nils-herrmann/clean_scirepeval huggingface dataset:
Asthma at 8 years of age in children born by caesarean section.

Caesarean section might be a risk factor for asthma because of delayed microbial colonisation, but the association remains controversial. A study was undertaken to investigate prospectively whether children born by caesarean section are more at risk of having asthma in childhood and sensitisation at the age of 8 years, taking into account the allergic status of the parents.



2917 children who participated in a birth cohort study were followed for 8 years. The definition of asthma included wheeze, dyspnoea and prescription of inhaled steroids. In a subgroup (n = 1454), serum IgE antibodies for inhalant and food allergens were measured at 8 years.



In the total study population, 12.4% (n = 362) of the children had asthma at the age of 8 years. Caesarean section, with a total prevalence of 8.5%, was associated with an increased risk of asthma (OR 1.79; 95% CI 1.27 to 2.51). This association was stronger among predisposed children (with two allergic parents: OR 2.91; 95% CI 1.20 to 7.05; with only one: OR 1.86; 95% CI 1.12 to 3.09) than in children with non-allergic parents (OR 1.36; 95% CI 0.77 to 2.42). The association between caesarean section and sensitisation at the age of 8 years was significant only in children of non-allergic parents (OR 2.14; 95% CI 1.16 to 3.98).



Children born by caesarean section have a higher risk of asthma than those born by vaginal delivery, particularly children of allergic parents. Caesarean section increases the risk for sensitisation to common allergens in children with non-allergic parents only.
5-Fluorouracil as adjuvant chemotherapy for large bowel cancer is it appropriate for routine community use?

At this time, adjuvant chemotherapy cannot be recommended as routine treatment for curative-resection large-bowel cancer with a high potential for metastatic relapse. 5-FU has been extensively evaluated and has made no significant impact on survival. No properly designed prospectively randomized trial of 5-FU adjuvant treatment has shown statistically significant benefit. The possibility that combination chemotherapy will prove beneficial remains. Several major protocols are on-going and remain to be analyzed. Since these combinations are potentially toxic, they should not be used prematurely by the practicing oncologist.
Activation of Neck and Low-Back Muscles Is Reduced with the Use of a Neck Balance System Together with a Lumbar Support in Urban Drivers

Driving is associated with high activation of low-back and neck muscles due to the sitting position and perturbations imposed by the vehicle. The aim of this study was to investigate the use of a neck balance system together with a lumbar support on the activation of low-back and neck muscles during driving. Twelve healthy male subjects (age 32±6.71 years) were asked to drive in two conditions: 1) with devices; 2) without devices. During vehicle accelerations and decelerations root mean square (RMS) of surface electromyography (sEMG) was recorded from the erector spinae, semispinalis capitis and sternocleidomastoid muscles and expressed as a percentage of maximal voluntary contraction (MVC). The pitch of the head was obtained by means of an inertial sensor placed on the subjects' head. A visual analog scale (VAS) was used to assess the level of perceived comfort. RMS of the low back muscles was lower with than without devices during both acceleration and deceleration of the vehicle (1.40±0.93% vs 29 2.32±1.90% and 1.88±1.45% vs 2.91±2.33%, respectively), while RMS of neck extensor muscles was reduced only during acceleration (5.18±1.96% vs 5.91±2.16%). There were no differences between the two conditions in RMS of neck flexor muscles, the pitch of the head and the VAS score. The use of these two ergonomic devices is therefore effective in reducing the activation of low-back and neck muscles during driving with no changes in the level of perceived comfort, which is likely due to rebalancing weight on the neck and giving a neutral position to lumbar segments.
Extrapyramidal motor side-effects of first- and second-generation antipsychotic drugs.

Second-generation antipsychotics have been thought to cause fewer extrapyramidal side-effects (EPS) than first-generation antipsychotics, but recent pragmatic trials have indicated equivalence.



To determine whether second-generation antipsychotics had better outcomes in terms of EPS than first-generation drugs.



We conducted an intention-to-treat, secondary analysis of data from an earlier randomised controlled trial (n = 227). A clinically significant difference was defined as double or half the symptoms in groups prescribed first- v. second-generation antipsychotics, represented by odds ratios greater than 2.0 (indicating advantage for first-generation drugs) or less than 0.5 (indicating advantage for the newer drugs). We also examined EPS in terms of symptoms emergent at 12 weeks and 52 weeks, and symptoms that had resolved at these time points.



At baseline those randomised to the first-generation antipsychotic group (n = 118) had similar EPS to the second-generation group (n = 109). Indications of resolved Parkinsonism (OR = 0.5) and akathisia (OR = 0.4) and increased tardive dyskinesia (OR = 2.2) in the second-generation drug group at 12 weeks were not statistically significant and the effects were not present by 52 weeks. Patients in the second-generation group were dramatically (30-fold) less likely to be prescribed adjunctive anticholinergic medication, despite equivalence in terms of EPS.



The expected improvement in EPS profiles for participants randomised to second-generation drugs was not found; the prognosis over 1 year of those in the first-generation arm was no worse in these terms. The place of careful prescription of first-generation drugs in contemporary practice remains to be defined, potentially improving clinical effectiveness and avoiding life-shortening metabolic disturbances in some patients currently treated with the narrow range of second-generation antipsychotics used in routine practice. This has educational implications because a generation of psychiatrists now has little or no experience with first-generation antipsychotic prescription.
Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure.

Nucleotide polymorphisms upstream of the interleukin 28B (IL28B) gene are strongly associated with hepatitis C virus (HCV) clearance in treatment-naïve patients treated with peginterferon/ribavirin (PegIFN/RBV). This subanalysis of the REALIZE study evaluated the impact of IL28B polymorphisms on sustained virologic response (SVR) in telaprevir-treated, HCV genotype 1-infected patients with prior PegIFN/RBV treatment failure.



Treatment-experienced patients were randomized to 12 weeks of telaprevir (750 mg every 8h) with/without a 4-week PegIFN/RBV lead-in, or placebo, each with PegIFN-α-2a (180 μg/week) and ribavirin (1000-1200 mg/day) for 48 weeks overall. Data from telaprevir arms were pooled.



Eighty percent (527/662) of patients consented to genetic testing and were included. Similar proportions of patients had IL28B CC, CT and TT genotypes across treatment arms; baseline characteristics were generally well balanced. SVR rates were higher in the pooled telaprevir versus placebo group for all IL28B genotypes; CC: 79% versus 29%, respectively; CT: 60% versus 16%, respectively; TT: 61% versus 13%, respectively. Within each prior response category (relapse, partial or null response), SVR and viral breakthrough rates with telaprevir-based treatment were comparable across IL28B genotypes. IL28B genotype did not significantly affect SVR (2-step multivariate analyses; p >0.16 in pairwise comparison among CC, TT, and CT). Variations in rapid virologic response and relapse rates were noted in certain patient subgroups.



Our findings suggest that IL28B genotype has a limited impact on SVR rates with telaprevir-based therapy in treatment-experienced patients. IL28B genotyping may have limited utility in the baseline evaluation of similar patients considered for telaprevir-based therapy.
The role of hypertension and diabetes mellitus in the severity of gait and balance disturbances in iNPH

Idiopathic normal pressure hydrocephalus (iNPH) is a disorder characterized by gait and balance disturbances, urinary incontinence and cognitive impairment. Of these three, gait and balance disorders are often the first to manifest and also the group that improve the most after shunt surgery. Vascular risk factors (particularly hypertension and diabetes mellitus) has been shown to increase the risk of developing iNPH. There is however further need to investigate if these risk factors have any impact on the severity of symptoms and improvement after shunt surgery. The aim of this study is to examine the connection between hypertension, diabetes mellitus (DM) and the severity of gait and balance disturbances in patients diagnosed with iNPH preand postoperativley. The aim was also to determine if patients with risk factors present show less improvement in gait and balance after surgery compared to controls.
Delivering tailored asthma family education in a pediatric emergency department setting: a pilot study.

Many children are brought to the pediatric emergency department (ED) with acute asthma symptoms. Emergency asthma care is costly, and many ED visits may be preventable. Families often do not have written asthma action plans and lack asthma self-management skills. This study tests a tailored self-management intervention delivered in the ED for families of children with asthma. The primary hypotheses were that the intervention group would have greater confidence to manage asthma 14 days postintervention and more well-asthma visits and fewer urgent care/ED visits at 9 and 12 months.



This randomized intervention/usual-care study was part of a larger ED asthma surveillance project in 4 urban pediatric ED sites. Asthma educators used a computer-based resource to tailor the intervention messages and provide a customized asthma action plan and educational summary. Children with acute asthma were enrolled during an ED visit, and follow-up telephone interviews were conducted during the next 9 months. The ED clinician classified the child's acute and chronic severity.



To date, 464 subjects aged 1 to 18 years have been enrolled. The ED clinicians reported that 46% had intermittent and 54% had persistent chronic severity with 51% having mild acute severity episodes. The confidence level to prevent asthma episodes and keep them from getting worse was significantly higher in the intervention group at 14 days postintervention. More subjects in the intervention group reported well-asthma visits by 9 months. Return ED visits were significantly lower in the intervention group in those with intermittent asthma. Twelve-month follow-up is in process.



The tailored ED self-management intervention demonstrates significant effects on caregiver self-confidence and well-visit follow-up. Additional evaluation is needed to determine what impact this intervention has long-term.
No effect of Pindolol on postural hypotension in Type 1 (insulin-dependent) diabetic patients with autonomic neuropathy. A randomised double-blind controlled study

Orthostatic hypotension is one of the most troublesome symptoms in diabetic autonomic neuropathy. Some reports have suggested Pindolol — a beta-adrenoceptor antagonist with intrinsic sympathomimetic activity — to be effective in the treatment of this condition. In order to elucidate the value of this therapy we performed a double-blind placebo controlled cross-over study with Pindolol (15 mg/day). Eight Type 1 (insulin-dependent) diabetic patients with autonomic neuropathy and signs and symptoms of orthostatic hypotension (systolic blood pressure decrease greater than 30 mm Hg when standing) participated in the study. Patients were treated for 10 weeks. Clinical examinations were performed every fortnight and patients registered postural symptoms twice daily on a visual analog scale. No significant changes were seen in blood pressure recordings, heart-rate or visual analog scale registration during treatment with Pindolol compared to placebo. Our study does not support the suggestion that Pindolol is a valuable drug for treatment of diabetic patients with autonomic neuropathy and postural giddiness.
Are old-old patients with major depression more likely to relapse than young-old patients during continuation treatment with escitalopram?

Escitalopram has shown efficacy and tolerability in the prevention of relapse in elderly patients with major depressive disorder (MDD). This post-hoc analysis compared time to relapse for young-old patients (n = 197) to that for old-old patients (n = 108).



Relapse prevention: after 12-weeks open-label treatment, remitters (MADRS ≤12) were randomised to double-blind treatment with escitalopram or placebo and followed over 24-weeks. Patients were outpatients with MDD from 46 European centers aged ≥75 years (old-old) or 65-74 years of age (young-old), treated with escitalopram 10-20 mg/day. Efficacy was assessed using the Montgomery Åsberg Depression Rating Scale (MADRS).



After open-label escitalopram treatment, a similar proportion of young-old patients (78%) and old-old patients (72%) achieved remission. In the analysis of time to relapse based on the Cox model (proportional hazards regression), with treatment and age group as covariates, the hazard ratio was 4.4 for placebo versus escitalopram (χ(2)-test, df = 1, χ(2)= 22.5, p < 0.001), whereas the effect of age was not significant, with a hazard ratio of 1.2 for old-old versus young-old (χ(2)-test, df = 1, χ(2) = 0.41, p = 0.520). Escitalopram was well tolerated in both age groups with adverse events reported by 53.1% of young-old patients and 58.3% of old-old patients. There was no significant difference in withdrawal rates due to AEs between age groups (χ(2)-test, χ(2) = 1.669, df = 1, p = 0.196).



Young-old and old-old patients with MDD had comparable rates of remission after open-label escitalopram, and both age groups had much lower rates of relapse on escitalopram than on placebo.
Antihypertensive efficacy of the angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin-converting enzyme inhibitor ramipril

Drug therapy often fails to control hypertension. Azilsartan medoxomil (AZL-M) is a newly developed angiotensin II receptor blocker with high efficacy and good tolerability. This double-blind, controlled, randomised trial compared its antihypertensive efficacy and safety vs the angiotensin-converting enzyme inhibitor ramipril (RAM) in patients with clinic systolic blood pressure (SBP) 150–180 mm Hg. Patients were randomised (n=884) to 20 mg AZL-M or 2.5 mg RAM once daily for 2 weeks, then force-titrated to 40 or 80 mg AZL-M or 10 mg RAM for 22 weeks. The primary endpoint was change in trough, seated, clinic SBP. Mean patient age was 57±11 years, 52.4% were male, 99.5% were Caucasian. Mean baseline BP was 161.1±7.9/94.9±9.0 mm Hg. Clinic SBP decreased by 20.6±0.95 and 21.2±0.95 mm Hg with AZL-M 40 and 80 mg vs12.2±0.95 mm Hg with RAM (P<0.001 for both AZL-M doses). Adverse events leading to discontinuation were less frequent with AZL-M 40 and 80 mg (2.4% and 3.1%, respectively) than with RAM (4.8%). These data demonstrated that treatment of stage 1–2 hypertension with AZL-M was more effective than RAM and better tolerated.
Cortical reorganization after motor imagery training in chronic stroke patients with severe motor impairment: a longitudinal fMRI study

Despite its clinical efficacy, few studies have examined the neural mechanisms of motor imagery training (MIT) in stroke. Our objective was to find the cortical reorganization patterns after MIT in chronic stroke patients. Twenty stroke patients with severe motor deficits were randomly assigned to the MIT or conventional rehabilitation therapy (CRT) group, but two lost in the follow-up. All 18 patients received CRT 5 days/week for 4 weeks. Nine subjects in the MIT group received 30-min MIT 5 days/week for 4 weeks. Before and after the interventions, the upper limb section of the Fugl–Meyer Scale (FM-UL) was blindly evaluated, and functional magnetic resonance imaging was administered while the patients executed a passive fist clutch task. Two cortical reorganization patterns were found. One pattern consisted of the growth in activation in the contralateral sensorimotor cortex (cSMC) for most patients (six in the MIT group, five in the CRT group), and the other consisted of focusing of the activation in the cSMC with increasing of the laterality index of the SMC for a small portion of patients (three in the MIT group, one in the CRT group). When we applied correlation analyses to the variables of relative ΔcSMC and ΔFM-UL in the 11 patients who experienced the first pattern, a positive relationship was detected. Our results indicate that different cortical reorganization patterns (increases in or focusing of recruitment to the cSMC region) exist in chronic stroke patients after interventions, and patients may choose efficient patterns to improve their motor function.
Effect of impaired renal function on the pharmacokinetics of tomopenem (RO4908463/CS-023), a novel carbapenem.

The objective of this study was to assess the impact of impaired renal function on the pharmacokinetics of tomopenem (RO4908463/CS-023), a novel carbapenem antibiotic, and its major metabolite in humans. Thirty-two subjects were enrolled in an open-label, two-center study. Subjects were evenly assigned to one of four groups, based on creatinine clearance ranges of > or =80, 50 to 79, 30 to 49, and <30 ml/min. The drug was given as a single 1,500-mg constant-rate intravenous infusion over 60 min. There were no safety concerns with increasing renal dysfunction. Renal impairment had a significant impact on exposure of both tomopenem and its metabolite. Mean (+/- standard deviation) areas under the curve for tomopenem increased with decreasing renal function, from 191 +/- 35.2 to 1,037 +/- 238 microg.h/ml. The maximum concentration of drug in plasma (C(max)) increased with a maximum difference of 44% between the severe and normal groups. In contrast, the corresponding increase in C(max) of the metabolite was much higher, at 174%. Total body clearance was linearly correlated with creatinine clearance (R(2) = 0.97; P < 0.0001). Renal clearance for tomopenem decreased with increasing severity of disease, with mean values decreasing from 4.63 +/- 0.89 to 0.59 +/- 0.19 liters/h. The results of this study indicated a strong correlation between the creatinine clearance and total clearance of tomopenem. While renal impairment appeared to have a significant effect on the pharmacokinetics of tomopenem, an even greater effect was seen on the elimination of the inactive metabolite.
HER2/neu testing for anti-HER2-based therapies in patients with unresectable and/or metastatic gastric cancer

To study the HER2 gene amplification or overexpression in patients with advanced gastric cancer (GC) and their association with patient characteristics and patient survival.



Tumour tissue samples from 148 patients with advanced GC were studied for HER2 by immunohistochemistry (IHC), fluorescence in situ hybridisation (FISH) and dual colour silver enhanced in situ hybridisation (dc-SISH) methods. Clinicopathological data from all patients were collected. Progression free survival and overall survival were also analysed.



Mean age was 67 (33-83) years; 75% were male subjects, and 51% had intestinal histological type. HER2+ rates were 10.1% (15/148) by IHC, 18.2% (27/148) by FISH+ or 21.6% (32/148) by dc-SISH+. There were significant differences in HER2+ rates according to histological type when FISH (intestinal, 23%; no intestinal, 4%; p<0.0001) or dc-SISH (intestinal, 26%; no intestinal, 6%; p<0.0001) amplification techniques were used. Median overall survival was significantly longer in HER2+ patients despite the determination technique used: IHC (21.4 vs 9.8 months, HR 0.42; p=0.005); FISH (19.6 vs 9.7 months, HR 0.49; p=0.007) or dc-SISH (19.6 vs 9.7 months, HR 0.53; p=0.009). Factors associated with favourable survival in the multivariate analysis were intestinal type and Her2+ determination by IHC, FISH or dc-SISH.



HER2 gene amplification is significantly associated with patient survival. HER2 gene amplification approaches might be an optimal HER2/neu testing strategy for the selection of HER2+ GC patients who are candidates to be treated with anti-HER2 therapies.
Effectiveness of two intensive treatment methods for smoking cessation and relapse prevention in patients with coronary heart disease: study protocol and baseline description

There is no more effective intervention for secondary prevention of coronary heart disease than smoking cessation. Yet, evidence about the (cost-)effectiveness of smoking cessation treatment methods for cardiac inpatients that also suit nursing practice is scarce. This protocol describes the design of a study on the (cost-)effectiveness of two intensive smoking cessation interventions for hospitalised cardiac patients as well as first results on the inclusion rates and the characteristics of the study population.



An experimental study design is used in eight cardiac wards of hospitals throughout the Netherlands to assess the (cost-)effectiveness of two intensive smoking cessation counselling methods both combined with nicotine replacement therapy. Randomization is conducted at the ward level (cross-over). Baseline and follow-up measurements after six and 12 months are obtained. Upon admission to the cardiac ward, nurses assess patients' smoking behaviour, ensure a quit advice and subsequently refer patients for either telephone counselling or face-to-face counselling. The counselling interventions have a comparable structure and content but differ in provider and delivery method, and in duration. Both counselling interventions are compared with a control group receiving no additional treatment beyond the usual care. Between December 2009 and June 2011, 245 cardiac patients who smoked prior to hospitalisation were included in the usual care group, 223 in the telephone counselling group and 157 in the face-to-face counselling group. Patients are predominantly male and have a mean age of 57 years. Acute coronary syndrome is the most frequently reported admission diagnosis. The ultimate goal of the study is to assess the effects of the interventions on smoking abstinence and their cost-effectiveness. Telephone counselling is expected to be more (cost-)effective in highly motivated patients and patients with high SES, whereas face-to-face counselling is expected to be more (cost-)effective in less motivated patients and patients with low SES.



This study examines two intensive smoking cessation interventions for cardiac patients using a multi-centre trial with eight cardiac wards. Although not all eligible patients could be included and the distribution of patients is skewed in the different groups, the results will be able to provide valuable insight into effects and costs of counselling interventions varying in delivery mode and intensity, also concerning subgroups.