nils-herrmann/clean_scirepeval huggingface dataset:
Feasibility of laparoscopy-assisted total gastrectomy in patients with clinical stage I gastric cancer

Laparoscopy-assisted total gastrectomy (LATG) for gastric cancer is not yet widespread because of the technical difficulty of reconstruction. We have performed LATG on 100 patients with clinical stage I gastric cancer. This study investigated the short-term outcomes of LATG. Between September 2001 and September 2012, 100 patients with clinical stage I gastric cancer underwent LATG with D1 plus beta or D2 lymphadenectomy. Roux-en-Y esophagojejunostomy was performed intracorporeally using end-to-side anastomosis with a circular stapler (the purse-string suture method). The primary endpoint was the proportion of postoperative complications during hospitalization. Mean operation time was 249 min; mean blood loss was 182 ml. There were no conversions to open surgery. According to the Clavien–Dindo classification, there were 8 grade II (8 %) and 10 grade IIIa/b (10 %) complications. There were no treatment-related deaths or grade IV complications. The most frequent complication was anastomotic or stump leakage (6 %), followed by pancreatic fistula (5 %). Reoperations were required in two patients with leakage. The short-term outcomes of LATG in our study involving 100 patients were outlined. LATG for gastric cancer patients should be attempted preferably in a clinical trial setting by surgeons with sufficient experience in laparoscopic gastrectomy.
¡ ects of metabolic control on vitamin E nutritional status in children with type 1 diabetes mellitus

To evaluate the e¡ects of themetabolic control of the insulin-dependent diabetes mellitus (IDDM) on the nutritional status of vitamin E.  A total of 47 children with IDDMand a mean age of11.9171.60 (mean7SD) years were studied, matched for age and sex with16 healthy children (11.7571.83 years). Following theAmerican and British Associations for IDDM, we used a classification of ‘good’, ‘moderate’or ‘poor’control of the illness: (a) good control [glycosilated haemoglobin (HbAlc) 7%]; (b) moderate control (7%o HbAlc 8%); and (c) poor control (HbAlc48%). Serum concentrations of total cholesterol (CHOL), triglycerides (TG), high-density lipoproteins-cholesterol (HDLc), very lowand low-density lipoproteins cholesterol (VLDLc and LDLc), plasma and erythrocyte vitamin E (Vit Ep andVit Ee) and plasma vitamin A (Vit Ap) were measured in all children.  The childrenwith ‘poor’metabolic control of the illness presented significantly higher plasma concentrations of CHOL, LDLc,VLDLc, LDLc/HDLc, (VLDL+LDL)c/HDLc,TG andVit Ep; higher indicesVit Ep/Vit Ee andVit Ep/Vit Ap relative to thosewith a‘good’control of the illness. Direct-linear correlationswere foundbetween Vit Ep and the percentage of HbAlc andwith the markers of atherogenic risk in the IDDM children.  There is a significant rise inVit Ep concentrations as metabolic control of the illness worsens, whereas Vit Ee remainedunchanged.These results suggest that vitamin Emaintains its nutritional status despite a poor control of the IDDMduring childhood. r 2002 Elsevier
Alcohol dependence and physical comorbidity: Increased prevalence but reduced relevance of individual comorbidities for hospital-based mortality during a 12.5-year observation period in general hospital admissions in urban North-West England.

Alcohol dependence (AD) is associated with an increase in physical comorbidities. The effects of these diseases on general hospital-based mortality are unclear. Consequently, we conducted a mortality study in which we investigated if the burden of physical comorbidities and their relevance on general hospital-based mortality differs between individuals with and without AD during a 12.5-year observation period in general hospital admissions.



During 1 January 2000 and 30 June 2012, 23,371 individuals with AD were admitted at least once to seven General Manchester Hospitals. Their physical comorbidities with a prevalence≥1% were compared to those of 233,710 randomly selected hospital controls, group-matched for age and gender (regardless of primary admission diagnosis or specialized treatments). Physical comorbidities that increased the risk of hospital-based mortality (but not outside of the hospital) during the observation period were identified using multiple logistic regression analyses.



Hospital-based mortality rates were 20.4% in the AD sample and 8.3% in the control sample. Individuals with AD compared to controls had a higher burden of physical comorbidities, i.e. alcoholic liver and pancreatic diseases, diseases of the conducting airways, neurological and circulatory diseases, diseases of the upper gastrointestinal tract, renal diseases, cellulitis, iron deficiency anemia, fracture neck of femur, and peripheral vascular disease. In contrast, coronary heart related diseases, risk factors of cardiovascular disease, diverticular disease and cataracts were less frequent in individuals with AD than in controls. Thirty-two individual physical comorbidities contributed to the prediction of hospital-based mortality in univariate analyses in the AD sample; alcoholic liver disease (33.7%), hypertension (16.9%), chronic obstructive pulmonary disease (14.1%), and pneumonia (13.3%) were the most frequent diagnoses in deceased individuals with AD. Multiple forward logistic regression analysis, accounting for possible associations of diseases, identified twenty-three physical comorbidities contributing to hospital-based mortality in individuals with AD. However, all these comorbidities had an equal or even lower impact on hospital-based mortality than in the comparison sample.



The excess of in-hospital deaths in general hospitals in individuals with AD is due to an increase of multiple physical comorbidities, even though individual diseases have an equal or even reduced impact on general hospital-based mortality in individuals with AD compared to controls.
A prospective study of short course radiotherapy in elderly patients with malignant glioma

Elderly patients with malignant glioma have a poorprognosis and the benefit of standard radical radiotherapyis equivocal. Twenty-two percent of the adult referralbase with malignant glioma at our centre isof age 70 years or greater. A phaseII study was undertaken to determine if ashorter course of therapy yields a comparable mediansurvival to radical radiotherapy and thus constitutes anappropriate investigational palliative regimen.25 patients were accrued between 1988–1995, all ofwhom had histologically proven malignant glioma, 23 glioblastomamultiforme and 2 anaplastic astrocytoma. The median agewas 73 (range 70–78) and median Karnofsky PerformanceStatus (KPS) was 70. 40% had a stereotacticbiopsy only for diagnosis. Radiotherapy was delivered tolimited fields to a dose of 37.5 Gyin 15 daily fractions over 3 weeks. Anintention-to-treat analysis was undertaken with survival determined fromdate of initial consultation. The median survival ofthe whole group was 8.0 months (95% CI4.8–9.6). Patients with good performance status (KPS >70) had a median survival of 10.4 months(95% CI 9.6–14.7).37.5 Gy in 15 daily fractions appears toyield comparable median survival to that of otherseries of radical radiotherapy. A phase III studyof this regimen is recommended in investigating optimalpalliation of elderly malignant glioma patients.
Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn's disease in the SONIC trial.

The Crohn's Disease Activity Index (CDAI) has been criticised due to heavy weighting on subjective clinical symptoms. C-reactive protein (CRP) and endoscopic lesions are objective measures of inflammation. We investigated the relationships between clinical disease activity, CRP normalisation and mucosal healing in Crohn's disease (CD).



The Study of Biologic and Immunomodulator Naive Patients in CD trial compared infliximab to azathioprine and to infliximab plus azathioprine in 508 CD patients. Mucosal healing was defined as the absence of mucosal ulceration at the week 26 ileocolonoscopy in a patient who had evidence of ulceration at the baseline ileocolonoscopy.



188 patients who had evaluable ileocolonoscopy with evidence of mucosal ulceration at baseline, CDAI scores and CRP values at baseline and week 26 were analysed. Seventy-two of 136 patients (53%) who had a CDAI<150 at week 26 achieved mucosal healing, and 38 of 90 patients (42%) achieved both CRP normalisation (CRP<0.8 mg/dL) and mucosal healing while in clinical remission. The positive predictive value (PPV) and negative predictive value (NPV) of CDAI to detect mucosal healing using 150 as a cut-off for CDAI were 65% and 53%, respectively. The PPV and NPV of CDAI to detect mucosal healing and CRP normalisation using 150 as a cut-off for CDAI were 79% and 42%, respectively.



Half the patients under azathioprine and/or infliximab in clinical remission have endoscopic and/or CRP evidence of residual active CD, whereas other patients with endoscopic and CRP normalisation have persistent clinical symptoms. Clinical symptoms as scored by CDAI are not a reliable measure of the underlying inflammation.
A phase II study of high-dose cetuximab plus irinotecan in colorectal cancer patients with KRAS wild-type tumors who progressed after standard dose of cetuximab plus irinotecan.

We conducted a phase II clinical trial of high-dose cetuximab plus irinotecan in KRAS wild-type patients who progressed on standard-dose cetuximab plus irinotecan.



Patients who progressed within 4 weeks from receiving a minimum of 6 weeks of standard-dose cetuximab plus irinotecan were included in this study. Cetuximab was administered at 500 mg/m(2)/week and irinotecan was administered at the same dose/schedule on which each individual patient had previously progressed. The study was closed early after having met its primary end point.



Twenty patients were treated. The regimen was found to be efficacious, with 9 patients achieving disease control lasting more than 12 weeks. The median progression-free survival and overall survival were 2.8 and 6.6 months, respectively. The toxicity profile was favorable, with the exception of grade 3-4 hypomagnesemia which was noted in 25% of patients.



High-dose cetuximab plus irinotecan rechallenge can re-elicit clinical benefits in patients who have previously failed cetuximab plus irinotecan treatment. The clinical benefits are modest and may be related to cetuximab rechallenge rather than cetuximab dose escalation.
Inverse regression methods based on fuzzy partitions

We consider a semiparametric regression model such that the dependent variable y is linked to some indices xβk through an unknown link function. Li (1991) introduced sliced inverse regression methods (SIR-I, SIR-II and SIRα) in order to estimate the effective dimension reduction space spanned by the vectors βk. These methods computationally fast and simple but are influenced by the choice of slices in the estimation process. In this paper, we suggest to use versions of SIR methods based on fuzzy clusters instead of slices which can be seen as hard clusters and we exhibit the corresponding algorithm. We illustrate the sample behaviour of the fuzzy inverse regression estimators and compare them with the SIR ones on simulation study.
Rise of oxyntomodulin in response to oral glucose after gastric bypass surgery in patients with type 2 diabetes.

The mechanisms by which Roux-en-Y gastric bypass surgery (GBP) results in sustained weight loss and remission of type 2 diabetes are not fully understood.



We hypothesized that the anorexic hormone oxyntomodulin (OXM) might contribute to the marked weight reduction and the rapid improvement in glucose metabolism observed in morbidly obese diabetic patients after GBP.



Twenty obese women with type 2 diabetes were studied before and 1 month after GBP (n=10) or after a diet-induced equivalent weight loss (n=10). Patients from both groups were matched for age, body weight, body mass index, and diabetes duration and control. OXM concentrations were measured during a 50-g oral glucose challenge before and after weight loss.



At baseline, OXM levels (fasting and stimulated values) were indistinguishable between the GBP and the diet group. However, OXM levels rose remarkably in response to an oral glucose load more than 2-fold (peak, 5.25+/-1.31 to13.8+/-16.2 pmol/liter; P=0.025) after GBP but not after diet. The peak of OXM after glucose was significantly correlated with glucagon-like peptide-1 and peptide YY3-36.



Our data suggest that the observed changes in OXM primarily occur in response to GBP and not as a consequence of weight loss. These changes were observed early after surgery and occurred in parallel with previously reported increases in incretins and peptide YY. We speculate that the combination of gut hormone changes is essential for the improved glucose homeostasis and may partially explain the success of this surgery on diabetes resolution and weight loss.
Common changes in cerebral blood flow in patients with social phobia treated with citalopram or cognitive-behavioral therapy.

Neurofunctional changes underlying effective antianxiety treatments are incompletely characterized. This study explored the effects of citalopram and cognitive-behavioral therapy on regional cerebral blood flow (rCBF) in social phobia.



By means of positron emission tomography with oxygen 15-labeled water, rCBF was assessed in 18 previously untreated patients with social phobia during an anxiogenic public speaking task. Patients were matched for sex, age, and phobia severity, based on social anxiety questionnaire data, and randomized to citalopram medication, cognitive-behavioral group therapy, or a waiting-list control group. Scans were repeated after 9 weeks of treatment or waiting time. Outcome was assessed by subjective and psychophysiological state anxiety measures and self-report questionnaires. Questions were readministered after 1 year.



Symptoms improved significantly and roughly equally with citalopram and cognitive-behavioral therapy, whereas the waiting-list group remained unchanged. Four patients in each treated group and 1 waiting-list patient were classified as responders. Within both treated groups, and in responders regardless of treatment approach, improvement was accompanied by a decreased rCBF-response to public speaking bilaterally in the amygdala, hippocampus, and the periamygdaloid, rhinal, and parahippocampal cortices. Between-group comparisons confirmed that rCBF in these regions decreased significantly more in treated groups than control subjects, and in responders than nonresponders, particularly in the right hemisphere. The degree of amygdalar-limbic attenuation was associated with clinical improvement a year later.



Common sites of action for citalopram and cognitive-behavioral treatment of social anxiety were observed in the amygdala, hippocampus, and neighboring cortical areas, ie, brain regions subserving bodily defense reactions to threat.
Solid-phase microextraction-gas chromatography-mass spectrometry method validation for the determination of endogenous substances: urinary hexanal and heptanal as lung tumor biomarkers.

Hexanal and heptanal are endogenous aldehydes coming from membrane lipid oxidation, found in lung cancer patients' blood, and suggested as lung tumor biomarkers. Here the urinary matrix was investigated instead of blood and the difficulties related to the determination of endogenous substances in biological matrices were faced by developing an external calibration HS-SPME/GC/MS method. The methodology was validated according to international validation procedures and it was verified analyzing unknown biological samples from cancer patients and healthy subjects. Percentage accuracy and precision, ranging from -11.25 to 10.85% and from 0.45 to 4.46%, respectively, were obtained, together with limits of detection (LODs) and lower limits of quantification (LLOQs) of 0.11 and 0.23 pg μL(-1) for hexanal and of 0.10 and 0.21 pg μL(-1) for heptanal. Analytes percentage recoveries (66.3%, hexanal and 70.5%, heptanal) and stability were evaluated. No analytes degradation was found at room temperature, while the remarkable analytes loss found after 1 month storage suggests analyzing biological samples within a week from storage. Results coming from the analysis of unknown biological samples showed no evident differences of heptanal urinary excretion between lung cancer patients and healthy subjects (0.22-0.95 and 0.21-0.69 pg μL(-1), respectively), while hexanal urinary concentrations in cancer patients (0.24-4.36 pg μL(-1)) were slightly higher than those found in control group ones (0.23-1.26 pg μL(-1)). The obtained results highly suggest to do further investigations in order to collect statistically significant biological data to discriminate between the pathological state of lung cancer patients and physiological conditions of healthy subjects, using the simple, rapid and cheap method here reported for the quantification of urinary aldehydes.
Core stabilization exercise with real-time feedback for chronic hemiparetic stroke: a pilot randomized controlled trials.

The purpose of this study was to examine the feasibility of core stabilization exercise with real-time feedback on balance and gait function in patients with chronic hemiparetic stroke.



Nineteen stroke subjects were enrolled in this study. The patients were randomly divided into the experimental (n = 10) and control groups (n = 9). Subjects in the experimental group performed core stabilization exercise with real-time feedback training for 30 minutes per day during a period of six weeks. Subjects in the control group performed core stabilization exercise during the same period. This study assessed the kinematic parameters using a portable walkway system, and timed up-and-go test.



Gait velocity showed significantly greater improvement in the experimental group (7.3 ± 5.0 sec) than in the control group (-0.7 ± 10.6). Stride length showed significantly greater increase in the experimental group (13.2 ± 7.9 on the affected side and 12.6 ± 8.0 on the less affected side) than the control group (3.5 ± 8.7 on the affected side and 3.4 ± 8.5 on the less affected side). After training, change in results on the timed up and go test was significantly greater in the experimental group than in the control group.



Core stabilization exercise using real-time feedback produces greater improvement in gait performance in chronic hemiparetic stroke patients than core stabilization exercise only.
The influence of g.19124G>a genetic polymorphism in the OPG gene on bone mineral density in Chinese women.

The aim of this study was to detect the influence of g.19124G>A genetic polymorphism in the osteoprotegerin (OPG) gene on bone mineral density (BMD) and osteoporosis in Chinese postmenopausal women.



A total of 403 primary osteoporosis subjects and 409 healthy controls were enrolled in this study. The BMD value of the femoral neck hip, lumbar spine (L(2-4)), and total hip was analyzed by Norland XR-46 dual energy X-ray absorptiometry. The polymerase chain reaction-restriction fragment length polymorphism method was utilized to investigate the genotype of g.19124G>A genetic polymorphism.



We found significant differences of the femoral neck hip, lumbar spine (L(2-4)), and total hip of BMD among different genotypes of g.19124G>A genetic polymorphism, individuals with the genotype GG had significantly higher BMD than those of genotype GA and AA (p<0.05).



These findings indicate that the g.19124G>A genetic polymorphism in the OPG gene is potentially related to BMD and osteoporosis in Chinese postmenopausal women, and the allele A could be associated with a lower BMD and an increased risk factor for osteoporosis.
Japanese POEMS syndrome with Thalidomide (J-POST) Trial: study protocol for a phase II/III multicentre, randomised, double-blind, placebo-controlled trial

Polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes (POEMS) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor (VEGF). Recently, the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma. However, no randomised clinical trial has been performed because of the rarity and severity of the disease.



The Japanese POEMS syndrome with Thalidomide (J-POST) Trial is a phase II/III multicentre, double-blinded, randomised, controlled trial that aims to evaluate the efficacy and safety of a 24-week treatment with thalidomide in POEMS syndrome, with an additional 48-week open-label safety study. Adults with POEMS syndrome who have no indication for transplantation are assessed for eligibility at 12 tertiary neurology centres in Japan. Patients who satisfy the eligibility criteria are randomised (1:1) to receive thalidomide (100-300 mg daily) plus dexamethasone (12 mg/m(2) on days 1-4 of a 28-day cycle) or placebo plus dexamethasone. Both treatments were administered for 24 weeks (six cycles; randomised comparative study period). Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent 48-week open-label safety study (long-term safety period). The primary end point of the study is the reduction rate of serum VEGF levels at 24 weeks.


ETHICS AND DISSEMINATION
The protocol was approved by the Institutional Review Board of each hospital. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, Japan (No. 22-1716). The J-POST Trial is currently ongoing and is due to finish in August 2015. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations and will also be disseminated to participants.
Transferred and Delayed Care of Patients with Colorectal Cancer in a Safety-Net Hospital System—Manifestations of a Distressed Healthcare System

Safety-net hospital systems provide care to a large proportion of United States’ under- and uninsured population. We have witnessed delayed colorectal cancer (CRC) care in this population and sought to identify demographic and systemic differences in these patients compared to those in an insured health-care system. We collected demographic, socioeconomic, and clinical data from 2005–2007 on all patients with CRC seen at Parkland Health and Hospital System (PHHS), a safety-net health system and at Presbyterian Hospital Dallas System (Presbyterian), a community health system, and compared characteristics among the two health-care systems. Variables associated with advanced stage were identified with multivariate logistic regression analysis and odds ratios were calculated. Three hundred and eighteen patients at PHHS and 397 patients at Presbyterian with CRC were identified. An overwhelming majority (75 %) of patients seen at the safety-net were diagnosed after being seen in the emergency department or at an outside facility. These patients had a higher percentage of stage 4 disease compared to the community. Patients within the safety-net with Medicare/private insurance had lower rates of advanced disease than uninsured patients (25 % vs. 68 %, p < 0.001). Insurance status and physician encounter resulting in diagnosis were independent predictors of disease stage at diagnosis. A large proportion of patients seen in the safety-net health system were transferred from outside systems after diagnosis, thus leading to delayed care. This delay in care drove advanced stage at diagnosis. The data point to a pervasive and systematic issue in patients with CRC and have fundamental health policy implications for population-based CRC screening.