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efficacy and safety

Napatthaorn Pongsrihadulchai, Thep Chalermchai, Suwirakorn Ophaswongse, Suriya Pongsawat, Montree Udompataikul
BACKGROUND: Striae distensae (SD) is a form of dermal scar. A number of treatments have been proposed, but they usually have unsatisfactory result especially in striae alba. Recently, nanofractional RF has been developed. Its mechanism of action is to stimulate dermal remodeling and epidermal re-epithelization. AIM: To evaluate the efficacy and safety of nanofractional RF in the treatment of striae alba. PATIENTS/METHODS: This is an experimental, assessor-blinded, before-after study...
October 21, 2016: Journal of Cosmetic Dermatology
Fausto Petrelli, Sandro Barni, Giacomo Bregni, Filippo de Braud, Serena Di Cosimo
BACKGROUND: The interest in platinum salts in breast cancer (BC) therapy has been recently renewed as inhibition of DNA damage response may enhance the effects of DNA-damaging agents in BC tumors with high genomic instability. The present systematic review and meta-analysis of randomized trials were performed to assess the efficacy and safety of therapy with platinum salts in patients with locally advanced or metastatic (hereinafter advanced) BC. METHODS: We searched PubMed, EMBASE, SCOPUS, Web of Science, the Cochrane Library, and CINAHL for phase II/III clinical trials that assessed efficacy of platinum-based therapy in patients with advanced BC...
October 21, 2016: Breast Cancer Research and Treatment
Mark R Gilbert, Stephanie L Pugh, Ken Aldape, A Gregory Sorensen, Tom Mikkelsen, Marta Penas-Prado, Felix Bokstein, Young Kwok, R Jeffrey Lee, Minesh Mehta
Angiogenesis, a hallmark of glioblastoma, can potentially be targeted by inhibiting the VEGF pathway using bevacizumab, a humanized monoclonal antibody against VEGF-A. This study was designed to determine the efficacy and safety of these regimens in the cooperative group setting. Eligibility included age ≥18, recurrent or progressive GBM after standard chemoradiation. Treatment was intravenous bevacizumab 10 mg/kg and either irinotecan (CPT) 125 mg/m(2) every 2 weeks or temozolomide (TMZ) 75-100 mg/m(2) day 1-21 of 28 day cycle...
October 21, 2016: Journal of Neuro-oncology
Robert N Goldstone, Shirin R Hasan, Steven Drury, Teresa M Darragh, Annemieke van Zante, Stephen E Goldstone
PURPOSE: Radiofrequency ablation (RFA) effectively treats esophageal high-grade dysplasia, but its efficacy in treating anal canal high-grade squamous intraepithelial lesions (HSILs) is unsubstantiated. This prospective study assessed the safety and efficacy of applying hemi-circumferential RFA to anal canal HSIL. METHODS: Twenty-one HIV-negative participants with HSIL occupying ≤ half the anal canal circumference were treated with hemi-circumferential anal canal RFA...
October 21, 2016: International Journal of Colorectal Disease
Ricarda Lechner, David Putzer, Michael Liebensteiner, Christian Bach, Martin Thaler
PURPOSE: Bone graft substitutes have been successfully used in posterolateral lumbar fusion, anterior cervical fusion and animal studies. This study has been conducted to assess the safety and efficacy of β-tricalcium phosphate (β-TCP) in instrumented anterior lumbar interbody fusion (ALIF) procedure. METHODS: In a prospective clinical study, ALIF cages were prefilled with β-TCP and additionally fixated with posterior pedicle screw. Computed tomography (CT) and X-rays were performed one year after surgery...
October 21, 2016: International Orthopaedics
Jennifer C Cook, Richard H Tran, J Herbert Patterson, Jo E Rodgers
PURPOSE: The pharmacology, clinical efficacy, and safety profiles of evolving therapies for the management of chronic heart failure (HF) and acute decompensated heart failure (ADHF) are described. SUMMARY: HF confers a significant financial burden despite the widespread use of traditional guideline-directed medical therapies such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, β-blockers, and aldosterone receptor antagonists, and the rates of HF-related mortality and hospitalization have remained unacceptably high...
November 1, 2016: American Journal of Health-system Pharmacy: AJHP
Yitao Zhang, Weijie Zeng, Shiyao Cheng, Zhichong Chen, Jiaojie Xue, Qing Wang, Maode Ou, Kanglin Cheng
BACKGROUND: Pulmonary hypertension (PH) is a serious disease, and treatment is a continuing challenge. Some in vitro and in vivo studies identified that statins were effective for PH. However, results of some randomised controlled trials (RCTs) have been controversial. The objective of our study was to clarify whether statins are effective and safe for pulmonary hypertension. METHODS: We systematically searched for eligible RCTs from PubMed, EMBASE, Web of Science, and the Cochrane Library during January 2016...
September 15, 2016: Heart, Lung & Circulation
Maria Celeste Buompadre, Kathleen Andres, Lee-Anne Slater, Hadi Mohseni-Bod, Anne-Marie Guerguerian, Helen Branson, Suzanne Laughlin, Derek Armstrong, Mahendranath Moharir, Gabrielle deVeber, Tilman Humpl, Osami Honjo, Shaf Keshavjee, Rebecca Ichord, Vitor Pereira, Nomazulu Dlamini
The updated American Heart Association/American Stroke Association guidelines include recommendation for thrombectomy in certain adult stroke cases. The safety and efficacy of thrombectomy in children are unknown. An 8-year-old girl experienced acute stroke symptoms on two occasions while therapeutically anticoagulated on Novalung. Computed tomography scans showed proximal vessel thrombi, which were retrieved using a Trevo device without hemorrhagic complications. Postprocedural assessment found respective decreases in the National Institutes of Health Stroke Scale score from 10 to 4 and 12 to 7...
September 14, 2016: Pediatric Neurology
C Franklin, E Livingstone, A Roesch, B Schilling, D Schadendorf
Malignant melanoma contributes the majority of skin cancer related deaths and shows an increasing incidence in the past years. Despite all efforts of early diagnosis, metastatic melanoma still has a poor prognosis and remains a challenge for treating physicians. In recent years, improved knowledge of the pathophysiology and a better understanding of the role of the immune system in tumour control have led to the development and approval of several immunotherapies. Monoclonal antibodies against different immune checkpoints have been revolutionizing the treatment of metastatic and unresectable melanoma...
September 2, 2016: European Journal of Surgical Oncology
Anthony L Cunningham, Nathalie Garçon, Oberdan Leo, Leonard R Friedland, Richard Strugnell, Béatrice Laupèze, Mark Doherty, Peter Stern
In the 21st century, an array of microbiological and molecular allow antigens for new vaccines to be specifically identified, designed, produced and delivered with the aim of optimising the induction of a protective immune response against a well-defined immunogen. New knowledge about the functioning of the immune system and host pathogen interactions has stimulated the rational design of vaccines. The design toolbox includes vaccines made from whole pathogens, protein subunits, polysaccharides, pathogen-like particles, use of viral/bacterial vectors, plus adjuvants and conjugation technology to increase and broaden the immune response...
October 18, 2016: Vaccine
Jyh-Ming Liou, Yu-Jen Fang, Chieh-Chang Chen, Ming-Jong Bair, Chi-Yang Chang, Yi-Chia Lee, Mei-Jyh Chen, Chien-Chuan Chen, Cheng-Hao Tseng, Yao-Chun Hsu, Ji-Yuh Lee, Tsung-Hua Yang, Jiing-Chyuan Luo, Chun-Chao Chang, Chi-Yi Chen, Po-Yueh Chen, Chia-Tung Shun, Wen-Feng Hsu, Wen-Hao Hu, Yen-Nien Chen, Bor-Shyang Sheu, Jaw-Town Lin, Jeng-Yih Wu, Emad M El-Omar, Ming-Shiang Wu
BACKGROUND: Whether concomitant therapy is superior to bismuth quadruple therapy or 14-day triple therapy for the first-line treatment of Helicobacter pylori infection remains poorly understood. We aimed to compare the efficacy and safety of 10-day concomitant therapy, 10-day bismuth quadruple therapy, and 14-day triple therapy in the first-line treatment of H pylori. METHODS: In this multicentre, open-label, randomised trial, we recruited adult patients (aged >20 years) with H pylori infection from nine medical centres in Taiwan...
October 18, 2016: Lancet
Elizabeth Bilotti, David H Vesole, Laura McBride, Linda Schmidt, Zhijie Gao, Madiha Gilani, Ann McNeill, Urszula Bednarz, Joshua Richter, Anthony Mato, Thorsten Graef, David S Siegel
BACKGROUND: This is a retrospective chart review to evaluate the efficacy of the addition of vorinostat to lenalidomide and dexamethasone in patients with multiple myeloma relapsed/refractory to lenalidomide and dexamethasone. METHODS: Charts from 26 consecutive patients able to obtain commercial vorinostat were analyzed for response and safety data. RESULTS: The overall response rate was 31%, and the clinical beneficial rate was 50%. The median duration of response was 3 months, and the median overall survival was 28...
October 2016: Clinical Lymphoma, Myeloma & Leukemia
B Eksteen, J Heatherington, J Oshiomogo, R Panaccione, G Kaplan, S Ghosh
This article has been retracted: please see Elsevier Policy on Article Withdrawal ( The abstract authors and presenters of PS124 - EFFICACY AND SAFETY OF INDUCTION DOSING OF VEDOLIZUMAB FOR REDUCING BILIARY INFLAMMATION IN PRIMARY SCLEROSING CHOLANGITIS (PSC) IN INDIVIDUALS WITH INFLAMMATORY BOWEL DISEASE submitted and presented at ILC 2016 have raised concerns that the source data in some cases are inconsistent and requires further evaluation to determine the true magnitude of effect...
2016: Journal of Hepatology
Ying Zhang, Jin Sun, Yun-Jiao Zhang, Qian-Yun Chai, Kang Zhang, Hong-Li Ma, Xiao-Ke Wu, Jian-Ping Liu
BACKGROUND: Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP). METHODS: The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting...
October 21, 2016: Trials
Arndt Vogel, Josefine Römmler-Zehrer, Jack Shiansong Li, Desmond McGovern, Alfredo Romano, Michael Stahl
BACKGROUND: The phase 3 MPACT trial in patients with metastatic pancreatic cancer demonstrated superior efficacy of nab-paclitaxel (nab-P) + gemcitabine (Gem) vs Gem monotherapy for all endpoints examined including overall survival, the primary endpoint. In the MPACT trial, patients were treated until progressive disease (PD) or unacceptable toxicity. The current exploratory analysis investigated outcomes of patients from the MPACT trial who were treated until PD, in order to understand how to maximize treatment benefit from nab-P + Gem...
October 21, 2016: BMC Cancer
Elena S Don, Alexandra G Emelyanova, Natalia N Yakovleva, Nataliia V Petrova, Marina V Nikiforova, Evgeniy A Gorbunov, Sergey A Tarasov, Sergey G Morozov, Oleg I Epstein
The assessment of dose-response is an essential part of drug development in terms of the determination of a drug's effective dose, finding the safety endpoint, estimation of the pharmacokinetic profile and even validation of drug activity, especially for therapeutic agents with a principally novel mechanism of action. Drugs based on released-active forms of antibodies are a good example of such a target. In this study, the efficacy of the antiviral drug Anaferon for children (released-active form of antibodies to interferon-gamma) was tested in a dose-dependent manner (at doses of 0...
October 21, 2016: Journal of Medical Virology
Xiao Zheng, Zhi Yuan Bo, Wei Wan, Ye Chen Wu, Tian Tian Wang, Jun Wu, Dao Jian Gao, Bing Hu
AIM: Endoscopic biliary radiofrequency ablation (RFA) has been increasingly used for unresectable malignant biliary obstruction (MBO). However, its efficacy and safety remain unclear. METHODS: A comprehensive search of Cochrane Library, PubMed and EMBASE was conducted to collect studies to evaluate endoscopic biliary RFA in the management of MBO. Meta-analysis was performed by extracting the data from included studies with regards to the technical effectiveness, overall survival, adverse events and mortality of endoscopic RFA...
October 21, 2016: Journal of Digestive Diseases
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
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
Marilyn J Hammer, Patricia Eckardt, Margaret Barton-Burke
The primary goal of the thousands of registered trials in cancer research is to extend survival. With evaluation of efficacy, safety, and tolerability, healthcare providers must ensure that the principles described in the Belmont Report are upheld and that patients are truly informed when signing a consent form. In this article, two cases are highlighted, and reasons for participating in clinical trials are discussed. Challenges, such as healthcare literacy, patients' dedication to their healthcare providers, and choosing between multiple trials, are also explored...
November 1, 2016: Oncology Nursing Forum
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