nils-herrmann/clean_scirepeval huggingface dataset:
The effect of LDL apheresis on progression of coronary artery disease in patients with familial hypercholesterolemia

This study investigated the effect of extracorporal lipid-lowering therapy by low-density lipoprotein (LDL) apheresis on coronary artery disease in a population characterized by early development and rapid progression of atherosclerosis. We treated 32 patients aged between 15 and 63 years with drug-refractory familial hypercholesterolemia, treated once a week by immuno-specific LDL apheresis for 3 years in a controlled prospective and non-randomized trial; 25 patients (14 females and 11 males) completed the study. Noninvasive data were obtained by physical examination, 12-lead ECG and exercise testing. Invasive cardiological data were obtained by cardiac catheterization according to a standardized protocol in four cardiological centers. Left ventricular ejection fraction was calculated using planimetry. Coronary stenoses were measured quantitatively in 23 defined coronary segments by a panel of four investigators with an electronic digital caliper. In addition, overall coronary atherosclerosis was visually qualified. Final decisions on a classification into one of three groups (regression, no change, progression) of coronary atherosclerosis were based on panel consensus. Six cardiac events occurred throughout the study: percutaneous transluminal coronary angioplasty in one patient, coronary bypass grafting in three and two deaths. Statistical analysis of exercise testing yielded no significant change for maximum power and work capacity during the study period. Hemodynamic data revealed no significant change; mean ejection fraction was calculated as 65.8 ± 15.9% at study entry and 67.0 ± 12.7% at completion. Quantitative measurement of 111 circumscribed coronary stenoses showed a mean stenosis degree of 45 ± 26% at entry cineangio-film and 43 ± 22% at final cineangio-film demonstrating no significant change. Eight localized stenoses showed a regression of more than 10% and 11 stenoses a progression of more than 10%. Panel consensus decision for overall coronary atherosclerosis resulted in regression in no patients, no change in 16, questionable progression in 3, definite progression in 5, and undecided in one. We conclude that specific LDL-apheresis therapy can be used effectively for primary and secondary prevention of coronary artery disease in patients with familial hypercholesterolemia. Its beneficial effect was the prevention of further progression of coronary artery disease in the majority of the study population.
Sequent calculi and abstract machines

We propose a sequent calculus derived from the λ―μμ˜-calculus of Curien and Herbelin that is expressive enough to directly represent the fine details of program evaluation using typical abstract machines. Not only does the calculus easily encode the usual components of abstract machines such as environments and stacks, but it can also simulate the transition steps of the abstract machine with just a constant overhead. Technically this is achieved by ensuring that reduction in the calculus always happens at a bounded depth from the root of the term. We illustrate these properties by providing shallow encodings of the Krivine (call-by-name) and the CEK (call-by-value) abstract machines in the calculus.
A DEVS model for demographic microsimulation

Microsimulation is increasingly applied in demography to project the development of populations. A stochastic model is being introduced that describes individual life courses on a continuous time base. Life courses are determined by sequences of demographic events. We show how this demographic multi-state projection model can be specified as an atomic model in DEVS. Thereby, strengths but also limitations of this approach are revealed. The limitations are addressed by exploiting a DEVS variant that supports variable structures, i.e., DYNPDEVS, and by modeling individuals as atomic models and the population as a network model. An example projection of a synthetical population based on the population of Italy shows the plausibility and the feasibility of the developed model.
The impact of exercise training compared to caloric restriction on hepatic and peripheral insulin resistance in obesity.

It has been difficult to distinguish the independent effects of caloric restriction versus exercise training on insulin resistance.



Utilizing metabolic feeding and supervised exercise training, we examined the influence of caloric restriction vs. exercise training with and without weight loss on hepatic and peripheral insulin resistance.



Thirty-four obese, older subjects were randomized to: caloric restriction with weight loss (CR), exercise training with weight loss (EWL), exercise training without weight loss (EX), or controls. Based on an equivalent caloric deficit in EWL and CR, we induced matched weight loss. Subjects in the EX group received caloric compensation. Combined with [6,6(2)H(2)]glucose, an octreotide, glucagon, multistage insulin infusion was performed to determine suppression of glucose production (SGP) and insulin-stimulated glucose disposal (ISGD). Computed tomography scans were performed to assess changes in fat distribution.



Body weight decreased similarly in EWL and CR, and did not change in EX and controls. The reduction in visceral fat was significantly greater in EWL (-71 +/- 15 cm(2)) compared to CR and EX. The increase in SGP was also almost 3-fold greater (27 +/- 2%) in EWL. EWL and CR promoted similar improvements in ISGD [+2.5 +/- 0.4 and 2.4 +/- 0.9 mg x kg fat-free mass (FFM)(-1) x min(-1)], respectively.



EWL promoted the most significant reduction in visceral fat and the greatest improvement in SGP. Equivalent increases in ISGD were noted in EWL and CR, whereas EX provided a modest improvement. Based on our results, EWL promoted the optimal intervention-based changes in body fat distribution and systemic insulin resistance.
Brief cognitive behavioural intervention for depression and anxiety symptoms improves quality of life in chronic haemodialysis patients.

Psychological treatment of depression in end-stage renal disease (ESRD) has focused on severely depressed patients. We designed and tested a brief (5 weeks) cognitive behavioural intervention (CBI) to reduce mild and moderate depression and anxiety symptoms in patients with ESRD.



For the purpose of this study, a single-blind, randomized controlled design was used to compare patients with ESRD under haemodialysis treatment with and without the CBI.



Depression and anxiety symptoms were screened in 152 subjects (18-60 years old, 84 male). Sixty participants (age 41.8 ± 14.7, 29 males) with mild or moderate scores of depression (Beck Depression Inventory) and anxiety (Beck Anxiety Inventory) were randomly assigned to CBI or the control group. CBI techniques consisted of positive self-reinforcement, deep breathing, muscle relaxation, and cognitive restructuring. Depression, anxiety, quality of life (QoL), and cognitive distortion scores were evaluated at baseline, after 5 weeks (end of treatment) and after 4-week follow-up. All scores were compared by ANOVA for repeated measures with post-hoc tests adjusted by Bonferroni's method (p < .05 was considered significant).



At follow-up, depression, anxiety, and cognitive distortions had decreased, and QoL had increased in the intervention group, and there were no changes in the control group. Clinical utility was 33% for depression and 43% for anxiety.



A brief CBI of 5 weeks is effective for decreasing mild or moderate depression and anxiety symptoms and improving QoL in ESRD haemodialysis patients.



A brief, systematic and structured cognitive behavioural intervention (CBI) decreases anxiety and depression symptoms and improves quality of life in patients with end-stage renal disease (ESRD) who are being treated with haemodialysis. These benefits are not achieved when anxiety and depression symptoms are identified but not treated psychologically. This CBI consisted of cognitive restructuring of the distorted thoughts (perfectionism, catastrophic thinking, negative self-labelling, and dichotomous thinking) that are correlated with depression and anxiety symptoms and that can be assessed by a validated questionnaire designed for patients with ESRD. The handbooks that were developed for this study are structured and systematic. They could be valuable in supporting the efforts and participation of non-specialized health professionals in CBI such as nurses, physicians, social workers, and psychologists, raising the possibility of further application in a variety of clinical populations. Both the therapy and the client workbooks are available in Spanish upon request.
Non-invasive ventilation in elderly patients with acute hypercapnic respiratory failure: a randomised controlled trial.

older patients usually receive less invasive and costly hospital care, even if they meet the criteria for Intensive Care Unit admission or have a 'do not intubate'(DNI) order. The aim of this randomised, controlled trial was to assess the effectiveness of non-invasive mechanical ventilation (NIV) versus the standard medical therapy (SMT) in reducing the need of intubation, improving survival and reducing respiratory distress in very old patients with acute hypercapnic respiratory failure (AHRF).



eighty-two patients aged >75 years (mean age 81.3 ± 3.5 years) were randomised to receive NIV or SMT.



three respiratory units.



the primary outcome was the rate of meeting the endotracheal intubation (ETI) criteria. Secondary outcomes were the mortality rate, the respiratory rate, dyspnoea score, arterial blood gases.



the rate of meeting the ETI criteria was lower in the NIV group compared with the SMT group (7.3 versus 63.4%, respectively; P < 0.001), as was the mortality rate [(odds ratios) OR = 0.40; 95% CI: 0.19-0.83; P = 0.014]. Twenty-two of 41 SMT patients with DNI orders received NIV as a rescue therapy. The mortality rate in this subgroup was comparable with the NIV group and significantly lower compared with patients receiving ETI (OR = 0.60, 95% CI: 0.18-1.92 versus 4.03, 95% CI: 2.35-6.94, respectively; P = 0.009). Arterial blood gases, respiratory rate and dyspnoea improved significantly faster with NIV than with SMT.



compared with SMT, NIV decreased the rate of meeting the ETI criteria and the mortality rate of very old patients with AHRF. NIV should be offered as an alternative to patients considered poor candidates for intubation and those with a DNI order.
Alfacalcidol improves muscle power, muscle function and balance in elderly patients with reduced bone mass

We investigated the effect of daily therapy with 1 mcg alfacalcidol (Doss®-TEVA/AWD-pharma) on muscle power, muscle function, balance performance and fear of falls in an open, multi-centered, uncontrolled, prospective study on a cohort of patients with reduced bone mass. Among the 2,097 participants, 87.1% were post-menopausal women and 12.9% were men. Mean age was 74.8 years and mean body mass index (BMI) 26.3 kg/m². A total of 75.3% of the study population had osteoporosis, 81% a diagnosis of “increased risk of falls” and 70.1% had a creatinine clearance (CrCl) of <65 ml/min. Participants underwent muscle function and muscle power tests at onset and after 3 and 6 months: the timed up and go test (TUG) and the chair rising test (CRT). At baseline and after 6 months, participants performed the tandem gait test (TGT) and filled out a questionnaire evaluating fear of falling. Successful performance in the muscle tests is associated with a significantly lower risk of falls and non-vertebral fractures in elderly patients (successful test performance: TUG ≤ 10 s (sec), CRT ≤ 10 s, TGT ≥ 8 steps). A significant improvement in the performance of the two muscle tests was proved already after 3 months of treatment with alfacalcidol and further increased by the end of the therapeutic intervention. There were significant increases in the number of participants able to successfully perform the tests: 24.6% at baseline and 46.3% at the end of trial for the TUG (P < 0.0001) and 21.7% at baseline and 44.2% at the end for the CRT test (P = 0.0001). The mean time used for the TUG was decreased by 3.0 s from the average onset value of 17.0 s and by 3.1 s from the initial average 16.5 s for the CRT. The percentage of participants able to perform the balance test (TGT) increased from 36.0% at onset to 58.6% at the end of the trial (P < 0.0001). An increased fear of falling was reduced by the end of the study in 74.4% of the patients. Throughout the study, there were 26 adverse drug reactions in 11 out of 2,097 patients (incidence 0.52%). No serious adverse drug reactions and no cases of hypercalcemia were documented. We conclude that treatment with alfacalcidol is safe, increases muscle power, muscle function and balance and reduces fear of falls. The significant improvement in the three muscle and balance tests and fear of falls may have a preventative effect on falls and fractures. We suggest that the quantitative risk tests used in this study could be reliable surrogate parameters for the risk of falls and fractures in elderly patients.
Interferon retreatment of nonresponders with HCV-RNA-Positive chronic hepatitis C

Interferon has been shown to be an effective treatment for some patients with chronic hepatitis C. In this study, the value of retreatment of nonresponders to interferon was investigated. Thirty-eight patients with hepatitis C virus (HCV)-RNA-positive chronic hepatitis C virus (HCV)-RNA-positive chronic hepatitis C who had been treated with betainterferon but still showed an alanine aminotransferase (ALT) level>50 KU upon completion of therapy were retreated with alpha-interferon. Eight patients (21.1%) had normalization of ALT levels after interferon retreatment were studied. Of 16 patients with transient HCV-RNA negativity 1 month after the initial interferon therapy, 7 (43.8%) had a complete response, with normalization of ALT levels and undetectable HCV-RNA, more than 6 months after interferon retreatment. On the other hand, of the 22 patients with HCV-RNA activity 1 month after the initial interferon therapy, only 1 (4.5%) had a complete response. Multivariate analysis, using a multiple logistic model, indicated that a complete response to readministration of interferon was most strongly correlated to transient negative conversion for HCV-RNA after the initial course of treatment.
Echocardiographic correlates of acute heart failure, cardiogenic shock, and in-hospital mortality in tako-tsubo cardiomyopathy.

The purpose of this study was to determine clinical and echocardiographic correlates of acute heart failure, cardiogenic shock and in-hospital mortality in a large cohort of tako-tsubo cardiomyopathy (TTC) patients.



Despite good long-term prognosis, life-threatening complications due to hemodynamic instability can occur early in TTC patients.



The study population consisted of 227 patients (66.2 ± 12.2 years of age; females, 90.3%) enrolled in the Tako-tsubo Italian Network, undergoing transthoracic two-dimensional echocardiography on admission and at short-term follow-up (4.3 [4 to 6] weeks). Patients were divided into two groups according to the presence or absence of major adverse events, a composite of acute heart failure, cardiogenic shock, and in-hospital mortality.



Major adverse events occurred in 59 patients (25.9%). The variables for elderly patients ≥ 75 years of age (42.4% vs. 23.8%; p = 0.011): left ventricular (LV) ejection fraction (35.1 ± 5.9% vs. 38.4 ± 4.6%, p < 0.001), wall motion score index (1.9 ± 0.2 vs. 1.7 ± 0.2, p < 0.001), E/e' ratio (13.5 ± 4.3 vs. 9.9 ± 3.3 [where E/e' is ratio of mitral E peak velocity and averaged e' velocity], p < 0.001), LV outflow tract obstruction (23.7 vs. 8.9%, p = 0.006), pulmonary artery systolic pressure (47.4 ± 12.3 mm Hg vs. 38.0 ± 9.2 mm Hg; p < 0.001), right ventricular involvement (28.8 vs. 9.5%; p < 0.001), and reversible moderate-to-severe mitral regurgitation (49.1 vs. 11.9%; p < 0.001), were significantly different between groups and were associated with adverse events. At multivariate analysis, LV ejection fraction (HR: 0.92; 95% CI: 0.89 to 0.95; p < 0.001), E/e' ratio (HR: 1.13; 95% CI: 1.02 to 1.24; p = 0.011), reversible moderate to severe mitral regurgitation (HR: 3.25; 95% CI: 1.16 to 9.10; p = 0.025), and age ≥ 75 years (HR: 2.81; 95% CI: 1.05 to 7.52; p = 0.039) were independent correlates of major adverse events.



Echocardiographic parameters provide additional information compared to other variables routinely used in clinical practice to identify patients at higher risk of hemodynamic deterioration and poor in-hospital outcome, allowing prompt institution of appropriate pharmacological treatment and adequate mechanical support.
Self-Management education for adults with poorly controlled epILEpsy (SMILE (UK)): a randomised controlled trial protocol

Teaching people with epilepsy to identify and manage seizure triggers, implement strategies to remember to take antiepileptic drugs, implement precautions to minimize risks during seizures, tell others what to do during a seizure and learn what to do during recovery may lead to better self-management. No teaching programme exists for adults with epilepsy in the United Kingdom although a number of surveys have shown patients want more information.



This is a multicentre, pragmatic, parallel group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of a two-day Self-Management education for epILEpsy (SMILE (UK)), which was originally developed in Germany (MOSES).Four hundred and twenty eight adult patients who attended specialist epilepsy outpatient clinics at 15 NHS participating sites in the previous 12 months, and who fulfil other eligibility criteria will be randomised to receive the intervention (SMILE (UK) course with treatment as usual- TAU) or to have TAU only (control). The primary outcome is the effect on patient reported quality of life (QoL). Secondary outcomes are seizure frequency and psychological distress (anxiety and depression), perceived impact of epilepsy, adherence to medication, management of adverse effects from medication, and improved self-efficacy in management (mastery/control) of epilepsy.Within the trial there will be a nested qualitative study to explore users' views of the intervention, including barriers to participation and the perceived benefits of the intervention. The cost-effectiveness of the intervention will also be assessed.



This study will provide quantitative and qualitative evidence of the impact of a structured self management programme on quality of life and other aspects of clinical and cost effectiveness in adults with poorly controlled epilepsy.
Does concomitant diabetes affect treatment responses in overactive bladder patients?

To compare the efficacy and tolerability of a muscarinic receptor antagonist, darifenacin, in the treatment of overactive bladder (OAB) patients with concomitant diabetes as compared with those without comorbidities.



Post hoc exploratory analysis of a published, large, non-interventional study in OAB patients treated with darifenacin including 532 diabetics and 1315 controls. Associations of diabetes with treatment responses were evaluated by multiple regression models.



Diabetics (largely type 2 patients) and controls differed in baseline age, body weight, duration of OAB symptoms and presence of co-medications. However, they exhibited similar OAB symptom episode frequency and problem rating and received similar starting doses of darifenacin. Presence of diabetes was associated with a significantly smaller reduction of OAB symptoms, but the effect attributable to diabetes was small relative to the overall treatment response. The presence of diabetes was not associated with differences in tolerability.



We conclude that a muscarinic receptor antagonist has comparable efficacy and tolerability in the treatment of OAB patients with and without concomitant diabetes.
Change in electrodermal activity after acute tryptophan depletion associated with aggression in young people with attention deficit hyperactivity disorder (ADHD)

We investigated the impact of acute tryptophan depletion (ATD) and reduced brain serotonin synthesis on physiological arousal in 15 young people with ADHD participating in an aggression-inducing game. ATD was not associated with altered physiological arousal, as indexed by electrodermal activity (EDA). Baseline aggression was negatively correlated with the mean ATD effect on EDA. In accordance with the low arousal theory related to aggressive behavior, subjects with reduced physiological responsiveness/lower electrodermal reactivity to ATD tended to display elevated externalizing behavior.
Sustained reduction in health care costs after adjunctive treatment of graded intensive short-term dynamic psychotherapy in patients with psychotic disorders

The aim of this pilot study was to evaluate the changes in symptom severity and long-term health care cost after intensive short-term dynamic psychotherapy (ISTDP) individually tailored and administered to patients with psychotic disorders undergoing standard psychiatric care. Eleven therapists with different levels of expertise delivered an average of 13 one-hour sessions of graded ISTDP to 38 patients with psychotic disorders. Costs for health care services were compiled for a one-year period prior to the start of ISTDP (baseline) along with four one-year periods after termination. Two validated self-report scales, the Brief Symptom Inventory and the Inventory of Interpersonal Problems, were administered at intake and termination of ISTDP. Results revealed that health care cost reductions were significant for the one-year post-treatment period relative to baseline year, for both physician costs and hospital costs, and the reductions were sustained for the follow-up period of four post-treatment years. Furthermore, at treatment termination self-reported symptoms and interpersonal problems were significantly reduced. These preliminary findings suggest that this brief adjunctive psychotherapy may be beneficial and reduce costs in selected patients with psychotic disorders, and that gains are sustained in long-term follow-up. Future research directions are discussed.
The outcomes of glucose abnormalities in pre-diabetic chronic hepatitis C patients receiving peginterferon plus ribavirin therapy.

Pre-diabetes is a risk factor for type 2 diabetes mellitus (DM) development. This study aimed to elucidate the impact of treatment response on sequential changes in glucose abnormalities in pre-diabetic chronic hepatitis C (CHC) patients.



Chronic Hepatitis C patients with a baseline haemoglobin A1C (A1C) range 5.7-6.4% who achieved 80/80/80 adherence were prospectively recruited. All patients received current peginterferon-based recommendations. The primary outcome measurement was their A1C level at the end of follow-up (EOF). The interaction between variants of the IL28B gene and outcomes of glucose metabolism was also measured.



A total of 181 consecutive CHC patients were enrolled. The mean A1C at EOF was 5.82 ± 0.41%, which was significantly lower than the baseline level (5.93 ± 0.21%, P < 0.001). At EOF, 63 (34.8%) patients became normoglycaemic, whereas 10 (5.5%) patients developed DM. The sustained virological response (SVR) rates of 63 normoglycaemics, 108 pre-diabetics and 10 diabetic patients at the EOF were 92.1%, 84.3% and 50% respectively (normoglycaemics vs. diabetics P = 0.003; pre-diabetics vs. diabetics P = 0.02). Achievement of an SVR was the only predictive factor associated with normoglycaemia development at EOF by multivariate logistic regression analysis (Odds ratio = 2.6, P = 0.04). The prevalence of the interleukin 28B rs8099917 TT variant in patients who developed DM (70.0%) at EOF tended to be lower than that in patients with pre-diabetics (87.0%) or normoglycaemics (92.1%).



Successful eradication of HCV improves glucose abnormalities in pre-diabetic CHC patients.