nils-herrmann/clean_scirepeval huggingface dataset:
Indications for Early Postoperative Intraperitoneal Chemotherapy of Advanced Gastric Cancer: Results of a Prospective Randomized Trial

Previous analysis of this prospective randomized trial and meta-analysis of published randomized trials of adjuvant intraperitoneal chemotherapy demonstrated improved survival in patients with advanced gastric cancer. Simple criteria applicable at the time of surgery for patient selection were sought in this analysis. From 1990 to 1995 a series of 248 patients with biopsy-proven gastric cancer were randomized intraoperatively to receive early postoperative intraperitoneal mitomycin C and 5-fluorouracil (125 patients) versus surgery only (123 patients). Gastric resection plus early postoperative intraperitoneal chemotherapy showed improved overall survival compared to surgery only (54% and 38%, respectively; p= 0.0278). There were statistically significant differences in patients with stage III (57% and 23%, respectively; p= 0.0024) and in those with stage IV (28% and 5%, respectively; p= 0.0098) gastric cancer. The improvement in survival rate was statistically significant for the subgroup of patients with gross serosal invasion (52% and 25%, respectively; p= 0.0004) and patients with lymph node metastasis (46% and 22%, respectively; p= 0.0027). The surgeons' impression about lymph node status was unreliable, but assessment of serosal invasion was accurate in 80% of cases. Gross serosal invasion with or without frozen section evaluation of lymph nodes can be used as the major selection criteria for early postoperative intraperitoneal chemotherapy of advanced gastric cancer.
A study to assess COPD Symptom-based Management and to Optimise treatment Strategy in Japan (COSMOS-J) based on GOLD 2011

The Global initiative for chronic Obstructive Lung Disease (GOLD) Committee has proposed a chronic obstructive pulmonary disease (COPD) assessment framework focused on symptoms and on exacerbation risk. This study will evaluate a symptom and exacerbation risk-based treatment strategy based on GOLD in a real-world setting in Japan. Optimal management of COPD will be determined by assessing symptoms using the COPD Assessment Test (CAT) and by assessing the frequency of exacerbations.



This study () is a 24-week, multicenter, randomized, double-blind, double-dummy, parallel-group study. It aims to recruit 400 patients with moderate-to-severe COPD. Patients will be randomized to receive treatment with either salmeterol/fluticasone propionate (SFC) 50/250 μg twice daily or with tiotropium bromide 18 μg once daily. Optimal management of patients will be assessed at four-weekly intervals and, if patients remain symptomatic, as measured using the CAT, or experience an exacerbation, they have the option to step up to treatment with both drugs, ie, SFC twice daily and tiotropium once daily (TRIPLE therapy). The primary endpoint of the study will be the proportion of patients who are able to remain on the randomized therapy.



No data are available. This paper summarizes the methodology of the study in advance of the study starting.



The results of this study will help physicians to understand whether TRIPLE therapy is more effective than either treatment strategy alone in controlling symptoms and exacerbations in patients with moderate-to-severe COPD. It will also help physicians to understand the GOLD recommendation work in Japan.
Advance directives for patients compulsorily admitted to hospital with serious mental illness. Randomised controlled trial.

An advance directive is a statement of a person's preferences for treatment, should he or she lose capacity to make treatment decisions in the future.



To evaluate whether use of advance directives by patients with mental illness leads to lower rates of compulsory readmission to hospital.



In a randomised controlled trial in two psychiatric services in inner London, 156 in-patients about to be discharged from compulsory treatment under the Mental Health Act were recruited. The trial compared usual psychiatric care with usual care plus the completion of an advance directive. The primary outcome was the rate of compulsory readmission.



Fifteen patients (19%) in the intervention group and 16 (21%) in the control group were readmitted compulsorily within 1 year of discharge. There was no difference in the numbers of compulsory readmissions, numbers of patients readmitted voluntarily, days spent in hospital or satisfaction with psychiatric services.



Users' advance instruction directives had little observable impact on the outcome of care at 12 months.
Translation into Brazilian Portuguese and validation of the five-part questionnaire for identifying hypermobility.

Joint hypermobility (JH) is an inherited clinical condition with increased joint elasticity in passive movements. In the general population, its frequency, which can be estimated through specific methods, such as the nine-point Beighton hypermobility score (Beighton score) and the self-reported five-part questionnaire for identifying hypermobility (five-part questionnaire), ranges from 10% to 20%.



To validate the Portuguese version of the five-part questionnaire and to determine its sensitivity and specificity when compared with the Beighton score for diagnosing JH.



The five-part questionnaire for identifying hypermobility was translated into Portuguese and applied to 2,523 Brazilian university students. Then, a sample with 394 randomly selected students was evaluated by use of the Beighton score, aiming at establishing the JH diagnosis. Finally, the two methods were statistically compared.



The JH frequency was 37.01% when using the five-part questionnaire, and 34% when using the Beighton score. Considering sex, the JH frequencies according to the five-part questionnaire and Beighton score were 43.54% and 44.26% in females, and 28.44% and 16% in males, respectively. The sensitivity of the self-reported questionnaire was 70.9% and its specificity was 77.4%, with an area under the receiver operating characteristic (ROC) curve of 0.786.



JH is frequent in Brazilian university students, and more common in women. The self-reported five-part questionnaire for JH identification, translated into Portuguese and validated, was an effective method when compared with the Beighton score for identifying JH.
Written action plan in pediatric emergency room improves asthma prescribing, adherence, and control.

An acute-care visit for asthma often signals a management failure. Although a written action plan is effective when combined with self-management education and regular medical review, its independent value remains controversial.



We examined the efficacy of providing a written action plan coupled with a prescription (WAP-P) to improve adherence to medications and other recommendations in a busy emergency department.



We randomized 219 children aged 1-17 years to receive WAP-P (n = 109) or unformatted prescription (UP) (n = 110). All received fluticasone and albuterol inhalers, fitted with dose counters, to use at the discretion of the emergency physician. The main outcome was adherence to fluticasone (use/prescribed × 100%) over 28 days. Secondary outcomes included pharmacy dispensation of oral corticosteroids, β(2)-agonist use, medical follow-up, asthma education, acute-care visits, and control.



Although both groups showed a similar drop in adherence in the initial 14 days, adherence to fluticasone was significantly higher over Days 15-28 in children receiving WAP-P (mean group difference, 16.13% [2.09, 29.91]). More WAP-P than UP patients filled their oral corticosteroid prescription (relative risk, 1.31 [1.07, 1.60]) and were well-controlled at 28 days (1.39 [1.04, 1.86]). Compared with UP, use of WAP-P increased physicians' prescription of maintenance fluticasone (2.47 [1.53, 3.99]) and recommendation for medical follow-up (1.87 [1.48, 2.35]), without group differences in other outcomes.



Provision of a written action plan significantly increased patient adherence to inhaled and oral corticosteroids and asthma control and physicians' recommendation for maintenance fluticasone and medical follow-up, supporting its independent value in the acute-care setting.
Platelet-activating factor, PAF acetylhydrolase, and severe anaphylaxis.

Platelet-activating factor (PAF) is an important mediator of anaphylaxis in animals, and interventions that block PAF prevent fatal anaphylaxis. The roles of PAF and PAF acetylhydrolase, the enzyme that inactivates PAF, in anaphylaxis in humans have not been reported.



We measured serum PAF levels and PAF acetylhydrolase activity in 41 patients with anaphylaxis and in 23 control patients. Serum PAF acetylhydrolase activity was also measured in 9 patients with peanut allergy who had fatal anaphylaxis and compared with that in 26 nonallergic pediatric control patients, 49 nonallergic adult control patients, 63 children with mild peanut allergy, 24 patients with nonfatal anaphylaxis, 10 children who died of nonanaphylactic causes, 15 children with life-threatening asthma, and 19 children with non-life-threatening asthma.



Mean (+/-SD) serum PAF levels were significantly higher in patients with anaphylaxis (805+/-595 pg per milliliter) than in patients in the control groups (127+/-104 pg per milliliter, P<0.001 after log transformation) and were correlated with the severity of anaphylaxis. The proportion of subjects with elevated PAF levels increased from 4% in the control groups to 20% in the group with grade 1 anaphylaxis, 71% in the group with grade 2 anaphylaxis, and 100% in the group with grade 3 anaphylaxis (P<0.001). There was an inverse correlation between PAF levels and PAF acetylhydrolase activity (P<0.001). The proportion of patients with low PAF acetylhydrolase values increased with the severity of anaphylaxis (P<0.001 for all comparisons). Serum PAF acetylhydrolase activity was significantly lower in patients with fatal peanut anaphylaxis than in control patients (P values <0.001 for all comparisons).



Serum PAF levels were directly correlated and serum PAF acetylhydrolase activity was inversely correlated with the severity of anaphylaxis. PAF acetylhydrolase activity was significantly lower in patients with fatal anaphylactic reactions to peanuts than in patients in any of the control groups. Failure of PAF acetylhydrolase to inactivate PAF may contribute to the severity of anaphylaxis.
Measuring Coverage in MNCH: A Prospective Validation Study in Pakistan and Bangladesh on Measuring Correct Treatment of Childhood Pneumonia

Antibiotic treatment for pneumonia as measured by Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys (MICS) is a key indicator for tracking progress in achieving Millennium Development Goal 4. Concerns about the validity of this indicator led us to perform an evaluation in urban and rural settings in Pakistan and Bangladesh.



Caregivers of 950 children under 5 y with pneumonia and 980 with "no pneumonia" were identified in urban and rural settings and allocated for DHS/MICS questions 2 or 4 wk later. Study physicians assigned a diagnosis of pneumonia as reference standard; the predictive ability of DHS/MICS questions and additional measurement tools to identify pneumonia versus non-pneumonia cases was evaluated. Results at both sites showed suboptimal discriminative power, with no difference between 2- or 4-wk recall. Individual patterns of sensitivity and specificity varied substantially across study sites (sensitivity 66.9% and 45.5%, and specificity 68.8% and 69.5%, for DHS in Pakistan and Bangladesh, respectively). Prescribed antibiotics for pneumonia were correctly recalled by about two-thirds of caregivers using DHS questions, increasing to 72% and 82% in Pakistan and Bangladesh, respectively, using a drug chart and detailed enquiry.



Monitoring antibiotic treatment of pneumonia is essential for national and global programs. Current (DHS/MICS questions) and proposed new (video and pneumonia score) methods of identifying pneumonia based on maternal recall discriminate poorly between pneumonia and children with cough. Furthermore, these methods have a low yield to identify children who have true pneumonia. Reported antibiotic treatment rates among these children are therefore not a valid proxy indicator of pneumonia treatment rates. These results have important implications for program monitoring and suggest that data in its current format from DHS/MICS surveys should not be used for the purpose of monitoring antibiotic treatment rates in children with pneumonia at the present time.
Effect of Modafinil on Impairments in Neurobehavioral Performance and Learning Associated with Extended Wakefulness and Circadian Misalignment

Although worldwide millions of people work prolonged hours, at adverse circadian phases, evidence suggests that cognitive function is impaired under these conditions with important societal consequences. In a double-blind placebo-controlled laboratory-based study, we investigated the effect of the wakefulness-promoting drug modafinil as a countermeasure against such neurobehavioral impairments induced by both prolonged wakefulness and circadian misalignment. Neurobehavioral performance, alertness, and sleep were studied in young healthy participants (N=18) who underwent a 25-day forced desynchrony protocol in which the period of the sleep-wakefulness cycle was scheduled to be 42.85 h (duration of each wakefulness episode: 28.57 h; sleep/rest episode: 14.28 h). Each waking day, participants were treated with either 400 mg modafinil, divided into three doses, or placebo, according to a randomized, parallel-group design. Treatment with modafinil significantly attenuated the performance decrements seen for several parameters including cognitive-psychomotor speed, visual attention and reaction times both with progressive hours awake and when working at adverse circadian phases. Subjective alertness and sleep parameters were similar between treatment groups, but modafinil-treated participants had fewer bouts of inadvertent sleep during scheduled waking. Modafinil reduced the neurobehavioral impairment associated with work, both during prolonged wakefulness and at adverse circadian phases, without adversely affecting subjective alertness or subsequent sleep. These features suggest that modafinil might be a particularly relevant countermeasure against the deleterious effects of prolonged work hours, shift work, and transmeridian travel.
The role of 18F-FDG uptake features in the differential diagnosis of solitary pulmonary lesions with PET/CT

The aim of this study is to evaluate the value of (18)F-FDG uptake features in the diagnosis of solitary pulmonary lesions.



One hundred thirty-nine patients with solitary pulmonary lesions were divided into full uptake, circular uptake, multi-focus uptake, mild uptake, and no-uptake groups according to the uptake features of (18)F-FDG in solitary pulmonary lesions. The incidence of benign and malignant lesions and the false-positive and false-negative rates in each group were analyzed. The sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) of the method using (18)F-FDG uptake features combined with maximum standard uptake value (SUVmax) (SUV method) in the differential diagnosis of solitary pulmonary lesions were evaluated.



There were 89 malignant and 50 benign lesions. (1) The malignant incidence of the full uptake group was 84.0% (63/75), and there were significant differences when compared with the other groups except the circular uptake group (16/23) (all P = 0.0001). The benign incidence of the multi-focus and no-uptake groups was 83.3% (10/12) and 82.4% (14/17), respectively, and there were significant differences when compared with the full uptake and the circular uptake groups, respectively (all P < 0.05). The benign incidence of the mild uptake group was 58.3% (7/12), and there were no significant differences when compared with the others except the full uptake group (all P > 0.05). No statistical significance was found between either two of the no-uptake, mild uptake, and multi-focus uptake groups (all P > 0.05). (2) In cases with SUVmax ≥2.5, the false-positive rate in the multi-focus uptake group was 83.3% (10/12), which was significantly higher than in the full uptake (12/75) or circular uptake group (7/23) (all P < 0.05). In cases with SUVmax <2.5, the false-negative rates in the mild and no-uptake groups were 41.7 and 17.6% (P = 0.218). (3) The sensitivity, specificity, accuracy, PPV, and NPV of the method using (18)F-FDG uptake features combined with SUVmax and the single SUV method were 88.7%/91.0%, 62.0%/42.0%, 79.1%/73.4%, 80.6%/73.6%, and 75.6%/72.4%, respectively.



The method using uptake features of (18)F-FDG combined with SUVmax can improve the diagnostic specificity and accuracy of solitary pulmonary lesions. The multi-focus uptake feature maybe a benign sign, which still needs more researches to confirm.
Inflammatory biomarkers improve clinical prediction of mortality in chronic obstructive pulmonary disease.

Accurate prediction of mortality helps select patients for interventions aimed at improving outcome.



Because chronic obstructive pulmonary disease is characterized by low-grade systemic inflammation, we hypothesized that addition of inflammatory biomarkers to established predictive factors will improve accuracy.



A total of 1,843 patients enrolled in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints study were followed for 3 years. Kaplan-Meier curves, log-rank analysis, and Cox proportional hazards analyses determined the predictive value for mortality of clinical variables, while C statistics assessed the added discriminative power offered by addition of biomarkers.



At recruitment we measured anthropometrics, spirometry, 6-minute walk distance, dyspnea, BODE index, history of hospitalization, comorbidities, and computed tomography scan emphysema. White blood cell and neutrophil counts, serum or plasma levels of fibrinogen, chemokine ligand 18, surfactant protein D, C-reactive protein, Clara cell secretory protein-16, IL-6 and -8, and tumor necrosis factor-α were determined at recruitment and subsequent visits. A total of 168 of the 1,843 patients (9.1%) died. Nonsurvivors were older and had more severe airflow limitation, increased dyspnea, higher BODE score, more emphysema, and higher rates of comorbidities and history of hospitalizations. The best predictive model for mortality using clinical variables included age, BODE, and hospitalization history (C statistic of 0.686; P < 0.001). One single biomarker (IL-6) significantly improved the C statistic to 0.708, but this was further improved to 0.726 (P = 0.003) by the addition of all biomarkers.



The addition of a panel of selected biomarkers improves the ability of established clinical variables to predict mortality in chronic obstructive pulmonary disease.
Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design

Chronic obstructive pulmonary disease (COPD) is associated with exercise limitation and physical inactivity, which are believed to have significant long-term negative health consequences for patients. While a number of COPD treatments and exercise training programmes increase exercise capacity, there is limited evidence for their effects on physical activity levels, with no clear association between exercise capacity and physical activity in clinical trials. Physical activity depends on a number of behaviour, environmental and physiological factors. We describe the design of the PHYSACTO trial, which is investigating the effects of bronchodilators, either alone or with exercise training, in combination with a standardised behaviour-change self-management programme, on exercise capacity and physical activity in patients with COPD. It is hypothesised that bronchodilators in conjunction with a behaviour-change self-management programme will improve physical activity and that this effect will be amplified by the addition of exercise training.



Patients are being recruited from 34 sites in Australia, New Zealand, the USA, Canada and Europe. Patients receiving a multicomponent intervention designed to support behaviour change related to physical activity are randomised to four treatment arms: placebo, tiotropium, tiotropium+olodaterol, and tiotropium+olodaterol+exercise training. The primary outcome is improvement in exercise capacity after 8 weeks, measured by endurance time during a shuttle walk test. The secondary outcome is improvement in physical activity, including objective accelerometer assessment and patient-reported functioning using the Functional Performance Inventory-Short Form and the novel hybrid PROactive instrument. Additionally, the influence of moderating variables (ie, factors influencing a patient's choice to be physically active) on increases in physical activity is also explored.


ETHICS AND DISSEMINATION
The study has been approved by the relevant Institutional Review Boards, Independent Ethics Committee and Competent Authority according to national and international regulations. The findings of the trial will be disseminated through relevant peer-reviewed journals and international conference presentations.
Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up

This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (−45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the “non-difference” in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (−73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time.