Whether closure of a patent foramen ovale reduces the risk of recurrence of ischemic stroke in patients who have had a cryptogenic ischemic stroke is unknown.
In a multicenter, randomized, open-label ...trial, with blinded adjudication of end-point events, we randomly assigned patients 18 to 60 years of age who had a patent foramen ovale (PFO) and had had a cryptogenic ischemic stroke to undergo closure of the PFO (PFO closure group) or to receive medical therapy alone (aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole; medical-therapy group). The primary efficacy end point was a composite of recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death after randomization. The results of the analysis of the primary outcome from the original trial period have been reported previously; the current analysis of data from the extended follow-up period was considered to be exploratory.
We enrolled 980 patients (mean age, 45.9 years) at 69 sites. Patients were followed for a median of 5.9 years. Treatment exposure in the two groups was unequal (3141 patient-years in the PFO closure group vs. 2669 patient-years in the medical-therapy group), owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat population, recurrent ischemic stroke occurred in 18 patients in the PFO closure group and in 28 patients in the medical-therapy group, resulting in rates of 0.58 events per 100 patient-years and 1.07 events per 100 patient-years, respectively (hazard ratio with PFO closure vs. medical therapy, 0.55; 95% confidence interval CI, 0.31 to 0.999; P=0.046 by the log-rank test). Recurrent ischemic stroke of undetermined cause occurred in 10 patients in the PFO closure group and in 23 patients in the medical-therapy group (hazard ratio, 0.38; 95% CI, 0.18 to 0.79; P=0.007). Venous thromboembolism (which comprised events of pulmonary embolism and deep-vein thrombosis) was more common in the PFO closure group than in the medical-therapy group.
Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow-up. (Funded by St. Jude Medical; RESPECT ClinicalTrials.gov number, NCT00465270 .).
T-cell acute lymphoblastic leukemia (ALL) is a rare disease in adults with inferior survival outcomes compared with those seen in pediatric patients. Although potentially curable with ∼50% survival ...at 5 years, adult patients with relapsed disease have dismal outcomes with <10% of patients surviving long term. This review will discuss the diagnosis and management of adult patients with newly diagnosed T-cell ALL with an emphasis on the immunophenotypic and genetic analyses required to assign prognosis, risk stratify, and guide post-remission therapy. The evidence for the main components of complex T-cell ALL treatment regimens is described. The importance of monitoring minimal residual disease is emphasized, with a discussion of the different methods used. The results of hematopoietic cell transplantation are analyzed, and recommendations made about which patients should be considered for this intervention. The treatment of the adolescent and young adult group is delineated, and the role of using “pediatric-inspired” regimens in older adults considered. We also describe the current data and potential future options for the use of novel therapies, including nelarabine and γ-secretase inhibitors, in adult patients with T-cell ALL.
Human needs in COVID-19 isolation Matias, Thiago; Dominski, Fabio H; Marks, David F
Journal of health psychology,
06/2020, Letnik:
25, Številka:
7
Journal Article
Recenzirano
Odprti dostop
To reduce the spread of COVID-19, the World Health Organization and the majority of governments have recommended that the entire human population should ‘stay-at-home’. A significant proportion of ...the population live alone or are vulnerable to mental health problems yet, in the vast majority of cases, individuals in social isolation have no access to mental healthcare. The only resource is people themselves using self-help, self-medication and self-care. During prolonged COVID-19 isolation, an in-built system of homeostasis can help rebalance activity, thought and feeling. Increased physical activity enables a reset of physical and mental well-being. During periods of lockdown, it is recommended that exercise should be as vigorously promoted as social distancing itself.
Homeostasis Theory of Well-being Marks, David F
Journal of Health Psychology,
06/2024, Letnik:
29, Številka:
7
Book Review, Journal Article
Recenzirano
The Homeostasis Theory of Well-being proposes a homeostatic modular system for the creation of human well-being. This article aims to: (i) provide a proof-of-concept demonstration of the feasibility ...of the theory in its biopsychosocial context; (ii) indicate prima facie empirical support for the homeostatic nature of the 16 proposed modules; (iii) discuss the similarities to and differences from other homeostasis theories of well-being. Following the Central Limit Theorem, any homeostatic system with multiple inputs produces outputs with a Gaussian distribution. The data-base of studies contains approximately 2000 publications reporting U- or inverse U-shaped curves for the 16 homeostatic domains specified in the theory. The Homeostasis Theory of Well-being remains speculative and requires controlled longitudinal study to determine the scientific validity of the causal network proposed by the theory. The theory has implications for our understanding of humans’ drive for balance, equilibrium and stability in this increasingly uncertain world.
Allogeneic hematopoietic stem cell transplantation (HSCT) in first complete remission is a standard of care for adult patients with Philadelphia chromosome (Ph)-negative acute lymphoblastic leukemia ...(ALL) and high risk of relapse. However, the stratification systems vary among study groups. Inadequate response at the level of minimal residual disease is the most commonly accepted factor indicating the need for alloHSCT. In this consensus paper on behalf of the European Working Group for Adult Acute Lymphoblastic Leukemia and the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation, we summarize available evidence and reflect current clinical practice in major European study groups regarding both indications for HSCT and particular aspects of the procedure including the choice of donor, source of stem cells and conditioning. Finally, we propose recommendations for daily clinical practice as well as for planning of prospective trials.
Research into the newly-coined ‘condition’ of ‘aphantasia’, an individual difference involving the self-reported absence of voluntary visual imagery, has taken off in recent years, and more and more ...people are ‘self-diagnosing’ as aphantasic. Yet, there is no consensus on whether aphantasia should really be described as a ‘condition’, and there is no battery of psychometric instruments to detect or ‘diagnose’ aphantasia. Instead, researchers currently rely on the Vividness of Visual Imagery Questionnaire (VVIQ) to ‘diagnose’ aphantasia. We review here fundamental and methodological problems affecting aphantasia research stemming from an inadequate focus on how we should define aphantasia, whether aphantasia is a pathological condition, and the extensive use of VVIQ as a ‘diagnostic test’ for aphantasia. Firstly, we draw attention to ‘literature blindness’ for visual imagery research from the 1960s to 1990s concerning individual differences in visual imagery vividness. Secondly, despite aphantasia being defined as a ‘condition’ where voluntary visual imagery is absent as indicated by the lowest score on the VVIQ, aphantasia studies inconsistently employ samples comprised of a mixture of participants with no visual imagery and low visual imagery, and we argue that this hinders the uncovering of the underlying cause of aphantasia. Thirdly, the scores used to designate the boundary between aphantasia and non-aphantasia are arbitrary and differ between studies, compromising the possibility for cross-study comparison of results. Fourthly, the problems of ‘diagnosing’ aphantasia are not limited to the academic sphere, as one can ‘self-diagnose’ online, for example by using the variant-VVIQ on the Aphantasia Network website. However, the variant-VVIQ departs from the original in ways likely to impact validity and accuracy, which could lead people to falsely believe they have been ‘diagnosed’ with aphantasia by a scientifically-validated measure. Fifthly, we discuss the hypothesis that people who believe they have been ‘diagnosed’ with aphantasia might be vulnerable to health anxiety, distress, and stigma. We conclude with a discussion about some fundamental aspects of how to classify a disorder, and suggest the need for a new psychometric measure of aphantasia.
Since the first case of human SARS-CoV-2 infection late in 2019 workers across multiple disciplines have been strenuously engaged in attempting to prevent the spread of the virus and to provide care ...to patients. Never in history has so much human effort been concentrated on a single health trauma. Much of the new research is empirical in nature with relatively few strands of theory. This article focuses on two recent theories relevant to COVID-19 protective behaviours, the COM-B and the General Theory of Behaviour. New empirical findings on the means, motives and opportunities for COVID-19 protective behaviours improve our knowledge and capacity to cope with pandemics using psychological homeostasis.
The immunosuppressive activity of mesenchymal stromal cells (MSCs) is well documented. However, the therapeutic benefit is completely unpredictable, thus raising concerns about MSC efficacy. One of ...the affecting factors is the unresolved conundrum that, despite being immunosuppressive, MSCs are undetectable after administration. Therefore, understanding the fate of infused MSCs could help predict clinical responses. Using a murine model of graft-versus-host disease (GvHD), we demonstrate that MSCs are actively induced to undergo perforin-dependent apoptosis by recipient cytotoxic cells and that this process is essential to initiate MSC-induced immunosuppression. When examining patients with GvHD who received MSCs, we found a striking parallel, whereby only those with high cytotoxic activity against MSCs responded to MSC infusion, whereas those with low activity did not. The need for recipient cytotoxic cell activity could be replaced by the infusion of apoptotic MSCs generated ex vivo. After infusion, recipient phagocytes engulf apoptotic MSCs and produce indoleamine 2,3-dioxygenase, which is ultimately necessary for effecting immunosuppression. Therefore, we propose the innovative concept that patients should be stratified for MSC treatment according to their ability to kill MSCs or that all patients could be treated with ex vivo apoptotic MSCs.
Whether closure of a patent foramen ovale is effective in the prevention of recurrent ischemic stroke in patients who have had a cryptogenic stroke is unknown. We conducted a trial to evaluate ...whether closure is superior to medical therapy alone in preventing recurrent ischemic stroke or early death in patients 18 to 60 years of age.
In this prospective, multicenter, randomized, event-driven trial, we randomly assigned patients, in a 1:1 ratio, to medical therapy alone or closure of the patent foramen ovale. The primary results of the trial were analyzed when the target of 25 primary end-point events had been observed and adjudicated.
We enrolled 980 patients (mean age, 45.9 years) at 69 sites. The medical-therapy group received one or more antiplatelet medications (74.8%) or warfarin (25.2%). Treatment exposure between the two groups was unequal (1375 patient-years in the closure group vs. 1184 patient-years in the medical-therapy group, P=0.009) owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat cohort, 9 patients in the closure group and 16 in the medical-therapy group had a recurrence of stroke (hazard ratio with closure, 0.49; 95% confidence interval CI, 0.22 to 1.11; P=0.08). The between-group difference in the rate of recurrent stroke was significant in the prespecified per-protocol cohort (6 events in the closure group vs. 14 events in the medical-therapy group; hazard ratio, 0.37; 95% CI, 0.14 to 0.96; P=0.03) and in the as-treated cohort (5 events vs. 16 events; hazard ratio, 0.27; 95% CI, 0.10 to 0.75; P=0.007). Serious adverse events occurred in 23.0% of the patients in the closure group and in 21.6% in the medical-therapy group (P=0.65). Procedure-related or device-related serious adverse events occurred in 21 of 499 patients in the closure group (4.2%), but the rate of atrial fibrillation or device thrombus was not increased.
In the primary intention-to-treat analysis, there was no significant benefit associated with closure of a patent foramen ovale in adults who had had a cryptogenic ischemic stroke. However, closure was superior to medical therapy alone in the prespecified per-protocol and as-treated analyses, with a low rate of associated risks. (Funded by St. Jude Medical; RESPECT ClinicalTrials.gov number, NCT00465270.).
The Journal of Health Psychology publishes here Dr Anthony Pelosi’s analysis of questionable science by one of the world’s best-known psychologists, the late Professor Hans J Eysenck. The provenance ...of a huge body of data produced by Eysenck and Ronald Grossarth-Maticek is highly controversial. In Open letters to King’s College London and the British Psychological Society, this editor is requesting a thorough investigation of the facts together with retraction or correction of 61 publications. Academic institutions have a conflict of interest concerning allegations of misconduct, which is why I believe that the only way forward is to have a National Research Integrity Ombudsperson to investigate allegations.
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