keyword
MENU ▼
Read by QxMD icon Read
search

fact trial

keyword
https://www.readbyqxmd.com/read/28344480/changing-paradigms-in-bioequivalence-trials-submitted-to-the-ema-for-evaluation-a-clinical-and-regulatory-perspective
#1
Nathaniel Refalo, Daniel Chetcuti, Amy Tanti, Anthony Serracino-Inglott, John Joseph Borg
BACKGROUND: The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a means to allow companies to reduce costs and reach the market earlier. We therefore investigated whether different approaches in various products assessed by the European Medicines Agency during the approval phase resulted in a reduction in resources required to show bioequivalence for different medicinal products...
February 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/28344464/the-biomechanics-of-standing-start-and-initial-acceleration-reliability-of-the-key-determining-kinematics
#2
Regan J Standing, Peter S Maulder
The reliability of the key determining kinematic variables associated with short sprint performance provide insight into how and why movement may vary between individual trials. Currently, literature surrounding these determinants is scarce when investigating the first three strides of a sprint. The purpose of this study was to investigate the reliability of sprint acceleration and the key kinematic determinants involved during the first three steps of the movement. The aim was to use a practical method of kinematic analysis to help explain why changes may occur in sprint performance via the use of correlative statistics and to provide reference values for intervention research to make conclusions about their change scores...
March 2017: Journal of Sports Science & Medicine
https://www.readbyqxmd.com/read/28327437/evaluating-the-effect-of-antioxidant-agents-on-shear-bond-strength-of-tooth-colored-restorative-materials-after-bleaching-a-systematic-review
#3
REVIEW
Atiyeh Feiz, Hamid Mosleh, Rahman Nazeri
PURPOSE: The main objective of the present study was to make a systematic review of how antioxidant agents affect shear bond strength of tooth-colored restorative materials after bleaching. DATA SOURCES: Electronic search was used to extract the related articles on the targeted key words such as "antioxidant", "dental bleaching" and "shear bond strength" (SBS) from MeSH, PubMed, Medline, and Cochrane electronic data bases. These articles were all published before 2016...
March 10, 2017: Journal of the Mechanical Behavior of Biomedical Materials
https://www.readbyqxmd.com/read/28326028/inter-trial-correlations-in-predictive-saccade-endpoints-fractal-scaling-reflects-differential-control-along-task-relevant-and-orthogonal-directions
#4
Pamela Federighi, Aaron L Wong, Mark Shelhamer
Saccades exhibit variation in performance from one trial to the next, even when paced at a constant rate by targets at two fixed locations. We previously showed that amplitude fluctuations in consecutive predictive saccades have fractal structure: the spectrum of the sequence of consecutive amplitudes has a power-law (f(-α)) form, indicative of inter-trial correlations that reflect the storage of prior performance information to guide the planning of subsequent movements. More gradual decay of these inter-trial correlations coincides with a larger magnitude of spectral slope α, and indicates stronger information storage over longer times...
2017: Frontiers in Human Neuroscience
https://www.readbyqxmd.com/read/28325150/managing-expectations-in-the-transition-to-proof-of-concept-studies
#5
Thomas Kieber-Emmons, Issam Makhoul, Angela Pennisi, Eric R Siegel, Peter D Emanuel, Bejotaloh Monzavi-Karbassi, Zenon Steplewski, J Thaddeus Beck, Laura F Hutchins
BACKGROUND: As we are moving away from the traditional chemotherapy era to targeted therapy, the validity of old assessment paradigms associated with therapeutics are being raised in the context of immunotherapy. The old paradigm required elaborate assessment of toxicity with no expectation of efficacy in early phase trials. Safety data from Phase 1 and 2 studies with many immunotherapeutics show that they display limited toxicities and draw attention to the need to demonstrate efficacy in the early evaluation of new agents...
March 21, 2017: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/28323035/naturally-occurring-anti-cancer-agents-targeting-ezh2
#6
Fahimeh Shahabipour, Michele Caraglia, Muhammed Majeed, Giuseppe Derosa, Pamela Maffioli, Amirhossein Sahebkar
Natural products are considered as promising tools for the prevention and treatment of cancer. The enhancer of zeste homolog 2 (EZH2) is a histone methyltransferase unit of polycomb repressor complexes such as PRC2 complex that has oncogenic roles through interference with growth and metastatic potential. Several agents targeting EZH2 has been discovered but they often induce side effects in clinical trials. Recently, EZH2 has emerged as a potential target of natural products with documented anti-cancer effects and this discloses a new scenario for the development of EZH2 inhibitory strategies with agents with low cytotoxic detrimental effects...
March 17, 2017: Cancer Letters
https://www.readbyqxmd.com/read/28321816/cancer-imaging-in-immunotherapy
#7
Yousra Eleneen, Rivka R Colen
Immune therapeutics are revolutionizing cancer treatments. In tandem, new and confounding imaging characteristics have appeared that are distinct from those typically seen with conventional cytotoxic therapies. In fact, only 10% of patients on immunotherapy may show tumor shrinkage, typical of positive responses on conventional therapy. Conversely, those on immune therapies may initially demonstrate a delayed response, transient enlargement followed by tumor shrinkage, stable size, or the appearance of new lesions...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/28318797/early-symptom-trajectories-as-predictors-of-treatment-outcome-for-citalopram-versus-placebo
#8
Sigal Zilcha-Mano, Steven P Roose, Patrick J Brown, Bret R Rutherford
OBJECTIVES: The high percentage of failed clinical trials for anti-depressant medications, especially in elderly populations, obscures the fact that some patients may benefit greatly from treatment. Early detection of patients who may benefit most from antidepressant medication may improve treatment decisions. We examined whether depressed patients in a large clinical trial exhibit distinct trajectories of early symptom change that predict differential response to medication or placebo...
February 3, 2017: American Journal of Geriatric Psychiatry
https://www.readbyqxmd.com/read/28314973/-should-cytoreductive-nephrectomy-be-performed-in-patients-with-metastatic-renal-cell-carcinoma-and-what-is-the-scientific-rationale
#9
N Gilbert, A S Merseburger, M W Kramer
Between 15 and 20% of patients diagnosed with renal cell carcinoma suffer from metastatic disease by the time of diagnosis. In the immunotherapy era, the standard treatment was to perform cytoreductive nephrectomy (CN) followed by treatment with interferon α. This was based on two prospective randomized trials and their combined analysis. Since the introduction of targeted therapy, the use of CN came into question and the number of performed CN has declined. Two trials (CARMENA and SURTIME) evaluating the role of CN in the times of targeted therapy have either closed early or are recruiting slowly and will probably not be able to answer this question...
March 17, 2017: Der Urologe. Ausg. A
https://www.readbyqxmd.com/read/28302178/laser-peripheral-iridotomy-versus-laser-peripheral-iridotomy-plus-laser-peripheral-iridoplasty-in-the-treatment-of-multi-mechanism-angle-closure-study-protocol-for-a-randomized-controlled-trial
#10
Shida Chen, Jianhua Lv, Sujie Fan, Hong Zhang, Lin Xie, Ling Xu, Bing Jiang, Huipin Yuan, Yuanbo Liang, Shuning Li, Pingyan Chen, Xiulan Zhang, Ningli Wang
BACKGROUND: China has the largest burden of primary angle-closure glaucoma (PACG) worldwide. The mechanism of the angle closure is complex and includes pupillary block and non-pupillary block. Currently, opinion is that laser peripheral iridotomy (LPI) alone is not sufficient to prevent disease progression. Laser peripheral iridoplasty (LPIP) is an alternative and effective way of widening the angle recess in eyes that are affected by primary angle closure (PAC). However, it is not known if greater benefit would be achieved using LPI plus LPIP for PAC with multiple mechanisms (MAC)...
March 17, 2017: Trials
https://www.readbyqxmd.com/read/28301702/space-for-the-prisoner-s-point-of-view
#11
Laura Haupt
The lead article in this issue discusses a potentially free metaphorical space-that of decision-making-within the confines, tangible and intangible, of life in jail or prison. By interviewing prisoner-participants from six clinical studies, Paul Christopher and colleagues sought to find out how these men and women would answer open-ended questions about their decision to enroll in the research. What the interviewers heard was that none saw themselves as having been inappropriately pressured to do so. In fact, a significant percentage of the prisoners described being dissuaded from participating in the studies...
March 2017: Hastings Center Report
https://www.readbyqxmd.com/read/28299615/remote-monitoring-in-heart-failure-the-current-state
#12
REVIEW
Rajeev C Mohan, J Thomas Heywood, Roy S Small
The treatment of congestive heart failure is an expensive undertaking with much of this cost occurring as a result of hospitalization. It is not surprising that many remote monitoring strategies have been developed to help patients maintain clinical stability by avoiding congestion. Most of these have failed. It seems very unlikely that these failures were the result of any one underlying false assumption but rather from the fact that heart failure is a progressive, deadly disease and that human behavior is hard to modify...
March 2017: Current Treatment Options in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28298187/icanadapt-early-protocol-randomised-controlled-trial-rct-of-clinician-supervised-transdiagnostic-internet-delivered-cognitive-behaviour-therapy-icbt-for-depression-and-or-anxiety-in-early-stage-cancer-survivors-vs-treatment-as-usual
#13
M J Murphy, J M Newby, P Butow, L Kirsten, K Allison, S Loughnan, M A Price, J Shaw, H Shepherd, J Smith, G Andrews
BACKGROUND: This RCT with two parallel arms will evaluate the efficacy of an internet-delivered transdiagnostic cognitive behavioural therapy (iCBT) intervention for the treatment of clinical depression and/or anxiety in early stage cancer survivors. METHODS/DESIGN: Early stage cancer survivors will be recruited via the research arm of a not-for-profit clinical research unit and randomised to an intervention (iCBT) group or a 'treatment as usual' (TAU) control group...
March 15, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28296338/effect-of-endocrine-disruptors-on-male-reproduction-in-humans-why-the-evidence-is-still-lacking
#14
D Bliatka, S Lymperi, G Mastorakos, D G Goulis
The so-called "endocrine disruption hypothesis" suggests that exposures to endocrine disruption (EDs) during fetal, neonatal and adult life may interfere with the development of reproductive organs and alter semen quality and reproductive hormone production. Even though animal studies provide substantial evidence of adverse effects of EDs on male reproductive system, epidemiological studies in humans arrive at conflicting results. The aim of the present study was to systematically review the literature to locate methodological characteristics of the studies that struggle the formation of an association between EDs and human male reproduction...
March 10, 2017: Andrology
https://www.readbyqxmd.com/read/28295991/antenatal-corticosteroids-it-s-all-about-timing
#15
Cynthia Gyamfi-Bannerman
Antenatal corticosteroids have been shown consistently to improve respiratory and other outcomes for infants born preterm (Roberts D et al. Cochrane database of systematic reviews. 2006(3):CD004454). Since Liggins and Howie we know that timing of corticosteroid administration influences the likelihood of benefit (Liggins GC et al. Pediatrics. 1972;50(4):515-525; Ring AM et al. Am J Obstet Gynecol. 2007;196(5):457 e451-456). In fact, the lack of benefit after seven days in their trial led to numerous studies evaluating serial administration of steroids...
March 11, 2017: BJOG: An International Journal of Obstetrics and Gynaecology
https://www.readbyqxmd.com/read/28293726/inflammation-in-iga-nephropathy
#16
Thomas Rauen, Jürgen Floege
Immunoglobulin A nephropathy (IgAN) is the most frequently occurring primary glomerulonephritis in Caucasian and Asian populations. Nonetheless, therapeutic recommendations are based on weak evidence, large controlled trials are scarce and, in particular, the additional value of immunosuppression beyond comprehensive supportive measures is not well-established. The use of immunosuppressants is supported by experimental insights into IgAN pathogenesis that suggest an autoimmune component in disease development...
March 14, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28293447/efficacy-and-safety-of-aceclofenac-in-osteoarthritis-a-meta-analysis-of-randomized-controlled-trials
#17
Parvati B Patel, Tejas K Patel
OBJECTIVE: To analyze the effects on pain, function, and safety of aceclofenac compared with other nonsteroidal anti-inflammatory drugs (NSAIDs) or pain relief medications in patients with osteoarthritis. MATERIAL AND METHODS: Two investigators independently searched the database. We included randomized controlled trials evaluating efficacy and/or safety of aceclofenac compared with control interventions (NSAIDs or acetaminophen) in patients with osteoarthritis...
March 2017: European Journal of Rheumatology
https://www.readbyqxmd.com/read/28290210/changing-concept-in-treatment-of-asymptomatic-severe-aortic-stenosis-and-normal-ejection-fraction-time-for-biomarkers-reappraisal
#18
Marko D Banovic
The uncertainty of whether/how to treat asymptomatic patients with isolated severe aortic stenosis and normal left ventricular ejection fraction is one of the most topical in cardiovascular medicine. Recently, the AVATAR trial: first ever randomized trial in the setting of aortic stenosis has been started in an attempt to adequately address this 'burning issue'. In light of this fact it is important to identify biomarkers which might help in risk stratification of these patients, not only in the referring physician's office during a routine exam, but also for preoperative patients scheduled for surgical replacement/transcatheter aortic valve implantation...
March 14, 2017: Biomarkers in Medicine
https://www.readbyqxmd.com/read/28289788/-failure-of-a%C3%A2-study-in-forensic-psychiatric-hospitals-clinical-trial-to-investigate-the-additive-effect-of-triptorelin-on-the-efficacy-of-psychotherapy
#19
Peer Briken, Jürgen L Müller, Wolfgang Berner, Rolf-Hasso Bödeker, Jochen Vollmann, Christian Kasperk, Matthias Koller
BACKGROUND: A testosterone-lowering medication is relatively commonly used as a form of treatment for sexual offenders with severe paraphilic disorders in German forensic psychiatric hospitals; however, a double-blind, controlled and randomized study, which investigates the efficacy of this medication, is still lacking. AIM: This article describes the process from the planning to the rejection of a clinical trial over the period from 2009 to 2015. METHODS AND RESULTS: Despite the careful planning with an interdisciplinary team and giving special consideration to the complex legal situation, the Federal Institute for Drugs and Medical Devices (BfArM) rejected the proposed trial in a brief formal letter with reference to the German Drug Law (§ 40 para...
March 13, 2017: Der Nervenarzt
https://www.readbyqxmd.com/read/28288636/the-effect-of-a-smartphone-based-coronary-heart-disease-prevention-sbchdp-programme-on-awareness-and-knowledge-of-chd-stress-and-cardiac-related-lifestyle-behaviours-among-the-working-population-in-singapore-a-pilot-randomised-controlled-trial
#20
Hui Zhang, Ying Jiang, Hoang D Nguyen, Danny Chiang Choon Poo, Wenru Wang
BACKGROUND: Coronary heart disease (CHD) is the most prevalent type of cardiac disease among adults worldwide, including those in Singapore. Most of its risk factors, such as smoking, physical inactivity and high blood pressure, are preventable. mHealth has improved in the last decade, showing promising results in chronic disease prevention and health promotion worldwide. Our aim was to develop and examine the effect of a 4-week Smartphone-Based Coronary Heart Disease Prevention (SBCHDP) programme in improving awareness and knowledge of CHD, perceived stress as well as cardiac-related lifestyle behaviours in the working population of Singapore...
March 14, 2017: Health and Quality of Life Outcomes
keyword
keyword
108339
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"