... placebo-controlled phase 2 clinical trial". The Lancet. 381 (9871): 1037-1045. doi:10.1016/S0140-6736(12)61764-4. PMID 23352749 ... Pullen, L.C. (November 7, 2011). "Epstein-Barr Virus Vaccine May Soon Enter Phase 3 Trial". Medscape Today. Retrieved April 24 ... "MERS vaccine shows promise in clinical trial, say researchers". "Developing a vaccine against Nipah virus". ScienceDaily (Press ... Adenovirus Vaccine Efficacy Trial Consortium (2013). "A phase 3, randomized, double-blind, placebo-controlled study of the ...
ICH E9: Statistical principles for clinical trials section III provides a general overview of common designs in clinical trials ... the use of meta-analysis and the use of only a single pivotal study in phase III clinical development. ICH E1: Population ... CPMP/EWP/2330/99: Application with 1. Meta-analyses; 2. One pivotal study (EMA) provides guidance on two topics: ... EMA/286914/2012: Multiplicity issues in clinical trials (EMA) addresses the multiplicity in the clinical trials in the context ...
Karonudib, an MTH1 inhibitor, is currently being evaluated a phase I clinical trial for safety and tolerability. A potent and ... Research into this topic is ongoing. MTH1 is a potential drug target to treat cancer, however there are conflicting results ... "MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class (MASTIFF)". ClinicalTrials.gov. U.S. National ... This makes it a topic of interest in cancer research, both as a potential method for healthy cells to prevent cancer and a ...
... at the time of conducting phase-2 clinical trials. Generally, the PAT initiative from FDA is only one topic within the broader ...
... and major depressive disorder in phase 2 clinical trials. Seltorexant is under development for treatment of major depressive ... Roecker AJ, Coleman PJ (2008). "Orexin receptor antagonists: medicinal chemistry and therapeutic potential". Current Topics in ... disorder however and is in phase 3 trials for this indication. Also, suvorexant is in a phase 4 trial for use as an adjunct to ... Clinical trial number NCT02669030 for "A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study ...
"Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever". ClinicalTrials.gov. ... In addition to Hantavax three more vaccine candidates have been studied in I-II stage clinical trials. They include a ... However, their prospects are unclear List of vaccine topics Seoul virus Gou virus Vaccine-naive Schmaljohn, C. S. (2012). " ... Field trial of an inactivated vaccine against hemorrhagic fever with renal syndrome in humans. Arch Virol. 1990;1(Suppl):35-47 ...
Preliminary data from a phase 1 clinical trial indicate that 92% of participants would be protected from Zika infection. "HJF ... Blank C (November 30, 2016). "Human trials of Zika vaccine underway". Drug Topics. "Human Trials Begin for Army-Developed Zika ... a phase 1b, randomised, double-blind, placebo-controlled clinical trial". Lancet. 385 (9977): 1545-54. doi:10.1016/S0140-6736( ... phase 1, randomised, double-blind, placebo-controlled clinical trials". The Lancet. 391 (10120): 563-571. doi:10.1016/S0140- ...
In the phase III clinical trials, misuse potential adverse events were reported in 3.0% with placebo, 4.1% with 15 or 20 mg ... Jacobson LH, Chen S, Mir S, Hoyer D (2016). "Orexin OX2 Receptor Antagonists as Sleep Aids". Current Topics in Behavioral ... A phase IV clinical trial of suvorexant as an adjunct to antidepressant therapy in people with major depressive disorder and ... As of October 2021, it is in phase III clinical trials for this indication. Suvorexant has been studied in the treatment of ...
ContraFect developed a Staphylococcal lysin that successfully completed FDA phase 1 and phase 2 human clinical trials, the only ... Some of Fischetti's popular videos include those dealing with the topic: 'aged eggnog made with raw eggs is safer than drinking ... A staphylococcal-specific lysin that the Fischetti lab developed is currently in phase 3 human clinical trials and if ... A lysibody directed against methicillin resistant Staphylococcus aureus (MRSA) is currently in pre-clinical development to be ...
In a phase I clinical trial, TIK-301 was shown to be effective as a chronobiotic at a dose of 5 mg/L, but not in lower doses. ... Current Topics in Medicinal Chemistry. 8 (11): 954-968. doi:10.2174/156802608784936719. PMID 18673165. Mody S, Hu Y, Ho MK, ... TIK-301 was in phase II clinical trials in 2002. In 2004, TIK-301 was designated an orphan drug by the FDA. TIK-301 is a high ... in Atlanta, GA by Phase II Discovery, where it was renamed to TIK-301. Currently, clinical trials are ongoing there. Because it ...
TIK-301 (PD-6735, LY-156735) has been in phase II clinical trial in the United States (US) since 2002. The FDA granted TIK-301 ... Current Topics in Medicinal Chemistry. 8 (11): 954-68. doi:10.2174/156802608784936719. PMID 18673165.{{cite journal}}: CS1 ... "Neurim Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of Piromelatine for the Treatment of Insomnia" (Press ... Tasimelteon completed the phase III clinical trial in the United States for primary insomnia in 2010. The Food and Drug ...
There have been some preclinical trials in mice and rats, but no phase-1 tests or clinical trials of safety in humans, as of ... Detoxification foot baths Colon cleansing Placebo Quackery Skepticism List of topics characterized as pseudoscience Neo- ... In a clinical trial of a randomized, placebo-controlled study in postoperative pain, dermorphin administered via the ... no clinical trials have tested them on humans, as of November 2019[update]. Reports of adverse effects are numerous, including ...
From the information technology perspective for clinical trials, it has been guided by another U.S. Food and Drug ... They will then seek approval and request a time and date to carry out the implementation phase. In rare cases where the ... In a good manufacturing practice regulated industry, the topic is frequently encountered by its users. Various industrial ... "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS". U.S. Food and Drug Administration. April 1999. Retrieved ...
In 2007, a randomized phase II clinical trial showed that LY-2140023 taken twice daily for 4 weeks improved schizophrenia ... Current Topics in Medicinal Chemistry. 8 (16): 1480-1. doi:10.2174/156802608786264209. PMID 19006848. Fraley ME (June 2009). " ... oral bioavailability in humans in a phase I clinical trial. A single dose of 200 mg results in an AUC value of 900 ng*h/ml. The ... a randomized Phase 2 clinical trial". Nature Medicine. 13 (9): 1102-7. doi:10.1038/nm1632. PMID 17767166. S2CID 6417333. Lebois ...
... the legislation included language guaranteeing that women and minorities were included in all federal health clinical trials ... The legislation would phase out the use of eight major classes of antibiotics in healthy food-producing animals, while allowing ... She cited her scientific training as the impetus for her dedicated interest on the topic, stating in an interview, "It wasn't ... Previously, all NIH-funded research was done on white males, even in trials related to predominantly female diseases such as ...
3-year randomized clinical trial, followed by a blinded extension) multicenter European phase III HD trial. This collaboration ... Other topics on which he published include neuroimaging and pain. Vast majority of Landwehrmeyer's publications are devoted to ... He contributed to Track-HD and Track-ON HD, two influential observational studies in HD, and to 26 phase I-III clinical trials ... "An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients With SEN0014196 (PADDINGTON)". ClinicalTrials.gov. ...
Tables on the Clinical trials of pandemic influenza prototype vaccines. July 2009". WHO.int. Archived from the original on 6 ... 2006). Influenza Virology: Current Topics. Caister Academic Press. ISBN 978-1-904455-06-6. "Current WHO phase of pandemic alert ... As of July 2009, more than 70 known clinical trials have been completed or are ongoing for pandemic influenza vaccines. In ... On 29 April the WHO raised the worldwide pandemic phase to 5. On 11 June 2009 the WHO raised the worldwide pandemic phase to 6 ...
When three surgeries and intense chemotherapy failed, she underwent a clinical trial that eradicated the cancer in 1997 but ... Her Ph.D. research focused phase diagram of block copolymers. After completing her Ph.D., Mayes worked two years as visiting ... Mayes research led to breakthroughs in many topics, including the development of polymeric electrolytes for lithium-ion ...
... results of a randomized clinical trial" (PDF). Journal of Consulting and Clinical Psychology. American Psychological ... The first phase is an interview phase that includes psychological testing, client self-monitoring, and a variety of reading ... The research conducted for CBT has been a topic of sustained controversy. While some researchers write that CBT is more ... "Randomized Clinical Trial of Cognitive Behavioral Therapy (CBT) Versus Acceptance and Commitment Therapy (ACT) for Mixed ...
... at ClinicalTrials.gov Clinical trial number NCT01086657 for "An Open-Label, Randomized Phase I Study in Healthy Adults of the ... Sederstrom J (July 19, 2019). "Researchers Exploring Oral Flu Vaccine and Treatment Options". Drug Topics. Archived from the ... phase 1 clinical trial". The Lancet. Infectious Diseases. 20 (1): 80-91. doi:10.1016/S1473-3099(19)30393-7. PMC 6928577. PMID ... in pre-clinical development and in clinical trials. In a 2007 report, the global capacity of approximately 826 million seasonal ...
Between 1989 and December 2018, over 2,900 clinical trials were conducted, with more than half of them in phase I. As of 2017[ ... Genetic engineering is a topic of moral debate among bioethicists. Genetic testing, genetic engineering, and stem cell research ... Many such gene therapies are available, made it through all phases of clinical research and are approved by the FDA. ... "Gene Therapy Clinical Trials Worldwide Database". The Journal of Gene Medicine. Wiley. June 2016.s Vaughn, Lewis (2023). ...
Clinical trial number NCT00561574 for "A Long-Term Safety Study of Org 50081 in Elderly Outpatients With Chronic Primary ... "A Phase 2 Randomized Dose-Finding Study With Esmirtazapine in Patients With Primary Insomnia". Journal of Clinical ... Current Topics in Medicinal Chemistry. 8 (11): 969-976. doi:10.2174/156802608784936700. PMID 18673166. Lewis V (November 2009 ... Journal of Clinical Sleep Medicine. 16 (9): 1455-1467. doi:10.5664/jcsm.8526. PMC 7970588. PMID 32351205. "Form 10-K" (PDF). ...
... the World Health Organization's International Clinical Trials Registry Platform (ICTRP) and Orphanet intend to make clinical ... The trials can be national or international and, regarding the phase they are in, either recruiting, ongoing or finished. Since ... Orphanet reports comprise a series of texts covering topics relevant to all rare diseases. New reports are regularly put online ... The clinical trials listed on Orphanet comprise interventional studies aiming to evaluate a drug (substance, or combination) to ...
It was in phase II clinical trials in 2008 but appears to have been discontinued as it is no longer in the company's ... Teegarden BR, Al Shamma H, Xiong Y (2008). "5-HT(2A) inverse-agonists for the treatment of insomnia". Current Topics in ... "Efficacy Study of LY2422347 to Treat Insomnia - Full Text View - ClinicalTrials.gov". 24 January 2007. "Eli Lilly and Company ...
Successful pre-clinical, Phase I, and Phase II trials looked promising to the company and its investors even up until the third ... There is some evidence for accumulation of deramciclane, though it is a topic of debate. It is important to understand the ... No severe side effects were reported in any clinical trial, and no side effects were found to be dose-dependent. Trial ... Phase I studies show little to no side effects of deramciclane. Phase II studies show little to no side effects and ...
The group took pafuramidine, a new orally available drug for human African trypanosomiasis, through phase III clinical trials, ... Barrett also writes regularly for a variety of newspapers and magazines on topics related to science and also spanning the arts ...
... as well as qualifications with respect to the conduct of clinical trials (phase II to IV). The working group "clinical studies ... the conduct of Cochrane Reviews and their regular update in the field of perioperative medicine and associated topics, a topic ... Among these trials, many[weasel words] studies were aiming to get a label for the indication of PONV prevention (phase II and ... Controlled Clinical Trials 2003; 24:736-51 C. C Apfel, P. Kranke, M. H. Katz, C. Goepfert, T. Papenfuss, S. Rauch, R. Heineck, ...
... was first studied in a phase I clinical trial in 1987 and the results of the first phase II clinical trial in ... Suzuki H, Kamiya N, Imamoto T, Kawamura K, Yano M, Takano M, Utsumi T, Naya Y, Ichikawa T (October 2008). "Current topics and ... A phase III clinical trial of bicalutamide in combination with an ethinylestradiol-containing combined oral contraceptive for ... Bicalutamide has also been studied in a phase II clinical trial for ovarian cancer in women. Bicalutamide has been studied in ...
Results of a phase III clinical trial for the treatment of Alzheimer's disease were reported in September 2017. The trial ... Current Topics in Medicinal Chemistry. 10 (2): 207-21. doi:10.2174/156802610790411036. PMID 20166958. Lowe, Derek (12 May 2015 ... Intepirdine also entered clinical trials for dementia with Lewy bodies, also with negative results. Consequently, Axovant ... GlaxoSmithKline for the treatment of Alzheimer's disease and demonstrated some preliminary efficacy in phase II clinical trials ...
Results of a Phase 2, Randomized, Controlled, Doseā€Ranging Clinical Trial". The Journal of Infectious Diseases. 201 (6): 814-22 ... Berger often lectures to physicians around the US on topics relating to incorporating of newer antiretroviral therapies into ... A randomised controlled phase III trial". The Lancet. 370 (9581): 49-58. doi:10.1016/S0140-6736(07)61049-6. PMID 17617272. ... A randomised controlled phase III trial". The Lancet. 370 (9581): 49-58. doi:10.1016/S0140-6736(07)61049-6. PMID 17617272. ...