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https://www.readbyqxmd.com/read/28822350/baclofen-for-alcohol-withdrawal
#1
REVIEW
Jia Liu, Lu-Ning Wang
BACKGROUND: Baclofen shows potential for rapidly reducing symptoms of severe alcohol withdrawal syndrome (AWS) in people with alcoholism. Treatment with baclofen is easy to manage and rarely produces euphoria or other pleasant effects, or craving for the drug. This is an updated version of the original Cochrane Review published in 2015, Issue 4. OBJECTIVES: To assess the efficacy and safety of baclofen for people with AWS. SEARCH METHODS: We updated our searches of the following databases to March 2017: the Cochrane Drugs and Alcohol Group Specialised Register, CENTRAL, PubMed, Embase, and CINAHL...
August 20, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28818347/use-of-supplemental-long-chain-omega-3-fatty-acids-and-risk-for-cardiac-death-an-updated-meta-analysis-and-review-of-research-gaps
#2
Kevin C Maki, Orsolya M Palacios, Marjorie Bell, Peter P Toth
BACKGROUND: Randomized controlled trials (RCTs) assessing use of long-chain omega-3 polyunsaturated fatty acids (LC-OM3), primarily eicosapentaenoic acid, and/or docosahexaenoic acid have shown mixed results. OBJECTIVE: The objectives of the study were to update and further explore the available RCT data regarding LC-OM3 supplementation and risk for cardiac death and to propose testable hypotheses for the mixed results obtained in RCTs regarding supplemental LC-OM3 use and cardiac risk...
August 2, 2017: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/28817967/pimavanserin-a-novel-antipsychotic-for-management-of-parkinson-s-disease-psychosis
#3
Yasaman Kianirad, Tanya Simuni
Parkinson's disease psychosis (PDP) may develop in up to 60% of Parkinson's patients and is associated with increased morbidity and mortality. It also correlates with depression and dementia, and can contribute to caregiver stress and burnout. Pimavanserin is the first FDA approved drug for the treatment of hallucinations and delusions associated with PDP. Areas covered: For this review, a MEDLINE literature search (via PubMed) and information provided by ACADIA Pharmaceuticals were used. References of our search results were screened for additional studies...
August 18, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28817175/drug-development-for-breast-colorectal-and-non-small-cell-lung-cancers-from-1979-to-2014
#4
Nancy A Nixon, Omar F Khan, Hasiba Imam, Patricia A Tang, Jose Monzon, Haocheng Li, Gavin Sun, Doreen Ezeife, Sunil Parimi, Scot Dowden, Vincent C Tam
BACKGROUND: Understanding the drug development pathway is critical for streamlining the development of effective cancer treatments. The objective of the current study was to delineate the drug development timeline and attrition rate of different drug classes for common cancer disease sites. METHODS: Drugs entering clinical trials for breast, colorectal, and non-small cell lung cancer were identified using a pharmaceutical business intelligence database. Data regarding drug characteristics, clinical trials, and approval dates were obtained from the database, clinical trial registries, PubMed, and regulatory Web sites...
August 17, 2017: Cancer
https://www.readbyqxmd.com/read/28810061/single-dose-pharmacokinetics-of-co-crystal-of-tramadol-celecoxib-results-of-a-4-way-randomized-open-label-phase-i-clinical-trial-in-healthy-subjects
#5
Sebastián Videla, Mounia Lahjou, Anna Vaqué, Mariano Sust, Mercedes Encabo, Lluis Soler, Artur Sans, Eric Sicard, Neus Gascón, Gregorio Encina, Carlos Plata-Salamán
AIM: Co-Crystal of Tramadol-Celecoxib (CTC) is a novel co-crystal molecule containing two active pharmaceutical ingredients (APIs) under development by Esteve (E-58425) and Mundipharma Research (MR308). This Phase I study compared single-dose pharmacokinetics (PK) of CTC with those of the individual reference products (immediate-release [IR] tramadol and celecoxib) alone and in open combination. METHODS: Healthy adults aged 18-55 years were orally administered four treatments under fasted conditions (separated by 7-day wash-out period): 200 mg IR CTC (equivalent to 88 mg tramadol and 112 mg celecoxib; Treatment-1); 100 mg IR tramadol (Treatment-2); 100 mg celecoxib (Treatment-3); and 100 mg IR tramadol and 100 mg celecoxib (Treatment-4)...
August 15, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28809931/the-cost-of-entry-an-analysis-of-pharmaceutical-registration-fees-in-low-middle-and-high-income-countries
#6
Steven G Morgan, Brandon Yau, Murray M Lumpkin
BACKGROUND: Advances in pharmaceuticals offer improved health outcomes for a wide range of illnesses, yet medicines are often inaccessible for many patients worldwide. One potential barrier to making medicines available to all is the cost of product registration, the fees for regulatory review and licensing for the sale of medicines beyond the cost of clinical trials, if needed. METHODS AND FINDINGS: We performed a cross-sectional analysis of pharmaceutical registration fees in low-, middle-, and high-income countries...
2017: PloS One
https://www.readbyqxmd.com/read/28807603/stem-cell-industry-update-2012-to-2016-reveals-accelerated-investment-but-market-capitalization-and-earnings-lag
#7
Mitchell Ng, Simon Song, Nicolas S Piuzzi, Kenneth Ng, Chukwuweike Gwam, Michael A Mont, George F Muschler
Treatments based on stem cells have long been heralded for their potential to drive the future of regenerative medicine and have inspired increasing medical and business interest. The stem cell therapy market has been expanding since 2012, but earnings and profitability still lag the broader health care sector (compounded annual growth rate in annual financing of 31.5% versus 13.4%, respectively). On the basis of historical financial data, approximately $23 billion has been invested in stem cell companies since 1994, with more than 80% of this raised from 2011 through 2016...
August 11, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28807033/sponsorship-bias-and-quality-of-randomised-controlled-trials-in-veterinary-medicine
#8
K J Wareham, R M Hyde, D Grindlay, M L Brennan, R S Dean
BACKGROUND: Randomised controlled trials (RCTs) are considered the gold standard form of evidence for assessing treatment efficacy, but many factors can influence their reliability including methodological quality, reporting quality and funding source. The aim of this study was to examine the relationship between funding source and positive outcome reporting in veterinary RCTs published in 2011 and to assess the risk of bias in the RCTs identified. METHODS: A structured search of PubMed was used to identify feline, canine, equine, bovine and ovine clinical trials examining the efficacy of pharmaceutical interventions published in 2011...
August 14, 2017: BMC Veterinary Research
https://www.readbyqxmd.com/read/28804696/neonatal-safety-information-reported-to-the-fda-during-drug-development-studies
#9
Debbie Avant, Gerri Baer, Jason Moore, Panli Zheng, Alfred Sorbello, Ron Ariagno, Lynne Yao, Gilbert J Burckart, Jian Wang
BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015...
2017: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/28803117/phenolics-from-rubus-fairholmianus-induces-cytotoxicity-and-apoptosis-in-human-breast-adenocarcinoma-cells
#10
Blassan P George, Heidi Abrahamse, Nanjundaswamy M Hemmaragala
Herbal medicine is an important part of health care system in most of the countries. Rubus fairholmianus is an unexplored berry in folkloric medicine. In this study, we aimed to understand the importance of R. fairholmianus in pharmaceutical industry for the development of cost-effective cancer therapeutic drugs using in vivo and in vitro analysis. Chemical characterisation, antioxidant, antiproliferative and apoptosis inducing properties of R. fairholmianus root methanolic column subfraction (RFM) were investigated...
August 9, 2017: Chemico-biological Interactions
https://www.readbyqxmd.com/read/28800058/effectiveness-of-mifamurtide-in-addition-to-standard-chemotherapy-for-high-grade-osteosarcoma-a-systematic-review
#11
Rincy Jimmy, Cindy Stern, Karolina Lisy, Sarahlouise White
BACKGROUND: Osteosarcoma mostly occurs during the period of rapid bone growth in children and adolescents as high-grade osteosarcomas. Current treatment recommended for high-grade non-metastatic and metastatic and/or relapsed osteosarcoma involves neoadjuvant multiagent conventional chemotherapy, followed by surgical resection of macroscopically detected tumor and postoperative adjuvant chemotherapy. However, residual micrometastatic deposits that develop following surgery have shown resistance to postoperative/adjuvant chemotherapy...
August 2017: JBI Database of Systematic Reviews and Implementation Reports
https://www.readbyqxmd.com/read/28798527/specific-pathologist-responses-for-standard-for-exchange-of-nonclinical-data-send
#12
REVIEW
Atsushi Watanabe, Osamu Kusuoka, Norihiro Sato, Osamu Nakazono, Michael Wasko, Daniel Potenta, Dai Nakae, Hirofumi Hatakeyama, Hijiri Iwata, Misaki Naota, Takayuki Anzai
The Standard for Exchange of Nonclinical Data (SEND), introduced by the US Food and Drug Administration (FDA), is a scheme for the computerization, electronic application, and screening of preclinical data. Since its establishment, related organizations have been working together to implement SEND. However, it is difficult for individual pharmaceutical companies that often outsource to achieve complete compliance with SEND; hence, the cooperation of contract research organizations (CROs) and SEND Registered Solution Providers (RSPs) is indispensable...
July 2017: Journal of Toxicologic Pathology
https://www.readbyqxmd.com/read/28791693/atypical-antipsychotics-for-disruptive-behaviour-disorders-in-children-and-youths
#13
REVIEW
Jik H Loy, Sally N Merry, Sarah E Hetrick, Karolina Stasiak
BACKGROUND: This is an update of the original Cochrane Review, last published in 2012 (Loy 2012). Children and youths with disruptive behaviour disorders may present to health services, where they may be treated with atypical antipsychotics. There is increasing usage of atypical antipsychotics in the treatment of disruptive behaviour disorders. OBJECTIVES: To evaluate the effect and safety of atypical antipsychotics, compared to placebo, for treating disruptive behaviour disorders in children and youths...
August 9, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28789565/qspr-studies-on-the-photoinduced-fluorescence-behaviour-of-pharmaceuticals-and-pesticides
#14
D López-Malo, J I Bueso-Bordils, M J Duart, P A Alemán-López, R V Martín-Algarra, G M Antón-Fos, L Lahuerta-Zamora, J Martínez-Calatayud
Fluorimetric analysis is still a growing line of research in the determination of a wide range of organic compounds, including pharmaceuticals and pesticides, which makes necessary the development of new strategies aimed at improving the performance of fluorescence determinations as well as the sensitivity and, especially, the selectivity of the newly developed analytical methods. In this paper are presented applications of a useful and growing tool suitable for fostering and improving research in the analytical field...
July 2017: SAR and QSAR in Environmental Research
https://www.readbyqxmd.com/read/28782609/prodrugs-recent-approvals-and-a-glimpse-of-the-pipeline
#15
REVIEW
Jarkko Rautio, Jussi Kärkkäinen, Kenneth B Sloan
Prodrugs offer a versatile strategy to overcome flaws of viable drug candidates or clinically approved drugs. However, the strategic importance of prodrugs in the pharmaceutical industry has often been challenged, and prodrugs are often considered as the last option after lead optimization and when the selected drug candidate has faced significant pharmaceutical and pharmacokinetic limitations. Based on recent success in marketed drugs, prodrug strategy should clearly be considered already in early stages of lead optimization...
August 3, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28770328/metformin-and-ageing-improving-ageing-outcomes-beyond-glycaemic-control
#16
REVIEW
Willy Marcos Valencia, Ana Palacio, Leonardo Tamariz, Hermes Florez
In a world where the population is ageing, there is growing interest and demand for research evaluating strategies that address the ageing process. After 60 years of successful use of metformin in our pharmaceutical armamentarium, we are learning that, beyond improving glycaemic control, metformin may have additional mechanisms and pathways of action that need further study. Although, metformin's effect on clinical ageing outcomes may still be considered speculative, the findings from studies into cellular and animal models and from observational and pilot human studies support the existence of beneficial effects on ageing...
August 2, 2017: Diabetologia
https://www.readbyqxmd.com/read/28766313/interventions-for-emergency-contraception
#17
REVIEW
Jie Shen, Yan Che, Emily Showell, Ke Chen, Linan Cheng
BACKGROUND: Emergency contraception (EC) is using a drug or copper intrauterine device (Cu-IUD) to prevent pregnancy shortly after unprotected intercourse. Several interventions are available for EC. Information on the comparative effectiveness, safety and convenience of these methods is crucial for reproductive healthcare providers and the women they serve. This is an update of a review previously published in 2009 and 2012. OBJECTIVES: To determine which EC method following unprotected intercourse is the most effective, safe and convenient to prevent pregnancy...
August 2, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28764618/hydroxychloroquine-in-the-primary-thrombosis-prophylaxis-of-antiphospholipid-antibody-positive-patients-without-systemic-autoimmune-disease
#18
D Erkan, O Unlu, S Sciascia, H M Belmont, D Ware Branch, M J Cuadrado, E Gonzalez, J S Knight, I Uthman, R Willis, Z Zhang, D Wahl, S Zuily, M G Tektonidou
Objective The objective of this study was to determine the efficacy of hydroxychloroquine (HCQ) in the primary thrombosis prevention of antiphospholipid antibody (aPL)-positive patients with no other systemic autoimmune diseases. Methods Under the auspices of Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking, a multicenter, international, randomized controlled trial (RCT) was initiated, in which persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases were randomized to receive HCQ or no treatment in addition to their standard regimen...
January 1, 2017: Lupus
https://www.readbyqxmd.com/read/28762143/pharmaceutical-interventions-for-diabetes-prevention-in-patients-at-risk
#19
REVIEW
Sudesna Chatterjee, Melanie Davies, Kamlesh Khunti
With the rising incidence and prevalence rates of type 2 diabetes globally, it is imperative that diabetes prevention strategies are implemented to stem the flow of new cases. Successful interventions include both lifestyle modification and pharmaceutical agents, and large, multicentre, randomised, controlled studies in different populations have identified the benefits of both. However, translating positive trial outcomes to the real world is particularly challenging, as lifestyle interventions require regular reinforcement from healthcare professionals to be maintained...
July 31, 2017: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/28760593/integration-of-technology-based-outcome-measures-in-clinical-trials-of-parkinson-and-other-neurodegenerative-diseases
#20
Carlo Alberto Artusi, Murli Mishra, Patricia Latimer, Joaquin A Vizcarra, Leonardo Lopiano, Walter Maetzler, Aristide Merola, Alberto J Espay
INTRODUCTION: We sought to review the landscape of past, present, and future use of technology-based outcome measures (TOMs) in clinical trials of neurodegenerative disorders. METHODS: We systematically reviewed PubMed and ClinicalTrials.gov for published and ongoing clinical trials in neurodegenerative disorders employing TOMs. In addition, medical directors of selected pharmaceutical companies were surveyed on their companies' ongoing efforts and future plans to integrate TOMs in clinical trials as primary, secondary, or exploratory endpoints...
July 26, 2017: Parkinsonism & related Disorders
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