nils-herrmann/clean_scirepeval huggingface dataset:
Does a GLP-1 receptor agonist change glucose tolerance in patients treated with antipsychotic medications? Design of a randomised, double-blinded, placebo-controlled clinical trial

Metabolic disturbances, obesity and life-shortening cardiovascular morbidity are major clinical problems among patients with antipsychotic treatment. Especially two of the most efficacious antipsychotics, clozapine and olanzapine, cause weight gain and metabolic disturbances. Additionally, patients with schizophrenia-spectrum disorders not infrequently consume alcohol. Glucagon-like peptide-1 (GLP-1) has shown to improve glycaemic control and reduce alcohol intake among patients with type 2 diabetes.



To investigate whether the beneficial effects of GLP-1 analogues on glycaemic control and alcohol intake, in patients with type 2 diabetes, can be extended to a population of pre-diabetic psychiatric patients receiving antipsychotic treatment.



Trial design, intervention and participants: The study is a 16-week, double-blinded, randomised, parallel-group, placebo-controlled clinical trial, designed to evaluate the effects of the GLP-1 analogue liraglutide on glycaemic control and alcohol intake compared to placebo in patients who are prediabetic, overweight (body mass index ≥27 kg/m(2)), diagnosed with a schizophrenia-spectrum disorder and on stable treatment with either clozapine or olanzapine.



The primary endpoint is the change in glucose tolerance from baseline (measured by area under the curve for the plasma glucose excursion following a 4 h 75 g oral glucose tolerance test) to follow-up at week 16. The secondary endpoints include changes of dysglycaemia, body weight, waist circumference, blood pressure, secretion of incretin hormones, insulin sensitivity and β cell function, dual-energy X-ray absorption scan (body composition), lipid profile, liver function and measures of quality of life, daily functioning, severity of the psychiatric disease and alcohol consumption from baseline to follow-up at week 16.  Currently recruiting patients.


ETHICS AND DISSEMINATION
Ethical approval has been obtained. Before screening, all patients will be provided oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations.
RETRACTED ARTICLE: Neutropenia and invasive fungal infection in patients with hematological malignancies treated with chemotherapy: a multicenter, prospective, non-interventional study in China

In this study, we explored the relationship between neutropenia (absolute neutrophil count (ANC) <1,500/mm3) and invasive fungal infection (IFI) in Chinese patients who had hematological malignancies treated with chemotherapy. We conducted a multicenter, prospective, non-interventional study of consecutive patients with hematological malignancies undergoing chemotherapy in China and determined clinical characteristics of patients who developed neutropenia and IFI. The results indicated that for the 2,177 neutropenic patients, 88 (4.0 %) were diagnosed with IFI. We found that a high risk of IFI (P < 0.05) is associated with male gender, non-remission of the primary disease, use of two or more broad-spectrum antibiotics, treatment with parenteral nutrition, presence of cardiovascular disease, history of IFI, and neutropenia. When the ANC was less than 1,000, 1,000∼500, 500∼100, and <100/mm3, the incidence of IFI was 0.5, 5.2, 3.9, and 4.7 %, respectively (ANC > 1,000/mm3 versus other groups, P < 0.001). When the ANC was less than 1,000, 500, or 100/mm3 for 10 days or more, the incidence of IFI was 3.2 versus 6.1 % (P = 0.0052), 3.5 versus 7.1 % (P = 0.0021), and 3.1 versus 10.0 % (P < 0.001). When the ANC was less than 100/mm3, taking antifungal prophylaxis reduced the incidence of IFI (P < 0.05). The IFI-attributable mortality rate was 11.7 %. In conclusion, Chinese patients with IFI, severe and prolonged neutropenia increases the incidence of IFI. The incidence of IFI associated with neutropenia was reduced when antifungal prophylaxis was given. IFI was associated with a significantly increased high mortality rate in hematological malignancy patients with neutropenia.
Immunogenicity of 13-Valent Conjugate Pneumococcal Vaccine in Patients 50 Years and Older with End-Stage Renal Disease and on Dialysis

Patients with end-stage renal disease (ESRD) and on dialysis are at increased risk of pneumococcal disease. We evaluated the immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) in this population. Eligible patients with ESRD and on dialysis were given a single dose of PCV13. The concentrations of serum antibodies against 13 pneumococcal capsular polysaccharides were measured at the baseline and at 2 and 12 months postvaccination. A response to the vaccine was defined as a >2-fold increase in antibody concentration from that at the baseline and an absolute postvaccination value of at least 1 g/ml. Seventeen patients completed the study. Increases in the concentrations of antibodies to the vaccine serotype were demonstrated 2 months after vaccination. The geometric mean antibody concentrations at 12 months postvaccination declined by 38% to 72% compared to those measured at 2 months postvaccination. A response to at least 1 serotype in the vaccine was seen in all patients at both 2 and 12 months postvaccination. The overall rate of the response to each individual vaccine serotype varied between 23.5% and 94.1% at 2 months postvaccination and 23.5% and 65% at 12 months postvaccination. Pain at the injection site was the most common local reaction. Vaccination with PCV13 induces antibody responses to vaccine serotypes in patients with ESRD and on dialysis at 2 months postvaccination. However, the decline in antibody concentrations at 12 months postvaccination with a conjugate pneumococcal vaccine requires further study. (This study has been registered at ClinicalTrials.gov under registration no. NCT01974817.)
Negative impact of chronic obstructive pulmonary disease on the health-related quality of life of patients. Results of the EPIDEPOC study

COPD is currently the fourth cause of morbidity and mortality in the developed world. Patients with COPD experience a progressive deterioration and disability, which lead to a worsening in their health-related quality of life (HRQoL). The aim of this work is to assess the Health-Related Quality of Life (HRQoL) of patients with stable COPD followed in primary care and to identify possible predictors of disease.



It is a multicenter, epidemiological, observational, descriptive study. Subjects of both sexes, older than 40 years and diagnosed of COPD at least 12 months before starting the study were included. Sociodemographic data, severity of disease, comorbidity, and use of health resources in the previous 12 months were collected. All patients were administered a generic quality-of-life questionnaire, the SF-12, that enables to calculate two scores, the physical (PCS-12) and the mental (MCS-12) component summary scores.



10,711 patients were evaluated (75.6% men, 24.4% women), with a mean age of 67.1 years (SD 9.66). The mean value of FEV1 was 35.9 +/- 10.0%. Mean PCS-12 and MCS-12 scores were 36.0 +/- 9.9 and 48.3 +/- 10.9, respectively. Compared to the reference population, patients with COPD had a reduction of PCS-12, even in mild stages of the disease. The correlation with FEV1 was higher for PCS-12 (r = 0.38) than for MCS-12 (r = 0.12). Predictors for both HRQoL components were sex, FEV1, use of oxygen therapy, and number of visits to emergency rooms and hospital admissions. Other independent predictors of PCS-12 were age, body mass index and educational level.



Patients with stable COPD show a reduction of their HRQoL, even in mild stages of the disease. The factors determining the HRQoL include sex, FEV1, use of oxygen therapy, and number of visits to emergency rooms and hospital admissions.
Trigger point acupuncture treatment of chronic low back pain in elderly patients--a blinded RCT.

There is some evidence for the efficacy of acupuncture in chronic low back pain, but it remains unclear which acupuncture modes are most effective. Our objective was to evaluate the effects of two different modes of trigger point acupuncture on pain and quality of life in chronic low back pain patients compared to standard acupuncture treatment.



Thirty five consecutive out-patients (25 women, 10 men; age range: 65-81 years) from the Department of Orthopaedic Surgery, Meiji University of Oriental Medicine, with non-radiating low back pain for at least six months and normal neurological examination, were randomised to one of three groups over 12 weeks. Each group received two phases of acupuncture treatment with an interval between them. Nine patients dropped out during the course of the study. The standard acupuncture group (n=9) received treatment at traditional acupuncture points for low back pain, while the other acupuncture groups received superficial (n=9) or deep (n=9) treatments on trigger points. Outcome measures were VAS pain intensity and Roland Morris Questionnaire.



After treatment, the group that received deep needling to trigger points reported less pain intensity and improved quality of life compared to the standard acupuncture group or the group that received superficial needling to trigger points, but the differences were not statistically significant. There was a significant reduction in pain intensity between the treatment and interval in the group that received deep needling to trigger points (P<0.01), but not in the standard acupuncture group or the group that received superficial needling to trigger points.



These results suggest that deep needling to trigger points may be more effective in the treatment of low back pain in elderly patients than either standard acupuncture therapy, or superficial needling to trigger points.
Efficacy of furosemide for prevention of exercise-induced pulmonary hemorrhage in Thoroughbred racehorses.

To evaluate the efficacy of furosemide for prevention of exercise-induced pulmonary hemorrhage (EIPH) in Thoroughbred racehorses under typical racing conditions.



Randomized, placebo-controlled, blinded, crossover field trial.



167 Thoroughbred racehorses.


PROCEDURES
Horses were allocated to race fields of 9 to 16 horses each and raced twice, 1 week apart, with each of the 2 races consisting of the same race field and distance. Each horse received furosemide (500 mg, IV) before one race and a placebo (saline solution) before the other, with the order of treatments randomly determined. Severity of EIPH was scored on a scale from 0 to 4 after each race by means of tracheobronchoscopy. Data were analyzed by means of various methods of multivariable logistic regression.



Horses were substantially more likely to develop EIPH (severity score >or= 1; odds ratio, 3.3 to 4.4) or moderate to severe EIPH (severity score >or= 2; odds ratio, 6.9 to 11.0) following administration of saline solution than following administration of furosemide. In addition, 81 of the 120 (67.5%) horses that had EIPH after administration of saline solution had a reduction in EIPH severity score of at least 1 when treated with furosemide.



Results indicated that prerace administration of furosemide decreased the incidence and severity of EIPH in Thoroughbreds racing under typical conditions in South Africa.
A phase-I trial of the epidermal growth factor receptor directed bispecific antibody MDX-447 without and with recombinant human granulocyte-colony stimulating factor in patients with advanced solid tumors

MDX-447 is a bispecific antibody directed against the epidermal growth factor receptor (EGFR) and the high affinity Fc receptor (FcγRI). Preclinical data suggest that co-administration of granulocyte-colony stimulating factor (G-CSF) may enhance the tumor cytotoxicity of bispecific antibodies. In group 1, patients received MDX-447 intravenously (IV) weekly. Dose levels of MDX-447 evaluated in group 1 were 1, 3.5, 7, 10, 15, 20, 30, and 40 mg/m2. In group 2, patients received MDX-447 IV weekly with G-CSF (3 mcg/kg/day) subcutaneously (days −3 to +2, 5–9, 12–16, etc.). Dose levels of MDX-447 evaluated in group 2 were 1, 3.5, 7, 10, and 15 mg/m2. Sixty-four patients with advanced solid tumors were treated. Forty-one patients received MDX-447 alone (group 1); 23 patients received MDX-447 + G-CSF (group 2). Hypotension was the predominant dose-limiting toxicity (DLT) in both treatment groups, with seven patients experiencing ≥grade 3 events. MDX-447 half-life (T1/2) ranged from 1.9 to 8.4 h, with no obvious differences between the two treatment groups. MDX-447 binding to neutrophils and peak levels of circulating tumor necrosis factor α (TNFα) and interleukin-6 (IL-6) were higher in group 2. The MTD for MDX-447 alone was 30 mg/m2. When G-CSF was given with MDX-447, treatment was not well tolerated and group 2 was closed early because of safety concerns, with the last patient being treated at the 7 mg/m2 dose level. There were no objective complete or partial responses in either group. MDX-447 alone was generally well tolerated, but did not achieve objective tumor responses. The MTD for MDX-447 alone was 30 mg/m2 weekly. Co-administration of G-CSF with MDX-447 precluded meaningful dose escalation.
A randomized trial comparing acupuncture and simulated acupuncture for subacute and chronic whiplash.

A randomized controlled trial with 3 and 6 months follow-up.



To compare the effectiveness of acupuncture with simulated acupuncture in patients with subacute and chronic whiplash-associated disorders.



Acupuncture is widely used for the treatment of neck and other musculoskeletal pain, and there is some evidence supporting its effectiveness for short-term pain relief. The effectiveness of acupuncture in the treatment of whiplash-associated disorders is not clear.



A total of 124 patients between 18 and 65 years with chronic (85%) or subacute whiplash-associated disorders (Grade I or II) were randomly allocated to real or simulated electroacupuncture treatment for 12 sessions during a 6-week period. Both treatments involved skin penetration with acupuncture needles and were provided by a single university-trained acupuncturist in a University Clinic in Sydney, Australia. Primary outcome measures were pain intensity (10-cm visual analog scale), disability (Neck Disability Index), and health-related quality of life (SF-36). Secondary outcomes were patient-specific activity scales, and the McGill Pain Rating Index.



Mean initial pain intensity for all participants was 5.6 cm. Participants receiving the real electroacupuncture treatment had significantly greater reduction in pain intensity at 3 and 6 months, 0.9 cm (P = 0.05) and 1.3 cm (P = 0.007), respectively, in comparison to the sham electro-acupuncture group. After adjustment for baseline status, there was no significant reduction in disability, or improvement in health-related quality of life. There was an improvement in the activity scales of a similar size to the reduction in pain, but no difference in the McGill Index.



Real electroacupuncture was associated with a significant reduction in pain intensity over at least 6 months. This reduction was probably not clinically significant. There was no improvement in disability or quality of life.
Research on the Application of Flipped Classroom Model in English Teaching

Flipped classroom model, which integrates the traditional face-to-face interaction model in classroom with self-paced e-learning model on the Internet, has significance to modern English teaching. In this study, we designed a series of teaching programs in combination with the teaching model of Robert Talbert and Jukui secondary school to explore the effectiveness of this teaching model in middle school English teaching. The results of four-month teaching practice show: first, the flipped classroom model is effective in improving students' academic achievements; second, it realizes individualized teaching and consequently enhances the students' autonomous learning ability and increases their learning efficiency; finally, both the students and the teachers involved hold a positive view to the flipped classroom. The students believe that if there is enough guidance and help from the teacher, this teaching model can make them more involved in classroom activities. As for the teachers, this teaching model reforms their way of teaching. It is helpful to complete the transformation from "teaching materials" to "using materials to teach" which promotes individualized learning. But the study also shows that the teachers need to take up more responsibilities and invest more time and energy to ensure that everything goes on smoothly, which becomes an additional workload for them.
Haemoglobin level and vascular access survival in haemodialysis patients.

A full correction of anaemia in haemodialysis (HD) patients may lead to an increased risk of vascular access (VA) failure. We studied the relationship between haemoglobin (Hb) level and VA survival.



Incident patients between January 2000 and December 2002 with <1 month on HD were considered. The relative risk (RR) of access failure was evaluated in four different groups of patients divided according to their Hb level (<10, 10-12, 12-13 and >13 g/dl). Other factors possibly influencing VA survival were also considered: age, gender, diabetes, vascular disease, intact parathyroid hormone (iPTH) and treatment with an angiotensin-converting enzyme (ACE) inhibitor, angiotensin receptor blocker (ARB) or recombinant human erythropoeitin therapy.



We studied 1254 patients (1057 with autologous fistulae, 75 grafts and 122 permanent catheters at admission). Based on Cox analysis, we found the next statistically significant RR of VA failure to be 2.3 times higher with grafts than with arterio-venous fistulae (AVFs) and 1.8 times higher in AVFs with Hb <10 g/dl than in AVFs of the next Hb group. There was no statistically significant difference in the RR of VA failure between patients with Hb 10-12 g/dl and those with Hb 12-13 g/dl or >13 g/dl. Diabetes (RR: 1.41, P = 0.06), age >65 years (RR: 1.32; P = 0.11) and iPTH (RR: 1.56; P = 0.01) were identified as predictive factors for VA failure; ACE inhibitors or ARB (RR: 0.69; P = 0.03) were found to be protective factors.



In the studied population, the correction of Hb level to >12 g/dl was not associated with a higher incidence of VA thrombosis than in patients with Hb between 10 and 12 g/dl. ACE inhibitors or ARBs were found to be protective factors, and diabetes, age >65 years and iPTH >400 pg/ml were negative predictive factors for VA survival.
Aspirin versus coumadin in the prevention of reocclusion and recurrent ischemia after successful thrombolysis: a prospective placebo-controlled angiographic study. Results of the APRICOT Study.

Successful coronary thrombolysis involves a risk for reocclusion that cannot be prevented by invasive strategies. Therefore, we studied the effects of three antithrombotic regimens on the angiographic and clinical courses after successful thrombolysis.



Patients treated with intravenous thrombolytic therapy followed by intravenous heparin were eligible when a patent infarct-related artery was demonstrated at angiography < 48 hours. Three hundred patients were randomized to either 325 mg aspirin daily or placebo with discontinuation of heparin or to Coumadin with continuation of heparin until oral anticoagulation was established (international normalized ratio, 2.8-4.0). After 3 months, in which conservative treatment was intended, vessel patency and ventricular function were reassessed in 248 patients. Reocclusion rates were not significantly different: 25% (23 of 93) with aspirin, 30% (24 of 81) with Coumadin, and 32% (24 of 74) with placebo. Reinfarction was seen in 3% of patients on aspirin, in 8% on Coumadin, and in 11% on placebo (aspirin versus placebo, p < 0.025; other comparison, p = NS). Revascularization rate was 6% with aspirin, 13% with Coumadin, and 16% with placebo (aspirin versus placebo, p < 0.05; other comparisons, p = NS). Mortality was 2% and did not differ between groups. An event-free clinical course was seen in 93% with aspirin, in 82% with Coumadin, and in 76% with placebo (aspirin versus placebo, p < 0.001; aspirin versus Coumadin, p < 0.05). An event-free course without reocclusion was observed in 73% with aspirin, in 63% with Coumadin, and in 59% with placebo (p = NS). An increase of left ventricular ejection fraction was only found in the aspirin group (4.6%, p < 0.001).



At 3 months after successful thrombolysis, reocclusion occurred in about 30% of patients, regardless of the use of antithrombotics. Compared with placebo, aspirin significantly reduces reinfarction rate and revascularization rate, improves event-free survival, and better preserves left ventricular function. The efficacy of Coumadin on these end points appears less than that of aspirin. The still-high reocclusion rate emphasizes the need for better antithrombotic therapy in these patients.
A phase 2 trial of bortezomib followed by the addition of doxorubicin at progression in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck: a trial of the Eastern Cooperative Oncology Group (E1303).

Bortezomib, an inhibitor of the 26S proteasome and NF-κB, may have antitumor activity in adenoid cystic carcinoma (ACC). Preclinical studies have shown synergy between bortezomib and doxorubicin.



Eligibility criteria included incurable ACC, any number of prior therapies but without an anthracycline, unidimensionally measurable disease, Eastern Cooperative Oncology Group performance status 0-2, and ejection fraction within normal limits. Patients with stable disease for ≥9 months were excluded. Patients received bortezomib 1.3 mg/m(2) by intravenous (IV) push on Days 1, 4, 8, and 11, every 21 days until progression. Doxorubicin 20 mg/m(2) IV on Days 1 and 8 was added at the time of progression.



Twenty-five patients were enrolled, of whom 24 were eligible; the most common distant metastatic sites were the lung (n = 22) and the liver (n = 7). There was no objective response with single-agent bortezomib; best response was stable disease in 15 (71%) of 21 evaluable patients. The median progression-free survival and overall survival were 6.4 months and 21 months, respectively. Of 10 evaluable patients who received bortezomib plus doxorubicin, 1 had a partial response, and 6 had stable disease. The most frequent toxicity with bortezomib was grade 3 sensory neuropathy (16%). With bortezomib plus doxorubicin, serious toxicities seen more than once were grade 3-4 neutropenia (n = 3) and grade 3 anorexia (n = 2).



Bortezomib was well tolerated and resulted in disease stabilization in a high percentage of patients but no objective responses. The combination of bortezomib and doxorubicin was also well tolerated and may warrant further investigation in ACC.