nils-herrmann/clean_scirepeval huggingface dataset:
Prospective randomized comparison of coronary bypass grafting with minimal extracorporeal circulation system (MECC) versus off-pump coronary surgery.

We aimed to evaluate the clinical results and biocompatibility of the minimal extracorporeal circulation system (MECC) compared with off-pump coronary revascularization (OPCABG).



In a prospective randomized study, 150 patients underwent coronary surgery with the use of MECC and 150 underwent OPCABG. End points were (1) circulating markers of inflammation and organ injury, (2) operative results, and (3) outcome at 1-year follow-up. Operative mortality and morbidity were comparable between the groups. Release of inflammatory markers was similar between groups at all time points (peak interleukin-6 167.2+/-13.5 versus 181+/-6.5 pg/mL, P=0.14, OPCABG versus MECC group, respectively). Peak creatine kinase was 419.3+/-103.5 versus 326+/-84.2 mg/dL (P=0.28), and peak S-100 protein was 0.13+/-0.08 versus 0.29+/-0.1 pg/mL (P=0.058, OPCABG versus MECC group, respectively). Length of hospital stay and use of blood products were similar between groups. Two cases of angina recurrence at 1 year in the MECC group were observed versus 5 cases observed in the OPCABG group (P=0.44). A residual perfusion defect at myocardial nuclear scan was less frequent among patients in the MECC group (3 versus 9 cases, P=0.14; odds ratio 0.32, 95% confidence interval 0.07 to 1.32). Six (OPCABG group) versus 3 (MECC group) coronary grafts were occluded or severely stenotic at 1 year (P=0.33, odds ratio 0.47, 95% confidence interval 0.09 to 2.14).



Clinical results of coronary revascularization with MECC are optimal when this procedure is performed by experienced teams. Postoperative morbidity is comparable to that with OPCABG. MECC is associated with little pump-related systemic and organ injury. It may achieve the benefits of OPCABG (less morbidity in high-risk patients) while facilitating complete revascularization in the case of complex lesions unsuitable for OPCABG.
Quality of life and healthcare resource use associated with angiographic vasospasm after aneurysmal subarachnoid hemorrhage.

In this analysis of data from a large clinical trial in aneurysmal subarachnoid hemorrhage, the impact of angiographic vasospasm (aVSP) on specific patient outcomes and inpatient healthcare resource use was assessed.



This was a post hoc analysis of exploratory end points collected for 409 patients with aneurysmal subarachnoid hemorrhage in the Clazosentan to Overcome Neurological Ischemia and Infarction Occurring After Subarachnoid Hemorrhage (CONSCIOUS-1) trial. Central reviewers graded severity of aVSP as none, mild, moderate, or severe based on comparison of catheter angiograms obtained at baseline and 7 to 11 days after aneurysmal subarachnoid hemorrhage. Assessments of cognitive status (Mini-Mental State Examination) and patient-relevant outcomes (EuroQol total score and visual analog scale and Functional Status Examination) were administered at Week 12. The relationship between severity of aVSP and these end points as well as inpatient healthcare resource use (intensive care, general ward, and total hospital lengths of stay) was assessed using univariate and multivariate analyses.



Cognitive status and all patient-relevant outcome measures varied significantly (P<0.0001) with severity of aVSP (mean for severe aVSP versus no aVSP, respectively: Mini-Mental State Examination, 18.0 versus 27.6; EuroQol total, 0.38 versus 0.74; EuroQol visual analog scale, 50.9 versus 75.5; Functional Status Examination, 20.5 versus 11.7). A significant inverse relationship with severity of aVSP was observed for total hospital days (P=0.008) and days in the intensive care unit (P<0.0001). On average, patients with severe aVSP stayed in the hospital 5 days longer than those with no aVSP.



Severe aVSP is associated with poor cognition, worse patient-relevant outcomes, and greater inpatient healthcare resource use. Future studies assessing new aVSP treatments should include outcome measures that evaluate quality of recovery among survivors.
Effect of increased warfarin use on warfarin-related cerebral hemorrhage: a longitudinal population-based study.

Warfarin use has rapidly increased with the aging of the population. We investigated the temporal trends in the incidence and outcome of warfarin-related intracerebral hemorrhages (ICHs) in a defined population.



We identified all subjects with first-ever primary ICH during 1993 to 2008 among the population of Northern Ostrobothnia, Finland. The number of warfarin users was obtained from the national register of prescribed medicines kept by the Social Insurance Institution of Finland. We calculated the annual incidence of warfarin-related ICHs, 28-day case fatality, and deaths from the primary bleed.



The proportion of warfarin users among the population increased 3.6-fold from 0.68% in 1993 to 2.28% in 2008. Of a total of 982 patients with ICH, 182 (18.5%) had warfarin-related ICH. One-year survival rate after onset of stroke was 35.2% among warfarin users and 67.9% among nonusers. The annual incidence (P=0.062) and 28-day case fatality of warfarin-related ICHs (P=0.002) decreased during the observation period. Warfarin users were older (mean difference 6.6; 95% CI, 5.0 to 8.1; P<0.001) than nonusers. Admission international normalized ratio values above the therapeutic range (2.0 to 3.0) decreased through the observation period, suggesting improved control of anticoagulant therapy over time.



The annual incidence and case fatality of warfarin-related ICHs decreased, although the proportion of warfarin users almost quadrupled in our population.
Trastuzumab beyond progression: overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer.

Continuation of trastuzumab plus capecitabine (XH) showed a significantly improved overall response rate and time to progression compared with capecitabine (X) alone in women with HER2-positive breast cancer progressing during trastuzumab treatment. Here, we report the final analysis on overall survival.



Patients with HER2-positive, advanced breast cancer who progressed during treatment with trastuzumab with or without 1st-line metastatic chemotherapy were prospectively randomised to X (2500mg/m(2) on days 1-14, q3w) or XH (6 (8)mg/kg, q3w). Overall survival was a pre-specified secondary end-point.



Median follow-up at June 2010 was 20.7months. Fifty nine of 74 and 60 of 77 patients died in the X and XH arm, respectively. Median overall survival was 20.6 and 24.9months with X and XH, respectively (HR=0.94 [0.65-1.35]; p=0.73). Performance status and metastatic site were independent prognosticators for overall survival. No difference between treatment arms was observed for patients who achieved clinical response or clinical benefit, respectively. Patients who continued/restarted anti-HER2 treatment (trastuzumab or lapatinib) after 2nd progression (N=52) had a post-progression survival of 18.8 compared with 13.3months for those who did not receive 3rd line treatment with anti-HER2 agents (N=88) (HR 0.63; p=0.02).



Final overall survival analysis of the GBG-26 study did not demonstrate a significant survival benefit for treatment beyond progression with trastuzumab. However, in a post-hoc analysis, patients receiving anti-HER2 treatment as 3rd line therapy showed a better post-progression survival than those not receiving this targeted treatment.
Chemotherapy of intermediate- and high-grade non-Hodgkin's lymphomas with an intensive epirubicin-containing regimen.

An intensive chemotherapy regimen (EVDAC), including high-dose epirubicin, vincristine, and dexamethasone followed by cyclophosphamide and high-dose cytarabine, was administered to 54 untreated adults with intermediate or high-grade non-Hodgkin's lymphomas (NHL). The median age was 59, 61% were Ann Arbor Stage IV, 57% had "B" symptoms, 50% had serum lactate dehydrogenase greater than 250 U/L, and 48% had masses greater than 7 cm (33% > 10 cm) in diameter. Seventy-six percent of patients attained complete or probable complete remissions. The Kaplan-Meier actuarial failure-free survival at 7 years is 50%, and 59% (32 of 54) of all patients started on therapy remain alive and in first remission at a median of 62+ (range, 49+ to 76+) months from completion of therapy. Nearly all patients developed severe neutropenia. Febrile episodes requiring hospitalization during neutropenia occurred after 56% of courses of epirubicin, vincristine, and dexamethasone and after 9% of courses of cyclophosphamide and cytarabine; 80% of patients were hospitalized at least once. Platelet count nadirs of less than 20,000/microL occurred after only 1 of 146 evaluable courses of epirubicin and after none of the cyclophosphamide/cytarabine courses. Although 8 patients had decreases of at least 0.12 in their left ventricular ejection fractions (5 to below normal levels), none have developed clinically evident congestive heart failure. Clinically significant mucositis occurred after only 8% of courses of high-dose epirubicin. Three deaths from infections and one from hyperkalemia with cardiac arrest occurred during therapy. These results confirm that high remission and sustained, failure-free survival rates can be achieved in patients with aggressive NHL, using high-dose anthracycline-containing chemotherapy regimens. Epirubicin appears to have an advantage over doxorubicin at high doses because of decreased toxicity at a therapeutically equivalent dose. These phase II study results need to be validated in a randomized phase III trial, and growth factors should be used to attempt to reduce the neutropenia-associated complications.
Effects of carotid endarterectomy or stenting on blood pressure in the International Carotid Stenting Study (ICSS).

Arterial hypotension is more frequently observed early after carotid artery stenting (CAS) than after carotid endarterectomy (CEA), but their long-term effects on blood pressure (BP) are unclear. We compared the effects of CAS and CEA on BP up to 1 year after treatment in the International Carotid Stenting Study.



Patients with symptomatic carotid stenosis were randomly allocated to CAS or CEA. Systolic and diastolic BP were recorded at baseline, at discharge, and at 1, 6, and 12 months. Antihypertensive medication use was recorded. A per-protocol analysis was performed. Patients with missing BP records were excluded. Between-group BP changes were compared and adjusted for baseline covariates with linear regression. Within-group BP changes were compared with the paired t test.



CAS (N=587) and CEA (N=637) were both associated with a decrease in BP at discharge, which was greater after CAS (mean difference in systolic BP between groups, 10.3 mm Hg; 95% CI, 7.3-13.3; P<0.0001; in diastolic BP, 4.1 mm Hg; 95% CI, 2.4-5.7; P<0.0001). During follow-up, BP changes were not different between groups. Adjustment for differences in baseline characteristics did not change the results. Fewer patients undergoing CAS used antihypertensive medication during follow-up than patients undergoing CEA (relative risk at 12 months, 0.91; 95% CI, 0.85-0.97; P=0.0073).



CAS leads to a larger early decrease in BP than CEA, but this effect does not persist over time. CAS may lessen the requirement for antihypertensive medication more than CEA.  . Unique identifier: ISRCTN25337470.
Ethnicity and neighbourhood deprivation determines the response rate in sexual dysfunction surveys

Self-administered questionnaires provide a better alternative to disclose sensitive information in sexual health research. We describe the factors that determine the positive response (initial recruitment) to an initial invitation and subsequent completion of study to a postal questionnaire on sexual dysfunction. South Asians (SA) and Europids with and without diabetes (DM) were recruited from GP clinics in UK. Men who returned the properly filled consent form (‘recruited-group’) were sent the questionnaire and those who returned it were considered as the ‘completed-group’. Index of Multiple Deprivation Scores (IMDs) were generated using UK postcodes. We calculated the recruitment rate and completion rate of the recruited and the study-completed groups respectively. Total approached sample was 9100 . Recruitment rate was 8.8 % and was higher in Europids and in patients with DM. Mean IMDs for the recruited group was 20.9 ± 11.9, and it was higher among recruited SA compared to Europids (p < 0.001). Mean IMDs was higher in the recruited group compared to non-recruited (p < 0.01). All four recruited groups (SA/Europid and DM/non-DM) had lower IMDs compared to non-recruited. Completion rate was 71.5 % (n 544) (SA: 62.3 %, Europids: 77.4 %; p < 0.05). Recruitment for postal sexual health surveys is positively influenced by presence of investigated disease, older age, being from lesser deprived areas and Europid ethnicity. Furthermore, Europids were more likely to complete survey than South Asians irrespective of disease status.
Positive outlook as a moderator of the effectiveness of an HIV/STI intervention with adolescents in detention.

Justice-involved adolescents engage in high levels of risky sexual behavior, underscoring the need for targeted, effective, prevention interventions geared toward this population. In a randomized controlled trial, 484 detained adolescents received a theory-based intervention or an information-only control. We have previously demonstrated that the theory-based intervention was superior to the control condition in changing theoretical mediators and in producing longitudinal decreases in risky sexual behavior. In the present study, we examined differential response to the intervention based on the adolescents' level of positive outlook (composed of self-esteem, perceived control over the future and optimism toward the future). Changes to putative theoretical mediators (attitudes, perceived norms, self-efficacy and intentions) were measured immediately post-intervention, and behavioral data were obtained 3, 6, 9 and 12 months later. Positive outlook significantly moderated program effects both in the context of the mediational path model and in the context of the longitudinal growth model. Specifically, intervention effects were strongest for those scoring relatively lower on the positive outlook dimension, whereas adolescents high in positive outlook demonstrated greater attitudes and self-efficacy and decreased risky sexual behavior, regardless of condition. Findings are discussed in terms of targeting and tailoring of intervention content.
Tolerability and pharmacokinetics of the nitrone NXY-059 in patients with acute stroke.

Increased free radical formation contributes to the damage caused to the brain by acute ischemia. NXY-059 is a nitrone-based free radical trapping agent in development for acute stroke. NXY-059 has neuroprotective efficacy when given 5 hours after onset of transient focal ischemia in the rat.



This was a randomized, double-blind, placebo-controlled, parallel group, multicenter study that evaluated the safety and tolerability of 2 NXY-059 dosing regimens compared with placebo within 24 hours of acute stroke. NXY-059 was administered as either 250 mg over 1 hour followed by 85 mg/h for 71 hours or 500 mg over 1 hour followed by 170 mg/h for 71 hours; plasma concentrations were monitored. Neurological and functional outcomes were recorded up to 30 days.



One hundred fifty patients were recruited, of whom 147 received study treatments and completed assessments (50 placebo, 48 lower-dose NXY-059, 49 higher-dose NXY-059). Mean (+/-SD) age was 68 (+/-10) years, and baseline National Institutes of Health Stroke Scale score was 7.9 (+/-6.2). Serious adverse events occurred in 16%, 23%, and 16% of patients, respectively, with deaths in 0%, 10%, and 4%, largely following the proportions with primary intracerebral hemorrhage (6%, 16%, and 8%). Hyperglycemia, headache, and fever were common but not related to treatment. The mean unbound steady state NXY-059 plasma concentrations were 25 and 45 micromol/L, respectively. Population pharmacokinetic analysis estimated clearance to be 4.6 L/h.



NXY-059 was well tolerated in patients with an acute stroke. The testing of higher doses in future trials may be justified.
Intravenous thrombolysis guided by a telemedicine consultation system for acute ischaemic stroke patients in China: the protocol of a multicentre historically controlled study

The rate of intravenous thrombolysis with tissue-type plasminogen activator or urokinase for stroke patients is extremely low in China. It has been demonstrated that a telestroke service may help to increase the rate of intravenous thrombolysis and improve stroke care quality in local hospitals. The aim of this study, also called the Acute Stroke Advancing Program, is to evaluate the effectiveness and safety of decision-making concerning intravenous thrombolysis via a telemedicine consultation system for acute ischaemic stroke patients in China.



This is a multicentre historically controlled study with a planned enrolment of 300 participants in each of two groups. The telestroke network consists of one hub hospital and 14 spoke hospitals in underserved regions of China. The usual stroke care quality in the spoke hospitals without guidance from the hub hospital will be used as the historical control. The telemedicine consultation system is an interactive, two-way, wireless, audiovisual system accessed on portable devices. The primary outcome is the percentage of patients treated with intravenous thrombolysis within 4.5 h of stroke onset.


ETHICS AND DISSEMINATION
The project has been approved by the Institutional Review Board of Xijing Hospital. The results will be published in scientific journals and presented to local government and relevant institutes.
Short- and long-term efficacy of high-dose oral diltiazem for angina due to coronary artery disease: a placebo-controlled, randomized, double-blind crossover study.

The effects of oral diltiazem (360 mg/day) on exercise tolerance, left ventricular performance, and plasma lactate and catecholamine levels were studied in 13 patients with atherosclerotic coronary artery disease in a placebo-controlled, randomized, double-blind protocol. Exercise duration to the onset of ischemic ST segment depression, time to angina pectoris, and time to peak exercise improved by 120, 174, and 144 sec, respectively (p less than .0001). Left ventricular ejection fraction, as determined by radionuclide angiography, increased in patients at rest from 52 +/- 11% (mean +/- SD) during placebo therapy to 58 +/- 11% during diltiazem therapy (p less than .001); at peak exercise ejection fraction increased from 44 +/- 11% during placebo treatment to 52 +/- 15% during diltiazem therapy (p less than .01). The mean plasma norepinephrine level in patients at rest increased from 498 +/- 221 pg/ml during placebo treatment to 667 +/- 272 pg/ml during diltiazem therapy (p less than .05). Resting standing blood pressure and supine and standing diastolic blood pressures decreased significantly with diltiazem. In all 10 patients followed over a long term, oral diltiazem caused persistent improvement in exercise performance at 12 to 20 weeks, without evidence of placebo effects. Thus, diltiazem is highly effective in divided doses of 360 mg/day for the therapy of chronic angina pectoris due to coronary artery disease.
Continuous subcutaneous insulin infusion preserves axonal function in type 1 diabetes mellitus.

Diabetic peripheral neuropathy is a common and debilitating complication of diabetes mellitus. Although strict glycaemic control may reduce the risk of developing diabetic peripheral neuropathy, the neurological benefits of different insulin regimens remain relatively unknown.



In the present study, 55 consecutive patients with type 1 diabetes mellitus underwent clinical neurological assessment. Subsequently, 41 non-neuropathic patients, 24 of whom were receiving multiple daily insulin injections (MDII) and 17 receiving continuous subcutaneous insulin infusion (CSII), underwent nerve excitability testing, a technique that assesses axonal ion channel function and membrane potential in human nerves. Treatment groups were matched for glycaemic control, body mass index, disease duration and gender. Neurophysiological parameters were compared between treatment groups and those taken from age and sex-matched normal controls.



Prominent differences in axonal function were noted between MDII-treated and CSII-treated patients. Specifically, MDII patients manifested prominent abnormalities when compared with normal controls in threshold electrotonus (TE) parameters including depolarizing TE(10-20ms), undershoot and hyperpolarizing TE (90-100 ms) (P < 0.05). Additionally, recovery cycle parameters superexcitability and subexcitability were also abnormal (P < 0.05). In contrast, axonal function in CSII-treated patients was within normal limits when compared with age-matched controls. The differences between the groups were noted in cross-sectional analysis and remained at longitudinal follow-up.



Axonal function in type 1 diabetes is maintained within normal limits in patients treated with continuous subcutaneous insulin infusion and not with multiple daily insulin injections. This raises the possibility that CSII therapy may have neuroprotective potential in patients with type 1 diabetes.
Comparison of Intravenous Anisoylated Plasminogen Streptokinase Activator Complex with Intracoronary Streptokinase in Acute Myocardial Infarction

In a randomised trial the efficacy and safety of anisoylated plasminogen streptokinase activator complex (APSAC) administered intravenously and streptokinase administered by intracoronary infusion were compared in patients with proven acute myocardial infarction. Occlusion of the infarct-related vessel, reperfusion and reocclusion were all assessed angiographically. Fibrinolytic therapy was started within 4 (mean 2.4) hours of the onset of symptoms. 85 patients entered the study; 42 were treated with a single intravenous injection of APSAC (30U) given over 3 to 5 minutes and 43 with an intracoronary infusion of streptokinase (250,000U) given over 60 minutes. 12 patients were excluded because of protocol violation. Reperfusion at 90 minutes was confirmed in 23/36 patients (63.9%) in the APSAC group and 25/37 (67.6%) in the streptokinase group; at 24 (± 6) hours reocclusion had occurred in 1/22 (4.5%) and 4/23 (13.0%) patients in each group, respectively. These results indicate that APSAC (30U intravenously) is as effective as intracoronary streptokinase (250,000U). The major advantages of APSAC in acute myocardial infarction are its rapid, convenient administration and its low rate of arterial reocclusion.