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نساء صغيرات
يحكي الكتاب عن أسرة مارش مكونة من أب وأم وأربع فتيات تتراوح أعمارهن بين العاشرة والسادسة عشرة، لكل واحدة منهن ميولها وطباعها وشخصيتها وما المشكلات التي واجهت هذه الأسرة حين ذهب الأب إلى الحرب، وكيف عملت لتحيا حياة كريمة؟ ما كانت قصص هذه الأسرة على مدى سنوات عشر، وما كانت المفاجآت السارة والمحزنة التي عاشتها ؟
BOOK
Immunosuppression for immune-related adverse events during checkpoint inhibition: an intricate balance
Immune checkpoint inhibitors (ICIs) have changed perspectives for patients with cancer, but come with severe immune-related adverse events (irAEs). To prevent fatality or chronicity, these irAEs are often promptly treated with high-dose immunosuppressants. Until recently, evidence on the effects of irAE management on ICI efficacy has been sparse. As a result, algorithms for irAE management are mostly expert-opinion based and barely consider possible detrimental effects of immunosuppressants on ICI efficacy. However, recent growing evidence suggests that vigorous immunosuppressive management of irAEs comes with unfavourable effects on ICI efficacy and survival. With expansion of the indications of ICIs, evidence-based treatment of irAEs without hampering tumour control becomes more and more important. In this review, we discuss novel evidence from pre-clinical and clinical studies on the effects of different irAE management regimens including corticosteroids, TNF inhibition and tocilizumab on cancer control and survival. We provide recommendations for pre-clinical research, cohort studies and clinical trials that can help clinicians in tailored irAE management, minimising patients’ burden while maintaining ICI efficacy.
Journal Article
On Kawara -- silence
\"This exhibition marks the first full museum overview of the work produced by On Kawara after 1963. It has been organized in close collaboration with the artist, who proposed most of the sections that comprise the final structure of the show...\"--Introduction, page 19.
Book
The Trial within Cohorts (TwiCs) study design in oncology: experience and methodological reflections
A Trial within Cohorts (TwiCs) study design is a trial design that uses the infrastructure of an observational cohort study to initiate a randomized trial. Upon cohort enrollment, the participants provide consent for being randomized in future studies without being informed. Once a new treatment is available, eligible cohort participants are randomly assigned to the treatment or standard of care. Patients randomized to the treatment arm are offered the new treatment, which they can choose to refuse. Patients who refuse will receive standard of care instead. Patients randomized to the standard of care arm receive no information about the trial and continue receiving standard of care as part of the cohort study. Standard cohort measures are used for outcome comparisons. The TwiCs study design aims to overcome some issues encountered in standard Randomized Controlled Trials (RCTs). An example of an issue in standard RCTs is the slow patient accrual. A TwiCs study aims to improve this by selecting patients using a cohort and only offering the intervention to patients in the intervention arm. In oncology, the TwiCs study design has gained increasing interest during the last decade. Despite its potential advantages over RCTs, the TwiCs study design has several methodological challenges that need careful consideration when planning a TwiCs study. In this article, we focus on these challenges and reflect on them using experiences from TwiCs studies initiated in oncology. Important methodological challenges that are discussed are the timing of randomization, the issue of non-compliance (refusal) after randomization in the intervention arm, and the definition of the intention-to-treat effect in a TwiCs study and how this effect is related to its counterpart in standard RCTs.
Journal Article
Toxicity and efficacy of chronomodulated chemotherapy: a systematic review
Timing chemotherapy on the basis of the body's intrinsic circadian clock—ie, chronomodulated chemotherapy—might improve efficacy and reduce treatment toxicity. This systematic review summarises the available clinical evidence on the effects of chronomodulated chemotherapy from randomised, controlled trials in adult patients with cancer, published between the date of database inception and June 1, 2021. This study complies with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and was registered on the International Prospective Register of Systematic Reviews (CRD42020177878). The protocol was published on Oct 21, 2020, before study initiation. The primary outcome measures comprised toxicity incidence, overall survival, progression-free survival, and objective response rate. Of 1455 identified abstracts, 18 studies including 2547 patients were selected. Studies were heterogeneous in study design, treatment, and population. 14 (77%) of 18 studies reported differences among groups in toxicity. 11 (61%) studies reported that chronomodulated chemotherapy resulted in a significant decrease in toxicity while maintaining anti-cancer activity. Two (11%) studies showed that chronomodulated chemotherapy reduced some toxic effects but increased others, and one (6%) study reported worse toxicity outcomes than standard chemotherapy. Three (17%) studies reported improved efficacy (survival measures, objective response rate, or time to treatment failure) of chronomodulated chemotherapy, and no studies reported a decrease in efficacy. In conclusion, most studies provide evidence of the reduction of toxicity resulting from chronomodulated chemotherapy, while efficacy is maintained. More and larger, carefully designed, randomised, controlled trials are needed to provide recommendations for clinical practice.
Journal Article
Control Group Design, Contamination and Drop-Out in Exercise Oncology Trials: A Systematic Review
Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of exercise-oncology trials and explores the association with contamination and drop-out rates.
Randomized controlled exercise-oncology trials from two Cochrane reviews were included. Additionally, a computer-aided search using Medline (Pubmed), Embase and CINAHL was conducted after completion date of the Cochrane reviews. Eligible studies were classified according to three control group design characteristics: the exercise instruction given to controls before start of the study (exercise allowed or not); and the intervention the control group was offered during (any (e.g., education sessions or telephone contacts) or none) or after (any (e.g., cross-over or exercise instruction) or none) the intervention period. Contamination (yes or no) and excess drop-out rates (i.e., drop-out rate of the control group minus the drop-out rate exercise group) were described according to the three design characteristics of the control group and according to the combinations of these three characteristics; so we additionally made subgroups based on combinations of type and timing of instructions received.
40 exercise-oncology trials were included based on pre-specified eligibility criteria. The lowest contamination (7.1% of studies) and low drop-out rates (excess drop-out rate -4.7±9.2) were found in control groups offered an intervention after the intervention period. When control groups were offered an intervention both during and after the intervention period, contamination (0%) and excess drop-out rates (-10.0±12.8%) were even lower.
Control groups receiving an intervention during and after the study intervention period have lower contamination and drop-out rates. The present findings can be considered when designing future exercise-oncology trials.
Journal Article
The Effect of Physical Activity Interventions Comprising Wearables and Smartphone Applications on Physical Activity: a Systematic Review and Meta-analysis
Background
Worldwide physical activity levels of adults are declining, which is associated with increased chronic disease risk. Wearables and smartphone applications offer new opportunities to change physical activity behaviour. This systematic review summarizes the evidence regarding the effect of wearables and smartphone applications on promoting physical activity.
Methods
PubMed, EMBASE and Cochrane databases were searched for RCTs, published since January 2008, on wearables and smartphone applications to promote physical activity. Studies were excluded when the study population consisted of children or adolescents, the intervention did not promote physical activity or comprised a minor part of the intervention, or the intervention was Internet-based and not accessible by smartphone. Risk of bias was assessed by the Cochrane collaboration tool. The primary outcome was changed in physical activity level. Meta-analyses were performed to assess the pooled effect on (moderate-to-vigorous) physical activity in minutes per day and daily step count.
Results
Eighteen RCTs were included. Use of wearables and smartphone applications led to a small to moderate increase in physical activity in minutes per day (SMD = 0.43, 95% CI = 0.03 to 0.82;
I
2
= 85%) and a moderate increase in daily step count (SMD = 0.51, 95% CI = 0.12 to 0.91;
I
2
= 90%). When removing studies with an unclear or high risk of bias, intervention effects improved and statistical heterogeneity was removed.
Conclusions
This meta-analysis showed a small to moderate effect of physical activity interventions comprising wearables and smartphone applications on physical activity. Hence, wearables and smartphone applications are likely to bring new opportunities in delivering tailored interventions to increase levels of physical activity.
Journal Article
Body mass index and cancer risk among adults with and without cardiometabolic diseases: evidence from the EPIC and UK Biobank prospective cohort studies
Background
Whether cancer risk associated with a higher body mass index (BMI), a surrogate measure of adiposity, differs among adults with and without cardiovascular diseases (CVD) and/or type 2 diabetes (T2D) is unclear. The primary aim of this study was to evaluate separate and joint associations of BMI and CVD/T2D with the risk of cancer.
Methods
This is an individual participant data meta-analysis of two prospective cohort studies, the UK Biobank (UKB) and the European Prospective Investigation into Cancer and nutrition (EPIC), with a total of 577,343 adults, free of cancer, T2D, and CVD at recruitment. We used Cox proportional hazard regressions to estimate multivariable-adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for associations between BMI and incidence of obesity-related cancer and in turn overall cancer with a multiplicative interaction between BMI and the two cardiometabolic diseases (CMD). HRs and 95% CIs for separate and joint associations for categories of overweight/obesity and CMD status were estimated, and additive interaction was quantified through relative excess risk due to interaction (RERI).
Results
In the meta-analysis of both cohorts, BMI (per ~ 5 kg/m
2
) was positively associated with the risk of obesity-related cancer among participants without a CMD (HR: 1.11, 95%CI: 1.07,1.16), among participants with T2D (HR: 1.11, 95% CI: 1.05,1.18), among participants with CVD (HR: 1.17, 95% CI: 1.11,1.24), and suggestively positive among those with both T2D and CVD (HR: 1.09, 95% CI: 0.94,1.25). An additive interaction between obesity (BMI ≥ 30 kg/m
2
) and CVD with the risk of overall cancer translated into a meta-analytical RERI of 0.28 (95% CI: 0.09–0.47).
Conclusions
Irrespective of CMD status, higher BMI increased the risk of obesity-related cancer among European adults. The additive interaction between obesity and CVD suggests that obesity prevention would translate into a greater cancer risk reduction among population groups with CVD than among the general population.
Journal Article
Leisure-time and occupational physical activity and health outcomes in cardiovascular disease
ObjectiveIn healthy populations, leisure-time physical activity (LTPA) improves health outcomes, while, paradoxically, occupational physical activity (OPA) is associated with detrimental health effects. This study aimed to investigate the associations of LTPA and OPA with mortality, cardiovascular events and type 2 diabetes (T2D) in patients with cardiovascular disease (CVD).MethodsIn 7058 outpatients with CVD (age 61±10 years, 75% male) from the prospective Utrecht Cardiovascular Cohort-Second Manifestations of ARTerial disease cohort, Cox models were used to quantify the associations between self-reported LTPA and OPA and all-cause mortality, cardiovascular events and T2D.ResultsOver 8.6 years (IQR: 4.6–12.5) of follow-up, 1088 vascular events, 1254 deaths and 447 incident T2D cases occurred. The top LTPA quarter had a lower risk of all-cause mortality (HR 0.63, 95% CI 0.54 to 0.74), recurrent cardiovascular events (HR 0.72, 95% CI 0.60 to 0.84) and incident T2D (HR 0.71, 95% CI 0.55 to 0.93), compared with the lowest quarter. The continuous LTPA associations were reverse J-shaped for all-cause mortality and vascular events and linear for T2D. OPA (heavy manual vs sedentary) showed a trend towards an increased risk of all-cause mortality (HR 1.08, 95% CI 0.86 to 1.35), cardiovascular events (HR 1.15, 95% CI 0.91 to 1.45) and T2D (HR 1.04, 95% CI 0.72 to 1.50). The detrimental effects of higher OPA were more pronounced in men, never-smokers, people with higher education and active employment.ConclusionsIn patients with CVD, LTPA was associated with lower risk of all-cause mortality, recurrent cardiovascular events and incident T2D. In contrast, OPA seemed to increase the risk of these outcomes. These findings support the existence of a physical activity paradox in patients with CVD.
Journal Article
Attendance and compliance with an exercise program during localized breast cancer treatment in a randomized controlled trial: The PACT study
Maintaining high adherence rates (session attendance and compliance) in exercise programs during breast cancer treatment can be challenging. We aimed to identify adherence rates and predictors to an exercise program during adjuvant breast cancer treatment.
Ninety-two patients with localized breast cancer undergoing chemotherapy were randomly assigned to an 18-week supervised moderate-to-high intensity aerobic and resistance exercise program, including two 1-hour sessions/week. Additionally, participants were asked to be physically active for at least 30 minutes/day on at least three other days. We report median percentages for attendance, compliance with the prescribed duration and intensity of aerobic and muscle strength exercises, and the exercise advice given. Predictors included in univariate and multivariable linear regression models were demographical, tumor- and treatment-related factors, constructs of the theory of planned behavior, psychological and physical factors.
Patients attended 83% (interquartile range: 69-91%) of the supervised sessions. Compliance with the duration of aerobic exercise, high-intensity aerobic exercise (cycling at the ventilatory threshold), muscle strength exercises and the exercise advice were 88%(64-97%), 50%(22-82%), 84%(65-94%) and 61%(33%-79%), respectively. Education, radiotherapy, BMI and physical fatigue were important predictors of adherence to supervised exercise. Beliefs about planned behaviors were important predictors, especially for compliance with the exercise advice.
Attendance to and compliance with an 18-week aerobic and strength exercise program were high. The lowest compliance was found for high-intensity supervised aerobic exercise. The identified predictors should be considered when designing or adapting exercise programs for patients with localized breast cancer to increase adherence.
Current Controlled Trials ISRCTN43801571 Dutch Trial Register NTR2138.
Journal Article