nils-herrmann/clean_scirepeval huggingface dataset:
Pilot study of low-molecular-weight heparin in the treatment of acute ischemic stroke.

Our purpose was to assess the feasibility and risk of performing a double-blind placebo-controlled study of low-molecular-weight heparin in the treatment of acute ischemic stroke.



Fifty-five patients were treated within 48 hours of stroke onset. Pretreatment computed tomography was performed to rule out cerebral hemorrhage. Fraxiparine (6000 IU per day) was given subcutaneously for 7 days. No adverse reaction was encountered during the treatment period. At 3 months, 26 patients were independent, 21 moderately disabled, 4 severely disabled, and 4 dead.



It would be safe and practical to conduct a clinical trial on the use of Fraxiparine in the treatment of acute ischemic stroke.
Hemodynamic predictors of incident hypertension. The Framingham Heart Study.

Previous reports indicate that cardiac output is increased early in the course of hypertension. The purpose of this study was to identify with echocardiography hemodynamic features in normotensive adults that predicted the development of hypertension. Framingham Heart Study subjects were eligible for this investigation if they were normotensive at the baseline examination (systolic blood pressure < 140 mm Hg, diastolic blood pressure < 90 mm Hg, and no antihypertensive medications) and if they were free of coronary heart disease, congestive heart failure, valvular heart disease, atrial fibrillation, hypertrophic cardiomyopathy, diabetes mellitus, and renal insufficiency. The study included 1118 men (mean age, 44 years) and 1559 women (mean age, 46 years). After 4 years of follow-up, of this normotensive cohort, 201 men (18.0%) and 257 women (16.5%) had developed hypertension. In separate, age-adjusted multivariable logistic regression analyses, increased cardiac index (men: odds ratio = 1.19 for one standard deviation increment, P = .03; women: odds ratio = 1.17, P = .02) and end-systolic wall stress (men: odds ratio = 1.24, P = .006; women: odds ratio = 1.43, P < .001) were related to the development of hypertension in both sexes. In addition, increased heart rate in men (odds ratio = 1.25, P = .006) was a significant predictor of hypertension. After adjustment for age and baseline blood pressure, none of the hemodynamic variables was a significant predictor of hypertension. In addition, load-independent indexes of contractility revealed only a minimally greater proportion of subjects with increased contractility at baseline in the group that developed hypertension compared with those who remained normotensive.(ABSTRACT TRUNCATED AT 250 WORDS)
Perceived mood and skin body temperature rhythm in depression

Eighteen inpatients affected by recurrent major depression were monitored in their clinical and biological features during the acute episode of illness. Diurnal mood variations rated with Visual Analogue Scale (VAS) and diurnal variations of skin body temperature were measured every 2 h consecutively for 2 days. Circadian rhythmicity of the two parameters was evaluated by cosinor analysis separately for each patient. The inspection of the individual cosine fitting shows that patients with a high circadian rhythmicity in perceived severity of symptomatology tend to show low circadian rhythmicity in skin body temperature, whereas patients with a low VAS oscillation tend to display a higher diurnal variation in skin body temperature. A chi-square test confirmed a statistical significance of the discordance between the two rhythms. We discuss our findings hypothesizing a different degree of entrainment of the disease process to the main circadian pacemaker.
Comparative randomised trial of online cognitive-behavioural therapy and an information website for depression: 12-month outcomes.

An earlier paper reported positive outcomes immediately following access to a cognitive-behavioural therapy (CBT) internet intervention and a depression information website.



To determine 6-month and 12-month outcomes of the interventions relative to a placebo control condition.



Participants allocated to the depression information website condition, the CBT internet intervention and the placebo control condition were followed up at 6 and 12 months by survey. The primary outcome measure was the Center for Epidemiologic Studies-Depression (CES-D) scale. Of 525 participants recruited, 79% completed their assigned intervention and 60% were retained at 12-month follow-up. Attrition was handled using mixed-model repeated-measures ANOVA.



Both the CBT site and depression information sites were associated with statistically significant benefits in CES-D score reduction compared with controls at post-test. At 6-months follow-up, the reduction seen for the people allocated to the CBT arm remained significant, whereas that for the depression information website arm was not. At 12 months, both active interventions were statistically significantly superior to the control condition.



There is some evidence that benefits of these brief internet interventions are retained beyond their endpoint. The impact of human support provided by interviewers in the trial must be considered when comparing these outcomes to routine use of both internet interventions.
Removal of contrast media by different extracorporeal treatments.

Although the capability of extracorporeal treatments after administration of contrast media to prevent radiocontrast-induced nephropathy is controversial, haemodialysis is performed in many institutions after radiographic procedures. There are conflicting reports on the efficacy of different dialysers and treatment modalities to remove contrast media.



We compared the contrast medium-removing ability of different extracorporeal treatments in a randomized trial. Thirty-nine patients on chronic renal-replacement therapy or with chronic renal failure were randomized to receive low-flux haemodialysis (Low-HD, n=10), high-flux haemodialysis (High-HD, n=10), online haemodiafiltration (HDF, 10 litre substitution, n=10) and online haemofiltration (HF, 18 litre substitution, n=9) after administration of contrast medium during routine radiological procedures. Plasma concentrations of contrast medium (iopromide or iomeprol) were measured by energy-dispersive X-ray fluorescence analysis.



The extraction ratio for contrast media was 0.64+/-0.1 for Low HD (P<0.05 vs. High-HD and vs. HDF), 0.74+/-0.1 for High-HD (P<0.05 vs. HF), 0.81+/-0.1 for HDF (P<0.05 vs HF), and 0.62+/-0.1 for HF. Mean extracorporeal plasma clearances were 82+/-2 for Low-HD (P<0.05 vs. High-HD and vs HDF), 100+/-2 for High-HD, 115+/-4 for HDF (P<0.05 vs. HF), and 86+/-5 ml/min for HF.



We conclude that HDF and High-HD remove contrast media more effectively than Low-HD and HF during the time of each treatment session. However, whether this is also true for the overall elimination of contrast media by these different procedures needs to be addressed in future studies, by a precise assessment of the drug time course after the session.
Adherence to protein restriction in patients with type 2 diabetes mellitus: a randomized trial

To describe the extent to which diet counselling can decrease protein intake, and to identify predictors of adherence. (1) Randomized trial; (2) observational longitudinal study. (1) 125 type 2 diabetic patients in primary care; (2) 59 patients in the experimental group. For a period of 12 months, dieticians provided guidance on protein restriction (experimental group, n=59) or the usual dietary advice (control group, n=66).Outcome measures: Adherence was estimated primarily from urinary urea excretion (UUE), but also from food-frequency questionnaires ( After 6 months protein intake was, according to the UUE and the FFQ, respectively, 8 g/day (95% CI −2, 13) (8%) and 15 g/day (95%−CI 9, 22) (16%) lower in the experimental than in the control group. After 12 months these differences were smaller. Linear regression analysis indicated that protein restriction was greater in patients who were well satisfied with their pre-existing diet (r=0.32, bper 1/10=3.6 (1, 6) g), in patients who were less overweight (r=0.32, bper kg.m−2=1.1 (0.2, 2.0) g), and in patients living alone (r=0.22, b=7.7 (−2, 17) g). These combined factors explained only 11% of variation in adherence. Adherence was not predicted by the number of barriers reported by the patients or by coinciding changes in diet satisfaction. The diet counselling resulted in a very moderate degree of protein restriction only. Predictors of adherence could be identified, but only a few, and their predictive power was limited. (2000) 54, 347–352
Coronary flow reserve by contrast enhanced transesophageal coronary sinus Doppler measurements can evaluate diabetic microvascular dysfunction.

This study was undertaken to investigate whether coronary flow reserve (CFR) using coronary sinus flow (CSF), which can be measured by transesophageal Doppler echocardiography (TEDE), especially when contrast enhanced, is useful in evaluating microvascular dysfunction in patients with diabetes mellitus (DM).



CSF recordings using contrast enhanced TEDE were performed before and after adenosine triphosphate infusion (0.15 mg x kg(-1) x min(-1)) in 16 patients with type 2 DM and diabetic retinopathy and in 13 non-DM patients (control). Coronary angiography revealed normal epicardial coronary arteries. CFR was defined as the ratio of the antegrade flow velocity time integral in hyperemic conditions and basal levels. Clear envelopes of CSF were obtained in all DM patients using contrast-enhanced TEDE. CFR using CSF in the DM group was significantly decreased compared with the control group (1.4+/-0.4 vs 2.1+/-0.5, p<0.01), but there were no significant differences of age, ejection fraction, rate of hypertension and hypercholesterolemia between the 2 groups. Using 1.7 of CFR as the cut-off value, diabetic microvascular dysfunction could be detected with 82% sensitivity and 83% specificity.



CFR calculated by CSF using contrast-enhanced TEDE may be useful for evaluating diabetic microvascular dysfunction.
The primary therapy chosen for patients with localized prostate cancer between the university hospital and its affiliated hospitals in Nara Uro-oncological research group registration

We investigated the differences between the preferential primary therapy conceived by the primary doctors and the primary therapy actually conducted for prostate cancer patients in Nara, Japan.



The distribution of primary therapy and clinical characteristics of 2303 prostate cancer patients - diagnosed between 2004 and 2006 at Nara Medical University and its 23 affiliated hospitals - were assessed. Moreover, the preferential primary therapy for the patients at each clinical stage (cT1-T3bN0M0) conceived by the primary doctors was investigated and compared to the actual therapy.



Of all patients, 51% received primary androgen deprivation therapy (PADT), 30% underwent radical prostatectomy (RP), and 14% received radiation therapy (RT). The preferential primary therapy for cT1-2N0M0 was RP (92%) while 38% of the patients actually received PADT (RP: 40%). For cT3aN0M0, the preferential primary therapy was both RP and external beam radiation therapy (EBRT) while 58% of the patients actually received PADT (RP: 16%, EBRT: 24%). For cT3bN0M0, the most preferential primary therapy was EBRT (46%) while 67% of the patients actually received PADT (EBRT: 21%). This trend was more notable in the affiliated hospitals than in the University hospital. The hospitals with lower volume of RP per year significantly conducted PADT compared with those with higher volume of RP.



PADT was commonly used to treat localized prostate cancer as well as locally advanced prostate cancer in Japan. There was a definite discrepancy between the preferential primary therapy conceived by the primary doctors and the actual therapy provided to the patients.
PINK1 heterozygous rare variants: prevalence, significance and phenotypic spectrum.

Heterozygous rare variants in the PINK1 gene, as well as in other genes causing autosomal recessive parkinsonism, have been reported both in patients and healthy controls. Their pathogenic significance is uncertain, but they have been suggested to represent risk factors to develop Parkinson disease (PD). The few large studies that assessed the frequency of PINK1 heterozygotes in cases and controls yielded controversial results, and the phenotypic spectrum is largely unknown. We retrospectively analyzed the occurrence of PINK1 heterozygous rare variants in over 1100 sporadic and familial patients of all onset ages and in 400 controls. Twenty patients and 6 controls were heterozygous, with frequencies (1.8% vs. 1.5%) not significantly different in the two groups. Clinical features of heterozygotes were indistinguishable to those of wild-type patients, with mean disease onset 10 years later than in carriers of two mutations but worse disease progression. A meta-analysis indicated that, in PINK1 heterozygotes, the PD risk is only slightly increased with a non significant odds ratio of 1.62. These findings suggest that PINK1 heterozygous rare variants play only a minor susceptibility role in the context of a multifactorial model of PD. Hence, their significance should be kept distinct from that of homozygous/compound heterozygous mutations, that cause parkinsonism inherited in a mendelian fashion.
Long-lasting effect of oral molsydomine on exercise performance: a new antianginal agent.

This study examines whether the beneficial effects of molsydomine, a recently introduced antianginal agent, on exercise performance of patients with angina pectoris are long lasting. The hemodynamic effects are known to persist for several hours. The effects of molsydomine on the duration of exercise and the time to the onset of ST depression were compared to those of placebo during two hours after oral administration. Molsydomine prolonged the duration of exercise in all eight patients (average 2.8 min, P less than 0.001) and delayed the onset of ST depression (average 2.2 min, P less than 0.001), while the placebo failed to alter these measurements. The increment of the duration of exercise produced by 2 mg of molsydomine in two hours following oral administration was comparable to the increment produced in a few minutes after 0.3 mg of nitroglycerin given sublingually. The results indicate that molsydomine offers prophylasis for angina pectoris that lasts at least two hours after oral administration.
Visualization of discrete microinfarction after percutaneous coronary intervention associated with mild creatine kinase-MB elevation.

Mild elevations in creatine kinase-MB (CK-MB) are common after successful percutaneous coronary interventions and are associated with future adverse cardiac events. The mechanism for CK-MB release remains unclear. A new contrast-enhanced MRI technique allows direct visualization of myonecrosis.



Fourteen patients without prior infarction underwent cine and contrast-enhanced MRI after successful coronary stenting; 9 patients had procedure-related CK-MB elevation, and 5 did not (negative controls). The mean age of all patients was 61 years, 36% had diabetes, 43% had multivessel coronary artery disease, and all had a normal ejection fraction. Twelve patients (86%) received an intravenous glycoprotein IIb/IIIa inhibitor; none underwent atherectomy, and all had final TIMI 3 flow. Of the 9 patients with CK-MB elevation, 5 had a minor side branch occlusion during stenting, 2 had transient ECG changes, and none developed Q-waves. The median CK-MB was 21 ng/mL (range, 12 to 93 ng/mL), which is 2.3x the upper limit of normal. Contrast-enhanced MRI demonstrated discrete regions of hyperenhancement within the target vessel perfusion territory in all 9 patients. Only one developed a new wall motion abnormality. The median estimated mass of myonecrosis was 2.0 g (range, 0.7 to 12.2 g), or 1.5% of left ventricular mass (range, 0.4% to 6.0%). Hyperenhancement persisted in 5 of the 6 who underwent a repeat MRI at 3 to 12 months. No control patient had hyperenhancement.



Contrast-enhanced MRI provides an anatomical correlate to biochemical evidence of procedure-related myocardial injury, despite the lack of ECG changes or wall motion abnormalities. Mild elevation of CK-MB after percutaneous coronary intervention is the result of discrete microinfarction.
Concurrent alcohol and tobacco treatment: Effect on daily process measures of alcohol relapse risk.

The aim of this study was to compare the effects of alcohol treatment along with concurrent smoking treatment or delayed smoking treatment on process measures related to alcohol relapse risk.



Alcohol dependent smokers (N = 151) who were enrolled in an intensive outpatient alcohol treatment program and were interested in smoking cessation were randomized to a concurrent smoking cessation (CSC) intervention or to a waiting list for delayed smoking cessation (DSC) intervention scheduled to begin 3 months later. Daily assessments of relapse process measures were obtained using an Interactive Voice Response (IVR) system for 12 weeks after the onset of smoking treatment in the CSC condition, and before beginning smoking treatment in the DSC condition. Smoking outcomes were assessed at 2 and 13 weeks after starting treatment.



Seven-day carbon monoxide (CO) verified smoking abstinence in the CSC condition was 50.5% at 2 weeks and 19.0% at 13 weeks compared with 2.2% abstinence at 2 weeks and 0% abstinence at 13 weeks for those in the DSC condition. Drinking outcomes were not significantly different for CSC versus DSC treatment conditions. On daily IVR assessments, CSC participants had significantly lower positive alcohol outcome expectancies relative to DSC participants.  analyses of within-person effects across the 12 weeks of daily monitoring showed that daily smoking abstinence was significantly associated with same day reports of lower alcohol consumption, lower urge to drink, lower negative affect, lower positive alcohol outcome expectancies, greater alcohol abstinence self-efficacy, greater alcohol abstinence readiness to change, and greater perceived self-control demands.



Analyses of process measures provide support for recommending smoking intervention concurrent with intensive outpatient alcohol treatment.
Folate co-administration improves the effectiveness of fenofibrate to decrease the lipoprotein oxidation and endothelial dysfunction surrogates.

Fibrate therapy results in elevation of plasma total homocysteine (tHcy), which is known to induce oxidative stress and endothelial dysfunction. We aimed to establish whether fibrate-induced elevation of tHcy has also similar consequences and whether they may be prevented by folate co-administration. Eighteen subjects with hypercholesterolemia were included in an open, prospective, cross-over study. We compared intra-individually the effect of fenofibrate on tHcy, oxidative stress and endothelial dysfunction surrogates, in monotherapy and when combined with 10 mg of folate. These effects were also compared with fluvastatin monotherapy. Fenofibrate in monotherapy significantly decreased LDL cholesterol, increased the tHcy by 39.5 %, while oxidized LDL (oxLDL), malondialdehyde (MDA), von Willebrand factors (vWf) and thrombomodulin (TMD) remained unchanged. When fibrate was co-administered with folate, the tHcy remained on the initial post-diet level, while both the total and oxLDL as well as MDA, vWf and TMD decreased. In contrast to fenofibrate monotherapy, fluvastatin (80 mg) had a similar effect as combined therapy with fenofibrate and folate, while tHcy remained uninfluenced. In conclusion, fenofibrate decreases the LDL cholesterol, but in contrast to fluvastatin, has no significant antioxidative and endothelium-protective potential, probably due to a concomitant increase of tHcy. These effects may be improved by co-administration of folate.
Investigating vulnerable atheroma using combined (18)F-FDG PET/CT angiography of carotid plaque with immunohistochemical validation.

Inflammation and angiogenesis are hypothesized to be important factors contributing to plaque vulnerability, whereas calcification is suggested to confer stability. To investigate this in vivo, we combined CT angiography and PET and compared the findings with immunohistochemistry for patients undergoing carotid endarterectomy.



Twenty-one consecutive patients (18 men, 3 women; mean age ± SD, 68.3 ± 7.3) undergoing carotid endarterectomy were recruited for combined carotid (18)F-FDG PET/CT angiography. Plaque (18)F-FDG uptake was quantified with maximum standardized uptake value, and CT angiography quantified percentage plaque composition (calcium and lipid). Surgical specimens underwent ex vivo CT aiding image registration, followed by immunohistochemical staining for CD68 (macrophage density) and vascular endothelial growth factor (angiogenesis). Relationships between imaging and immunohistochemistry were assessed with Spearman rank correlation and multivariable regression.



The mean (±SD) surgically excised carotid plaque (18)F-FDG metabolism was 2.4 (±0.5) versus 2.2 (±0.3) contralaterally (P = 0.027). There were positive correlations between plaque (18)F-FDG metabolism and immunohistochemistry with CD68 (ρ = 0.55; P = 0.011) and vascular endothelial growth factor (ρ = 0.47; P = 0.031). There was an inverse relationship between plaque (18)F-FDG metabolism and plaque percentage calcium composition on CT (ρ = -0.51; P = 0.018) and between calcium composition and immunohistochemistry with CD68 (ρ = -0.57; P = 0.007). Regression showed that maximum standardized uptake value and calcium composition were independently significant predictors of angiogenesis, and calcium composition was a predictor of macrophage density.



We provide in vivo evidence that increased plaque metabolism is associated with increased biomarkers of angiogenesis and inflammation, whereas plaque calcification is inversely related to PET and histologic biomarkers of inflammation.
Interferon and amantadine in naive chronic hepatitis C: a double-blind, randomized, placebo-controlled trial.

Recent controlled trials on the efficacy of an amantadine/interferon combination in treatment-naive patients with chronic hepatitis C yielded contradictory results. We therefore conducted a large, double-blind, placebo-controlled, multicenter trial in naive patients with chronic hepatitis C: 246 patients were randomized to receive interferon alfa-2a (6 MIU sc thrice weekly for 20 weeks, then 3 MIU sc thrice weekly) and either amantadine sulphate (2 x 100 mg p.o. QD) or placebo. Treatment continued for a total of 52 weeks, if HCV-RNA in serum polymerase chain reaction (PCR) had fallen below detection limit (1,000 copies/mL) at treatment week 10, and stopped otherwise. All patients were followed for 24 weeks off therapy. After 10 weeks of treatment, 66/121 patients treated with amantadine (55%) and 78/125 treated with placebo (62%) had lost HCV-RNA (n.s.). After 24 weeks of follow-up, 25 patients in the amantadine (21%) and 17 (14%) in the placebo group remained HCV-RNA negative (n.s.). During therapy, virologic breakthroughs occurred less often in the amantadine than in the placebo group [14 (12%) vs. 27 (22%) patients; P =.04]. Multivariate logistic regression analysis revealed genotype, viremia level, age, and amantadine therapy [risk ratio 0.4 (95%CI 0.2-1.0), P =.05] as predictors of sustained virologic response. Adverse events and impact of therapy on quality of life were similar in amantadine and placebo treated patients. Compared with current standard treatment (interferon/ribavirin), the interferon/amantadine combination was not cost-effective. In conclusion, amantadine does not add to a clinically relevant extent to the treatment of naive patients with chronic hepatitis C.