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https://www.readbyqxmd.com/read/28545508/open-label-versus-double-blind-placebo-treatment-in-irritable-bowel-syndrome-study-protocol-for-a-randomized-controlled-trial
#1
Sarah Ballou, Ted J Kaptchuk, William Hirsch, Judy Nee, Johanna Iturrino, Kathryn T Hall, John M Kelley, Vivian Cheng, Irving Kirsch, Eric Jacobson, Lisa Conboy, Anthony Lembo, Roger B Davis
BACKGROUND: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo...
May 25, 2017: Trials
https://www.readbyqxmd.com/read/28540977/oral-contraceptive-pill-progestogen-or-oestrogen-pretreatment-for-ovarian-stimulation-protocols-for-women-undergoing-assisted-reproductive-techniques
#2
REVIEW
Cindy Farquhar, Luk Rombauts, Jan Am Kremer, Anne Lethaby, Reuben Olugbenga Ayeleke
BACKGROUND: Among subfertile women undergoing assisted reproductive technology (ART), hormone pills given before ovarian stimulation may improve outcomes. OBJECTIVES: To determine whether pretreatment with the combined oral contraceptive pill (COCP) or with a progestogen or oestrogen alone in ovarian stimulation protocols affects outcomes in subfertile couples undergoing ART. SEARCH METHODS: We searched the following databases from inception to January 2017: Cochrane Gynaecology and Fertility Group Specialised Register, The Cochrane Central Register Studies Online, MEDLINE, Embase, CINAHL and PsycINFO...
May 25, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28536655/supporting-looked-after-children-and-care-leavers-in-decreasing-drugs-and-alcohol-solid-protocol-for-a-pilot-feasibility-randomised-controlled-trial-of-interventions-to-decrease-risky-substance-use-drugs-and-alcohol-and-improve-mental-health-of-looked-after
#3
Hayley Alderson, Ruth McGovern, Rebecca Brown, Denise Howel, Frauke Becker, Louise Carr, Alex Copello, Tony Fouweather, Eileen Kaner, Paul McArdle, Elaine McColl, Janet Shucksmith, Alison Steele, Luke Vale, Raghu Lingam
BACKGROUND: Looked after children (LAC) and care leavers are young people who have been placed under the legal care of local authorities, in many instances due to a history of abuse and/or neglect. These young people have a significantly increased risk of substance use and mental disorder compared to their peers. The aim of the SOLID study is to assess the feasibility and acceptability of a definitive three-arm multi-centre randomised controlled trial (RCT) that compares the effectiveness of two interventions that aim to reduce risky drug and alcohol use and improve mental health among LAC aged 12 to 20 years with usual care...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/28535964/income-is-an-independent-risk-factor-for-worse-asthma-outcomes
#4
Juan Carlos Cardet, Margee Louisias, Tonya S King, Mario Castro, Christopher D Codispoti, Ryan Dunn, Linda Engle, B Louise Giles, Fernando Holguin, John J Lima, Dayna Long, Njira Lugogo, Sharmilee Nyenhuis, Victor E Ortega, Sima Ramratnam, Michael E Wechsler, Elliot Israel, Wanda Phipatanakul
BACKGROUND: Socioeconomic status (SES) is associated with asthma morbidity in observational studies but the factors underlying this association are uncertain. OBJECTIVE: We investigated whether three SES correlates-low income, low education, and high perceived stress- were independent risk factors for treatment failure and asthma exacerbations in the context of a randomized controlled trial (RCT). METHODS: The effect of low SES [household income (defined as <$50,000/year), household educational level (defined as less than a bachelor's degree) and high perceived stress (defined as a score of >20 on a perceived stress scale)] on asthma morbidity was analyzed in 381 participants utilizing Poisson regression models...
May 20, 2017: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28535887/discrepancies-between-protocols-and-publications-of-clinical-drug-trials-results-of-an-inception-cohort-study
#5
Cornelis A van den Bogert, Patrick C Souverein, Cecile Tm Brekelmans, Susan Wj Janssen, Gerard H Koëter, Hubert Gm Leufkens, Lex M Bouter
OBJECTIVE: To identify the occurrence and determinants of protocol-publication discrepancies in clinical drug trials. STUDY DESIGN AND SETTING: All published clinical drug trials reviewed by the Dutch Institutional Review Boards in 2007 were analyzed. Discrepancies between trial protocols and publications were measured among key reporting aspects. We evaluated the association of trial characteristics with discrepancies in primary endpoints by calculating the risk ratio (RR) and 95% confidence interval (CI)...
May 20, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28533916/pediatric-intensive-care-stress-ulcer-prevention-pic-up-a-protocol-for-a-pilot-randomized-trial
#6
Mark Duffett, Karen Choong, Jennifer Foster, Elaine Gilfoyle, Jacques Lacroix, Nikhil Pai, Lehana Thabane, Deborah J Cook
BACKGROUND: Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences-increasing the risk of nosocomial infections-which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot RCT is crucial...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/28533319/evaluating-the-cardiovascular-safety-of-nonsteroidal-anti-inflammatory-drugs
#7
REVIEW
Elliott M Antman
Some drugs used to treat noncardiovascular conditions may adversely impact the cardiovascular status of individuals both with and without known cardiovascular disease. When the US Food and Drug Administration judges the potential cardiovascular safety signal to be of sufficient concern, it may require the pharmaceutical manufacturer of the drug in question to conduct a postmarketing (phase 4) randomized controlled trial (RCT). Although historically many phase 4 RCTs focused on efficacy (using a superiority design), contemporary phase 4 RCTs often are focused on safety and use a noninferiority design...
May 23, 2017: Circulation
https://www.readbyqxmd.com/read/28532499/laparoscopic-roux-en-y-gastric-bypass-versus-laparoscopic-mini-gastric-bypass-in-the-treatment-of-obesity-study-protocol-for-a-randomized-controlled-trial
#8
Marko Kraljević, Tarik Delko, Thomas Köstler, Elena Osto, Thomas Lutz, Sarah Thommen, Raoul A Droeser, Lincoln Rothwell, Daniel Oertli, Urs Zingg
BACKGROUND: Laparoscopic Roux-en-Y gastric bypass (LRYGB) is considered the gold standard in bariatric surgery, achieving durable long-term weight loss with improvement of obesity-related comorbidities. Lately, the laparoscopic mini gastric bypass (LMGB) has gained worldwide popularity with similar results to LRYGB in terms of weight loss and comorbidity resolution. However, there is a lack of randomized controlled trials (RCT) comparing LMGB and LRYGB. This article describes the design and protocol of a randomized controlled trial comparing the outcomes of these two bariatric procedures...
May 22, 2017: Trials
https://www.readbyqxmd.com/read/28532478/study-protocol-a-double-blind-randomised-control-trial-of-high-volume-image-guided-injections-in-achilles-and-patellar-tendinopathy-in-a-young-active-population
#9
Robert M Barker-Davies, Alastair Nicol, I McCurdie, James Watson, Polly Baker, Patrick Wheeler, Daniel Fong, Mark Lewis, Alexander N Bennett
BACKGROUND: Chronic tendinopathy is a significant problem particularly in active populations limiting sporting and occupational performance. The prevalence of patellar tendinopathy in some sports is near 50% and the incidence of lower limb tendinopathy is 1.4% p.a. in the UK Military. Management includes isometric, eccentric, heavy slow resistance exercises and extracorporeal shockwave therapy (ESWT). Often these treatments are inadequate yet there is no good evidence for injection therapies and success rates from surgery can be as low as 50%...
May 22, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28526087/a-multimodal-day-treatment-program-for-multi-problem-young-adults-study-protocol-for-a-randomized-controlled-trial
#10
Marie-Jolette A Luijks, Floor Bevaart, Josjan Zijlmans, Laura van Duin, Reshmi Marhe, Theo A H Doreleijers, Henning Tiemeier, Jessica J Asscher, Arne Popma
BACKGROUND: Effective interventions for young adults with severe, multiple problems - such as psychosocial and psychiatric problems, delinquency, unemployment and substance use - are scarce but urgently needed in order to support an adequate transition to adulthood. A multimodal day treatment program called "New Opportunities" (in Dutch: "De Nieuwe Kans"; DNK) was specifically developed to target multi-problem young adults in The Netherlands. The aim of this study protocol is to describe the design of a randomized controlled trial (RCT) in clinical practice to examine the effectiveness of DNK in comparison with care as usual (CAU)...
May 19, 2017: Trials
https://www.readbyqxmd.com/read/28526060/comparison-of-the-effect-of-oral-care-with-four-different-antiseptics-to-prevent-ventilator-associated-pneumonia-in-adults-protocol-for-a-network-meta-analysis
#11
Zhigang Zhang, Yuying Hou, Jun Zhang, Bo Wang, Juxia Zhang, Ailing Yang, Ge Li, Jinhui Tian
BACKGROUND: Ventilator-associated pneumonia (VAP) is defined as the occurrence of pneumonia in patients receiving mechanical ventilation for more than 48 h after endotracheal intubation. The implementation of effective oral care with antiseptics may reduce the incidence of ventilator-associated pneumonia. However, previous studies have been unclear about the best antiseptic for this purpose. Therefore, present protocol proposed to perform a network meta-analysis to evaluate the efficacy of different antiseptics to prevent ventilator-associated pneumonia...
May 19, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28526046/balloon-versus-stenting-in-severe-ischaemia-of-the-leg-3-basil-3-study-protocol-for-a-randomised-controlled-trial
#12
Benjamin D Hunt, Matthew A Popplewell, Huw Davies, Lewis Meecham, Hugh Jarrett, Gareth Bate, Margaret Grant, Smitaa Patel, Catherine Hewitt, Lazaros Andronis, Jonathan J Deeks, Andrew Bradbury
BACKGROUND: Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources...
May 19, 2017: Trials
https://www.readbyqxmd.com/read/28521796/effects-of-nurse-telesupport-on-transition-between-specialized-and-primary-care-in-diabetic-patients-study-protocol-for-a-randomized-controlled-trial
#13
Ana Marina Moreira, Roberta Marobin, Dimitris Varvaki Rados, Camila Bergonsi de Farias, Sabrina Coelli, Bárbara Luiza Bernardi, Lívia de Almeida Faller, Laura Ferraz Dos Santos, Ana Maria Matzenbacher, Natan Katz, Erno Harzheim, Sandra Pinho Silveiro
BACKGROUND: According to the Global Diabetes Plan, a unified health system with preventive and educational strategies is essential to proper diabetes care and primary settings should be the main site of care. In Brazil, there is limited access to outpatient hospital diabetes services, while primary-care diabetes support is underutilized. Telemedicine can be a useful adjunct to support discharge of stable patients with type 2 diabetes to the primary care setting. In this paper, we present a randomized controlled trial (RCT) protocol designed to evaluate the effects of telehealth support for stable type 2 diabetes patients discharged from hospital outpatient diabetes clinics...
May 18, 2017: Trials
https://www.readbyqxmd.com/read/28515957/a-psychologically-informed-audiologist-delivered-manualised-intervention-for-tinnitus-protocol-for-a-randomised-controlled-feasibility-trial-tin-man-study
#14
John A Taylor, Deborah A Hall, Dawn-Marie Walker, Mary McMurran, Amanda Casey, David Stockdale, Debbie Featherstone, Dean M Thompson, Carol MacDonald, Derek J Hoare
BACKGROUND: Chronic tinnitus is a common incurable condition often associated with depression, anxiety, insomnia and reduced quality of life. Within National Health Service (NHS) audiology in the United Kingdom (UK), no standard protocol currently exists for the treatment of tinnitus. Counselling is only available in less than half of audiology departments, and there is no agreed standard for what constitutes tinnitus counselling. There is substantial evidence from systematic reviews for the clinical benefit of cognitive behaviour therapy (CBT) for tinnitus delivered by clinical psychologists or psychiatrists, but no studies have sufficiently evidenced the NHS model of tinnitus care where management is increasingly being delivered by audiology professionals...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/28507993/enhanced-recovery-after-emergency-surgery-a-systematic-review
#15
REVIEW
Mihai Paduraru, Luca Ponchietti, Isidro Martinez Casas, Peter Svenningsen, Mauro Zago
OBJECTIVE: To evaluate the current scientific evidence for the applicability, safety and effectiveness of pathways of enhanced recovery after emergency surgery (ERAS). METHODS: We undertook a search using PubMed and Cochrane databases for ERAS protocols in emergency cases. The search generated 65 titles; after eliminating the papers not meeting search criteria, we selected 4 cohort studies and 1 randomized clinical trial (RCT). Data extracted for analysis consisted of: patient age, type of surgery performed, ERAS elements implemented, surgical outcomes in terms of postoperative complications, mortality, length of stay (LOS) and readmission rate...
April 2017: Bulletin of Emergency and Trauma
https://www.readbyqxmd.com/read/28501812/integrating-culturally-informed-approaches-into-the-physiotherapy-assessment-and-treatment-of-chronic-pain-protocol-for-a-pilot-randomised-controlled-trial
#16
Bernadette Brady, Irena Veljanova, Siobhan Schabrun, Lucinda Chipchase
INTRODUCTION: There is strong evidence that biopsychosocial approaches are efficacious in the management of chronic pain. However, implementation of these approaches in clinical practice is known not to account for the beliefs and values of culturally and linguistically diverse (CALD) patients. This limitation in translation of research contributes to the disparities in outcomes for CALD patients with chronic pain adding to the socioeconomic burden of this prevalent condition. Cultural adaptation of chronic pain assessment and management is urgently required...
May 12, 2017: BMJ Open
https://www.readbyqxmd.com/read/28498880/a-two-arm-multicenter-phase-ii-trial-of-one-cycle-chemoselection-split-dose-docetaxel-cisplatin-and-5-fluorouracil-tpf-induction-chemotherapy-before-two-cycles-of-split-tpf-followed-by-curative-surgery-combined-with-postoperative-radiotherapy-in-patients-with
#17
J Inhestern, H Schmalenberg, A Dietz, N Rotter, G Maschmeyer, M Jungehülsing, C Grosse-Thie, T Kuhnt, M Görner, H Sudhoff, C Wittekindt, O Guntinas-Lichius
Background: : Induction chemotherapy (ICT) with docetaxel, cisplatin and fluorouracil (TPF) followed by radiotherapy is an effective treatment option for locally advanced head and neck cancer. This phase II study investigated the effectivity of a split-dose TPF ICT prior to surgery for locally advanced resectable (stage III/IVA) oral and oropharyngeal cancer. Patients and methods: : Patients received TPF split on two dosages on day 1 and 8 per cycle (30 mg/m 2 docetaxel, 40 mg/m 2 cisplatin, 2000 mg/m 2 fluorouracil per week)...
May 11, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28494802/reducing-depressive-symptomatology-with-a-smartphone-app-study-protocol-for-a-randomized-placebo-controlled-trial
#18
Cezar Giosan, Oana Cobeanu, Cristina Mogoaşe, Aurora Szentagotai, Vlad Mureşan, Rareș Boian
BACKGROUND: Depression has become one of the leading contributors to the global disease burden. Evidence-based treatments for depression are available, but access to them is still limited in some instances. As technology has become more integrated into mental health care, computerized cognitive behavioral therapy (CBT) protocols have become available and have been recently transposed to mobile environments (e.g., smartphones) in the form of "apps." Preliminary research on some depression apps has shown promising results in reducing subthreshold or mild to moderate depressive symptoms...
May 12, 2017: Trials
https://www.readbyqxmd.com/read/28487264/optimizing-protein-intake-and-nitrogen-balance-opinib-in-adult-critically-ill-patients-a-study-protocol-for-a-randomized-controlled-trial
#19
Matteo Danielis, Giulia Lorenzoni, Laura Cavaliere, Mariangela Ruffolo, Luca Peressoni, Amato De Monte, Rodolfo Muzzi, Fabio Beltrame, Dario Gregori
BACKGROUND: Adequate nutrition of critically ill patients plays a key role in the modulation of metabolic response to stress. OBJECTIVE: This paper presents the development of a protocol for a randomized controlled trial (RCT) aimed at comparing clinical outcomes of patients in the intensive care unit (ICU) administered with standard and protein-fortified diet. Together with the RCT study protocol, the results of the observational analysis conducted to assess the feasibility of the RCT are presented...
May 9, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28486704/cost-effectiveness-analysis-of-lifestyle-intervention-in-obese-infertile-women
#20
A M van Oers, M A Q Mutsaerts, J M Burggraaff, W K H Kuchenbecker, D A M Perquin, C A M Koks, R van Golde, E M Kaaijk, J M Schierbeek, N F Klijn, Y M van Kasteren, J A Land, B W J Mol, A Hoek, H Groen
STUDY QUESTION: What is the cost-effectiveness of lifestyle intervention preceding infertility treatment in obese infertile women? SUMMARY ANSWER: Lifestyle intervention preceding infertility treatment as compared to prompt infertility treatment in obese infertile women is not a cost-effective strategy in terms of healthy live birth rate within 24 months after randomization, but is more likely to be cost-effective using a longer follow-up period and live birth rate as endpoint...
May 9, 2017: Human Reproduction
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