nils-herrmann/clean_scirepeval huggingface dataset:
Should radiologists and pathologists talk to patients?

THE RESEARCH ENTERPRISE RANDOMISED CONTROLLED TRIALS (RCTs) are seen as the evidence “gold standard” for the effectiveness of clinical interventions. However, as a method of evaluating complex interventions in community-based settings they have significant limitations. Because of the poor uptake in Australia of secondary prevention for alcohol misuse among Indigenous people,1 we set out to trial a brief intervention (involving motivational interviewing of individuals not presenting primarily with an alcohol problem2) in this population. This intervention has been subjected to a rigorous multinational trial under the auspices of the World Health Organization (WHO)3 and found to help patients reduce their risk of alcohol-related harm.4,5 However, there were too few Indigenous people in the Australian arm of the WHO trial to provide evidence of the effectiveness of the intervention in this population. Here we report on an attempt to address this gap through implementation of a trial in an urban Aboriginal Medical Service.
Inhibition of platelet function with clopidogrel is associated with a reduction of inflammation in patients with peripheral artery disease.

The reactivity of platelets is increased in patients with peripheral artery disease (PAD). RANTES and sCD40L are chemokines which are stored in the alpha-granules of platelets. Clopidogrel inhibits and thus reduces platelet reactivity. Whether a treatment with clopidogrel is associated with an inhibition of systemic inflammation in patients with PAD has not been thoroughly explored. This study examined the effect of clopidogrel on platelet reactivation and the release of inflammatory chemokines in patients with PAD.



40 patients with PAD were randomized into two groups. In the first group A the patients were treated with 100mg acetylsalicylic acid (ASA) and additional placebo for 4weeks. The patients in group B received 75mg/d clopidogrel in addition to ASA 100mg for 4weeks. After obtaining blood at days 0, 7 and 28 the platelet activation was determined by measuring the surface protein expression of CD63, CD62p and thrombospondin (TSP) after stimulation with TRAP and ADP. The release of the chemokines RANTES and sCD40L from platelets was analyzed by ELISA.



Platelet activation markers (CD62p and CD63) and chemokine RANTES were significantly reduced in patients with PAD after 7 and 28days after treatment with clopidogrel. No alterations were found in TSP expression and sCD40L during the treatment.



The treatment with clopidogrel leads to a reduction of platelet reactivity and release of RANTES from the platelets of patients with PAD.
The ACTIVE Trial: comparison of the effects on renal function of iomeprol-400 and iodixanol-320 in patients with chronic kidney disease undergoing abdominal computed tomography.

We performed a multicenter, double-blind, randomized, parallel-group study to compare the renal effects of iomeprol-400 and iodixanol-320 in patients with preexisting chronic kidney disease undergoing contrast-enhanced multidetector computed tomography of the liver.



One hundred forty-eight patients with moderate-to-severe chronic kidney disease, ie, serum creatinine (SCr) > or =1.5 mg/dL (132.6 micromol/L) and/or calculated creatinine clearance (CrCl) <60 mL/min, undergoing contrast-enhanced multidetector computed tomography of the liver were randomized to equi-iodine doses (40 gI) of either the low-osmolar agent iomeprol-400 (400 mgI/mL, 726 mOsm/kg, N = 76) or the isotonic agent iodixanol-320 (320 mgI/mL, 290 mOsm/kg, N = 72), injected intravenously at 4 mL/S, followed by a bolus of 20 mL normal saline solution at the same rate. SCr was obtained at screening, baseline and at 48 to 72 hours postdose. SCr measurements and CrCl calculations were performed by a central laboratory. Contrast-induced nephropathy (CIN) was defined as an absolute SCr increase of > or =0.5 mg/dL (44.2 micromol/L) from baseline to 48 to 72 hours postdose. Mean SCr changes from baseline were also assessed. A Renal Safety Review Board comprised 3 medical experts reviewed the renal safety data, demographics, medical history, CIN risk factors, concomitant medications, and hydration status of each subject in a blinded manner.



The 2 study groups were comparable with regard to age, gender distribution, concomitant nephrotoxins, hydration status, and total iodine dose; however, the iomeprol-400 group showed a significantly higher proportion of patients with diabetes mellitus (P = 0.02). Baseline SCr was 1.7 +/- 0.6 mg/dL (150.3 +/- 53.0 micromol/L) in the iomeprol-400 group and 1.7 +/- 0.7 mg/dL (150.3 +/- 61.9 micromol/L) in the iodixanol-320 group (P = 0.87). Predose CrCl was 41.5 +/- 13.1 mL/Min in the iomeprol-400 group and 43.0 +/- 13.3 mL/Min in the iodixanol-320 group (P = 0.49). Five of 72 patient receiving iodixanol-320 (6.9%) and none of the patients receiving iomeprol-400 showed an increase of > or =0.5 mg/dL (44.2 micromol/L) from baseline [P = 0.025, 95% CI (-12.8%, -1.1%)]. The mean SCr change from baseline was significantly higher (P = 0.017 ANCOVA) after iodixanol-320 (0.06 +/- 0.27) than after iomeprol-400 (-0.04 +/- 0.19).



The incidence of CIN was significantly higher after IV administration of iodixanol-320 than iomeprol-400. The mean rise in SCr from baseline was also higher in patients receiving iodixanol.
Development and evaluation of an implementation strategy for the German guideline on community-acquired pneumonia.

Data of the German Competence Network for Community-Acquired Pneumonia showed a gap between the recommendations of the national guideline for management of community-acquired pneumonia (CAP) and the routine care. We developed and evaluated an implementation strategy to improve the quality of care of patients with CAP.



A prospective, randomised, controlled trail was conducted within CAPNETZ. In four local clinical centres (LCC), the guideline was implemented by different strategies. The other four LCC served as control group. Indicators for guideline adherence comprised initial site of treatment, initial antibiotic treatment and duration of antibiotic treatment. As patient-related factors, we assessed the effect of guideline implementation on 30-day mortality and length of hospital stay.



Active guideline implementation yielded an increased proportion of guideline adherence to the length of antibiotic treatment in outpatients (+9.2%), the recommended antibiotic treatment (+5.6%) and duration of antibiotic treatment in inpatients (+5.0%) compared with baseline. In contrast, the proportion of patients in the control group, treated according to the guideline, decreased in the same period by 7.9%, 2.9% and 4.7%, respectively. None of these results was statistically significant. Decrease of CAP-related mortality was higher in the intervention group compared with the control group (2.9% vs 0.5%, ns).



This study showed improvements in the process of care after implementation of a guideline for treating CAP. Further strategies, such as quality improvement cycles and medical practice audits, may enhance this effect.
Pilot assessment of supply chains for pharmaceuticals and medical commodities for malaria, tuberculosis and HIV infection in Ethiopia.

To obtain preliminary data on the drug supply management system in Ethiopia, selected facilities were assessed for the availability of essential drugs and commodities for malaria, TB and HIV. Of the 48 surveyed hospitals and health centers, 9 (19%), 9 (19%) and 10 (21%) did not have malaria, TB or HIV drugs, respectively. Similarly, of 27 health posts, 9 (33%) and 6 (22%) did not have rapid diagnostic tests and antimalarial drugs, respectively. The findings indicated an inadequate availability of essential drugs and commodities in the surveyed facilities as well as weaknesses in human resources and training. Assessments of commodity supply chains to ensure operational program success and impact are important.
Randomized, blinded, placebo-controlled phase I trial of pegylated recombinant human megakaryocyte growth and development factor with filgrastim after dose-intensive chemotherapy in patients with advanced cancer.

Thrombocytopenia caused by chemotherapy is an important cause of morbidity and mortality in the treatment of malignant disease. Recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) is a potent stimulator of megakaryocytopoiesis and prevents chemotherapy-induced thrombocytopenia in preclinical studies. We administered PEG-rHuMGDF with filgrastim after dose-intensive chemotherapy to 41 patients with advanced cancers to determine its safety and effects on hematologic recovery. Carboplatin 600 mg/m2 and cyclophosphamide 1,200 mg/m2 were administered to patients with advanced cancer. Patients were randomly assigned to receive blinded study drug, either PEG-rHuMGDF or placebo (3-to-1 ratio), commencing the day after chemotherapy. PEG-rHuMGDF was given at doses of 0.03, 0.1, 0.3, 1.0, 3.0, and 5.0 microg per kilogram body weight by daily subcutaneous injection for between 7 and 20 days. All patients received concurrent filgrastim 5 microg per kilogram body weight per day until neutrophil recovery. Fifteen patients had received PEG-rHuMGDF alone in a previous phase I study. Platelet function and peripheral blood progenitor cells (PBPC) were assessed. PEG-rHuMGDF enhanced platelet recovery in a dose-related manner when compared with placebo. The platelet nadir occurred earlier in patients given PEG-rHuMGDF (P = .002) but there was no difference in the depth of the nadir. Recovery to baseline platelet count was achieved significantly earlier following PEG-rHuMGDF administration compared with placebo (median, 17 days for PEG-rHuMGDF 0.3 to 5.0 microg/kg versus 22 days for placebo, P = .014). In addition, platelet recovery was faster in patients who had previously received PEG-rHuMGDF, suggesting that pretreatment might be beneficial. Platelet function did not change during or after administration of PEG-rHuMGDF. Levels of PBPC on day 15 after chemotherapy were significantly greater in patients administered PEG-rHuMGDF 0.3 to 5.0 microg/kg and filgrastim compared with those given placebo plus filgrastim. PEG-rHuMGDF was well tolerated at all doses. Two patients given PEG-rHuMGDF had a thrombotic episode. PEG-rHuMGDF accelerates platelet recovery after moderately dose-intensive carboplatin and cyclophosphamide, and is likely to be clinically useful in treatment of chemotherapy-induced thrombocytopenia. Because it enhances mobilization of PBPC by filgrastim, PEG-rHuMGDF might also allow more efficient collection of stem cells for autologous or allogeneic transplantation.
A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease

About 90 % of patients with intra-thoracic malignancy experience breathlessness. Breathing training is helpful, but it is unknown whether repeated sessions are needed. The present study aims to test whether three sessions are better than one for breathlessness in this population.



This is a multi-centre randomised controlled non-blinded parallel arm trial. Participants were allocated to three sessions or single (1:2 ratio) using central computer-generated block randomisation by an independent Trials Unit and stratified for centre. The setting was respiratory, oncology or palliative care clinics at eight UK centres. Inclusion criteria were people with intrathoracic cancer and refractory breathlessness, expected prognosis ≥3 months, and no prior experience of breathing training. The trial intervention was a complex breathlessness intervention (breathing training, anxiety management, relaxation, pacing, and prioritisation) delivered over three hour-long sessions at weekly intervals, or during a single hour-long session. The main primary outcome was worst breathlessness over the previous 24 hours ('worst'), by numerical rating scale (0 = none; 10 = worst imaginable). Our primary analysis was area under the curve (AUC) 'worst' from baseline to 4 weeks. All analyses were by intention to treat.



Between April 2011 and October 2013, 156 consenting participants were randomised (52 three; 104 single). Overall, the 'worst' score reduced from 6.81 (SD, 1.89) to 5.84 (2.39). Primary analysis [n = 124 (79 %)], showed no between-arm difference in the AUC: three sessions 22.86 (7.12) vs single session 22.58 (7.10); P value = 0.83); mean difference 0.2, 95 % CIs (-2.31 to 2.97). Complete case analysis showed a non-significant reduction in QALYs with three sessions (mean difference -0.006, 95 % CIs -0.018 to 0.006). Sensitivity analyses found similar results. The probability of the single session being cost-effective (threshold value of £20,000 per QALY) was over 80 %.



There was no evidence that three sessions conferred additional benefits, including cost-effectiveness, over one. A single session of breathing training seems appropriate and minimises patient burden.
Expression of heterogeneous nuclear ribonucleoprotein A2/B1 in bronchial epithelium of chronic smokers.

The monoclonal antibody 703D4, which binds heterogeneous nuclear ribonucleoprotein A2/B1 (hnRNP A2/B1), has been reported to detect lung cancer more than a year earlier than routine chest X-ray or cytomorphology. To explore the biological basis of this detection, we studied the expression of this antigen in the central airways of smokers with evidence of bronchial metaplasia using specimens from a previously reported, randomized retinoid chemoprevention trial. By analyzing 1078 available biopsy specimens from 147 individuals at baseline and 68 individuals who completed the intervention, we frequently detected overexpression of hnRNP A2/B1 in normal and abnormal bronchial epithelium (i.e., in 41% of normal and 37% of squamous metaplasia samples). There was no correlation between hnRNP A2/B1 overexpression and the different histological changes. In cases with hnRNP A2/B1 overexpression, immunoreactivity was homogeneously expressed in all biopsied sites. For the 68 cases with serial biopsies, there was no significant modulation of hnRNP expression by retinoid intervention or smoking status. With lung cancer cell lines, 0.5-4 microM concentrations of 13-cis-retinoic acid reduced hnRNP A2/B1 overexpression by immunocytochemistry. We conclude that hnRNP A2/B1 overexpression is frequently found in central airways of chronic smokers, consistent with the pattern of expression that we reported previously in airways surrounding resected primary lung cancers. Oral 13-cis-retinoic acid at a dose of 1 mg/kg has no demonstrable effects on modulating hnRNP A2/B1 expression in proximal bronchial epithelium.
Effect of erythropoietin on exercise capacity in patients with moderate to severe chronic heart failure.

Patients with chronic heart failure (CHF) are frequently anemic. An increase in hemoglobin could enhance exercise performance by increasing oxygen delivery. We investigated the effect of erythropoietin (EPO) on exercise performance in anemic patients with CHF.



Twenty-six anemic patients aged 57+/-11 years were randomized to receive EPO (15 000 to 30 000 IU per week) or placebo for 3 months. Parameters measured at baseline and end therapy included blood parameters (hemoglobin, hematocrit, plasma volume), exercise parameters (peak oxygen consumption [VO2], exercise duration, 6-minute walk), muscle aerobic metabolism (half-time of VO2 and near infrared recovery), and forearm vasodilatory function. EPO was well tolerated by all patients. Twelve patients in the EPO group felt improvement versus 1 in the placebo group (P<0.05). There were significant increases in hemoglobin (11.0+/-0.5 to 14.3+/-1.0 g/dL, P<0.05), peak VO2 (11.0+/-1.8 to 12.7+/-2.8 mL. min(-1) x kg(-1), P<0.05) and exercise duration (590+/-107 to 657+/-119 s, P<0.004) in the EPO group but no significant changes in the control group. Resting and hyperemic forearm vascular resistance and indices of the rate of muscle oxidative capacity were unchanged in both groups.



EPO significantly enhances exercise capacity in patients with CHF. One mechanism of improvement in VO2 is increased oxygen delivery from increased hemoglobin concentration.
Photoablation using the turbo-booster and excimer laser for in-stent restenosis treatment: twelve-month results from the PATENT study.

To evaluate the performance of the Turbo Elite laser catheter in combination with the Turbo-Booster guiding catheter for the treatment of femoropopliteal in-stent restenosis (ISR).



The PATENT study (Photoablation Using the Turbo-Booster and Excimer Laser for In-Stent Restenosis Treatment) was a multicenter prospective industry-sponsored registry involving 5 European centers. Patients with symptomatic femoropopliteal ISR (Rutherford categories 2-5) and an ankle-brachial index ≤0.8 were treated with excimer laser atherectomy (ELA). Ninety patients (65 men; mean age 69.5±9.3 years) were enrolled. The majority of patients were Rutherford category 3 (63, 71.6%), and 32 (35.6%) patients had previous treatment for ISR. The average lesion length was 123±95.9 mm, and 30 (34.1%) lesions were total occlusions. The main efficacy outcome was primary patency at 12 months as measured by duplex ultrasonography. The primary safety outcome was freedom from major adverse events (MAE) during hospitalization and at 30-day follow-up to include all death, unplanned major amputation, or target lesion revascularization (TLR).



The Turbo Elite laser catheter created a pilot channel in 87 (96.7%) of 90 lesions, with a mean of 1.5 passes, followed by the Turbo Booster with a mean of 5.7 passes. Adjunctive balloon dilation was performed in 79 (87.8%) lesions. Procedure success (<30% residual stenosis without stenting) was 96.7%. The mean percentage stenosis improved from a baseline of 87.0% to 32.3% after laser atherectomy and to 7.4% after final treatment. The MAE rate through 30 days was 2.2%. Nine (10.0%) patients experienced distal embolization. Estimates of freedom from TLR at 6 and 12 months were 87.8% and 64.4%, respectively. Primary patency at 6 and 12 months was 64.1% and 37.8%, respectively. Only a history of prior intervention for ISR (p<0.01) was a predictor of TLR at 12 months.



The PATENT study has established excimer laser atherectomy as safe for the treatment of femoropopliteal ISR, achieving high procedure success. Recurrence of restenosis indicates that removing hyperproliferative tissue alone does not solve the problem of ISR. New concepts, such as the combination of ELA with drug-eluting balloons, may prove beneficial.
Interrupted nitinol U-Clips versus standard running suture for the central arterial T-graft anastomosis: a prospective randomized study.

Studies carried out to date suggest that the interrupted suture technique using U-Clips for anastomoses in coronary surgery may be superior to the standard running polypropylene suture. The purpose of this study was to compare safety and effectiveness of a central T-graft anastomosis constructed with the left internal thoracic artery (LITA) in situ (to the left anterior descending (LAD)) in which the free right internal thoracic artery (to the circumflex branch of the right coronary artery (RCX)) was implanted (RITA-to-LITA) using either self-closing nitinol U-Clips or simple continuous suture. We hypothesized that internal thoracic arteries could adapt their diameter to the blood flow.



Thirty patients underwent total arterial revascularization using a T-graft constructed with free LITA in situ to LAD in which the free RITA to the circumflex artery was implanted (central T-graft anastomosis). In all cases, free RITA was used as a sequential graft with two peripheral anastomoses. Patients were randomly assigned to two groups: in group A (n=15), central T-graft anastomosis was performed using a standard 8/0 polypropylene running suture. In group B (n=15), central T-graft anastomosis was performed using U-Clips. Intra-operative transit time flow measurements were recorded. Patency control was performed in 30 patients 2 weeks and 6 months postoperatively, using 64-slice computed tomography (CT) angiography. The diameter of the LITA was measured proximal and distal and the diameter of the RITA distal to the central T-graft anastomosis.



Perioperative results were similar in the two groups (P=ns). Intra-operative transit time flow measurement showed patent grafts in all patients. There were no hospital deaths. Two weeks postoperatively, all grafts were patent. At 6-month follow-up, one RITA and one LITA (both in group B) were closed distal to the central T-graft anastomosis. There was no death and no re-intervention during follow-up. Statistical analysis showed no significant changes in graft diameters after 2 weeks and 6 months in both groups.



The U-Clip anastomosis technique is in our experience safe but not superior to the standard running suture using polypropylene material. Remodeling of the ITA grafts close to the central T-graft anastomosis was neither observed for the standard running suture nor for the U-Clip anastomoses.
Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation.

The aim of the present study was to test two brief planning interventions designed to encourage cardiac patients to engage in regular physical exercise following discharge from rehabilitation. The interventions comprised action plans on (a) when, where, and how to act, and (b) coping plans on how to deal with anticipated barriers.



An experimental longitudinal trial was conducted to test two interventions that either focused on action planning alone, or on a combination of action planning and coping planning. A total of 211 participants completed assessments at baseline and 2 months after discharge. Participants were randomly assigned to either one of the intervention groups or a standard-care control group.



Participants in the combined planning group did significantly more physical exercise 2 months post-discharge than those in the other groups.



The theoretical distinction between action planning and coping planning as introduced in the present study has proven useful in explaining changes in health-related behaviour. The combined planning intervention can be applied in the context of cardiac rehabilitation programmes.
Rheumatoid atlantoaxial subluxation can be prevented by intensive use of traditional disease modifying antirheumatic drugs.

To evaluate the 5-year incidence of cervical spine disorders in patients with early rheumatoid arthritis (RA) treated by 2 different disease modifying antirheumatic drug (DMARD) strategies.



In a national, multicenter, prospective FIN-RACo-trial, a cohort of 199 patients with early, clinically active RA was randomly assigned to treatment with a combination of 3 DMARD and prednisolone (Combi group) or with a single DMARD (Single group) with or without prednisolone, aiming to induce remission. After 2 years, the DMARD therapy was unrestricted. Lateral view cervical spine radiographs during full flexion and extension were taken at the 5-year followup visits. The presence of anterior atlantoaxial subluxation (aAAS), atlantoaxial impaction (AAI), and subaxial subluxation (SAS) was assessed in the 149 patients with radiographs available (80 Single and 69 Combi).



At the 5-year visits, aAAS, AAI, and SAS were found in 13 (9%), 6 (4%), and 9 (6%) patients, respectively. The corresponding Single/Combi group ratios were 11/2, 5/1, and 5/4. Of the baseline data, only poor physical function [Health Assessment Questionnaire (HAQ); p = 0.024] and Single treatment strategy (p = 0.019) were significantly associated with aAAS. Worse HAQ scores and Disease Activity Score 28 values were found in patients who developed aAAS during the 5-year followup.



RA patients with sustained clinical disease activity and poor HAQ are at increased risk of developing aAAS. The development of aAAS during the first 5 years of RA was rare among the patients treated with a combination of DMARD for at least 2 years from the diagnosis. Intensive treatment with traditional DMARD prevents or retards the development of aAAS in patients with recent-onset RA.