nils-herrmann/clean_scirepeval huggingface dataset:
Caring for Aged Dementia Care Resident Study (CADRES) of person-centred care, dementia-care mapping, and usual care in dementia: a cluster-randomised trial

Evidence for improved outcomes for people with dementia through provision of person-centred care and dementia-care mapping is largely observational. We aimed to do a large, randomised comparison of person-centred care, dementia-care mapping, and usual care.



In a cluster randomised controlled trial, urban residential sites were randomly assigned to person-centred care, dementia-care mapping, or usual care. Carers received training and support in either intervention or continued usual care. Treatment allocation was masked to assessors. The primary outcome was agitation measured with the Cohen-Mansfield agitation inventory (CMAI). Secondary outcomes included psychiatric symptoms including hallucinations, neuropsychological status, quality of life, falls, and cost of treatment. Outcome measures were assessed before and directly after 4 months of intervention, and at 4 months of follow-up. Hierarchical linear models were used to test treatment and time effects. Analysis was by intention to treat.  Registry, number ACTRN12608000084381.



15 care sites with 289 residents were randomly assigned. Pairwise contrasts revealed that at follow-up, and relative to usual care, CMAI score was lower in sites providing mapping (mean difference 10.9, 95% CI 0.7-21.1; p=0.04) and person-centred care (13.6, 3.3-23.9; p=0.01). Compared with usual care, fewer falls were recorded in sites that used mapping (0.24, 0.08-0.40; p=0.02) but there were more falls with person-centred care (0.15, 0.02-0.28; p=0.03). There were no other significant effects.



Person-centred care and dementia-care mapping both seem to reduce agitation in people with dementia in residential care.
Catechol-O-methyltransferase genotype and susceptibility to Parkinson's disease in Japan

We report −108Met/Val polymorphism of the COMT gene in Japanese patients with Parkinson's disease (PD). The allele frequency for −108Val was higher in PD patients compared with controls, although the differences did not reach the statistical significance. However, the frequency of -108Val homozygotes was significantly higher in PD patients (56.8%) than in control subjects (44.2%), and heterozygotes of −108Met/Val were less in PD. COMT gene polymorphism may constitute a genetic risk factor for PD among Japanese.
Reduced Ventrolateral fMRI Response during Observation of Emotional Gestures Related to the Degree of Dopaminergic Impairment in Parkinson Disease

Recent findings point to a perceptive impairment of emotional facial expressions in patients diagnosed with Parkinson disease (PD). In these patients, administration of dopamine can modulate emotional facial recognition. We used fMRI to investigate differences in the functional activation in response to emotional and nonemotional gestures between PD patients and age-matched healthy controls (HC). In addition, we used PET to evaluate the striatal dopamine transporter availability (DAT) with [11C]d-threo-methylphenidate in the patient group. Patients showed an average decrease to 26% in DAT when compared to age-corrected healthy references. Reduction in the DAT of the left putamen correlated not only with motor impairment but also with errors in emotional gesture recognition. In comparison to HC, PD patients showed a specific decrease in activation related to emotional gesture observation in the left ventrolateral prefrontal cortex (VLPFC) and the right superior temporal sulcus. Moreover, the less DAT present in the left putamen, the lower the activation in the left VLPFC. We conclude that a loss of dopaminergic neurotransmission in the putamen results in a reduction of ventrolateral prefrontal access involved in the recognition of emotional gestures.
Impaired gastric motility and its relationship to reflux symptoms in patients with nonerosive gastroesophageal reflux disease

More than half of patients with refluxrelated symptoms have no endoscopic evidence of mucosal breaks. These patients are considered to have nonerosive gastroesophageal reflux disease (NERD). The pathogenesis of NERD may be multifactorial, but the role played by gastric motility in symptom generation in patients with NERD has not been examined. In this study, we elucidate gastric motility in patients with NERD and the efficacy of a prokinetic agent in the treatment of NERD. Gastric motility was evaluated with electrogastrography (EGG) and by measurement of gastric emptying using the acetaminophen method in 26 patients with NERD and in 11 matched healthy controls. NERD patients were treated with a prokinetic agent (mosapride 15 mg, orally three times daily) for a period of 4 weeks, after which gastric motility was measured again. Compared with the healthy controls, the NERD patients showed a significantly lower percentage of normogastria, a lower power ratio in EGG, and delayed gastric emptying. Ten patients had normal gastric motor function (group A), and 16 showed abnormalities of either gastric myoelectrical activity or gastric emptying (group B). After treatment with mosapride, gastric motility improved significantly in both groups of patients compared with pretreatment values. The subjective assessment by the patient after the treatment was improved in 20.0% of group A versus 62.5% of group B patients (P < 0.05). Gastric hypomotility appears to be an important factor in reflux symptom generation in some NERD patients.
Hierarchical clustering of human papilloma virus genotype patterns in the ASCUS-LSIL triage study.

Anogenital cancers are associated with ∼13 carcinogenic human papilloma virus (HPV) types in a broader group that cause cervical intraepithelial neoplasia (CIN). Multiple concurrent cervical HPV infections are common, which complicates the attribution of HPV types to different grades of CIN. Here we report the analysis of HPV genotype patterns in the atypical squamous cells of undetermined significance-low-grade squamous intraepithelial lesion triage study with the use of unsupervised hierarchical clustering. Women who underwent colposcopy at baseline (n = 2,780) were grouped into 20 disease categories based on histology and cytology. Disease groups and HPV genotypes were clustered with the use of complete linkage. Risk of 2-year cumulative CIN3+, viral load, colposcopic impression, and age were compared between disease groups and major clusters. Hierarchical clustering yielded four major disease clusters: cluster 1 included all CIN3 histology with abnormal cytology; cluster 2 included CIN3 histology with normal cytology and combinations with either CIN2 or high-grade squamous intraepithelial lesion cytology; cluster 3 included older women with normal or low-grade histology/cytology and low viral load; and cluster 4 included younger women with low-grade histology/cytology, multiple infections, and the highest viral load. Three major groups of HPV genotypes were identified: group 1 included only HPV16; group 2 included nine carcinogenic types, plus noncarcinogenic HPV53 and HPV66; and group 3 included noncarcinogenic types, plus carcinogenic HPV33 and HPV45. Clustering results suggested that colposcopy missed a prevalent precancer in many women with no biopsy/normal histology and high-grade squamous intraepithelial lesion. This result was confirmed by an elevated 2-year risk of CIN3+ in these groups. Our novel approach to study multiple genotype infections in cervical disease with the use of unsupervised hierarchical clustering can address complex genotype distributions on a population level.
The SNP rs6500843 in 16p13.3 is associated with survival specifically among chemotherapy-treated breast cancer patients

We have utilized a two-stage study design to search for SNPs associated with the survival of breast cancer patients treated with adjuvant chemotherapy. Our initial GWS data set consisted of 805 Finnish breast cancer cases (360 treated with adjuvant chemotherapy). The top 39 SNPs from this stage were analyzed in three independent data sets: iCOGS (n=6720 chemotherapy-treated cases), SUCCESS-A (n=3596), and POSH (n=518). Two SNPs were successfully validated: rs6500843 (any chemotherapy; per-allele HR 1.16, 95% C.I. 1.08-1.26, p=0.0001, p(adjusted)=0.0091), and rs11155012 (anthracycline therapy; per-allele HR 1.21, 95% C.I. 1.08-1.35, p=0.0010, p(adjusted)=0.0270). The SNP rs6500843 was found to specifically interact with adjuvant chemotherapy, independently of standard prognostic markers (p(interaction)=0.0009), with the rs6500843-GG genotype corresponding to the highest hazard among chemotherapy-treated cases (HR 1.47, 95% C.I. 1.20-1.80). Upon trans-eQTL analysis of public microarray data, the rs6500843 locus was found to associate with the expression of a group of genes involved in cell cycle control, notably AURKA, the expression of which also exhibited differential prognostic value between chemotherapy-treated and untreated cases in our analysis of microarray data. Based on previously published information, we propose that the eQTL genes may be connected to the rs6500843 locus via a RBFOX1-FOXM1 -mediated regulatory pathway.
The psychological factors associated with poor compliance with treatment in asthma.

Poor patient compliance with inhaled medication is known to cause morbidity and mortality in asthma. The reasons for nonadherence are not fully understood. We wondered whether psychological factors, such as patient attitudes to asthma and its treatment, anxiety, depression, and interpersonal problems, may be related to asthma self-care and compliance. In a prospective study, 102 patients with asthma, aged 18-70 yrs, requiring treatment with regular inhaled corticosteroids and beta-agonists were recruited from a hospital out-patient clinic and four general practices in South East London. They underwent psychological assessment using the Hospital Anxiety and Depression Scale (HADS), the Inventory of Interpersonal Problems (IIP), and a semi-structured interview focusing on patient attitudes, self-care, compliance, social support and treatment beliefs. Patients were given terbutaline and budesonide turbohalers to use twice daily over 12 weeks. Turbohaler Inhalation Computers (TICs) recorded each inhalation, providing a measurement of compliance. Seventy two patients completed the study. Thirty seven took less than 70% of the prescribed dose over the study period or omitted doses for 1 week and were defined as noncompliant. The noncompliant group had a higher mean (SD) score for depression (4.7 (3.3)) than the compliant group (3.2 (2.5)). The sample had a high mean (SD) score for anxiety (8.3 (4.4)), but there was no significant difference between the compliant and noncompliant groups. Patients' self-report and clinicians' impressions of compliance were not good predictors of actual compliance. Using discriminant analysis, a model was obtained from the questionnaires and interview items, which correctly classified 74% of the patients as compliant or non-compliant.(ABSTRACT TRUNCATED AT 250 WORDS)
Preload or afterload reduction: Which is more beneficial for patients with ischemic heart disease?

We studied the acute hemodynamic effects of molsidomine, a selective preload reducing agent, and nifedipine, a selective afterload reducing agent. Thirty-two patients with stable angina pectoris and angiographically significant coronary artery disease were randomized into two groups: group A patients received 4 mg of molsidomine, and group B patients received 20 mg of nifedipine orally. Molsidomine was associated with a significant reduction of the left ventricular end-diastolic pressure and an increase in Vcf. Nifedipine caused a significant reduction of the mean arterial pressure and an increase of the heart rate. Hemodynamic parameters associated with chronic exertional angina pectoris in patients with angiographically significant coronary artery disease improved more with a preload reducing agent, like molsidomine.
Evaluation of four sensitive troponin assays for risk assessment in acute coronary syndromes using a new clinically oriented approach for comparison of assays.

Measurement of cardiac troponin T or I (cTnT; cTnI) is useful for risk prediction in acute coronary syndromes. The objective of the present study was to compare the prognostic capacity of four sensitive cardiac troponin assays using a new method for comparison.



Cardiac troponin was analyzed in serum samples from 1335 patients with acute coronary syndrome using the Elecsys high sensitivity TnT (hs-cTnT), ARCHITECT STAT high sensitivity TnI (hs-cTnI), Access AccuTnI (Acc-cTnI) and Architect cTnI (Arc-cTnI) assays. All patients were followed for 30 days regarding death and acute myocardial infarction (AMI), and for 1 year regarding mortality.



By receiver operating characteristic (ROC) curve analyses, there were only minor differences in the area under the curves (AUC) between the assays. At a given sensitivity of 85% the hs-cTnT, Arc-cTnI and Acc-cTnI assays showed comparable specificities, while 90% or higher sensitivity was only possible to achieve with the hs-cTnT, hs-cTnI and Acc-cTnI assays. The highest odds ratios for death/AMI at 30 days and death at 1 year, respectively, were reached by cut-off levels yielding 95% sensitivity; these cut-off levels were below the respective 99th percentile levels.



By the adoption of a new method for the comparison of cardiac troponin assays we showed that the hs-cTnT, hs-cTnI and Acc-cTnI assays had comparable prognostic properties, while the Arc-cTnI assay had inferior prognostic sensitivity.
The effectiveness of a non-pharmacological intervention for weight gain management in severe mental disorders: results from a national multicentric study.

To evaluate the effectiveness of a non-pharmacological intervention for weight gain management in severe mental disorders.



An open, multicentre interventional study was conducted in 93 mental health services. Patients concerned with weight gain were included in this study and received a 12-week 1-hour group intervention focused on nutrition counseling, lifestyle, physical activity and self-esteem. Weight, waist circumference and blood pressure were measured before and after the intervention.



1,071 patients were enrolled in the study, and 73.9% completed the 12-week intervention. Significant weight loss (Mean difference: 0.41, CI 95%: 0.18 to 0.64, p = 0.001) and a significant BMI reduction (Mean difference: 0.13, CI 95%: 0.04 to 0.22, p = 0.006) were observed. During the intervention 37 (4.4%) patients lost > 7% of their initial weight, 780 (92.5%) maintained their weight, and 26 (3.1%) of the patients had a meaningful weight gain (> 7%). There was a significant increase in the proportion of patients undertaking physical activity after the intervention (70.8%, p < 0.001).



In this 3-month open study we found a small weight and waist reduction, and increased physical activity practice, suggesting a trend towards anthropometric profile improvement. However, further randomized-controlled trials are necessary to evaluate the efficacy and clinical relevance of this psychosocial intervention for weight gain.
A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer.

The 4Kscore combines measurement of four kallikreins in blood with clinical information as a measure of the probability of significant (Gleason ≥7) prostate cancer (PCa) before prostate biopsy.



To perform the first prospective evaluation of the 4Kscore in predicting Gleason ≥7 PCa in the USA.



Prospective enrollment of 1012 men scheduled for prostate biopsy, regardless of prostate-specific antigen level or clinical findings, was conducted at 26 US urology centers between October 2013 and April 2014.



The 4Kscore.


OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary outcome was Gleason ≥7 PCa on prostate biopsy. The area under the receiver operating characteristic curve, risk calibration, and decision curve analysis (DCA) were determined, along with comparisons of probability cutoffs for reducing the number of biopsies and their impact on delaying diagnosis.



Gleason ≥7 PCa was found in 231 (23%) of the 1012 patients. The 4Kscore showed excellent calibration and demonstrated higher discrimination (AUC 0.82) and net benefit compared to a modified Prostate Cancer Prevention Trial Risk Calculator 2.0 model and standard of care (biopsy for all men) according to DCA. A possible reduction of 30-58% in the number biopsies was identified with delayed diagnosis in only 1.3-4.7% of Gleason ≥7 PCa cases, depending on the threshold used for biopsy. Pathological assessment was performed according to the standard of care at each site without centralized review.



The 4Kscore showed excellent diagnostic performance in detecting significant PCa. It is a useful tool in selecting men who have significant disease and are most likely to benefit from a prostate biopsy from men with no cancer or indolent cancer.



The 4Kscore provides each patient with an accurate and personalized measure of the risk of Gleason ≥7 cancer to aid in decision-making regarding the need for prostate biopsy.
Impairment of estramustine phosphate absorption by concurrent intake of milk and food

The effect of milk and food on the pharmacokinetics of estramustine phosphate was investigated in six patients with prostatic cancer. In a randomized three-way cross-over study, the patients were given single doses of the drug together with low calcium water, low calcium food and milk. The evaluation was based upon the plasma concentration of two metabolites, estromustine and estrone, as parent drug could not be detected in plasma. The tmax and lag time of estromustine were significantly increased by milk and food intake and Cmax and AUC were significantly decreased. In comparison with water, the AUC of estromustine was 41% when the drug was taken with milk and 67% after simultaneous intake of standardized food. Corresponding figures for the peak values were 32 and 57%, respectively. The effect of milk and food intake on the pharmacokinetics of estrone was similar. Studies in vitro demonstrated that the dissolution of estramustine phosphate disodium was markedly impaired in the presence of calcium. It was concluded that the rate and extent of absorption of estramustine phosphate were decreased when the drug was taken with milk or food due to the formation of a poorly absorbable calcium complex. To obtain high and reproducible absorption of Estracyt®, the drug should not be taken together with milk, milk products or other calcium-rich food or drugs.
Dual-phase 18F-fluoro-2-deoxy-d-glucose positron emission tomography as a prognostic parameter in patients with pancreatic cancer

Recently, dual-phase 18F-fluoro-2-deoxy-d-glucose (FDG) positron emission tomography (PET) was shown to be useful in the differentiation between malignant and benign pancreatic lesions. The aim of this prospective study was to evaluate the value of dual-phase FDG-PET as a prognostic parameter in patients with pancreatic cancer. Sixty-five consecutive patients with pancreatic cancer underwent dual-phase FDG-PET. Standardised uptake values at 1 h (SUV1) and 2 h (SUV2) following the injection of FDG were determined, and the retention index (RI) was calculated by dividing the difference between SUV2 and SUV1 by SUV1. The prognostic value of SUV1, SUV2 and RI was analysed, along with the various clinical and biochemical parameters. Multivariate analysis showed that only three factors had an independent association with longer patient survival: female gender (p<0.01), TNM stage I–III (p<0.05) and RI>10% (p<0.01). Neither SUV1 nor SUV2 showed any prognostic significance. Combination of tumour stage and RI allowed more accurate prognostic evaluation. Patients at stage I–III with RI>10% survived longer than did patients at the same stage with RI<10% (15.3 vs 11.5 months, p<0.01). Patients at stage IV with RI>10% had an intermediate prognosis, with a median survival of 9.5 months; patients at stage IV with RI<10% showed the worst prognosis, with a median survival of 4.9 months (p<0.05). RI calculated with dual-phase FDG-PET can be used not only as a tool for initial diagnosis and staging of pancreatic cancer but also as a strong independent prognostic parameter that can allow accurate identification of those patients who will benefit from intensive anticancer treatment at different stages of the disease.
Whole-body hyperthermia combined with hyperthermic intraperitoneal chemotherapy for the treatment of stage IV advanced gastric cancer.

Currently known as a metastatic disease, stage IV gastric cancer cannot be cured by surgery, but treatments are recommended to relieve symptoms such as pain and to prolong survival.



With better access to metastases and certain large or inoperable tumours, we applied two treatment sessions of combined therapy of whole-body hyperthermia and hyperthermic intraperitoneal chemo-perfusion in the treatment group, while patients in the control group were treated with oxaliplatin combined with 5-fluorouracil chemotherapy or Xeloda. We used the RECIST criteria for outcome evaluation.



With the combined treatment, we found the complete and partial remission rate of patients to be 61.5%, and the rate of stable disease was 19.2%. Symptoms such as pain and a large volume of ascites were alleviated, and the quality of life was correspondingly improved. In addition, the combined treatment had a significant therapeutic benefit against the primary tumour and the metastases to the lymph nodes and liver. Survival time was also significantly prolonged (the 1-year survival rate was 38.5% compared to the control group rate of 19%).



These results suggest that whole-body hyperthermia combined with hyperthermic intraperitoneal chemotherapy is an effective treatment for patients with advanced gastric malignancies.
Ile118Val genetic polymorphism of CYP3A4 and its effects on lipid-lowering efficacy of simvastatin in Chinese hyperlipidemic patients

To determine the frequencies of CYP3A4 alleles (CYP3A4*4,*5 and *6) in Chinese hyperlipidemic patients and to observe the impact of CYP3A4*4 (Ile118Val) genetic polymorphism on the lipid-lowering effects of simvastatin and on the activity of CYP3A4. From hospitalized and non-hospitalized patients, 211 unrelated hyperlipidemic patients were recruited for genotyping. CYP3A4 genotypes were determined by means of polymerase chain reaction and restriction fragment length polymorphism analysis. Of the non-hospitalized hyperlipidemic patients, 8 with CYP3A4*1/*1 and 8 with CYP3A4*1/*4 genotypes were selected to be treated with 20 mg simvastatin daily for 4 weeks. Serum triglycerides (TG), cholesterol (CHO) and low-density lipoprotein (LDL) levels were determined using an automated analyzer (Hitachi 747, Boehringer Mannheim, Mannheim, Germany). CYP3A4 activity was determined by the ratio of 6-hydroxycortisol to free cortisol (6-OHC/FC) in the morning spot urine with a high-throughput liquid chromatography–tandem mass spectrometry method. Of 211 subjects, 14 (allele frequency 3.32%) were heterozygous for CYP3A4*4 (Ile118Val). Nevertheless, no subjects with a CYP3A4*5 or CYP3A4*6 allele or homozygous for CYP3A4*4 were identified. The ratio of 6β-OHC/FC was 9.9±13.7 and 56.6±35.7 in subjects with the Ile118Val variant (n=8) and in CYP3A4 wild-type subjects (n=8), respectively (P=0.0039). After oral intake of simvastatin 20 mg daily for 4 weeks, the change of serum lipids in CYP3A4*1/*1 and CYP3A4*1/*4 groups showed a significant difference, with a mean decrease in triglycerides and total cholesterol of 38.1±7.6% versus 25.1±8.3% (P=0.034) and of 35.8±9.6% versus 22.0±20.4% (P=0.0015) (means ± SD), respectively. We found no statistically significant difference in the reductions of LDL between subjects carrying the *1 and *4 genotypes (29.0±7.4% versus 36.8±8.8%, P=0.0721). The allele frequency of CYP3A4*4 was 3.32% among the hyperlipidemic patients from the Chinese mainland. CYP3A4*4 was an allelic variant related to a functional decrease of CYP3A4 activity, and *4 expression seemed to increase the lipid-lowering effects of simvastatin.