nils-herrmann/clean_scirepeval huggingface dataset:
Allogeneic bone marrow transplantation vs filgrastim-mobilised peripheral blood progenitor cell transplantation in patients with early leukaemia: first results of a randomised multicentre trial of the European Group for Blood and Marrow Transplantation

In a multicentre trial involving 20 transplant centres from 10 countries haematopoietic stem cells were obtained either from the bone marrow of 33 sibling donors or from the peripheral blood of 33 such donors after administration of filgrastim (10 μg/kg/day). The haematopoietic stem cells were infused into their HLA-identical recipients suffering from acute leukaemias in remission or chronic myeloid leukaemia in chronic phase. PBPC donors tolerated filgrastim administration and leukapheresis well with the most frequent side-effects being musculoskeletal pain, headache, and mild increases of LDH, AP, Gamma-GT or SGPT. Pain and haematoma at the harvest site and mild anaemia were the most frequent complaints of BM donors. Severe or life-threatening complications were not seen with any type of harvest procedure. Time to platelet recovery greater than 20 × 109/l was 15 days (95% confidence interval (CI) 13–16 days) in the PBPCT group and 19 days (CI 16–25) in the BMT group. Time to neutrophil recovery greater than 0.5 × 109/l was 14 days (CI 12–15 days) in the PBPCT group as compared to 15 days (CI 15–16 days) in the BMT group. The numbers of platelet transfusions administered to PBPCT and BMT patients were 12 (range: 1–28) and 10 (range: 3–39), respectively. Sixteen patients (48%) transplanted with bone marrow and 18 patients (54%) transplanted with PBPC developed acute GVHD of grades II–IV; acute GVHD of grades III or IV developed in six (18%) and seven (21%) patients, respectively. Kaplan–Meier plots for transplant-related mortality until day 100 and leukaemia-free survival at a median of 400 days after BMT or PBPCT showed no significant differences. Administration of filgrastim and leukapheresis in normal donors were feasible and well tolerated. The number of days with restricted activity and of nights spent in hospital was lower in donors of PBPC. Transplantation of PBPC to HLA-identical siblings with early leukaemia resulted in earlier platelet engraftment. The incidence of moderate to severe acute GVHD, transplant-related mortality, and leukaemia-free survival did not show striking differences. Further investigation of allogeneic PBPCT as a substitute for allogeneic BMT is warranted.
The potential of phototherapy to reduce body fat, insulin resistance and "metabolic inflexibility" related to obesity in women undergoing weight loss treatment.

The metabolic flexibility is often impaired in diseases associated with obesity, and many studies are based on the hypothesis that dysfunction in peripheral tissues such as skeletal muscle, liver and adipose tissue represent the etiology of development of metabolic inflexibility. Experimental evidence shows that the use of phototherapy combined with exercise was effective in controlling the lipid profile, reducing the mass of adipose tissue, suggesting increased metabolic activity and changes in lipid metabolism. However, we found few data in the literature involving the use of phototherapy in association to physical training in the obese population. Thus, our objective was to evaluate the effects of exercise training (aerobic plus resistance exercises) plus phototherapy (laser, 808 nm) on metabolic profile and adiponectinemia in obese women.



Sixty-four obese women (BMI 30-40 kg/m2 , age between 20 and 40 years old) were randomly assigned in two groups: Exercise Training plus SHAM group (ET-SHAM, n = 32) and Exercise Training plus Phototherapy group (ET-PHOTO, n = 32). The treatment consisted in physical exercise intervention and the individual application of phototherapy immediately after the end of the training session. However, in the ET-SHAM group the device was turned off simulating the phototherapy application (placebo effect). The study protocol lasted for 20 weeks and comprised of three weekly sessions of aerobic plus resistance training and application of phototherapy (when applicable). The body composition and metabolic parameters were assessed (HOMA, adiponectin, insulin, glucose).



Comparing the magnitude of effects between groups (ET-PHOTO vs. ET-SHAM), we observed that physical training plus phototherapy was more effective than physical training in reducing the delta of percentage of fat mass (%; -5.60 ± 1.59 vs. -4.33 ± 1.5; P < 0.04); fat mass (kg; -11.26 ± 2.82 vs. -5.80 ± 2.82; P < 0.0002); HOMA-IR index (-38.08 ± 9.23 vs. -20.91 ± 14.42; P < 0.0001). In addition, we observed an increase in delta (%) of total skeletal muscle mass (kg; 0.60 ± 1.09 vs. -1.38 ± 1.70; P < 0.003), adiponectin concentration (ng/ml; 1.08 (0.04-3.62) vs. -0.42 (-3.15 to 2.26); P < 0.03) in the same comparison.



Our results demonstrated for the first time that phototherapy enhances the physical exercise effects in obese women undergoing weight loss treatment promoting significant changes in inflexibility metabolic profile.
Factors related to the impact of antihypertensive treatment in antioxidant activities and oxidative stress by-products in human hypertension.

The objective was to study factors related to the changes induced by antihypertensive treatment on oxidative status, antioxidant activities, and reactive oxygen species by-products in whole blood and mononuclear peripheral cells. Eighty-nine hypertensive patients (mean age 46 years, 46 men, average 24-h blood pressure 139/88 mm Hg, body mass index 29) were included. After 3 months of nonrandomized allocation to antihypertensive treatment (20 nonpharmacologic, 36 beta-blockers, 33 angiotensin receptor blocker), oxidized/reduced glutathione ratio and malondialdehyde were significantly reduced, and the activity of superoxide dismutase, catalase, and glutathione peroxidase was significantly increased in both whole blood and peripheral mononuclear cells. The content of damaged base 8-oxo-2'-deoxyguanosine in nuclear and mitochondrial DNA in hypertensive subjects was also significantly reduced during the antihypertensive treatment. In a group of 42 subjects, the oxidative stress was further reduced and the antioxidant enzyme activities further increased after 12 months of antihypertensive treatment. The changes were independent of the kind of antihypertensive treatment. In conclusion, antihypertensive treatment improved the increased oxidative stress and the decreased antioxidant mechanisms. It is independent of the type of treatment and the beneficial effect of treatment increases over time.
A randomized comparison of daunorubicin 90 mg/m2 vs 60 mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients.

Modifying induction therapy in acute myeloid leukemia (AML) may improve the remission rate and reduce the risk of relapse, thereby improving survival. Escalation of the daunorubicin dose to 90 mg/m(2) has shown benefit for some patient subgroups when compared with a dose of 45 mg/m(2), and has been recommended as a standard of care. However, 60 mg/m(2) is widely used and has never been directly compared with 90 mg/m(2). As part of the UK National Cancer Research Institute (NCRI) AML17 trial, 1206 adults with untreated AML or high-risk myelodysplastic syndrome, mostly younger than 60 years of age, were randomized to a first-induction course of chemotherapy, which delivered either 90 mg/m(2) or 60 mg/m(2) on days 1, 3, and 5 combined with cytosine arabinoside. All patients then received a second course that included daunorubicin 50 mg/m(2) on days 1, 3, and 5. There was no overall difference in complete remission rate (73% vs 75%; odds ratio, 1.07 [0.83-1.39]; P = .6) or in any recognized subgroup. The 60-day mortality was increased in the 90 mg/m(2) arm (10% vs 5% (hazard ratio [HR] 1.98 [1.30-3.02]; P = .001), which resulted in no difference in overall 2-year survival (59% vs 60%; HR, 1.16 [0.95-1.43]; P = .15). In an exploratory subgroup analysis, there was no subgroup that showed significant benefit, although there was a significant interaction by FLT3 ITD mutation.
Diagnostic and treatment pathways for men with prostate cancer in Queensland: investigating spatial and demographic inequalities

Patterns of diagnosis and management for men diagnosed with prostate cancer in Queensland, Australia, have not yet been systematically documented and so assumptions of equity are untested. This longitudinal study investigates the association between prostate cancer diagnostic and treatment outcomes and key area-level characteristics and individual-level demographic, clinical and psychosocial factors. A total of 1064 men diagnosed with prostate cancer between February 2005 and July 2007 were recruited through hospital-based urology outpatient clinics and private practices in the centres of Brisbane, Townsville and Mackay (82% of those referred). Additional clinical and diagnostic information for all 6609 men diagnosed with prostate cancer in Queensland during the study period was obtained via the population-based Queensland Cancer Registry. Respondent data are collected using telephone and self-administered questionnaires at pre-treatment and at 2 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-treatment. Assessments include demographics, medical history, patterns of care, disease and treatment characteristics together with outcomes associated with prostate cancer, as well as information about quality of life and psychological adjustment. Complementary detailed treatment information is abstracted from participants' medical records held in hospitals and private treatment facilities and collated with health service utilisation data obtained from Medicare Australia. Information about the characteristics of geographical areas is being obtained from data custodians such as the Australian Bureau of Statistics. Geo-coding and spatial technology will be used to calculate road travel distances from patients' residences to treatment centres. Analyses will be conducted using standard statistical methods along with multilevel regression models including individual and area-level components. Information about the diagnostic and treatment patterns of men diagnosed with prostate cancer is crucial for rational planning and development of health delivery and supportive care services to ensure equitable access to health services, regardless of geographical location and individual characteristics. This study is a secondary outcome of the randomised controlled trial registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000233426)
Validation of 3 termination of resuscitation criteria for good neurologic survival after out-of-hospital cardiac arrest.

Several termination of resuscitation criteria have been proposed to identify patients who will not survive to hospital discharge after out-of-hospital cardiac arrest. However, only 1 set has been derived to specifically predict survival to hospital discharge with good neurologic function. The objectives of this study were to externally validate the basic life support (BLS) termination of resuscitation, advanced life support (ALS) termination of resuscitation, and neurologic termination of resuscitation criteria and compare their abilities to predict survival to hospital discharge with good neurologic function after out-of-hospital cardiac arrest.



This was a secondary analysis of the Denver Cardiac Arrest Registry. Consecutive adult nontraumatic cardiac arrest patients in Denver County from January 1, 2003, through December 31, 2004, were included in the study. The BLS termination of resuscitation, ALS termination of resuscitation, and neurologic termination of resuscitation criteria were applied to the cohort, and their predictive proportions and 95% confidence intervals (CIs) were calculated for each set of criteria.



Of the 715 patients included in this study, the median age was 65 years (interquartile range 52 to 78 years), and 69% were male patients. In addition, 223 (31%) had return of spontaneous circulation, 175 (24%) survived to hospital admission, 58 (8%) survived to hospital discharge, and 42 (6%) survived to hospital discharge with good neurologic function. The proportion of patients with good neurologic survival to hospital discharge correctly identified for continued resuscitation was 100% (95% CI 92% to 100%) for all 3 termination of resuscitation criteria. The proportion of patients with poor neurologic survival to hospital discharge or no survival to hospital discharge correctly identified as eligible for termination of resuscitation was 36% (95% CI 32% to 40%) with the BLS termination of resuscitation criteria, 25% (95% CI 22% to 29%) with the ALS termination of resuscitation criteria, and 6% (95% CI 4% to 8%) with the neurologic termination of resuscitation criteria. Use of the BLS termination of resuscitation criteria would have reduced transport of the largest number of patients.



All 3 termination of resuscitation criteria had equally high abilities to identify patients requiring continued resuscitation. The BLS termination of resuscitation criteria, however, had the best combined ability to predict good neurologic survival and poor neurologic survival or death. These findings and the relative simplicity of the BLS termination of resuscitation criteria support their use.
Incidence, diagnostic methods, and evolution of left ventricular thrombus in patients with anterior myocardial infarction and low left ventricular ejection fraction: a prospective multicenter study.

We aimed to assess the incidence and evolution of left ventricular (LV) thrombi in a high-risk population of patients with LV systolic dysfunction after anterior myocardial infarction (ant-MI). We also compared the accuracy of transthoracic echocardiography (TTE) and cardiac magnetic resonance imaging with contrast-delayed enhancement (CMR-DE) in detecting LV thrombi.



We prospectively included 100 consecutive patients with LV ejection fraction (LVEF) <45% at the first TTE performed <7 days after ant-MI. A second evaluation with TTE and CMR-DE (by blinded examiners) was performed at 30 days. A third TTE and assessment of clinical status were performed between 6 and 12 months after ant-MI.



Patients (males 71%; mean age 59.1 ± 12.1 years; mean LVEF 33.5% ± 6.0%) were included at a median of 5.5 days (interquartile range 25th-75th percentile 4.25-6.0 days) after ant-MI. Thrombi were detected among 26 (26%) patients at a median of 12.0 days after ant-MI (7 patients at 1-7 days after MI; 15 at 8-30 days; and 4 after day 30). Sensitivity and specificity for LV thrombi detection were 94.7% and 98.5%, respectively, for TTE as compared with CMR-DE. Most thrombi (n = 24; 92.3%) disappeared after triple antithrombotic therapy (vitamin K antagonist in addition to dual antiplatelet therapy).



Left ventricular thrombus is a frequent complication after ant-MI with systolic dysfunction. When a search for thrombus is prespecified, the accuracy of TTE is high as compared with CMR-DE. The best antithrombotic strategy is not known.
Accuracy of in vivo palpation-guided acromioclavicular joint injection assessed with contrast material and fluoroscopic evaluations

The purpose of this study was to evaluate the accuracy of in vivo acromioclavicular (AC) joint injections without fluoroscopic guidance and assess whether patient demographics affected the accuracy of injections. A consecutive cohort of patients who presented with painful acromioclavicular joints was prospectively evaluated. All patients had clinical and radiographic evidence of AC arthritis, had failed conservative measures, and thus had received intraarticular corticosteroid injections. All injections were performed by experienced fellowship-trained musculoskeletal radiologists and by blinded digital palpation technique. Accuracy of injections was assessed with biplanar fluoroscopic views. Forty-one AC injections in 22 males and 16 females with a mean age of 51 years (range 18 to 78) were identified. Twenty-three injections were in the right shoulder and 18 in the left. Only 15 injections were confirmed to be in the intraarticular AC joint, yielding an accuracy of 36.5 %. There were no significant differences in the mean age (54 vs. 52 years; p = 0.58), male-to-female ratio (p = 0.73), and side of the injection between the accurate and inaccurate injections, respectively. Based on the findings of the present study, the authors encourage the use of image guidance for corticosteroid treatment of the AC joint.
Importance of rate control or rate regulation for improving exercise capacity and quality of life in patients with permanent atrial fibrillation and normal left ventricular function: a randomised controlled study.

To determine the importance of rhythm regulation or rate control in patients with permanent atrial fibrillation (AF) and normal left ventricular function.



Thirty six patients with a mixed fast and slow ventricular response rate to their AF were randomised to either His bundle ablation (HBA) and VVIR pacemaker (HBA group) or VVI pacemaker and atrioventricular modifying drugs (Med group). Outcomes assessed at one, three, six, and 12 months included exercise duration and quality of life.



Exercise duration significantly improved from baseline in both groups. There was no difference in outcome between the groups (Med +40% v HBA +20%, p = NS). The heart rate profile on exercise was similarly slowed in both groups compared to baseline. Quality of life significantly improved in both treatment arms for the modified Karolinska questionnaire (KQ) (Med +50% v HBA +50%, p = NS) and the Nottingham health profile (NHP) (Med +40% v HBA +20%, p = NS). However, for the individual symptom scores of each questionnaire more were improved in the Med group (KQ-Med 6 improved v HBA 4, NHP-Med 3 v HBA 1). Left ventricular function was equally preserved by both treatments during follow up.



In these patients control of ventricular response rate with either HBA + VVIR pacemaker or atrioventricular modifying drugs + VVI pacemaker will lead to a significant improvement in exercise duration and quality of life. Rhythm regulation by HBA did not confer additional benefit, suggesting rate control alone is necessary for the successful symptomatic treatment of these patients in permanent AF.
Safety and Immunogenicity of DNA and MVA HIV-1 Subtype C Vaccine Prime-Boost Regimens: A Phase I Randomised Trial in HIV-Uninfected Indian Volunteers

A randomized, double-blind, placebo controlled phase I trial.



The trial was conducted in 32 HIV-uninfected healthy volunteers to assess the safety and immunogenicity of prime-boost vaccination regimens with either 2 doses of ADVAX, a DNA vaccine containing Chinese HIV-1 subtype C env gp160, gag, pol and nef/tat genes, as a prime and 2 doses of TBC-M4, a recombinant MVA encoding Indian HIV-1 subtype C env gp160, gag, RT, rev, tat, and nef genes, as a boost in Group A or 3 doses of TBC-M4 alone in Group B participants. Out of 16 participants in each group, 12 received vaccine candidates and 4 received placebos.



Both vaccine regimens were found to be generally safe and well tolerated. The breadth of anti-HIV binding antibodies and the titres of anti-HIV neutralizing antibodies were significantly higher (p<0.05) in Group B volunteers at 14 days post last vaccination. Neutralizing antibodies were detected mainly against Tier-1 subtype B and C viruses. HIV-specific IFN-γ ELISPOT responses were directed mostly to Env and Gag proteins. Although the IFN-γ ELISPOT responses were infrequent after ADVAX vaccinations, the response rate was significantly higher in group A after 1(st) and 2(nd) MVA doses as compared to the responses in group B volunteers. However, the priming effect was short lasting leading to no difference in the frequency, breadth and magnitude of IFN-γELISPOT responses between the groups at 3, 6 and 9 months post-last vaccination.



Although DNA priming resulted in enhancement of immune responses after 1(st) MVA boosting, the overall DNA prime MVA boost was not found to be immunologically superior to homologous MVA boosting.
KRAS mutation status is not predictive for objective response to anti-EGFR treatment with erlotinib in patients with advanced pancreatic cancer

It has not yet been defined if KRAS has a prognostic value or is a predictive biomarker for the efficacy of erlotinib in advanced pancreatic cancer (PC). AIO-PK0104 was a phase III trial comparing gemcitabine/erlotinib followed by capecitabine with capecitabine/erlotinib followed by gemcitabine in advanced PC. For this post hoc subgroup analysis, biomarker data on the KRAS exon 2 mutation status were correlated with objective response to 1st-line therapy and with overall survival after start of 2nd-line chemotherapy (OSc). KRAS codon 12 was mutated in 121 of 173 (70 %) patients. The KRAS status showed no association with objective response (p = 0.40), but KRAS wildtype patients had an improved OS (HR 1.68, p = 0.005). A trend for a survival benefit was also observed during (non-erlotinib containing) 2nd-line chemotherapy, with a HR of 1.47 (p = 0.10) for the OSc. This post hoc analysis of AIO-PK0104 supports the assumption that KRAS is rather a prognostic than a predictive biomarker in PC.
Baseline trajectories of heavy drinking and their effects on postrandomization drinking in the COMBINE Study: empirically derived predictors of drinking outcomes during treatment.

The Combined Pharmacotherapies and Behavioral Interventions (COMBINE) Study sought to answer questions about the benefits of combining behavioral and pharmacological interventions (naltrexone and acamprosate) in alcohol-dependent patients. Our goals were to identify trajectories of heavy drinking before randomization in COMBINE, to characterize patients in these trajectories, and to assess whether prerandomization trajectories predict drinking outcomes. We analyzed daily indicators of heavy drinking 90 days before randomization using a trajectory-based approach. Each patient was assigned to the most likely prerandomization heavy-drinking trajectory, and the baseline characteristics of participants in the baseline trajectories were compared. The main and interactive effects of these trajectories and treatment factors (acamprosate, naltrexone, or combined behavioral intervention) on summary drinking measures during active treatment (16 weeks) were assessed. We identified five trajectories of heavy drinking prerandomization: "T1: frequent heavy drinkers"; "T2: very frequent heavy drinkers"; "T3: nearly daily heavy drinkers"; "T4: daily heavy drinkers"; and "T5: daily heavy drinkers stopping early" before randomization. Trajectory membership was significantly associated with all drinking outcomes. Patients in "T5: daily heavy drinkers stopping early" had comparable drinking outcomes to those in "T1: frequent heavy drinkers," whereas the remaining trajectories were associated with significantly worse outcomes. The baseline trajectory did not interact significantly with the treatment condition. These exploratory analyses confirmed the hypothesis that baseline trajectories predict postrandomization drinking outcomes. Interestingly, "T5: daily heavy drinkers stopping early" had outcomes that were comparable to the least severe baseline trajectory "T1: frequent heavy drinkers," and baseline trajectories of heavy drinking did not moderate the treatment effects.