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https://www.readbyqxmd.com/read/28651648/the-risk-of-oxygen-during-cardiac-surgery-rocs-trial-study-protocol-for-a-randomized-clinical-trial
#1
Marcos G Lopez, Mias Pretorius, Matthew S Shotwell, Robert Deegan, Susan S Eagle, Jeremy M Bennett, Bantayehu Sileshi, Yafen Liang, Brian J Gelfand, Adam J Kingeter, Kara K Siegrist, Frederick W Lombard, Tiffany M Richburg, Dane A Fornero, Andrew D Shaw, Antonio Hernandez, Frederic T Billings
BACKGROUND: Anesthesiologists administer excess supplemental oxygen (hyper-oxygenation) to patients during surgery to avoid hypoxia. Hyper-oxygenation, however, may increase the generation of reactive oxygen species and cause oxidative damage. In cardiac surgery, increased oxidative damage has been associated with postoperative kidney and brain injury. We hypothesize that maintenance of normoxia during cardiac surgery (physiologic oxygenation) decreases kidney injury and oxidative damage compared to hyper-oxygenation...
June 26, 2017: Trials
https://www.readbyqxmd.com/read/28646924/ciprofloxacin-for-contacts-of-cases-of-meningococcal-meningitis-as-an-epidemic-response-study-protocol-for-a-cluster-randomized-trial
#2
Matthew E Coldiron, Gabriel Alcoba, Iza Ciglenecki, Matt Hitchings, Ali Djibo, Anne-Laure Page, Celine Langendorf, Rebecca F Grais
BACKGROUND: Epidemics of meningococcal meningitis are common in the "African meningitis belt." Current response strategies include reactive vaccination campaigns, which are often organized too late to have maximal impact. A novel strain of Neisseria meningitidis serogroup C has been circulating in recent years, and vaccine supplies are limited. An evaluation of chemoprophylaxis with single-dose ciprofloxacin for household contacts of meningitis cases has therefore been recommended. METHODS/DESIGN: A three-arm cluster-randomized trial has been designed for implementation during a meningococcal meningitis epidemic in a health district in Niger in which at least two Health Zones (HZs) have met the weekly epidemic threshold...
June 24, 2017: Trials
https://www.readbyqxmd.com/read/28646892/effect-of-acupuncture-on-cerebrovascular-reserve-in-patients-with-acute-cerebral-infarction-protocol-for-a-randomized-controlled-pilot-study
#3
Shaosong Wang, Tingting Ma, Linpeng Wang, Lu Liu, Huilin Liu, Bin Li, Yuanbo Fu
BACKGROUND: The incidence of cerebral infarction has been growing year by year in China and around the world. According to clinical observation, acupuncture utilizing the "waking up the spirit" needling method is widely used in patients with cerebral infarction, though the underlying mechanisms remain unclear. Additionally, a number of studies have begun to focus on the relationship between cerebrovascular reserve (CVR) and cerebral infarction. The present study aims to investigate whether CVR is one of potential mechanisms underpinning this effect of acupuncture on patients with cerebral infarction...
June 24, 2017: Trials
https://www.readbyqxmd.com/read/28646887/intrapleural-dornase-and-tissue-plasminogen-activator-in-pediatric-empyema-dtpa-a-study-protocol-for-a-randomized-controlled-trial
#4
Michael H Livingston, Sanjay Mahant, Felix Ratjen, Bairbre L Connolly, Kevin Thorpe, Muhammad Mamdani, Ian Maclusky, Sophie Laberge, Lucy Giglia, J Mark Walton, Connie L Yang, Ashley Roberts, Anna C Shawyer, Mary Brindle, Simon J Parsons, Cristina A Stoian, Eyal Cohen
BACKGROUND: A randomized controlled trial of adults with empyema recently demonstrated decreased length of stay in hospital in patients treated with intrapleurally administered dornase alfa and fibrinolytics compared to fibrinolytics alone. Whether this treatment strategy is safe and effective in children remains unknown. METHODS/DESIGN: This study protocol is for a superiority, placebo-controlled, parallel-design, multicenter randomized controlled trial. The participants are previously well children admitted to a children's hospital with a diagnosis of empyema requiring chest tube insertion and fibrinolytics administered intrapleurally...
June 24, 2017: Trials
https://www.readbyqxmd.com/read/28645301/the-sternal-management-accelerated-recovery-trial-s-m-a-r-t-standard-restrictive-versus-an-intervention-of-modified-sternal-precautions-following-cardiac-surgery-via-median-sternotomy-study-protocol-for-a-randomised-controlled-trial
#5
Md Ali Katijjahbe, Linda Denehy, Catherine L Granger, Alistair Royse, Colin Royse, Rebecca Bates, Sarah Logie, Sandy Clarke, Doa El-Ansary
BACKGROUND: The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound...
June 23, 2017: Trials
https://www.readbyqxmd.com/read/28637515/current-globalization-of-drug-interventional-clinical-trials-characteristics-and-associated-factors-2011-2013
#6
Sohyun Jeong, Minji Sohn, Jae Hyun Kim, Minoh Ko, Hee-Won Seo, Yun-Kyoung Song, Boyoon Choi, Nayoung Han, Han-Sung Na, Jong Gu Lee, In-Wha Kim, Jung Mi Oh, Euni Lee
BACKGROUND: Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013. METHODS: The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials...
June 21, 2017: Trials
https://www.readbyqxmd.com/read/28637494/euiiyin-tang-in-the-treatment-of-obesity-study-protocol-for-a-randomised-controlled-trial
#7
Chunhoo Cheon, Soobin Jang, Jeong-Su Park, Youme Ko, Doh Sun Kim, Byung Hoon Lee, Hyun Jong Song, Yun-Kyung Song, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko
BACKGROUND: Obesity is a public health concern in many countries due to its increasing prevalence. Euiiyin-tang is an herbal medicine formula often used as a clinical treatment for obesity. It acts to eliminate humidity and purify the blood, the causes of obesity identified by the theoretical framework of Korean medicine. The purpose of this study is to evaluate the efficacy and safety of Euiiyin-tang in treating obesity. METHODS/DESIGN: This study is a randomised, double-blinded and placebo-controlled, multicentre trial...
June 21, 2017: Trials
https://www.readbyqxmd.com/read/28633675/acupuncture-treatment-on-the-motor-area-of-the-scalp-for-motor-dysfunction-in-patients-with-ischemic-stroke-study-protocol-for-a-randomized-controlled-trial
#8
Jun Wang, Jian Pei, Dhiaedin Khiati, Qinhui Fu, Xiao Cui, Yi Song, Minghang Yan, Lijun Shi, Yiwen Cai, Yuhong Ma
BACKGROUND: Scalp acupuncture has shown a remarkable treatment efficacy on motor dysfunction in patients with stroke in China, especially the motor area of Jiao's scalp acupuncture, which is the most widely used treatment. However, previous studies have summarized that the clinical curative effect of acupuncture treatment for stroke remains uncertain. Meanwhile, no randomized controlled trials on Jiao's scalp acupuncture have been performed. The aim of this study is to evaluate the efficacy and safety of Jiao's scalp acupuncture for motor dysfunction in ischemic stroke...
June 20, 2017: Trials
https://www.readbyqxmd.com/read/28629473/emergency-treatment-with-levetiracetam-or-phenytoin-in-status-epilepticus-in-children-the-eclipse-study-study-protocol-for-a-randomised-controlled-trial
#9
Mark D Lyttle, Carrol Gamble, Shrouk Messahel, Helen Hickey, Anand Iyer, Kerry Woolfall, Amy Humphreys, Naomi E A Bacon, Louise Roper, Franz E Babl, Stuart R Dalziel, Mary Ryan, Richard E Appleton
BACKGROUND: Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the family and the health and social care systems. The current recommended first-choice, second-line treatment in children aged 6 months and above is intravenous phenytoin (fosphenytoin in the USA), although there is a lack of evidence for its use and it is associated with significant side effects...
June 19, 2017: Trials
https://www.readbyqxmd.com/read/28629471/improving-child-nutrition-and-development-through-community-based-childcare-centres-in-malawi-the-neep-ie-study-study-protocol-for-a-randomised-controlled-trial
#10
Aulo Gelli, Amy Margolies, Marco Santacroce, Katie Sproule, Sophie Theis, Natalie Roschnik, Aisha Twalibu, George Chidalengwa, Amrik Cooper, Tyler Moorhead, Melissa Gladstone, Patricia Kariger, Mangani Kutundu
BACKGROUND: The Nutrition Embedded Evaluation Programme Impact Evaluation (NEEP-IE) study is a cluster randomised controlled trial designed to evaluate the impact of a childcare centre-based integrated nutritional and agricultural intervention on the diets, nutrition and development of young children in Malawi. The intervention includes activities to improve nutritious food production and training/behaviour-change communication to improve food intake, care and hygiene practices. This paper presents the rationale and study design for this randomised control trial...
June 19, 2017: Trials
https://www.readbyqxmd.com/read/28629447/transcranial-direct-current-stimulation-for-depression-in-alzheimer-s-disease-study-protocol-for-a-randomized-controlled-trial
#11
Zui Narita, Yuma Yokoi
BACKGROUND: Patients with Alzheimer's disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits. Above all, depression is one of the most common neuropsychiatric symptoms in Alzheimer's disease but antidepressant drugs have not shown significant beneficial effects on it. Moreover, electroconvulsive therapy has not ensured its safety for potential severe adverse events although it does show beneficial clinical effect. Transcranial direct current stimulation can be the safe alternative of neuromodulation, which applies weak direct electrical current to the brain...
June 19, 2017: Trials
https://www.readbyqxmd.com/read/28623947/effects-of-digital-cognitive-behavioural-therapy-for-insomnia-on-cognitive-function-study-protocol-for-a-randomised-controlled-trial
#12
Simon D Kyle, Madeleine E D Hurry, Richard Emsley, Annemarie I Luik, Ximena Omlin, Kai Spiegelhalder, Colin A Espie, Claire E Sexton
BACKGROUND: The daytime effects of insomnia pose a significant burden to patients and drive treatment seeking. In addition to subjective deficits, meta-analytic data show that patients experience reliable objective impairments across several cognitive domains. While Cognitive Behavioural Therapy for Insomnia (CBT-I) is an effective and scalable treatment, we know little about its impact upon cognitive function. Trials of CBT-I have typically used proxy measures for cognitive functioning, such as fatigue or work performance scales, and no study has assessed self-reported impairment in cognitive function as a primary outcome...
June 17, 2017: Trials
https://www.readbyqxmd.com/read/28623944/the-effect-of-combining-manual-therapy-with-exercise-for-mild-chronic-obstructive-pulmonary-disease-study-protocol-for-a-randomised-controlled-trial
#13
Roger M Engel, Jaxson Wearing, Peter Gonski, Subramanyam Vemulpad
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major cause of disability and hospital admission. Current management strategies have not been successful in altering the loss of lung function typically seen as the disease progresses. A recent systematic review into the use of spinal manipulative therapy (SMT) in the management of COPD concluded that there was low level evidence to support the view that a combination of SMT and exercise had the potential to improve lung function more than exercise alone in people with moderate to severe COPD...
June 17, 2017: Trials
https://www.readbyqxmd.com/read/28619121/exploring-patients-treatment-journeys-following-randomisation-in-mental-health-trials-to-improve-future-trial-conduct-a-synthesis-of-multiple-qualitative-data-sets
#14
Katrina M Turner, John Percival, David Kessler, Jenny Donovan
BACKGROUND: The way in which pragmatic trials are designed suggests that there are differences between the experiences of participants randomised to usual care and intervention arms. These potential differences relate not only to which treatment participants receive but also how they access and engage with their allocated treatment. Such differences could affect trial results. The aim of this study was to assess whether such differences exist and, if they do, to consider their implications for the design of future trials...
June 15, 2017: Trials
https://www.readbyqxmd.com/read/28619114/reducing-the-rate-and-duration-of-re-admissions-among-patients-with-unipolar-disorder-and-bipolar-disorder-using-smartphone-based-monitoring-and-treatment-the-radmis-trials-study-protocol-for-two-randomized-controlled-trials
#15
Maria Faurholt-Jepsen, Mads Frost, Klaus Martiny, Nanna Tuxen, Nicole Rosenberg, Jonas Busk, Ole Winther, Jakob Eyvind Bardram, Lars Vedel Kessing
BACKGROUND: Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization are a major burden. Smartphones comprise an innovative and unique platform for the monitoring and treatment of depression and mania. No prior trial has investigated whether the use of a smartphone-based system can prevent re-admission among patients discharged from hospital...
June 15, 2017: Trials
https://www.readbyqxmd.com/read/28619061/rituximab-versus-cyclophosphamide-for-the-treatment-of-connective-tissue-disease-associated-interstitial-lung-disease-recital-study-protocol-for-a-randomised-controlled-trial
#16
Peter Saunders, Vicky Tsipouri, Gregory J Keir, Deborah Ashby, Marcus D Flather, Helen Parfrey, Daphne Babalis, Elisabetta A Renzoni, Christopher P Denton, Athol U Wells, Toby M Maher
BACKGROUND: Interstitial lung disease (ILD) frequently complicates systemic autoimmune disorders resulting in considerable morbidity and mortality. The connective tissue diseases (CTDs) most frequently resulting in ILD include: systemic sclerosis, idiopathic inflammatory myositis (including dermatomyositis, polymyositis and anti-synthetase syndrome) and mixed connective tissue disease. Despite the development, over the last two decades, of a range of biological therapies which have resulted in significant improvements in the treatment of the systemic manifestations of CTD, the management of CTD-associated ILD has changed little...
June 15, 2017: Trials
https://www.readbyqxmd.com/read/28619049/non-inferiority-versus-superiority-drug-claims-the-not-so-subtle-distinction
#17
LETTER
Jitendra Ganju, Dror Rom
BACKGROUND: Current regulatory guidance and practice of non-inferiority trials are asymmetric in favor of the test treatment (Test) over the reference treatment (Control). These trials are designed to compare the relative efficacy of Test to Control by reference to a clinically important margin, M. MAIN TEXT: Non-inferiority trials allow for the conclusion of: (a) non-inferiority of Test to Control if Test is slightly worse than Control but by no more than M; and (b) superiority if Test is slightly better than Control even if it is by less than M...
June 15, 2017: Trials
https://www.readbyqxmd.com/read/28619025/evaluating-the-effectiveness-of-a-healthy-lifestyle-clinician-in-addressing-the-chronic-disease-risk-behaviours-of-community-mental-health-clients-study-protocol-for-a-randomised-controlled-trial
#18
Caitlin Fehily, Kate Bartlem, John Wiggers, Paula Wye, Richard Clancy, David Castle, Sonia Wutzke, Chris Rissel, Andrew Wilson, Paul McCombie, Fionna Murphy, Jenny Bowman
BACKGROUND: People with a mental illness experience a greater morbidity and mortality from chronic diseases relative to the general population. A higher prevalence of modifiable health risk behaviours such as smoking, poor nutrition, physical inactivity and harmful alcohol consumption contribute substantially to this disparity. Despite clinical practice guidelines recommending that mental health services routinely provide care to address these risk behaviours, the provision of such care is consistently reported to be low internationally and in Australia...
June 15, 2017: Trials
https://www.readbyqxmd.com/read/28610638/baderi-an-online-database-to-coordinate-handsearching-activities-of-controlled-clinical-trials-for-their-potential-inclusion-in-systematic-reviews
#19
Hector Pardo-Hernandez, Gerard Urrútia, Leticia A Barajas-Nava, Diana Buitrago-Garcia, Julieth Vanessa Garzón, María José Martínez-Zapata, Xavier Bonfill
BACKGROUND: Systematic reviews provide the best evidence on the effect of health care interventions. They rely on comprehensive access to the available scientific literature. Electronic search strategies alone may not suffice, requiring the implementation of a handsearching approach. We have developed a database to provide an Internet-based platform from which handsearching activities can be coordinated, including a procedure to streamline the submission of these references into CENTRAL, the Cochrane Collaboration Central Register of Controlled Trials...
June 13, 2017: Trials
https://www.readbyqxmd.com/read/28610601/positioning-in-macular-hole-surgery-pims-statistical-analysis-plan-for-a-randomised-controlled-trial
#20
Lauren Bell, Richard Hooper, Catey Bunce, Saruban Pasu, James Bainbridge
BACKGROUND: The treatment of idiopathic full-thickness macular holes involves surgery to close the hole. Some surgeons advise patients to adopt a face-down position to increase the likelihood of successful macular hole closure. However, patients often find the face-down positioning arduous. There is a lack of conclusive evidence that face-down positioning improves the outcome. The 'Positioning In Macular hole Surgery' (PIMS) trial will assess whether advice to position face-down after surgery improves the surgical success rate for the closure of large (≥400 μm) macular holes...
June 13, 2017: Trials
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