nils-herrmann/clean_scirepeval huggingface dataset:
Usefulness of the adenosine triphosphate with a sufficient observation period for detecting reconduction after pulmonary vein isolation.

Although reconduction after pulmonary vein (PV) isolation is considered to play a key role in the recurrence of paroxysmal atrial fibrillation (AF), there have been few reports regarding the precise time course of early reconduction. Several studies have suggested that transient PV reconduction facilitated by adenosine may predict long-term AF recurrence. This study was designed to clarify the incidence and time course of early reconduction after PVI during the procedure and to confirm whether the use of ATP after a certain observation period was useful to detect early reconduction after PVI.



In 21 patients (18 males, 56 +/- 11 years) with drug refractory AF, radiofrequency circumferential PV antrum ablation was performed in all 4 PVs. After the completion of isolation, electrograms in each PV were repeatedly recorded (1.98 +/- 0.57 times per PV) using a circular mapping catheter for an observation period of 87 +/- 29 minutes. After isolation of all 4 PVs, 30 mg of adenosine triphosphate (ATP) was administered during isoproterenol infusion.



PV electrical isolation was initially achieved in all 81 PVs. During the observation period, 12 (15%) PVs in 10 (48%) of 21 patients exhibited spontaneous reconduction. Among the remaining 69 PVs, 8 (12%) additional PVs had reconduction with the use of ATP. All PV reconduction was successfully eliminated by 4.5 +/- 2.2 additional radiofrequency applications.



A sufficient observation period and the use of ATP are useful to detect early reconduction after PV isolation.
COPD screening in general practice using a telephone questionnaire.

Chronic obstructive pulmonary disease (COPD) is a growing health problem, and an underestimated and underdiagnosed disease in primary care. The aim of this survey was to study the feasibility of detecting undiagnosed COPD patients in the general practice population with the aid of a telephone questionnaire. The study was held in 2 general practices in the Netherlands. During 2 weeks, all patients registered with these 2 practices and aged between 40 and 75 years were contacted through a call center. Persons known with a previous history or diagnosis of COPD or asthma or comorbidity were excluded from the telephone list. The telephone interview used the Respiratory Health Screening Questionnaire (DB Price, 2006). Based on the score on this instrument, respondents were classified as having a low, moderate or high risk of having COPD. Smoking behaviour and BMI were also recorded. Patients with medium and high risk for COPD were invited for spirometry, performed by 2 experienced registered nurses. The results of the telephone interview and spirometric findings were assessed by the attending GP, who established the final diagnosis. The call center reached 1032 persons, 813 of whom answered the questions. The percentage of smokers was 49.2%, with an average number of pack-years of 17.9 (SD = 17); mean BMI was 26.1. Spirometry and analysis by the GP showed that 15.7% of the medium-risk group had previously undiagnosed COPD, versus 39.6% of the high-risk group. The number of undiagnosed COPD patients in the general practice population is considerable. Case finding can focus on moderate- and high-risk groups after telephone risk assessment.
Determinants of health-related quality of life in pharmacoresistant epilepsy: results from a large multicenter study of consecutively enrolled patients using validated quantitative assessments.

To evaluate the relative contribution of demographic and epilepsy-related variables, depressive symptoms, and adverse effects (AEs) of antiepileptic drugs (AEDs) to health-related quality of life (HRQOL) in adults with pharmacoresistant epilepsy.



Individuals with epilepsy whose seizures failed to respond to at least one AED were enrolled consecutively at 11 tertiary referral centers. HRQOL was assessed by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), AEs by the Adverse Event Profile (AEP), and depressive symptoms by the Beck Depression Inventory-II (BDI-II). Multivariate linear regression models were used to identify variables associated with QOLIE-31 total score and subscale scores.



Of 933 enrolled individuals aged 16 years or older, 809 (87%) were able to complete the self-assessment instruments and were included in the analysis. Overall, 61% of the variance in QOLIE-31 scores was explained by the final model. The strongest predictors of HRQOL were AEP total scores (β = -0.451, p < 0.001) and BDI-II scores (β = -0.398, p < 0.001). These factors were also the strongest predictors of scores in each of the seven QOLIE-31 subscales. Other predictors of HRQOL were age (β = -0.060, p = 0.008), lack of a driving license (β = -0.053, p = 0.018), pharmacoresistance grade, with higher HRQOL in individuals who had failed only one AED (β = 0.066, p = 0.004), and location of the enrolling center. Epilepsy-related variables (seizure frequency, occurrence of tonic-clonic seizures, age of epilepsy onset, disease duration) and number of AEDs had no significant predictive value on HRQOL. The AEP total score was the strongest negative predictor of HRQOL in the subgroup of 362 patients without depressive symptoms (BDI-II score <10), but even in this subgroup the BDI-II score was retained as a significant predictor.



In individuals with pharmacoresistant epilepsy, AEs of medication and depressive symptoms are far more important determinants of HRQOL than seizures themselves. When seizure freedom cannot be achieved, addressing depressive comorbidity and reducing the burden of AED toxicity is likely to be far more beneficial than interventions aimed at reducing the frequency of seizures.
28 EFFECTS OF PHENOBARBITAL ON CEREBRAL HEMODYNAMICS IN PRETERM NEONATES

We evaluated the effect of phenobarbital (pb) versus placebo (saline) on cerebral hemodynamics in eleven, clinically stable preterm neonates. The mean (+SD) post natal age at study entry was 12 (3) hours. The mean (+SD) birth weight and gestational age were 1286 (387 g) and 30.5 (3) weeks respectively. We measured cerebral blood flow velocity (CBFV), using a pulsed wave Doppler monitor. Every subject was his own control. Placebo was systematically injected prior to pb (20 mg.kg −1 over 20 min). Simultaneous recording of heart rate, arterial blood pressure, TcPCO2, TcPO2, SaO2 were made before, at the end of the injection, and a 15, 30, 60, 90, 120 min after the end of each administration of either placebo or pb.  pb was in anticonvulsant concentrations (16 to 24 μg/ml). No significant changes ocurred in systemic hemodynamics, or in blood gases. CBFV remains stable and no different during placebo or phenobarbital administration. We conclude that a pb loading dose of 20 mg −1, has no effect on systemic and cerebral hemodynamics during steady state. The cerebral protective action of phenobarbital may not result by decreasing baseline cerebral blood flow as previously suggested.
Validation of defining characteristics for the nursing diagnosis of fatigue in oncological patients.

The objective of this study was to validate the defining characteristics for the nursing diagnosis of Fatigue in adult oncological patients. It is a cross-sectional, descriptive study with a quantitative perspective, and its type is diagnostic content validation. Data collection was carried out in a University Hospital. The sample was made up of 35 expert nurses. The instrument used was subdivided into four parts. The data was analyzed by descriptive statistics. 15 defining characteristics were identified, considered secondary indicators. With an average weighting of less than 0.50, four defining characteristics were excluded. The defining characteristic Impaired social interaction, added to those described by NANDA-I after review of the literature, was validated with a weighted average of 0.71. It was concluded that the subjectivity of the defining characteristics and the difficulty nurses have in recognizing them influence the identification of this diagnosis.
Synovitis and the risk of knee osteoarthritis: the MOST Study.

To identify the independent relation of synovitis with incident radiographic knee osteoarthritis (OA) after adjusting for other structural factors known to cause synovitis.



We examined MRIs from knees that developed incident radiographic OA from the Multicenter Osteoarthritis Study (MOST) and compared these case knees with controls that did not develop OA. We examined baseline MRIs for knees developing OA at any time up to 84 months follow-up. We scored lesions in cartilage, meniscus, bone marrow and synovitis. Synovitis scores were summed (0-9) across three regions, suprapatellar, infrapatellar and intercondylar region, each of which was scored 0-3. After bivariate analyses examining each factor's association with incidence, we carried out multivariable regression analyses adjusting for age, sex, BMI, alignment and cartilage and meniscal damage.



We studied 239 case and 731 control knees. In bivariate analyses, cartilage lesions, meniscal damage, synovitis and bone marrow lesions were all risk factors for OA. After multivariable analyses, synovitis was associated with incident OA. A higher synovitis score increased the risk of incident OA (adjusted OR per unit increase 1.1; (95% CI 1.0, 1.2, P = .02)), but increased risk was associated only with synovitis scores of ≥3 (adjusted OR 1.6; 95% CI 1.2, 2.1, P = .003).



Synovitis, especially when there is a substantial volume within the knee, is an independent cause of OA.
A phase II randomized multicenter trial of gefitinib plus FOLFIRI and FOLFIRI alone in patients with metastatic colorectal cancer.

Gefitinib inhibits the epidermal growth factor receptor tyrosine kinase and preclinical studies indicate that it may enhance CPT-11 cytotoxicity. This randomized phase II trial investigates the feasibility and efficacy of gefitinib and 5-fluorouracil, folinic acid, irinotecan (FOLFIRI) in patients with metastatic colorectal cancer.



Patients were randomized to FOLFIRI +/- gefitinib 250 mg daily p.o. Patients randomized to FOLFIRI + gefitinib without disease progression after 6 months continued to receive gefitinib alone until disease progression.



From October 2002 to September 2004, 100 patients were enrolled. Twenty-three patients (47.9%) in the FOLFIRI arm and 23 (45.1%) in the FOLFIRI + gefitinib arm experienced an objective response. The median progression-free survival and overall survival were 8.3 and 18.6 months in the FOLFIRI arm, and 8.3 and 17.1 months in the FOLFIRI + gefitinib arm, respectively. In the combination arm, grades 3-4 adverse events were experienced by 35 (67.3%) patients versus 25 patients (52.1%) in the FOLFIRI arm; 12 patients (23.1%) withdrew for an adverse event in the FOLFIRI + gefitinib arm and 5 (10.4%) in the FOLFIRI arm.



These data show that adding gefitinib to FOLFIRI does not improve the efficacy of FOLFIRI regimen. These disappointing results could be related to the high toxicity observed that led to significant dose reductions and delays.
Dehydroepiandrosterone (DHEA) improves pulmonary hypertension in chronic obstructive pulmonary disease (COPD): a pilot study.

It was previously shown that dehydroepiandrosterone (DHEA) reverses chronic hypoxia-induced pulmonary hypertension (PH) in rats, but whether DHEA can improve the clinical and hemodynamic status of patients with PH associated to chronic obstructive pulmonary disease (PH-COPD) has not been studied whereas it is a very severe poorly treated disease.



Eight patients with PH-COPD were treated with DHEA (200mg daily orally) for 3 months. The primary end-point was the change in the 6-minute walk test (6-MWT) distance. Secondary end-points included pulmonary hemodynamics, lung function tests and tolerance of treatment.



The 6-MWT increased in all cases, from 333m (median [IQR]) (257; 378) to 390m (362; 440) (P<0.05). Mean pulmonary artery pressure decreased from 26mmHg (25; 27) to 21.5mmHg (20; 25) (P<0.05) and pulmonary vascular resistance from 4.2UI (3.5; 4.4) to 2.6UI (2.5; 3.8) (P<0.05). The carbon monoxide diffusing capacity of the lung (DLCO % predicted) increased significantly from 27.4% (20.1; 29.3) to 36.4% (14.6; 39.6) (P<0.05). DHEA treatment did not change respiratory parameters of gas exchange and the 200mg per day of DHEA used was perfectly tolerated with no side effect reported.



DHEA treatment significantly improves 6-MWT distance, pulmonary hemodynamics and DLCO of patients with PH-COPD, without worsening gas exchange, as do other pharmacological treatments of PH (trial registration NCT00581087).
Validation of internal control genes for gene expression analysis in diabetic glomerulosclerosis.

Gene expression analysis is an invaluable tool in the study of diabetic glomerulosclerosis. The necessary denominator for the quantitative expression of a specific gene is the expression level of a second gene that is presumed to remain unchanged. Thus, it is critical that the stability of this housekeeping gene in diabetic glomeruli or in cultured glomerular cells is not altered by the disease or a high glucose environment, respectively. Although gene expression quantification, achieved by Northern blot analysis or real-time reverse transcription-polymerase chain reaction (RT-PCR) has been extensively applied in diabetic renal tissue in vivo and in vitro, there are no studies validating the use of any specific endogenous control gene in these measurements.



We performed real-time RT-PCR using RNA from microdissected diabetic glomeruli and from mesangial cells cultured in high glucose concentration to investigate gene expression stability of beta-actin, glyceraldehyde-3-phosphate dehydrogenase (GADPH), phospholipase A2, beta2-microglobulin, acidic ribosomal protein 36B4, and cyclophilin A.



Using an analysis method which is independent of gene abundance and compares the pair-wise variation of a given housekeeping gene with all other control genes, beta-actin and phospholipase A2, were found to be the most stable genes in diabetic glomeruli and in primary mesangial cells exposed to 20 mmol/L glucose.



It is proposed that the expression level of these genes is the best reference to evaluate relative changes in gene activity in diabetic/high glucose exposed glomerular tissues.
The validity and reliability of the Malaysian Osteoporosis Knowledge Tool in postmenopausal women.

To design a valid and reliable questionnaire, the Malaysian Osteoporosis Knowledge Tool (MOKT), to assess the knowledge of postmenopausal osteoporotic women in Malaysia, on osteoporosis and its treatment.



A 40-item instrument was designed and tested in this study. The scores ranged from 1 to 40, which were then converted into percentage. This was administered to 88 postmenopausal osteoporotic women who were taking alendronate (patient group) and 43 pharmacists (professional group). The MOKT was administered again to the patient group after 1 month.



Flesch reading ease was 57, which is satisfactory, while the mean difficulty factor+/-S.D. was 0.73+/-0.25, indicating that the MOKT is moderately easy. Internal consistency of the instrument was good with Cronbach's alpha=0.82. The test and retest scores showed no significant difference for 38 out of the 40 items, indicating that the questionnaire has achieved a stable reliability. Level of knowledge on osteoporosis and its treatment was good with a mean score+/-S.D. of 69.0+/-13.9 and 81.6+/-9.5 in the patient and professional group, respectively. The difference in knowledge scores between the two groups was statistically significant (p<0.001).



In conclusion, the 40-item questionnaire (MOKT) is a reliable and valid instrument for measuring knowledge on osteoporosis in the Malaysian setting. Therefore, it can be used to identify individuals in need of educational interventions and to assess the effectiveness of education efforts as part of osteoporosis management.
Adalimumab for the treatment of fistulas in patients with Crohn’s disease

To evaluate the efficacy of adalimumab in the healing of draining fistulas in patients with active Crohn's disease (CD).



A phase III, multicentre, randomised, double-blind, placebo controlled study with an open-label extension was conducted in 92 sites.



A subgroup of adults with moderate to severely active CD (CD activity index 220-450) for >or=4 months who had draining fistulas at baseline.



All patients received initial open-label adalimumab induction therapy (80 mg/40 mg at weeks 0/2). At week 4, all patients were randomly assigned to receive double-blind placebo or adalimumab 40 mg every other week or weekly to week 56 (irrespective of fistula status). Patients completing week 56 of therapy were then eligible to enroll in an open-label extension.



Complete fistula healing/closure (assessed at every visit) was defined as no drainage, either spontaneous or with gentle compression.



Of 854 patients enrolled, 117 had draining fistulas at both screening and baseline (70 randomly assigned to adalimumab and 47 to placebo). The mean number of draining fistulas per day was significantly decreased in adalimumab-treated patients compared with placebo-treated patients during the double-blind treatment period. Of all patients with healed fistulas at week 56 (both adalimumab and placebo groups), 90% (28/31) maintained healing following 1 year of open-label adalimumab therapy (observed analysis).



In patients with active CD, adalimumab therapy was more effective than placebo for inducing fistula healing. Complete fistula healing was sustained for up to 2 years by most patients in an open-label extension trial.
A preliminary study on the relationship between central auditory processing and childhood primary headaches in the intercritical phase

Recently, an increasing number of articles have appeared on central auditory processing disorders, but in the literature there is only one study that evaluated the possible correlation between migraine in the critical phase and central auditory processing. The aim of our study was to assess the correlation between auditory processing information and childhood primary headaches in the intercritical phase. This is an observational study. We enrolled 54 patients, 30 with primary headache (migraine and tension headache) and 24 normal controls, matched for sex and age. The mean age at first observation was 9 years 10 months; the duration of observational follow-up was 2 years. Both groups had normal audiological and neurological profiles, normal peripheral hearing acuity and normal cognitive and behavioral skills. We excluded patients who had undergone pharmacological prophylactic treatment for headaches in the 6 months preceding the study and subjects with a frequency of headache lower than one every two months. After enrolment, both groups were analyzed with a computerized test battery for Speech Perception Tests in silence and in noise background to assess speech perception disabilities. In addition, with a test battery of Speech Perception Tests, we compared patients with migraines and tension-type headaches. The non-parametric χ2 test, the Mann–Whitney U-test and the Wilcoxon signed ranks test were used for statistical analysis. P-values <0.05 were considered significant and STATA 10 software was used for statistical analyses. Our results showed that patients with primary headache (migraine and tension-type headache), had a deficit of auditory processing in noisy background compared to control cases, but we found no significant differences when we compared patients with migraine and tension-type headache. This is a work in progress and further studies are needed to assess the relationship between the impairment of auditory processing and primary headache, not only to improve the diagnostic approach to primary headache, but also to improve therapeutic intervention.
Docosahexaenoic acid-concentrated fish oil supplementation in subjects with mild cognitive impairment (MCI): a 12-month randomised, double-blind, placebo-controlled trial

Epidemiological studies have suggested a beneficial effect of fish oil supplementation in halting the initial progression of Alzheimer’s disease. However, it remains unclear whether fish oil affects cognitive function in older people with mild cognitive impairment (MCI). This study investigated the effects of fish oil supplementation on cognitive function in elderly person with MCI. This was a 12-month, randomised, double-blind, placebo-controlled study using fish oil supplementation with concentrated docosahexaenoic acid (DHA). Thirty six low-socioeconomic-status elderly subjects with MCI were randomly assigned to receive either concentrated DHA fish oil (n = 18) or placebo (n = 18) capsules. The changes of memory, psychomotor speed, executive function and attention, and visual-constructive skills were assessed using cognitive tests. Secondary outcomes were safety and tolerability of the DHA concentrate. The fish oil group showed significant improvement in short-term and working memory (F = 9.890; ηp 2 = 0.254; p < 0.0001), immediate verbal memory (F = 3.715; ηp 2 = 0.114; p < 0.05) and delayed recall capability (F = 3.986; ηp 2 = 0.121; p < 0.05). The 12-month change in memory (p < 0.01) was significantly better in the fish oil group. Fish oil consumption was well tolerated, and the side effects were minimal and self-limiting. This study suggested the potential role of fish oil to improve memory function in MCI subjects. Studies with larger sample sizes, longer intervention periods, different fish oil dosages and genetic determinations should be investigated before definite recommendations can be made.
An integrated intervention program to control diabetes in overweight Chinese women and men with type 2 diabetes.

This study evaluated a structured and integrated intervention program on diabetes management in individuals with type 2 diabetes in Shanghai, China. Men and women with type 2 diabetes and body mass index > 23 kg/m2 were randomized into a 24-week, prospective, randomized clinical trial. The Reference Group (n=50) received diabetes education including diet and physical activity instruction only; the Intervention Group (n=100) received more intensive intervention, including diabetes education with frequent blood glucose monitoring, nutritional counseling, meal plans with diabetes-specific nutritional meal replacement, and weekly progress updates with study staff. Major study assessments were obtained at baseline, and after 12 and/or 24 weeks of intervention. The Intervention Group improved fasting blood glucose, insulin, systolic and diastolic blood pressures compared to Reference Group ( p <0.05). Importantly, HbA1c was lower ( p <0.001) in the Intervention Group at 12 weeks (-0.6 +/- 0.1%) and 24 weeks (-0.8 +/- 0.1%). Weight loss was modest, but significant differences were observed between groups ( p <0.05). Weight change from baseline after 12 and 24 weeks was -2.8 +/- 0.2% and -3.7 +/- 0.3%, respectively, in the Intervention Group vs -1.8 +/- 0.4% and -2.5 +/- 0.4% in the Reference Group. Additionally, waist and hip circumferences and waist:hip ratio decreased in the Intervention compared to the Reference Group ( p <0.05). In conclusion, this study demonstrates that Chinese men and women with type 2 diabetes following an integrated intervention program including diabetes education, frequent blood glucose monitoring and daily use of a diabetes-specific meal replacement, can achieve significant improvements in glycemic control and markers of cardiovascular health.