nils-herrmann/clean_scirepeval huggingface dataset:
Feasibility of Azacitidine Added to Standard Chemotherapy in Older Patients with Acute Myeloid Leukemia — A Randomised SAL Pilot Study

Older patients with acute myeloid leukemia (AML) experience short survival despite intensive chemotherapy. Azacitidine has promising activity in patients with low proliferating AML. The aim of this dose-finding part of this trial was to evaluate feasibility and safety of azacitidine combined with a cytarabine- and daunorubicin-based chemotherapy in older patients with AML.



Patients aged 61 years or older, with untreated acute myeloid leukemia with a leukocyte count of <20,000/µl at the time of study entry and adequate organ function were eligible. Patients were randomised to receive azacitidine either 37.5 (dose level 1) or 75 mg/sqm (dose level 2) for five days before each cycle of induction (7+3 cytarabine plus daunorubicine) and consolidation (intermediate-dose cytarabine) therapy. Dose-limiting toxicity was the primary endpoint.



Six patients each were randomised into each dose level and evaluable for analysis. No dose-limiting toxicity occurred in either dose level. Nine serious adverse events occurred in five patients (three in the 37.5 mg, two in the 75 mg arm) with two fatal outcomes. Two patients at the 37.5 mg/sqm dose level and four patients at the 75 mg/sqm level achieved a complete remission after induction therapy. Median overall survival was 266 days and median event-free survival 215 days after a median follow up of 616 days.



The combination of azacitidine 75 mg/sqm with standard induction therapy is feasible in older patients with AML and was selected as an investigational arm in the randomised controlled part of this phase-II study, which is currently halted due to an increased cardiac toxicity observed in the experimental arm.
HbA(1c) in the prediction of type 2 diabetes compared with fasting and 2-h post-challenge plasma glucose: The Asturias study (1998-2005).

Fasting plasma glucose (FPG) and the 2-h post-challenge plasma glucose (2hPG) are commonly used to identify those at risk of type 2 diabetes. However, the role of HbA(1c) in this prediction has still not been ascertained.



The Asturias study is a prospective population-based survey of diabetes and cardiovascular risk factors. Baseline examination, carried out during 1998-1999, involved 1034 individuals, aged 30-75 years, randomly selected to determine the prevalence of type 2 diabetes and prediabetes in the principality of Asturias (northern Spain). In 2004-2005, these same subjects were invited to a follow-up examination, and 700 participated. The present study includes only those who did not have diabetes at baseline. All participants with no known diabetes underwent an OGTT. Baseline HbA(1c) levels were measured by HPLC.



Diabetes had developed in 44 participants at the time of follow-up. Quartiles of baseline HbA(1c) values were 3.4-4.8 (Q1), 4.9-5.1 (Q2), 5.2-5.4 (Q3) and 5.5-6.9 (Q4), and the incidence rates of diabetes by quartiles were 1.0 (0.1-7.1), 4.0 (1.5-10.7), 7.9 (4.0-15.9) and 32.6 (22.9-46.4) cases/1000 person-years, respectively. ROC curve analysis comparing HbA(1c), FPG and 2hPG in the prediction of diabetes showed areas under the curve (ROC-AUC) of 0.80 (0.74-0.86), 0.83 (0.77-0.90) and 0.79 (0.72-0.87), respectively. The combination of FPG and HbA(1c) had the best predictive performance with an ROC-AUC of 0.88 (0.82-0.93).



Our study indicates that HbA(1c) is strongly predictive of new-onset diabetes in this northern Spanish population, and was similar to FPG and 2hPG in predictive capability. Also, the combined measurement of FPG and HbA(1c) improved their individual predictive performance.
Inhaled budesonide therapy for patients with stable COPD.

A significant minority of patients with COPD have favorable response to corticosteroid treatment. In addition, the benefit of corticosteroid treatment may be outweighed by the side effects. Long-term administration of inhaled steroids is a safe means of treatment. We hypothesized that treatment with high-dose inhaled budesonide would improve clinical symptoms and pulmonary function in subjects with COPD, and that the response to inhaled beta 2-agonist will serve to individualize steroid responders. We compared a 6-week course of 800 micrograms/d inhaled budesonide with placebo, separated by 4 weeks when no medication was taken, in a double-blind crossover trial, in 8 patients responding to inhaled beta 2-agonist, and in 22 nonresponders with stable COPD. In six of eight "responders to beta 2-agonist," there was a significant improvement in the FEV1 (defined as > or = 20%) following inhaled budesonide, as compared with placebo. In the 22 "nonresponders to beta 2-agonist," there was no significant improvement in the mean FEV1 (1.41 +/- 0.1 L before, and 1.61 +/- 0.1 L after treatment) with inhaled budesonide or placebo. Over the 6-week course of treatment by either budesonide or placebo, the nonresponders reported similar beta 2-agonist consumption (4.8 +/- 0.2 and 5.0 +/- 0.1 puffs per patient per day, respectively). However, there was a significant difference between the two periods of treatment in the responders as for the mean daily number of beta 2-agonist inhalations (2.4 +/- 0.1 in the budesonide period as compared with 5.3 +/- 0.1 in the placebo period; p < 0.005). We conclude that treatment with inhaled steroids improved spirometry data and inhaled beta 2-agonist consumption in about 25% of patients with stable COPD, and this rate is increased to about 75% in patients who respond to beta 2-agonist inhalation.
Genetics and the environment affect the relationship between depression and low back pain: a co-twin control study of Spanish twins.

Although the co-occurrence of low back pain (LBP) and depression is common, the nature of this association remains unclear. We aimed to investigate whether symptoms of depression are associated with LBP after adjusting for various confounders, including genetics. We used cross-sectional data from 2148 twins from the Murcia Twin Registry, Spain. All twins answered questions about lifetime prevalence of LBP (outcome variable) and symptoms of depression, collected through two instruments, deriving 3 measures: (1) self-report feelings of depression and anxiety; (2) state depression, and (3) trait depression. First, associations were investigated using logistic regression analysis of the total sample. We performed subsequent matched within-pair twin case-control analyses with all complete twin pairs discordant for LBP regardless of zygosity, and separately for dizygotic and monozygotic pairs. This sequential analysis allows for more precise estimates of the relationship between variables, as in each step, the impact of early shared environment and genetics is further considered. Symptoms of depression and anxiety were associated with higher prevalence of LBP in the total sample analysis (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.31-2.05), and this relationship was stronger in the subsequent case-control analysis (OR, 1.74; 95% CI, 1.13-2.69) and dizygotic case-control analysis (OR, 2.39; 95% CI, 1.39-4.08) but disappeared when the analysis was conducted for monozygotic twins (OR, 0.92; 95% CI, 0.42-2.05). A similar pattern was found for state and trait depression. The depression-LBP relationship disappears when high levels of control for confounding factors are applied and seems to be driven by genetic or environmental factors that influence both conditions.
Combination With Low-dose Dextromethorphan Improves the Effect of Amlodipine Monotherapy in Clinical Hypertension

The combination of low rather than high dose of dextromethorphan (DXM) with amlodipine (AM) could improve blood pressure (BP) reduction in hypertensive animals. The study aimed to evaluate the feasibility of different doses of DXM combined with standard AM treatment in clinical hypertension.This was a prospective, 14-week, dose-escalation, multicenter study. After 2-week run-in period with AM 5 mg/day, hypertensive patients who got the BP goal of 140/90 mmHg kept receiving AM monotherapy for another 12 weeks. The nonresponders, while kept on AM 5 mg/day, received additional DXM treatment for 3 sequential dose-titrated periods with initially 2.5 mg/day, followed by 7.5 mg/day, and finally 30 mg/day. Each period was for 4 weeks. The patients at BP goal after each treatment period were defined as the responders and kept on the same combination till the end of the study. The responder rate of each treatment period was recorded. The changes of BP and serum antioxidant/endothelial markers between week 14 and week 2 were evaluated.Of the 103 patients initially enrolled, 89 entered the treatment period. In the 78 patients completing the study, 31 (40%) at BP goal after 2-week AM run-in kept on AM monotherapy (DXM0). The addition of 2.5 (DXM2.5) and 7.5 mg/day (DXM7.5) of DXM enabled BP goal achievement in 22 (47%) nonresponders to AM monotherapy including 16 (29%) with DXM2.5 and 6 (18%) with DXM7.5. Only 4 patients (16%) reached BP goal with the combination of DXM 30 mg/day (DXM30). Overall, 73% of the 78 patients reached BP goal at the end of the 14-week study. Mean systolic BP was reduced by 7.9% ± 7.0% with DXM2.5 (P < 0.001) and by 5.4% ± 2.4% with DXM7.5 (P = 0.003) respectively at week 14 from that at week 2, which was unchanged in either DXM0 or DXM30 group. Besides, the effects of combination treatment were particularly significant in the patients with impaired endothelial function suggested by reduced serum NOx level at baseline.Accordingly, the combination with low dose of DXM was feasible to improve BP control in patients who failed to achieve the BP goal by standard AM monotherapy. The benefit effects might be significant especially in patients with impaired endothelial function.
Substance use among Dutch homeless people, a follow-up study: prevalence, pattern and housing status.

Previous studies have shown that substance use among homeless people is a prevalent problem that is associated with longer durations of homelessness. Most studies of substance use among the homeless were carried out outside Europe and have limited generalizability to European countries. This study therefore aimed to address the prevalence of substance use among homeless people in the Netherlands, the pattern of their use and the relationship with housing status at follow-up.



This study included 344 participants (67.1% of the initial cohort) who were followed from baseline to 18 months after the baseline interview. Multinomial logistic regression analyses examined the relationship between substance use and housing status.



The most reported substances which were used among these homeless people were cannabis (43.9%) and alcohol (≥5 units on one occasion) (30.7%). Other substances were used by around 5% or less of the participants. Twenty-seven percent were classified as substance misuser and 20.9% as substance dependent. The odds to be marginally housed (4.14) or institutionalized (2.12) at follow-up compared to being housed of participants who were substance users were significantly higher than those of participants who did not use substances. The odds to be homeless were more than twice as high (2.80) for participants who were substance dependent compared with those who were not.



Homeless people who use substances have a more disadvantageous housing situation at follow-up than homeless people who do not use substances. Attention is needed to prevent and reduce long-term homelessness among substance-using homeless people.
Evaluation of the clinical practicability of intraoperative optical imaging comparing three different camera setups.

Intraoperative optical imaging (IOI) is a method to visualize functional activated brain areas during brain surgery using a camera system connected to a standard operating microscope. Three different high-resolution camera systems (Hamamatsu EB-CCD C7190-13W, Hamamatsu C4742-96-12G04, and Zeiss AxioCam MRm) have been evaluated for suitability to detect activated brain areas by detecting stimulation-dependent blood volume changes in the somatosensory cerebral cortex after median nerve stimulation. The image quality of the camera systems was evaluated in 14 patients with tumors around the somatosensory cortex. The intraoperative images of the brain surface were continuously recorded over 9 min. With all three camera systems, the activity maps of the median nerve area could be visualized. The image quality of a highly sensitive electron-bombarded camera was up to 10-fold lower compared with two less sensitive standard cameras. In each IOI-positive case, the activated area was in accordance with the anatomical and neurophysiological location of the corresponding cortex. The technique was found to be very sensitive, and several negative influencing factors were identified. However, all possible artifacts seem to be controllable in the majority of the cases, and the IOI method could be well adapted for routine clinical use. Nevertheless, further systematic studies are needed to demonstrate the reliability and validity of the method.
Potential for dose-escalation and reduction of risk in pancreatic cancer using IMRT optimization with lexicographic ordering and gEUD-based cost functions.

Radiotherapy for pancreatic cancer is limited by the tolerance of local organs at risk (OARs) and frequent overlap of the planning target volume (PTV) and OAR volumes. Using lexicographic ordering (LO), a hierarchical optimization technique, with generalized equivalent uniform dose (gEUD) cost functions, we studied the potential of intensity modulated radiation therapy (IMRT) to increase the dose to pancreatic tumors and to areas of vascular involvement that preclude surgical resection [surgical boost volume (SBV)]. We compared 15 forward planned three-dimensional conformal (3DCRT) and IMRT treatment plans for locally advanced unresectable pancreatic cancer. We created IMRT plans optimized using LO with gEUD-based cost functions that account for the contribution of each part of the resulting inhomogeneous dose distribution. LO-IMRT plans allowed substantial PTV dose escalation compared with 3DCRT; median increase from 52 Gy to 66 Gy (a=-5,p<0.005) and median increase from 50 Gy to 59 Gy (a=-15,p<0.005). LO-IMRT also allowed increases to 85 Gy in the SBV, regardless of a value, along with significant dose reductions in OARs. We conclude that LO-IMRT with gEUD cost functions could allow dose escalation in pancreas tumors with concomitant reduction in doses to organs at risk as compared with traditional 3DCRT.
Extended duration of the detectable stage by adding HPV test in cervical cancer screening

The human papillomavirus test (HPV) test could improve the (cost−) effectiveness of cervical screening by selecting women with a very low risk for cervical cancer during a long period. An analysis of a longitudinal study suggests that women with a negative Pap smear and a negative HPV test have a strongly reduced risk of developing cervical abnormalities in the years following the test, and that HPV testing lengthens the detectable stage by 2–5 years, compared to Pap smear detection alone.
The effect of pyridostigmine on bronchial hyperreactivity.

We examined the effect of pyridostigmine (PY) at a dose of 30 mg orally three times a day on nonspecific bronchial hyperreactivity in ten normal nonsmokers (NNS), ten smokers (SM), and ten mild asthmatics (AS). We conducted a double-blind, placebo-controlled, crossover trial, randomly assigning subjects to receive either placebo (PL) or PY before undergoing bronchoprovocation challenge with eucapnic voluntary hyperventilation (EVH) using dry gas. Compliance with PY was confirmed by measuring red blood cell acetylcholinesterase (Achase) levels during both days of testing. While taking PL, the mean (+/- SEM) falls in FVC and FEV1 after the bronchoprovocation were as follows: NNS, 1.0 percent (+/- 0.6) FVC and 4.3 percent (+/- 1.0) FEV1; SM, 2.4 percent (+/- 1.1) FVC and 2.7 percent (+/- 1.3) FEV1; AS, 5.3 percent (+/- 2.3) FVC and 11.5 percent (+/- 2.8) FEV1. The mean decreases in FVC and FEV1 while taking PY were as follows: NNS, 1.8 percent (+/- 0.7) FVC and 4.3 percent (+/- 0.8) FEV1; SM, 3.8 percent (+/- 1.4) FVC and 5.2 percent (+/- 1.6) FEV1; AS, 4.4 percent (+/- 1.3) FVC and 11.8 percent (+/- 2.8) FEV1. Within each category, using a paired t test to compare the results on each day of testing, no statistically significant differences were noted. Pyridostigmine at the tested dose has no significant effect on nonspecific bronchial hyperreactivity in normal NNS, SM, or AS.
Neurohumoral effects of aliskiren in patients with symptomatic heart failure receiving a mineralocorticoid receptor antagonist: the Aliskiren Observation of Heart Failure Treatment study.

We evaluated the influence of concomitant mineralocorticoid receptor antagonists (MRAs) on the safety and neurohumoral effects of a direct renin inhibitor in the ALiskiren Observation of Heart Failure Treatment (ALOFT) study.



Patients with stable New York Heart Association class II-IV heart failure (HF), plasma B-type natriuretic peptide (BNP) concentration >100 pg/mL, and treated with an angiotensin-converting enzyme inhibitor (or angiotensin receptor blocker) and β-blocker were randomized to once-daily, double-blind treatment with aliskiren 150 mg or placebo, added to optimal HF therapy, for 12 weeks. Safety, tolerability, and effects of aliskiren on neurohumoral biomarkers were assessed in patients who received (MRA+) and did not receive (MRA-) MRA treatment at baseline. Of the 302 randomized patients, 101 were receiving MRA treatment (aliskiren, n = 52; placebo, n = 49). Mineralocorticoid receptor antagonist status did not affect the ability of aliskiren 150 mg, added to standard HF therapy, to lower BNP, N-terminal proBNP, plasma renin activity, and urinary aldosterone. For example, the end-of-study to baseline ratio of geometric mean for BNP was: MRA+ group: aliskiren 0.68 [95% confidence interval (CI) 0.47, 0.98], placebo 0.85 (0.58, 1.24); MRA- group: aliskiren 0.62 (0.45, 0.84), placebo 0.85 (0.63, 1.15), interaction P= 0.720. The incidence of pre-specified adverse events (renal dysfunction, symptomatic hypotension, and hyperkalaemia) was low, and there were no significant differences between aliskiren and placebo in either MRA subgroup.



Aliskiren 150 mg added to standard HF therapy was well tolerated over 12 weeks and provided beneficial changes in neurohumoral biomarkers regardless of concomitant MRA treatment.
De novo combination therapy adefovir plus lamivudine as a treatment for women of child-bearing age with HBeAg-positive chronic hepatitis B before pregnancy.

Substantial progress has been achieved in antiviral therapy for chronic hepatitis B; however, options for women of child-bearing age with HBeAg-positive chronic hepatitis B remain a challenge. In this study, we sought to determine whether de novo combination therapy of Adefovir plus Lamivudine was a super treatment for women of child-bearing age with HBeAg-positive chronic hepatitis B prior to conception. A total of 122 women patients of child-bearing age with HBeAg-positive chronic hepatitis B were randomly assigned to receive (i) 10 mg Adefovir plus 100 mg Lamivudine (64 patients) or (ii) 10 mg Adefovir monotherapy (58 patients), administrated orally once daily for 96 weeks. The therapeutic efficacy within each group was compared at weeks 48 and 96. The results showed that de novo combination therapy of Adefovir plus Lamivudine significantly reduced HBV-DNA detectability, and enhanced ALT normalization and HBeAg seroconversion in women of child-bearing age with HBeAg-positive chronic hepatitis B. No virological breakthrough and genotypic resistance were observed in the combination therapy group. Additionally, the combination therapy with Adefovir plus Lamivudine was well tolerated. This study suggests that de novo combination therapy of Adefovir plus Lamivudine offers a therapeutic advantage for women of child-bearing age with HBeAg-positive chronic hepatitis B when taken before conception.
Measuring quality of life in thai women with breast cancer.

Breast cancer has become a commonly diagnosed disease among Thai women in the last decade, despite the fact that Thai women generally have a lower rates than their Western counterparts. With the rising incidence and survival rates, it is crucial for nurses to look at the long term quality of life of these patients. A broad range of instruments have been used in clinical trials among breast cancer patients in oncology, like the EORTC questionnaire including the general quality of life questions (QLQ-C30) and the breast cancer module (QLQ-BR23), and the FACT-B questionnaire consisting of both a generic part (FACT-G) and a breast cancer specific module. They have been shown to have good validity and reliability properties both for the English original and translations into various languages including Thai. A few studies on quality of life in Thai context exist, covering quality of life in women with breast cancer. Therefore, the purpose of this study was to find which standard measure of common Western quality of life scales is appropriate to assess quality of life in Thai women with breast cancer. Results revealed the Thai version of EORTC QLQ-C30 and FACT-G questionnaires to be reliable and valid to assess quality of life in general. The best fit for measuring quality of life in Thai women with breast cancer during adjuvant treatment should be the EORTC QLQ-C30/-BR23.
Review of "Enterprise Ajax: Strategies for Building High-performance Web Applications by David Johnson, Alexei White, and Andre Charland, " Prentice Hall PTR, 2007, ISBN 0132242060

Ian Stephenson, Springer-Verlag New York, Inc., 2007, $39.95, ISBN: 1846283442 RenderMan, a rendering API associated with film production, is an essential tool for creating many of the effects and images in recent animated films (such as Monsters Inc. and Finding Nemo). Essential RenderMan is a self-paced tutorial that facilitates the understanding of many of the features of the API. The tone of the book is set in the preface, where author Ian Stephenson explains why he wrote the first edition (2003) and the reason for the second edition.
Virtual reality improves embodiment and neuropathic pain caused by spinal cord injury

To investigate changes in body ownership and chronic neuropathic pain in patients with spinal cord injury (SCI) using multisensory own body illusions and virtual reality (VR).



Twenty patients with SCI with paraplegia and 20 healthy control participants (HC) participated in 2 factorial, randomized, repeated-measures design studies. In the virtual leg illusion (VLI), we applied asynchronous or synchronous visuotactile stimulation to the participant's back (either immediately above the lesion level or at the shoulder) and to the virtual legs as seen on a VR head-mounted display. We tested the effect of the VLI on the sense of leg ownership (questionnaires) and on perceived neuropathic pain (visual analogue scale pain ratings). We compared illusory leg ownership with illusory global body ownership (induced in the full body illusion [FBI]), by applying asynchronous or synchronous visuotactile stimulation to the participant's back and the back of a virtual body as seen on a head-mounted display.



Our data show that patients with SCI are less sensitive to multisensory stimulations inducing illusory leg ownership (as compared to HC) and that leg ownership decreased with time since SCI. In contrast, we found no differences between groups in global body ownership as tested in the FBI. VLI and FBI were both associated with mild analgesia that was only during the VLI specific for synchronous visuotactile stimulation and the lower back position.



The present findings show that VR exposure using multisensory stimulation differently affected leg vs body ownership, and is associated with mild analgesia with potential for SCI neurorehabilitation protocols.