nils-herrmann/clean_scirepeval huggingface dataset:
Effect evaluation of a self-management programme for employees with complaints of the arm, neck or shoulder: a randomised controlled trial.

To evaluate the effectiveness of a self-management intervention (including an eHealth module), compared with usual care, in employees with chronic non-specific complaints of the arm, neck or shoulder (persisting >3 months).



Participants were randomised into the self-management group (SG) or usual care group (UCG). The SG participated in 6 self-management sessions and could use an eHealth module; the UCG could use all available usual care. The primary outcome of the study was score on the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Secondary outcomes included: absenteeism, pain in the previous week, quality of life, pain catastrophising, self-efficacy, work style, presenteeism, fatigue, and limitations experienced during work. Data were analysed using generalised estimating equations (GEE) linear regression and Mann-Whitney U tests, and were collected at baseline, 3-month, 6-month, and 12-month follow-up.



On the general module of the DASH, no significant difference between SG and the UCG was detected. On most of the other outcome measures, there were no significant between-group differences. In the DASH work module, the between-group effect was -3.82 (95% CI -7.46 to -0.19, p=0.04). For limitations experienced in job-related activities the between-group effect was -1.01 (95% CI -1.97 to -0.04, p=0.04). The mean hours of sport activities in the past 3 months, measured at 12 months, was 1.00 h (95% CI -1.90 to -0.12 h, p=0.03) less in the SG compared with the UCG.



The self-management intervention improved the participants' perceived disability during work. Since no significant between-group differences were found on most outcome measures, the results of this study should be interpreted with caution.
Development and preliminary validation of the cancer family impact scale for colorectal cancer.

The aim of our study was to develop a measure of how a family history of colorectal cancer (CRC) affects families from the viewpoint of unaffected family members.



Using data from 1,285 participants (637 families) in the Johns Hopkins Colon Cancer Genetic Testing study, we developed and validated The Cancer Family Impact Scale (CFIS), an instrument for use in studies investigating relationships among family factors and CRC prevention behaviors when family history is a risk factor.



Through exploratory factor analysis (EFA) using a 50% random sample of participants, we identified 5 latent constructs among 18 items: (1) NEGATIVE: negative effects of cancer on the family; (2) POSITIVE: positive effects of cancer on the family; (3) COMMUNICATE: how families communicate about cancer; (4) FLOW: how information about cancer is conveyed in families; and (5) NORM: how individuals react to family norms about cancer. Confirmatory factor analysis (CFA) on the same sample showed the CFIS to have a reasonably good fit (chi(2) = 389.97, degree of freedom (df ) = 122, root mean square error of approximation = 0.06 [0.05-0.07], comparative fit index = 0.90, Tucker-Lewis index = 0.88, goodness of fit index = 0.94), and findings were cross-validated on the remaining 50% of the participants. The reliability of the scale was alpha = 0.65.



The CFIS could be used to clarify the role that family factors play in the association between CRC family history and CRC prevention behaviors, and also aid in the development and evaluation of family-based cancer prevention interventions.
Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up

The European Randomised study of Screening for Prostate Cancer (ERSPC) has shown significant reductions in prostate cancer mortality after 9 years and 11 years of follow-up, but screening is controversial because of adverse events such as overdiagnosis. We provide updated results of mortality from prostate cancer with follow-up to 2010, with analyses truncated at 9, 11, and 13 years.



ERSPC is a multicentre, randomised trial with a predefined centralised database, analysis plan, and core age group (55-69 years), which assesses prostate-specific antigen (PSA) testing in eight European countries. Eligible men aged 50-74 years were identified from population registries and randomly assigned by computer generated random numbers to screening or no intervention (control). Investigators were masked to group allocation. The primary outcome was prostate cancer mortality in the core age group. Analysis was by intention to treat. We did a secondary analysis that corrected for selection bias due to non-participation. Only incidence and no mortality data at 9 years' follow-up are reported for the French centres. 
With data truncated at 13 years of follow-up, 7408 prostate cancer cases were diagnosed in the intervention group and 6107 cases in the control group. The rate ratio of prostate cancer incidence between the intervention and control groups was 1·91 (95% CI 1·83-1·99) after 9 years (1·64 [1·58-1·69] including France), 1·66 (1·60-1·73) after 11 years, and 1·57 (1·51-1·62) after 13 years. The rate ratio of prostate cancer mortality was 0·85 (0·70-1·03) after 9 years, 0·78 (0·66-0·91) after 11 years, and 0·79 (0·69-0·91) at 13 years. The absolute risk reduction of death from prostate cancer at 13 years was 0·11 per 1000 person-years or 1·28 per 1000 men randomised, which is equivalent to one prostate cancer death averted per 781 (95% CI 490-1929) men invited for screening or one per 27 (17-66) additional prostate cancer detected. After adjustment for non-participation, the rate ratio of prostate cancer mortality in men screened was 0·73 (95% CI 0·61-0·88).



In this update the ERSPC confirms a substantial reduction in prostate cancer mortality attributable to testing of PSA, with a substantially increased absolute effect at 13 years compared with findings after 9 and 11 years. Despite our findings, further quantification of harms and their reduction are still considered a prerequisite for the introduction of populated-based screening.



Each centre had its own funding responsibility.
Tetanus toxoid and CCL3 improve dendritic cell vaccines in mice and glioblastoma patients

After stimulation, dendritic cells (DCs) mature and migrate to draining lymph nodes to induce immune responses. As such, autologous DCs generated ex vivo have been pulsed with tumour antigens and injected back into patients as immunotherapy. While DC vaccines have shown limited promise in the treatment of patients with advanced cancers including glioblastoma, the factors dictating DC vaccine efficacy remain poorly understood. Here we show that pre-conditioning the vaccine site with a potent recall antigen such as tetanus/diphtheria (Td) toxoid can significantly improve the lymph node homing and efficacy of tumour-antigen-specific DCs. To assess the effect of vaccine site pre-conditioning in humans, we randomized patients with glioblastoma to pre-conditioning with either mature DCs or Td unilaterally before bilateral vaccination with DCs pulsed with Cytomegalovirus phosphoprotein 65 (pp65) RNA. We and other laboratories have shown that pp65 is expressed in more than 90% of glioblastoma specimens but not in surrounding normal brain, providing an unparalleled opportunity to subvert this viral protein as a tumour-specific target.  Td had enhanced DC migration bilaterally and significantly improved survival. In mice, Td pre-conditioning also enhanced bilateral DC migration and suppressed tumour growth in a manner dependent on the chemokine CCL3. Our clinical studies and corroborating investigations in mice suggest that pre-conditioning with a potent recall antigen may represent a viable strategy to improve anti-tumour immunotherapy.
Reflecting on reflection: framing a design landscape

Designing for reflection is becoming of increasing interest to HCI researchers, especially as digital technologies move to supporting broader professional and quality of life issues. However, the term 'reflection' is being used and designed for in diverse ways and often with little reference to vast amount of literature on the topic outside of HCI. Here we synthesize this literature into a framework, consisting of aspects such as purposes of reflection, conditions for reflection and levels of reflection (where the levels capture the behaviours and activities associated with reflection). We then show how technologies can support these different aspects and conclude with open questions that can guide a more systematic approach to how we understand and design for support of reflection.
Accuracy of a commercial enzyme-linked immunosorbent assay for CagA in patients from Brazil with and without gastric carcinoma.

We validated a commercial enzyme-linked immunosorbent assay for the detection of anti-CagA antibodies in Brazilian patients with Helicobacter pylori infection. The test presented high sensitivity (97.4%) and specificity (88.9%) when employed in patients without gastric carcinoma. However, in gastric carcinoma patients, the test was neither sensitive nor specific enough to detect cagA-positive H. pylori infection.
Neither cytochrome P450 family genes nor neuroendocrine factors could independently predict the SSRIs treatment in the Chinese Han population.

This study was intended to explore the relationship between the genetic polymorphisms of the 8 single nucleotide polymorphisms (SNPs) at CYP genes, neuroendocrine factors and the response to selective serotonin reuptake inhibitors (SSRIs) in Chinese Han depressive patients.



This was a 6-week randomized controlled trial consisting of 290 Chinese Han depressive patients treated with SSRIs. 8 SNPs of CYP450 genes and 7 neuroendocrine factors were detected. Allele and genotype frequencies were compared between responders and non-responders. The relationships between neuroendocrine factors and treatment response were also analyzed.



No significant differences were found in clinical features between 2 groups at the baseline. No statistical correlation was found between either the genotype or allele frequencies of SNPs in CYP1A2, CYP2C19, or CYP2D6 gene and the -efficacy of SSRIs. There were strong linkage disequilibria between rs4986894, rs1853205, and rs12767583 of CYP2C19 genes, and rs2472299, rs2472300 of CYP1A2 genes. No associations were found between the above haplotypes and the antidepressant response. No neuroendocrine factor was a significant predictor for a response to SSRI antidepressants independently. The combination of neuroendocrine factors, however, predicted the response by 76.1%.



There were no significant associations between the 6 SNPs of CYP gene polymorphisms and SSRI response. Neither cytochrome P450 family genes nor neuroendocrine factors independently predict the patients' response to the antidepressants separately. A combination of neuroendocrine factors, however, does have the potential to predict the response.
Patients with known or suspected lung cancer: evaluation of clinical management changes due to 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) study.

To determine prospectively from the referring physician's point of view the impact of F-fluorodeoxyglucose positron emission tomography (F-FDG PET) results on the management decisions in patients with known or suspected lung cancer.



Seventy-five consecutive patients (58 men, 17 women; age range, 33-82 years; mean age, 64 years) with a diagnosis of a pulmonary lesion, obtained by means of morphological imaging studies and/or cytological sampling, were included in the study. The patient population consisted of three groups: (A) patients (n=18) with a solitary lung nodule; (B) patients (n=37) with untreated lung cancer; and (C) patients (n=20) with treated lung cancer. All were referred for whole-body F-FDG PET within 15 days (mean, 11 days) of lung lesion detection. To determine whether and how PET findings could modify the treatment strategy, a questionnaire was sent to the referring physician before and after the PET results. With regard to the treatment strategy, four major options were recognized: (1) further diagnostic investigations; (2) medical therapy; (3) surgical treatment; (4) wait-and-see. For data analysis, intermodality changes, defined as changes between treatment strategies related to PET findings, were considered.



Before the PET study, the planned management for the overall patient population was as follows: further diagnostic investigations in 44 cases (58%), medical therapy in 17 (23%), surgical treatment in nine (12%) and wait-and-see in five (7%). After the PET study, further diagnostic tools were indicated in 27 cases (36%), medical therapy in 17 (23%), surgical treatment in 28 (37%) and wait-and-see in three (4%). Relative to the initially planned strategy, changes in patient management after PET imaging occurred in 34 (45%) cases. Overall, the most relevant variation after PET concerned the surgical treatment strategy. The highest percentage (67%) of changes in management after PET was found in patients with a solitary pulmonary nodule; the percentages of changes of the three patient groups were significantly different (chi-squared test; P=0.021).



In patients with known or suspected lung cancer, F-FDG PET results determined significant variations in major clinical management decisions.
Acupuncture for low back pain: traditional diagnosis and treatment of 148 patients in a clinical trial.

To assess patterns of diagnosis, including concordance, and treatment within a clinical trial of traditional acupuncture for low back pain.



In a pragmatic randomised controlled clinical trial, 148 patients with low back pain, of between 4 weeks and 12 months duration, were randomised to the offer of individualised acupuncture and received up to 10 treatments.



Standardised diagnosis and treatment records were completed by practitioners for 148 patients. The diagnosis was based on three pre-defined low back pain syndromes. For a subgroup of patients, one of the six practitioners then independently re-examined the patients, blind to the original diagnosis. The diagnostic inter-rater reliability was assessed in terms of percentage congruent classifications and Cohen's Kappa. Structured interviews of practitioners established further details about practice styles.



The most commonly diagnosed syndrome associated with low back pain was Qi and Blood Stagnation (88% of patients), followed by Kidney Deficiency (53%) and Bi Syndrome (28%), with more than one syndrome being identified for 65% of patients. For the subgroup examined twice, practitioner concordance was reasonable: between 47 and 80% of classifications were congruent, while Kappa values lay between 0 ("the same as chance") and 0.67 ("good"). Practitioners provided 1269 treatments in total, using 177 different acupuncture points. Most commonly used channels were Bladder and Gall Bladder, and the commonest points were BL-23 and the two lowest Huatuojiaji points. Auxiliary treatments were utilised by all practitioners to varying degrees.



Diagnostic concordance among practitioners was reasonable, and clear themes emerged for treatment. Further research is required to develop a flexible trial protocol with scope for individualised treatment.
The epothilone B analogue ixabepilone in patients with advanced hepatobiliary cancers: a trial of the University of Chicago Phase II Consortium

Hepatobiliary cancers respond poorly to cytotoxic chemotherapy. We evaluated the activity and safety of ixabepilone, an epothilone B analogue which stabilizes microtubules, in a phase II trial in patients with advanced cancers of the gallbladder, bile duct, and liver.  Eligible patients had previously-untreated, histologically-proven unresectable hepatobiliary cancer. Ixabepilone, 40 mg/m2, was administered intravenously over 3 h every 21 days.  Between January 2002 and April 2005, 54 patients (19 hepatocelluar carcinoma, 13 cholangiocarcinomas, 22 gallbladder carcinomas) were enrolled; 47 patients were evaluable for efficacy. The objective response rate was 8.5%; 51% had stable disease. Median overall survival was 7.0 months (95% CI, 5.0 to 10.8 months) and median progression-free survival was 2.6 months (95% CI, 1.4 to 4.1 months). Grade 3/4 toxicities included neutropenia (39%), fatigue (9%), allergic/hypersensitivity reaction (4%) and sensory neuropathy (4%).  Single agent ixabepilone has limited activity in advanced hepatobiliary cancers.
Efficacy of early postoperative enteral nutrition in supporting patients after esophagectomy.

This study aims to investigate and evaluate the efficacy and safety of early enteral nutrition (EN) in maintaining and improving the postoperative nutritional status in patients undergoing esophagectomy.



A randomized, controlled clinical trial was conducted in 120 adult patients with esophageal cancer and undergoing esophagectomy. Patients were randomly divided into two groups receiving either EN (N.=64) or parenteral nutrition (PN) (N.=56) postoperatively. The nutritional intake was isonitrogenic and isocalorie for both groups. Nutritional status was evaluated preoperatively as well as on postoperative day I and day 8. Daily nitrogen balance was measured and 7-day cumulative nitrogen balance was calculated. The levels of serum markers including d-lactate, diamine oxidase (DAO), and endotoxin were determined on 1st, 4th and 8th postoperative day for analyzing intestinal barrier function. Postoperative infection rate and the incidence of nutrition support-related complications were examined.



The concentrations of serum albumin and prealbumin in patients of EN group were significantly higher than those in PN group and the concentrations of blood glucose, γ-GT, AKP, TB, and DB were significantly lower compared to those in the PN group (P<0.05). Both daily nitrogen balance and cumulative nitrogen balance of EN group were better than those of PN group since postoperative day III. The serum levels of d-lactate, DAO, and endotoxin of EN group were significantly lower than those of PN group on postoperative day VIII (P<0.01). The incidence of postoperative infections in blood, lung, and intestinal tract in EN group was lower compared to PN group (P<0.05). No severe complications associated with nutritional support occurred in EN group. The time to flatus passage in EN group was significantly shorter, and the cost of nutritional support was significantly less compared to PN group (P<0.05).



Postoperative early enteral nutrition was safe and feasible for patients undergoing esophagectomy. Compared to PN, EN more efficiently ameliorated postoperational nutritional status of the patients undergoing esophagectomy, played an important role in restoring intestinal barrier function postoperatively, reduced the incidence of postoperative infection, and decreased the cost of hospital stay.
Solomon's Sword Beats Occam's Razor

I've told you a googol times or more: Don't exaggerate! And, less often, I've ever-so-gently urged you not to understate. Why is my advice ignored? Why can't you get IT... just right, balanced beyond dispute? Lez Joosts Mildews, as my mam was fond of sayin, boxing both my ears with equal devotion. Follow the Middle Way as Tao did in his Middle Kingdom. Or "straight down the middle," as golfer Bing Crosby used to croon. His other golf song was "The Wearing of the Green," but such digressions run counter to my straight, plow-on-ahead advice. I've just smoked a cigarette branded Cleopatra, but that's none of your beeswax neither, and strictly between me and my Egyptian placements sponsor.
Computer-aided diagnosis of solid breast nodules: use of an artificial neural network based on multiple sonographic features

A computer-aided diagnosis (CAD) algorithm identifying breast nodule malignancy using multiple ultrasonography (US) features and artificial neural network (ANN) classifier was developed from a database of 584 histologically confirmed cases containing 300 benign and 284 malignant breast nodules. The features determining whether a breast nodule is benign or malignant were extracted from US images through digital image processing with a relatively simple segmentation algorithm applied to the manually preselected region of interest. An ANN then distinguished malignant nodules in US images based on five morphological features representing the shape, edge characteristics, and darkness of a nodule. The structure of ANN was selected using k-fold cross-validation method with k=10. The ANN trained with randomly selected half of breast nodule images showed the normalized area under the receiver operating characteristic curve of 0.95. With the trained ANN, 53.3% of biopsies on benign nodules can be avoided with 99.3% sensitivity. Performance of the developed classifier was reexamined with new US mass images in the generalized patient population of total 266 (167 benign and 99 malignant) cases. The developed CAD algorithm has the potential to increase the specificity of US for characterization of breast lesions.
Coprescription of levodopa with antipsychotics in a population of 84,596 psychiatric inpatients from 1994 to 2008.

Patients on levodopa therapy frequently require additional antipsychotic pharmacotherapy. However, consideration must be given to antagonistic interactions on dopamine receptors between levodopa and antipsychotics, and efficacy and safety of such combinations. We therefore aimed to explore the practice and rationale of coprescription between levodopa and antipsychotics in psychiatric patients.



A descriptive retrospective study based on cross-sectional prescription data repeatedly collected from psychiatric inpatients through the international Drug Safety in Psychiatry (AMSP) program between 1994 and 2008 was undertaken.



Within a population of 84 596 psychiatric patients the prevalence of levodopa therapy was 1.0% (n=886). Among those patients on levodopa therapy 59.6% (n=528) also received antipsychotics. Quetiapine coprescription increased after its first marketing in 2000 to 45.9% in 2008. Coprescription of clozapine and olanzapine decreased from up to 25 and 22%, respectively, before to less than 10% after the introduction of quetiapine. Coprescribing of other antipsychotics remained approximately stable with average prevalences between 6 and less than 1%.



Quetiapine has now replaced clozapine as the most frequently coprescribed neuroleptic in psychiatric patients with levodopa therapy. This is in accordance with recent data indicating a low potential for clinically relevant interactions with levodopa and efficacy against psychosis in levodopa-treated patients. The combined use of antipsychotics other than quetiapine and clozapine with levodopa is less common and generally not supported by appropriate evidence.
Prospective feasibility study to evaluate neoadjuvant-synchronous S-1 + RT for locally advanced rectal cancer: a multicenter phase II trial (UMIN ID: 03396).

In Western countries, the standard treatment for locally advanced rectal cancer is preoperative chemoradiotherapy followed by total mesorectal excision. However, in Japan, the treatment results without preoperative chemoradiotherapy are by no means inferior; therefore, extrapolation of the results of preoperative treatment in Western countries to Japan is controversial. We consider that survival may be improved by preoperative chemoradiotherapy with new anticancer agents as they are expected not only to decrease the local recurrence rate but also to prevent distant metastases. We are conducting a multicentre Phase II study to evaluate the safety and efficacy of neoadjuvant chemoradiotherapy using S-1 in patients with locally advanced rectal cancer. The primary endpoint is the rate of complete treatment of neoadjuvant chemoradiotherapy. Secondary endpoints are the response rate of neoadjuvant chemoradiotherapy, short-term clinical outcomes, rate of curative resection and pathological evaluation. The short-term clinical outcomes are adverse events of neoadjuvant chemoradiotherapy and surgery-related complications. Thirty-five patients are required for this study.