nils-herrmann/clean_scirepeval huggingface dataset:
Postoperative improvement in health-related quality of life: a national comparison of surgical treatment for focal (one- to two-level) lumbar spinal stenosis compared with total joint arthroplasty for osteoarthritis.

The results of single-center studies have shown that surgical intervention for lumbar spinal stenosis yielded comparable health-related quality of life (HRQoL) improvement to total joint arthroplasty (TJA). Whether these results are generalizable to routine clinical practice in Canada is unknown.



The primary purpose of this equivalence study was to compare the relative improvement in physical HRQoL after surgery for focal lumbar spinal stenosis (FLSS) compared with TJA for hip and knee osteoarthritis (OA) across six Canadian centers.



A Canadian multicenter ambispective cohort study.



A cohort of 371 primary one- to two-level spinal decompression (n=214 with instrumented fusion) for FLSS (n=179 with degenerative lumbar spondylolisthesis [DLS]) was compared with a cohort of primary total hip (n=156) and knee (n=208) arthroplasty for OA.



The primary outcome was the change in preoperative to 2-year postoperative 36-Item Short Form Health Survey Physical Component Summary (PCS) score as reflected by the number of patients reaching minimal clinically important difference (MCID) and substantial clinical benefit (SCB).



Univariate analyses were conducted to identify baseline differences and factors that were significantly related to outcomes at 2 years. Multivariable regression modeling was used as our primary analysis to compare outcomes between groups.



The mean age (years) and percent females for the spine, hip, and knee groups were 63.3/58.5, 66.0/46.9, and 65.8/64.3, respectively. All three groups experienced significant improvement of baseline PCS (p<.001). Multivariate analyses, adjusting for baseline differences (age, gender, baseline Mental Component Summary score, baseline PCS), demonstrated no significant differences in PCS outcome between spinal surgery and arthroplasty (combined hip and knee cohorts) patients with an odds ratio of 0.80 (95% confidence interval [CI], 0.57-1.11; p=.17) and 0.79 (95% CI, 0.58-1.09; p=.15) for achieving MCID or SCB, respectively. In subgroup analysis, spine and knee outcomes were not significantly different, with hip arthroplasty superior to both (p<.0001).



Significant improvement in physical HRQoL after surgical treatment of FLSS (including DLS) is consistently achieved nationally. Our overall results demonstrate that a comparable number of patients can expect to achieve MCID and SCB 2 years after surgical intervention for FLSS and total knee arthroplasty.
Effectiveness of mindfulness-based cognitive therapy for co-morbid depression in drug-dependent males.

The present study aimed at examining the effect of Mindfulness-Based Cognitive Therapy (MBCT) in decreasing depression symptoms in dully diagnosed males (drug dependent males with co-morbid depression).An experimental research design with pre- and post-tests and a control group was used. The sample of the study comprised 33 drug-dependent men who also endorsed depression symptoms on the Beck Depression Inventory II (BDI-II). All the selected individuals were assigned randomly to either the intervention group or control group (16 to the intervention and 17 to the control group). The intervention group experienced eight 2-h sessions of training in MBCT. At the end of the training, the subjects were once again evaluated using the BDI-II. Analysis of co-variance was used to analyze the data. The results suggested that MBCT did contribute to a significant decrease in the depression symptoms of the dully diagnosed individuals. It is recommended that the MBCT be used for treating depression in drug-dependent males undergoing detoxification and treatment for their drug dependence.
Assessment of QRS duration and presence of fragmented QRS in patients with Behçet's disease.

QRS prolongation and the presence of QRS fragmentation in 12-lead ECG are associated with increased mortality and sudden cardiac death in the long term. In this study we aimed to assess QRS duration and fragmentation in patients with Behçet's disease (BD).



A total of 50 patients (mean age 42.7±12.0 years) previously diagnosed with BD were recruited. In addition, a control group consisting of 50 healthy people (mean age 39.4±12.5 years) was formed. The longest QRS duration was measured in surface 12-lead ECG and QRS complexes were evaluated in terms of fragmentation. Serum C-reactive protein levels were also obtained.



QRS duration and corrected QT duration were significantly longer in patients with BD compared with controls (102.75±11.91 vs. 96.99±10.91 ms, P=0.007; 438.55±30.80 vs. 420.23±28.06 ms, P=0.003, respectively). Fragmented QRS (fQRS) pattern was more common in patients with BD than controls [n=27 (54%) vs. n=16 (32%), P=0.026]. Disease duration was longer in patients with BD with fQRS compared with those without (12.67±8.68 vs. 7.09±7.06 years, P=0.010). Furthermore, C-reactive protein level was higher in patients with BD with fQRS compared with those without (6.53±4.11 vs. 4.97±6.32 mg/dl, P=0.043). Correlation analysis revealed no association between disease duration and QRS duration (r=0.219, P=0.126).



QRS duration is greater and fQRS complexes are more frequent in patients with BD. These findings may indicate subclinical cardiac involvement in BD. Given the prognostic significance of ECG parameters, it is reasonable to evaluate patients with BD with prolonged and fQRS complexes more in detail such as late potentials in signal averaged ECG in terms of cardiac involvement.
Specific active immunotherapy with a VEGF vaccine in patients with advanced solid tumors. results of the CENTAURO antigen dose escalation phase I clinical trial.

CIGB-247 is a novel cancer therapeutic vaccine that uses a human VEGF variant molecule as antigen, in combination with a bacterial adjuvant. In mice, CIGB-247 has anti-tumor and anti-metastatic effects. The vaccine induces anti-VEGF blocking antibodies and a cellular response targeting tumor cells producing VEGF, and has proven to be safe in mice, rats, rabbits and non-human primates. Herein we report the results of a Phase I clinical trial (code name CENTAURO) where safety, tolerance, and immunogenicity of CIGB-247 were studied in 30 patients with advanced solid tumors, at three antigen dose levels. Individuals were subcutaneously immunized for 8 consecutive weeks with 50, 100 or 400 μg of antigen, and re-immunized on week twelve. On week sixteen, evaluations of safety, tolerance, clinical status, and immunogenicity (seroconversion for anti-VEGF IgG, serum VEGF/KDR-Fc blocking ability, and gamma-IFN ELISPOT with blood cells stimulated in vitro with mutated VEGF) were done. Surviving patients were eligible for off-trial additional 4-week re-immunizations with 400 μg of antigen. Immunogenicity and clinical status were again studied on weeks 25 and 49. Vaccination was shown to be safe at the three dose levels, with only grade 1-2 adverse events. CIGB-247 was immunogenic and higher numbers of individuals positive to the three immune response tests were seen with increasing antigen dose. Off-protocol long-term vaccination produced no additional adverse events or negative changes in immunogenicity. Eleven patients are still alive, with overall survivals ranging from 20 to 24 months. Twelve of the thirty patients exhibited objective clinical benefits, and two individuals have complete responses. Most patients with higher survivals are positive in the three immune response tests. In summary, this is the first clinical testing report of a cancer therapeutic vaccine based on a human VEGF related molecule as antigen. The CIGB-247 vaccine is safe, immunogenic, and merits further clinical development.
High volume intraperitoneal chemotherapy (“Belly bath”) for ovarian cancer

The currently accepted therapies for ovarian cancer have produced only limited numbers of extended complete remissions in advanced-stage disease. Studies of high-volume intraperitoneal chemotherapy have been initiated to define the toxicology, pharmacokinetics, and the therapeutic effectiveness of this treatment modality. This technique has been virtually ignored until recently, because little success has been achieved with it except in one study (Rutledge, 1966), in which large intraperitoneal fluid volumes were used. The general lack of success probably reflects inadequate attention to physiologic and pharmacologic principles of drug distribution and absorption in a space as large as the peritoneal cavity. Biomedical engineers, pharmacologists, and clinicians at the NCI have cooperated in the development of a rational chemotherapy for ovarian cancer. Following mathematical pharmacokinetic modeling and toxicologic studies in rat, a Phase I clinical trial of intraperitoneal methotrexate administered in large volumes of dialysis fluid was initiated. Results in three patients confirm the practicality of this approach, and further investigation is warranted.
Accuracy of Computed Tomographic Angiography and Single-Photon Emission Computed Tomography-Acquired Myocardial Perfusion Imaging for the Diagnosis of Coronary Artery Disease.

Establishing the diagnosis of coronary artery disease (CAD) in symptomatic patients allows appropriately allocating preventative measures. Single-photon emission computed tomography (CT)-acquired myocardial perfusion imaging (SPECT-MPI) is frequently used for the evaluation of CAD, but coronary CT angiography (CTA) has emerged as a valid alternative.



We compared the accuracy of SPECT-MPI and CTA for the diagnosis of CAD in 391 symptomatic patients who were prospectively enrolled in a multicenter study after clinical referral for cardiac catheterization. The area under the receiver operating characteristic curve was used to evaluate the diagnostic accuracy of CTA and SPECT-MPI for identifying patients with CAD defined as the presence of ≥1 coronary artery with ≥50% lumen stenosis by quantitative coronary angiography. Sensitivity to identify patients with CAD was greater for CTA than SPECT-MPI (0.92 versus 0.62, respectively; P<0.001), resulting in greater overall accuracy (area under the receiver operating characteristic curve, 0.91 [95% confidence interval, 0.88-0.94] versus 0.69 [0.64-0.74]; P<0.001). Results were similar in patients without previous history of CAD (area under the receiver operating characteristic curve, 0.92 [0.89-0.96] versus 0.67 [0.61-0.73]; P<0.001) and also for the secondary end points of ≥70% stenosis and multivessel disease, as well as subgroups, except for patients with a calcium score of ≥400 and those with high-risk anatomy in whom the overall accuracy was similar because CTA's superior sensitivity was offset by lower specificity in these settings. Radiation doses were 3.9 mSv for CTA and 9.8 for SPECT-MPI (P<0.001).



CTA is more accurate than SPECT-MPI for the diagnosis of CAD as defined by conventional angiography and may be underused for this purpose in symptomatic patients.
The impact of a measurement and feedback intervention on blood pressure control in ambulatory cardiology practice.

Although hypertension is a modifiable cardiovascular risk factor, up to one-third of ambulatory patients have uncontrolled blood pressure (BP). We evaluated the impact of a targeted provider feedback intervention on rates of BP control.



Clinic BP readings were aggregated among approximately 3,000 hypertensive patients followed up in 42 outpatient cardiology clinic practices at a large quaternary care academic medical center. Physician practices received quarterly reports on BP control rates. Provider-specific reports were benchmarked vs overall peer performance and distributed quarterly between September 2011 and September 2012. Rates of BP control were evaluated before and after the intervention. Medical record reviews were performed for a subset of patients with uncontrolled BP before (n = 300) and after (n = 300) the intervention to evaluate provider responses and interventions.



At baseline, 27.9% of clinic patients had uncontrolled BP. After one 1 of reports, the rate of uncontrolled BP remained unchanged (27.7%, P = .86). Analysis of provider performance revealed a subset of providers who consistently outperform their peers. In the sample of patients selected for medical record reviews, at baseline (n = 300) and follow-up (n = 300), cardiologists discussed BP in 80% of clinic notes for patients with uncontrolled BP. Cardiologists more frequently documented repeat measurements after the intervention (28.0% vs 35.7%, P = .04). No other changes were found in documentation of provider responses to BP.



Clinician-specific audit and feedback reports as a stand-alone intervention did not affect overall BP control rates in cardiology clinics. Future BP control interventions should consider real-time patient-specific reminders, provider incentive programs, and patient engagement interventions.
Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia.

The purpose of this study was to evaluate the safety and efficacy of asenapine in adolescents with schizophrenia.



In an 8 week, randomized, double-blind placebo-controlled trial, subjects (12-17 years of age) meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria for schizophrenia were randomized 1:1:1 to placebo, asenapine 2.5 mg b.i.d., or asenapine 5 mg b.i.d. Subjects who completed the 8 week acute study could participate in a 26 week flexible-dose asenapine-only open-label extension (OLE).



A similar percentage of subjects completed treatment on day 56 (2.5 mg b.i.d. (n=98): 83%; 5 mg b.i.d.  79%; placebo [n=102]: 79%). In the mixed model for repeated measures analysis of the primary end-point (with Hochberg correction for multiplicity), least squares (LS) mean differences between asenapine and placebo on the Positive and Negative Syndrome Scale (PANSS) total score at day 56 were not significant (-4.8 for 2.5 mg b.i.d., p=0.070; -5.6 for 5 mg b.i.d., p=0.064). Significant improvement in the Clinical Global Impressions-Severity score was observed in the 5 mg b.i.d. group versus placebo on day 56 (LS mean -0.3, p=0.024). In the acute phase, ≥7% weight gain and the composite event of somnolence, sedation, and hypersomnia were more common in both asenapine groups than in the placebo group. Akathisia, fasting glucose elevation, and extrapyramidal syndrome were more common in the 5 mg b.i.d. group than in the placebo group. There were no unexpected adverse events in the OLE, and PANSS total scores decreased by -16.1 points in the group previously treated with placebo (n=62) and by -11.2 points in the continuous asenapine group (n=131) from OLE baseline to week 26.



Although improvements in PANSS total score at day 56 of the acute phase were numerically greater for both asenapine 2.5 and 5 mg b.i.d. than for placebo and were maintained in the OLE, the primary end-point did not achieve statistical significance in the acute phase. No new or unexpected safety concerns were detected during the acute phase or after an additional 26 weeks of asenapine treatment in the adolescent population with schizophrenia.
Weekly paclitaxel in the adjuvant treatment of breast cancer.

We compared the efficacy of two different taxanes, docetaxel and paclitaxel, given either weekly or every 3 weeks, in the adjuvant treatment of breast cancer.



We enrolled 4950 women with axillary lymph node-positive or high-risk, lymph node-negative breast cancer. After randomization, all patients first received 4 cycles of intravenous doxorubicin and cyclophosphamide at 3-week intervals and were then assigned to intravenous paclitaxel or docetaxel given at 3-week intervals for 4 cycles or at 1-week intervals for 12 cycles. The primary end point was disease-free survival.



As compared with patients receiving standard therapy (paclitaxel every 3 weeks), the odds ratio for disease-free survival was 1.27 among those receiving weekly paclitaxel (P=0.006), 1.23 among those receiving docetaxel every 3 weeks (P=0.02), and 1.09 among those receiving weekly docetaxel (P=0.29) (with an odds ratio >1 favoring the groups receiving experimental therapy). As compared with standard therapy, weekly paclitaxel was also associated with improved survival (odds ratio, 1.32; P=0.01). An exploratory analysis of a subgroup of patients whose tumors expressed no human epidermal growth factor receptor type 2 protein found similar improvements in disease-free and overall survival with weekly paclitaxel treatment, regardless of hormone-receptor expression. Grade 2, 3, or 4 neuropathy was more frequent with weekly paclitaxel than with paclitaxel every 3 weeks (27% vs. 20%).



Weekly paclitaxel after standard adjuvant chemotherapy with doxorubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer.
Assessment of tachyphylaxis following prolonged therapy of asthma with inhaled albuterol aerosol.

Controversy exists concerning possible tachyphylaxis of the acute bronchodilating effect of albuterol, especially with regard to the duration of its acute bronchodilating action. We evaluated 140 patients with bronchial asthma in a prospective double-blind controlled study of possible tachyphylaxis to albuterol aerosol as compared to isoproterenol aerosol. We demonstrated statistically significant tachyphylaxis with regard to duration of acute bronchodilating effect. We believe that this tachyphylaxis is not clinically significant because there was no tachyphylaxis with regard to peak bronchodilating effect and because the duration of bronchodilating effect remains significantly greater, both quantitatively and statistically, when compared to isoproterenol aerosol. Moreover, it appeared that most of the tachyphylaxis was present at four weeks of therapy. There was a small increment of tachyphylaxis after eight weeks of therapy, but no further increase in tachyphylaxis was demonstrated after 13 weeks of inhaled albuterol therapy. We therefore feel that clinically significant tachyphylaxis to inhaled albuterol aerosol must be quite unusual and that chronic therapy with inhaled albuterol aerosol is probably both safe and efficacious for bronchospastic disorders.
Cyclophosphamide and Nandrolone Decanoate in the Treatment of Advanced Carcinoma of the Breast—Results of a Comparative Controlled Trial of the Agents Used Singly and in Combination

A random trial in which cyclophosphamide, nandrolone decanoate and the two drugs in combination were used in the treatment of advanced breast carcinoma is described. The results suggest that it is preferable to use cyclophosphamide on its own.
Controlled trial of anti-tuberculous chemotherapy for two years in Crohn's disease.

One hundred and thirty patients with active symptoms of Crohn's disease were treated in a double blind randomised controlled trial with rifampicin, isoniazid, and ethambutol, or identical placebos for up to two years. All other treatment considered necessary was continued. Analyses were based on 126 patients, 63 in each treatment group. Thirty seven in the active and 30 in the placebo group had previous surgical procedures. There was no difference in concomitant treatment between the two groups. Thirty in the active and 46 in the placebo groups were taking corticosteroids at entry to the trial. Forty eight of 63 patients in the active and 49 of 63 in the placebo group, completed at least 12 months' therapy. Reasons for early withdrawal included pregnancy, adverse reaction, and failure to comply. There was no significant difference in the mean number of months completed between the two groups. Nineteen adverse reactions were recorded for 17 patients in the active group compared with three reactions in patients on placebo. All of the nine patients withdrawn early because of adverse reactions were in the active group. Fifteen patients on active treatment and 14 on placebo had surgery during the trial with no difference in the type of surgery required between the groups. Radiological assessments based on 98 patients at the end of the trial showed no significant differences between groups in changes of extent of disease. More patients developed strictures on placebo compared with active treatment but without a statistically significant difference. No differences were found between groups for the total prednisolone dose or the number of days on which prednisolone dose was 10 mg or above. Serial measurements of body weight and Crohn's disease activity index (CDAI) together with blood values for albumin, haemoglobin, white cell count, and platelets showed no consistent different differences between groups. There were occasional significant differences for some of these values between groups, which were not sustained. The trail provides little evidence of tangible benefit from the trail treatment.
An Assessment of the Validity and Reliability of the SOGS-RA

The present is a validation study seeking to determine the degree of confidence that can be placed on inferences about problem gambling among adolescents in the Atlantic provinces, based on their South Oaks Gambling Screen-Revised for Adolescents (SOGS-RA) scores. The major source of data was a 1998 survey of 13,549 students in junior and high school of the public school systems of the 4 Atlantic provinces of Canada. The SOGS-RA was found to have adequate stability and internal consistency reliability. Statistically significant gender differences were demonstrated relative to endorsement and construct validity. Regarding the latter, this study shows that the existing cut-point of the SOGS-RA score for problem gambling identifies as problem gamblers, markedly different proportions of male than female daily gamblers. Regarding construct validity in relation to the Atlantic Alcohol and Drug Risk Continua, this study suggests that while statistically highly significant, the association between problem gambling and substance-related problems may be of low clinical significance. Regarding criterion validity, there is an urgent need to perform the types of enquiry that will allow clarification about how adolescent problem gambling is conceptualized, by adults versus adolescents, by males versus females, and from a clinical versus a public or population health perspective.