Search Results - "clinical trial"

Legal regulation on clinical trials by Jahn Kassim, Puteri Nemie

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Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study by Prayle, A.P., Hurley, M.N., Smyth, Alan R.

“…Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. …”
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Clinical trial: protocol design and amendment by Ab Rashid, Islah Munjih

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Chitosan dressing: a clinical trial by Ahmad Alwi, Akmal Azim

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Clinical trial: investigator's brochure and essential document by Ab Rashid, Islah Munjih

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The clinical trial: harmonising with developing modern law by Jahn Kassim, Puteri Nemie

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Data Visualization and Visual Analytics in Clinical trials by Telladarla, Lakshmi Chaitanya

“…In clinical trials even small amounts of data is critical in shaping the successful formulation of a drug and there is an increasing demand for easy and intuitive access to the data. …”
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Systematic overview of clinical trials of antiarrhythmic drugs by Shilbayeh, Sirin

“…Although numerous clinical trials have been conducted, the value of antiarrhythmic drugs in many indications remains controversial. …”
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Delayed publications of clinical trials in cystic fibrosis by Hurley, M.N., Prayle, A.P., Smyth, Alan R.

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Clinical Trial Outsourcing: India's Regulatory Landscape. by Mukherjee, Anasua

“…This has substantially added to the location-advantage of the Indian Clinical Trial Market.…”
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Designing clinical trials for assessing the effectiveness of interventions for tinnitus by Hall, Deborah A.

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Overcoming challenges to data quality in the ASPREE clinical trial by Lockery, J.E., Collyer, T.A., Reid, Christopher, Ernst, M.E., Gilbertson, D., Hay, N., Kirpach, B., McNeil, J.J., Nelson, M.R., Orchard, S.G., Pruksawongsin, K., Shah, R.C., Wolfe, R., Woods, R.L.

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Evaluation of the PPAR-γ agonist pioglitazone in mild asthma: a double-blind randomized controlled trial by Anderson, J.R., Mortimer, K., Pang, Linhua, Smith, K.M., Bailey, H., Hodgson, D.B., Shaw, Dominick E., Knox, Alan J., Harrison, Timothy W.

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Servitisation of the global pharmaceutical industry and implications for clinical trials organisations. by Howard, Megan

“…This report looks at opportunities for servitisation within the pharmaceutical industry and implications of this for clinical trials organisations.…”
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Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial by Johnson, Sebastian L., Szigeti, Matyas, Cross, Mary, Brightling, Christopher, Chaudhuri, R., Harrison, Timothy W., Mansur, Adel, Robison, Laura, Sattar, Zahid, Jackson, David, Mallia, Patrick, Wong, Ernie, Corrigan, Christopher, Higgins, Bernhard, Ind, Philip, Singh, Dave, Thomson, Neil C., Ashby, Deborah, Chauhan, Anoop

“…DESIGN, SETTING, AND PARTICIPANTS The Azithromycin Against Placebo in Exacerbations of Asthma (AZALEA) randomized, double-blind, placebo-controlled clinical trial, a United Kingdom–based multicenter study in adults requesting emergency care for acute asthma exacerbations, ran from September 2011 to April 2014. …”
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New considerations in the design of clinical trials of acute kidney injury by Md Ralib, Azrina, Pickering, John W., Nejat, Maryam, Endre, Zoltan H.

“…The translation of promising experimental treatments to effective clinical trials has been hampered by the lack of a means to detect acute kidney injury early. …”
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Serious adverse event reporting in investigator-initiated clinical trials by Wallace, S., Myles, P., Zeps, Nikolajs, Zalcberg, J.

“…. • Pragmatic, investigator-initiated Phase IV clinical trials of post-marketed drugs or devices are needed to understand their role in everyday clinical practice. …”
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Stroke outcome in clinical trial patients deriving from different countries by Ali, Myzoon, Atula, Sari, Bath, Philip M.W., Grotta, James, Hacke, Werner, Lyden, Patrick D., Marler, John R., Sacco, Ralph L., Lees, Kennedy R.

“…Conclusion—We identified regional variations in index stroke severity, outcome, and mortality for patients enrolled in ischemic stroke clinical trials over the past 13 years that were not fully explained by case mix. …”
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Core outcome sets for clinical trials and observational studies in vulvovaginal disease by Foster, David C., Stockdale, Colleen K., Simpson, Rosalind C., Kirtschig, Gudula

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Immunogenicity and safety of SARS-CoV-2 vaccines in clinical trials by Lim, Hui Xuan *, Masita, Arip, Abdul Aziz, Al-Fattah Yahaya *, Jazayeri, S. D. *, Poppema, Sibrandes *, Poh, Chit Laa *

“…Tremendous research efforts have resulted in the development of at least 64 vaccine candidates that have reached Phase I to III clinical trials within 14 months. The primary efficacy endpoint for a random placebo-controlled clinical trial of a COVID-19 vaccine to be approved by US FDA should confer at least 50% protection against COVID-19. …”
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