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Rivastigmine for vascular cognitive impairment
2013
The Cochrane library
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Ginkgo biloba for cognitive impairment and dementia
2009
The Cochrane library
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Donepezil for dementia due to Alzheimer's disease
2006
The Cochrane library
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In recent years, acetylcholinesterase inhibitors have been approved for the treatment of Alzheimer's disease. This has been mainly on the strength of many randomised placebocontrolled trials showing a statistically significant improvement in cognitive, functional and behavioural scores mainly at 12 and 24 weeks. 1,2,3 The questions now are whether this statistical difference translates into a clinically meaningful difference and whether treatment is cost-effective. The AD2000 trial 4 sheds
doi:10.1002/14651858.cd001190.pub2
pmid:16437430
fatcat:6nd7e2ebfnaudcb3ja3bl46my4
more »
... on this question. This placebo-controlled trial of donepezil was not sponsored by a drug company. The trial has many strengths as it: ■ is the only trial to look at end points beyond one year ■ focuses primarily on clinical end points such as time to institutionalisation or progression to disability ■ includes measures of caregiver burden (as a secondary outcome) ■ enrolled a broader spectrum of patients than those typically included in trials sponsored by drug companies. The drawbacks of the trial were that recruitment was slower and smaller than planned (566 versus 3000 patients). It had a complex design (multiple treatment phases and washout periods) and a large withdrawal rate. This makes a true intention-to-treat analysis difficult, however, the overall effect of these factors is to bias away from the null, that is to overstate the effect size. With this caveat in mind, the results show: ■ A difference in the 30-point mini-mental state examination of 0.8 points (95% CI 0.5-1.2*) between the treatment and placebo groups at two years. This is about half the treatment effect previously seen at one year in other trials (1.8 points, 95% CI 0.5-3.2). ■ No difference in institutionalisation (RR=0.97 † , 95% CI 0.72-1.3) over 114 weeks. This conflicts with a previous drug company-sponsored trial indicating a significant delay in nursing home placement of about 21 months. 5 However, the sponsored trial was a non-randomised, open-label study with large potential for selection bias. The survival curves for AD2000 seem to indicate some gap at one year (Fig. 1), a potential 2-3 month delay in institutionalisation. This is consistent with many studies showing a 2-3 month delay in symptomatic progression, however this is not sustained and the overall rates at two years are similar. ■ No difference in progression to disability (RR=1.02, 95% CI 0.72-1.45) over 114 weeks. ■ There was a statistical difference in the functional score (as measured on the Bristol activities of daily living scale, BADLS) of about 1 point, out of a total of 60. Like the statistical difference in the mini-mental state examination, this difference was present by 24 weeks, but there was no further divergence (or convergence) of the curves with continued treatment. Neither of these score differences met previous, externally set criteria for clinical significance. ■ There was no difference in behavioural and psychological symptoms as measured by the neuropsychiatric inventory. * CI confidence interval † RR relative risk Knowledge about new drugs is usually limited to the experience of the carefully selected patients who participated in the clinical trials. A drug which satisfies short-term criteria of safety and efficacy may be less effective in the long term. The editorial by John Attia and Peter Schofield suggests that any benefits of donepezil may not be sustained, while Jeffrey Post and Mark Kelly say that cardiovascular diseasemay be emerging as a long-term adverse effect of antiretroviral therapy. To improve our knowledge of drug safety it is important to report adverse events, particularly to new drugs. Kerri Mackay explains what happens to your reports of adverse reactions. Amiodarone is a drug with many possible adverse reactions. Terry Campbell therefore advises on how to minimise the risk of serious adverse effects.
Donepezil for dementia due to Alzheimer's disease
2018
The Cochrane library
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In recent years, acetylcholinesterase inhibitors have been approved for the treatment of Alzheimer's disease. This has been mainly on the strength of many randomised placebocontrolled trials showing a statistically significant improvement in cognitive, functional and behavioural scores mainly at 12 and 24 weeks. 1,2,3 The questions now are whether this statistical difference translates into a clinically meaningful difference and whether treatment is cost-effective. The AD2000 trial 4 sheds
doi:10.1002/14651858.cd001190.pub3
pmid:29923184
fatcat:6woy2cwj25f3paxeucl6ctda5a
more »
... on this question. This placebo-controlled trial of donepezil was not sponsored by a drug company. The trial has many strengths as it: ■ is the only trial to look at end points beyond one year ■ focuses primarily on clinical end points such as time to institutionalisation or progression to disability ■ includes measures of caregiver burden (as a secondary outcome) ■ enrolled a broader spectrum of patients than those typically included in trials sponsored by drug companies. The drawbacks of the trial were that recruitment was slower and smaller than planned (566 versus 3000 patients). It had a complex design (multiple treatment phases and washout periods) and a large withdrawal rate. This makes a true intention-to-treat analysis difficult, however, the overall effect of these factors is to bias away from the null, that is to overstate the effect size. With this caveat in mind, the results show: ■ A difference in the 30-point mini-mental state examination of 0.8 points (95% CI 0.5-1.2*) between the treatment and placebo groups at two years. This is about half the treatment effect previously seen at one year in other trials (1.8 points, 95% CI 0.5-3.2). ■ No difference in institutionalisation (RR=0.97 † , 95% CI 0.72-1.3) over 114 weeks. This conflicts with a previous drug company-sponsored trial indicating a significant delay in nursing home placement of about 21 months. 5 However, the sponsored trial was a non-randomised, open-label study with large potential for selection bias. The survival curves for AD2000 seem to indicate some gap at one year (Fig. 1), a potential 2-3 month delay in institutionalisation. This is consistent with many studies showing a 2-3 month delay in symptomatic progression, however this is not sustained and the overall rates at two years are similar. ■ No difference in progression to disability (RR=1.02, 95% CI 0.72-1.45) over 114 weeks. ■ There was a statistical difference in the functional score (as measured on the Bristol activities of daily living scale, BADLS) of about 1 point, out of a total of 60. Like the statistical difference in the mini-mental state examination, this difference was present by 24 weeks, but there was no further divergence (or convergence) of the curves with continued treatment. Neither of these score differences met previous, externally set criteria for clinical significance. ■ There was no difference in behavioural and psychological symptoms as measured by the neuropsychiatric inventory. * CI confidence interval † RR relative risk Knowledge about new drugs is usually limited to the experience of the carefully selected patients who participated in the clinical trials. A drug which satisfies short-term criteria of safety and efficacy may be less effective in the long term. The editorial by John Attia and Peter Schofield suggests that any benefits of donepezil may not be sustained, while Jeffrey Post and Mark Kelly say that cardiovascular diseasemay be emerging as a long-term adverse effect of antiretroviral therapy. To improve our knowledge of drug safety it is important to report adverse events, particularly to new drugs. Kerri Mackay explains what happens to your reports of adverse reactions. Amiodarone is a drug with many possible adverse reactions. Terry Campbell therefore advises on how to minimise the risk of serious adverse effects.
Is Ginkgo biloba Effective and Safe for Dementia and Cognitive Impairment?
2004
Neuroepidemiology
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Reference 1 Birks J, Grimley Evans J: Ginkgo biloba for cognitive impairment and dementia (Cochrane Review); in: The Cochrane Library, issue 1, 2003, Update Software. ...
Birks J, Grimley Evans J: Ginkgo biloba for cognitive impairment and dementia (Cochrane Review); in: The Cochrane Library, issue 1, 2003, Update Software. ...
doi:10.1159/000075959
fatcat:3pnmoj3o2rba7aglfze7vmlrwe
Does Donepezil Improve Well-Being for Dementia due to Alzheimer's Disease?
2005
Neuroepidemiology
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Evidence-based pharmacotherapy of Alzheimer's disease
2004
International Journal of Neuropsychopharmacology
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Tables 1-4 summarize the details of included trials and results from systematic reviews carried out by the Cochrane Dementia and Cognitive Improvement Group (Birks and Harvey, 2004; Birks et al., 2004a ...
This group of patients was targeted partly because they are at the stage of disease at which there (Birks and Harvey, 2004) ; galantamine (Olin and Schneider, 2004) ; rivastigmine (Birks et al., 2004a ...
doi:10.1017/s1461145704004444
pmid:15228642
fatcat:x6ycsgptnna2rh7nws2zn63cdq
Bowman-Birk inhibitor concentrate prevents atrophy, weakness, and oxidative stress in soleus muscle of hindlimb-unloaded mice
2007
Journal of applied physiology
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We tested the hypothesis that dietary supplementation with Bowman-Birk inhibitor concentrate (BBIC), a soy protein extract, would oppose these changes. ...
BBIC, Bowman-Birk inhibitor concentrate. aBBIC, heat-inactivated (autoclaved) BBIC. *P Ͻ 0.05 vs. control. ...
Bowman-Birk inhibitor (BBI) concentrate (BBIC) supplementation protects mouse soleus muscle during 12 days of hindlimb unloading. ...
doi:10.1152/japplphysiol.00538.2006
pmid:17110517
fatcat:tlybci3j4jfdbj25ffem2fyfxa
Two Acute Liver Injuries in a Patient With Malnutrition
2021
Journal of Medical Cases
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Chronic starvation and refeeding have been associated with liver injury (LI). We present a patient with anorexia nervosa who exhibited both phenomena of malnutrition-related LI. At presentation, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were elevated at 154 and 136 U/L, respectively, and rose rapidly to peaks of 750 and 638 U/L, respectively, as nutrition was introduced. Mechanisms of starvation-related LI include impaired degradation and secretion of lipids, as well
doi:10.14740/jmc3713
pmid:34434480
pmcid:PMC8383592
fatcat:dtnyx3n5mzfefm4pjw2lkjrr4i
more »
... starvation-induced autophagy. LI during refeeding may be related to rapid increase in glucose availability. These phenomena are crucial to consider in patients with chronic starvation undergoing refeeding.
Comparing different ways of calculating sample size for two independent means: A worked example
2019
Contemporary Clinical Trials Communications
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We discuss different methods of sample size calculation for two independent means, aiming to provide insight into the calculation of sample size at the design stage of a parallel two-arm randomised controlled trial (RCT). We compare different methods for sample size calculation, using published results from a previous RCT. We use variances and correlation coefficients to compare sample sizes using different methods, including 1. The choice of the primary outcome measure: post-intervention score
doi:10.1016/j.conctc.2018.100309
pmid:30582068
pmcid:PMC6297128
fatcat:agx3rbwb5nhwbmu5yy3iqfxp5a
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... vs. change from baseline score. 2. The choice of statistical methods: t-test without using correlation coefficients vs. analysis of covariance (ANCOVA). We show that the required sample size will depend on whether the outcome measure is the post-intervention score, or the change from baseline score, with or without baseline score included as a covariate. We show that certain assumptions have to be met when using simplified sample size equations, and discuss their implications in sample size calculation when planning an RCT. We strongly recommend publishing the crucial result "mean change (SE, standard error)" in a study paper, because it allows (i) the calculation of the variance of the change score in each arm, and (ii) to pool the variances from both arms. It also enables us to calculate the correlation coefficient in each arm. This subsequently allows us to calculate sample size using change score as the outcome measure. We use simulation to demonstrate how sample sizes by different methods are influenced by the strength of the correlation.
Evaluation of a prediction model for colorectal cancer: retrospective analysis of 2.5 million patient records
2017
Cancer Medicine
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Birks et al. ...
Birks et al. ...
doi:10.1002/cam4.1183
pmid:28941187
pmcid:PMC5633543
fatcat:oq6afzu3znfhxlmqwcmsoxf2mm
Methylene blue fluorescence of the ureter during colorectal surgery
2018
Surgical Endoscopy
Preserved Fulltext
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Barnes, Roel Hompes, Jacqueline Birks, Neil J. Mortensen, Oliver Jones, Ian Lindsey, Richard Guy, Bruce George, Chris Cunningham, and Trevor M. ...
doi:10.1007/s00464-018-6219-8
pmid:29785456
pmcid:PMC6096537
fatcat:mlklur2iivf3fbwylctpkvnf7y
Early warning scores for detecting deterioration in adult hospital patients: a systematic review protocol
2017
BMJ Open
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Disparate Regulatory Mechanisms Control Fat3 and P75NTR Protein Transport through a Conserved Kif5-Interaction Domain
2016
PLoS ONE
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Directed transport delivers proteins to specific cellular locations and is one mechanism by which cells establish and maintain polarized cellular architectures. The atypical cadherin Fat3 directs the polarized extension of dendrites in retinal amacrine cells by influencing the distribution of cytoskeletal regulators during retinal development, however the mechanisms regulating the distribution of Fat3 remain unclear. We report a novel Kinesin/Kif5 Interaction domain (Kif5-ID) in Fat3 that
doi:10.1371/journal.pone.0165519
pmid:27788242
pmcid:PMC5082931
fatcat:y7fpwxpv6nffjkgacvvnlse3mu
more »
... tates Kif5B binding, and determines the distribution of Fat3 cytosolic domain constructs in neurons and MDCK cells. The Kif5-ID sequence is conserved in the neurotrophin receptor P75 NTR , which also binds Kif5B, and Kif5-ID mutations similarly result in P75 NTR mislocalization. Despite these similarities, Kif5B-mediated protein transport is differentially regulated by these two cargos. For Fat3, the Kif5-ID is regulated by alternative splicing, and the timecourse of splicing suggests that the distribution of Fat3 may switch between early and later stages of retinal development. In contrast, P75 NTR binding to Kif5B is enhanced by tyrosine phosphorylation and thus has the potential to be dynamically regulated on a more rapid time scale. Immunofluorescence Cells plated on trans-well filters or glass coverslips were fixed with 4% paraformaldehyde in PBS, permeabilized with 0.5% Triton X-100 in PBS for 10 min, and blocked in a solution of Regulating Kif5-Dependent Protein Transport PLOS ONE |
Trends of vital signs with gestational age in normal pregnancies: a systematic review protocol
2016
BMJ Open
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Vital signs (blood pressure, heart rate, temperature, oxygen saturation and respiratory rate) are thought to undergo changes during and immediately after pregnancy. However, these physiological changes are not taken into account in the normal ranges, which themselves are not evidence-based, used in routine and acute care monitoring. We aim to synthesise the existing evidence base for changes in vital signs during pregnancy, in order to derive new centile charts for each stage of pregnancy and
doi:10.1136/bmjopen-2015-008769
pmid:26733567
pmcid:PMC4716207
fatcat:agmfdf34svgn7l6j3ldfw7j2gy
more »
... e immediate postpartum period. Methods and analysis: We will search the Loerup L, et al. BMJ Open 2016;6:e008769.
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