nils-herrmann/clean_scirepeval huggingface dataset:
New Q waves on the presenting electrocardiogram independently predict increased cardiac mortality following a first ST-elevation myocardial infarction.

The prognostic significance of pathological Q waves appearing in the acute phase of myocardial infarction has not been determined. We investigated whether new Q waves on the presenting electrocardiogram of patients with acute ST-segment elevation were independently associated with a worse outcome after a first myocardial infarction.



The presence or absence of new Q waves on the presenting electrocardiogram was assessed in 481 patients who presented within 4 h of symptom onset and were randomized to receive either captopril or placebo within 2 h of streptokinase therapy for myocardial infarction. Ventriculography was performed at 22+/-6 days and mortality status was obtained at a median follow-up of 5.6 years. New Q waves were associated with a lower ejection fraction (51+/-13% vs 61+/-12%, P<0.0001), a larger end-systolic volume index (37 ml vs 28 ml, P<0.001), and increased cardiac mortality at 30 days (7% vs 2%, P=0.01) and at follow-up (17% vs 7%, P=0.002). On multivariate analysis, age (P<0.01), new Q waves at presentation (P<0.01) and a history of angina (P=0.046) were independent predictors of cardiac mortality, whereas randomization to captopril and the time from symptom onset to streptokinase administration were not.



New Q waves at presentation are independently associated with a worse outcome after a first myocardial infarction. The presence of new Q waves on the presenting electrocardiogram allows very early identification of patients at risk of increased cardiac mortality.
Statistical Validation of a Web-Based GIS Application and Its Applicability to Cardiovascular-Related Studies

There is abundant evidence that neighborhood characteristics are significantly linked to the health of the inhabitants of a given space within a given time frame. This study is to statistically validate a web-based GIS application designed to support cardiovascular-related research developed by the NIH funded Research Centers in Minority Institutions (RCMI) Translational Research Network (RTRN) Data Coordinating Center (DCC) and discuss its applicability to cardiovascular studies.



Geo-referencing, geocoding and geospatial analyses were conducted for 500 randomly selected home addresses in a U.S. southeastern Metropolitan area. The correlation coefficient, factor analysis and Cronbach's alpha (α) were estimated to quantify measures of the internal consistency, reliability and construct/criterion/discriminant validity of the cardiovascular-related geospatial variables (walk score, number of hospitals, fast food restaurants, parks and sidewalks).



Cronbach's α for CVD GEOSPATIAL variables was 95.5%, implying successful internal consistency. Walk scores were significantly correlated with number of hospitals (r = 0.715; p < 0.0001), fast food restaurants (r = 0.729; p < 0.0001), parks (r = 0.773; p < 0.0001) and sidewalks (r = 0.648; p < 0.0001) within a mile from homes. It was also significantly associated with diversity index (r = 0.138, p = 0.0023), median household incomes (r = -0.181; p < 0.0001), and owner occupied rates (r = -0.440; p < 0.0001). However, its non-significant correlation was found with median age, vulnerability, unemployment rate, labor force, and population growth rate.



Our data demonstrates that geospatial data generated by the web-based application were internally consistent and demonstrated satisfactory validity. Therefore, the GIS application may be useful to apply to cardiovascular-related studies aimed to investigate potential impact of geospatial factors on diseases and/or the long-term effect of clinical trials.
A shared decision-making communication training program for physicians treating fibromyalgia patients: effects of a randomized controlled trial.

Fibromyalgia syndrome (FMS) is a condition of chronic widespread pain that is difficult to control and is associated with strains in physician-patient interaction. Shared decision making (SDM) can be a potential solution to improve interaction. We evaluated the effects of an SDM intervention, including an SDM communication training program for physicians, in a randomized controlled trial with FMS patients. The main objective was to assess whether SDM improves the quality of physician-patient interaction from patients' perspective.



Patients were randomized to either an SDM group or an information-only group. The SDM group was treated by physicians trained in SDM communication and had access to a computer-based information package; the information-only group received only the information package and was treated by standard physicians. All patients were offered the same evidence-based treatment options for FMS. Patients were assessed with questionnaires on physician-patient interaction (main outcome criteria) and decisional processes. Physicians filled out a questionnaire on interaction difficulties. Assessment took place immediately after the initial consultation.



Data from 85 FMS patients (44 in the SDM group and 41 in the information-only group) were analyzed. The mean age was 49.9 years (S.D.=10.2), and 91.8% of patients were female. The quality of physician-patient interaction was significantly higher in the SDM group than in the information-only group (P<.001). We found no differences in secondary outcome measures.



SDM with FMS patients might be a possible means to achieve a positive quality of physician-patient interaction. A specific SDM communication training program teaches physicians to perform SDM and reduces frustration in patients.
Intravenous administration of enprofylline to asthmatic patients

In 6 asthmatic patients, the possibility of obtaining a steady state plasma level of 5 mg/l of enprofylline by administration of two constant rate infusions was examined. The simulated plasma concentration curves, based on information from pressessment of individual pharmacokinetic parameters, were in good agreement with the plasma levels obtained. The side-effects and bronchodilatation produced by enprofylline were compared to those obtained with theophylline at a steady state level of 15 mg/l. Enprofylline and theophylline caused a mean maximal increase in FEV1.0 of 14% and 2.6% per mg/l in plasma, respectively. Side-effects, head-ache, nausea and vomiting, became pronounced in 2 patients in whom the plasma enprofylline level was about 6 mg/l. No other serious adverse reaction was seen. It is suggested that enprofylline should be further evaluated as a possible anti-asthmatic drug.
When symptoms persist: choosing among alternative somatic treatments for schizophrenia.

Many patients with schizophrenia continue to have significant disabling symptoms despite adequate trials of different types and doses of traditional neuroleptics. Clinicians treating these neuroleptic-resistant patients must look to other treatments in the hope of providing some relief. The literature on many of the alternative treatments is too scanty for firm conclusions. We offer criteria for deciding which treatments may warrant consideration. We review the evidence for the eight treatments we found to meet these criteria and discuss clinical points salient to their use in this population. Although not always conclusive, the data do offer clues for treatment guidelines and an approach to choosing among the available treatments is suggested.
Cost-effectiveness of lapatinib plus capecitabine in women with HER2+ metastatic breast cancer who have received prior therapy with trastuzumab

In a phase III trial of women with HER2+ metastatic breast cancer (MBC) previously treated with trastuzumab, an anthracycline, and taxanes (EGF100151), lapatinib plus capecitabine (L + C) improved time to progression (TTP) versus capecitabine monotherapy (C-only). In a trial including HER2+ MBC patients who had received at least one prior course of trastuzumab and no more than one prior course of palliative chemotherapy (GBG 26/BIG 03-05), continued trastuzumab plus capecitabine (T + C) also improved TTP. An economic model using patient-level data from EGF100151 and published results of GBG 26/BIG 03-05 as well as other literature were used to evaluate the incremental cost per quality-adjusted life-year [QALY] gained with L + C versus C-only and versus T + C in women with HER2+ MBC previously treated with trastuzumab from the UK National Health Service (NHS) perspective. Expected costs were £28,816 with L + C, £13,985 with C-only and £28,924 with T + C. Corresponding QALYs were 0.927, 0.737 and 0.896. In the base case, L + C was estimated to provide more QALYs at a lower cost compared with T + C; cost per QALY gained was £77,993 with L + C versus C-only. In pairwise probabilistic sensitivity analyses, the probability that L + C is preferred to C-only was 0.03 given a threshold of £30,000. The probability that L + C is preferred to T + C was 0.54 regardless of the threshold. When compared against capecitabine alone, the addition of lapatinib has a cost-effectiveness ratio exceeding the threshold normally used by NICE. Compared with T + C, L + C is dominant in the base case and approximately equally likely to be cost-effective in probabilistic sensitivity analyses over a wide range of threshold values.
The effect of bucindolol on the airway function of asthmatics

The airway and cardiovascular effects of separate single oral doses of 50, 100 and 200 mg of bucindolol were compared to those of placebo in a double-blind trial in 16 patients with mild to moderately severe asthma. Heart rate (HR), blood pressure (BP), forced vital capacity (FVC), forced expired volume in one second (FEV1), maximum expiratory flow at 50% of vital capacity (FEF50) and maximum expiratory flow at 75% of expired vital capacity (FEF75) were measured before and at intervals for 4 h, when salbutamol (200 µg) was inhaled and the measurements repeated 15 min later. There was an interval of at least 4 days between each drug treatment day. Four of the 16 patients developed clinically significant bronchoconstriction with 50 mg (3) or 100 mg (1) of bucindolol and were withdrawn from the study. The remaining patients showed impaired bronchodilator response to salbutamol for each bucindolol dose as compared to placebo. No significant BP or HR effects were measured. Two patients withdrew because of circumstances unrelated to bucindolol induced bronchoconstriction. The development of bucindolol induced bronchoconstriction in this group of mild to moderate asthmatics was not predicted by the level of baseline pulmonary function, or the level of histamine responsiveness. However, there was a weak relationship between bucindolol induced bronchoconstriction and salbutamol induced bronchodilation. There was no definitive asthmatic characteristic to predict the likelihood of significant bucindolol induced bronchoconstriction in this asthmatic population.
Systemic and bronchodilator effects of inhaled rac-formoterol in subjects with chronic obstructive pulmonary disease: a dose-response study.

THIS SUBJECT
The long-acting inhaled beta(2)-agonist formoterol has systemic effects when taken in high doses. It can be used as relief medication in asthma and there is interest in this approach in chronic obstructive pulmonary disease (COPD). Relief medication can involve high doses, and in subjects with COPD who have limited ability to bronchodilate the adverse effects can outweigh the benefits. There are concerns with the overall safety of high-dose beta(2)-agonists in subjects with COPD, and this study looks at the balance of beneficial and adverse effects of a range of doses of inhaled formoterol.


 THIS STUDY ADDS
Among subjects with COPD, high-dose inhaled formoterol produced a dose-related increase in forced expiratory volume in 1 s without a corresponding reduction in dyspnoea or increase in walk distance. Systemic effects were modest, however, and high doses did not appear to reduce patient satisfaction. Although further safety data are needed, inhaled formoterol may have a role as relief medication in COPD.  Rac-formoterol is effective as maintenance treatment for both asthma and chronic obstructive pulmonary disease (COPD) and is now used as relief therapy in asthma. Using rac-formoterol for relief and maintenance treatment could involve inhalation of high doses, and whether this is of benefit in COPD is uncertain. Our aim was to determine whether higher doses of inhaled rac-formoterol produce systemic adverse effects that outweigh the limited bronchodilator benefit seen in subjects with COPD.



We examined airway and systemic effects of 6, 12, 24 and 48 microg rac-formoterol and placebo on separate days in 20 subjects with symptomatic COPD [forced expiratory volume in 1 s (FEV(1)) 47% predicted]. FEV(1), oxygen saturation, dyspnoea, 6-min walk distance, patient satisfaction and systemic effects were measured and treatment was assessed against placebo and for dose-response effects.



FEV(1)[area under the time-response curve (AUC)] and satisfaction scores increased with all formoterol doses compared with placebo, as did AUC tremor with the 24- and 48-microg doses and AUC heart rate with the 48-microg dose. A dose-response relationship was seen with FEV(1) and tremor, but not with satisfaction scores. There was no difference between placebo and rac-formoterol for other variables.



Our results show that in patients with COPD rac-formoterol improves FEV(1) and patient satisfaction without a corresponding reduction in dyspnoea. Since the systemic effects from a relatively high dose were minimal, its use as relief medication in COPD merits further evaluation.
Safety of immunotherapy in patients with rhinitis, asthma or atopic dermatitis using an ultra-rush buildup. A retrospective study.

Allergen-specific immunotherapy is a proven, highly effective treatment for IgE-mediated diseases. However, ultra-rush immunotherapy is prescribed infrequently because of the perception that accelerated immunotherapy buildup leads to a higher rate of systemic reactions.



To evaluate the frequency of adverse reactions in patients with IgE-mediated diseases receiving house dust mite (HDM) ultra-rush immunotherapy.



A retrospective, observational study was conducted for patients with IgE-mediated diseases receiving allergen-specific immunotherapy. Subcutaneous immunotherapy with depigmented polymerized mites extract was administered in two refracted doses of 0.2 and 0.3 ml at first injection, and in single 0.5 ml doses in subsequent monthly injections. A 30 min observation time was required after each injection. Systemic reactions were graded using the World Allergy Organisation grading system.



575 patients were included. The age range was 1-83 years. Most patients had respiratory diseases (544) and 101 patients had atopic dermatitis. A total of 27 patients (4.6%) experienced 139 reactions (reactions/injections: 1.9%); 22 patients (3.8%) experienced 134 local reactions (local reactions/injections: 1.8%). Eight patients (1.3%) experienced eight systemic reactions (systemic reactions/injections: 0.1%). Five systemic reactions were grade 2 and three grade 1. Two systemic reactions were reported during buildup. There were no fatalities.



Taking into account the possible bias for the retrospective design of this study we observed that immunotherapy for patients with IgE-mediated diseases using a depigmented polymerized mites extract, with an ultra-rush buildup, has similar frequency of systemic reactions than that seen in slower buildup immunotherapy in other studies. Accelerated buildup could improve patients' adherence and reduce dropout rates.
100% Adherence Study: Educational Workshops vs. Video Sessions to Improve Adherence Among ART-Naïve Patients in Salvador, Brazil

We conducted a randomized trial to test an intervention aimed at increasing adherence to antiretroviral therapy (ART) among HIV-positive, ART-naïve patients in Salvador, Brazil. Participants (N = 107) were randomized to either educational workshops based on the information-motivation-behavioral skills model (n = 52) or a control video session (n = 55). Changes in self-reported ART adherence, viral load, CD4 cell counts and ART pharmacy records were measured periodically over 12 months. After 3–6 months, ART adherence (≥95%) was 77.8% in the workshop group and 85.7% in video group (as treated) and 53.8% and 65.5%, respectively, using intention-to-treat (ITT) analysis (both P > 0.05) At 9–12 months, ART adherence decreased to 73.7% in the workshop group and 79.1% in the video group (as treated) and 53.8% and 61.8% using ITT, respectively. No differences were found in self-reported adherence, viral load or pharmacy records between groups. We found that the educational workshop intervention does not increase adherence to ART.
Effect of Rivastigmine Augmentation in Treatment of Male Patients With Combat-Related Chronic Posttraumatic Stress Disorder: A Randomized Controlled Trial.

Posttraumatic stress disorder (PTSD) is one of the chronic and disabling psychiatric disorders, particularly in combat veterans. In a case series, rivastigmine was suggested to be an effective augmentation in treatment of PTSD. The aim of the present study was to evaluate this finding in a randomized controlled trial.



A 12-week, double-blind, placebo-controlled clinical trial was performed on 36 male patients (aged 42-60 years) diagnosed with chronic, combat-related PTSD. Subjects were screened for apparent cognitive deficits by means of Mini-Mental State Examination. All patients received selective serotonin reuptake inhibitors plus sodium valproate for 4 weeks and then reevaluated. Subjects who did not show adequate response were randomly assigned into 3 groups receiving rivastigmine (up to 6 mg/d), placebo, or the prior treatment regimen. Efficacy of medication was measured by administering PTSD Check List-Military Version at baseline and weeks 2, 4, 8, and 12. Collected data were analyzed by analysis of variance and repeated measurement. Reported differences were considered significant at the level of 0.05 or less.



The 3 groups showed statistically significant reductions in the total PTSD Check List-Military Version, avoidance subscale, and the reexperience subscale but not in the hyperarousal subscale. No significant differences were found between the 3 groups.



In contrast to the previous case series, findings of the current study did not support the efficacy of adjunctive rivastigmine in treatment of PTSD. This hypothetically could be due to the fact that all the study's subjects scored higher than 25 on Mini-Mental State Examination.
A randomised controlled trial of a probiotic ‘functional food’ in the management of irritable bowel syndrome

Irritable Bowel Syndrome (IBS) is a common condition characterised by pain, distension and altered bowel habit. Evidence suggests functional foods containing probiotics improve gastrointestinal transit, however, data are limited by short follow-up periods and evaluation in selected populations.



A multi-centre, randomized, double blind, controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element (IBS-Constipation or IBS-Mixed profile). Set in 13 general practices within central England. Individuals meeting the ROME III criteria for IBS, aged 18-65 completed a pre-study diary. Eligible individuals were randomized to consume dairy 'yoghurt' products which either did or did not contain active probiotics twice daily and to complete a daily diary. Primary outcome was subjective global assessment of symptom relief at week 4. Other outcomes comprised, IBS symptom scores, pain, bloating and flatulence levels, stool frequency, stool consistency, ease of bowel movement and quality of life.



179 were randomized (91 active, 88 placebo). 76 (43 active, 33 placebo) completed the study. No significant between group differences existed at 4 weeks (57% active vs 53% placebo, reported adequate relief (p = 0.71)). By week 8, 46% active vs 68% placebo reported adequate relief (p = 0.03). This was sustained at week 12.



Significant improvements were reported for most outcomes in all trial participants but improvement did not differ by group. This trial does not provide evidence for effectiveness of a probiotic in IBS, in variance with a body of published literature and review conclusions. Differential drop out may however cloud interpretation of data.
Sarilumab plus methotrexate suppresses circulating biomarkers of bone resorption and synovial damage in patients with rheumatoid arthritis and inadequate response to methotrexate: a biomarker study of MOBILITY

Interleukin 6 (IL-6) signaling plays a key role in the pathophysiology of rheumatoid arthritis (RA) and is inhibited by sarilumab, a human monoclonal antibody blocking the IL-6 receptor alpha (IL-6Rα). The effects of sarilumab plus methotrexate (MTX) on serum biomarkers of joint damage and bone resorption were assessed in two independent studies (phase II (part A) and phase III (part B)) of patients with RA with a history of inadequate response to MTX from the MOBILITY study (NCT01061736).



Serum samples were analyzed at baseline and prespecified posttreatment time points. Biomarkers of tissue destruction, cartilage degradation, and synovial inflammation were measured in part A; assessment of these markers was repeated in part B and included additional analysis of biomarkers of bone formation and resorption (including soluble receptor activator of nuclear factor-kB ligand (sRANKL)). A mixed model for repeated measures was used to compare treatment effects on change in biomarkers. Additionally, changes from baseline in biomarkers were compared between American College of Rheumatology 50 % responders and nonresponders and between patients who achieved or did not achieve low disease activity (LDA), separately by treatment group, at week 24.



In part A, sarilumab 150 and 200 mg every 2 weeks (q2w) significantly reduced biomarkers of tissue destruction, cartilage degradation, and synovial inflammation at both 2 and 12 weeks posttreatment (p < 0.05 vs placebo). These results were replicated in part B, with markers of these damaging processes reduced at weeks 2 and 24 (p < 0.05 vs placebo). Additionally, sarilumab 200 mg q2w significantly reduced both sRANKL and sRANKL/osteoprotegerin ratio at week 24 (p < 0.01 vs placebo). Trends for reduction were noted for several biomarkers in patients who achieved LDA compared with those who did not.



Sarilumab plus MTX significantly suppressed biomarkers of bone resorption and joint damage, as compared with placebo plus MTX, in patients with RA. Additional work is needed to determine whether differences in biomarker profiles at baseline or posttreatment can identify patients who achieve improvement in disease activity.