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https://www.readbyqxmd.com/read/28814317/collaborative-care-for-panic-disorder-generalised-anxiety-disorder-and-social-phobia-in-general-practice-study-protocol-for-three-cluster-randomised-superiority-trials
#1
Nadja Kehler Curth, Ursula Ødum Brinck-Claussen, Annette Sofie Davidsen, Marianne Engelbrecht Lau, Merete Lundsteen, John Hagel Mikkelsen, Claudio Csillag, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov
BACKGROUND: People with anxiety disorders represent a significant part of a general practitioner's patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately...
August 16, 2017: Trials
https://www.readbyqxmd.com/read/28810895/understanding-the-cluster-randomised-crossover-design-a-graphical-illustraton-of-the-components-of-variation-and%C3%A2-a-sample-size%C3%A2-tutorial
#2
Sarah J Arnup, Joanne E McKenzie, Karla Hemming, David Pilcher, Andrew B Forbes
BACKGROUND: In a cluster randomised crossover (CRXO) design, a sequence of interventions is assigned to a group, or 'cluster' of individuals. Each cluster receives each intervention in a separate period of time, forming 'cluster-periods'. Sample size calculations for CRXO trials need to account for both the cluster randomisation and crossover aspects of the design. Formulae are available for the two-period, two-intervention, cross-sectional CRXO design, however implementation of these formulae is known to be suboptimal...
August 15, 2017: Trials
https://www.readbyqxmd.com/read/28807045/a-randomized-multi-center-prospective-study-comparing-best-medical-treatment-versus-best-medical-treatment-plus-renal-artery-stenting-in-patients-with-hemodynamically-relevant-atherosclerotic-renal-artery-stenosis-radar-one-year-results-of-a-pre-maturely-terminated
#3
Thomas Zeller, Hans Krankenberg, Andrejs Erglis, Erwin Blessing, Torsten Fuss, Dierk Scheinert, Ralf Weser, Beatrix B Doerr, Wilfrid D Yollo, Joerg Radermacher
BACKGROUND: The indications for conservative "best medical treatment" (BMT) versus additional renal artery stenting are a matter of ongoing debate. The RADAR study aimed to evaluate the impact of percutaneous renal artery stenting on the impaired renal function in patients with hemodynamically significant atherosclerotic renal artery stenosis (RAS). METHODS: RADAR is an international, prospective, randomized (1:1) controlled study comparing BMT alone versus BMT plus renal artery stenting in patients with duplex sonographic hemodynamically relevant RAS...
August 14, 2017: Trials
https://www.readbyqxmd.com/read/28807006/the-impact-of-active-stakeholder-involvement-on-recruitment-retention-and-engagement-of-schools-children-and-their-families-in-the-cluster-randomised-controlled-trial-of-the-healthy-lifestyles-programme-help-a-school-based-intervention-to-prevent-obesity
#4
J Lloyd, C McHugh, J Minton, H Eke, K Wyatt
BACKGROUND: Recruitment and retention of participants is crucial for statistical power and internal and external validity and participant engagement is essential for behaviour change. However, many school-based interventions focus on programme content rather than the building of supportive relationships with all participants and tend to employ specific standalone strategies, such as incentives, to improve retention. We believe that actively involving stakeholders in both intervention and trial design improves recruitment and retention and increases the chances of creating an effective intervention...
August 14, 2017: Trials
https://www.readbyqxmd.com/read/28806908/changing-the-default-for-tobacco-cessation-treatment-in-an-inpatient-setting-study-protocol-of-a-randomized-controlled-trial
#5
Babalola Faseru, Edward F Ellerbeck, Delwyn Catley, Byron J Gajewski, Taneisha S Scheuermann, Theresa I Shireman, Laura M Mussulman, Niaman Nazir, Terry Bush, Kimber P Richter
BACKGROUND: Most health care providers do not treat tobacco dependence routinely. This may in part be due to the treatment "default." Current treatment guidelines recommend that providers (1) ask patients if they are willing to quit and (2) provide cessation-focused medications and counseling only to smokers who state that they are willing to quit. The default is that patients have to "opt in" to receive cessation assistance: providers ask smokers if they are willing to quit, and only offer medications and cessation support to those who say "yes...
August 14, 2017: Trials
https://www.readbyqxmd.com/read/28806907/effect-of-acupuncture-and-its-influence-on-cerebral-activity-in-perimenopausal-insomniacs-study-protocol-for-a-randomized-controlled-trial
#6
Xiao Wu, Wei Zhang, Yuanyuan Qin, Xuguang Liu, Zhengyan Wang
BACKGROUND: Perimenopausal insomnia is one of the core symptoms of the menopausal transition. Acupuncture is considered to exert a positive effect on restoring the normal sleep-wake cycle. However, there is little intuitive evidence besides evaluation using clinical effectiveness scales. We therefore designed this study, aiming to use more intuitive and reliable detection techniques such as functional magnetic resonance imaging before and after applying acupuncture to provide neuroimaging evidence, as well as to verify the effectiveness with other curative effect indicators...
August 14, 2017: Trials
https://www.readbyqxmd.com/read/28800778/effects-of-intraoperative-peep-optimization-on-postoperative-pulmonary-complications-and-the-inflammatory-response-study-protocol-for-a-randomized-controlled-trial
#7
Zoltán Ruszkai, Erika Kiss, Ildikó László, Fanni Gyura, Erika Surány, Péter Töhötöm Bartha, Gergely Péter Bokrétás, Edit Rácz, István Buzogány, Zoltán Bajory, Erzsébet Hajdú, Zsolt Molnár
BACKGROUND: Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs. Recent studies show benefits of lung-protective mechanical ventilation with the use of low tidal volumes, a moderate level of positive end-expiratory pressure (PEEP) and regular alveolar recruitment maneuvers during general anesthesia, even in patients with healthy lungs. The purpose of this clinical trial is to evaluate the effects of intraoperative lung-protective mechanical ventilation, using individualized PEEP values, on postoperative pulmonary complications and the inflammatory response...
August 11, 2017: Trials
https://www.readbyqxmd.com/read/28800755/the-influence-of-3%C3%A2-months-of-physical-exercises-and-verbal-stimulation-on-functional-efficiency-and-use-of-free-time-in-an-older-population-under-institutional-care-study-protocol-for-a-randomized-controlled-trial
#8
Agnieszka Wiśniowska-Szurlej, Agnieszka Ćwirlej-Sozańska, Anna Wilmowska-Pietruszyńska, Natalia Milewska, Bernard Sozański
BACKGROUND: In recent years, there has been a significant change in the demographics of developed countries, including an increase in the number of older people. This aging population and the associated need for medical care and assistance places great strain on health care systems worldwide. In older populations, improved knowledge and understanding of the relationship between moderate exercise and health might result in greater motivation to engage in such activity; thus improving the overall health of this population...
August 11, 2017: Trials
https://www.readbyqxmd.com/read/28797307/using-smartphones-to-decrease-substance-use-via-self-monitoring-and-recovery-support-study-protocol-for-a-randomized-control-trial
#9
Christy K Scott, Michael L Dennis, David H Gustafson
BACKGROUND: Alcohol abuse, other substance use disorders, and risk behaviors associated with the human immunodeficiency virus (HIV) represent three of the top 10 modifiable causes of mortality in the US. Despite evidence that continuing care is effective in sustaining recovery from substance use disorders and associated behaviors, patients rarely receive it. Smartphone applications (apps) have been effective in delivering continuing care to patients almost anywhere and anytime. This study tests the effectiveness of two components of such apps: ongoing self-monitoring through Ecological Momentary Assessments (EMAs) and immediate recovery support through Ecological Momentary Interventions (EMIs)...
August 10, 2017: Trials
https://www.readbyqxmd.com/read/28797281/the-efficacy-of-transcutaneous-electrical-nerve-stimulation-on-the-improvement-of-walking-distance-in-patients-with-peripheral-arterial-disease-with-intermittent-claudication-study-protocol-for-a-randomised-controlled-trial-the-tens-pad-study
#10
Florent Besnier, Jean-Michel Sénard, Vincent Grémeaux, Mélanie Riédel, Damien Garrigues, Thibaut Guiraud, Marc Labrunée
BACKGROUND: In patients with peripheral arterial disease (PAD), walking improvements are often limited by early pain onset due to vascular claudication. It would thus appear interesting to develop noninvasive therapeutic strategies, such as transcutaneous electrical nerve stimulation (TENS), to improve the participation of PAD patients in rehabilitation programmes, and thus improve their quality of life. Our team recently tested the efficacy of a single 45-min session of 10-Hz TENS prior to walking...
August 10, 2017: Trials
https://www.readbyqxmd.com/read/28793919/prevention-of-diabetes-in-overweight-obese-children-through-a-family-based-intervention-program-including-supervised-exercise-predikid-project-study-protocol-for-a-randomized-controlled-trial
#11
Lide Arenaza, María Medrano, María Amasene, Beatriz Rodríguez-Vigil, Ignacio Díez, Manuel Graña, Ignacio Tobalina, Edurne Maiz, Edurne Arteche, Eider Larrarte, Inge Huybrechts, Catherine L Davis, Jonatan R Ruiz, Francisco B Ortega, Javier Margareto, Idoia Labayen
BACKGROUND: The global pandemic of obesity has led to an increased risk for prediabetes and type-2 diabetes (T2D). The aims of the current project are: (1) to evaluate the effect of a 22-week family based intervention program, including supervised exercise, on insulin resistance syndrome (IRS) risk in children with a high risk of developing T2D and (2) to identify the profile of microRNA in circulating exosomes and in peripheral blood mononuclear cells in children with a high risk of developing T2D and its response to a multidisciplinary intervention program including exercise...
August 10, 2017: Trials
https://www.readbyqxmd.com/read/28793916/a-manual-based-vocational-rehabilitation-program-for-patients-with-an-acquired-brain-injury-study-protocol-of-a-pragmatic-randomized-controlled-trial-rct
#12
Louise K Hoeffding, Maria Haahr Nielsen, Morten A Rasmussen, Anne Norup, Juan Carlos Arango-Lasprilla, Ulrikka K Kjær, Kristoffer Sølvsten Burgdorf, Trine Schow
BACKGROUND: An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed. Therefore, the aim of this study is to evaluate the effect of an individually targeted manual-based VR for patient with ABI compared to conventional VR (usual care)...
August 10, 2017: Trials
https://www.readbyqxmd.com/read/28793921/standardising-the-reporting-of-outcomes-in-gastric-cancer-surgery-trials-protocol-for-the-development-of-a-core-outcome-set-and-accompanying-outcome-measurement-instrument-set-the-gastros-study
#13
Bilal Alkhaffaf, Anne-Marie Glenny, Jane M Blazeby, Paula Williamson, Iain A Bruce
BACKGROUND: Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools - a 'core outcome set' (COS) - to be used by all future trials examining therapeutic surgical interventions for gastric cancer...
August 9, 2017: Trials
https://www.readbyqxmd.com/read/28784181/effectiveness-of-a-low-fructose-and-or-low-sucrose-diet-in-decreasing-insulin-resistance-disfrute-study-study-protocol-for-a-randomized-controlled-trial
#14
Santiago Domínguez Coello, Lourdes Carrillo Fernández, Jesús Gobierno Hernández, Manuel Méndez Abad, Carlos Borges Álamo, José Antonio García Dopico, Armando Aguirre Jaime, Antonio Cabrera de León
BACKGROUND: Research published to date on the relationship between insulin resistance (IR) and fructose consumption is scarce, has used different methods, and has yielded sometimes contradictory results. This study aims to determine whether a low-fructose and/or low-sucrose diet supervised by a physician or nurse decreases IR compared to a standard diet. METHODS/DESIGN: This field trial is located at primary care centers. The participants are adults aged 29 to 66 years, with a Body mass Index (BMI) between 29 and 40...
August 7, 2017: Trials
https://www.readbyqxmd.com/read/28784142/to-evaluate-if-increased-supervision-and-support-of-south-african-government-health-workers-home-visits-improves-maternal-and-child-outcomes-study-protocol-for-a-randomized-control-trial
#15
Mary Jane Rotheram-Borus, Karl Le Roux, Ingrid M Le Roux, Joan Christodoulou, Christina Laurenzi, Nokwanele Mbewu, Mark Tomlinson
BACKGROUND: Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in research evaluations, efficacy disappears when programs are scaled broadly. In this cluster randomized controlled trial (RCT), we examine whether the benefits of ongoing accountability and supervision within an existing government funded and implemented community health workers (CHW) home visiting program ensure the effectiveness of home visiting...
August 7, 2017: Trials
https://www.readbyqxmd.com/read/28778175/jail-to-community-treatment-continuum-for-adults-with-co-occurring-substance-use-and-mental-disorders-study-protocol-for-a-pilot-randomized-controlled-trial
#16
Richard A Van Dorn, Sarah L Desmarais, Candalyn B Rade, Elizabeth N Burris, Gary S Cuddeback, Kiersten L Johnson, Stephen J Tueller, Megan L Comfort, Kim T Mueser
BACKGROUND: Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population...
August 4, 2017: Trials
https://www.readbyqxmd.com/read/28778174/determining-the-efficacy-of-guppies-and-pyriproxyfen-sumilarv%C3%A2-2mr-combined-with-community-engagement-on-dengue-vectors-in-cambodia-study-protocol-for-a-randomized-controlled-trial
#17
John Hustedt, Dyna Doum, Vanney Keo, Sokha Ly, BunLeng Sam, Vibol Chan, Neal Alexander, John Bradley, Didot Budi Prasetyo, Agus Rachmat, Shafique Muhammad, Sergio Lopes, Rithea Leang, Jeffrey Hii
BACKGROUND: Evidence on the effectiveness of low-cost, sustainable, biological vector-control tools for the Aedes mosquitoes is limited. Therefore, the purpose of this trial is to estimate the impact of guppy fish (guppies), in combination with the use of the larvicide pyriproxyfen (Sumilarv® 2MR), and Communication for Behavioral Impact (COMBI) activities to reduce entomological indices in Cambodia. METHODS/DESIGN: In this cluster randomized controlled, superiority trial, 30 clusters comprising one or more villages each (with approximately 170 households) will be allocated, in a 1:1:1 ratio, to receive either (1) three interventions (guppies, Sumilarv® 2MR, and COMBI activities), (2) two interventions (guppies and COMBI activities), or (3) control (standard vector control)...
August 4, 2017: Trials
https://www.readbyqxmd.com/read/28778170/development-of-a-core-outcome-set-for-orthodontic-trials-using-a-mixed-methods-approach-protocol-for-a-multicentre-study
#18
Aliki Tsichlaki, Kevin O'Brien, Ama Johal, Zoe Z Marshman, Philip P Benson, Fiorella B Colonio Salazar, Padhraig S Fleming
BACKGROUND: Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people...
August 4, 2017: Trials
https://www.readbyqxmd.com/read/28774339/measurement-education-and-tracking-in-integrated-care-metric-use-of-a-culturally-adapted-education-tool-versus-standard-education-to-increase-engagement-in-depression-treatment-among-hispanic-patients-study-protocol-for-a-randomized-control-trial
#19
Katherine Sanchez, Brittany H Eghaneyan, Michael O Killian, Leopoldo Cabassa, Madhukar H Trivedi
BACKGROUND: Significant mental health disparities exist for Hispanic populations, especially with regard to depression treatment. Stigma and poor communication between patients and their providers result in low use of antidepressant medications and early treatment withdrawal. Cultural factors which influence treatment decisions among Hispanics include fears about the addictive and harmful properties of antidepressants, worries about taking too many pills, and the stigma attached to taking medications...
August 3, 2017: Trials
https://www.readbyqxmd.com/read/28774317/measuring-the-effect-of-nurse-practitioner-np-led-care-on-health-related-quality-of-life-in-adult-patients-with-atrial-fibrillation-study-protocol-for-a-randomized-controlled-trial
#20
Marcie J Smigorowsky, Colleen M Norris, Micheal Sean McMurtry, Ross T Tsuyuki
BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia associated with significant morbidity, mortality, and healthcare resource use. The prevalence of AF is increasing with a growing and aging population, and timely access to care for these patients is a concern. Nontraditional models of care delivery, such as nurse practitioner (NP)-led clinics, may improve access to care and quality of care, but they require formal assessment. The objective of this study is to assess the effect of NP-led care on the health-related quality of life (HRQoL) of adult patients with AF...
August 3, 2017: Trials
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