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Random controlled trial

Felipe Donoso, Helene Engstrand Lilja
Background Since 2005, infants with esophageal atresia (EA) in our unit are given prophylactic proton pump inhibitors (PPI) after repair until 1 year of age. The aims of this study were to identify risk factors for anastomotic strictures (AS) and to assess the efficacy of postoperative PPI prophylaxis in reducing the incidence of AS compared with symptomatic PPI. Methods Patients who underwent EA repair from 1994 to 2013 in our unit were included in this retrospective observational study approved by the local ethics review board...
October 21, 2016: European Journal of Pediatric Surgery
Annika Clamor, Julian Koenig, Julian F Thayer, Tania M Lincoln
Arousal and the way it is coped with are relevant to the emergence of psychotic symptoms. Heart rate variability (HRV) stems from autonomic responses to environmental demands such as stress and is an index of physiological arousal, adaptability, and homeostatic reflexes forming autonomic balance. A randomized-controlled between-subjects trial that compared HRV-biofeedback (BF) to an active relaxation and to a waiting control condition was conducted in a sample with attenuated subclinical psychotic symptoms (N = 84)...
October 11, 2016: Behaviour Research and Therapy
Han Qin, Lin Luo, Zexin Zhu, Jiwei Huang
OBJECTIVE: To examine whether pancreaticogastrostomy (PG) or pancreaticojejunostomy (PJ) is the best reconstruction method to reduce occurrence of postoperative complications, especially pancreatic fistula (PF), after pancreaticoduodenectomy (PD). BACKGROUND: PF is one of the most severe complications after PD. The best reconstruction method to reduce occurrence of PF is controversial. Therefore, we carried out this meta-analysis to compare PG with PJ. METHODS: A systematic review was conducted in PubMed, EMBASE, and Cochrane Library to identify studies comparing PG with PJ, published up to October 2015...
October 18, 2016: International Journal of Surgery
Pang Yao, Liang Sun, Ling Lu, Hong Ding, Xiafei Chen, Lixin Tang, Xinming Xu, Gang Liu, Yao Hu, Yiwei Ma, Feijie Wang, Qianlu Jin, He Zheng, Huiyong Yin, Rong Zeng, Yan Chen, Frank B Hu, Huaixing Li, Xu Lin
CONTEXT: Little is known how genetic and non-genetic factors modify responses of vitamin D supplementation in nonwhite populations. OBJECTIVE: To investigate factors modifying 25-hydroxyvitamin D (25[OH]D) and bioavailable 25(OH)D (25[OH]DBio) responses after vitamin D3 supplementation. Design, Setting, Participants, and Intervention: In this randomized, double-blinded, placebo-controlled trial, 448 Chinese with vitamin D deficiency (25[OH]D<50 nmol/L) received 2000 IU/d vitamin D3 or placebo for 20 weeks...
October 21, 2016: Journal of Clinical Endocrinology and Metabolism
Jiang Yue, James F Griffith, Fan Xiao, Lin Shi, Defeng Wang, Jiayun Shen, Priscilla Wong, Edmund K Li, Martin Li, Tena K Li, Tracy Y Zhu, Vivian W Hung, Ling Qin, Lai-Shan Tam
Objective To compare the bone healing effects of denosumab and alendronate in female rheumatoid arthritis (RA) patients by high-resolution peripheral quantitative computed tomography (HR-pQCT). Methods This is a post-hoc analysis of a randomized-controlled trial (NCT01770106). 40 patients were randomized in a 1:1 ratio to receive either subcutaneous denosumab (60mg) once or oral alendronate (70mg) weekly for 6 months. The size of individual bone erosions and the presence and extent of erosion-associated sclerosis (marginal osteosclerosis) were measured in the second metacarpal head of the non-dominant hand at baseline, 3 and 6 months...
October 21, 2016: Arthritis Care & Research
Simon M Wilksch, Susan J Paxton, Susan M Byrne, S Bryn Austin, Anne O'Shea, Tracey D Wade
OBJECTIVE: To investigate if baseline shape and weight concern (SWC) moderated outcomes in Prevention Across the Spectrum, a randomized-controlled trial (RCT) of 3 school-based programs aimed at reducing eating disorder and obesity risk factors. METHOD: N = 1,316 Grade 7 and 8 girls and boys (M age = 13.21 years) across three Australian states were randomly allocated to: Media Smart; Life Smart; Helping, Encouraging, Listening and Protecting Peers Initiative (HELPP) or control (usual school class)...
October 21, 2016: International Journal of Eating Disorders
William M Jackson, Nicholas Davis, Stephen A Sands, Robert A Whittington, Lena S Sun
RESEARCH QUESTION: Is there an association between regular exercise, defined as a structured program of increased physical activity at least 1 month in duration, and improvements in measures of executive functions compared with children who engage in their normal daily activities? CONTEXT: The association between increased physical activity and changes in performance on tasks of executive functions have not been well elucidated in children. Executive functioning is important to intellectual development and academic success in children, and inexpensive, nonpharmacological methods for the treatment of executive dysfunction represent an attractive interventional target...
October 2016: Journal of Neurosurgical Anesthesiology
Gijsbert D Musters, Charlotte E L Klaver, Robbert J I Bosker, Jacobus W A Burger, Peter van Duijvendijk, Boudewijn van Etten, Anna A W van Geloven, Eelco J R de Graaf, Christiaan Hoff, Jeroen W A Leijtens, Harm J T Rutten, Baljit Singh, Ronald J C L M Vuylsteke, Johannes H W de Wilt, Marcel G W Dijkgraaf, Willem A Bemelman, Pieter J Tanis
OBJECTIVE: To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR). BACKGROUND: Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing. METHODS: Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm)...
September 20, 2016: Annals of Surgery
David Picker, Maria Dans, Kevin Heard, Thomas Bailey, Yixin Chen, Chenyang Lu, Marin H Kollef
OBJECTIVE: To determine whether an Early Warning System could identify patients wishing to focus on palliative care measures. DESIGN: Prospective, randomized, pilot study. SETTING: Barnes-Jewish Hospital, Saint Louis, MO (January 15, 2015, to December 12, 2015). PATIENTS: A total of 206 patients; 89 intervention (43.2%) and 117 controls (56.8%). INTERVENTIONS: Palliative care in high-risk patients targeted by an Early Warning System...
October 20, 2016: Critical Care Medicine
Yanping Li, Rong Cheng Li, Qiang Ye, Changgui Li, You Ping Liu, Xiao Ma, Yanan Li, Hong Zhao, Xiaoling Chen, Deepak Assudani, Naveen Karkada, Htay Htay Han, Olivier Van Der Meeren, Narcisa Mesaros
We conducted three phase III, randomized, open-label, clinical trials assessing the safety, reactogenicity (all studies), immunogenicity (Primary vaccination study) and persistence of immune responses (Booster study) to the combined diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b vaccine (DTPa-IPV/Hib) in Chinese infants and toddlers. In the Pilot study (NCT00964028), 50 infants (randomized 1:1) received three doses of DTPa-IPV/Hib at 2-3-4 (Group A) or 3-4-5 months of age (Group B)...
October 21, 2016: Human Vaccines & Immunotherapeutics
K Reich, M Gooderham, L Green, A Bewley, Z Zhang, I Khanskaya, R M Day, J Goncalves, K Shah, V Piguet, J Soung
BACKGROUND: Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate to severe psoriasis. OBJECTIVE: Evaluate efficacy and safety of apremilast vs. placebo in biologic-naive patients with moderate to severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double-blind, placebo-controlled study (NCT01690299). METHODS: 250 patients were randomized to placebo (n=84), apremilast 30 mg BID (n=83) or etanercept 50 mg QW (n=83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104...
October 21, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
Stefano Salciccia, Alessandro Gentilucci, Susanna Cattarino, Alessandro Sciarra
On the basis of the trials available, are we ready to consider GnRH antagonists better than agonists? Is there a population of patients who may benefit from antagonists more than agonists?We specifically focused our analysis on the significance of oncological results obtained in phase III trials directly comparing Degarelix with GnRH agonists. Oncological results were evaluated only in 1 trial (CS21) with some subanalysis and they were not the primary endpoints of the study. The follow-up duration was 364 days, and therefore, the number of events (all causes deaths and prostate cancer (PC), Prostate Specific Antigen (PSA), Hazard ratio (HR)-related deaths) was very low in both groups and this aspect strongly reduces the significance of overall survival evaluation...
October 15, 2016: Urologia
David Maidment, William Brassington, Heather Wharrad, Melanie Ferguson
Purpose: The purpose of the study was to assess whether Internet competency predicted practical hearing aid knowledge and handling skills in first-time hearing aid users. Method: The design was a prospective, randomized controlled trial of a multimedia educational intervention consisting of interactive video tutorials (or reusable learning objects [RLOs]). RLOs were delivered through DVD for TV or PC, and online. Internet competency was measured at the hearing aid fitting appointment, whereas hearing aid knowledge and practical handling skills were assessed 6 weeks postfitting...
October 1, 2016: American Journal of Audiology
Helen Cullington, Padraig Kitterick, Lisa DeBold, Mark Weal, Nicholas Clarke, Eva Newberry, Lisa Aubert
Purpose: This research note describes a planned project to design, implement, and evaluate remote care for adults using cochlear implants and compare their outcomes with those of individuals following the standard care pathway. Method: Sixty people with cochlear implants will be recruited and randomized to either the remote care group or a control group. The remote care group will use new tools for 6 months: remote and self-monitoring, self-adjustment of device, and a personalized online support tool...
October 1, 2016: American Journal of Audiology
Kathryn L Kreicher, Jeremy S Bordeaux
Importance: Cutaneous surgery is performed by otolaryngologists, plastic surgeons, oculoplastic surgeons, dermatologic surgeons, and some primary care physicians. Practice gaps exist among cutaneous surgeons, as do differences in how different physicians approach preoperative, intraoperative, and postoperative decision-making. Objective: To present the newest and best evidence to close common practice gaps in cutaneous surgery. Evidence Review: We performed a detailed search of peer-reviewed publications that were identified through a search of PubMed/MEDLINE (January 1, 2000, through June 30, 2016) using the literature search terms "cutaneous surgery," "Mohs micrographic surgery," "plastic surgery," in combination with "safety," "cost," "anesthesia," "anti-coagulation," "bleeding," "pain," "analgesia," "anxiety," or "infection," among others...
October 20, 2016: JAMA Facial Plastic Surgery
David E Rosow, Jamal Ahmed
Importance: Adult laryngotracheal stenosis (LTS) is typically managed surgically, but some patients fail treatment because of rapid restenosis or granulation tissue formation. The need for frequent surgery or tracheostomy reduces the quality of life in these patients and poses a significant challenge for the treating physician. New adjuvant treatments are required to reduce the surgical burden of this condition. Objective: To examine whether patients with rapidly recurrent nonvasculitic LTS who fail surgical management of their stenosis (ie, requiring dilation more frequently than every 6 months) experience longer intervals between surgical procedures when receiving adjuvant treatment with low-dose methotrexate...
October 20, 2016: JAMA Otolaryngology—Head & Neck Surgery
Jessica Quinlan-Woodward, Autumn Gode, Jeffery A Dusek, Adam S Reinstein, Jill R Johnson, Sue Sendelbach
PURPOSE/OBJECTIVES: To compare the effect of acupuncture to a standard-of-care (control) group on pain, nausea, anxiety, and ability to cope. 
. DESIGN: Pilot randomized, controlled trial. 
. SETTING: Abbott Northwestern Hospital, a large, urban, tertiary care hospital in Minneapolis, Minnesota.
. SAMPLE: 30 adult women undergoing surgery for breast cancer.
. METHODS: Women were randomly assigned to two hospital-based acupuncture treatments versus usual care after breast cancer surgery...
November 1, 2016: Oncology Nursing Forum
Rachel Hirschey, Isaac Lipkus, Lee Jones, Christopher Mantyh, Richard Sloane, Wendy Demark-Wahnefried
PURPOSE/OBJECTIVES: To test effects of gain-framed versus loss-framed mailed brochures on increasing physical activity (PA) among colorectal cancer (CRC) survivors.
. DESIGN: Randomized trial with repeated measures at baseline, 1 month, and 12 months postintervention.
. SETTING: Mail recruitment from tumor registries.
. SAMPLE: 148 inactive CRC survivors who had completed primary therapy. 
. METHODS: PA and constructs from the Theory of Planned Behavior (TPB) were assessed at baseline, 1 month, and 12 months...
November 1, 2016: Oncology Nursing Forum
David Feifel, Katherine Pappas
Repetitive transcranial magnetic stimulation (rTMS) is an emerging non-pharmacological approach to treating many brain-based disorders. rTMS uses electromagnetic coils to stimulate areas of the brain non-invasively. Deep transcranial magnetic stimulation (dTMS) with the Brainsway H1-coil system specifically is a type of rTMS indicated for treating patients with major depressive disorder (MDD) who are resistant to medication. The unique H1-coil design of this device is able to stimulate neuronal pathways that lie deeper in the targeted brain areas than those reached by conventional rTMS coils...
October 4, 2016: Journal of Visualized Experiments: JoVE
Yan-Ling Liu, Man-Na Zhang, Guo-Yu Tong, Shou-Yue Sun, Yan-Hua Zhu, Ying Cao, Jie Zhang, Hong Huang, Ben Niu, Hong Li, Qing-Hua Guo, Yan Gao, Da-Long Zhu, Xiao-Ying Li
A multicenter, open-label, randomized, controlled superiority trial with 18 months of follow-up was conducted to investigate whether oral zinc supplementation could further promote spermatogenesis in males with isolated hypogonadotropic hypogonadism (IHH) receiving sequential purified urinary follicular-stimulating hormone/human chorionic gonadotropin (uFSH/hCG) replacement. Sixty-seven Chinese male IHH patients were recruited from the Departments of Endocrinology in eight tertiary hospitals and randomly allocated into the sequential uFSH/hCG group (Group A, n = 34) or the sequential uFSH plus zinc supplementation group (Group B, n = 33)...
October 21, 2016: Asian Journal of Andrology
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