nils-herrmann/clean_scirepeval huggingface dataset:
Effect of alpha-lipoic acid on blood glucose, insulin resistance and glutathione peroxidase of type 2 diabetic patients.

To examine the effects of alpha-lipoic acid (ALA) treatment over a period of 2 months on fasting blood glucose (FBG), insulin resistance (IR), and glutathione peroxidase (GH-Px) activity in type 2 diabetes (T2DM) patients.



This study took place in Motahari Clinic, Shiraz, Iran, which is affiliated to Shiraz University of Medical Sciences from May to October 2006. Type 2 DM patients (n=57) were divided into 2 groups to receive either ALA (300 mg daily) or placebo by systematic randomization, and were followed-up for 8 weeks. After an overnight fasting and 2 hours after breakfast, patients' blood samples were drawn and tested for FBG, 2 hours PPG, serum insulin level, and GH-Px activity.



The result of the study showed a significant decrease in FBG and PPG levels, IR-Homeostasis Model Assessment (IR-HOMA index) and GH-Px level in the ALA group. The comparison of differences between FBG and IR at the beginning and at the end of study in the ALA treated group and the placebo group were also significant.



This study supports the use of ALA as an antioxidant in the care of diabetic patients.
Validity of the PAS-ADD for detecting psychiatric symptoms in adults with learning disability (mental retardation)

The Psychiatric Assessment Schedule for Adults with Developmental Disability (PAS-ADD) is a semi-structured interview for use with respondents who have learning disability and for key informants. This report investigates the ability of the instrument to detect symptoms that had been found to exist during routine clinical assessment of the patients. Field trials involved 95 referred patients with learning disability and a key informant for each sample member. Clinical opinions of the referring psychiatrists were sought using a symptom checklist. Referrer checklist symptoms and PAS-ADD data were both factor analysed. Validity testing involved (a) computation of correlations between PAS-ADD factors and checklist data and (b) comparison of PAS-ADD and referrers' diagnoses. Results indicated good validity for the PAS-ADD in relation to psychotic symptoms and depressive symptoms. Anxiety symptom identification was not well validated, probably due to small numbers. Expansive mood identified by the referrers was not detected by the PAS-ADD because there is currently no corresponding section in the interview. Where the PAS-ADD produced a diagnosis (in 58 members of the sample), 44 were in agreement with the referrer. Probability of diagnosis by PAS-ADD increased with the number of relevant active symptoms identified by the referrer. The PAS-ADD has been shown in a previous report to have the sensitivity to detect mental disorders not known to psychiatric services. For psychotic and depressive conditions, our results showed that symptom detection was in good agreement with the information provided by the referring psychiatrists on their patients. The PAS-ADD needs a section on hypomania and further investigation of its detection of anxiety disorders.
Cognitions in generalized anxiety disorder and panic disorder patients. A prospective approach.

Self-observations of cognitions during episodes of anxiety were examined in 38 patients with generalized anxiety disorder and 36 patients with panic disorder. Two independent observers who where blind to the diagnoses categorised the cognitions. The inter-rater reliability was high (mean kappa 0.82). The GAD-patients had significantly more cognitions in the following categories: interpersonal confrontation, competence, acceptance, concern about others and worry over minor matters, while the PD-patients had significantly more cognitions in the physical catastrophe category. Furthermore, GAD-patients with a comorbidity of social phobia reported more cognitions regarding social embarrassment than did GAD-patients with other or no (axis-I) comorbidity. The results of this study support the cognitive theory regarding the cognitive specificity of anxiety disorders. The implications of these results are discussed, along with the issues of reliability and validity of the instrument used.
Is endoscopic band ligation superior to injection therapy for Dieulafoy lesion?

Dieulafoy lesion is a rare but serious cause of gastrointestinal system bleeding. An aberrant submucosal artery, which was described in 1884, causes the bleeding. The lesion can be located anywhere in the gastrointestinal tract but is most commonly found in the proximal stomach up to 6 cm from the gastroesophageal junction. Increased experience in endoscopy has led to an increased frequency of its proper diagnosis. Various methods are used to achieve successful hemostasis by endoscopy in Dieulafoy lesion; however, comparative studies about the success rates of these methods are still needed. In this study, we compared two of these endoscopic hemostatic methods: band ligation, and injection therapy in Dieulafoy lesions. In this prospective study, 18 patients admitted to the Emergency Surgical Unit between January 2002 and December 2005 with upper gastrointestinal bleeding diagnosed as Dieulafoy lesion were included. Diagnose of Dieulafoy lesion was made at initial or second-look endoscopy. Patients were randomized in two groups according to therapy method: injection therapy and band ligation groups. Therapy was applied immediately after recognizing the lesion at the same endoscopic procedure. Two groups were compared regarding demographical data, presence of comorbid diseases, history of medication and previous gastrointestinal system bleeding, hemodynamic status, laboratory values, need for transfusion, endoscopic findings, success rate of the treatment method, mean hospital stay, complications, and recurrence of bleeding. Of 588 patients admitted with upper gastrointestinal hemorrhage, Dieulafoy lesion was recognized in 18 cases (3.1%) at initial or second-look endoscopy. All patients were men with a mean age of 62.8 (range, 30–80) years. Band ligation was applied to ten patients and the remaining eight were treated by injection therapy. During the follow-up period, rebleeding occurred in six of the patients (75%) with injection therapy, whereas no rebleeding occurred for the patients in the band ligation group. The rebleeding rate and mean hospital stay was significantly higher for the injection therapy group. Our study suggests that of the endoscopic treatment methods, band ligation is superior to injection therapy for the treatment Dieulafoy lesions.
Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study

To obtain large scale and generalisable data on the long term predictive value of cytology and human papillomavirus (HPV) testing for development of cervical intraepithelial neoplasia grade 3 or cancer (CIN3+).



Multinational cohort study with joint database analysis.



Seven primary HPV screening studies in six European countries.



24,295 women attending cervical screening enrolled into HPV screening trials who had at least one cervical cytology or histopathology examination during follow-up.



Long term cumulative incidence of CIN3+.



The cumulative incidence rate of CIN3+ after six years was considerably lower among women negative for HPV at baseline (0.27%, 95% confidence interval 0.12% to 0.45%) than among women with negative results on cytology (0.97%, 0.53% to 1.34%)). By comparison, the cumulative incidence rate for women with negative cytology results at the most commonly recommended screening interval in Europe (three years) was 0.51% (0.23% to 0.77%). The cumulative incidence rate among women with negative cytology results who were positive for HPV increased continuously over time, reaching 10% at six years, whereas the rate among women with positive cytology results who were negative for HPV remained below 3%.



A consistently low six year cumulative incidence rate of CIN3+ among women negative for HPV suggests that cervical screening strategies in which women are screened for HPV every six years are safe and effective.
Humanised monoclonal antibody therapy for rheumatoid arthritis

Monoclonal antibodies that target T cells have shown some benefit in rheumatoid arthritis although responses have not been long lasting. This is partly due to insufficient therapy consequent upon antibody immunogenicity. Use of humanised antibodies, which are expected to be less foreign to man than conventional rodent antibodies, might overcome this problem. We therefore assessed in a phase 1 open study the potential of a "lymphocyte depleting" regimen of the humanised monoclonal antibody CAMPATH-1H in 8 patients with refractory rheumatoid arthritis. Apart from symptoms associated with first infusions of antibody, adverse effects were negligible. Significant clinical benefit was seen in 7 patients, lasting for eight months in 1. After one course of therapy, there was no measurable antiglobulin response, although 3 out of 4 patients have become sensitised on retreatment. Humanisation reduces the immunogenicity of rodent antibodies but anti-idiotype responses may still be seen on repeated therapy, even in patients sharing immunoglobulin allotype with the humanised antibody.
Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD.

Previous observational studies examining outcomes associated with the timing of dialysis therapy initiation in the United States have often been limited by lead time and survivor bias.



Retrospective cohort study comparing the effectiveness of early versus later (conventional) dialysis therapy initiation in advanced chronic kidney disease (CKD). The analysis used inverse probability weighting to account for an individual's contribution to different exposure groups over time in a pooled logistic regression model. Patients contributed risk to both exposure categories (early and later initiation) until there was a clear treatment strategy (ie, dialysis therapy was initiated early or estimated glomerular filtration rate [eGFR] decreased to <10mL/min/1.73m(2)).



Patients with CKD who had at least one face-to-face outpatient encounter with a Cleveland Clinic health care provider as of January 1, 2005, and at least 3 eGFRs in the range of 20-30mL/min/1.73m(2) measured at least 180 days apart.



Timing of dialysis therapy initiation as determined using model-based interpolation of eGFR trajectories over time. Timing was defined as early (interpolated eGFR at dialysis therapy initiation≥10mL/min/1.73m(2)) or later (eGFR < 10mL/min/1.73m(2)) and was time-varying.



Death from any cause occurring from the time that eGFR was equal to 20mL/min/1.73m(2) through September 15, 2009.



The study population consisted of 652 patients meeting inclusion criteria. Most (71.3%) of the study population did not initiate dialysis therapy during follow-up. Patients who did not initiate dialysis therapy (n=465) were older, more likely to be white, and had more favorable laboratory profiles than those who started dialysis therapy. Overall, 146 initiated dialysis early and 80 had eGFRs decrease to <10mL/min/1.73m(2). Many participants (n=426) were censored prior to attaining a clear treatment strategy and were considered undeclared. There was no statistically significant survival difference for the early compared with later initiation strategy (OR, 0.85; 95% CI, 0.65-1.11).



In patients with advanced CKD, timing of dialysis therapy initiation was not associated with mortality when accounting for lead time bias and survivor bias.
Experience with the Biostator for diagnosis and assisted surgery of 21 insulinomas.

Surgical removal is the treatment of choice for insulinomas. Definitive biochemical diagnosis of organic hyperinsulinism has to be established before surgery. These tumors are sometimes undetected by preoperative imaging investigations and, in addition, surgical management may also be complicated by the absence of palpable tumors or the presence of multiple tumors. We report the value of the euglycemic clamp technique for diagnosis and surgical treatment in 21 patients with confirmed insulinomas. Data were compared with 12 controls, and nine patients were retested after surgery. During the euglycemic hyperinsulinic clamp, the mean C-peptide value was 3.6+/-2.2 ng/ml and it remained high (3.8+/-2.5 ng/ml), despite exogenous hyperinsulinemia (1762.7+/-233.2 microU/ml for the highest plateau). In contrast, the C-peptide concentration declined in 12 control patients (0.3+/-0.1 ng/ml, P < 0.001) and after successful surgery in nine retested patients (0.3+/-0.2 ng/ml, P < 0.01). During continuous glucose monitoring, successful removal of the insulin-secreting tumor was accompanied by an increase in plasma glucose concentrations and a loss of requirement for endogenous glucose within 36 min (range 28-43 min). The continuing requirement for glucose after the ablation of the tumor revealed the existence of additional and initially undetected tumors in four patients, among whom two had the multiple endocrine neoplasia type I (MEN I) syndrome. We conclude that the euglycemic hyperinsulinic clamp is a reliable and convenient diagnostic test for insulinoma, as it is both safe (no hypoglycemia) and relatively brief (3 x 90 min). Glucose monitoring and glucose clamping provide a reliable indicator of complete removal of insulin-hypersecreting tissue, especially in patients with occult or multiple tumors.
Comparison of the effects of salbutamol and adrenaline on airway smooth muscle contractility in vitro and on bronchial reactivity in vivo.

The effect of adrenergic agonists in asthma depends on their net effect on microvascular leakage, mucosal oedema, vascular clearance of spasmogens, inhibition of cholinergic neurotransmission, and airway smooth muscle contractility. It has been postulated that adrenaline, by virtue of its alpha effects on the vasculature and cholinergic neurotransmission, may have additional useful properties in asthma compared with selective beta agonists such as salbutamol.



The airway effects of adrenaline (a non-selective adrenoreceptor agonist) were compared with the selective beta 2 agonist salbutamol. Their airway smooth muscle relaxant potencies and effect on histamine contraction in human bronchi in vitro were compared with their effects on airway calibre and histamine reactivity in asthmatic subjects in vivo. For the in vitro studies changes in tension were measured in response to these agents in thoracotomy specimens of human airways. In vivo the effects of adrenaline and salbutamol on airway calibre and histamine reactivity were measured in eight subjects with mild to moderate asthma in a randomised crossover study.



Salbutamol and adrenaline had approximately equivalent airway smooth muscle relaxant potencies in vitro and bronchodilator potency in vivo. However, their effects on histamine induced contraction in vitro were significantly different from their effects on histamine reactivity in vivo. Salbutamol was less potent in vitro producing a mean (SE) 2.4 (0.15) doubling dose increase in the histamine EC20 and adrenaline a 5.2 (0.18) doubling dose increase (mean difference between salbutamol and adrenaline 2.8 doubling doses; 95% CI 1.1 to 4.5). Salbutamol had no effect on the maximal response to histamine whereas adrenaline reduced it by 54%. In contrast, salbutamol was more potent in vivo producing a mean (SE) increase in PD20 histamine of 1.84 (0.5) doubling doses whereas adrenaline was without effect increasing PD20 by only 0.06 (0.47) doubling doses (mean difference between adrenaline and salbutamol 1.78, 95% CI 0.26 to 3.29 doubling doses).



These findings suggest that the alpha adrenergic airway effects of non-selective adrenoreceptor agonists such as adrenaline offer no additional protection against histamine-induced broncho-constriction in vivo than beta 2 selective drugs such as salbutamol, despite adrenaline providing greater protection against histamine-induced contraction in vitro. The differences between the effects of these agents in vitro and in vivo may be related to their opposing vascular effects in vivo.
Prospective randomized double-blind comparison of nephrotoxicity and auditory toxicity of tobramycin and netilmicin.

Netilmicin or tobramycin was administered to 197 patients in a prospective randomized double-blind trial. Of these patients, 140 recipients of nine or more doses of netilmicin or tobramycin could be evaluated for nephrotoxicity. Fifty-five patients were able to cooperate in the administration of serial audiograms. Nephrotoxicity of similar severity developed in 7 of 73 (9.6%) recipients of tobramycin and in 7 of 67 (10.4%) recipients of netilmicin (P greater than 0.05). Mild or slight auditory toxicity developed in 5 of 28 (17.8%) recipients of tobramycin and in 2 of 27 (7.4%) recipients of netilmicin (P greater than 0.05).
An Adaptive Thresholding Method for BTV Estimation Incorporating PET Reconstruction Parameters: A Multicenter Study of the Robustness and the Reliability

The aim of this work was to assess robustness and reliability of an adaptive thresholding algorithm for the biological target volume estimation incorporating reconstruction parameters.



In a multicenter study, a phantom with spheres of different diameters (6.5-57.4 mm) was filled with (18)F-FDG at different target-to-background ratios (TBR: 2.5-70) and scanned for different acquisition periods (2-5 min). Image reconstruction algorithms were used varying number of iterations and postreconstruction transaxial smoothing. Optimal thresholds (TS) for volume estimation were determined as percentage of the maximum intensity in the cross section area of the spheres. Multiple regression techniques were used to identify relevant predictors of TS.



The goodness of the model fit was high (R(2): 0.74-0.92). TBR was the most significant predictor of TS. For all scanners, except the Gemini scanners, FWHM was an independent predictor of TS. Significant differences were observed between scanners of different models, but not between different scanners of the same model. The shrinkage on cross validation was small and indicative of excellent reliability of model estimation.



Incorporation of postreconstruction filtering FWHM in an adaptive thresholding algorithm for the BTV estimation allows obtaining a robust and reliable method to be applied to a variety of different scanners, without scanner-specific individual calibration.
Small prosthesis size in aortic valve replacement does not affect mortality.

Small prosthesis size has been associated with poorer postoperative outcomes in aortic valve replacement (AVR). We hypothesized that the use of small aortic valve (AV) prostheses does not independently increase operative mortality following AVR, but that mortality may instead be related to comorbidities.



We examined the mortality among 4,621 patients who underwent primary AVR operations at 13 different statewide centers from 2003 to 2008. Patients were stratified by prosthesis size into groups with small (≤21 mm, n=1,810) and standard AV prostheses (≥23 mm, n=2,811). The effect of prosthesis size on outcomes was evaluated with univariate and multivariable regression analyses.



Operative mortality among patients undergoing primary AVR operations was 3.7%. Among isolated operations, small AV prostheses were implanted in more females (79.9% vs 21.0%, p<0.001) and older patients (68.9±12.3 years vs 63.8±13.9 years, p<0.001) than were standard-size AV prostheses, and carried a higher predicted risk of mortality according to the Society of Thoracic Surgeons Predicted Risk of Mortality Score (3.1 [interquartile range, 3.0] versus 2.2 [2.0], p<0.001) than did standard-size AV prostheses. Small AV prostheses incurred more major complications (19.5% vs 15.7%, p=0.01), a greater mortality (3.9% vs 2.3%, p=0.03), a longer postoperative length of stay (6.0 [3.0] vs 5.0 [3.0] days, p<0.001), and higher total costs ($29,738 [18,196] vs $26,679 [14,890], p<0.001) than did standard AV prostheses. However, when analyzed with multivariate regression, small AV prosthesis size and female gender were not independent predictors of operative mortality, whereas advanced age, cardiopulmonary bypass time, and aortic annular enlargement were important predictors of operative mortality.



Small aortic valve prosthesis size does not independently increase operative mortality following primary AVR. Increased morbidity and mortality among patients undergoing the implantation of small AV prostheses is related to the confounding effects of preoperative and operative risk factors. Annular enlargement may not always reduce mortality.
Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials

All sectors of the economy, including the health research sector, must reduce their carbon emissions. The UK National Institute for Health Research has recently prepared guidelines on how to minimize the carbon footprint of research. We compare the carbon emissions from two international clinical trials in order to identify where emissions reductions can be made.



We conducted a carbon audit of two clinical trials (the CRASH-1 and CRASH-2 trials), quantifying the carbon dioxide emissions produced over a one-year audit period. Carbon emissions arising from the coordination centre, freight delivery, trial-related travel and commuting were calculated and compared.



The total emissions in carbon dioxide equivalents during the one-year audit period were 181.3 tonnes for CRASH-1 and 108.2 tonnes for CRASH-2. In total, CRASH-1 emitted 924.6 tonnes of carbon dioxide equivalents compared with 508.5 tonnes for CRASH-2. The CRASH-1 trial recruited 10,008 patients over 5.1 years, corresponding to 92 kg of carbon dioxide per randomized patient. The CRASH-2 trial recruited 20,211 patients over 4.7 years, corresponding to 25 kg of carbon dioxide per randomized patient. The largest contributor to emissions in CRASH-1 was freight delivery of trial materials (86.0 tonnes, 48% of total emissions), whereas the largest contributor in CRASH-2 was energy use by the trial coordination centre (54.6 tonnes, 30% of total emissions).



Faster patient recruitment in the CRASH-2 trial largely accounted for its greatly increased carbon efficiency in terms of emissions per randomized patient. Lighter trial materials and web-based data entry also contributed to the overall lower carbon emissions in CRASH-2 as compared to CRASH-1.