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Matthew D Hale, Matthew Nankivell, Gordon G Hutchins, Sally P Stenning, Ruth E Langley, Wolfram Mueller, Nicholas P West, Alexander I Wright, Darren Treanor, Lindsay C Hewitt, William H Allum, David Cunningham, Jeremy D Hayden, Heike I Grabsch
BACKGROUND: Neoadjuvant chemotherapy followed by surgery is the standard of care for UK patients with locally advanced resectable oesophageal carcinoma (OeC). However, not all patients benefit from multimodal treatment and there is a clinical need for biomarkers which can identify chemotherapy responders. This study investigated whether the proportion of tumour cells per tumour area (PoT) measured in the pre-treatment biopsy predicts chemotherapy benefit for OeC patients. PATIENTS AND METHODS: PoT was quantified using digitized haematoxylin/eosin stained pre-treatment biopsy slides from 281 OeC patients from the UK MRC OE02 trial (141 treated by surgery alone (S); 140 treated by 5-fluorouracil/cisplatin followed by surgery (CS))...
October 18, 2016: Oncotarget
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
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
Christine Aroney, Samantha Fraser-Bell, Ecosse L Lamoureux, Mark C Gillies, Lyndell L Lim, Eva K Fenwick
Purpose: To determine the patient-centered effectiveness of treatment with the slow-release dexamethasone intravitreal implant (DEX implant) and intravitreal bevacizumab using the Impact of Vision Impairment Questionnaire (IVI), a vision-related quality of life (VRQoL) measure, in patients with visual impairment secondary to center-involving diabetic macular edema (DME). Methods: Patients with DME were enrolled in a phase 2, prospective, multicenter, randomized, single-masked clinical trial and received either DEX implant 4 monthly or bevacizumab monthly, both pro re nata...
October 1, 2016: Investigative Ophthalmology & Visual Science
Pirow Bekker, Daniel Dairaghi, Lisa Seitz, Manmohan Leleti, Yu Wang, Linda Ertl, Trageen Baumgart, Sarah Shugarts, Lisa Lohr, Ton Dang, Shichang Miao, Yibin Zeng, Pingchen Fan, Penglie Zhang, Daniel Johnson, Jay Powers, Juan Jaen, Israel Charo, Thomas J Schall
The complement 5a receptor has been an attractive therapeutic target for many autoimmune and inflammatory disorders. However, development of a selective and potent C5aR antagonist has been challenging. Here we describe the characterization of CCX168 (avacopan), an orally administered selective and potent C5aR inhibitor. CCX168 blocked the C5a binding, C5a-mediated migration, calcium mobilization, and CD11b upregulation in U937 cells as well as in freshly isolated human neutrophils. CCX168 retains high potency when present in human blood...
2016: PloS One
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
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
Michael C Sklar, Karen Burns, Nuttapol Rittayamai, Ashley Lanys, Michela Rauseo, Lu Chen, Martin Dres, Guang-Qiang Chen, Ewan C Goligher, Neill Kj Adhikari, Laurent Brochard, Jan O Friedrich
Introduction Spontaneous breathing trials (SBTs) are designed to simulate conditions following extubation and it is essential to understand the physiological impact of different methods. We conducted a systematic review and pooled measures reflecting patient respiratory effort among studies comparing SBT methods in a meta-analysis. Methods We searched Medline, EMBASE, and Web of Science from inception to January 2016 to identify randomized and non-randomized clinical trials reporting physiological measurements of respiratory effort (pressure-time product, PTP) or work of breathing during at least 2 SBT techniques...
October 21, 2016: American Journal of Respiratory and Critical Care Medicine
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
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
Cheryl L Cox, M Robyn Andersen, Aimee K Santucci, Les L Robison, Melissa M Hudson
PURPOSE/OBJECTIVES: To document the per survivor and per additional survivor screening costs of a mailed survivorship care plan (SCP) with advanced practice nurse (APN) telephone counseling (SCP+C) or without APN telephone counseling (SCP).
. DESIGN: Randomized, longitudinal clinical trial.
. SETTING: St. Jude Children's Research Hospital in Memphis, Tennessee.
. SAMPLE: 411 at-risk pediatric cancer survivors (aged 26-59 years), stratified by age (younger than 30 years versus 30 years or older), recommended screening frequency (every one, two, or five years), gender, and cancer diagnosis (hematologic versus solid tumor)...
November 1, 2016: Oncology Nursing Forum
H Esfandiari, M Pakravan, Z Zakeri, S Ziaie, P Pakravan, V Ownagh
PurposeThe purpose of the study was to investigate ocular hypertensive effect of exogenous glucosamine in comparison with placebo in patients with osteoarthritis.Patients and methodsIn this double-masked randomized clinical trial, 88 patients with osteoarthritis were included. Forty-four patients were randomized into either glucosamine sulfate or the placebo group.Comprehensive ophthalmologic exam including intraocular pressure (IOP) at baseline, month 1, and 3 was performed. Ocular response analyzer parameters were also checked at baseline and month 3...
October 21, 2016: Eye
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
Jeffrey Cummings, Philip Scheltens, Ian McKeith, Rafael Blesa, John E Harrison, Paulo H F Bertolucci, Kenneth Rockwood, David Wilkinson, Wouter Wijker, David A Bennett, Raj C Shah
BACKGROUND: Souvenaid® (uridine monophosphate, docosahexaenoic acid, eicosapentaenoic acid, choline, phospholipids, folic acid, vitamins B12, B6, C, and E, and selenium), was developed to support the formation and function of neuronal membranes. OBJECTIVE: To determine effect sizes observed in clinical trials of Souvenaid and to calculate the number needed to treat to show benefit or harm. METHODS: Data from all three reported randomized controlled trials of Souvenaid in Alzheimer's disease (AD) dementia (Souvenir I, Souvenir II, and S-Connect) and an open-label extension study were included in analyses of effect size for cognitive, functional, and behavioral outcomes...
October 20, 2016: Journal of Alzheimer's Disease: JAD
Michael O Childress, José A Ramos-Vara, Audrey Ruple
OBJECTIVE To determine the effect of prednisone omission from a multidrug chemotherapy protocol on outcome in dogs with peripheral nodal lymphomas. DESIGN Single-center, nonblinded, parallel-group, randomized, controlled trial. ANIMALS 40 client-owned dogs with a histopathologically confirmed diagnosis of peripheral nodal lymphoma and an expected survival time of > 4 weeks with treatment. PROCEDURES Treatment consisted of a combination of L-asparaginase, cyclophosphamide, doxorubicin, vincristine, and prednisone (L-CHOP) or an identical protocol except for the omission of prednisone (L-CHO)...
November 1, 2016: Journal of the American Veterinary Medical Association
Khaled Sinjab, Nouf Zimmo, Guo-Hao Lin, Ming-Pang Chung, Lujain Shaikh, Hom-Lay Wang
BACKGROUND: The use of statins on adult chronic patients showed a positive effect on their periodontal status. However, The effect of locally delivered statins on periodontal treatment has not yet been systematically analyzed. Hence, the present systematic review and meta-analyses aimed to evaluate the efficacy of statins on treating localized periodontal intrabony defects. MATERIAL AND METHODS: An electronic search of 3 databases (1965-2016 March 1(st)), including PubMed, Embase, CINAHL, and a hand search of peer-reviewed journals for relevant articles were performed...
October 21, 2016: Journal of Periodontology
Hans R Preus, Per Gjermo, Vibeke Baelum
BACKGROUND: Tooth loss is the ultimate negative consequence of periodontitis, and reports of the extent to which different treatment strategies may influence the loss of teeth in the long run are hard to find. AIM: To test the hypothesis that there is no difference in the 5-year clinical outcome of therapy in terms of tooth mortality between groups of patients treated with conventional over-weeks scaling and root planing (SRP) or same-day full-mouth disinfection (FDIS), with or without adjunctive metronidazole...
October 21, 2016: Journal of Periodontology
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