nils-herrmann/clean_scirepeval huggingface dataset:
A triage strategy based on clinical risk factors for selecting elderly women for treatment or bone densitometry: the EPIDOS prospective study

A triage strategy, based on a clinical hip fracture risk score, may be used to classify elderly women into three groups: one at high risk and requiring treatment, another needing further assessment by bone densitometry, and a third at low risk. We used prospective data from the EPIDOS study (7512 women older than 75 years and followed for an average of 3.9 years) to assess the potential value of such a strategy for identifying elderly women with a hip fracture risk twice the cohort average (i.e. ≥20 per 1000 woman-years). An individual fracture risk score was calculated with the final risk function (Cox model). To compare this strategy with systematic BMD measurement and with current European recommendations, we examined the number of high-risk women identified, their average risk levels, sensitivity for hip fracture, and the number of high-risk women who need to be treated to prevent one hip fracture (hypotheses: all identified women are treated; sensitivity is equal to the point estimate; treatment reduces fracture risk by 35%). A triage strategy based on age, fracture history since the age of 40 years, body mass index, number of instrumental activities of daily living for which assistance is needed, grip strength, and visual acuity can identify 20% of the cohort as at high risk, 75% of them from clinical factors only, and the rest after BMD measurements (threshold: –2.5 T-score). The triage strategy would be significantly more sensitive than systematic BMD screening (51 versus 35%) and would require many fewer BMD examinations (10%). Compared with current recommendations, triage would identify fewer women (20 versus 28%) but at a significantly higher average risk of hip fracture (30 versus 20 per 1000 woman-years). Fewer high-risk women would be treated to prevent one hip fracture (29 versus 41) and fewer bone densitometry tests would be needed (10% versus 54%). The proposed triage strategy may be a useful clinical tool for selecting elderly women for treatment or bone densitometry.
Strategies for improving memory: a randomized trial of memory groups for older people, including those with mild cognitive impairment.

Governments are promoting the importance of maintaining cognitive health into older age to minimize risk of cognitive decline and dementia. Older people with amnestic mild cognitive impairment (aMCI) are particularly vulnerable to memory challenges in daily activities and are seeking ways to maintain independent living.



To evaluate the effectiveness of memory groups for improving memory strategies and memory ability of older people, especially those with aMCI.



113 healthy older adults (HOA) and 106 adults with aMCI were randomized to a six-week memory group or a waitlist control condition. Outcome was evaluated through knowledge and use of memory strategies, memory ability (self-report and neuropsychological tests), and wellbeing. Assessments included a six-month follow-up.



Using intention to treat analyses, there were intervention effects for HOA and aMCI groups in strategy knowledge (HOA: η2= 0.20; aMCI: η2= 0.06), strategy use (HOA: η2= 0.18; aMCI: η2= 0.08), and wellbeing (HOA: η2= 0.11; aMCI: η2= 0.05). There were also intervention effects in the HOA group, but not the aMCI group, in self-reported memory ability (η2= 0.06) and prospective memory tests (η2= 0.02). By six-month follow-up, gains were found on most HOA outcomes. In the aMCI group gains were found in strategy use, and by this stage, gains in prospective memory were also found.



Memory groups can engage older people in techniques for maintaining cognitive health and improve memory performance, but more modest benefits are seen for older adults with aMCI.
Individualized anticoagulation with dermatan sulphate for haemodialysis in chronic renal failure.

Dermatan sulphate (DS) is a selective thrombin inhibitor with antithrombotic properties and low bleeding potential. In preliminary studies it was reported to be effective for preventing clot formation in the haemodialysis circuit.



Ten patients on maintenance haemodialysis for chronic renal failure underwent three consecutive investigation phases. In phase 1 (individual dose titration), repeated dialyses were performed with increasing doses of DS until successful dialysis was obtained in two sessions at the same dose. In phase 2, individualized DS doses were validated by a randomized crossover comparison with the individual heparin dose of each patient. In phase 3, each patient underwent 24 consecutive dialyses with DS over 8 weeks. Successful dialysis was defined as completion of the procedure without visible clot formation in the bubble traps and lines or a greater than 20% decrease in dialyser capacity. Dialysis efficiency (decrease in serum urea and creatinine, Kt/V), APTT prolongation, bleeding time, and DS plasma concentrations were also assessed.



Phase 1: successful dialysis was achieved in nine patients with 4 mg/kg DS as a predialysis intravenous bolus followed by continuous infusion of 0.65 mg/kg/h. One patient required 5 mg/kg plus 1.3 mg/kg/h. Phase 2: no statistically significant differences were found between DS and heparin in any of the investigated variables. Residual dialyser capacity and dialysis efficiency indexes indicated equivalent efficacy. Phase 3: residual dialyser capacity and dialysis efficiency did not change with time. There was no accumulation of DS in plasma. No bleeding or thrombocytopenia were observed.



The dose of DS can be individually titrated to suppress clot formation during haemodialysis as efficiently as with individualized heparin. Such an individualized DS regimen maintains its anticoagulant efficacy and is safe in prolonged use.
A randomized study of decitabine versus conventional care for maintenance therapy in patients with acute myeloid leukemia in complete remission

We would like to thank Angelo Willems and Carine Seynaeve for their expert technical assistance. The work was financially supported by the International Myeloma Foundation, Fonds voor Wetenschappelijk Onderzoek Vlaanderen (FWO-Vl), Stichting tegen Kanker, King Baudouin Foundation, Multiple Myeloma Research Foundation, the European Stem cell network (EUFP6 MSCNET) and the Onderzoeksraad Vrije Universiteit Brussel (GOA48, OZR-VUB). E Van Valckenborgh, E Menu and E De Bruyne are postdoctoral fellows, and E Schouppe and K Movahedi are predoctoral fellows of FWO-Vl. JA Van Ginderachter is supported by Stichting tegen Kanker. OT-1 mice were a kind gift of Dr Muriel Moser (ULB, Brussels, Belgium). Non-labeled antiCCR2 (MC-21) was a gift of Dr Matthias Mack (University of Regensburg, Germany).
Switching from natalizumab to fingolimod in multiple sclerosis: a French prospective study.

The safety and efficacy of switching from natalizumab to fingolimod have not yet been evaluated in a large cohort of patients with multiple sclerosis (MS) to our knowledge.



To collect data from patients with MS switching from natalizumab to fingolimod.



The Enquête Nationale sur l'Introduction du Fingolimod en Relais au Natalizumab (ENIGM) study, a survey-based, observational multicenter cohort study among MS tertiary referral centers. Participants were patients for whom a switch from natalizumab to fingolimod was planned. Clinical data were collected on natalizumab treatment, duration and management of the washout period (WP), and relapse or adverse events during the WP and after the initiation of fingolimod.



Occurrence of MS relapse during the WP or during a 6-month follow-up period after the initiation of fingolimod.



Thirty-six French MS tertiary referral centers participated. In total, 333 patients with MS switched from natalizumab to fingolimod after a mean of 31 natalizumab infusions (female to male ratio, 2.36; mean age, 41 years; and Expanded Disability Status Scale score at the initiation of natalizumab, 3.6). Seventy-one percent were seropositive for the JC polyomavirus.  Twenty-seven percent of patients relapsed during the WP. A WP shorter than 3 months was associated with a lower risk of relapse (odds ratio, 0.23; P = .001) and with less disease activity before natalizumab initiation (P = .03). Patients who stopped natalizumab because of poor tolerance or lack of efficacy also had a higher risk of relapse (odds ratio, 3.20; P = .004). Twenty percent of patients relapsed during the first 6 months of fingolimod therapy. Three percent stopped fingolimod for efficacy, tolerance, or compliance issues. In the multivariate analysis, the occurrence of relapse during the WP was the only significant prognostic factor for relapse during fingolimod therapy (odds ratio, 3.80; P = .05).



In this study, switching from natalizumab to fingolimod was associated with a risk of MS reactivation during the WP or shortly after fingolimod initiation. The WP should be shorter than 3 months.
Validation and Recalibration of Two Multivariable Prognostic Models for Survival and Independence in Acute Stroke

Various prognostic models have been developed for acute stroke, including one based on age and five binary variables ('six simple variables' model; SSVMod) and one based on age plus scores on the National Institutes of Health Stroke Scale (NIHSSMod). The aims of this study were to externally validate and recalibrate these models, and to compare their predictive ability in relation to both survival and independence.



Data from a large clinical trial of oxygen therapy (n = 8003) were used to determine the discrimination and calibration of the models, using C-statistics, calibration plots, and Hosmer-Lemeshow statistics. Methods of recalibration in the large and logistic recalibration were used to update the models.



For discrimination, both models functioned better for survival (C-statistics between .802 and .837) than for independence (C-statistics between .725 and .735). Both models showed slight shortcomings with regard to calibration, over-predicting survival and under-predicting independence; the NIHSSMod performed slightly better than the SSVMod. For the most part, there were only minor differences between ischaemic and haemorrhagic strokes. Logistic recalibration successfully updated the models for a clinical trial population.



Both prognostic models performed well overall in a clinical trial population. The choice between them is probably better based on clinical and practical considerations than on statistical considerations.
Process Evaluation of a Psychosocial Intervention Addressing Women in a Disadvantaged Setting

This paper presents the process evaluation of a community-based randomized psycho-social trial aimed to enhance reproductive and mental health outcomes of disadvantaged women living in the southern suburb of Beirut-Lebanon. Process evaluation of public health interventions involves the monitoring and documentation of interventions' implementation to allow for better understanding of planned outcomes and of intervention effectiveness.



A community-based randomized trial was conducted. The intervention consisted of 12 sessions (of combined 30 minutes of relaxation exercises and 75 minutes of structured support groups) delivered twice per week over a period of six-weeks. A process evaluation was conducted during the implementation of the intervention. This process evaluation aimed to ensure that the intervention was delivered and implemented as planned, as well as to monitor women's satisfaction and attendance. The main components of the process evaluation included: dose delivered, dose received, and reach. Closed ended questionnaires were administered before/after/during each intervention session. Data was entered and analyzed using SPSS. Analysis revolved around simple frequency distribution for categorical variables and means (SD) for continuous variables. Limited bivariate analysis (using CHI Square and Anova) was done.



RESULTS indicated that the delivery, implementation, and reach of the intervention were favorable. Participation was acceptable and satisfaction rates were very high.



These favorable findings pertaining to intervention satisfaction, reach and participation highlight a number of lessons for future intervention studies in the context of disadvantaged settings. They also support the importance of involving the local community members in intervention planning, implementation and evaluation early on. We believe that the community involvement in this trial directly and significantly contributed to the results of this process evaluation.
Translational PK–PD modelling of molecular target modulation for the AMPA receptor positive allosteric modulator Org 26576

The α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) receptor potentiator Org 26576 represents an interesting pharmacological tool to evaluate the utility of glutamatergic enhancement towards the treatment of psychiatric disorders. In this study, a rat–human translational pharmacokinetic–pharmacodynamic (PK–PD) model of AMPA receptor modulation was used to predict human target engagement and inform dose selection in efficacy clinical trials. Modelling and simulation was applied to rat plasma and cerebrospinal fluid (CSF) pharmacokinetic and pharmacodynamic measurements to identify a target concentration (EC80) for AMPA receptor modulation. Human plasma pharmacokinetics was determined from 33 healthy volunteers and eight major depressive disorder patients. From four out of these eight patients, CSF PK was also determined. Simulations of human CSF levels were performed for several doses of Org 26576. Org 26576 (0.1–10 mg/kg, i.v.) potentiated rat hippocampal AMPA receptor responses in an exposure-dependant manner. The rat plasma and CSF PK data were fitted by one-compartment model each. The rat CSF PK–PD model yielded an EC80 value of 593 ng/ml (90% confidence interval 406.8, 1,264.1). The human plasma and CSF PK data were simultaneously well described by a two-compartment model. Simulations showed that in humans at 100 mg QD, CSF levels of Org 26576 would exceed the EC80 target concentration for about 2 h and that 400 mg BID would engage AMPA receptors for 24 h. The modelling approach provided useful insight on the likely human dose–molecular target engagement relationship for Org 26576. Based on the current analysis, 100 and 400 mg BID would be suitable to provide ‘phasic’ and ‘continuous’ AMPA receptor engagement, respectively.
Efficacy and safety of mizoribine by one single dose administration for patients with rheumatoid arthritis.

Mizoribine (MZR) is an immunosuppressant that inhibits nucleic acid metabolism and is a relatively safe disease-modifying anti-rheumatic drug (DMARD). We evaluated the efficacy and safety of one single dose per day for patients with rheumatoid arthritis (RA).



In this study 32 patients with RA received MZR therapy. We evaluated the average dose of MZR and prednisolone, response to treatment and peak plasma level of MZR.



The average dose of MZR was 146.1±31.2 (range: 50-200) mg/day. The average dose of prednisolone was 4.63±3.59 (range: 0-14) mg/day. The average plasma level of MZR, measured after 3 hours, was 2.20±0.49 µg/mL in the responder group and 1.59±0.82 µg/mL in the non-responder group (p=0.020). The treatment with MZR for 24 weeks was completed by 71.9% of patients and the proportion of patients who achieved a good and moderate response rate according to the European League Against Rheumatism (EULAR) criteria was 56.3% at 24 weeks. The plasma level of MZR which was greater than or equal to 2.12 µg/mL was significantly correlated with the clinical response (p<0.01). Only one of thirty-two cases discontinued the treatment, because of skin eruption.



This study included patients that could not be treated with other DMARDs and/or biologic agents because of age, interstitial pneumonia and other complications. We show that MZR may be a useful and relatively safe therapy for patients in this group.
Therapeutic compliance of first line disease-modifying therapies in patients with multiple sclerosis. COMPLIANCE Study.

Non-adherence to disease-modifying therapies (DMTs) in multiple sclerosis may be associated with reduced efficacy. We assessed compliance, the reasons for non-compliance, treatment satisfaction, and quality of life (QoL) of patients treated with first-line therapies.



A cross-sectional, multicenter study was conducted that included relapsing multiple sclerosis patients. Compliance in the past month was assessed using Morisky-Green test. Seasonal compliance and reasons for non-compliance were assessed by an ad-hoc questionnaire. Treatment satisfaction and QoL were evaluated by means of TSQM and PRIMUS questionnaires.



A total of 220 patients were evaluated (91% relapsing-remitting); the mean age was 39.1 years, 70% were female, and the average time under treatment was 5.4 years. Subcutaneous interferon (IFN) β-1b was used in 23% of the patients, intramuscular IFN β-1a in 21%, subcutaneous IFN β-1a in 37%, and with glatiramer acetate in 19%. The overall compliance was 75%, with no significant differences related to the therapy, and 81% did not report any seasonal variation. Compliant patients had significantly lower disability scores and time of diagnosis, and greater satisfaction with treatment and its effectiveness. Discomfort and flu-like symptoms were the most frequent reasons for non-compliance. The satisfaction and QoL were associated with less disability and number of therapeutic switches.



The rate of compliance, satisfaction and QoL in multiple sclerosis patients under DMTs is high, especially for those newly diagnosed, less disabled, and with fewer therapeutic switches. Discomfort and flu-like symptoms associated with injected therapies significantly affect adherence.
Efficacy of oral physostigmine in primary degenerative dementia

To examine the efficacy of cholinergic enhancement in senile dementia of the Alzheimer type (SDAT), oral physostigmine was given to eight patients in a cross-over trial of three dose levels and a matching placebo. A dose-related improvement in memory as measured by objective verbal memory tests was observed. Performance was significantly better on the highest dose, 2 mg every 2 h, than on the lower doses. The effect was most systematically present for very short-term memory, which raises the question of whether the improvement may involve attention rather than longer term storage and retrieval.
Wingspan stent-assisted coiling of intracranial aneurysms with symptomatic parent artery stenosis: experience in 35 patients with mid-term follow-up results.

There is a potential risk of aneurysm rupture after parent artery revascularization because of increased blood flow. The purpose of this study is to assess the efficacy and safety of Wingspan stent-assisted coil embolization in the treatment of intracranial aneurysms with symptomatic parent artery stenosis.



Thirty-five consecutive patients (19 men, 16 women; age range, 48-79 years; mean age, 60.4 years) harboring 35 unruptured wide-necked or fusiform intracranial aneurysms (mean size 6.8mm; range 2.5-18 mm.) with symptomatic parent artery stenosis (mean degree 71.1%; range 50-92%) were treated with the Wingspan stent-assisted coiling. Twenty-four lesions were located in the anterior circulation and eleven in the posterior circulation. Patients were premedicated with antiplatelet therapy consisting of aspirin 300 mg and clopidogrel 75 mg for at least 3 days before the procedure. Following pre-dilatation and stent placement, a coiling microcatheter entered the aneurysm through the interstices of the stent, and then coiling was performed. After the procedure, clopidogrel 75 mg daily was recommended for an additional 30 days, and aspirin 100mg was recommended throughout follow-up. For all patients, clinical follow-up was conducted by clinic visitation, or telephone interview. Angiographic follow-up with DSA was recommended at 6 months and 1 year after the procedure. Angiography follow-up (mean time 10.6 months) was obtained in 31 cases (88.6%). The technical feasibility of the procedure, procedure-related complications, angiographic results, clinical outcome and follow-up angiography were evaluated.



In every case, technical success was achieved. The degree of stenosis was reduced from 71.1% to 17.4% after balloon angioplasty and stenting. Immediate angiography demonstrated complete occlusion in 25 cases (71.4%), neck remnant in 7 cases (20.0%), and incomplete occlusion in 3 cases (8.6%). Procedure-related morbidity occurred in two patients (5.7%), including thromboembolism (n=1) and occlusion of small penetrating arteries (n=1). At follow-up (mean time 18.3 months), two additional cases of ischemic stroke occurred. The overall frequency of any stroke, intracranial hemorrhage, or death within 30 days or ipsilateral stroke beyond 30 days was 11.4%. No rehemorrhage of treated aneurysm occurred. At angiographic follow-up, four cases demonstrated ≥ 50% in-stent restenosis (12.9%), one of which was symptomatic, and two aneurysms (6.4% of the follow-up angiograms) demonstrated recanalization.



We found that the Wingspan stent-assisted coil embolization was helpful in the treatment of intracranial aneurysms with parent artery stenosis.
Sustainability of service provisioning systems under attack

We propose a resource allocation model that captures the interaction between legitimate users of a distributed service provisioning system with malicious intruders attempting to disrupt its operation. The system consists of a bank of servers providing service to incoming requests. Malicious intruders generate fake traffic to the servers attempting to degrade service provisioning. Legitimate traffic may be balanced using available mechanisms in order to mitigate the damage from the attack. We characterize the guaranteed region, i.e. the set of legitimate traffic intensities that are sustainable given specific intensities of the fake traffic, under the assumption that the fake traffic is routed using static policies. This assumption will be relaxed, allowing arbitrary routing policies,  of this work.
Evaluation of a self-efficacy enhancement program to prevent pressure ulcers in patients with a spinal cord injury.

This study developed a self-efficacy enhancement program and evaluated its effects on the self-care behaviors, self-care knowledge, and self-efficacy regarding pressure ulcer prevention in patients with a spinal cord injury.



This was a multicenter randomized controlled trial. Six hospitals were invited to recruit patients with a spinal cord injury who were undergoing rehabilitation after receiving acute treatment. These hospitals were randomly allocated into experimental (three hospitals) or control (three hospitals) groups and 47 patients participated (24 in the experimental group and 23 in the control group). The experimental group was given an 8 week self-efficacy enhancement program for pressure ulcer prevention. The self-efficacy enhancement program consisted of small-group face-to-face intervention (education and skills training), education with computer animation, phone counseling, face-to-face counseling, and self-management records. The control group only received a pressure ulcer prevention information booklet. Self-care knowledge, self-efficacy, self-care behaviors, and pressure ulcer incidence were measured at baseline and after the 8 week self-efficacy enhancement program.



The experimental group showed a significantly greater improvement in self-care knowledge, self-efficacy, and self-care behaviors for pressure ulcer prevention than did the control group. One participant in the control group developed a pressure ulcer, while none of the participants in the experimental group developed a pressure ulcer; this difference was not statistically significant.



The self-efficacy enhancement program enabled patients with a spinal cord injury to engage in continued self-care behaviors and helped them to improve their knowledge and self-efficacy concerning pressure ulcer prevention.