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Randomized-controlled trial

Yao Cheng, Jie Xia, Mingliang Lai, Nansheng Cheng, Sirong He
BACKGROUND: The use of surgical drains has been considered mandatory after pancreatic surgery. The role of prophylactic abdominal drainage to reduce postoperative complications after pancreatic surgery is controversial. OBJECTIVES: To assess the benefits and harms of routine abdominal drainage after pancreatic surgery, compare the effects of different types of surgical drains, and evaluate the optimal time for drain removal. SEARCH METHODS: For the initial version of this review, we searched the Cochrane Library (2015, Issue 3), MEDLINE (1946 to 9 April 2015), Embase (1980 to 9 April 2015), Science Citation Index Expanded (1900 to 9 April 2015), and Chinese Biomedical Literature Database (CBM) (1978 to 9 April 2015)...
October 21, 2016: Cochrane Database of Systematic Reviews
Paolo Prandoni, Enrico Bernardi, Fabio Dalla Valle, Adriana Visonà, Pietro F Tropeano, Carlo Bova, Eugenio Bucherini, Md Shahidul Islam, Andrea Piccioli
Patients with unprovoked venous thromboembolism (VTE) may harbor occult cancer. Whether an extensive diagnostic work-up for cancer has additional value over a more limited screening for detection of underlying malignancy in these patients is controversial. We performed a randomized multicenter trial to assess if in patients with unprovoked VTE, a computed tomography (CT)-based diagnostic strategy including thoracic, abdominal, and pelvic CT in combination with fecal occult blood test yields a higher cancer detection rate than a nonstandardized testing approach based on physicians' clinical judgment and patients' preferences...
October 20, 2016: Seminars in Thrombosis and Hemostasis
Sun Mi Choi, Jinwoo Lee, Young Sik Park, Chang-Hoon Lee, Sang-Min Lee, Jae-Joon Yim
BACKGROUND: Patients undergoing flexible bronchoscopy usually experience anxiety before and during the procedure. OBJECTIVES: We performed this study to investigate whether verbal empathy and intentional touch from a bronchoscopist could reduce anxiety in patients undergoing flexible bronchoscopy. METHODS: We conducted a prospective randomized trial in a university-affiliated hospital. Participants were randomly assigned to one of the following groups: a control group, a verbal empathy group, or a verbal empathy and touch group...
October 21, 2016: Respiration; International Review of Thoracic Diseases
Rodrigo Hagemann, Vanessa Dos Santos Silva, Fábio Cardoso Carvalho, Pasqual Barretti, Luis Cuadrado Martin, Diana Vassallo, Philip A Kalra, Roberto Jorge da Silva Franco
BACKGROUND: To date, renal revascularization has not been shown to be advantageous when compared to optimized medical treatment in patients with atheromatous renovascular disease (ARVD). This study aims to investigate the effect of revascularization in patients with pre-intervention worsening renal function and in those with stable renal function. PATIENTS AND METHODS: In this single-centre observational study, patients who were diagnosed with at least 60% angiographic stenosis unilaterally or bilaterally between January 1996 and October 2008 and who were followed-up until February 2011 were retrospectively analysed...
October 21, 2016: Nephron
Elisa A Marques, Pedro Figueiredo, Tamara B Harris, Flávia A Wanderley, Joana Carvalho
This study aimed to compare the magnitude of knee muscle strength and static and dynamic balance change in response to 8 months of progressive RE and AE training in healthy community-dwelling older women. A secondary aim was to assess the relationship between muscle strength and balance changes (up and go test (UGT), one-leg stance test, and center of pressure measures). This study was a secondary analysis of longitudinal data from a randomized controlled trial, a three-arm intervention study in older women (n=71, mean age 69...
October 11, 2016: Archives of Gerontology and Geriatrics
D Bogdanou, M Penna-Martinez, N Filmann, T L Chung, Y Moran-Auth, J Wehrle, C Cappel, S Huenecke, E Herrmann, U Koehl, K Badenhoop
BACKGROUND: Type 1 diabetes mellitus (T1D) is mediated by autoaggressive T effector cells with an underlying regulatory T cell (Treg) defect. Vitamin D (VD) deficiency is highly prevalent in T1D which can aggravate immune dysfunction. High dose VD treatment may enhance Tregs and improve metabolism in T1D patients. METHODS: In a randomized, double-blind, placebo-controlled trial with cross-over design, patients received either for three months cholecalciferol 4000 IU/d, followed by three months placebo or the sequential alternative...
October 20, 2016: Diabetes/metabolism Research and Reviews
Linda Resnik, Sarah Ekerholm, Erin E Johnson, Marsha L Ellison, Thomas P O'Toole
OBJECTIVE: Veterans Affairs (VA) is expanding peer support. Research is limited on Veterans' perspective on benefits from peer services. We describe homeless Veteran perceptions of value and examine characteristics associated with benefit. METHOD: From a sample of Veterans in a multisite randomized control trial, we studied addition of peers in VA Primary Care and homeless-oriented primary care clinics. We used qualitative methods to study the perceptions of peer services among a subsample of homeless Veterans...
October 20, 2016: Journal of Clinical Psychology
Steffen T Simon, Irene J Higginson, Sara Booth, Richard Harding, Vera Weingärtner, Claudia Bausewein
BACKGROUND: This is an updated version of the original Cochrane review published in Issue 1, 2010, on 'Benzodiazepines for the relief of breathlessness in advanced malignant and non-malignant diseases in adults'. Breathlessness is one of the most common symptoms experienced in the advanced stages of malignant and non-malignant disease. Benzodiazepines are widely used for the relief of breathlessness in advanced diseases and are regularly recommended in the literature. At the time of the previously published Cochrane review, there was no evidence for a beneficial effect of benzodiazepines for the relief of breathlessness in people with advanced cancer and chronic obstructive pulmonary disease (COPD)...
October 20, 2016: Cochrane Database of Systematic Reviews
Mu Qin, Xu Liu, Shao-Hui Wu, Xiao-Dong Zhang
Several clinically relevant outcomes post atrial substrate modification in patients with atrial fibrillation (AF) have not been systematically analyzed among published studies on adjunctive cardiac ganglionated plexi (GP) or complex fractionated atrial electograms (CFAE) ablation vs. pulmonary vein isolation (PVI) alone. Out of 176 reports identified, the present meta-analysis included 14 randomized and non-randomized controlled trials (1613 patients) meeting inclusion criteria. Addition of GP ablation to PVI significantly increased freedom from atrial tachyarrhythmia in short- (OR: 1...
2016: PloS One
H MacPherson, E A Vertosick, N E Foster, G Lewith, K Linde, K J Sherman, C M Witt, A J Vickers
There is uncertainty regarding how long the effects of acupuncture treatment persist after a course of treatment. We aimed to determine the trajectory of pain scores over time following acupuncture, using a large individual patient dataset from high quality randomized trials of acupuncture for chronic pain. The available individual patient dataset included 29 trials and 17,922 patients. The chronic pain conditions included musculoskeletal pain (low back, neck and shoulder), osteoarthritis of the knee and headache/migraine...
October 17, 2016: Pain
David Sanders, Dianne Bryant, Christina Tieszer, Abdel Lawendy, Mark MacLeod, Steven Papp, Liew Allan, Viskontas Darius, Coles Chad, Gurr Kevin, Carey Tim, Gofton Wade, Bailey Chris, Bartley Debra, Andrew Trenholm, Stone Trevor, Leighton Ross, Julia Foxall, Mauri Zomar, Kelly Trask
OBJECTIVES: To compare outcomes in elderly patients with intertrochanteric hip fractures treated with either the sliding hip screw (SHS) or InterTAN intramedullary device (IT). DESIGN: Prospective, randomized, multi-centre clinical trial SETTING:: Five level 1 trauma centresPatients/Participants: 249 patients aged 55 years or older with AO/OTA 31A1 (43) and OA/OTA 31A2 (206) fractures were prospectively enrolled and followed for 12 months. INTERVENTION: Computer generated randomization to either IT (n=123) or SHS (n=126)...
September 30, 2016: Journal of Orthopaedic Trauma
J Y Park, K H Kim
OBJECTIVES: The purpose of this clinical trial was to evaluate the effectiveness of a natural extract from Schisandra chinensis for relief of various menopausal symptoms. METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted from January 1, 2014 until January 13, 2015. We recruited women between the ages of 40 and 70 years who complained of menopausal symptoms measured by the Kupperman Index (KI). Patients were randomly assigned to treatment with either an extract from Schisandra chinensis (BMO-30) or placebo...
October 20, 2016: Climacteric: the Journal of the International Menopause Society
Jefferson Luis Vieira, Francisco Yuri Macedo, Alexandre Miguel Benjo, Guilherme V Guimarães, Johanna Paola Contreras, Edimar A Bocchi
INTRODUCTION: Ambient air pollution is associated with adverse cardiovascular events. This meta-analysis aimed to investigate the short-term association between air pollution and cardiovascular effects on healthy volunteers. METHODS: We searched databases to identify randomized trials with controlled human exposures to either of two models for studying ambient particulate matter: diesel-exhaust or concentrated ambient particles. Estimates of size effect were performed using standardized mean difference (SMD)...
October 20, 2016: Annals of Medicine
Rupert M Pearse, Tom E Abbott, Richard Haslop, Tahania Ahmad, Brennan C Kahan, Claudia Filipini, Andrew Rhodes, Marco Ranieri
BACKGROUND: Over 300 million patients undergo surgery worldwide each year. Postoperative morbidity - particularly respiratory complications - are most frequent and severe among high-risk patients undergoing major abdominal surgery. However, standard treatments, like physiotherapy or supplemental oxygen, often fail to prevent these. Preliminary research suggests that prophylactic continuous positive airways pressure (CPAP) can reduce the risk of postoperative respiratory complications...
October 20, 2016: Minerva Anestesiologica
Manish Mehta, Yi Zhou, Philip S K Paty, Medhi Teymouri, Kamran Jafree, Humayun Bakhtawar, Jeffrey Hnath, Paul Feustel
BACKGROUND: This study evaluated the feasibility, safety, and effectiveness of endovascular interventions for common femoral artery (CFA) occlusive disease. METHODS: Using a prospectively maintained multicenter database, we analyzed outcomes in 167 consecutive patients who underwent percutaneous CFA interventions for Rutherford class 3 to class 6 (R3-R6) disease. The standardized treatment approach included primary percutaneous transluminal angioplasty (PTA) only, atherectomy + PTA, and provisional stenting...
August 2016: Journal of Vascular Surgery
Vahideh Lajevardi, Afsaneh Ghayoumi, Robabeh Abedini, Hamed Hosseini, Azadeh Goodarzi, Zahra Akbari, Kosar Hedayat
BACKGROUND: Melasma's high prevalence and profound psychological impact on patients necessitate efficacious, economical, and safe therapeutic interventions. Adjunctive therapies such as tranexamic acid (TA) can enhance the therapeutic effect of standard treatments like hydroquinone 4% cream (HQ). OBJECTIVE: To conduct an assessor- and analyst-blinded, parallel, superiority, randomized controlled trial to compare the clinical efficacy and safety of oral TA plus HQ vs...
October 20, 2016: Journal of Cosmetic Dermatology
Ling-Feng Zeng, Ye Cao, Lu Wang, Yun-Kai Dai, Ling Hu, Qi Wang, Li-Ting Zhu, Wen-Hu Bao, Yuan-Ping Zou, Yun-Bo Chen, Wei-Hua Xu, Wei-Xiong Liang, Ning-Sheng Wang
Current evidence demonstrated certain beneficial effects of medicinal herbs as an adjuvant therapy for post-stroke depression (PSD) in China; Chai-hu (Chinese Thorowax Root, Radix Bupleuri) is an example of a medicinal plant for Liver-Qi regulation (MPLR) in the treatment of PSD. Despite several narrative reports on the antidepressant properties of MPLR, it appears that there are no systematic reviews to summarize its outcome effects. Therefore, the aim of this review was to assess the effectiveness and safety of MPLR adjuvant therapy in patients with PSD...
October 20, 2016: Phytotherapy Research: PTR
F Creamer, A Balfour, S Nimmo, I Foo, J D Norrie, L J Williams, K C Fearon, H M Paterson
BACKGROUND: Combined oral modified-release oxycodone-naloxone may reduce opioid-induced postoperative gut dysfunction. This study examined the feasibility of a randomized trial of oxycodone-naloxone within the context of enhanced recovery for laparoscopic colorectal resection. METHODS: In a single-centre open-label phase II feasibility study, patients received analgesia based on either oxycodone-naloxone or oxycodone. Primary endpoints were recruitment, retention and protocol compliance...
October 20, 2016: British Journal of Surgery
Nasir Hussain, Corey Sermer, Parker J Prusick, Laura Banfield, Amit Atrey, Mohit Bhandari
The two commonly performed surgical techniques used to repair displaced midshaft clavicle fractures are plate fixation or intramedullary nailing; however, despite recent evidence, the optimal method to treat such fractures remains a continued topic of debate. A meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate long term function, complications, and operative duration in adult patients receiving intramedullary nailing in comparison to plating. Seven RCTs and three quasi-randomized trials were included...
October 20, 2016: Scientific Reports
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