historical and clinical trials
Báo cáo sinh học: "Shipping blood to a central laboratory in multicenter clinical trials: effect of ambient temperature on specimen temperature, and effects of temperature on mononuclear cell yield, viability and immunologic function" potx
Ngày tải lên :
18/06/2014, 19:20
... approval (IRB-HSR# 10598, 10524, and1 1491) and review by the FDA (BB-IND# 9847 and 12191) Patients’ blood specimens from clinical trials (HSR# 1524(HSR# 10524 and 11491) were monitored during ... and Bill Goodwin Additional philanthropic support was provided by Frank and Jane Batten, the James and Rebecca Craig Foundation, George S Suddock, Richard and Sherry Sharp, and the Patients and ... handling before and after cryopreservation Some studies have defined optimal time intervals between venipuncture and cryopreservation [26-29] and optimal conditions for freezing [30] Also, handling...
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Báo cáo hóa học: " Ventilator-induced lung injury: historical perspectives and clinical implications" docx
Ngày tải lên :
21/06/2014, 01:20
... mL/kg and PEEP of cmH2O) only 36 h after randomization [62] However, this study was not designed to address whether these decreases were associated with improved clinical endpoints and the clinical ... lung injury; and 3) studies modulating hormonal and metabolic pathways: inhibition of the renin-angiotensin system [92,93] and pretreatment with atorvastatin or simvastatin [94,95] Clinical relevance ... al.: Ventilator-induced lung injury: historical perspectives and clinical implications Annals of Intensive Care 2011 1:28 Submit your manuscript to a journal and benefit from: Convenient online...
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Báo cáo y học: "Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and meta-analysis of information from company clinical trial report" potx
Ngày tải lên :
09/08/2014, 06:22
... Clinical ulcers and bleeds Clinical ulcers and bleeds in the company clinical trial reports were as reported by investigators, and were not subjected to independent, blinded adjudication in trials ... authors independently read each clinical trial report and scored the reports for reporting quality and validity Disagreements were discussed and consensus achieved Trials were scored for quality ... Arthritis Research & Therapy Vol No Moore et al Results Trials Clinical reports of 31 randomised trials – 21 in osteoarthritis, in rheumatoid arthritis, and in mixed osteoarthritis or rheumatoid arthritis...
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Báo cáo y học: " Molecular therapies for systemic lupus erythematosus: clinical trials and future prospects" pptx
Ngày tải lên :
09/08/2014, 14:21
... hopefully some of them represent interesting candidates for future clinical trials Two peptides and one peptide construct have reached advanced clinical trials in lupus patients The efficacy of the ... phase I and phase II clinical trials conducted by ImmuPharma (Mulhouse, France) Peptide P140 was found to be safe and well tolerated by subjects, and significantly improved the SLEDAI score and biological ... activity and patients deteriorated [18] DHEA or prasterone Androgen Review: analysis of randomized controlled trials (7) comparing DHEA with a placebo in SLE patients (842 participants) Little clinical...
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Báo cáo y học: "Moxibustion and other acupuncture point stimulation methods to treat breech presentation: a systematic review of clinical trials" pptx
Ngày tải lên :
13/08/2014, 15:21
... studies and reviews in the electronic databases http://www.cmjournal.org/content/4/1/4 Inclusion criteria We included randomized controlled trials (RCTs) and non-randomized controlled clinical trials ... the trials with similar study designs [13,16] in our meta-analysis We included in the present review both randomized and non-randomized trials because many trials carried out in China are non-randomized ... remaining 13 in China Six trials were published in English [6,14,15,17,22,24] and three trials had more than two arms Among the included trials, ten RCTs and seven CCTs involved 2090 and 1409 pregnant...
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Báo cáo y học: "Systematic review of clinical trials of cervical manipulation: control group procedures and pain outcomes" pptx
Ngày tải lên :
13/08/2014, 15:21
... single and 2) multiple intervention session trials Methods Search Strategy Data extraction and analyses A search for randomized controlled clinical trials was performed in PubMed 1966-May 2010 ... Spinal"[Mesh]) AND Clinical Trial “[Publication Type] Reference lists from these selected trials were searched for any additional trials The reference lists of two prior studies, one review [4] and one ... areas for improvement in future controlled clinical trials Twenty-one (21) trials were identified, multi-session trials and 12 singlesession trials The most commonly employed control group procedure...
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Báo cáo y học: "because I am something special" or "I think I will be something like a guinea pig": information and assent of legal minors in clinical trials – assessment of understanding, appreciation and reasoning'''' pot
Ngày tải lên :
13/08/2014, 18:21
... and adolescents with ADHD and/ or ODD and their parents, we examined both the feasibility of providing information about clinical trials according to informed consent criteria and the understanding ... information related to clinical trials The appreciation of children and adolescents and their parents of what a clinical trial involved and their reasoning about participation in a clinical trial were ... not well understood and appreciation was low – by both children and adolescents and often by parents The capacity to understand the nature of placebo was low and children and adolescents had...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 1 ppsx
Ngày tải lên :
14/08/2014, 07:20
... Budgets and Expenditures 50 For Further Information 51 Trial Design 55 Baseline Measurements 56 Controlled Randomized Clinical Trials 57 Randomized Trials 58 Blocked Randomization 59 Stratified Randomization ... on Trial: The Clash of Medical Evidence and the Law, New York: Norton CHAPTER CUT COSTS AND INCREASE PROFITS CLINICAL TRIALS Clinical trials consist of a randomized comparison over a fixed period ... A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS Second Edition Phillip I Good, Ph.D A JOHN WILEY...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 2 pps
Ngày tải lên :
14/08/2014, 07:20
... pharmacologist and/ or manufacturing specialist who will be responsible for providing the drugs and/ or devices needed for the trials; clinical monitors who will train, deliver, and monitor the ... universities and hospitals.” “CROs fail to provide sufficient oversight of clinical trials. ” from the Financial Times for 10 September 2001 You can use your full-time employees to conduct the clinical trials ... Phase I and Phase II The trials need not be concurclinical trials, respectively.) You rent and can often benefit from should also have some ideas the results of other trials in their concerning...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 3 pps
Ngày tải lên :
14/08/2014, 07:20
... Of Clinical Trials, 3rd ed St Louis: Mosby Iber FL; Riley WA; and Murray PJ (1987) Conducting Clinical Trials New York: Plenum Medical Book Mulay M (2001) A Step-By-Step Guide To Clinical Trials ... cancer clinical trials Control Clin Trials 21:360–368 Fleming TR (1995) Surrograte markers in AIDS and cancer trials Stat Med 13:1423–1435 Fleming T; DeMets DL (1993) Monitoring of clinical trials: ... Jones and Bartlett Spilker B (1991) Guide to Clinical Trials New York: Raven Texts Focusing on Specific Clinical Areas Fayers P; Hays R eds (2005) Assessing Quality of Life in Clinical Trials: ...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 4 potx
Ngày tải lên :
14/08/2014, 07:20
... Detecting selection bias in randomized clinical trials Control Clin Trials 20:319–327 Berger VW (2005) Selection Bias and Covariate Imbalances in Randomized Clinical Trials Chichester: John Wiley ... (1996) Randomized clinical- trials in the presence of diagnostic uncertainty—implications for measures of efficacy and samplesize Control Clin Trials 17:191–200 Cavan BN (1995) Improving clinical trials ... Subverting randomization in controlled trials JAMA 274:1456–1458 Shuster JJ (1993) Practical Handbook of Sample Size Guidelines for Clinical Trials Boca Raton, FL: CRC Simon R (1982) Randomized clinical...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 5 potx
Ngày tải lên :
14/08/2014, 07:20
... resource is profit-based clinical resource centers that have been set up specifically to conduct clinical trials An annotated CHAPTER RECRUITING AND RETAINING PATIENTS AND PHYSICIANS 109 guide ... this guide might note the number of trials the center has assisted in, the number of resident physicians, their backgrounds and clinical trials experience, and their medical specialties One center ... multicenter clinical trials group: trends, seasonality and the effect of large studies BMC Med Res Methodol 1:4 Haidich AB; Ioannidis JP (2003) Late-starter sites in randomized controlled trials J...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 6 pdf
Ngày tải lên :
14/08/2014, 07:20
... needs to sit down with the principal investigator and coordinator at each site to ensure a mutual understanding of recruitment guidelines and patient handling After such discussions, each site coordinator ... regardless of differences in time zones? SUPPORT IS ESSENTIAL “Electronic clinical trials put very few technology demands on a user, and sites are usually unaware of the complexity of the underlying ... to the acceptance of electronic clinical trials In the long term, this problem will be alleviated as the proportion of electronic trials run at sites increases and the sites develop or outsource...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 7 pot
Ngày tải lên :
14/08/2014, 07:20
... data collection and verification is conducted via the Web, new data management methods and software may be required See, for example, Brandt et al (2000) and Wübbelt, Fernandez, and Heymer (2000) ... project manager and production and supplies on hand continually matched to forecast needs LATE AND INCOMPLETE FORMS Late and incomplete forms are the major source of cost overruns and trial delays ... (2005) The Internet and clinical trials: background, online resources, examples and issues J Med Internet Res 2005 7(1):e5 158 PART II DO Prokscha S (1999) Practical Guide to Clinical Data Management...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 8 pot
Ngày tải lên :
14/08/2014, 07:20
... optimality in clinical trials Int Stat Rev 53:15–24 CHAPTER 14 MANAGING THE TRIALS 187 Artinian NT; Froelicher ES; Vander Wal JS (2004) Data and safety monitoring during randomized controlled trials ... methods and their application in clinical trials Commun Stat Theory Meth 13:2315–2338 Fleming T; DeMets DL (1993) Monitoring of clinical trials: issues and recommendations Control Clin Trials ... Wei LJ (1988) Randomization in clinical trials: conclusions and recommendations Control Clin Trials 9:365–374 Li G; Shih WJ; Wang Y (2005) Two-stage adaptive design for clinical trials with survival...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 9 doc
Ngày tải lên :
14/08/2014, 07:20
... Properties of sample randomization in clinical trials Contr Clin Trials 9:312–326 Lachin JM (1988) Statistical properties of randomization in clinical trials Contr Clin Trials 9:289–311 Linnet ... Simpson’s paradox and clinical trials: what you find is not necessarily what you prove Ann Emerg Med 21:1480–1482 Altman DG; Dore CJ (1990) Randomisation and baseline comparisons in clinical trials Lancet ... conduct a second set of controlled clinical trials Here are three examples taken (with suitable modifications to conceal their identity) from actual clinical trials Random, Representative Samples The...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 10 potx
Ngày tải lên :
14/08/2014, 07:20
... and warehouse for all trial data and 240 APPENDIX SOFTWARE records Data entry includes range and logic checks ClinicalTrialsNet Inc, 12 John Street, Charleston, SC 29403, 843.965.5598, info@clinicaltrialsnet.com ... designing, managing, and analyzing clinical trials Some programs offer to it all, whereas others, more specialized, provide for speech recognition and collecting information from handheld devices ... Manager’s Guide to the Design and Conduct of Clinical Trials, by Phillip I Good Copyright ©2006 John Wiley & Sons, Inc APPENDIX SOFTWARE 237 Oracle Clinical Has the standard features of Oracle Automatically...
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Báo cáo y học: "Hepatitis C Virus Serologic and Virologic Tests and Clinical Diagnosis of HCVRelated Liver Disease"
Ngày tải lên :
02/11/2012, 09:56
... genotypes and (B), and genotypes 4, and (C) Int J Med Sci 2006, HCV genotypes and Patients infected with HCV genotypes or have a 70%-80% likelihood of an SVR with a low dose of ribavirin and only ... to treat patients with mild lesions and to re-assess their liver disease after to years The patients with inflammation and/ or fibrosis (Metavir score A ≥ and/ or F ≥ 2) have an indication for ... at the end of therapy and 24 weeks later in order to determine whether the virological response is sustained (Figure 1B) [1, 18] HCV genotypes 4, and In the absence of any clinical trial including...
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