nils-herrmann/clean_scirepeval huggingface dataset:
A Home-Based Walking Program Improves Respiratory Endurance in Patients With Acute Myocardial Infarction: A Randomized Controlled Trial.

The purpose of this study was to evaluate respiratory muscle strength and endurance in the inpatient period in patients who recently experienced myocardial infarction (MI) and investigate the effects of a home-based walking program on respiratory strength and endurance in low-risk patients after MI.



Patients were randomized into a usual-care group (UCG) entailing regular care (n = 23) and an intervention group (IG) entailing an outpatient home-based walking program (n = 31). Healthy sex- and age-matched participants served as a control group for respiratory endurance variables. Respiratory muscle strength was evaluated through maximal inspiratory pressure (MIP) and endurance during the inpatient period, at 15 days, and at 60 days after MI. Submaximal functional capacity was determined by a 6-minute walk test (6MWT) at hospital discharge and 60 days after MI.



Both groups showed impaired inspiratory muscle strength at hospital discharge. When compared with healthy individuals, after MI, patients had worse respiratory muscle endurance pressure (PTHmax = 73.02 ± 8.40 vs 44.47 ± 16.32; P < 0.05) and time (Tlim = 324.1 ± 12.2 vs 58.7 ± 93.3; P < 0.05). Only the IG showed a significant improvement in MIP and PTHmax at 15 days and 60 days after MI (P < 0.05). When comparing groups, the IG achieved higher values for MIP, PTHmax, and Tlim 15 and 60 days after MI (P < 0.01). The 60-day assessment revealed that the 6MWT distance and level of physical activity was significantly higher in the IG compared with the UCG.



Low-risk patients recently experiencing MI demonstrate impaired MIP and respiratory endurance compared with healthy participants. A home-based walking program improved respiratory endurance and functional capacity.
Validation of the Edinburgh Postnatal Depression Scale among women in a high HIV prevalence area in urban Zimbabwe

Despite the significant burden of common mental disorders (CMD) among women in sub Saharan Africa, data on postnatal depression (PND) is very limited, especially in settings with a high HIV prevalence. The Edinburgh Postnatal Depression Scale (EPDS), a widely used screening test for PND has been validated in many countries, but not in Zimbabwe. We assessed the validity of the EPDS scale among postpartum women compared with Diagnostic Manual of Mental Disorders (DSM-IV) criteria for major depression. Six trained community counselors administered the Shona version of the EPDS to a random sample of 210 postpartum HIV-infected and uninfected women attending two primary care clinics in Chitungwiza. All women were subsequently subjected to mental status examination using DSM IV criteria for major depression by 2 psychiatrists, who were blinded to the subject’s EPDS scores. Data were analyzed using receiver operating characteristic (ROC) curve analysis. Of the 210 postpartum mothers enrolled, 64 (33%) met DSM IV criteria for depression. Using a cut-off score of 11/12 on the Shona version of the EPDS for depression, the sensitivity was 88%, and specificity was 87%, with a positive predictive value of 74%, a negative predictive value of 94%, and an area under the curve of 0.82. Cronbach's alpha coefficient for the whole scale was 0.87.  The Shona version of the EPDS is a reliable and valid tool to screen for PND among HIV-infected and un-infected women in Zimbabwe. Screening for PND should be integrated into routine antenatal and postnatal care in areas with high HIV prevalence.
Impact of complete gastric fundus mobilization on outcome after laparoscopic total fundoplication

With the objective of further optimizing the outcome of antireflux surgery, we have studied the importance of dividing the short gastric vessels when performing a laparoscopic total fundoplication. Ninetynine consecutive patients with chronic gastroesophageal reflux disease (GERD) were enrolled in the trial. Forty-seven patients (25 men, age 52 ±1.6 years [mean ± standard error]) were randomized to undergo a laparoscopic Nissen-Rossetti total fundic wrap with intact short gastric vessels, whereas 52 patients (29 men, 48 ±1.4 years) had complete division of these vessels. Quality of life was assessed by means of the psychological general well-being and gastrointestinal symptom rating scale indices. The 6- and 12-month follow-up data are reported. Two patients were converted to open surgery. Mobilization of the fundus significantly prolonged the operative time (120 vs. 104 minutes, P = 0.05); otherwise the complication rates were similar in the two groups. Both procedures were equally effective in controlling gastroesophageal reflux at 6 and 12 months’ postoperatively. Division of the short gastric vessels had no significant impact on the point prevalence of postfundoplication complaints at the given follow-up time points. Quality of life was significantly improved by both operative procedures and remained “normal” throughout the followup period. Dividing all short gastric vessels had no impact on the functional outcome during the first year of recovery after a total laparoscopic fundoplication.
Cognitive, affective, and conative theory of mind (ToM) in children with traumatic brain injury

We studied three forms of dyadic communication involving theory of mind (ToM) in 82 children with traumatic brain injury (TBI) and 61 children with orthopedic injury (OI): Cognitive (concerned with false belief), Affective (concerned with expressing socially deceptive facial expressions), and Conative (concerned with influencing another's thoughts or feelings). We analyzed the pattern of brain lesions in the TBI group and conducted voxel-based morphometry for all participants in five large-scale functional brain networks, and related lesion and volumetric data to ToM outcomes. Children with TBI exhibited difficulty with Cognitive, Affective, and Conative ToM. The perturbation threshold for Cognitive ToM is higher than that for Affective and Conative ToM, in that Severe TBI disturbs Cognitive ToM but even Mild-Moderate TBI disrupt Affective and Conative ToM. Childhood TBI was associated with damage to all five large-scale brain networks. Lesions in the Mirror Neuron Empathy network predicted lower Conative ToM involving ironic criticism and empathic praise. Conative ToM was significantly and positively related to the package of Default Mode, Central Executive, and Mirror Neuron Empathy networks and, more specifically, to two hubs of the Default Mode Network, the posterior cingulate/retrosplenial cortex and the hippocampal formation, including entorhinal cortex and parahippocampal cortex.
Protocol for a block randomised controlled trial of an intervention to improve heart failure care.

To describe the design of a randomised controlled trial conducted to evaluate a culturally tailored, nurse-led educational intervention.



Self-care strategies are critical to improving health outcomes in heart failure. The family unit is crucial in collectivist cultures, but little is known about involving the family in the self-care of patients with heart failure.



Involving the family in the self-care of heart failure is a novel approach. To the authors' knowledge, no one has evaluated it using a randomised controlled trial.



A valid comparison of outcomes between the control group and the intervention group involved in the study was provided in this trial. The chosen design, randomised controlled trial, enabled the assessment of the intervention.



The application of a family self-care intervention in a collectivist culture was shown to improve clinical and quality outcomes of patients with heart failure. Considering the individual and the community needs is vital in improving these outcomes.
Assessment of whether in-hospital mortality for lobectomy is a useful standard for the quality of lung cancer surgery: retrospective study.

To calculate in-hospital mortality after lobectomy for primary lung cancer in the United Kingdom; to explore the validity of using such data to assess the quality of UK thoracic surgeons; and to investigate the relation between in-hospital mortality and the number of procedures performed by surgeons.



Retrospective study.



36 departments dealing with thoracic surgery in UK hospitals.



4028 patients who had undergone lobectomy for primary lung cancer by one of 102 surgeons.



In-hospital mortality in relation to individual surgeons, among all patients, and among each of five groups of patients defined by the number of operations performed by the surgeon.



103 patients (2.6%, 95% confidence interval 2.1% to 3.1%) died after surgery during the same hospital admission. No significant difference was found for in-hospital mortality between the five groups.



The number of procedures performed by a thoracic surgeon is not related to in-hospital mortality. Reporting data on in-hospital mortality after lobectomy for primary lung cancer is a poor tool for measuring a surgeon's performance.
Efficacy of therapeutic fluoroscopy-guided lumbar spine interventional procedures.

To evaluate the benefit of fluoroscopy-guided lumbar spine interventional procedures in treatment of low back pain.



This prospective descriptive study was performed on 60 patients with back/radicular pain after showing no improvement with conservative treatment.



One hundred and two injection sessions were done (average 1.7 injection per patient). Caudal and lumbar transforaminal injections were effective in 55.9% and 78.5%, respectively. Facet and sacroiliac interventions were effective in 28.3% and 10%, respectively. Complications occurred in 20% of the procedures.



Lumbar injections improved pain/disability related to discogenic lumbar spinal diseases. Efficacy of facet and sacroiliac injections is limited.
Extraperitoneal leakage as a possible explanation for failure of one-time intraperitoneal treatment in ovarian cancer.

We conducted a single-arm study to determine the biodistribution of intraperitoneally (i.p.) administered 90yttrium-labeled murine monoclonal antibody HMFG1 (90Y-muHMFG1) in patients with advanced stage ovarian cancer. Seventeen (17) patients in complete clinical remission for epithelial ovarian cancer were included. After completion of chemotherapy, a mixture of 111indium-labeled muHMFG1 (imaging) and 90Y-muHMFG1 (therapy) was i.p. administered by a surgically placed, indwelling i.p. catheter. Planar and single-photon emission computed tomography images were recorded to determine the distribution of the study medication during the first 6 days postinjection. Of the first 3 patients, 2 patients had extraperitoneal leakage of up to 50% of the injected dose within 24 hours after injection of the study medication. Extraperitoneal leakage was mainly seen in the retroperitoneal spaces covering the upper and lower quadrant of the abdomen. After adjustments in the procedure, leakage was observed in 2 of the remaining 14 patients. Extraperitoneal leakage of i.p. administered therapy does occur. Such leakage would reduce the locally delivered dose of a drug and could potentially have a negative impact on therapeutic efficacy. Given the potential attraction of developing i.p. treatments for intra-abdominal cancer, the observations in this study need to be taken into consideration.
Red blood cell and platelet microparticles in myocardial infarction patients treated with primary angioplasty.

Red blood cell and platelet microparticles (RBCm and PLTm, respectively) have drawn research attention as to their potential prothrombotic and vasoconstrictive effects in experimental settings. However, the relevance of circulating microparticles in clinical settings is largely undetermined.



Circulating microparticles were quantified with a flow cytometric method in blood samples from consecutive STEMI patients after primary PCI. A matched cohort of healthy volunteers was used to derive reference values for comparison. STEMI patients were followed for 6 months for a composite clinical endpoint.



Fifty-one STEMI patients (age 59.8 ± 8.8 years) and 50 controls (age 56.2 ± 9.2 years; p=0.155) were enrolled. RBCm concentration was 18,198 ± 6062/μl in the reference cohort versus 33,740 ± 21,169/μl in STEMI patients (p<0.001). RBCm count was not correlated to total RBCs (standardized beta 0.018; p=0.861). PLTm did not differ between groups (17,529 ± 16,292/μl in STEMI patients versus 14,372 ± 6211/μl in controls; p=0.203). RBCm c-statistic was 0.832 (95% confidence interval 0.720 to 0.944), while PLTm prognostic value was not statistically significant (c-statistic 0.614, 95% confidence interval 0.444 to 0.784). In the multivariate analysis, RBCm concentration was independently associated with the occurrence of the clinical endpoint, after adjustment for age, ejection fraction, serum creatinine and presence of diabetes (adjusted p=0.034).



The present study demonstrates for the first time that erythrocyte microparticles are elevated in patients with STEMI treated with primary PCI, with levels approximately double those measured in a reference population of healthy volunteers, and their concentrations appear to be positively associated with adverse clinical events.
Single-event multilevel surgery in children with spastic diplegia: a pilot randomized controlled trial.

Single-event multilevel surgery is considered the standard of care to improve gait and functioning of children with spastic diplegic cerebral palsy. However, the evidence base is limited. This pilot study is the first randomized controlled trial of single-event multilevel surgery, to our knowledge.



Nineteen children (twelve boys and seven girls with a mean age of nine years and eight months) with spastic diplegia were enrolled. Eleven children were randomized to the surgical group and eight, to the control group. The control group underwent a program of progressive resistance strength training. The randomized phase of the trial concluded at twelve months. The control group then exited the study and progressed to surgery, whereas the surgical group continued to be followed in a prospective cohort study. The primary outcome measures were the Gait Profile Score (GPS) and the Gillette Gait Index (GGI). Secondary outcome measures were gross motor function (Gross Motor Function Measure-66 [GMFM-66]), functional mobility (Functional Mobility Scale [FMS]), time spent in the upright position, and health-related quality of life (Child Health Questionnaire [CHQ]).



A total of eighty-five surgical procedures were performed, with a mean of eight procedures per child (standard deviation, four). The surgical group had a 34% improvement in the GPS and a 57% improvement in the GGI at twelve months. The control group had a small nonsignificant deterioration in both indices. The between-group differences for the change in the GPS (-5.5; 95% confidence interval, -7.6 to -3.4) and the GGI (-218; 95% confidence interval, -299 to -136) were highly significant. The differences between the groups with regard to the secondary outcome measures were not significant at twelve months. At twenty-four months after surgery, there was a 4.9% increase in the GMFM-66 score and improvements in the FMS score, time spent in the upright position, and the physical functioning domain of the CHQ in the surgical group.



This study provides Level-II evidence that single-event multilevel surgery improves the gait of children with spastic diplegic cerebral palsy twelve months after surgery. Improvements in other domains, including gross motor function and quality of life, were not observed until twenty-four months after surgery.
Treatment of advanced colorectal cancer with doxorubicin combined with two potential multidrug-resistance-reversing agents: high-dose oral tamoxifen and dexverapamil

On the basis of the overexpression of theMDR1 gene in human colorectal cancer, which may constitute a molecular basis for intrinsic drug resistance that can be reversed, and because of the limited therapeutic value of conventional cytotoxic treatment in this common disease, the present phase II study of P-glycoprotein-directed double modulation was initiated. Fifteen patients with measurable metastatic colorectal cancer, all of whom were refractory to first-line chemotherapy with 5-fluorouracil/leukovorin, were entered in this trial. Treatment consisted of 80 mg tamoxifen twice daily on days 1–9, oral dexverapamil every day on days 7–9, and 60 mg/m2 doxorubicin given by intravenous bolus injection on day 8. Courses were repeated every 4 weeks. After a median of three (between one and six) courses, none of the 14 evaluable patients had objective response, and 4 had stable disease. Adverse reactions consisted mainly of myelosuppression (WHO grade IV granulocytopenia was noted in 40%), and mild and reversible dexverapamil-related cardiovascular side-effects, specifically hypotension (47%). Our results suggest that, despite the histological demonstration of high levels of P-glycoprotein in colorectal cancer and administration of two potentially synergistic chemosensitizers, we were unsuccessful in circumventing its primary resistance to chemotherapy.
Current recommended 25-hydroxyvitamin D targets for chronic kidney disease management may be too low.

It is uncertain whether increasing 25-hydroxyvitamin D (25-D) levels in chronic kidney disease (CKD) patients above those recommended by current guidelines result in progressive amelioration of secondary hyperparathyroidism. Our objective was to identify a potential therapeutic 25-D target which optimally lowers plasma parathyroid hormone (PTH) without producing excessive hypercalcemia or hyperphosphatemia in CKD.



We performed a cross-sectional analysis of 14,289 unselected stage 1-5 CKD patients from US primary care and nephrology practices utilizing a laboratory-based CKD clinical decision support service between September 2008 and May 2012. Estimated glomerular filtration rate (eGFR), plasma PTH, and serum 25-D, calcium, and phosphorus results were analyzed.



In CKD stages 3-5, progressively higher 25-D pentiles contained progressively lower mean PTH levels. Regression analysis of log PTH on 25-D was significant in all CKD stages with no evidence of a decreasing effect of 25-D to lower PTH until 25-D levels of 42-48 ng/ml. Progressively higher 25-D concentrations were not associated with increased rates of hypercalcemia or hyperphosphatemia.



We found evidence for an optimal level of 25-D above which suppression of PTH progressively diminishes. This level is more than twice that currently recommended for the general population. We found no association between these higher 25-D levels and hyperphosphatemia or hypercalcemia. Additional prospective trials seem appropriate to test the idea that 25-D levels around 40-50 ng/ml could be a safe and effective treatment target for secondary hyperparathyroidism in CKD.
Pulsed lavage reduces the incidence of radiolucent lines under the tibial tray of Oxford unicompartmental knee arthroplasty

The aim of the study was to determine whether the incidence of radiolucencies can be reduced using pulsed lavage before cementing the tibia in unicompartmental knee arthroplasty (UKA). We prospectively studied a consecutive series of 112 cemented Oxford UKA in 100 patients in two centres. In group A (n = 56) pulsed lavage and in group B (n = 56) conventional syringe lavage was used to clean the cancellous bone. The same standardised cementing technique was applied in all cases. At a minimum follow-up of one year patients were evaluated clinically and screened radiographs were obtained. The cement bone interface under the tibial plateau was divided into four zones and evaluated for the presence of radiolucent lines. All radiographs were evaluated (n = 112), and radiolucencies in all four zones were found in two cases in group A (4%) and in 12 cases in group B (22%) (p = 0.0149). Cement penetration showed a median of 2.6 mm (group A) and 1.5 mm (group B) (p < 0.0001). We recommend the routine use of pulsed lavage in Oxford UKA to reduce the incidence of radiolucency and to improve long-term fixation. Le but de cette étude est de déterminer les possibilités de réduction de l’incidence des liserés en utilisant un lavage pulsé avant la cimentation du tibia dans les prothèses unicompartimentales du genou (UKA). Nous avons réalisé une étude prospective consécutive de 112 prothèses (UKA) chez 100 patients, interventions réalisées dans deux centres. Dans le groupe A (n = 56): utilisation d’un lavage pulsé et dans le groupe B (n = 56): lavage conventionnel à la seringue de façon à nettoyer l’os spongieux. La même technique standardisée de cimentation a été utilisée dans tous les cas. Après un suivi minimum d’un an, les patients ont été évalués cliniquement et radiographiquement. L’interface os/ciment sous le plateau tibial a été divisé en 4 zones pour mieux analyser la présence des liserés. Toutes les radiographies ont été analysées (n = 112) et les liserés dans les 4 zones ont été trouvés dans deux cas, dans le groupe A (4%) et dans le groupe B (22%) (p = 0,0149). La pénétration médiane du ciment dans le groupe A est de 2,6 mm et dans le groupe B de 1,5 mm (p < 0,0001). Nous recommandons donc, en routine, l’utilisation d’un lavage pulsé de façon à réduire l’incidence des liserés et améliorer la fixation à long terme dans la mise en place des prothèses uni-compartimentales de type Oxford.
Phase II trial combining docetaxel and doxorubicin as neoadjuvant chemotherapy in patients with operable breast cancer.

This study was conducted to assess the antitumour activity of docetaxel in combination with doxorubicin for neoadjuvant therapy of patients with breast cancer.



Forty-eight women were treated with intravenous doxorubicin 50 mg/m(2) over 15 min followed by a 1-h infusion of docetaxel 75 mg/m(2) every 3 weeks for six cycles. Dexamethasone or prednisolone premedication was allowed. Granulocyte colony-stimulating factor was not allowed as primary prophylaxis. The primary end point was the pathologically documented complete response rate (pathological response).



The mean relative dose intensity calculated for four or more cycles was 0.99 for doxorubicin and 0.99 for docetaxel. Overall, the pathological response rate was 13%. There were 11 complete and 29 partial clinical responses for an overall response rate of 85% [95% confidence interval (CI) 75% to 95%] in the evaluable population (n = 47). Disease-free and overall survival rates were 85% (95% CI 71% to 94%) and 96% (95% CI 85% to 99%), respectively, after a median follow-up of 36.6 months. Grade 3/4 neutropenia was observed in 65% of patients and 17% reported grade 4 febrile neutropenia.



Docetaxel and doxorubicin is an effective and well-tolerated combination in the neoadjuvant therapy of breast cancer. Future controlled trials are warranted to investigate the best schedules and to correlate response with biological factors.