nils-herrmann/clean_scirepeval huggingface dataset:
Efficiency of naproxen/esomeprazole in association for osteoarthrosis treatment in Spain.

To assess, from the perspective of the National Healthcare System, the efficiency of a fixed-dose combination of naproxen and esomeprazole (naproxen/esomeprazole) in the treatment of osteoarthritis (OA) compared to other NSAID, alone or in combination with a proton pump inhibitor (PPI).



A Markov model was used; it included different health states defined by gastrointestinal (GI) events: dyspepsia, symptomatic or complicated ulcer; or cardiovascular (CV) events: myocardial infarction, stroke or heart failure. The model is similar to the one used by NICE in its NSAID evaluation of OA published in 2008. The total costs (€, 2012), including drug and event-related costs, and the health outcomes expressed in quality-adjusted life years (QALY) were estimated in patients with increased GI risk, aged 65 or over, for a 1-year time horizon and a 6-month treatment with celecoxib (200mg/day), celecoxib+PPI, diclofenac (150mg/day)+PPI, etoricoxib (60mg/day), etoricoxib+PPI, ibuprofen (1,800mg/day)+PPI, naproxen (1,000mg/day)+PPI or naproxen/esomeprazole (naproxen 1,000mg/esomeprazole 40mg/day). The selected PPI was omeprazole (20mg/day).



Naproxen/esomeprazole was a dominant strategy (more effective and less costly) compared to celecoxib, etoricoxib and diclofenac+PPI. Celecoxib+PPI and etoricoxib+PPI were more effective. Considering a cost-effectiveness threshold of €30,000 per additional QALY, naproxen/esomeprazole was cost-effective compared to ibuprofen+PPI and naproxen+PPI with incremental cost-effectiveness ratios (ICER) of €15,154 and €5,202 per additional QALY, respectively.



A fixed-dose combination of naproxen and esomeprazole is a cost-effective, and even dominant, alternative compared to other options in OA patients with increased GI risk.
Long–term exercise improves functional impairment but not quality of life in multiple sclerosis

Regular exercise is important for patients with multiple sclerosis (MS) to maintain their functional ability and general health. The aim of this study was to determine whether a long–term exercise program has any effect on functional impairment or healthrelated quality of life (HRQOL) in subjects with mild to moderate MS. In a randomised controlled trial, subjects in the intervention group (n = 47) exercised according to a progressive exercise program, mainly consisting of resistance training, for six months. Subjects in the control group (n = 48) received no intervention. The subjects were assessed at baseline and at six months using the Multiple Sclerosis Functional Composite (MSFC), the Expanded Disability Status Scale (EDSS), the Functional Independence Measure (FIM), the MS Quality of Life–54 (MSQOL–54) questionnaire and the Centre for Epidemiologic Studies Depression Scale (CES–D). The drop–out rate was low (4%) with 91 subjects completing the study. At six months, the exercising subjects showed improvement on the MSFC (mean score change 0.114, 95% confidence interval [CI] 0.010 to 0.218), whereas the control subjects showed deterioration (mean score change –0.128, 95 % CI –0.232 to –0.025). The change between groups was statistically significant (interaction, p = 0.001). Consistent with the physical nature of the intervention, the change predominantly occurred in leg function/ambulation. The effect seen in the EDSS, FIM, MSQOL–54 or CES–D was nil. These findings indicate that MSFC is more sensitive than EDSS in the detection of improvement in functional impairment as a result of regular exercise. The unfavourable results from HRQOL do not rule out the possibility that other types of exercise programs may improve it in MS.
Recruiting Small Manufacturing Worksites That Employ Multiethnic, Low-wage Workforces Into a Cancer Prevention Research Trial

Worksites, including those that employ multiethnic, low-wage workforces, represent a strategic venue for reaching populations at risk for developing cancer.



We surveyed 197 small manufacturing worksites prior to an effort to recruit their workforces into a randomized clinical trial designed to test the effectiveness of a cancer prevention intervention among multiethnic, low-wage manufacturing workers. This paper assesses the external validity of the trial based on three factors: the percentage of potential trial sites excluded from consideration, the percentage of eligible worksites that adopted the trial, and worksite characteristics associated with adoption.



We found no statistically significant differences between worksites that adopted the trial and worksites that declined the trial with regard to employee demographics, anticipated changes in workforce size, and perceived importance and history of offering health promotion and occupational health and safety activities.



Small manufacturing worksites present a viable venue for reaching multiethnic, low-wage populations with cancer prevention programs, although program adoption rates may be low in this sector. Worksites that adopted the trial are likely to represent worksites deemed eligible for the trial.
Repair of erosions occurs almost exclusively in damaged joints without swelling.

Negative radiographic change scores obtained under blinded time-sequence conditions suggest that repair of joints may indeed occur. It is likely that, if repair truly exists, it would be preferentially seen in clinically inactive joints from patients treated with drugs with well-known structural efficacy.



To determine whether repair is associated with both the absence or improvement of swelling and with treatment.



Radiographs from patients of the TEMPO trial were scored twice by two readers according to the Sharp-van der Heijde score, blinded to both treatment and true time sequence. Single-joint change scores in erosions were coupled with single-joint swelling scores obtained from clinical examination. Consistency of observed improvement across readers and repeat reads was described, and factors expected to increase the likelihood of occurrence of both worsening and improvement of erosion were tested by generalised estimating equations (GEE) modelling.



In all of the four independent reads, the mean change in erosion score was statistically significantly negative only in the subgroup of joints with absent or improved swelling, when erosions were present at baseline. Multivariate analysis showed that worsening of the erosion score in a joint was significantly increased if that joint was already damaged at study entry, clinical swelling persisted and methotrexate was used instead of etanercept. Repair was associated with improvement of swelling and use of etanercept (p<or=0.007 for all associations).



Repair of erosions almost exclusively occurs in joints with improvement or absence of swelling, in patients treated with etanercept. Progression is seen more frequently in joints with persistent swelling, in patients receiving methotrexate monotherapy, primarily if damage is already present.
Proof-of-concept randomized controlled trial of pregnenolone in schizophrenia

Preclinical and clinical data suggest that pregnenolone may be a promising therapeutic in schizophrenia. Pregnenolone is neuroprotective and enhances learning and memory, myelination, and microtubule polymerization. Treatment with pregnenolone elevates allopregnanolone (a neurosteroid that enhances GABAA receptor responses) and pregnenolone sulfate (a positive NMDA receptor modulator). Pregnenolone could thus potentially mitigate GABA dysregulation and/or NMDA receptor hypofunction in schizophrenia via metabolism to other neurosteroids. The objective of this study is to conduct a randomized controlled trial of adjunctive pregnenolone in schizophrenia. Following a placebo lead-in, 120 participants were randomized to pregnenolone or placebo for 8 weeks (Institute for Mental Health, Singapore). Primary endpoints were changes in MATRICS Consensus Cognitive Battery (MCCB) composite scores (cognitive symptoms), UCSD Performance-based Skills Assessment—Brief (UPSA-B) composite scores (functional capacity), and Scale for Assessment of Negative Symptoms (SANS) total scores (negative symptoms). A modified intent-to-treat analysis approach was utilized. No significant changes compared to placebo were demonstrated in composite MCCB scores. In contrast, participants randomized to pregnenolone (n = 56) demonstrated greater improvements in functional capacity (UPSA-B composite changes) compared to placebo (n = 55), p = 0.03. Pregnenolone was also superior to placebo in the communication subscale of the UPSA-B (p < 0.001). Serum pregnenolone changes post-treatment were correlated with UPSA-B composite score changes in females (r s = 0.497, p < 0.042, n = 17) but not in males. Mean total SANS scores were very low at baseline and did not improve further post-treatment. Pregnenolone was well-tolerated. Pregnenolone improved functional capacity in participants with schizophrenia, but did not improve cognitive symptoms over an 8-week treatment period. Neurosteroid changes correlated with functional improvements in female participants. Neurosteroid interventions may exhibit promise as new therapeutic leads for schizophrenia.
Massage application for occupational low back pain in nursing staff.

This is a clinical trial which aims to evaluate the efficiency of massage in the reduction of occupational low back pain, and its influence on the performance of work and life activities for the nursing team. The sample consisted of 18 employees who received seven to eight sessions after their work period. From the Numerical Pain Rating Scale, significant improvements were found between the 3rd and 1st evaluations (p=0.000) and between the 3rd and 2nd (p=0.004), using the Wilcoxon test. Regarding the Oswestry Disability Index, the paired t test showed a statistical difference (p=0.02) between the baseline, with a mean of 21.33% and the second evaluation (18.78%), which was also seen between the second and third evaluation (16.67%). The score for the Handling and Transfer Risk Evaluation Scale was 18 points (medium risk). It is concluded that massage was effective in reducing occupational low back pain, and provided improvement in activities of work and life.
Peri-insular hemispherotomy in paediatric epilepsy

Outline the indications, investigation, surgical technique, pitfalls, complications and benefits of peri-insular hemispherotomy (PIH) in the surgical treatment of paediatric epilepsy. This report is based on a consecutive series of 43 children who underwent PIH. Sixty percent were males; there were slightly more left-sided surgeries. Median interval between seizure onset and surgery was 5 years. In more than half the cases, the anatomical substrate was congenital. There were few complications: one death, one hydrocephalus and two anatomically remote haemorrhages. Ninety percent of the patients have remained in Engel’s class I epilepsy outcome. There are clear indications for hemispherectomy in children. In some instances of incomplete deficit, timing of surgery remains a major concern. The less invasive approach to eliminate the influence of the diseased hemisphere, in our opinion, is with disconnective techniques of hemispherectomy, and among the latter, peri-insular hemispherotomy provides, in our opinion, the best complications–benefits ratio.
A phase I study of the pan bcl-2 family inhibitor obatoclax mesylate in patients with advanced hematologic malignancies.

The outcome of patients with refractory leukemia and myelodysplasia is poor, and new therapies are needed. The antiapoptotic proteins of the Bcl-2 family are overexpressed in these malignancies and are potential therapeutic targets. Therefore, we conducted a phase I clinical trial of the small-molecule pan-Bcl-2 inhibitor, obatoclax mesylate, in patients with refractory leukemia and myelodysplasia to assess its safety and define its optimal dose.



Forty-four patients with refractory leukemia or myelodysplasia were treated with obatoclax mesylate by continuous intravenous infusion at increasing doses and frequencies.



A total of 306 infusions of obatoclax mesylate were administered with a median of 5 infusions per patient. The study drug was well tolerated up to the highest dose planned without dose-limiting toxicity. Grade 1/2 central nervous system symptoms were the most common adverse events attributable to the study drug. One patient with acute myeloid leukemia with mixed lineage leukemia t(9;11) rearrangement achieved a complete remission, which lasted 8 months. Three of 14 patients with myelodysplasia showed hematologic improvement with RBC or platelet transfusion independence.



Obatoclax mesylate is well tolerated and these results support its further investigation in patients with leukemia and myelodysplasia.
Perceived exertion and rehabilitation with arm crank in elderly patients after total hip arthroplasty: a preliminary study.

This preliminary study examined, in a restricted randomized trial, the effects of a 6-week arm-crank rehabilitation training program in elderly osteoarthrosis patients after total hip arthroplasty, first on physiological and perceptual responses and second on physical function. Two groups of patients were studied: a training group (N = 7, mean age = 74.9 yr, standard deviation [SD] = 5.0 yr) who followed a training program in addition to traditional rehabilitation, and a control group who followed traditional rehabilitation only (N = 7 mean age = 75.4 yr, SD = 5.1 yr). At the beginning of the training program, the heart rate and the perceived exertion were not significantly correlated during the exercise session. However, at the end of the training program, five patients had a significant heart rate/perceived exertion relationship (p < 0.05). Furthermore, positive effects of the arm-crank rehabilitation training program were observed on cardioventilatory and functional responses in the training group compared with the control group. These results suggest that after an habituation period, most of our elderly osteoarthrosis patients experienced physical sensations that were connected to physiological responses. Therefore, perceived exertion could be useful in these patients to regulate exercise intensity, especially at the end of and after the rehabilitation period.
Psychological morbidity and health-related quality of life in patients with differing awareness of cancer diagnosis: a cross-sectional study.

Concealment of cancer diagnosis from patients is not rare worldwide and physicians in mainland China are in fact discouraged from disclosing a cancer diagnosis to cancer patients. Preventing worsened psychological morbidity is at the core of the argument for nondisclosure. The purpose of this study was to quantify anxiety, depression, and distress among patients with various degrees of awareness of their cancer diagnosis. Quality of life was also measured.



Using a cross-sectional and blinded design, the Hospital Anxiety and Depression Scale questionnaire, the Distress Thermometer, and the SF-36 Health Survey were administered to 287 hospitalized patients with oral and maxillofacial tumors. Independently, the patients' awareness of disease was assessed with semistructured interviews.



Hospital Anxiety and Depression Scale, Distress Thermometer, and SF-36 did not identify significant differences in scores among the hospitalized patients with various degrees of awareness of their cancer diagnosis: an awaiting diagnosis group, a concealed diagnosis group, and a disclosed diagnosis group.



Before surgery, inpatients who were hospitalized because of oral and maxillofacial tumors with various degrees of awareness of their cancer diagnosis had similar psychological morbidity and quality of life. Informing hospitalized cancer patients of their diagnosis before surgery may not deteriorate their psychiatric condition or their quality of life.
The effect of sulphurous air pollutant exposures on symptoms, lung function, exhaled nitric oxide, and nasal epithelial lining fluid antioxidant concentrations in normal and asthmatic adults.

To explore the effects in normal and asthmatic adults of exposure to 200 ppb sulphur dioxide (SO2) and 200 microg/m3 and 2000 microg/m3 aerosols of ammonium bisulphate (AB) and sulphuric acid (SA) (MMD 0.3 microm).



Exposures were placebo controlled, for one hour at rest, double blind in random order. DeltaFEV1 was the primary outcome; secondary outcomes included symptoms, ventilation, exhaled nitric oxide (NO) concentrations, and nasal lavage fluid ascorbic (AA) and uric acid (UA) concentrations.



There were no significant changes in spirometry or symptoms with any exposure in either group. SO2 exposure was associated with an increased respiratory rate relative to air exposure in the asthmatic group (SO2: 958.9 breaths/hour; air: 906.8 breaths/hour) but the mean volume breathed did not differ significantly (SO2: 318.8 litres; air: 311.4 litres). AB exposures were associated with a significant rise in [NO] in the asthmatic (+1.51 ppb, and +1.39 ppb), but not in the normal group. Mean pre- and post-exposure [AA] tended to be higher in the normal than in the asthmatic group. Within each group, [AA] did not change significantly with any exposure. Post-exposure [UA] were greater than pre-exposure concentrations for all exposures, significantly so in the normal group for all exposures except SO2. There were no significant differences in the mean change in [UA] for any exposure relative to air.



The pollutant exposure concentrations employed in this study were generally much greater than ambient. It is unlikely that short lived exposures at lower concentrations would show significant effects, but effects of longer term lower concentration exposures cannot be ruled out.
CT quality assurance in the lung screening study component of the National Lung Screening Trial: implications for multicenter imaging trials.

The purpose of this study was to describe the effect of implementing an imaging quality assurance program on CT image quality in the Lung Screening Study component of the National Lung Screening Trial.



The National Lung Screening Trial is a multicenter study in which 53,457 subjects at increased risk of lung cancer were randomized to undergo three annual chest CT or radiographic screenings for lung cancer to determine the relative effect of use of the two screening tests on lung cancer mortality. Of the 26,724 subjects randomized to the CT screening arm of the National Lung Screening Trial, the Lung Screening Study randomized 17,309 through 10 screening centers. The others were randomized through the American College of Radiology Imaging Network. Quality assurance procedures were implemented that included centralized review of a random sample of 1,504 Lung Screening Study CT examinations. Quality defect rates were tabulated.



Quality defect rates ranged from 0% (section reconstruction interval) to 7.1% (reconstructed field of view), and most errors were sporadic. However, a recurrently high effective tube current-time product setting at one center, excessive streak artifact at one center, and excessive section thickness at one center were detected and corrected through the quality assurance process. Field-of-view and scan length errors were less frequent over the second half of the screening period (p < 0.01 for both parameters, two-tailed, paired Student's t test). Error rates varied among the screening centers and reviewers for most parameters evaluated.



Our experience suggested that centralized monitoring of image quality is helpful for reducing quality defects in multicenter trials.
Using Cluster Analysis to Identify Phenotypes and Validation of Mortality in Men with COPD

Cluster analysis has been proposed to examine phenotypic heterogeneity in chronic obstructive pulmonary disease (COPD). The aim of this study was to use cluster analysis to define COPD phenotypes and validate them by assessing their relationship with mortality. Male subjects with COPD were recruited to identify and validate COPD phenotypes. Seven variables were assessed for their relevance to COPD, age, FEV1 % predicted, BMI, history of severe exacerbations, mMRC, SpO2, and Charlson index. COPD groups were identified by cluster analysis and validated prospectively against mortality during a 4-year follow-up. Analysis of 332 COPD subjects identified five clusters from cluster A to cluster E. Assessment of the predictive validity of these clusters of COPD showed that cluster E patients had higher all cause mortality (HR 18.3, p < 0.0001), and respiratory cause mortality (HR 21.5, p < 0.0001) than those in the other four groups. Cluster E patients also had higher all cause mortality (HR 14.3, p = 0.0002) and respiratory cause mortality (HR 10.1, p = 0.0013) than patients in cluster D alone. COPD patient with severe airflow limitation, many symptoms, and a history of frequent severe exacerbations was a novel and distinct clinical phenotype predicting mortality in men with COPD.
Pilot study of a robotic protocol to treat shoulder subluxation in patients with chronic stroke

Shoulder subluxation is a frequent complication of motor impairment after stroke, leading to soft tissue damage, stretching of the joint capsule, rotator cuff injury, and in some cases pain, thus limiting use of the affected extremity beyond weakness. In this pilot study, we determined whether robotic treatment of chronic shoulder subluxation can lead to functional improvement and whether any improvement was robust. 18 patients with chronic stroke (3.9 ± 2.9 years from acute stroke), completed 6 weeks of robotic training using the linear shoulder robot. Training was performed 3 times per week on alternate days. Each session consisted of 3 sets of 320 repetitions of the affected arm, and the robotic protocol alternated between training vertical arm movements, shoulder flexion and extension, in an anti-gravity plane, and training horizontal arm movements, scapular protraction and retraction, in a gravity eliminated plane. Training with the linear robot improved shoulder stability, motor power, and resulted in improved functional outcomes that were robust 3 months after training. In this uncontrolled pilot study, the robotic protocol effectively treated shoulder subluxation in chronic stroke patients. Treatment of subluxation can lead to improved functional use of the affected arm, likely by increasing motor power in the trained muscles.
Long-term outcomes of catheter ablation of atrial fibrillation post-cardiac valve replacement.

The long-term outcomes of catheter ablation of atrial fibrillation (AF) developing post-cardiac valve replacement (VR) remain undefined.



Eighty-nine post-VR patients with AF (44% longstanding persistent AF, LSP-AF) were enrolled. Cumulative success rate of circumferential pulmonary vein ablation (CPVA for paroxysmal AF) and bidirectional block of lines and disappearance of complex fractionated atrial electrograms (CFAEs for persistent and LSP-AF) as index and repeat procedural endpoints reached 57% (mean, 1.3 procedures) during the first year, and dropped to 42% at median follow-up of 40months (range, 24-70months) for multiple procedures (mean, 1.6±0.9 [1-5]); incidence of procedural complications was similar to that of conventional procedures. In multivariate analysis, larger right atrium (RA, 9.40 [2.64-33.36]; P=0.001) and rheumatic valvular disease etiology (OR, 5.49 [95% CI, 1.26-23.96]; P=0.023) were significant independent predictors of recurrent atrial tachyarrhythmia (ATa); in contrast, long-term freedom from ATa was comparable between single and double valve replacement groups (42.1% vs. 43.7%, P=0.880), or mechanical and bioprosthetic valves groups (41.7% vs. 50.0%, P=0.620).



In this single-center prospective study, treatment of post-VR AF with commonly used ablation strategies including CPVA and linear and CFAE ablation had limited long-term success, with ATa recurrence risk appearing higher in the setting of RA enlargement and rheumatic valvular disease and unrelated to valves characteristics.