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Clinical trials

M Aurich, D Albrecht, P Angele, C Becher, S Fickert, J Fritz, P E Müller, P Niemeyer, M Pietschmann, G Spahn, M Walther
Background: Osteochondral lesions (OCL) of the ankle are a common cause of ankle pain. Although the precise pathophysiology has not been fully elucidated, it can be assumed that a variety of factors are responsible, mainly including traumatic events such as ankle sprains. Advances in arthroscopy and imaging techniques, in particular magnetic resonance imaging (MRI), have improved the possibilities for the diagnosis of OCLs of the ankle. Moreover, these technologies aim at developing new classification systems and modern treatment strategies...
October 21, 2016: Zeitschrift Für Orthopädie und Unfallchirurgie
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
Daniel Lordelo San Martin, Dislene Nascimento Dos Santos, Abrahão Fontes Baptista
OBJECTIVE: To describe the pain in patients infected with human T-cell lymphotropic virus type 1, clinically and epidemiologically. METHODS: This systematic review was based on The PRISMA Statement. Four reviewers searched PUBMED, SciELO, LILACS and BIREME for data from observational studies and clinical trials (n≥30) regarding pain prevalence, characteristics, and associated factors in patients with human T-cell lymphotropic virus type 1. No limits on publication date or language were established...
October 18, 2016: Brazilian Journal of Infectious Diseases
Alan F Cowman, Julie Healer, Danushka Marapana, Kevin Marsh
Malaria has been a major global health problem of humans through history and is a leading cause of death and disease across many tropical and subtropical countries. Over the last fifteen years renewed efforts at control have reduced the prevalence of malaria by over half, raising the prospect that elimination and perhaps eradication may be a long-term possibility. Achievement of this goal requires the development of new tools including novel antimalarial drugs and more efficacious vaccines as well as an increased understanding of the disease and biology of the parasite...
October 20, 2016: Cell
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
Rui Wang, Yan Dong, Jia Weng, Emily Z Kontos, Ronald D Chervin, Carol L Rosen, Carole L Marcus, Susan Redline
RATIONALE: Prior research found that individual-level environmental and social indicators did not explain the racial disparity in obstructive sleep apnea syndrome. Neighborhood socioeconomic variables, risk factors for a range of adverse behavioral and health outcomes, may better explain this racial disparity and help identify modifiable intervention targets. OBJECTIVES: To evaluate the associations of neighborhood socioeconomic variables with obstructive sleep apnea severity and to assess whether the neighborhood variables explain the association between race and obstructive sleep apnea severity...
October 21, 2016: Annals of the American Thoracic Society
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
Scott Shannon, Janet Opila-Lehman
INTRODUCTION: Anxiety and sleep disorders are often the result of posttraumatic stress disorder and can contribute to an impaired ability to focus and to demonstration of oppositional behaviors. CASE PRESENTATION: These symptoms were present in our patient, a ten-year-old girl who was sexually abused and had minimal parental supervision as a young child under the age of five. Pharmaceutical medications provided partial relief, but results were not long-lasting, and there were major side effects...
October 12, 2016: Permanente Journal
Neena Kapoor, Daniel M Blumenthal, Stacy E Smith, Ivan K Ip, Ramin Khorasani
Purpose To determine whether there were sex differences in full professorship after accounting for factors known to influence academic advancement. Materials and Methods Institutional review board approval was obtained for this HIPAA-compliant study, with waiver of informed consent. In this cross-sectional study, the authors used a comprehensive 2014 physician database (5089 academic radiologists, inclusive of all U.S. academic radiologists in 2014; 11.3% of all U.S. radiologists) containing information on physician age, years since residency, National Institutes of Health funding, scientific publications (first or last author and total), clinical trial investigation, and clinical volume measured according to 2013 Medicare reimbursement...
October 21, 2016: Radiology
Xin Yao, Lian-Lian Bian, Wei-Wei Lu, Jing-Xin Li, Qun-Ying Mao, Yi-Ping Wang, Fan Gao, Xing Wu, Qiang Ye, Xiu-Ling Li, Feng-Cai Zhu, Zhenglun Liang
Herpangina (HA) and hand, foot, and mouth disease (HFMD) are common infectious diseases caused by human enteroviruses and frequently occurr in young children. Previous published studies have mainly focused on HFMD, while the HA epidemiological and etiological characteristics in mainland China have not been described. From June, 2013 to March, 2014, HA and HFMD patients were monitored in participants from clinical trial of EV-A71 vaccine conducted during 2012-2013. A total of 95 HA patients and 161 HFMD patients were defined...
October 21, 2016: Human Vaccines & Immunotherapeutics
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
Renzo Colombo, Hans van Valenberg, Marco Moschini, Johannes A Witjes
OBJECTIVE: An updated review of intravesical radiofrequency (RF)-induced thermo-chemotherapy effect (RITE) for NMIBC with regard to efficacy, adverse events (AEs) and perspectives. EVIDENCE ACQUISITION: An extensive and sensitive search for RF-induced chemo-hyperthermia in Medline, Embase, Cochrane and databases was performed. A table of published clinical trials up to 2016 was constructed. No meta-analysis could be performed on the basis of new papers...
October 4, 2016: Urologia
Monique Vanaman Wilson, Sabrina Guillen Fabi, Ryan Greene
Importance: The pivotal approval trial for a smooth, highly cohesive, viscous, 20-mg/mL hyaluronic acid filler demonstrated sustained aesthetic improvement, with a mean injection volume of 6.65 mL. In daily practice, however, it is not often practical or necessary to use large injection volumes to achieve the desired cosmetic outcome. Objective: To assess the efficacy, longevity, and patient satisfaction associated with correction of age-related midface volume loss using the low volumes of hyaluronic acid filler more commonly used in day-to-day practice...
October 20, 2016: JAMA Facial Plastic Surgery
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
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