/27894329/efficacy-of-early-controlled-motion-of-the-ankle-compared-with-no-motion-after-non-operative-treatment-of-an-acute-achilles-tendon-rupture-study-protocol-for-a-randomized-controlled-trial
#15
Kristoffer Weisskirchner Barfod, Maria Swennergren Hansen, Per Holmich, Anders Troelsen, Morten Tange Kristensen
BACKGROUND: Early controlled ankle motion is widely used in the non-operative treatment of acute Achilles tendon rupture, though its safety and efficacy have never been investigated in a randomized setup. The objectives of this study are to investigate if early controlled motion of the ankle affects functional and patient-reported outcomes. METHODS/DESIGN: The study is performed as a blinded, randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups...
November 29, 2016: Trials
https://www.readbyqxmd.com/read/27887662/the-effects-of-water-lubrication-of-tracheal-tubes-on-post-intubation-airway-complications-study-protocol-for-a-randomized-controlled-trial
#16
Eugene Kim, Seong Mi Yang, So Jeong Yoon, Jae-Hyon Bahk, Jeong-Hwa Seo
BACKGROUND: Water is known to have lubricating properties, thus it is used for lubrication of tracheal tubes to reduce airway injuries caused by intubation. However, there is no definite evidence to substantiate the beneficial effects of lubricating tracheal tubes using water for attenuating airway injuries. Moreover, the lubrication pretreatment may cause contamination of the tube, leading to respiratory infections. Therefore, this trial aims to assess whether no pretreatment of tracheal tubes does not increase post-intubation airway complications as compared with water lubrication of tubes...
November 25, 2016: Trials
https://www.readbyqxmd.com/read/27887632/adjuvant-therapies-in-advanced-hepatocellular-carcinoma-moving-forward-from-the-storm
#17
LETTER
Mohamed Bouattour, Olivier Soubrane, Armand de Gramont, Sandrine Faivre
: Like other previous treatments and approaches, sorafenib, an antiangiogenic drug, failed to show any benefit in the adjuvant setting for hepatocellular carcinoma in a large clinical trial. We discuss reasons and implications of these negative results and the implications for clinical practice and future research. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00692770 . Registered 5 June 2008. This study has been completed.
November 25, 2016: Trials
https://www.readbyqxmd.com/read/27884204/lateral-pelvic-lymph-node-dissection-after-neoadjuvant-chemo-radiation-for-preoperative-enlarged-lateral-nodes-in-advanced-low-rectal-cancer-study-protocol-for-a-randomized-controlled-trial
#18
Mingtian Wei, Qingbin Wu, Chuanwen Fan, Yan Li, Xiangzheng Chen, Zongguang Zhou, Junhong Han, Ziqiang Wang
BACKGROUND: Lateral lymph node (LLN) metastasis is a major cause of local recurrence of advanced rectal cancer. Although there is much controversy between Western and Eastern countries on whether lateral pelvic lymph node dissection (LLND) or neoadjuvant chemo-radiation (nCRT) is preferable for the treatment of LLN metastases, existing retrospective cohorts mainly focus on all middle/low advanced rectal cancer patients, not the specific individuals with suspicion of LLN metastases. The aim of this trial is to assess the efficacy and safety of LLND for rectal cancer patients with suspicion of LLN metastases...
November 25, 2016: Trials
https://www.readbyqxmd.com/read/27881184/stereotactic-radiotherapy-for-wet-age-related-macular-degeneration-star-study-protocol-for-a-randomised-controlled-clinical-trial
#19
James E Neffendorf, Riti Desai, Yanzhong Wang, Joanna Kelly, Caroline Murphy, Barnaby C Reeves, Usha Chakravarthy, Sarah Wordsworth, Cornelius Lewis, Janet Peacock, Shahir Uddin, Joe M O'Sullivan, Timothy L Jackson
BACKGROUND: The standard of care for neovascular age-related macular degeneration (nAMD) involves ongoing intravitreal injections of anti-angiogenic drugs targeting vascular endothelial growth factor (VEGF). The most commonly used anti-VEGF drugs are ranibizumab, bevacizumab and aflibercept. The main objective of the STAR trial is to determine if stereotactic radiotherapy can reduce the number of anti-VEGF injections that patients with nAMD require. METHODS/DESIGN: STAR is a multicentre, double-masked, randomised, sham-controlled clinical trial...
November 24, 2016: Trials
https://www.readbyqxmd.com/read/27881152/fitness-and-mobility-training-in-patients-with-intensive-care-unit-acquired-muscle-weakness-fitonicu-study-protocol-for-a-randomised-controlled-trial
#20
Jan Mehrholz, Simone Thomas, Jane H Burridge, André Schmidt, Bettina Scheffler, Ralph Schellin, Stefan Rückriem, Daniel Meißner, Katja Mehrholz, Wolfgang Sauter, Ulf Bodechtel, Bernhard Elsner
BACKGROUND: Critical illness myopathy (CIM) and polyneuropathy (CIP) are a common complication of critical illness. Both cause intensive-care-unit-acquired (ICU-acquired) muscle weakness (ICUAW) which increases morbidity and delays rehabilitation and recovery of activities of daily living such as walking ability. Focused physical rehabilitation of people with ICUAW is, therefore, of great importance at both an individual and a societal level. A recent systematic Cochrane review found no randomised controlled trials (RCT), and thus no supporting evidence, for physical rehabilitation interventions for people with defined CIP and CIM to improve activities of daily living...
November 24, 2016: Trials
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