nils-herrmann/clean_scirepeval huggingface dataset:
Twelve-month safety of intravitreal injections of bevacizumab (Avastin®): results of the Pan-American Collaborative Retina Study Group (PACORES)

Vascular endothelial growth factor (VEGF) plays an important role in many diseases of the posterior pole that are characterized by macular edema and/or intraocular neovascularization. Recently anti-VEGF agents such as ranibizumab and pegaptanib sodium have been shown to be beneficial in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (ARMD). However in most parts of the world, both pegaptanib sodium and ranibizumab are not readily available. Bevacizumab, a humanized recombinant monoclonal IgG antibody that binds and inhibits all VEGF isoforms, has been proposed as an alternative treatment option. A total of 1,265 consecutive patients were injected with bevacizumab for diseases such as proliferative diabetic retinopathy, diabetic macular edema, retinal vein occlusions, and CNV of several etiologies including ARMD at eight Latin American institutions from 1 September 2005 to 31 January 2006. Of these 1,265, 92 were excluded because they were injected once and lost to follow-up. The remaining 1,173 patients constitute the subjects of this retrospective, multicenter, open label, uncontrolled interventional case series that reports the cumulative systemic and ocular adverse events following intravitreal bevacizumab during 12 months of follow-up. Patients were examined at baseline and then monthly. If the patients were unable to attend the 12-month visit, a telephone interview was conducted to assess for possible systemic complications. A total of 4,303 intravitreal injections of bevacizumab on 1,310 eyes was reported. All 1,173 patients were accounted for at the 12-month visit. Systemic adverse events were reported in 18 (1.5%) patients. These included seven (0.59%) cases of an acute elevation of systemic blood pressure, six (0.5%) cerebrovascular accidents, five (0.4%) myocardial infarctions, two (0.17%) iliac artery aneurysms, two (0.17%) toe amputations and five (0.4%) deaths. Ocular complications included seven (0.16%) bacterial endophthalmitis, seven (0.16%) tractional retinal detachments, four (0.09%) uveitis, and a case (0.02%) each of rhegmatogenous retinal detachment and vitreous hemorrhage. Despite the limited follow-up, repeated intravitreal injections of either 1.25 mg or 2.5 mg of bevacizumab appears to be safe and well tolerated during the 1st year.
The cost-effectiveness of a treatment-based classification system for low back pain: design of a randomised controlled trial and economic evaluation

Systematic reviews have shown that exercise therapy and spinal manipulation are both more effective for low back pain (LBP) than no treatment at all. However, the effects are at best modest. To enhance the clinical outcomes, recommendations are to improve the patient selection process, and to identify relevant subgroups to guide clinical decision-making. One of the systems that has potentials to improve clinical decision-making is a treatment-based classification system that is intended to identify those patients who are most likely to respond to direction-specific exercises, manipulation, or stabilisation exercises.



The primary aim of this randomised controlled trial will be to assess the effectiveness of a classification-based system. A sample of 150 patients with subacute and chronic LBP who attend a private physical therapy clinic for treatment will be recruited. At baseline, all participants will undergo a standard evaluation by trained research physical therapists and will be classified into one of the following subgroups: direction-specific exercises, manipulation, or stabilisation. The patient will not be informed about the results of the examination. Patients will be randomly assigned to classification-based treatment or usual care according to the Dutch LBP guidelines, and will complete questionnaires at baseline, and 8, 26, and 52 weeks after the start of the treatment. The primary outcomes will be general perceived recovery, functional status, and pain intensity. Alongside this trial, an economic evaluation of cost-effectiveness and cost-utility will be conducted from a societal perspective.



The present study will contribute to our knowledge about the effectiveness and cost-effectiveness of classification-based treatment in patients with LBP.
Effects of valproate or lamotrigine monotherapy on the reproductive endocrine and insulin-related metabolic profile in Chinese adults with epilepsy: A prospective randomized study

Cross-sectional studies have suggested that valproate treatment may be associated with hyperinsulinemia and hyperandrogenism in women. Few prospective data are available. We evaluated the reproductive endocrine and insulin-related metabolic parameters in men and women with untreated epilepsy randomized to valproate (n=44) or lamotrigine (n=37) monotherapy for 12 months. On treatment, there was no significant difference in fasting serum insulin concentrations between the two groups. In women (n=40), there was no significant difference between the two groups in change from baseline in serum total testosterone, dehydroepiandrosterone sulfate, luteinizing hormone, or follicle-stimulating hormone. In men (n=41), follicle-stimulating hormone concentration significantly decreased in patients taking valproate compared with those on lamotrigine as early as 3 months after treatment. Greater attention should be paid to investigate the potential impact of valproate on reproductive function in men.
Perfusion CT findings in patients with metastatic carcinoid tumors undergoing bevacizumab and interferon therapy.

The purpose of this article is to assess tumor changes on perfusion CT with bevacizumab and interferon (IFN) therapy in patients with metastatic carcinoid tumors and to evaluate perfusion CT differences between the two therapies.



In a phase 2 clinical trial, 44 patients were randomized to receive monotherapy with bevacizumab or IFN for 18 weeks (stage 1), followed by dual-therapy with both drugs (stage 2). Twenty-four patients consented to have optional perfusion CT examinations, which were undertaken at baseline and 18 weeks and at intervening 2 days (bevacizumab arm) or 9 weeks (IFN arm), and subsequently at 2 days after the addition of bevacizumab (IFN arm) and 9 weeks after the addition of IFN (bevacizumab arm). Tumor blood flow, blood volume, and permeability were evaluated.



In the bevacizumab arm (n = 12), mean (± SD) blood flow reduced significantly after 2 days compared with baseline (16.2 ± 6.9 vs 32.3 ± 21.3 mL/min/100 g; p = 0.02), a 41.4% reduction (p < 0.0001) that was relatively fixed. Blood volume was similarly reduced from baseline values (2.8 ± 1.3 vs 4.3 ± 2.1 mL/100 g; p = 0.02), a 27.9% reduction (p < 0.02). Both measures remained essentially unchanged at 18 weeks. Similar changes in blood flow and blood volume were observed with the addition of bevacizumab in stage 2. No significant changes in blood flow or blood volume were detected in the IFN arm (n = 12), and no significant changes in permeability were detected in either arm.



Perfusion CT detects significant changes in perfusion parameters in metastatic carcinoid tumors treated with bevacizumab. Such changes are apparent just 2 days into therapy, are sustained, and are significantly different from those associated with IFN treatment. Tumor blood flow decreased with bevacizumab treatment by a relatively fixed percentage relative to baseline measurements.
Study of the bronchodilating effect of three doses of nebulized oxitropium bromide in asthmatic preschool children using the forced oscillation technique

The aim of this study was to evaluate the bronchodilating capacity of nebulized oxitropium bromide (OB) in preschool asthmatic children and to determine an appropriate dose for usage in this age group. The trial enrolled 20 patients with moderate to severe stable asthma aged between 3.2 and 6.2 years (mean 4.7). Applying a placebo controlled, double-blind design, the effect of placebo was compared with three different doses of OB (375, 750 and 1500 μg) and with 400 μg fenoterol. The three different doses of OB resulted in a highly significant bronchodilation within 15 min after administration. The observed bronchodilation was comparable between the three doses during the first 2 h. However, after 4 h the lowest dose was significantly less powerful than the highest dose. Compared to the additional bronchodilation induced by fenoterol, no difference was found with the degree of bronchodilation of OB which occurred during the first 2 h. Furthermore, <%b>after 4 h only the lowest dose of OB was significantly less powerful than fenoterol assessed 10 min following a single 400 μg dose.  Oxitropium bromide is a potent and long-acting bronchodilator in preschool children at a dose of 750 μg and 1500 μg. No side-effects were observed. The exact duration of action remains uncertain, but even 4␣h after inhaling 750 or 1500 μg of OB no additive bronchodilation induced by fenoterol could be observed.
Lateral approach is advantageous in total knee arthroplasty for valgus deformed knee

For the total knee arthroplasty in valgus deformed knee, superiority of the medial or lateral approach is still controversial. We compared the short-term result of two approach groups. Forty-seven knees in rheumatoid arthritis with valgus deformity from 6° to 24° were randomly divided into two group; medial approach (24 knees) and lateral approach (24 knees). We used Scorpio NRG PS for all knees. Median postoperative periods were 43 months in both groups. We compared the surgical time, and alignment on standing radiograph, range of motion (ROM) pre/postoperatively, and degrees of soft-tissue release procedure, and lateral laxity measured by stress radiograph immediately after operation and at final follow-up. Pre/postoperative alignment, surgical time, lateral laxity, and preoperative ROM had no significant in two groups; however, postoperative flexion was superior in lateral approach group 123.8°, 109° in medial approach group. All cases required iliotibial band (ITB) release at Gerdy’s tubercle, 83 % ITB at joint level, 21 % lateral collateral ligament (LCL), 17 % popliteus tendon (PT) in medial approach group, and 88 % ITB at Gerdy’s tubercle, 46 % ITB at joint level, 13 % LCL, 4 % PT in lateral approach group. In the valgus knee, lateral structures are tight. Lateral approach can directly adjust the tight structure, and also less vascular compromise to the patella than medial approach with lateral patellar release. Less invasiveness to the quadriceps muscle in lateral approach could result into better range of motion after the surgery.
The added value of semimicroelectrode recording in deep brain stimulation of the subthalamic nucleus for Parkinson disease.

OBJECT
Accurate placement of the leads is crucial in deep brain stimulation (DBS). To optimize the surgical positioning of the lead, a combination of anatomical targeting on MRI, electrophysiological mapping, and clinical testing is applied during the procedure. Electrophysiological mapping is usually done with microelectrode recording (MER), but the relatively undocumented semimicroelectrode recording (SMER) is a competing alternative. In this study the added value and safety of SMER for optimal lead insertion in the subthalamic nucleus (STN) in a consecutive cohort of patients with Parkinson disease (PD) was assessed.



Between 2001 and 2010, a consecutive single-center cohort of 46 patients with PD underwent DBS of the STN (85 lead insertions). After exclusion of 11 lead insertions for mostly technical reasons, 74 insertions were included for the assessment. Anatomical target localization was based on either 1.5-T MRI or fused 3-T MRI with CT, with reference to anterior commissure-posterior commissure coordinates. Electrophysiological mapping was performed with SMER. Intraoperative clinical testing was dominant in determining the final lead position. The target error was defined as the absolute distance between the anatomical or electrophysiological target and the final lead position. The effect of SMER on anatomical target error reduction and final target selection was analyzed. Also, the anatomical and electrophysiological target error was judged against the different imaging strategies. For safety evaluation, the adverse events related to all lead insertions were assessed.



The use of SMER significantly reduced the anatomical target error from 1.7 (SD 1.6) mm to 0.8 (SD 1.3) mm (p < 0.0001). In particular, the anatomical target error based on 1.5-T MRI was significantly reduced by SMER, from 2.3 (SD 1.5) mm to 0.1 (SD 0.5) mm (p < 0.001). Anatomical target error reduction based on 3-T MRI fused with CT was not significantly influenced by SMER (p = 0.2), because the 3-T MRI-CT combination already significantly reduced the anatomical target error from 2.3 (SD 1.5) mm to 1.5 (SD 1.5) mm compared with 1.5-T MRI (p = 0.03). No symptomatic intracerebral hemorrhage was reported. Intracerebral infection was encountered in 1 patient following lead insertion.



Semimicroelectrode recording has added value in targeting the STN in DBS for patients with PD based on 1.5-T MRI. The use of SMER does not significantly reduce the anatomical target error in procedures with fused 3-T MRI-CT studies and therefore might be omitted. With the absence of hemorrhagic complications, SMER-guided lead implantation should be considered a safe alternative to MER.
Optimizing efficiency of psychopathology assessment through quantitative modeling: development of a brief form of the Externalizing Spectrum Inventory.

The Externalizing Spectrum Inventory (ESI; Krueger, Markon, Patrick, Benning, & Kramer, 2007) provides for integrated, hierarchical assessment of a broad range of problem behaviors and traits in the domain of deficient impulse control. The ESI assesses traits and problems in this domain through 23 lower order facet scales organized around 3 higher order dimensions, reflecting general disinhibition, callous aggression, and substance abuse. The full-form ESI contains 415 items, and a shorter form would be useful for questionnaire screening studies or multimethod research protocols. In the current work, we employed item response theory and structural modeling methods to create a 160-item brief form (ESI-BF) that provides for efficient measurement of the ESI's lower order facets and quantification of its higher order dimensions either as scale-based factors or as item-based composites. The ESI-BF is recommended for use in research on psychological or neurobiological correlates of problems such as risk-taking, delinquency, aggression, and substance abuse, and studies of general and specific mechanisms that give rise to problems of these kinds.
Abdominal vascular and visceral parenchymal contrast enhancement in MDCT: effects of injection duration.

To evaluate and compare the effect of short and long injection durations on aortic, pancreatic and hepatic enhancement in abdominal MDCT.



Triphasic contrast-enhanced CT images (16-MDCT, 1.25-mm collimation, 5-mm thickness, 6.1-s acquisition time for each phase) were obtained with 2 mL/kg injection of 300 mgI/mL iodine contrast material in 116 patients. Patients were prospectively randomized into two groups: one receiving contrast medium for 25-s injection duration and the other for 35-s injection duration. In both groups, triphasic scans were initiated 5, 15, and 40s after the completion of contrast injection for the first, second and third phases, respectively. CT values (HU) in the abdominal aorta, liver, spleen, pancreas, splenic and superior mesenteric arteries, and veins (splenic, superior mesenteric, portal, and hepatic) were measured. Quantitative and qualitative analysis for the degree of contrast enhancement between the two groups in various organs was compared at each scan phase.



The aortic and arterial enhancements in the first-phase scan were higher for the 25-s group than those of the 35-s group (P<.001). Hepatic enhancement was higher for the 35-s group in the first (P<.001) and second (P<.01) phases, but no difference in the third-phase. No difference was found between the groups for the pancreatic enhancement at any phases. Qualitative results were in good agreement with quantitative results.



Contrast administration with shorter injection duration increased peak aortic and arterial enhancement and contributed to improvement in the quality of CT angiograms, but for the solid abdominal organs 35-s protocol is recommended.
Diabetes mellitus and subsite-specific colorectal cancer risks in the Iowa Women's Health Study.

Controversy remains regarding the association between type 2 diabetes mellitus (DM) and colorectal cancer (CRC) risk. To clarify and extend the existing data, we prospectively evaluated the association between self-reported type 2 DM (onset at >30 years of age) and incident CRC, overall and by anatomic subsite, among postmenopausal women in the Iowa Women's Health Study (n = 35,230).



After 14 years of follow-up, a total of 870 incident CRC cases were identified through annual linkage to the Iowa Cancer Registry. DM was analyzed as reported at baseline and as a time-dependent variable using information obtained during follow-up. CRC risks were estimated using Cox proportional hazards regression models.



After adjusting for age, body mass index and other potential confounding variables, the relative risk (RR) for women with DM versus women without DM was modestly increased at 1.4 [95% confidence interval (95% CI), 1.1-1.8]. By anatomic subsite, the RR for proximal colon cancer was statistically significantly increased (RR, 1.9; 95% CI, 1.3-2.6), whereas the RRs for distal colon (RR, 1.1; 95% CI, 0.6-1.8) and rectal cancer (RR, 0.8; 95% CI, 0.4-1.6) were not statistically different from unity. Analyses that included DM ascertained at baseline and follow-up yielded similar results.



In this large, prospective study of postmenopausal women, the association between DM and incident CRC was found to be subsite specific. If confirmed by others, this finding implies that CRC prevention strategies among type 2 DM patients should include examination of the proximal colon.
Automated localization and segmentation of lung tumor from PET-CT thorax volumes based on image feature analysis

Positron emission tomography - computed tomography (PET-CT) plays an essential role in early tumor detection, diagnosis, staging and treatment. Automated and more accurate lung tumor detection and delineation from PET-CT is challenging. In this paper, on the basis of quantitative analysis of contrast feature of PET volume in SUV (standardized uptake value), our method firstly automatically localized the lung tumor. Then based on analysing the surrounding CT features of the initial tumor definition, our decision strategy determines the tumor segmentation from CT or from PET. The algorithm has been validated on 20 PET-CT studies involving non-small cell lung cancer (NSCLC). Experimental results demonstrated that our method was able to segment the tumor when adjacent to mediastinum or chest wall, and the algorithm outperformed the other five lung segmentation methods in terms of overlapping measure.
Impact of renal denervation on 24-hour ambulatory blood pressure: results from SYMPLICITY HTN-3.

Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure.



SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) was a prospective, blinded, randomized, sham-controlled trial. The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization.



Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control. Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization. The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure (SBP). Nondipper to dipper (nighttime blood pressure [BP] 10% to 20% lower than daytime BP) conversion was calculated at 6 months.



The 24-h ambulatory SBP changed -6.8 ± 15.1 mm Hg in the denervation group and -4.8 ± 17.3 mm Hg in the sham group: difference of -2.0 mm Hg (95% confidence interval [CI]: -5.0 to 1.1; p = 0.98 with a 2 mm Hg superiority margin). The daytime ambulatory SBP change difference between groups was -1.1 (95% CI: -4.3 to 2.2; p = 0.52). The nocturnal ambulatory SBP change difference between groups was -3.3 (95 CI: -6.7 to 0.1; p = 0.06). The percent of nondippers converted to dippers was 21.2% in the denervation group and 15.0% in the sham group (95% CI: -3.8% to 16.2%; p = 0.30). Change in 24-h heart rate was -1.4 ± 7.4 in the denervation group and -1.3 ± 7.3 in the sham group; (95% CI: -1.5 to 1.4; p = 0.94).



This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP in either the 24-h or day and night periods compared with sham (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261).
Type III procollagen-N-peptide as a predictor of persistent atrial fibrillation recurrence after cardioversion.

Fibrosis and inflammation may play a significant role in the pathogenesis of atrial fibrillation (AF) recurrence. Type III procollagen-N-peptide (PIIINP) may be related to atrial fibrosis and play a role in predicting the recurrence of AF. We investigated whether PIIINP as a fibrosis marker predicts the recurrence of AF after cardioversion.



Serum PIIINP, interleukin-6, high-sensitivity C-reactive protein, brain natriuretic peptide, renin and aldosterone were measured at baseline and 24 months in 88 patients (62%) with sinus rhythm (SR) maintenance and 54 patients (38%) with AF recurrence. Furthermore, the root mean square voltage in the last 20 ms (RMS20) via P-wave signal-averaged electrocardiogram (P-SAECG) was measured and the relationship between fibrosis biomarkers and RMS20 was examined. Baseline PIIINP with AF recurrence was significantly higher than for those with SR maintenance (0.664 vs. 0.581 U/mL, P = 0.001). However, there were no significant differences in other biomarkers. A logistic regression identified PIIINP (odds ratio 2.61, P = 0.008) as an independent predictor of AF recurrence. The RMS20 as measured by P-SAECG with SR maintenance and PIIINP levels <0.72 U/mL (at baseline) was significantly higher after 24 months than at baseline. Furthermore, the RMS20 with AF recurrence and PIIINP levels >0.72 U/mL (at baseline) was significantly lower after 24 months than baseline.



Elevated baseline PIIINP concentration is an independent predictor for AF recurrence after cardioversion. Furthermore, there is a relationship between PIIINP and RMS20 and the fibrosis of AF.