during clinical trials of medicines
Báo cáo hóa học: " Pilot proof of concept clinical trials of Stochastic Targeted (STAR) glycemic control" docx
Ngày tải lên :
20/06/2014, 23:20
... al Annals of Intensive Care 2011, 1:38 http://www.annalsofintensivecare.com/content/1/1/38 Page of 12 Table Summary of cohort glycemic performance results STAR pilot trials SPRINT clinical data ... et al Annals of Intensive Care 2011, 1:38 http://www.annalsofintensivecare.com/content/1/1/38 Page of 12 Number of patients with cTIB cutoff >= 0.80 Num patients 2 Days on STAR % of patients with ... doi:10.1186/2110-5820-1-38 Cite this article as: Evans et al.: Pilot proof of concept clinical trials of Stochastic Targeted (STAR) glycemic control Annals of Intensive Care 2011 1:38 Submit your manuscript to...
12
281
0
Báo cáo y học: "An analysis of correlations among four outcome scales employed in clinical trials of patients with major depressive disorder" pdf
Ngày tải lên :
08/08/2014, 23:21
... number of weeks available), and for the final on-therapy (FOT) visit HAM-D17, MADRS, CGI-S, and CGI-I Table 1: Summary of 22 placebo-controlled clinical trials of venlafaxine for treatment of major ... correlation coefficient (r), a measure of the tendency of two variables to increase or decrease together, was used to measure the correlation of a pair of two efficacy variables measured on the ... both sets of outcomes Effect sizes across the individual studies varied considerably, but the pattern of results was largely consistent with that of the pooled data In the majority of studies,...
6
466
0
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
... dosing In trials of to weeks, 88% of the doses were 200 mg daily In trials of 12 weeks' duration, 46% of doses were 200 mg and 46% were of 400 mg daily In trials of 24 weeks or longer, 92% of doses ... expected in clinical practice, where the population may be sicker, or take more medications, than in clinical trials Using company clinical trial reports removes some of the problems of selective ... characteristics of patients for the individual trials All trials conformed to good clinical practice guidelines Available online http://arthritis-research.com/content/7/3/R644 Table Included studies of tolerability,...
22
863
0
Báo cáo y học: "Protein C as a surrogate end-point for clinical trials of sepsis" docx
Ngày tải lên :
13/08/2014, 10:20
... of higher doses of DrotAA (up to 48 μg/kg per hour) and longer infusion times (up to days), and the efficacy of these infusions for normalization of protein C levels We agree that these are clinical ... death, based on the baseline biomarker cut-off levels The relative risk for death was compared in those treated with DrotAA in each of these two risk groups Of the biomarkers studied, the only significant ... demonstrated that in DrotAA-treated patients, a higher proportion of individuals had normal protein C levels (>80% of normal) at the end of the drug infusion compared with control individuals, and...
2
222
0
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
... critical of the extant clinical trials in manipulation for neck pain Vernon et al [10] conducted a systematic review of the outcome of control groups used in clinical trials of conservative treatments ... manipulation trials not result in subject blinding Clinical outcomes of these groups were varied with about one third of groups demonstrating a clinically important change The greatest majority of trials ... effect of unmasking of control subjects makes the interpretation of the existing clinical trials challenging At the very least, future clinical trial reports should include an indication of the...
12
274
0
The use of hypothesis-testing statistics in clinical trials
Ngày tải lên :
01/11/2013, 11:20
... criteria” of a study 55 Section 3: Chance One way in which generalizability is discussed is often by using the term efficacy for the results of the samples of patients in clinical trials, and ... of depressive episodes (one of the frequently emphasized secondary outcomes) (Goodwin et al., 2004) Another example of the issue of generalizability involves studies of combination therapy, often ... expected SD (the variability of the data) For an acceptable power estimate of 80% (for β), and an expected effect size of 25% difference between 52 Chapter 8: Clinical trials drug and placebo, one...
16
504
0
SURVEY OF CURRENT GUIDANCE FOR CHILD HEALTH CLINICAL TRIALS pot
Ngày tải lên :
05/03/2014, 10:20
... children in clinical investigation of FDA-regulated 13 products 2004 Textbook of clinical trials, chapter: clinical trials in pediatrics Survey of current guidance for child health clinical trials ... monitor the level of risk of a study and to give advice about early stopping of clinical trials. 23;51 Practical issues Only three guidelines addressed practical issues of clinical trials in children.8;59;61 ... Twenty out of 22 guidelines addressed ethical aspects of clinical research in children, while ethics was the main topic of Survey of current guidance for child health clinical trials 11 of these...
37
233
0
Textbook of Clinical Trials pdf
Ngày tải lên :
23/03/2014, 01:20
... Textbook of Clinical Trials Textbook of Clinical Trials Edited by D Machin, S Day and S Green 2004 John Wiley & Sons, Ltd ISBN: 0-471-98787-5 Textbook of Clinical Trials Edited by David ... t.wykes@iop.kcl.ac.uk Preface This Textbook of Clinical Trials is not a textbook of clinical trials in the traditional sense Rather, it catalogues in part both the impact of clinical trials – particularly the ... interaction of statistical and clinical disciplines The impact of the results from clinical trials, particularly the randomised controlled trial, on the practice of clinical medicine and other areas of...
409
219
0
Báo cáo hóa học: " The status of clinical trials: Cause for concern" potx
Ngày tải lên :
18/06/2014, 16:20
... report [10] dealing with the tracking of off-shore clinical trials was telling It reported that the number of foreign clinical investigators conducting clinical research under an IND increased ... meeting the Nation's goal of improving the health of its citizens *NIH definition of Clinical Studies: "The definition of Clinical Studies for this study is taken from 45CFR46 Clinical research is ... pstable.htm] 10 Rehnquist J, Office of the Inspector General: The Globalization of Clinical Trials A Growing Challenge in Protecting Human Subjects, US Department of Health and Human Services,...
4
427
0
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
... processing of blood and cryopreservation of PBMC at off-site locations is expensive and requires oversight and quality control of the processing lab at each center Thus, for many multicenter clinical trials ... facility of the University of Virginia Data were analyzed with FlowJo software (Treestar, Ashland OR) Testing of Blood Shipping Packages The standard shipping container used in our clinical trials ... isolation and cryopreservation of PBMC at each participating clinical center and indeed, optimization of cryopreservation media and of thawing practices has improved recovery of immunological responses...
13
606
0
Báo cáo hóa học: " The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials" pdf
Ngày tải lên :
18/06/2014, 22:20
... terms of stability, the test-retest reliability coefficients ranged from 0.80 to 0.88 An assessment of change scores among a subset of patients provided initial evidence of the responsiveness of ... RDQ may have the potential to meet some of the questionnaire needs for GERD clinical trials In this study, the performance of the RDQ was assessed in a clinical treatment trial for patients with ... status as a result of therapy in a large clinical population of patients diagnosed as having GERD The concordance between the RDQ evaluations of symptom severity was compared to those offered by specialty...
6
462
0
Báo cáo y học: " Maintenance of response with atypical antipsychotics in the treatment of schizophrenia: a post-hoc analysis of 5 double-blind, randomized clinical trials" ppsx
Ngày tải lên :
11/08/2014, 16:23
... feelings of sadness or gloominess) on item (reported sadness) of the MADRS 28 Schz Initial PANSS Total score of ≥ 75, a minimum score of ≥ on one of the PANSS positive, and a minimum score of on ... loss of who had where loss of response was defined as a ≥ Meier (KM) Analysis of 1–7 Kaplan Meier (KM) Analysis of olanzapine versus risperidone for days to loss of response, where loss of response ... loss of who had where loss of response was defined as a ≥ Meier (KM) Analysis of 1–7 Kaplan Meier (KM) Analysis of olanzapine versus ziprasidone for days to loss of response, where loss of response...
12
360
0
báo cáo khoa học:" Study on the clinical application of pulsed DC magnetic technology for tracking of intraoperative head motion during frameless stereotaxy" pdf
Ngày tải lên :
11/08/2014, 23:22
... identification e.g of a trajectory chosen on the basis of the image data Accuracy of frameless stereotaxy with the DRF in the clinical application The overall precision of the DRF in clinical use is ... were assigned to one of three types of interventions according to head fixation and use of the DRF including its mode of attachment (Figure 6) To assign the patients to one of the three groups, ... fixation of an additional reference tool [18] Nevertheless, all of these techniques have physical limitations which allow mobility of the head only in a restricted range of motion after completion of...
16
422
0
Báo cáo y học: " Therapeutic efficacy of alpha-1 antitrypsin augmentation therapy on the loss of lung tissue: an integrated analysis of 2 randomised clinical trials using computed " potx
Ngày tải lên :
12/08/2014, 11:22
... from of the subjects Volume correction of CT Scans The level of inspiration during scan acquisition is recognised to influence lung density and reduce the Figure Measurement of progression of emphysema ... combination of comparable studies is necessary For example, meta-analysis of several studies has been used to support the use of antibiotics in acute exacerbations of COPD [22] In clinical medicine, ... content, and has provided final approval of the version to be published AD was the principal investigator of the multicentre, randomised clinical trials of augmentation therapy with AAT He has...
8
257
0
Báo cáo y học: "Efficacy assessed in follow-ups of clinical trials: methodological conundrum" docx
Ngày tải lên :
12/08/2014, 14:22
... explanation of differences after 10 years of intangibly trying to influence patients’ fates Does this make Rantalaiho and colleagues’ results useless? Absolutely not We welcome cohorts of patients ... world full of treatment choices that differ in efficacy, effectiveness and cost Explained in terms of contradictio in terminis, the contradiction is in the recognition that the randomised part of a RCT ... treatment effects after a decade of follow-up of that trial Abbreviations Fin-RACo, Finnish Rheumatoid Arthritis Combination Therapy; RA, rheumatoid arthritis; RCT, randomised clinical trial Competing...
2
238
0
Báo cáo khoa học: " Hemodynamic goals in randomized clinical trials in patients with sepsis: a systematic review of the literature" pptx
Ngày tải lên :
13/08/2014, 03:21
... clinical research in the field of sepsis Key messages • Most sepsis clinical trials reviewed did not include hemodynamic goals of therapy Of note, the four largest clinical trials evaluating novel therapies ... exception of a narrowed cardiac index range (data not shown) Discussion The present systematic review of hemodynamic goals in sepsis clinical trials has two major findings First, of the 126 clinical ... of the study procedures Of note, one of these studies that required the use of a pulmonary artery catheter as part of the protocol did not specify treatment goals that would require the use of...
9
313
0
Báo cáo y học: "Sequential emergence and clinical implications of viral mutants with K70E and K65R mutation in reverse transcriptase during prolonged tenofovir monotherapy in rhesus macaques with chronic RT-SHIV infection" pptx
Ngày tải lên :
13/08/2014, 09:21
... effect of the presence of either one of these alleles and viremia during the first 20 weeks of infection (prior to tenofovir therapy), MamuA*01-positive animals responded initially to tenofovir ... Selection of K70E followed by K65R mutation in RT during prolonged tenofovir monotherapy For of the 10 animals for which viremia decreased following the onset of tenofovir therapy, the nadir of plasma ... Figure of Kinetics K70E and K65R RT mutants during tenofovir therapy Kinetics of K70E and K65R RT mutants during tenofovir therapy Twelve RT-SHIV infected macaques were started on tenofovir treatment...
22
442
0
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
... comparative trials, the maximal number of trials in one outcome was three Due to the low number of trials, no meaningful funnel plots could be produced Safety Four trials reported outcomes of adverse ... final version of the manuscript Additional material Additional file Clinical trials excluded from the present review The table provides the bibliographic information of the clinical trials excluded ... term of pregnancy), a consensus protocol of the intervention, and clinical and end-point outcomes Trials should be reported according to the CONSORT Statement [33] To investigate the efficacy of...
8
487
0
Xem thêm