nils-herrmann/clean_scirepeval huggingface dataset:
In-hospital case fatality rates for acute myocardial infarction in Romania.

We describe the clinical characteristics, treatments and in-hospital case-fatality rates in an unselected population of patients admitted for acute myocardial infarction.



From January 2000 to June 2007, we tracked consecutive patients who were admitted to 7 tertiary referral and 21 county hospitals in Romania for medical treatment of ST-segment elevation acute myocardial infarction. These patients were enrolled in the Romanian Registry for ST-segment Elevation Myocardial Infarction. For this prospective study, we collected data on demographic characteristics, cardiovascular risk factors, various aspects of treatment for myocardial infarction, and in-hospital death.



The 9186 patients in the study group had a mean age of 63.8 years. The median time from onset of symptoms to thrombolysis was 230 (interquartile range 120-510) minutes. Of the 9186 patients, 4986 (54.3%) had hypertension, 1974 (21.5%) had diabetes mellitus, 3545 (38.6%) had lipid disorders and 4653 (50.7%) were smokers. The in-hospital mortality rate was 12.7% (1170 deaths). The study group consisted of 2893 women and 6293 men. The women were older than the men and had higher rates of hypertension and diabetes mellitus but were less likely to be smokers. A smaller proportion of women than men presented within 2 hours after onset of symptoms (23.1% v. 34.4%, p < 0.001). Smaller proportions of women received thrombolytics (40.8% v. 53.5%, p < 0.001), anticoagulants (93.4% v. 95.2%; p = 0.001), antiplatelet agents (88.3% v. 91.2%, p < 0.001) and primary percutaneous coronary interventions (1.5% v. 2.2%, p = 0.030). The risk of in-hospital death was greater for women, even after adjustment for confounders (odds ratio 1.33, 95% confidence interval 1.13-1.56; p < 0.001).



The rates of reperfusion therapy for patients with acute myocardial infarction were low, and in-hospital case-fatality rates were high in this study. Excess in-hospital mortality was more pronounced among women.
An individualized, adjustable maintenance regimen of budesonide/formoterol provides effective asthma symptom control at a lower overall dose than fixed dosing.

PRINCIPLES
Current asthma management employing inhaled corticosteroids (ICS) and longacting b2-agonists (LABA) aims to rapidly achieve and then maintain overall asthma control including symptoms with minimal medication. This study compared self-guided adjustable maintenance dosing with budesonide/formoterol in a single inhaler with fixed dosing.



In an open-label, parallel-group, multicentre study, 127 asthmatic patients, well controlled on ICS and LABA, were treated with budesonide/formoterol (Symbicort) Turbuhaler) 200/6 mg (equivalent to 160/4.5 mg delivered dose) 2 inhalations bid for 4 weeks, and were then randomised to budesonide/formoterol adjustable dosing (n = 69) (guided self-adjustment of dose: 1 inhalation bid or 2 inhalations at night with interim step ups to 2 inhalations bid and if not sufficient up to 4 inhalations bid for 14 days) or fixed dosing (2 inhalations bid) (n = 58) for 12 weeks.



Patients used adjustable dosing effectively; >50% used a decreased maintenance dose on >50% of the days. Seventy-two percent (50/69) from the adjustable-dosing group reduced their maintenance dose within the first 2 treatment weeks. Thirteen adjustable-dose patients (18.8%) never reduced their dose and 4 (5.8%) stepped up their dose. Symptom severity (NHLBI severity grade) decreased in both groups; however, the decrease was only statistically significant (p = 0.004) in the adjustable-dosing group. Treatment failures occurred in 17% and 24% of patients (adjustable and fixed dosing, respectively p = 0.35). Nocturnal awakenings (0.057 vs. 0.067/night, p = 0.006) and rescue medication use (0.15 vs. 0.23 inhalations/day, p <0.0001) were significantly less frequent with adjustable dosing, and the average daily medication dose was significantly reduced (3.0 vs. 3.9, p <0.0001) compared with fixed dosing. Lung function measurements (FEV1 and PEF) were not significantly different between groups during the study. There were no asthma-related hospital admissions.



Asthma patients on adjustable maintenance dosing with budesonide/ formoterol maintained control of symptoms using significantly less medication overall than fixed dosing. Thus, adjustable maintenance dosing achieved guideline goals of effective asthma control at an appropriately low maintenance dose. However, larger studies on adjustable maintenance dosing are needed.
EEG sedation for children with autism.

Seizures are reported to occur more frequently among children with diagnoses of autism and pervasive developmental disorder (PDD), and some reports indicate a frequency as high as 30%. Sedation is often necessary to perform diagnostic electroencephalograms (EEGs) in these children, who are known to be difficult to sedate with current available pediatric sedating agents, including chloral hydrate. We used clonidine as a sedative agent in children with autism and PDD, and our findings are presented. In a prospective study, 27 children with autism and PDD diagnoses underwent conscious sedation for EEG recording. Informed consents were obtained, and clonidine was administered orally as a sedating agent in a dose ranging from 0.05 mg to 0.2 mg. Subjects were monitored for pulse rate, respiration rate, blood pressure, and oxygen saturation on a continuous basis by a registered nurse. Study parameters included time to induction, time to recovery, changes in vital signs, and technical quality of EEGs. Sedation was achieved in 23 of 27 patients (85%) per our sedation criteria, and this included five patients who had previously failed to be sedated with chloral hydrate. Two patients did not satisfy the sedation criteria but cooperated enough to allow acceptable EEG tracings, increasing the success rate to 93% (25/27). The mean time to achieve sedation was 58 minutes, and the mean time to recovery was 105 minutes. Two patients (0.07%) experienced an asymptomatic heart rate reduction up to 40%, which was not sustained and recovered promptly without any intervention. Two patients (0.07%) experienced systolic blood pressure reductions of 30% and 40%. They remained asymptomatic, had no changes in other cardiorespiratory parameters, and required no intervention. All EEGs were of good technical quality without any "drug effect." Clonidine is a viable alternative for sedation in children with autism and PDD. It is well tolerated without any significant side effects and is efficacious in children with autism and PDD. The advantages of clonidine include ease of administration, shorter duration of total sedation, lack of EEG drug effect, and high overall success rate.
Study of the Atopic March: Development of Atopic Comorbidities.

Atopic dermatitis (AD) is often the first step in the atopic march leading to the development of asthma or allergic rhinitis. The goal of this study was to determine whether early intervention with pimecrolimus limits the atopic march in infants with AD and to evaluate its efficacy and safety.



This was a 3-year double-blind study in which patients were randomized to pimecrolimus or vehicle and then open-label pimecrolimus for a planned further 3 years. Rescue topical corticosteroid was permitted if 3 days of study medication led to no improvement; investigators made decisions on rescue medication until week 14 and caregivers thereafter. Efficacy assessments included disease-free days, Eczema Area and Severity Index, and body surface area affected.



Infants ages 3 to 18 months with recent-onset AD (≤3 months) were observed for a mean of 2.8 years (N = 1,091). No significant differences between pimecrolimus- and placebo-treated groups were found in the percentage of patients with AD who developed asthma (10.7%) or other allergic conditions (allergic rhinitis, 22.4%; food allergy, 15.9%; allergic conjunctivitis, 14.1%; one or more atopic comorbidities, 37.0%) by study end. Allergic rhinitis, food allergy, and having one or more atopic comorbidities (but not asthma or allergic conjunctivitis alone) developed significantly more often in infants with greater AD severity at baseline. Pimecrolimus was significantly more effective than vehicle for AD treatment at week 14. Adverse event incidences were similar.



This longitudinal observation of infants with AD provides evidence of the atopic march. Pimecrolimus was safe and effective in infants with mild to moderate AD.
Electrocardiographic predictors of response to cardiac resynchronization therapy in patients with intraventricular conduction delay.

Little is known about predictors of response to cardiac resynchronization therapy (CRT) in patients with intraventricular conduction delay (IVCD). The purpose of this study was to investigate the benefits of CRT and significant variables on surface electrocardiogram (ECG) to predict response to CRT in those patients.



Among the cohort of 152 CRT patients, 40 patients with IVCD were evaluated. Sixteen patients (40%) were responders. At baseline, responders had a wider QRS duration (158±18 vs. 144±18ms, P=0.02) and a higher frequency of left axis deviation (LADEV; 75% vs. 29%, P=0.004) compared with non-responders. After CRT, greater shortening of QRS duration (ΔQRS; 26±24 vs. 7±24ms, P=0.02), axis shift from LADEV to right axis deviation (RADEV; 69% vs. 13%, P<0.001), and both rightward forces in lead I and anterior forces in V1 (56% vs. 13%, P=0.003) were found more frequently in responders. Multivariable logistic regression analysis showed that LADEV at baseline, or ΔQRS and axis shift from LADEV to RADEV after CRT were independent predictors of response to CRT.



Patients with IVCD may not respond to CRT, but LADEV at baseline and reversal of ventricular activation after CRT on surface ECG could be important to predict response to CRT.
The effect of suit wear during an intensive therapy program in children with cerebral palsy.

To examine the effects of suit wear during an intensive therapy program on motor function among children with cerebral palsy.



Twenty children were randomized to an experimental (TheraSuit) or a control (control suit) group and participated in an intensive therapy program. The Pediatric Evaluation of Disability Inventory (PEDI) and Gross Motor Function Measure (GMFM)-66 were administered before and after (4 and 9 weeks). Parent satisfaction was also assessed.



No significant differences were found between groups. Significant within-group differences were found for the control group on the GMFM-66 and for the experimental group on the GMFM-66, PEDI Functional Skills Self-care, PEDI Caregiver Assistance Self-care, and PEDI Functional Skills Mobility. No adverse events were reported.



Children wearing the TheraSuit during an intensive therapy program did not demonstrate improved motor function compared with those wearing a control suit during the same program.
Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial.

Cognitive behaviour therapy (CBT) has been shown to be an effective treatment for anxiety disorders in children, but few affected seek or receive treatment. Internet-delivered CBT (ICBT) could be a way to increase the availability of empirically supported treatments.



A randomised controlled trial was conducted to evaluate ICBT for children with anxiety disorders.



Families (N = 93) with a child aged 8-12 years with a principal diagnosis of generalised anxiety disorder, panic disorder, separation anxiety, social phobia or specific phobia were recruited through media advertisement. Participants were randomised to 10 weeks of ICBT with therapist support, or to a waitlist control condition. The primary outcome measure was the Clinician Severity Rating (CSR) and secondary measures included child- and parent-reported anxiety. Assessments were made at pre-treatment, post-treatment and at three-month follow-up.



At post-treatment, there were significant reductions on CSR in the treatment group, with a large between-group effect size (Cohen's d = 1.66). Twenty per cent of children in the treatment group no longer met criteria for their principal diagnosis at post-treatment and at follow-up this number had increased to 50%. Parent-reported child anxiety was significantly lower in the treatment group than in the waitlist group at post-treatment, with a small between-group effect size (Cohen's d = 0.45). There were no significant differences between the groups regarding child-ratings of anxiety at post-treatment. Improvements were maintained at three-month follow-up, although this should be interpreted cautiously due to missing data.



Within the limitations of this study, results suggest that ICBT with therapist support for children with anxiety disorders can reduce clinician- and parent-rated anxiety symptoms.
Assessing inattention and impulsivity in children during the Go/NoGo task.

Behavioural performance in the Go/NoGo task was compared with caregiver and teacher reports of inattention and hyperactivity-impulsivity in 1,151 children (N = 557 boys; N = 594 girls) age 9- 10-years-old. Errors of commission (NoGo errors) were significantly correlated with symptom counts of hyperactivity-impulsivity, while errors of omission (Go errors) were significantly correlated with symptom counts for inattention in both caregiver and teacher reports. Cross-correlations were also evident, however, such that errors of commission were related to inattention symptoms, and errors of omission were related to hyperactivity-impulsivity. Moreover, hyperactivity-impulsivity and inattention symptoms were highly intercorrelated in both caregiver (r = .52) and teacher reports (r = .70), while errors of commission and omission were virtually uncorrelated in the Go/NoGo task (r = .06). The results highlight the difficulty in disentangling hyperactivity-impulsivity and inattention in questionnaires, and suggest that these constructs may be more clearly distinguished in laboratory measures such as the Go/NoGo task.
Effect of naloxone on maximal exercise performance and control of ventilation in COPD.

Elevated endorphin levels in patients with COPD may act to diminish the sensation of dyspnea. Exogenous opioids decrease exertional dyspnea and increase exercise capacity in COPD patients. The purpose of this study was to determine the effects of endogenous opioids on the exercise capacity and control of breathing in patients with COPD. We hypothesized that naloxone, an opioid antagonist, would block the endogenous endorphins and decrease the exercise capacity of our patients. Six patients (mean age, 58.8 +/- 3.2 years) with COPD (mean FEV1, 1.28 +/- 0.46 L) underwent identical incremental cycle ergometer tests to exhaustion (Emax) and assessment of their hypercapnic and hypoxic ventilatory responses and mouth occlusion pressure responses following the IV administration of naloxone (0.4 mg/kg) (N) or placebo (P) in a randomized, double-blind fashion. Perceived dyspnea (modified Borg scale), breathing patterns, and expired gas levels were compared at rest and at maximal workload (WL). There was no significant difference after N compared with after P in the WL or the duration of work. At Emax there were no significant differences after N compared with after P in ventilation, the level of dyspnea, P0.1, VO2, or VCO2. The ventilatory response to CO2 production during exercise (delta VE/delta VCO2) and the ventilatory and mouth occlusion pressure responses to hypoxia and hypercapnia did not differ significantly after N compared with after P. This study does not support the hypothesis that endogenous opioids play a significant role in dampening dyspnea and facilitating exercise in patients with COPD.
24-Month Data from the BRAVISSIMO: A Large-Scale Prospective Registry on Iliac Stenting for TASC A & B and TASC C & D Lesions.

To evaluate the 24-month outcome of stenting in Trans-Atlantic Inter-Society Consensus (TASC) A & B and TASC C & D iliac lesions in a controlled setting.



The BRAVISSIMO study is a prospective, nonrandomized, multicenter, multinational, monitored registry including 325 patients with aortoiliac lesions. The end point is the primary patency at 24 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio >2.0). A separate analysis for TASC A & B versus TASC C & D population is performed.



Between July 2009 and September 2010, 190 patients with TASC A or B and 135 patients with TASC C or D aortoiliac lesions were included. The demographic data were comparable for TASC A & B cohort and TASC C & D cohort. Technical success was 100%. Significantly more balloon-expandable stents were deployed in TASC A & B lesions, and considerably more self-expanding stents were placed in TASC C & D (P = 0.01). The 24-month primary patency rate after 24 months for the total population was 87.9% (88.0% for TASC A, 88.5% for TASC B, 91.9% for TASC C, and 84.8% for TASC D). No statistically significant difference was shown when comparing these groups. The 24-month primary patency rates were 92.1% for patients treated with the self-expanding stent, 85.2% for patients treated with the balloon-expandable stent, and 75.3% for patients treated with a combination of both stents (P = 0.06). Univariate and multivariable regression analyses using Cox proportional hazards model identified only kissing stent configuration (P = 0.0012) and obesity (P = 0.0109) as independent predictors of restenosis (primary patency failure). Interestingly, as all TASC groups enjoyed high levels of patency, neither TASC category nor lesion length was predictive of restenosis.



The 24-month data from this large, prospective, multicenter study confirm that endovascular therapy may be considered the preferred first-line treatment option of iliac lesions, irrespectively of TASC lesion category.
Preliminary data suggesting the efficacy of attention training for school-aged children with ADHD

A pilot randomized clinical trial was conducted to examine the initial efficacy of Pay Attention!, an intervention training sustained, selective, alternating, and divided attention, in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). After a diagnostic and baseline evaluation, school-aged children with ADHD were randomized to receive 16 bi-weekly sessions of Pay Attention! (n=54) or to a waitlist control group (n=51). Participants completed an outcome evaluation approximately 12 weeks after their baseline evaluation. Results showed significant treatment effects for parent and clinician ratings of ADHD symptoms, child self-report of ability to focus, and parent ratings of executive functioning. Child performance on neuropsychological tests showed significant treatment-related improvement on strategic planning efficiency, but no treatment effects were observed on other neuropsychological outcomes. Treatment effects were also not observed for teacher ratings of ADHD. These data add to a growing body of literature supporting effects of cognitive training on attention and behavior, however, additional research is warranted.
The effects of a commercially available weight loss program among obese patients with type 2 diabetes: a randomized study.

The purpose of this study was to assess the effects of a commercially available weight loss program on weight and glycemic control among obese patients with type 2 diabetes. Participants included 69 patients (49 females, 20 males) with type 2 diabetes who had a mean +/- SD age of 52.2 +/- 9.5 years, a body mass index of 39.0 +/- 6.2 kg/m(2), and hemoglobin A1c (HbA1c) of 7.5 +/- 1.6%. Over half (52.2%) of the participants were African American. Participants were randomly assigned to: 1) a portion-controlled diet (NutriSystem D) (PCD) or 2) a diabetes support and education (DSE) program. After the initial 3 months, the PCD group continued on the PCD for the remaining 3 months, and the DSE group crossed over to PCD for the remaining 3 months. The primary comparison for this study was at 3 months. At 3 months, the PCD group lost significantly more weight (7.1 +/- 4%) than the DSE group (0.4 +/- 2.3%) (P < 0.0001). From 3 to 6 months the change in weight for both groups was statistically significant. After 3 months, the PCD group had greater reductions in HbA1c than the DSE group (-0.88 +/- 1.1 vs 0.03 +/- 1.09; P < 0.001). From 3 to 6 months the PCD group had no further change in HbA1c, while the DSE group showed a significant reduction. These data suggest that obese patients with type 2 diabetes will experience significant improvements in weight, glycemic control, and cardiovascular disease risk factors after the use of a commercially available weight management program.
Varenicline for treatment of alcohol dependence: a randomized, placebo-controlled trial.

Alcohol dependence is a devastating illness affecting a large population, and new pharmacological treatments with good efficacy are greatly needed. One potential candidate is varenicline, a smoking cessation agent with partial agonist action at α4 β2 nicotinic acetylcholine receptors.



A total of 160 subjects, 30 to 70 years of age, fulfilling DSM-IV criteria for alcohol dependence without any serious physical or mental disorders, were recruited through advertisement at 3 university clinics in Sweden during March 2009 to January 2011. After a 2-week placebo run-in period, subjects received 2 mg varenicline daily (titrated from 0.5 mg during first week) or placebo for 12 weeks in a double-blind manner.



The primary outcome was the proportion of heavy drinking days, measured by self-reported alcohol consumption. Primary and secondary outcomes were calculated as a mean over the 10-week steady-state active treatment period. In the primary outcome analysis, no effect of varenicline over placebo was found (p = 0.73 for the intention to treat [ITT] and 0.92 for per protocol [PP]). Secondary outcome analysis found a significant reduction of specific alcohol marker phosphatidylethanol (PEth) in the blood in the varenicline group compared to placebo (p = 0.02 ITT). Craving (p = 0.048 PP) and Alcohol Use Disorders Identification Test (AUDIT) scores (p = 0.015 ITT) were also reduced in the active treatment group. PEth more strongly correlated with self-reported alcohol consumption than carbohydrate-deficient ttransferrin and γ-glutamyl transferase, and correlation coefficients were higher in the varenicline group than in the placebo group for all markers.



Although the results of the main outcome of this study did not support an effect of varenicline in alcohol-dependent individuals, the secondary analyses of PEth, craving and AUDIT score support an effect of varenicline on alcohol consumption. The disclosure of a treatment effect and the lack of a clear placebo effect when using PEth as outcome variable, together with a nonsymmetric bias associated with self-reported data, strongly argue for using the specific biomarker PEth in studies of treatments of alcohol dependence.