Survival analysis and the log-rank test will be used to compare treatment groups according to the intention-to-treat principle, including participants who require open-label anticoagulation for newly detected atrial fibrillation. Study outcomes The primary efficacy outcome is recurrent stroke of any type. The primary safety outcomes are symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage. Discussion ARCADIA is the first trial to test whether anticoagulant therapy reduces stroke recurrence in patients with atrial cardiopathy but no known atrial fibrillation.

The primary outcome measure is a favorable clinical outcome, defined as a modified Rankin Scale Score of 0-2 at 3 months. The primary safety measure is mortality at 3 months and symptomatic ICH within the 24 h of randomization.

No abstract

Background Ischemic stroke and other vascular outcomes occur in 10–20% of patients in the 3 months following a TIA or minor ischemic stroke, and many are disabling. The highest risk period for these outcomes is the early hours and days immediately following the ischemic event. Aspirin is the most common antithrombotic treatment used for these patients. Aim The aim of POINT is to determine whether clopidogrel plus aspirin taken <12 hours after TIA or minor ischemic stroke symptom onset is more effective in preventing major ischemic vascular events at 90 days in the high-risk, and acceptably safe, compared to aspirin alone. Design POINT is a prospective, randomized, double-blind, multicenter trial in patients with TIA or minor ischemic stroke. Subjects are randomized to clopidogrel (600 mg loading dose followed by 75 mg/day) or matching placebo, and all will receive open-label aspirin 50–325 mg/day, with a dose of 162 mg daily for 5 days followed by 81 mg daily strongly recommended. Study Outcomes The primary efficacy outcome is the composite of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death, by 90 days. The primary safety outcome is major hemorrhage, which includes symptomatic intracranial hemorrhage. Discussion Aspirin is the most common antithrombotic given to patients with a stroke or TIA as it reduces the risk subsequent of stroke. This trial expects to determine whether more aggressive antithrombotic therapy with clopidogrel plus aspirin, initiated acutely, is more effective than aspirin alone.

Background and Purpose Human albumin has been shown to exert neuroprotective effects in animal models of cerebral ischemia and humans with various intracranial pathologies. We investigated the safety and tolerability of 25% human albumin (ALB) in patients with subarachnoid hemorrhage (SAH). Methods The ALISAH (Albumin in Subarachnoid Hemorrhage) Pilot Clinical Trial was an open-label, dose-escalation study. We intended to study 4 different dosages of ALB of increasing magnitude (0.625 g/kg: tier 1; 1.25 g/kg: tier 2; 1.875 g/kg: tier 3; and 2.5 g/kg: tier 4). Each dosage was to be given to 20 adult patients. Treatment was administered daily for 7 days. We investigated the maximum tolerated dose of ALB based on the rate of severe-to-life-threatening heart failure and anaphylactic reaction, and functional outcome at 3 months. Results We treated 47 adult subjects: 20 in tier 1; 20 in tier 2; and 7 in tier 3. We found that doses ranging up to 1.25 g/kg/day × 7 days were tolerated by patients without major dose-limiting complications. We also found that outcomes trended towards better responses in those subjects enrolled in tier 2 compared to tier 1 (OR: 3.0513; CI: 0.6586 – 14.1367) and to the International Intra-operative Hypothermia for Aneurysm Surgery Trial cohort (OR: 3.1462; CI: 0.9158 – 10.8089). Conclusions ALB in doses ranging up to 1.25 g/Kg/day × 7 days was tolerated by patients with SAH without major complications and may be neuroprotective. Based on these results, planning of the ALISAH II, a Phase III, randomized, placebo-controlled trial to test the efficacy of ALB is underway. Clinical Trial Registration Information: NCT00283400 (clinicaltrials.gov) http://clinicaltrials.gov/ct2/show/NCT00283400?term=subarachnoid+hemorrhage+houston&rank=1

Background: In the context of evidence-based management of historic collections, a damage function combines aspects of material degradation, use, and consideration of material attributes that are important for satisfactory extraction of benefits from user interaction with heritage. In libraries and archives, it has been shown that users (readers and visitors) are mainly concerned with loss of textual information, which could lead to degradation being described as unacceptable, at which an object might become unfit for use and therefore damaged. The contribution explores the development of the damage function for historic paper based on data available in the literature. Results:We have modelled the dose-response function taking into account 121 paper degradation experiments with known T, RH of the environment, and pH of paper. The function is based on the Arrhenius equation and published water absorption isotherm functions for paper. New isoperm plots have been calculated and isochrones have been developed. These are plots linking points of equal expected 'lifetime' , i.e. time until an object is expected to reach the state of threshold fitness-for-use. We also modelled demographic curves for a well-characterised research collection of historic papers, exploring the loss of fitness for use with time. Conclusions:The new tools enable us to evaluate scenarios of management of the storage environment as well as levels of access, for different types of library and archival paper. In addition, the costs and benefits of conservation interventions can be evaluated. The limitations of the function are the context of use (dark storage and reading), exclusive focus on the properties of an average paper type, and de-prioritised effect of pollutants; however, the latter can be considered separately. This work also demonstrates that transparent and publically accountable collection management decisions can be informed, and challenged by, effective interaction with a variety of stakeholders including the lay public.

The trial will continue through 2010. The study is proceeding as planned.

Background:In heritage science literature and in preventive conservation practice, damage functions are used to model material behaviour and specifically damage (unacceptable change), as a result of the presence of a stressor over time. For such functions to be of use in the context of collection management, it is important to define a range of parameters, such as who the stakeholders are (e.g. the public, curators, researchers), the mode of use (e.g. display, storage, manual handling), the long-term planning horizon (i.e. when in the future it is deemed acceptable for an item to become damaged or unfit for use), and what the threshold of damage is, i.e. extent of physical change assessed as damage. Results:In this paper, we explore the threshold of fitness for use for archival and library paper documents used for display or reading in the context of access in reading rooms by the general public. Change is considered in the context of discolouration and mechanical deterioration such as tears and missing pieces: forms of physical deterioration that accumulate with time in libraries and archives. We also explore whether the threshold fitness for use is defined differently for objects perceived to be of different value, and for different modes of use. The data were collected in a series of fitness-for-use workshops carried out with readers/visitors in heritage institutions using principles of Design of Experiments. Conclusions:The results show that when no particular value is pre-assigned to an archival or library document, missing pieces influenced readers/visitors' subjective judgements of fitness-for-use to a greater extent than did discolouration and tears (which had little or no influence). This finding was most apparent in the display context in comparison to the reading room context. The finding also best applied when readers/visitors were not given a value scenario (in comparison to when they were asked to think about the document having personal or historic value). It can be estimated that, in general, items become unfit when text is evidently missing. However, if the visitor/reader is prompted to think of a document in terms of its historic value, then change in a document has little impact on fitness for use.