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https://www.readbyqxmd.com/read/28096109/financial-ties-of-principal-investigators-and-randomized-controlled-trial-outcomes-cross-sectional-study
#1
Rosa Ahn, Alexandra Woodbridge, Ann Abraham, Susan Saba, Deborah Korenstein, Erin Madden, W John Boscardin, Salomeh Keyhani
OBJECTIVE:  To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding. DESIGN:  Cross sectional study of randomized controlled trials (RCTs). SETTING:  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013. PARTICIPANTS:  Random sample of RCTs focused on drug efficacy...
January 17, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28095913/effects-of-a-purified-krill-oil-phospholipid-rich-in-long-chain-omega-3-fatty-acids-on-cardiovascular-disease-risk-factors-in-non-human-primates-with-naturally-occurring-diabetes-type-2-and-dyslipidemia
#2
Petter-Arnt Hals, Xiaoli Wang, Yong-Fu Xiao
BACKGROUND: High serum levels of cholesterol, in particular low-density lipoprotein cholesterol, are considered a significant risk factor for development of cardiovascular disease. Therefore, rigorous treatment regimens with statins and other pharmaceuticals have been used extensively to reduce elevated cholesterol levels. Literature data have not clearly concluded whether long-chain omega-3 fatty acids reduce, increase or leave circulating cholesterol unaffected. In the present study a novel krill-oil derived preparation of omega-3 rich phospholipids, mainly phosphatidylcholine, was administered orally at increasing doses for 12 weeks to dyslipidemic non-human primates, and cholesterols and several other risk factors for cardiovascular disease were measured before, during and after treatment...
January 17, 2017: Lipids in Health and Disease
https://www.readbyqxmd.com/read/28095531/future-applications-of-deoxycholic-acid-in-body-contouring
#3
Jonathan M Sykes, Amir Allak, Brian Klink
Deoxycholic acid (KybellaTM, Allergan Pharmaceuticals, Irvine, CA) is a novel injectable treatment used for the cosmetic reduction of redundant submental fat. By inducing adipose cell lysis, the soft tissue alteration induces subsequent contour change and sharpening of the cervicomental angle.The safety and efficacy have been well established in several prospective clinical trials and subsequent FDA approval for this purpose. This has provided an effective and less invasive alternative to surgical liposuction with virtually no recovery time and less overall discomfort...
January 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28095073/preclinical-and-potential-applications-of-common-western-herbal-supplements-as-complementary-treatment-in-parkinson-s-disease
#4
Luke A Morgan, Oliver Grundmann
Parkinson's disease (PD) is a neurological disorder with a complex pathological etiology, which is not fully understood. Progression of PD may be the result of a buildup of iron in the substantia nigra, microglia-mediated neuroinflammation, dysfunctional mitochondria, or abnormal protein handling. Dopamine is the main neurotransmitter affected, but as the disease progresses, a decrease in all the brain's biogenic amines occurs. Current medication used in the treatment of PD aims to prevent the breakdown of dopamine or increase dopaminergic neurotransmission in the central nervous system...
January 17, 2017: Journal of Dietary Supplements
https://www.readbyqxmd.com/read/28092474/novel-histone-deacetylase-6-hdac6-selective-inhibitors-a-patent-evaluation-wo2014181137
#5
Claudia A Simões-Pires, Philippe Bertrand, Muriel Cuendet
The invention described in this patent (WO2014181137) is related to hydroxamic acid derivatives with inhibitory activity towards histone deacetylases (HDACs), their synthetic process and pharmaceutical formulations, as well as a method for treating patients suffering from a list of selected tumoral, inflammatory, cardiac and chronic disorders. HDACs are known to deacetylate histones and other proteins, which makes HDAC inhibitors able to affect cell survival, cell signaling, transport, and gene expression. Those effects have been associated to the therapeutic success of HDAC inhibitors...
January 16, 2017: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/28089286/historical-perspective-on-the-medical-use-of-cannabis-for-epilepsy-ancient-times-to-the-1980s
#6
REVIEW
Daniel Friedman, Joseph I Sirven
There has been a dramatic surge in the interest of utilizing cannabis for epilepsy treatment in the US. Yet, access to cannabis for research and therapy is mired in conflicting regulatory policies and shifting public opinion. Understanding the current state of affairs in the medical cannabis debate requires an examination of the history of medical cannabis use. From ancient Chinese pharmacopeias to the current Phase III trials of pharmaceutical grade cannabidiol, this review covers the time span of cannabis use for epilepsy therapy so as to better assess the issues surrounding the modern medical opinion of cannabis use...
January 11, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28088572/bcs-class-iv-drugs-highly-notorious-candidates-for-formulation-development
#7
REVIEW
Rohan Ghadi, Neha Dand
BCS class IV drugs (e.g., amphotericin B, furosemide, acetazolamide, ritonavir, paclitaxel) exhibit many characteristics that are problematic for effective oral and per oral delivery. Some of the problems associated include low aqueous solubility, poor permeability, erratic and poor absorption, inter and intra subject variability and significant positive food effect which leads to low and variable bioavailability. Also, most of the class IV drugs are substrate for P-glycoprotein (low permeability) and substrate for CYP3A4 (extensive pre systemic metabolism) which further potentiates the problem of poor therapeutic potential of these drugs...
January 11, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28078991/vegetable-organosulfur-compounds-and-their-health-promoting-effects
#8
Spyridon A Petropoulos, Francesco Di Gioia, Georgia Ntatsi
BACKGROUND: Trends in modern pharmaceutical science show an increase in demand for new drugs and diet supplements derived from natural products, while during the last decades, great research is conducted regarding the natural compounds and their medicinal and bioactive properties. Organosulfur compounds are present in many plants and their bioactive properties have been used in folk and traditional medicine throughout the centuries. Not until recently, modern science confirmed and revealed the chemical compounds that are responsible for these properties, the chemistry involved in their biosynthesis and the main mechanisms of action...
January 10, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28076854/open-angle-glaucoma-drug-development-pipeline-during-the-last-20-years-1995-2015
#9
André Vicente, Sylvie Prud'homme, Joana Ferreira, Luís Abegão Pinto, Ingeborg Stalmans
OBJECTIVES: To analyse drug development for open-angle glaucoma during the last 20 years. METHODS: Research was performed by referring to clinical trials registered at the International Clinical Trials Registry Platform (ICTRP). A search for the condition "open-angle glaucoma" with the intervention "drug" was performed. We included trials registered from 01/01/1995 to 01/01/2015, only involving studies in phases 1, 2, and 3. Only studies resorting to novel treatment strategies (either novel drugs or yet-untested fixed associations of approved medication) were considered...
January 12, 2017: Ophthalmic Research
https://www.readbyqxmd.com/read/28076634/immediate-versus-delayed-treatment-for-recently-symptomatic-carotid-artery-stenosis
#10
Vladimir Vasconcelos, Nicolle Cassola, Edina Mariko Koga da Silva, José Carlos Costa Baptista-Silva
BACKGROUND: The timing of surgery for recently symptomatic carotid artery stenosis remains controversial. Early cerebral revascularization may prevent a disabling or fatal ischemic recurrence, but it may also increase the risk of hemorrhagic transformation, or of dislodging a thrombus. This review examined the randomized controlled evidence that addressed whether the increased risk of recurrent events outweighed the increased benefit of an earlier intervention. OBJECTIVES: To assess the risks and benefits of performing very early cerebral revascularization (within two days) compared with delayed treatment (after two days) for people with recently symptomatic carotid artery stenosis...
November 2016: São Paulo Medical Journal, Revista Paulista de Medicina
https://www.readbyqxmd.com/read/28076585/-priorities-of-clinical-drug-trials-in-brazil-and-neglected-diseases-of-poverty
#11
Rafael Santos Santana, Silvana Nair Leite
Objective: To identify clinical drug trials performed in Brazil between 2012 and 2015, with emphasis on those focusing on neglected diseases of poverty. Method: Two clinical trial registries, ReBEC (Brazilian registry) and ClinicalTrials.gov were surveyed. The following aspects were investigated: distribution of clinical trials in relation to the burden of disease in Brazil, distribution of trials regarding their focus on diseases of poverty vs. diseases not linked to poverty, phase of trials, performing institution, and type of funding (private, public, or mixed)...
November 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/28076528/the-brief-life-of-norplant%C3%A2-in-brazil-controversies-and-reassemblages-between-science-society-and-state
#12
Ana Cristina de Lima Pimentel, Cláudia Bonan Jannotti, Paula Gaudenzi, Luiz Antonio da Silva Teixeira
Norplant® is the brand name of the world's first registered subdermal hormonal contraceptive implant, developed by the laboratories of the Population Council, an international organisation working in the area of fertility and population growth. The article revisits the trajectory of this contraceptive in Brazil from its arrival through clinical trials to its eventual ban in 1986 by the Brazilian regulatory agency responsible for approving medications at the time. Its circulation generated controversies related to research practices, side effects and political uses of the drug as a birth control method...
January 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/28075527/recent-development-of-the-second-and-third-generation-irreversible-egfr-inhibitors
#13
REVIEW
Weiwei Han, Yongli Du
Recent reports suggested that essential directions for new lung cancer, breast carcinoma therapies, as well as the roomier realm of targeted cancer therapies were provided through targeting the epidermal growth factor receptor (EGFR). Patients who carrying non-small cell lung carcinoma (NSCLC) with activating mutations in EGFR initially respond well to the EGFR inhibitors erlotinib and gefitinib, which were located the active site of the EGFR kinase and designed to act as competitive inhibitors of combining with the ATP...
January 11, 2017: Chemistry & Biodiversity
https://www.readbyqxmd.com/read/28073970/estimated-generic-prices-for-novel-treatments-for-drug-resistant-tuberculosis
#14
Dzintars Gotham, Joseph Fortunak, Anton Pozniak, Saye Khoo, Graham Cooke, Frederick E Nytko, Andrew Hill
BACKGROUND: The estimated worldwide annual incidence of MDR-TB is 480 000, representing 5% of TB incidence, but 20% of mortality. Multiple drugs have recently been developed or repurposed for the treatment of MDR-TB. Currently, treatment for MDR-TB costs thousands of dollars per course. OBJECTIVES: To estimate generic prices for novel TB drugs that would be achievable given large-scale competitive manufacture. METHODS: Prices for linezolid, moxifloxacin and clofazimine were estimated based on per-kilogram prices of the active pharmaceutical ingredient (API)...
January 10, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28070861/efficacy-and-safety-of-vedolizumab-in-ulcerative-colitis-and-crohn-s-disease-patients-stratified-by-age
#15
Vijay Yajnik, Nabeel Khan, Marla Dubinsky, Jeffrey Axler, Alexandra James, Brihad Abhyankar, Karen Lasch
INTRODUCTION: The efficacy and safety of vedolizumab, a gut-selective α4β7 integrin antibody, were demonstrated in the GEMINI 1 and GEMINI 2 clinical trials of adults aged 18-80 years. We investigated the efficacy and safety of vedolizumab in patients stratified by age from the GEMINI trials. METHODS: Safety and efficacy, including clinical response, clinical remission, and corticosteroid-free remission, at week 6 and/or 52 were determined post hoc in patients aged <35, 35 to <55, and ≥55 years...
January 9, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28070712/microdialysis-monitoring-in-clinical-traumatic-brain-injury-and-its-role-in-neuroprotective-drug-development
#16
Eric Peter Thelin, Keri L H Carpenter, Peter J Hutchinson, Adel Helmy
Injuries to the central nervous system continue to be vast contributors to morbidity and mortality; specifically, traumatic brain injury (TBI) is the most common cause of death during the first four decades of life. Several modalities are used to monitor patients suffering from TBI in order to prevent detrimental secondary injuries. The microdialysis (MD) technique, introduced during the 1990s, presents the treating physician with a robust monitoring tool for brain chemistry in addition to conventional intracranial pressure monitoring...
January 9, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28069357/control-strategies-for-drug-product-continuous-direct-compression-state-of-control-product-collection-strategies-and-startup-shutdown-operations-for-the-production-of-clinical-trial-materials-and-commercial-products
#17
Ahmad Almaya, Lawrence De Belder, Robert Meyer, Karthik Nagapudi, Hung-Ren Homer Lin, Ian Leavesley, Jayanthy Jayanth, Gurjit Bajwa, James DiNunzio, Anthony Tantuccio, Dan Blackwood, Admassu Abebe
Continuous Manufacturing (CM) has emerged in the pharmaceutical industry as a paradigm shift with significant advantages related to cost, efficiency, flexibility and higher assurance of quality. The inherent differences from batch processes justify examining the CM control strategy more holistically. This paper describes the current thinking for the control and implementation of CM, using the example of a direct compression process and taking into consideration the ICH Q10 definition of "state of control" and process validation requirements...
January 6, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28066881/short-acting-erythropoiesis-stimulating-agents-for-anaemia-in-predialysis-patients
#18
REVIEW
Deirdre Hahn, Christopher I Esezobor, Noha Elserafy, Angela C Webster, Elisabeth M Hodson
BACKGROUND: The benefits of erythropoiesis-stimulating agents (ESA) for chronic kidney disease (CKD) patients have been previously demonstrated. However, the efficacy and safety of short-acting epoetins administered at larger doses and reduced frequency as well as of new epoetins and biosimilars remains uncertain. OBJECTIVES: This review aimed to evaluate the benefits and harms of different routes, frequencies and doses of epoetins (epoetin alpha, epoetin beta and other short-acting epoetins) for anaemia in adults and children with CKD not receiving dialysis...
January 9, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28065968/therapeutic-uses-of-pineapple-extracted-bromelain-in-surgical-care-a-review
#19
Zehra Abdul Muhammad, Tashfeen Ahmad
Bromelain is an extract obtained from the pineapple plant and is used as a traditional folk remedy for several ailments. In this review, a comprehensive electronic database search was carried out to compile available literature on therapeutic implications of bromelain. Pharmaceutical value of bromelain has been demonstrated in different surgical sub-specialties. Diverse biological processes like anti-inflammatory, anti-oedematous, analgesic, anti-thrombotic, exfoliation etc. are involved in bromelain's therapeutic actions, mediated through the kallikrein-kinin and arachidonic acid pathways as well as through effects on cell mediated immunity...
January 2017: JPMA. the Journal of the Pakistan Medical Association
https://www.readbyqxmd.com/read/28064353/who-is-a-healthy-subject-consensus-results-on-pivotal-eligibility-criteria-for-clinical-trials
#20
REVIEW
Kerstin Breithaupt-Groegler, Christoph Coch, Martin Coenen, Frank Donath, Katharina Erb-Zohar, Klaus Francke, Karin Goehler, Mario Iovino, Klaus Peter Kammerer, Gerd Mikus, Jens Rengelshausen, Hildegard Sourgens, Reinhard Schinzel, Thomas Sudhop, Georg Wensing
INTRODUCTION/METHODS: A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key eligibility criteria and stopping rules for clinical trials with healthy subjects, enrolling stakeholders from the pharmaceutical industry, contract research organisations, academia, ethics committees and competent authority. RESULTS: Pivotal eligibility criteria were defined for trials with new investigational medicinal products (IMPs) or with clinically established IMPs...
January 7, 2017: European Journal of Clinical Pharmacology
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