nils-herrmann/clean_scirepeval huggingface dataset:
Feasibility and efficacy of gemcitabine and docetaxel combination chemotherapy for bone and soft tissue sarcomas: multi-institutional retrospective analysis of 134 patients

Bone and soft tissue sarcomas (BSTS) are rare malignant tumors. Recently, the combination of gemcitabine and docetaxel (GD) was shown to have activity as second-line setting in BSTS. However, the efficacy as first-line and adjuvant settings and precise profiles of adverse events in Japanese patients are not known yet. In the present study, the feasibility and efficacy of GD in patients with BSTS were investigated.



Patients with BSTS treated with GD in our institutions were retrospectively analyzed. Information regarding clinical features, adverse events, and outcome was collected and statistically studied. Factors related to survival were analyzed using log-rank test and Cox proportional hazard regression method.



A total of 134 patients were analyzed. GD was carried out as adjuvant setting in 9, first-line in 23, second-line in 56, and third-or-greater line in 46 patients. The response rate (RR) for all patients was 9.7%. RR for the patients treated as adjuvant or first-line setting was 18.8%, whereas that as second-or-greater line was 6.9%. The median progression-free survival (PFS) and overall survival (OS) of all patients were 4.8 (95% CI 3.5-6.1) and 16.4 (95% CI 9.8-22.9) months, respectively. Survival tended to be better in the patients treated as first-line than in those treated as second-or-greater line. Multivariate analysis demonstrated that history of prior chemotherapy (p = 0.046) and response to GD (p = 0.009) was significantly associated with PFS and OS, respectively. The leucopenia and neutropenia were the most frequent adverse events, and grade 3 or 4 leucopenia and neutropenia were observed in 69.4 and 72.4% of the patients. Grade 2 or 3 pneumonitis was observed in one (0.7%) and four (3.0%) patients, respectively. All the patients with pneumonitis had experienced prior chemotherapy and/or radiotherapy.



GD used as both first- and second/later line is effective chemotherapy for a proportion of patients with advanced BSTS. Higher response rate and better outcome was achieved in chemotherapy-naïve patients. This regimen is associated with high incidence of severe hematological toxicity, as well as the risk of severe pneumonitis, especially in pre-treated patients. GD is promising for further analysis by phase III study for the patients with BSTS.
Acid Challenge to the Human Esophageal Mucosa: Effects on Epithelial Architecture in Health and Disease

The histological changes that occur in the squamous epithelium in response to acute acid challenge was examined in healthy controls and proton pump inhibitor-treated gastroesophageal reflux disease (GERD) patients and related to the state of untreated erosive GERD in a saline-controlled, randomized perfusion study. In the basal state a stepwise significant increase in the thickness of the basal cell layer, papillary length, and dilatation of intercellular spaces (DIS) was seen when the three groups were compared. Acid perfusion induced a slight increase in the height of the basal cell layer mainly in healthy volunteers; this layer appears to be reactive to acute acid challenge as well as to acid suppressive therapy. DIS increases promptly in response to acute acid exposure in the healthy epithelium but no changes were seen in the lengths of the papillae or regarding DIS in the GERD patients. A protective effect of luminal nitric oxide on DIS development is suggested.
Glucose Level Estimation in Diabetes Mellitus By Saliva: A Bloodless Revolution.

Diabetes mellitus is a massive, growing, silent epidemic that has the potential to cripple health services in all parts of the world. Currently, a diagnosis of diabetes is achieved by evaluating plasma glucose levels. Saliva offers some distinctive advantages. Whole saliva can be collected non-invasively and by individuals with limited training. The present study was aimed to estimate and correlate the plasma and salivary glucose levels in diabetic and non diabetic subjects, with special reference to age.



The study population consisted of three groups: Group I consisted of diabetics with BGL>200mg/dl and Group 2 consisted of diabetics with BGL 130-200mg/dl based on their random plasma glucose levels. Group 3 consisted of healthy population as controls with BGL <130 mg/dl. 2 ml of peripheral blood was collected for the estimation of random plasma glucose levels and unstimulated saliva was collected for the estimation of salivary glucose



The salivary glucose levels were significantly higher in group 1 and group 2 diabetics when compared with controls. The salivary glucose levels show a significant correlation with plasma glucose levels between study populations, suggesting that salivary glucose levels can be used as a monitoring tool for predicting glucose level in diabetic patients.



The present study found that estimation of salivary glucose levels can be used as a noninvasive, painless technique for the measurement of diabetic status of a patient in a dental set up.
Association of rhinosinusitis with nasopharyngeal carcinoma: a population-based study.

Although it is already known that the inflammation process elevates the risk of developing cancer, to date the association between rhinosinusitis and nasopharyngeal carcinoma (NPC) remains unknown. This study aimed to evaluate the association between rhinosinusitis and NPC based on a nationwide database.



Case-control study.



In total, the cases comprised of 2,242 subjects with NPC and 6,726 randomly selected subjects as controls. Separate conditional logistic regression analyses were used to calculate the odds ratio (OR) for having been previously diagnosed with chronic and acute rhinosinusitis between the cases and controls.



Of the total sample, 607 subjects (6.77%) had been diagnosed with chronic rhinosinusitis prior to the index date: 322 (14.36%) cases with NPC and 285 (4.24%) controls (P<.001). A conditional logistic regression analysis revealed that the OR of prior chronic rhinosinusitis for subjects with NPC is 3.83 (95% confidence interval [CI], 3.23-4.53) as compared to controls after adjusting for the factors of income, urbanization, geographic location, tobacco use disorder, and alcohol abuse/dependence syndrome. Furthermore, 1,199 (53.48%) cases and 2,938 (42.19%) controls had been diagnosed with acute rhinosinusitis prior to the index date (P<.001).The adjusted OR of prior acute rhinosinusitis for subjects with NPC was 1.57 (95% CI, 1.43-1.73) that of controls.



This study detected an association between NPC and rhinosinusitis. We recommend that patients who are diagnosed with rhinosinusitis, either acute or chronic, seek out aggressive management to reduce the tissue burden and lower the risk of subsequently developing NPC.
Barriers to care and primary care for vulnerable children with asthma.

I tested the hypothesis that, for vulnerable children with asthma, barriers to care (pragmatics, skills, knowledge and beliefs, expectations of care, and marginalization) affect primary care experiences, after accounting for financial, potential, and realized access to care, demographic features, and asthma severity.



Patients, recruited primarily from urban, federally qualified health centers, were between 3 and 12 years of age and had been diagnosed as having asthma. Bilingual, bicultural interviewers administered surveys in participants' homes. Validated instruments were used to measure barriers to care (Barriers to Care Questionnaire) and primary care experiences (Parent's Perceptions of Primary Care measure).



Of 252 families recruited, 56.6% of parents were monolingual Spanish speakers, 73.6% of mothers had not graduated from high school, and 24.5% of children were uninsured. Asthma severity was 27% mild persistent, 40.5% moderate persistent, and 32.5% severe persistent. In bivariate analyses, better access to care (being insured and having a regular provider) was related to better primary care experiences. Consistent with the hypothesis, multivariate regression analyses showed that fewer barriers (Barriers to Care Questionnaire scores) predicted better primary care (Parent's Perceptions of Primary Care total and subscale scores), after controlling for access to care, demographic features, and asthma severity (a 1-point change in Barriers to Care Questionnaire scores was associated with a 0.59-point change in Parent's Perceptions of Primary Care total scale scores). Having a regular doctor and not having experienced foregone care were also significant predictors of Parent's Perceptions of Primary Care scores in the multivariate analysis.



For vulnerable children with asthma, barriers to care explain variance in primary care characteristics beyond that explained by access, demographic factors, and disease severity.
Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study.

To prospectively assess the short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures (VCF) treated with percutaneous vertebroplasty (PV) compared with optimal pain medication (OPM).



Randomization of patients in 2 groups: treatment by PV or OPM. After 2 weeks, patients from the OPM arm could change therapy to PV. Patients were evaluated 1 day and 2 weeks after treatment. Visual analog score (VAS) for pain and analgesic use were assessed before, and 1 day and 2 weeks after start of treatment. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Roland-Morris Disability (RMD) questionnaire scores were assessed before and 2 weeks after start of treatment. Follow-up scores in patients requesting PV treatment after 2 weeks OPM treatment were compared with scores during their OPM period.



Eighteen patients treated with PV compared with 16 patients treated with OPM had significantly better VAS and used less analgesics 1 day after treatment. Two weeks after treatment, the mean VAS was less but not significantly different in patients treated with OPM, whereas these patients used significantly less analgesics and had better QUALEFFO and RMD scores. Scores in the PV arm were influenced by occurrence of new VCF in 2 patients. After 2 weeks OPM, 14 patients requested PV treatment. All scores, 1 day and 2 weeks after PV, were significantly better compared with scores during conservative treatment.



Pain relief and improvement of mobility, function, and stature after PV is immediate and significantly better in the short term compared with OPM treatment.
Strain rate imaging after dynamic stress provides objective evidence of persistent regional myocardial dysfunction in ischaemic myocardium: regional stunning identified?

To investigate whether persistent ischaemic dysfunction of the myocardium after dynamic stress can be diagnosed from changes in ultrasonic strain rate and strain.



Prospective observational study, with age matched controls.



University hospital.



26 patients (23 men, mean (SD) age 58.9 (8.1) years) with coronary artery disease but no infarction and 12 controls (9 men, aged 56.1 (8.8) years) with normal coronary arteriography and negative exercise test underwent treadmill exercise (Bruce protocol). Tissue Doppler echocardiography was performed at baseline, at peak exercise, and at intervals up to one hour. Systolic and diastolic velocity, strain, and strain rate were recorded in the basal anterior segment of 16 patients with proximal left anterior descending coronary artery disease.



Patients developed ischaemia, since they experienced angina, exercised for less time, and reached a lower workload than the control group, and had ST segment depression (-2.4 mm). Myocardial systolic velocity immediately after exercise increased by 31% and strain rate fell by 25% compared with increases of 92% and 62%, respectively, in the control group (p < 0.05). During recovery, myocardial systolic velocity and strain rate normalised quickly, whereas systolic strain remained depressed at 30 and 60 minutes after exercise, by 21% and 23%, respectively, compared with baseline (p < 0.05 versus controls). Myocardial diastolic velocities and strain rate normalised but early diastolic strain remained depressed by 32% compared with controls for 60 minutes (p < 0.05). Strain during atrial contraction was abnormal for 30 minutes.



Myocardial strain shows regional post-ischaemic dysfunction in systole and diastole and may become a useful diagnostic tool in patients presenting with chest pain with a normal ECG.
A preliminary study of fMRI-guided rTMS in the treatment of generalized anxiety disorder.

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method that holds promise for treating several psychiatric disorders. Yet the most effective location and parameters for treatment need more exploration. Also, whether rTMS is an effective treatment for individuals with a DSM-IV diagnosis of generalized anxiety disorder (GAD) has not been empirically tested. The goal of this pilot study was to evaluate whether functional magnetic resonance imaging (fMRI)-guided rTMS is effective in reducing symptoms of GAD.



Ten participants with a DSM-IV diagnosis of GAD, recruited from the UCLA Anxiety Disorders Program, and between the ages of 18 and 56 years were enrolled in the study from August 2006 to March 2007. A pretreatment symptom provocation fMRI experiment was used to determine the most active location in the prefrontal cortex of the participants. Ten participants completed 6 sessions of rTMS over the course of 3 weeks, stereotactically directed to the previously determined prefrontal location. The primary efficacy measures were the Hamilton Rating Scale for Anxiety (HAM-A) and the Clinical Global Impressions-Improvement of Illness (CGI-I) scale. Response to treatment was defined as a reduction of 50% or more on the HAM-A and a CGI-I score of 1 or 2 ("very much improved" or "much improved," respectively).



Overall, rTMS was associated with significant decreases in HAM-A scores (t = 6.044, p = .001) indicative of clinical improvement in GAD symptoms. At endpoint, 6 (60%) of the 10 participants who completed the study showed reductions of 50% or more on the HAM-A and a CGI-I score of 1 or 2; those 6 subjects also had an endpoint HAM-A score < 8, therefore meeting criteria for remission.



Results of the current study suggest that fMRI-guided rTMS treatment may be a beneficial technique for the treatment of anxiety disorders. Limitations include a small sample size and open-label design with a technology that may be associated with a large placebo response. These limitations necessitate further research to determine whether rTMS is indeed effective in treating anxiety disorders.
Accuracy of diagnosing atrial fibrillation on electrocardiogram by primary care practitioners and interpretative diagnostic software: analysis of data from screening for atrial fibrillation in the elderly (SAFE) trial.

To assess the accuracy of general practitioners, practice nurses, and interpretative software in the use of different types of electrocardiogram to diagnose atrial fibrillation.



Prospective comparison with reference standard of assessment of electrocardiograms by two independent specialists.



49 general practices in central England.



2595 patients aged 65 or over screened for atrial fibrillation as part of the screening for atrial fibrillation in the elderly (SAFE) study; 49 general practitioners and 49 practice nurses.



All electrocardiograms were read with the Biolog interpretative software, and a random sample of 12 lead, limb lead, and single lead thoracic placement electrocardiograms were assessed by general practitioners and practice nurses independently of each other and of the Biolog assessment.



Sensitivity, specificity, and positive and negative predictive values.



General practitioners detected 79 out of 99 cases of atrial fibrillation on a 12 lead electrocardiogram (sensitivity 80%, 95% confidence interval 71% to 87%) and misinterpreted 114 out of 1355 cases of sinus rhythm as atrial fibrillation (specificity 92%, 90% to 93%). Practice nurses detected a similar proportion of cases of atrial fibrillation (sensitivity 77%, 67% to 85%), but had a lower specificity (85%, 83% to 87%). The interpretative software was significantly more accurate, with a specificity of 99%, but missed 36 of 215 cases of atrial fibrillation (sensitivity 83%). Combining general practitioners' interpretation with the interpretative software led to a sensitivity of 92% and a specificity of 91%. Use of limb lead or single lead thoracic placement electrocardiograms resulted in some loss of specificity.



Many primary care professionals cannot accurately detect atrial fibrillation on an electrocardiogram, and interpretative software is not sufficiently accurate to circumvent this problem, even when combined with interpretation by a general practitioner. Diagnosis of atrial fibrillation in the community needs to factor in the reading of electrocardiograms by appropriately trained people.
A national multicenter phase 2 study of prostate-specific antigen (PSA) pox virus vaccine with sequential androgen ablation therapy in patients with PSA progression: ECOG 9802.

E9802 was a phase 2 multi-institution study conducted to evaluate the safety and effectiveness of vaccinia and fowlpox prostate-specific antigen (PSA) vaccine (step 1) followed by combination with androgen ablation therapy (step 2) in patients with PSA progression without visible metastasis.



To test the hypothesis that vaccine therapy in this early disease setting will be safe and have a biochemical effect that would support future studies of immunotherapy in patients with minimal disease burden.



Patients who had PSA progression following local therapy were treated with PROSTVAC-V (vaccinia)/TRICOM on cycle 1 followed by PROSTVAC-F (fowlpox)/TRICOM for subsequent cycles in combination with granulocyte-macrophage colony-stimulating factor (step 1). Androgen ablation was added on progression (step 2).


OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Step 1 primary end points included progression at 6 mo and characterization of change in PSA velocity pretreatment to post-treatment. Step 2 end points included PSA response with combined vaccine and androgen ablation.



In step 1, 25 of 40 eligible patients (63%) were progression free at 6 mo after registration (90% confidence interval [CI], 48-75). The median pretreatment PSA velocity was 0.13 log(PSA)/mo, in contrast to median postregistration velocity of 0.09 log(PSA)/mo (p=0.02), which is an increase in median PSA doubling time from 5.3 mo to 7.7 mo. No grade ≥4 treatment-related toxicity was observed. In the 27 patients eligible and treated for step 2, 20 patients achieved a complete response (CR) at 7 mo (CR rate: 74%; 90% CI, 57-87). Although supportive of larger studies in the cooperative group setting, this study is limited by the small number of patients and the absence of a control group as in a phase 3 study.



A viral PSA vaccine can be administered safely in the multi-institutional cooperative group setting to patients with minimal disease volume alone and combined with androgen ablation, supporting the feasibility of future phase 3 studies in this population.



These data support consideration of vaccine therapy earlier in the course of prostate cancer progression with minimal disease burden in future studies of vaccine approaches in earlier stages of disease.
Muscle ergoreceptor overactivity reflects deterioration in clinical status and cardiorespiratory reflex control in chronic heart failure.

In chronic heart failure (CHF), overactivation of ergoreceptors (afferents sensitive to the metabolic effects of muscular work) may be a link between peripheral changes, sympathetic overactivation, and increased hemodynamic and ventilatory responses to exercise. The relationship between ergoreceptors, autonomic changes, and the progression of the syndrome has not yet been studied.



Thirty-eight stable CHF patients (age, 57+/-1 years; ejection fraction, 26+/-2%) were compared with 12 age-matched normal control subjects. The ergoreflex contribution to the ventilatory and hemodynamic responses to exercise, together with peripheral and central chemoreceptor sensitivity, arterial baroreflex sensitivity, plasma norepinephrine, epinephrine, and heart rate variability, were measured. Enhanced ergoreflex effects on ventilation (78+/-2% versus 50+/-8%), peripheral chemosensitivity (0.6+/-0.4 versus 0.2+/-0.1 L/min per percent SaO(2)), and central chemosensitivity (2.9+/-0.2 versus 2.0+/-0.2 L. min(-1). ) and an impaired baroreflex function (4.1+/-0.6 versus 9.1+/-5.6 ms/mm Hg) were confirmed in CHF compared with control subjects (P<0.01 in all comparisons). Ergoreceptor overactivity was associated with a worse symptomatic state (NYHA class, P<0.05), lower exercise tolerance (peak VO(2), P<0.05), and pronounced exercise hyperventilation (VE/VCO(2), P<0.01). It was also a strong predictor of increased central chemosensitivity (independently of clinical parameters), baroreflex impairment, and sympathetic activation (plasma catecholamines and heart rate variability indexes; all P<0.05). In multivariate analysis, among all reflexes studied, the ventilatory component of the ergoreflex was the only independent predictor of peak VO(2) and VE/VCO(2).



In CHF, overactivation of the ergoreflex is associated with abnormal cardiorespiratory reflex control, independently of clinical severity. Among impaired reflexes, overactivation of the ergoreflex is an important determinant of exercise hyperventilation and reduced exercise tolerance.
Prevalence of anterior pituitary dysfunction in patients following traumatic brain injury in a German multi-centre screening program.

We determined the prevalence of anterior pituitary dysfunction in a multi-centre screening program across five German endocrine centres in patients rehabilitating from TBI (GCS<13).



246 patients (39+/-14 yrs; 133 males, 12+/-8 months after TBI) underwent a series of baseline endocrine tests with central assessment of TSH, free T4, prolactin, LH, FSH, testosterone (m), estradiol (f), cortisol, GH, and IGF-I. If IGF-I was <-2 SDS dynamic testing was performed. GHD was defined according to BMI-dependent cut-off values for GH response to GHRH+arginine of <4.2, <8.0 and <11.5 ng/ml in obese, overweight and lean subjects, respectively, or <3 micro g/l in ITT. Hypocortisolism was suggested when basal cortisol was <200 nmol/l and confirmed by ITT (peak<500 nmol/l).



In TBI patients some degree of impaired pituitary function was shown in 21% (n=52/246). Total, multiple and isolated deficits were present in 1%, 2% and 18%, respectively. 19% had an IGF-I of <-1 SDS, 9% of <-2 SDS. In 5% GHD was confirmed. 9% had hypogonadism. 4% had hypocortisolism and 1% of patients had confirmed ACTH-deficiency. 12% had TSH-deficiency.



In summary, in this large series carried out on an unselected group of TBI survivors we have found hypopituitarism in every fifth patient with predominantly secondary hypogonadism and hypothyreosis. Regarding somatotrope insufficiency IGF-I is decreased in 50% of GHD patients.



These findings strongly suggest that patients who suffer head trauma should routinely undergo endocrine evaluation.