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Randomized controled trial

John J Wroblewski, Allen Y Hu
BACKGROUND AND OBJECTIVE: To evaluate the effects of squalamine (OHR-102; Ohr Pharmaceuticals, New York, NY) and ranibizumab (Lucentis; Genentech, South San Francisco, CA) on macular edema (ME) secondary to retinal vein occlusion (RVO). PATIENTS AND METHODS: Twenty consecutive, treatment-naïve patients with RVO-related ME received topical squalamine and intravitreal ranibizumab 0.5 mg for 10 weeks, followed by randomization to continue or discontinue squalamine...
October 1, 2016: Ophthalmic Surgery, Lasers & Imaging Retina
Mandeep S Tamber, Dimitrios Nikas, Alexandra Beier, Lissa C Baird, David F Bauer, Susan Durham, Paul Klimo, Alexander Y Lin, Catherine Mazzola, Catherine McClung-Smith, Laura Mitchell, Rachana Tyagi, Ann Marie Flannery
BACKGROUND: No evidence-based guidelines exist on the role of cranial-molding orthosis (helmet) therapy for patients with positional plagiocephaly. OBJECTIVE: To address the clinical question: "Does helmet therapy provide effective treatment for positional plagiocephaly?" and to make treatment recommendations based on the available evidence. METHODS: The US National Library of Medicine Medline database and the Cochrane Library were queried by using MeSH headings and key words relevant to the objective of this systematic review...
November 2016: Neurosurgery
Lissa C Baird, Paul Klimo, Ann Marie Flannery, David F Bauer, Alexandra Beier, Susan Durham, Alexander Y Lin, Catherine McClung-Smith, Laura Mitchell, Dimitrios Nikas, Mandeep S Tamber, Rachana Tyagi, Catherine Mazzola
BACKGROUND: Evidence-based guidelines are not currently available for the treatment of positional plagiocephaly and, in particular, for the use of physical therapy for treatment. OBJECTIVE: To answer the question: "does physical therapy provide effective treatment for positional plagiocephaly?" Treatment recommendations are created based on the available evidence. METHODS: The PubMed and the Cochrane Library were queried using MeSH headings and key words relevant to the objective of this systematic review...
November 2016: Neurosurgery
Dong-Liang Chen, Yu-Hong Li, Zhi-Juan Wang, Ye-Ke Zhu
Gabapentin has been used as an adjuvant for treatment of cancer pain. Previous studies showed that opioids combined with gabapentin for management of cancer pain reduced the dosage of opioids.The objective of this study was to explore the clinical effect and patients' satisfaction of oxycontin combined with gabapentin in treatment of severe cancer pain. After titration of morphine, 60 severe cancer patients with visual analog score (VAS) more than 7 were randomly divided into trial group (n = 30) and control group (n = 30)...
October 2016: Medicine (Baltimore)
Bin Yu, Miao He, Guang-Yu Cai, Tian-Xiao Zou, Na Zhang
BACKGROUND: Continuous femoral nerve block and fascia iliaca compartment block are 2 traditional anesthesia methods in orthopedic surgeries, but it is controversial which method is better. The objective of this study was to compare the practicality, efficacy, and complications of the 2 modalities in hip replacement surgery in the elderly and to assess the utility of a novel cannula-over-needle set. METHODS: In this prospective, randomized controlled clinical investigation, 60 elderly patients undergoing hip replacement were randomly assigned to receive either continuous femoral nerve block or continuous fascia iliaca compartment block...
October 2016: Medicine (Baltimore)
Lingling He, Xiaoli Liu, Lijia Wang, Zhiyun Yang
The findings regarding the effects of thiazolidinediones (TZDs) in nonalcoholic steatohepatitis (NASH) patients have been inconsistent, and the assessment of different clinical variables for evaluating the effects of TZDs confound a direct comparison of the results of different randomized clinical trials (RCTs), especially with regard to lifestyle changes. In this paper, we performed a meta-analysis of randomized controlled trials to clarify the effects of TZD treatment with and without lifestyle changes on histological markers of NASH and clinical variables related to insulin resistance (IR), hyperlipidemia, and obesity...
October 2016: Medicine (Baltimore)
Gen Sugawara, Yukihiro Yokoyama, Tomoki Ebata, Takashi Mizuno, Tetsuya Yagi, Masahiko Ando, Masato Nagino
OBJECTIVE: To evaluate the optimal duration of antimicrobial prophylaxis in patients undergoing "complicated"' major hepatectomy with extrahepatic bile duct resection. BACKGROUND: To date, 4 randomized controlled trials (RCTs) have assessed the duration of antimicrobial prophylaxis after hepatectomy. However, all of these previous studies involved only "simple" hepatectomy without extrahepatic bile duct resection. METHODS: Patients with suspected hilar obstruction scheduled to undergo complicated hepatectomy after biliary drainage were randomized to 2-day (antibiotic treatment on days 1 and 2) or 4-day (on days 1 to 4) groups...
October 17, 2016: Annals of Surgery
Stephen T McSorley, David Mansouri, Paul G Horgan, Donald C McMillan
No abstract text is available yet for this article.
October 17, 2016: Annals of Surgery
Julian C Harnoss, Isabelle Zelienka, Pascal Probst, Kathrin Grummich, Catharina Müller-Lantzsch, Jonathan M Harnoss, Alexis Ulrich, Markus W Büchler, Markus K Diener
OBJECTIVE: The aim was to investigate available evidence regarding effectiveness and safety of surgical versus conservative treatment of acute appendicitis. SUMMARY OF BACKGROUND DATA: There is ongoing debate on the merits of surgical and conservative treatment for acute appendicitis. METHODS: A systematic literature search (Cochrane Library, Medline, Embase) and hand search of retrieved reference lists up to January 2016 was conducted to identify randomized and nonrandomized studies...
October 17, 2016: Annals of Surgery
Ana Rosa Cunha, Jenifer D'El-Rei, Fernanda Medeiros, Bianca Umbelino, Wille Oigman, Rhian M Touyz, Mario F Neves
BACKGROUND: Epidemiological studies demonstrate an inverse association between serum magnesium and incidence of cardiovascular disease. Diuretics commonly cause hypomagneseamia. METHOD: We evaluated effects of magnesium supplementation on blood pressure (BP) and vascular function in thiazide-treated hypertensive women in a randomized, double-blind, clinical trial. Hypertensive women (40-65 years) on hydrochlorothiazide and mean 24-h BP at least 130/80 mmHg were divided into placebo and supplementation (magnesium chelate 600 mg/day) groups...
October 18, 2016: Journal of Hypertension
Kristian Reich, Craig Leonardi, Mark Lebwohl, Francisco Kerdel, Yukari Okubo, Ricardo Romiti, Orin Goldblum, Ellen B Dennehy, Lisa Kerr, Howard Sofen
BACKGROUND: Scalp is a frequently affected and difficult-to-treat area in psoriasis patients. OBJECTIVES: We assessed the efficacy of ixekizumab in the treatment of patients with scalp psoriasis over 60 weeks using the Psoriasis Scalp Severity Index (PSSI). METHODS: In three Phase 3, multicenter, double-blind, placebo-controlled trials, patients with moderate-to-severe psoriasis in UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224), and UNCOVER-3 (N = 1346) were randomized to subcutaneous 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) after a 160 mg starting dose, or placebo through Week 12...
October 19, 2016: Journal of Dermatological Treatment
V E Radzinskii, I V Kuznetsova, Y B Uspenskaya, N B Repina, Y K Gusak, O M Zubova, D I Burchakov, A A Osmakova
Peri- and postmenopausal women commonly suffer from climacteric symptoms. We evaluated the effectiveness and safety of dietary supplement Amberen to relieve vasomotor and psychosomatic symptoms during the course of a 3-month, randomized, double-blind, placebo-controlled study. General clinical assessment, evaluation using the Greene climacteric test and Spielberger-Hanin test, determination of plasma levels of gonadotropins, estradiol, leptin and apolipoproteins were used to evaluate 42-60-year-old women with vasomotor and psychosomatic menopausal symptoms...
October 2016: Gynecological Endocrinology
Z Zingler, M Pritsch, C J Lux, S Kneist
AIM: To evaluate the correlation between clinical and salivary microbial parameters during treatment with removable orthodontic appliances with or without use of fluoride mouth rinse. MATERIALS AND METHODS: A group of 48 patients completed this randomized, controlled, parallel-group, clinical pilot study. 24 patients of the test group (TG) rinsed after tooth brushing with a fluoride mouth rinse (100 ppm AmF/150 ppm NaF) while 21 patients of the control group (CG) did not...
September 2016: European Journal of Paediatric Dentistry: Official Journal of European Academy of Paediatric Dentistry
Sean C Rice, Tina Higginbotham, Melanie J Dean, James C Slaughter, Patrick S Yachimski, Keith L Obstein
OBJECTIVES: Successful outpatient colonoscopy (CLS) depends on many factors including the quality of a patient's bowel preparation. Although education on consumption of the pre-CLS purgative can improve bowel preparation quality, no study has evaluated dietary education alone. We have created an educational video on pre-CLS dietary instructions to determine whether dietary education would improve outpatient bowel preparation quality. METHODS: A prospective randomized, blinded, controlled study of patients undergoing outpatient CLS was performed...
October 18, 2016: American Journal of Gastroenterology
Bernt Johan von Scholten, Frederik Persson, Signe Rosenlund, Peter Hovind, Jens Faber, Tine Willum Hansen, Peter Rossing
AIMS: Patients with type 2 diabetes and albuminuria have high cardiorenal morbidity and mortality despite multifactorial treatment. Short-term reduction in albuminuria is considered suggestive of long-term renoprotective effects. We evaluated the renal effects of the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide on top of multifactorial care, including renin-angiotensin-system (RAS)-inhibition. MATERIALS AND METHODS: Randomised, double-blind, placebo-controlled, cross-over trial including patients with type 2 diabetes and persistent albuminuria (urinary albumin-to-creatinine ratio > 30 mg/g) and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1...
October 17, 2016: Diabetes, Obesity & Metabolism
Hiromitsu Kumada, Hiroshi Miyakawa, Taro Muramatsu, Naoki Ando, Takanori Oh, Kenji Takamori, Hidetomo Nakamoto
AIMS: Patients with chronic liver disease sometimes develop cholestasis, which induces severe whole-body pruritus that may disrupt daily activities and sleep. To determine the efficacy of nalfurafine hydrochloride (5 µg), which is a selective κ-opioid receptor agonist, in improving pruritus, we conducted a double-blind placebo-controlled study in patients with chronic liver disease with refractory pruritus. Nalfurafine hydrochloride at 2.5 µg was also used to evaluate the dose-response relationship...
October 18, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
Alexander I Tröster, Joseph Jankovic, Michele Tagliati, DeLea Peichel, Michael S Okun
OBJECTIVE: The aim of this study was to evaluate the neurobehavioral safety of constant-current subthalamic deep brain stimulation and to compare the neuropsychological effects of stimulation versus electrode placement alone. METHODS: A total of 136 patients with Parkinson's disease underwent bilateral subthalamic device implantation in this randomized trial. Patients received stimulation either immediately after device implantation (n = 101; active stimulation) or beginning 3 months after surgery (n = 35; delayed activation control)...
October 18, 2016: Movement Disorders: Official Journal of the Movement Disorder Society
Paul Rohde, Eric Stice, Jeff M Gau
OBJECTIVE: The study aimed to identify variables that predicted persistence versus desistence of eating disorder-related compensatory behaviors in a high-risk factor sample of women who reported repeated compensatory behaviors at baseline. Data came from a randomized trial evaluating two brief obesity prevention interventions for college students with weight concerns. METHOD: Two hundred and sixty one young women (Mean age = 19.1, 79% European American) with weight concerns were randomly assigned to one of two brief obesity prevention interventions or educational video control...
October 18, 2016: International Journal of Eating Disorders
Wesam Saleh A Al Attar, Najeebullah Soomro, Peter J Sinclair, Evangelos Pappas, Ross H Sanders
BACKGROUND: Hamstring injuries are among the most common non-contact injuries in sports. The Nordic hamstring (NH) exercise has been shown to decrease risk by increasing eccentric hamstring strength. OBJECTIVE: The purpose of this systematic review and meta-analysis was to investigate the effectiveness of the injury prevention programs that included the NH exercise on reducing hamstring injury rates while factoring in athlete workload. METHODS: Two researchers independently searched for eligible studies using the following databases: the Cochrane Central Register of Controlled Trials via OvidSP, AMED (Allied and Complementary Medicine) via OvidSP, EMBASE, PubMed, MEDLINE, SPORTDiscus, Web of Science, CINAHL and AusSportMed, from inception to December 2015...
October 17, 2016: Sports Medicine
Gang Deng, Zhan-Dong Qiu, Da-Yong Li, Yu Fang, Su-Ming Zhang
Obstructive sleep apnea (OSA) is an independent risk factor for cardiovascular diseases. Aldosterone was reported to be increased in patients with OSA and correlated with OSA severity. Many studies investigated the effect of continuous positive airway pressure (CPAP) therapy on plasma aldosterone concentrations (PAC) in OSA patients. The results, however, were inconsistent. In the present study, we aimed to evaluate the effects of CPAP therapy on PAC by performing a meta-analysis. Literature search was carried out in electronic databases including PubMed/Medline, Cochrane Library, Embase and Web of Science...
October 2016: Journal of Huazhong University of Science and Technology. Medical Sciences
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