phase iii clinical trials classic and novel designs
Báo cáo y học: "A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis" ppsx
Ngày tải lên :
12/08/2014, 11:22
... the efficacy and safety of CCII in RA patients further, we treated two groups of RA patients with oral CCII or MTX in a randomized, doubleblind, multicenter, and controlled phase III clinical trial ... CCII and an adjuvant such as mannitol and glidantin Figure shows the flow sheet of production of CCII Clinical assessments Clinical assessments of efficacy were made at baseline and repeated 12 and ... trials In a randomized, double-blind, multicenter, and controlled phase II clinical trial involving 236 patients with severe active RA, a decrease in the number of swollen joints and tender joints...
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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 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 ... any role in deciding what to publish, when to publish, or where to publish it Trials Thirty-one Phase II, III, and IV clinical trial reports of celecoxib in osteoarthritis or rheumatoid arthritis ... 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...
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Báo cáo khoa học: " A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients" pdf
Ngày tải lên :
09/08/2014, 10:21
... [3-5], and treatment often follows the management of other dermatoses There are a number of reports from prospective controlled clinical studies for breast cancer patients including phase II and III ... and propylparaben The gel was applied in a manner identical to that described above for the APP cream Statistical considerations The study was designed as a prospective and randomized Phase III ... the analyses and drafted the manuscript CB, JS, PB and DP conducted patient exams and participated in data collection TD participated in the collection of data and data analyses CL and XX assisted...
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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
... 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 ... to the sites of inflammation Phase I, phase II and phase III clinical trials have been conducted mostly in patients with multiple sclerosis (Novartis, Basel, Switzerland) (reviewed in [49]) Results ... placebo-controlled phase II /III clinical trials under the sponsorshop of Zymogenetics/Merck Serono (Seattle, WA, USA and Geneva, Switzerland), targets B-lymphocyte stimulator and APRIL, two members...
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Báo cáo y học: "Safety and Effectiveness of two treatment regimes with tranexamic acid to minimize inflammatory response in elective cardiopulmonary bypass patients: a randomized double-blind, dosedependent, phase IV clinical trial." pdf
Ngày tải lên :
10/08/2014, 09:22
... coagulation-fibrinolysis parameters and interpretation JMB and BM, was responsible for determination of IL-6 and interpretation RM was the surgical team and was responsible for preoperative clinical and analytical ... interpretation, and drafting the manuscript MB, LL, RP and MLM, were responsible for data collection and processing blood simples during the study and provided useful suggestions PM and JMR, was ... means between groups in clinical signs (bleeding) and laboratory parameters (D-dimer, creatine kinase and troponin I) at baseline, h and 24 h after surgery For bleeding and D-dimer, correction...
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báo cáo khoa học: "Novel histone deacetylase inhibitors in clinical trials as anti-cancer agents" ppt
Ngày tải lên :
10/08/2014, 22:20
... located in both cytoplasm and nucleus and belongs to class IV [20] It has a conserved domain in the catalytic region and shares features with both class I and II The class III of HDACs is the so-called ... approved HDAC inhibitor for clinical treatment of T cell lymphoma Other compounds, for example, CBHA [28,29] and LBH589 [30-32], have been used in pre- and clinical trials in this group Another ... including both hematological and solid malignancies Vorinostat clinical trials have been updated lately [13,74] This review focuses on recent development in clinical trials testing newer HDAC inhibitors...
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Báo cáo y học: "rogesterone in traumatic brain injury: time to move on to phase III trials" doc
Ngày tải lên :
13/08/2014, 11:22
... results of phase III trials with progesterone in traumatic brain injury In the meantime, the scientific community needs to continue to pursue similar, early phase trials with other candidate neuroprotective ... injury, may be efficacious, and that expanded multicenter trials are necessary The challenge moving forward will be the design of an appropriate multicenter phase III trial with several questions ... this clinical trial are promising and provide compelling evidence to support the use of progesterone in head injured patients While this trial provides further safety data and longer term 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
... 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 ... 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 ... 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 ... optimal dose levels and procedures have been established through Phase I and Phase II trials, begin to think on a transnational basis Most large-scale trials are multicenter trials By establishing ... 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...
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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
... design and conduct of clinical trials PLAN A Predesign Phase Form your design team (see Chapter 4) Your team’s first step should be to decide whether the study is actually worth performing and whether ... 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...
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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
... Controlled Trials, http://www controlled -trials. com/ These are comprehensive online resources offering detailed profiles of new investigational treatments in Phase I through III clinical trials Updated ... 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...
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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
... INFORMATION Read articles and sign up for free newsletter on issues in electronic data capture at http://www.phaseforward.com/ A guide to eClinical Trials: Planning and Implementation may be ... 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...
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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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