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pharmaceutical trials

Lauren E Arthur, Russell S Kizor, Adrian G Selim, Mieke L van Driel, Leonardo Seoane
BACKGROUND: Ventilator-associated pneumonia (VAP) is a significant cause of morbidity and mortality, complicating the medical course of approximately 10% of mechanically-ventilated patients, with an estimated attributable mortality of 13%. To treat VAP empirically, the American Thoracic Society currently recommends antibiotic therapy based on the patients' risk of colonisation by an organism with multidrug resistance. The selection of initial antibiotic therapy in VAP is important, as inappropriate initial antimicrobial treatment is associated with higher mortality and longer hospital stay in intensive care unit (ICU) patients...
October 20, 2016: Cochrane Database of Systematic Reviews
Hao Huang, Linfu Li, Weimei Shi, Hai Liu, Jianqiong Yang, Xiaoliang Yuan, Longhuo Wu
Nobiletin (NOB) chemically known as 5,6,7,8,3',4'-hexamethoxyflavone is a dietary polymethoxylated flavonoid found in Citrus fruits. Recent evidences show that NOB is a multifunctional pharmaceutical agent. The various pharmacological activities of NOB include neuroprotection, cardiovascular protection, antimetabolic disorder, anticancer, anti-inflammation, and antioxidation. These events may be underpinned by modulation of signaling cascades, including PKA/ERK/MEK/CREB, NF-κB, MAPK, Ca(2+)/CaMKII, PI3K/Akt1/2, HIF-1α, and TGFβ signaling pathways...
2016: Evidence-based Complementary and Alternative Medicine: ECAM
Daniel W Birch, Jerry T Dang, Noah J Switzer, Namdar Manouchehri, Xinzhe Shi, Ghassan Hadi, Shahzeer Karmali
BACKGROUND: Intraoperative hypothermia during both open and laparoscopic abdominal surgery may be associated with adverse events. For laparoscopic abdominal surgery, the use of heated insufflation systems for establishing pneumoperitoneum has been described to prevent hypothermia. Humidification of the insufflated gas is also possible. Past studies on heated insufflation have shown inconclusive results with regards to maintenance of core temperature and reduction of postoperative pain and recovery times...
October 19, 2016: Cochrane Database of Systematic Reviews
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
Helena H Borba, Astrid Wiens, Laiza M Steimbach, Cassio M Perlin, Fernanda S Tonin, Maria L A Pedroso, Fernando Fernandez-Llimos, Roberto Pontarolo
PURPOSE: This study aimed to compare the efficacy among direct-acting antiviral agents (first and second-generation direct-acting antiviral agents (DAAs)) with placebo and with standard dual therapy (pegylated interferon + ribavirin (Peg-IFN + RBV)) in terms of rapid virologic response (RVR) and sustained virologic response (SVR) in chronic hepatitis C genotype 1 treatment. METHODS: We performed a systematic review of randomized controlled trials (RCTs) in MEDLINE, International Pharmaceutical Abstracts, Cochrane Library, SCIELO, and Scopus and conducted a network meta-analysis to compare the efficacy of boceprevir (BOC), daclatasvir (DCV), grazoprevir, simeprevir (SMV) and telaprevir (TVR), in treatment-naive and treatment-experienced patients...
October 19, 2016: European Journal of Clinical Pharmacology
Cecilia Ferreira da Silva, Miriam Ventura da Silva, Claudia Garcia Serpa Osorio-de-Castro
Objective To analyze the pathway of clinical trials of monoclonal antibodies and biological medicines for cancer treatment involving Brazilian institutions from 2003 to 2012. Method This retrospective, descriptive study was based on review of two clinical trial registries, and the Brazilian registry ReBEC. Phase II or III studies with participation from Brazilian institutions listed in at least one of the registries were included. Following selection of the trials, the pathway of monoclonal antibodies and biological medicines was investigated from the research stage until licensing by the Brazilian Agency for Sanitary Surveillance (Anvisa), Food and Drug Administration (FDA), and European Medicines Agency (EMA)...
March 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Jing Zhang, Lei Sun, Yu Liu, Hongyi Wang, Ningling Sun, Jia Yu, Yao He, Sijin Yan, Puhong Zhang
OBJECTIVE: To evaluate the feasibility and acceptability of a mobile device based electronical data capture (mEDC) system applied in one randomized clinical trial (RCT). DESIGN AND METHOD: The mEDC, an android smartphone-based application, was developed to support real-time data capture, project management and quality control in a multicenter randomized double-blinded parallel controlled pharmaceutical trial. Four user interfaces are shown in Figure 1. The RCT is to evaluate the efficacy of telmisartan (40mg) and hydrochlorothiazide (25mg) monotherapy in high sodium intake patients with mild to moderate hypertension in 14 hospitals, including one baseline survey and three follow-ups...
September 2016: Journal of Hypertension
Seong-Choon Choe
There are several classes of anti-hypertensive agents in the world, the most recently developed agent is angiotensin receptor blocker (ARB). There are already 8 ARBs in the market, but still medical unmet need for treatment of hypertension is existed. The 'ideal' anti-hypertensive agent would have a number of characteristics: (1) effective in lowering blood pressure to recommend goals; (2) high efficacy as monotherapy; (3) rapid onset of effect; (4) convenient once-daily administration to maximize compliance; (5) sustained efficacy over 24 hours; (6) response increases with higher doses (clear dose-response effect); and (7) optimum tolerability profile...
September 2016: Journal of Hypertension
Iwao Kuwajima
Since a concept of Evidence-based Medicine appeared in medical field in 1991, modern medical treatment have been remarkably changed.However, delusive belief of EBM without criticism has brought negative aspect, such as utilization of EBM by companies as a tool of promotion of drug or medical device.Although most of clinical trials were financially supported by drug companies. result of clinical trial does not always ended in favor of test drug or device. When negative results appeared, various way were taken by industry such as usage of SPIN, emphasizing secondary endpoint...
September 2016: Journal of Hypertension
Tazeen Jafar
Chronic kidney disease (CKD) defined as reduced estimated glomerular filtration rate (eGFR) or presence of albuminuria, progresses to end stage renal disease (ESRD), needing dialysis or kidney transplant to sustain life, and is associated with increased risks of premature cardiovascular disease (CVD) and mortality. CKD ranked 18 leading (and most rapidly rising cause of mortality by the Global Burden of Disease Study 2010. The social and economic consequences of CKD are far worse in low and middle income countries (LMICs) including India, Pakistan, Bangladesh, and Sri Lanka...
September 2016: Journal of Hypertension
Jesús F San-Miguel, Vania T M Hungria, Sung-Soo Yoon, Meral Beksac, Meletios A Dimopoulos, Ashraf Elghandour, Wieslaw W Jedrzejczak, Andreas Günther, Thanyaphong N Nakorn, Noppadol Siritanaratkul, Robert L Schlossman, Jian Hou, Philippe Moreau, Sagar Lonial, Jae H Lee, Hermann Einsele, Monika Sopala, Bourras-Rezki Bengoudifa, Florence Binlich, Paul G Richardson
BACKGROUND: Panobinostat plus bortezomib and dexamethasone significantly increased median progression-free survival compared with placebo plus bortezomib and dexamethasone in the phase 3 PANORAMA 1 trial. Here, we present the final overall survival analysis for this trial. METHODS: PANORAMA 1 is a randomised, placebo-controlled, double-blind, phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma with one to three previous treatments...
October 14, 2016: Lancet Haematology
Dominic Way, Hortense Blazsin, Ragnar Löfstedt, Frederic Bouder
This paper reviews the main tools for communicating benefit-risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also reviewed as they show great promise for being usefully adapted to the pharmaceutical context. The evolution of benefit-risk medicines communication is first contextualised within the broader risk communication literature...
October 14, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Stephanie Prescott, Jessica Keim-Malpass
BACKGROUND: The incidence of hemodynamically significant patent ductus arteriosus (hsPDA) increases with decreasing gestational age and is associated with many common morbidities of extreme prematurity. Controversies remain surrounding the definition of hsPDA, the population of infants requiring treatment, the appropriate timing and method of treatment, and the outcomes associated with PDA and its therapies. PURPOSE: This integrative literature review focuses on diagnostic and treatment recommendations derived from the highest levels of evidence...
October 8, 2016: Advances in Neonatal Care: Official Journal of the National Association of Neonatal Nurses
Mel S Lee, Tsung-Cheng Yin, Pei-Hsun Sung, John Y Chiang, Cheuk-Kwan Sun, Hon-Kan Yip
Despite state-of-the-art pharmaceutical regimens, continuous improvements in diagnostic techniques as well as refinements in equipment and interventional procedures, many diseases remain refractory to conventional therapies. Recent advances in stem cell (SC) biology have opened an avenue to exploring its therapeutic potential in various disease entities, especially those that are ischemia-related and refractory to conventional treatment. A number of experimental studies and clinical trials have already demonstrated promising outcomes...
October 13, 2016: Journal of Pineal Research
W Kievit, F A C Berden, J P H Drenth
Pharmaceutical companies are under increasing scrutiny because of their strategy for gaining market access and reimbursement authorisation for novel drugs. The tool most often used is that of a randomised controlled trial (RCT) in a highly selected population that has a high chance of responding on the treatment but a low chance of developing side effects. This population differs to a large extent from real-life patients, who have diverging characteristics that can influence effectiveness and safety; these include co-morbidity, age and disease severity...
2016: Nederlands Tijdschrift Voor Geneeskunde
Nicola Lindson-Hawley, Jamie Hartmann-Boyce, Thomas R Fanshawe, Rachna Begh, Amanda Farley, Tim Lancaster
BACKGROUND: Although smoking cessation is currently the only guaranteed way to reduce the harm caused by tobacco smoking, a reasonable secondary tobacco control approach may be to try and reduce the harm from continued tobacco use amongst smokers unable or unwilling to quit. Possible approaches to reduce the exposure to toxins from smoking include reducing the amount of tobacco used, and using less toxic products, such as pharmaceutical, nicotine and potential reduced-exposure tobacco products (PREPs), as an alternative to cigarettes...
October 13, 2016: Cochrane Database of Systematic Reviews
Jessica W Skelley, C Whitney White, Angela R Thomason
To review the use of the direct oral anticoagulant (DOAC) agents in inherited thrombophilia based on the literature. MEDLINE, International Pharmaceutical Abstracts, and Google Scholar searches (1970-May 2016) were conducted for case reports, case series, retrospective cohorts, or clinical trials using the key words: protein C deficiency, protein S deficiency, antithrombin deficiency, activated protein C resistance, Factor V Leiden, hypercoagulable, NOACs, dabigatran, apixaban, rivaroxaban, betrixaban, edoxaban, Xa inhibitor, direct thrombin inhibitor...
October 12, 2016: Journal of Thrombosis and Thrombolysis
Arka Chattopadhyay, Stephen Frey, Ghiselle Green
BACKGROUND: Bifeprunox is a novel antipsychotic drug designed to treat schizophrenia. However, research into the drug was ceased in 2009 due to rejection of licence to go to market by the US Food and Drug Administration (FDA), who could not approve the drug for acute or long-term symptoms of schizophrenia because more research was required to demonstrate convincing effects "beyond those already achieved" with currently licenced drugs. There were also concerns expressed over one death of a person whilst on the drug...
October 12, 2016: Cochrane Database of Systematic Reviews
Ruey Terng Ng, Way Seah Lee, Hak Lee Ang, Kai Ming Teo, Yee Ian Yik, Nai Ming Lai
BACKGROUND: Childhood constipation is a common problem with substantial health, economic and emotional burdens. Existing therapeutic options, mainly pharmacological, are not consistently effective, and some are associated with adverse effects after prolonged use. Transcutaneous electrical stimulation (TES), a non-pharmacological approach, is postulated to facilitate bowel movement by modulating the nerves of the large bowel via the application of electrical current transmitted through the abdominal wall...
October 12, 2016: Cochrane Database of Systematic Reviews
Arman Zargaran, Saeid Daneshamouz, Gholamreza Kordafshari, Abdolali Mohagheghzadeh
The Ergh-al-Nassa pill (Hab) is a traditional combination suggested as one of the most effective preparations useful for treatment of sciatica. Although traditional preparations can be applied as new therapeutic drugs for investigations and clinical trials, they need to be reformulated to achieve pharmacopoeial standards for modern medicine. In this research, based on seven traditional Persian pharmacopeias for Ergh-al-NassaHab, nine different molded tablets were reformulated. Each formulation comprised the same amount of colchicum, ginger, aloe and yellow myrobalan fruit...
September 2016: Pakistan Journal of Pharmaceutical Sciences
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