nils-herrmann/clean_scirepeval huggingface dataset:
Hepatitis C infection among injecting drug users in general practice: a cluster randomised controlled trial of clinical guidelines' implementation.

Hepatitis C is a common infection among injecting drug users and has important implications for general practice. Although several clinical guidelines concerning the infection have been published, their effectiveness has yet to be tested.



To assess the effectiveness of a general practice-based complex intervention to support the implementation of clinical guidelines for hepatitis C management among current or former drug users attending general practice.



Cluster randomised controlled trial.



General practices in the Eastern Regional Health Authority area of Ireland.



Twenty-six practices were randomly allocated within strata to receive the intervention under study or to provide care as usual for a period of 6 months. There was screening for patients attending general practice for methadone maintenance treatment for hepatitis C and referral of anti-HCV antibody positive patients to a specialist hepatology department for assessment.



At study completion, patients in the intervention group were significantly more likely to have been screened for hepatitis C than those in the control group, odds ratio adjusted for clustering 3.76 (95% confidence interval [CI] = 1.3 to 11.3) and this association remained significant after adjusting for other potentially confounding variables, using multiple logistic regression, with the odds ratio adjusted for clustering 4.53 (95% CI = 1.39 to 14.78). Although anti-HCV antibody positive patients in the intervention group were more likely to have been referred to a hepatology clinic, this was not statistically significant (P = 0.06).



General practice has an important role in the care of people at risk of hepatitis C and when appropriately supported can effectively implement current best practice.
Somatosensory and brainstem auditory evoked potentials in cardiac arrest patients treated with hypothermia.

To evaluate the prognostic value of short-latency median nerve somatosensory evoked potentials and brainstem auditory evoked potentials in outcome prediction for comatose cardiac arrest patients treated with hypothermia.



Prospective, randomized, controlled trial of mild hypothermia after out-of-hospital cardiac arrest; a substudy of the European Hypothermia After Cardiac Arrest study.



Intensive care unit of a tertiary referral hospital (Helsinki University Central Hospital).



Sixty consecutive patients (aged 18-75 yrs) resuscitated from out-of-hospital ventricular fibrillation and comatose at 24 hrs after cardiac arrest; all patients were randomly assigned either to therapeutic hypothermia of 33 degrees C or normothermia.



All patients received standard intensive care for at least 2 days. Patients randomized to hypothermia were cooled with an external cooling device for 24 hrs and then allowed to rewarm slowly for 12 hrs. In the normothermia group, the core temperature was kept below 38 degrees C with antipyretics and by physical means. The clinical outcome was assessed 6 months after cardiac arrest.



Somatosensory evoked potentials and brainstem auditory evoked potentials were recorded 24-28 hrs after cardiac arrest. All wave latencies were significantly prolonged in the hypothermia group. Bilaterally absent N20 waves predicted permanent coma with a specificity of 100% in both treatment groups. Brainstem auditory evoked potential recordings did not correlate with the outcome in either treatment group.



The prognostic ability of median nerve short-latency somatosensory evoked potentials does not seem to be affected by therapeutic hypothermia. Brainstem auditory evoked potentials had no additional value in outcome prediction.
Effects of ACE inhibition on circulating endothelial progenitor cells, vascular damage, and oxidative stress in hypertensive patients

The pathogenic role of angiotensin-converting enzyme (ACE) inhibition in hypertensive patients regarding endothelial progenitor-cell (EPC) function is still poorly understood. The aim of the study was to evaluate EPC number, function, and relationship to carotid intima media thickness (IMT) progression. We studied 36 newly diagnosed mildly hypertensive patients free of cardiovascular disease and related risk factors without prior or concurrent therapy with ACE inhibitors. Patients were randomized to receive enalapril 20 mg/day (n = 18) or zofenopril 30 mg/day (n = 18). EPC number and migrating capacity, plasma nitrite and nitrate (NOx), and isoprostane concentrations were evaluated. Carotid IMT was determined by ultrasonography at baseline and after 1 and 5 years of follow-up. EPC number increased during the follow-up, with no statistical differences between treatment groups. There was an inverse correlation between circulating EPCs and IMT increase over time. Plasma NOx decreased during the study without evident differences between treatment groups. Isoprostanes decreased more markedly in zofenopril-treated patients. Multiple linear regression model demonstrated that carotid IMT was significantly inversely correlated with EPC but not with migratory cells after adjusting for confounders. The study demonstrated that EPC levels increased during the follow-up in both groups of newly diagnosed hypertensive patients treated with ACE inhibitors. These drugs prevented progression of vascular damage, with an inverse correlation between circulating EPC levels and IMT values.
Comparison between metal and biodegradable suture anchors in the arthroscopic treatment of traumatic anterior shoulder instability: a prospective randomized study

The purpose of this study was to compare the clinical outcome of arthroscopic treatment of shoulder instability with metal and biodegradable suture anchors. Arthroscopic stabilization was performed in 78 patients with recurrent traumatic anterior shoulder instability. They were divided into 2 groups of 39 patients each, according to suture anchors used: metal anchors in group 1, and biodegradable anchors in group 2. Results were evaluated by use of the Disabilities of the Arm, Shoulder and Hand (DASH) self-administered questionnaire; Rowe score; Constant score normalized for age and gender, and recurrence of dislocation. On analyzing the results at a 2-year follow-up, we considered the following independent variables: age; gender; arm dominance; duration of symptoms, age at first dislocation, number of dislocations, type of work; type of sport; sports activity level; lesion of the anterior labrum and anterior-inferior gleno-humeral ligament; SLAP lesion, and number of suture anchors. Comparison between groups did not show significant differences for each variable considered. Overall, according to the results, median DASH scores were 4.5 points (range 0–27) in group 1 and 7 points (range 0–25) in group 2 (n.s.); median Rowe scores were 100 points (range 60–100) and 100 points (range 25–100), respectively (n.s.); and median Constant scores were 98 points (range 81–107) and 98 points (range 87–121), respectively (n.s.). Recurrence was observed in 1 patient (2.8%) in group 1 and in 2 patients (5.9%) in group 2. Overall recurrence rate was 4.3%. Univariate and multivariate analysis showed that age, duration of symptoms, number of dislocations, type of work, and type of sports significantly and independently influenced the outcomes. Differences between groups 1 and 2 were not significant. At a short-term follow-up, differences between arthroscopic shoulder stabilization with metal and biodegradable suture anchors were not statistically significant. Clinical relevance of the study is that there is no difference in the use of metal or biodegradable suture anchors for the arthroscopic treatment of shoulder instability.
A phase 1 study of OSI-211 given as an intravenous infusion days 1, 2, and 3 every three weeks in patients with solid cancers

To define the maximum tolerated dose (MTD), recommended phase II dose (RD) and dose limiting toxicity (DLT) of liposomal lurtotecan, OSI-211 (formerly known as NX211), given as a short intravenous infusion on days 1, 2, and 3 every three weeks.  Thirty-seven patients were enrolled and treated in a dose escalation study from a starting dose of 0.15 mg/m2 daily × 3 to 2.1 mg/m2 daily × 3. Detailed pharmacokinetic analyses of blood were done on both days 1 and 3 of the first cycle and toxicity was monitored.  Two MTDs were defined; one for patients defined as minimally pretreated and one for those heavily pretreated. Dose limiting toxicity was myelosuppression: primarily thrombocytopenia although neutropenia was also noted. The MTD was 2.1 mg/m2/d (total dose of 6.3 mg/m2) in minimally pretreated patients and 1.8 mg/m2/d (5.4 mg/m2 total dose) in heavily pretreated patients. Pharmacokinetics revealed that AUC and C max increased with dose and were significantly higher than that of free lurtotecan (AUC approx. 100 fold higher). The half life and duration of the active lactone form were also significantly longer than historical data on free drug. Two partial responses were seen, one each in a patient with breast and ovarian cancer.  Two Phase II recommended doses were established for OSI-211 given as a daily × 3 schedule every three weeks. The recommended phase II dose is 1.8 mg/m2 daily × 3 for minimally pretreated patients and 1.5 mg/m2 for those heavily pretreated. Phase II studies should be initiated in sensitive tumours.
Comparison of bedside assessed arm and leg fluid filtration determined by venous congestion plethysmography in perioperative cancer patients

In recent years, pathophysiology and clinical impact of microvascular fluid filtration has regained interest. As the latest data in surgical patients have been published almost 20 years ago, there is need for further research to better understand fluid filtration during the perioperative period. Venous congestion plethysmography (VCP) provides a rapid and noninvasive method, which has been shown suitable for the assessment of fluid filtration in limbs. Fluid filtration assessed by VCP can be obtained from forearm and calf measurement sites, while in many clinical situations a reduced access to the patient often restricts the measurements to patient's forearm. We aimed to investigate if fluid filtration obtained from forearm and calf measurement site is interchangeable in nonsedated perioperative patients.Fluid filtration by VCP was obtained simultaneously from forearm and calf in patients with ovarian cancer at 4 time points during the perioperative course and assessed by the difference of volume changes of the limb between third and sixth minutes (VC6-3min) during venous congestion. VC6-3min obtained from forearm and calf measurement sites was compared with respect to agreement and evaluated regarding the association with the presence of leg edema.A total of 74 paired measurements were analyzed in 29 patients. Forearm VC6-3min was significantly higher than calf VC6-3min (median [25th; 75th quartile], 0.6 (0.4; 0.9) vs 0.4 [0.3; 0.6] %, P = 0.008). Bland-Altman and Polar analysis revealed a poor agreement between forearm and calf VC6-3min at predefined time points and changes of VC6-3min during the perioperative course (bias +0.23%, limits of agreement [LOA] -1.1% to 1.6%; angular bias -2.5°, radial LOA -82° to +77°). Forearm VC6-3min was significantly increased in patients with presence of leg edema (0.7 (0.5; 1.0) vs 0.5 (0.4; 0.6) %, P < 0.001) while calf VC6-3min did not differ in patients with and without edema.This study indicates that forearm and calf measurement sites are not interchangeable when bedside assessing fluid filtration by VCP in nonsedated perioperative patients. Considering that only forearm fluid filtration was related to the presence of edema, forearm measurement site should be chosen as a primary site for assessing fluid filtration.
Altered trunk muscle recruitment in people with low back pain with upper limb movement at different speeds.

To compare trunk muscle coordination in people with and without low back pain with varying speeds of limb movement.



Abdominal and back extensor muscle activity in association with upper limb movement was compared among three speeds of movement and between people with and without low back pain.



Fourteen subjects with a history of recurrent low back pain and a group of age- and sex-matched control subjects.



The onsets of electromyographic activity of the trunk and limb muscles, frequency of trunk muscle responses, and angular velocity of arm movements.



Early activation of transversus abdominis (TrA) and obliquus internus abdominis (OI) occurred in the majority of trials, with movement at both the fast and intermediate speeds for the control group. In contrast, subjects with low back pain failed to recruit TrA or OI in advance of limb movement with fast movement, and no activity of the abdominal muscles was recorded in the majority of intermediate speed trials. There was no difference between groups for slow movement.



The results indicate that the mechanism of preparatory spinal control is altered in people with lower back pain for movement at a variety of speeds.
Efficacy and duration of action of the antileukotriene zafirlukast on cold air-induced bronchoconstriction.

The objectives of the study were to assess the magnitude of the effect of the leukotriene receptor antagonist, zafirlukast, against cold air-induced bronchoconstriction following the first dose and to assess magnitude and duration after 5 days of dosing. Nineteen patients with asthma were included. In a randomized cross-over design, either zafirlukast 20 mg or 80 mg b.d. or placebo were given over 5 days. Challenges were performed 3 h post first dose and 3, 8, 12 and 24 h post last dose. The authors assessed the provocative ventilation rate necessary to achieve a 10% (PV10) and 20% (PV20) fall in forced expiratory volume in one second. The median PV20 3 h post first dose was 69.1 L x min-1 for zafirlukast 80 mg compared to 40 L x min-1 for placebo (p=0.004). The corresponding median value for zafirlukast 20 mg was 59.9 L x min-1 (p=0.06). At steady state the differences in PV20, between zafirlukast 80 mg and placebo were significant at 8 h and 12 h post last dose. The corresponding difference for zafirlukast 20 mg was statistically significant at 8 h post last dose. The analysis of PV10 yielded compatible results. There was no significant protection 24 h after last dose. This study has demonstrated that zafirlukast offers significant protection against cold air-induced bronchoconstriction in asthma. The degree and duration of protection were dose-dependent. However, there was a large interindividual variability for the protective effect of this leukotriene receptor antagonist.
Efficacy and Safety of Zhuanggu Joint Capsules in Combination with Celecoxib in Knee Osteoarthritis: A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Trial

Knee osteoarthritis (KOA) is a chronic joint disease that manifests as knee pain as well as different degrees of lower limb swelling, stiffness, and movement disorders. The therapeutic goal is to alleviate or eliminate pain, correct deformities, improve or restore joint functions, and improve the quality of life. This study aimed to evaluate the efficacy and safety of Zhuanggu joint capsules combined with celecoxib and the benefit of treatment with Zhuanggu alone for KOA.



This multi-center, randomized, double-blind, double-dummy, parallel controlled trial, started from December 2011 to May 2014, was carried out in 6 cities, including Beijing, Shanghai, Chongqing, Changchun, Chengdu, and Nanjing. A total of 432 patients with KOA were divided into three groups (144 cases in each group). The groups were treated, respectively, with Zhuanggu joint capsules combined with celecoxib capsule simulants, Zhuanggu joint capsules combined with celecoxib capsules, and celecoxib capsules combined with Zhuanggu joint capsule simulants for 4 weeks consecutively. The improvement of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and the decreased rates in each dimension of WOMAC were evaluated before and after the treatment. Intergroup and intragroup comparisons of quantitative indices were performed. Statistically significant differences were evaluated with pairwise comparisons using Chi-square test (or Fisher's exact test) and an inspection level of α = 0.0167.



Four weeks after treatment, the total efficacies of Zhuanggu group, combination group, and celecoxib group were 65%, 80%, and 64%, respectively, with statistically significant differences among the three groups (P = 0.005). Intergroup pairwise comparisons showed that the total efficacy of the combination group was significantly higher than that of the Zhuanggu (P = 0.005) and celecoxib (P = 0.003) groups. The difference between the latter two groups was not statistically significant (P > 0.0167). Four weeks after discontinuation, the efficacies of the three groups were 78%, 95%, and 65%, respectively, with statistically significant differences (P < 0.0001). Intergroup pairwise comparisons revealed that the efficacy of the combination group was significantly better than that of the Zhuanggu and the celecoxib groups (P < 0.0001). The difference between the latter two groups was not statistically significant (P > 0.0167). The incidences of adverse events in Zhuanggu group, combination group, and celecoxib group were 8.5%, 8.5%, and 11.1%, respectively, with insignificant differences (P > 0.05).



Zhuanggu joint capsules alone or combined with celecoxib showed clinical efficacy in the treatment of KOA. The safety of Zhuanggu joint capsules alone or combined with celecoxib was acceptable.
A randomised controlled pilot trial to evaluate and optimize the use of anti-platelet agents in the perioperative management in patients undergoing general and abdominal surgery—the APAP trial (ISRCTN45810007)

Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, owing to a lack of evidence-based data, a widely accepted consensus on the perioperative management of these patients in the setting of non-cardiac surgery has not yet been reached. Primary objective was to evaluate the safety of continuous versus discontinuous use of ASA in the perioperative period in elective general or abdominal surgery. Fifty-two patients undergoing elective cholecystectomy, inguinal hernia repair or colonic/colorectal surgery were recruited to this pilot study. According to cardiological evaluation, non-high-risk patients who were on long-term treatment with low-dose ASA were eligible for inclusion. Patients were allocated randomly to continuous use of ASA or discontinuation of ASA intake for 5 days before until 5 days after surgery. The primary outcome was the incidence of major haemorrhagic and thromboembolic complications within 30 days after surgery. A total of 26 patients were allocated to each study group. One patient (3.8%) in the ASA continuation group required re-operation due to post-operative haemorrhage. In neither study group, further bleeding complications occurred. No clinically apparent thromboembolic events were reported in the ASA continuation and the ASA discontinuation group. Furthermore, there were no significant differences between both study groups in the secondary endpoints. Perioperative intake of ASA does not seem to influence the incidence of severe bleeding in non-high-risk patients undergoing elective general or abdominal surgery. Further, adequately powered trials are required to confirm the findings of this study.
Effects of chronic omega-3 polyunsaturated fatty acid supplementation on human atrial electrophysiology.

Omega-3 polyunsaturated fatty acids in fish oils may have antifibrillatory effects. Their mechanism of action in humans is poorly understood.



The purpose of this study was to investigate the effects of chronic fish oil supplementation on human atrial electrophysiology (EP).



Two groups of patients without clinical AF or structural heart disease and fish intake ≤1/week were prospectively recruited into a control group (n = 30) and a fish oil group (n = 31). The latter were prescribed 6 g/day of fish oil for ≥1 month before an EP study. The following were compared at time of EP study: serum omega-3 levels; right atrial and coronary sinus effective refractory periods (ERPs); interatrial, intra-atrial, left atrial, and coronary sinus conduction at baseline and the maximal conduction delay with the shortest propagated extrastimulus; and inducibility of AF (10 inductions/patient).



The following significant differences were noted favoring the fish oil group at time of EP: (1) twofold higher total omega-3 levels (P < .001); (2) lengthening of ERPs by 8%-14% at all measured sites and pacing cycle lengths (P < .05); (3) no effect on baseline interatrial, intra-atrial, left atrial, and coronary sinus conduction but a significant attenuation of maximal conduction delay (P < .05); (4) less inducible AF (AF ≥30 seconds: 24.2% vs. 7.9%; P < .001); (5) shorter mean duration of induced AF (P = .003); and (6) prolongation of induced AF cycle length (P < .001).



Chronic fish oil supplementation in humans prolongs atrial refractoriness and reduces vulnerability to inducible AF. These EP changes may explain the antifibrillatory effect of chronic fish oil ingestion.
Improved visualisation of real-time recordings during third generation cryoballoon ablation: a comparison between the novel short-tip and the second generation device

The third-generation Cryoballoon Advance Short-tip (CB-ST) has been designed with a 40 % shortened tip length compared with the former second generation CB advance device (CB-A). Ideally, a shorter tip should permit an improved visualisation of real-time recordings in the pulmonary vein (PV) due to a more proximal positioning of the inner lumen mapping catheter. We sought to compare the incidence of visualisation of real-time recordings in patients having undergone ablation with the CB-ST with patients having received CB-A ablation. All patients having undergone CB ablation using CB-ST technology and the last 500 consecutive patients having undergone CB-A ablation were analysed. Exclusion criteria were the presence of an intracavitary thrombus, uncontrolled heart failure, moderate or severe valvular disease, and contraindications to general anaesthesia. A total of 600 consecutive patients (58.1 ± 12.9 years, 64 % males) were evaluated (100 CB-ST and 500 CB-A ablations). Real-time recordings were significantly more prevalent in the CB-ST population compared with CB-A group (85.7 vs 67.2 %, p < 0.0001). Real-time recordings could be more frequently visualised in the CB-ST group in all types of veins (LSPV 89 vs 73.4 %, p = 0.0005; LIPV 84 vs 65.6 %, p = 0.0002; RSPV 87 vs 67.4 %, p < 0.0001; RIPV 83 vs 62.4 %, p < 0.0001). The rate of visualisation of real-time recordings is significantly higher during third-generation CB-ST ablation if compared to the second-generation CB-A device. Real-time recordings can be visualised in approximately 85.7 % of veins with this novel cryoballoon.