nils-herrmann/clean_scirepeval huggingface dataset:
The pediatric asthma intervention: a comprehensive cost-effective approach to asthma management in a disadvantaged inner-city community.

To compare three pediatric asthma interventions for their impact on improving the health status of inner-city asthmatic children and in achieving cost savings.



A total of 212 children 1 to 16 years of age were randomized into three groups: group 1 (n = 74) received one individualized asthma education session; group 2 (n = 68) received reinforced asthma education; group 3 (n = 70) received reinforced asthma education plus case management. Asthma-related health resource utilization and cost were primary outcomes. The cost-benefit analysis sought to estimate the expected cost savings to the Illinois Department of Healthcare and Family Services (Medicaid administrator) associated with the intervention.



Participants in all three groups used significantly fewer emergency health care services in the follow-up year. Averaged across all three groups, the magnitudes of declines were substantial: 81% for hospitalizations, 69% for hospital days, 64% for emergency department visits, and 58% for clinic visits. Although there were no statistically significant differences between study groups for three of the four main outcome measures, group 3 participants consistently improved to the greatest degree. All three interventions were associated with considerable cost savings ranging from $4,021/child/year for group 1 to $4,503/child/year for group 3.



Asthma education with or without case management services enhances the health of children with asthma thereby reducing associated costs.
Prevention of Heel Pressure Injuries and Plantar Flexion Contractures With Use of a Heel Protector in High-Risk Neurotrauma, Medical, and Surgical Intensive Care Units: A Randomized Controlled Trial.

The purpose of this study was to compare the use of a heel protector to standard of care (pillows) in the prevention of hospital-acquired pressure injuries (HAPI) of the heels and prevention of plantar flexion contractures.



Randomized controlled trial.



The study took place on a surgical intensive care unit, medical intensive care unit, and neurotrauma intensive care unit. Inclusion criteria were a minimum of 5 days of sedation related to care for a critical illness, immobility for 6 to 8 hours before study initiation, a Braden Scale for Pressure Sore Risk score 18 or less, and a mobility subscale score 2 or less. Patients were included if they had preexisting heel pressure injury or plantar flexion contracture. The sample comprised 54 subjects; 37 were randomly allocated to the intervention group and 17 to the control group. Their average age-mean (standard deviation)-was 40.7 (14.96) years in the control group and 44.6 (17.15) years in the intervention group.



Data were collected from patients' electronic medical records. We recorded subject demographics, presence of diabetes mellitus or peripheral vascular disease, Glasgow Coma Scale scores (every shift), Braden Scale for Pressure Sore Risk scores (every shift), heel skin assessments (every shift), goniometric measurements (every other day), and adverse events (every shift). Assessments and measurements were continued until the patient was discharged from the study.



None of the patients in the intervention group developed HAPI of the heels, as compared to 7 in the control group (0% vs 41%, P < .001). Patients in the intervention group had a significantly greater decrease in goniometric scores (mean decrease = 1.4 ± 2.25) compared to the control group by day 3 (mean decrease = 0.1 ± 0.52 P = .004) and the last study day (mean decrease = 2.0 ± 3.02 for the intervention group vs 0.07 ± 0.96 for the control group; P < .001).



Study findings indicate that a heel protector that ensures off-loading and maintains the foot in a neutral position is more effective for prevention of HAPI of the heel and contractures as compared to standard care using pillows to position the heel and redistribute pressure.
Effect of cyclosporine on reperfusion injury in acute myocardial infarction.

Experimental evidence suggests that cyclosporine, which inhibits the opening of mitochondrial permeability-transition pores, attenuates lethal myocardial injury that occurs at the time of reperfusion. In this pilot trial, we sought to determine whether the administration of cyclosporine at the time of percutaneous coronary intervention (PCI) would limit the size of the infarct during acute myocardial infarction.



We randomly assigned 58 patients who presented with acute ST-elevation myocardial infarction to receive either an intravenous bolus of 2.5 mg of cyclosporine per kilogram of body weight (cyclosporine group) or normal saline (control group) immediately before undergoing PCI. Infarct size was assessed in all patients by measuring the release of creatine kinase and troponin I and in a subgroup of 27 patients by performing magnetic resonance imaging (MRI) on day 5 after infarction.



The cyclosporine and control groups were similar with respect to ischemia time, the size of the area at risk, and the ejection fraction before PCI. The release of creatine kinase was significantly reduced in the cyclosporine group as compared with the control group (P=0.04). The release of troponin I was not significantly reduced (P=0.15). On day 5, the absolute mass of the area of hyperenhancement (i.e., infarcted tissue) on MRI was significantly reduced in the cyclosporine group as compared with the control group, with a median of 37 g (interquartile range, 21 to 51) versus 46 g (interquartile range, 20 to 65; P=0.04). No adverse effects of cyclosporine administration were detected.



In our small, pilot trial, administration of cyclosporine at the time of reperfusion was associated with a smaller infarct by some measures than that seen with placebo. These data are preliminary and require confirmation in a larger clinical trial.
Effect of a six month gemfibrozil treatment and dietary recommendations on the metabolic risk profile of visceral obese men

The aim of the present study was to investigate the effects of a 6 month gemfibrozil treatment. A sample of 64 visceral obese men (age 46±6 y; body mass index 31±3 kg/m2; waist circumference 104±7 cm; mean±s.d.) who received dietary recommendations. Subjects were randomly assigned to receive a placebo (n=32) or gemfibrozil (1200 mg/day) (n=32).RESULTS: In both placebo and gemfibrozil treated groups, significant reductions were noted in body weight, fat mass, waist circumference and visceral adipose tissue area measured by computed tomography (0.0001<P<0.05). Plasma cholesterol (CHOL) and apolipoprotein B (apo B) levels were also decreased in both groups (P<0.01) whereas plasma high density lipoprotein (HDL) and HDL-3-CHOL levels were only significantly (P<0.01) increased in the gemfibrozil-treated group. After the 6 month treatment period, gemfibrozil-treated men displayed significantly lower plasma triglycerides (TG) levels, compared to those who received the placebo (P<0.01). Finally, both fasting plasma insulin concentration and insulin area measured during an oral glucose load were significantly decreased only in the placebo group (P<0.05). Taken together, these results suggest that the improvement in plasma lipid/lipoprotein profile observed in gemfibrozil treated visceral obese men seems to be independent from changes in adipose tissue mass and in visceral fat accumulation. Furthermore, improvements in the plasma lipoprotein profile produced by gemfibrozil therapy appear to be independent from changes in indices of plasma glucose–insulin homeostasis.
A cluster randomized controlled trial to determine the efficacy of Trauma Risk Management (TRiM) in a military population.

Trauma Risk Management is a peer-support program that aims to promote help-seeking in the aftermath of traumatic events. Prior to its implementation, the British military conducted a randomized controlled trial of Trauma Risk Management against standard care in 12 warships; 6 were randomized to use Trauma Risk Management after collecting baseline measurements. Follow up after 12-18 months found no significant change in psychological health or stigma scores in either group; however, the studied vessels only encountered low numbers of critical incidents. Additionally, measurements of organizational functioning were modestly better in the Trauma Risk Management ships. The authors conclude that within organizations using Trauma Risk Management may be beneficial and may, in time, lead to a valuable cultural shift.
Cluster ing of insul in resistance , total and central abdominal fat : same genes or same envi ronment ?

Obesi ty, insul in resistance and disturbed glucose metabol ism cluster wi thin the Insul in Resistance Syndrome (IRS). Whether this reflects shared genetic or envi ronmental factors detectable in ‘normal ’ populations (not selected for IRS features) is unknown. This study estimated (i ) genetic influences on IRS trai ts and (i i ) shared and specific genetic and envi ronmental factors on the relationships between these trai ts in heal thy female twins. Fasting insul in, glucose, total and central fat were measured in 59 monozygotic (MZ) and 51 dizygotic (DZ) female twin pai rs aged ( ± SD) 52 ± 13 years. Body fat was measured by dual -energy X-ray absorptiometry, insul in resistance and secretion by a modified homeostasis model assessment. Using intraclass correlation coefficients and univar iate model -fi tting analyses, genetic influences were found in total fat, central fat, insul in resistance, fasting glucose and insul in secretion, wi th genetic factors explaining 64, 57, 59, 75 and 68% of thei r var iance, respectively, using the latter technique. In matched analysis intra-pai r di fferences in total and central fat related to intra-pai r di fferences in insul in resistance (r 2 = 0.19, P < 0.001). Mul tivar iate model -fi tting showed a close genetic relationship between total and central fat (r = 0.88). The genetic correlation between IR and central fat (0.41) was significantly greater than that for total fat (0.24), suggesting that central fat is not only a predictor of, but shares considerable genetic influence wi th, insul in resistance. In Cholesky analysis, these genetic influences were separate from those shared between central and total fat. In conclusion, both shared and specific genetic factors regulate components of the IRS in heal thy females. However, there were discrete genetic influences on -cel l insul in secretion, not shared wi th other IRS components, suggesting that a separate genetic propensi ty exists for Type2 diabetes. These findings suggest we may understand the genetic and envi ronmental influences on IRS from the study of the normal population.
An open-label randomized trial comparing itraconazole oral solution with fluconazole oral solution for primary prophylaxis of fungal infections in patients with haematological malignancy and profound neutropenia.

This trial studied the efficacy and safety of itraconazole and fluconazole in the prevention of invasive fungal infections in neutropenic patients with haematological malignancies.



An 8 week, open-label, randomized, parallel-group, multicentre trial comparing itraconazole oral solution (2.5 mg/kg twice daily; N=248) with fluconazole oral solution or capsules (400 mg daily; N=246) in 494 patients with anticipated profound neutropenia (i.e. neutrophil count expected to be <500 cells/mm3 for at least 10 days) from tertiary care centres.



Invasive fungal infections were reported for 4 out of 248 patients (1.6%) in the itraconazole group and 5 out of 246 patients (2.0%) in the fluconazole group. Invasive Aspergillus infections were proven for 2 out of 248 patients (0.8%) in the itraconazole group and 3 out of 246 patients (1.2%) in the fluconazole group. For both the ITT and profoundly neutropenic populations, no differences were detected between treatment groups in proven or suspected invasive fungal infections or other endpoints. The mortality rates owing to proven invasive fungal infections were 2 out of 248 patients (0.8%) for the itraconazole group and 3 out of 246 patients (1.2%) for the fluconazole group. There was also no difference between treatment groups in the number of patients who recovered from neutropenia or in the duration of neutropenia. More discontinuation of drug intake owing to nausea and more hypokalaemia occurred in the itraconazole group, other adverse events and the total number of adverse events were similar in both groups.



In this study there were no differences in the efficacy and safety of itraconazole and fluconazole prophylaxis in neutropenic patients with haematological malignancies.
Under-diagnosis of smear-positive pulmonary tuberculosis in Nairobi, Kenya.

Nairobi City Council Chest Clinic, Nairobi, Kenya.



To determine if under-reading of sputum smears is a contributing factor in the disproportionate increase in smear-negative tuberculosis in Nairobi, Kenya.



Between October 1997 and November 1998, patients fulfilling the local programme definition of smear-negative presumed pulmonary tuberculosis were enrolled in the study. Two further sputum specimens were collected for examination in a research laboratory by fluorescence microscopy.



Of 163 adult subjects enrolled, 55% were seropositive for the human immunodeficiency virus type 1 (HIV-1). One hundred subjects had had two pre-study sputum smears assessed before recruitment and produced two further sputum specimens for re-examination in the research laboratory; of these 19 (19%) were sputum smear-positive on re-examination and a further seven (7%) became smear-positive on second re-examination.



Of those patients with smear-negative presumed pulmonary tuberculosis by the local programme definition, 26% were smear-positive when reexamined carefully with two repeat sputum smears. This suggests that the high rates of smear-negative tuberculosis being seen may in part be due to under-reading. This is probably as a result of the overwhelming burden of tuberculosis leading to over rapid and inaccurate sputum examination. Retraining of existing technicians and training of more technicians is likely to reduce underreading and increase the yield of smear-positive tuberculosis. This finding also stresses the need for regular quality assurance.
Comparison of olmesartan combined with a calcium channel blocker or a diuretic in elderly hypertensive patients (COLM Study): safety and tolerability

The cardiovascular effects of combined therapy with the angiotensin receptor blocker (olmesartan) and a dihydropyridine calcium channel blocker (CCB) or a diuretic were compared in high-risk elderly Japanese hypertensive patients by performing a randomized, open label, blinded-endpoint study of morbidity and mortality (the COLM study). Here we report the results obtained with respect to safety and tolerability. High-risk hypertensive patients aged 65–84 years were enrolled and were randomized to receive olmesartan combined with either a CCB (amlodipine or azelnidipine) or a low-dose diuretic for at least 3 years. The primary endpoint was a composite of fatal and non fatal cardiovascular events, whereas adverse events (AEs) and the percentage of patients who discontinued the allocated treatment were evaluated as secondary endpoints. A total of 5141 patients were randomized. Both combination regimens achieved a similar reduction of cardiovascular morbidity and mortality. The incidences of AEs, serious AEs, drug-related serious AEs and discontinuation due to serious AEs were lower in the olmesartan plus CCB group than in the olmesartan plus diuretic group. Serum levels of uric acid and creatinine were significantly higher in the olmesartan plus diuretic group than in the olmesartan plus CCB group. Olmesartan combined with a CCB was significantly superior to olmesartan plus a diuretic with regard to the frequency of AEs and discontinuation of treatment.
Role of angiotensin II in plasma PAI-1 changes induced by imidapril or candesartan in hypertensive patients with metabolic syndrome

To evaluate the relationship between plasma plasminogen activator inhibitor-1 (PAI-1) and angiotensin II (Ang II) changes during treatment with imidapril and candesartan in hypertensive patients with metabolic syndrome. A total of 84 hypertensive patients with metabolic syndrome were randomized to imidapril 10 mg or candesartan 16 mg for 16 weeks. At weeks 4 and 8, there was a dose titration to imidapril 20 mg and candesartan 32 mg in nonresponders (systolic blood pressure (SBP) >140 and/or diastolic blood pressure (DBP) >90 mm Hg). We evaluated, at baseline and after 2, 4, 8, 12 and 16 weeks, clinic blood pressure, Ang II and PAI-1 antigen. Both imidapril and candesartan induced a similar SBP/DBP reduction (−19.4/16.8 and −19.5/16.3 mm Hg, respectively, P<0.001 vs. baseline). Both drugs decreased PAI-1 antigen after 4 weeks of treatment, but only the PAI-1 lowering effect of imidapril was sustained throughout the 16 weeks (−9.3 ng ml−1, P<0.01 vs. baseline), whereas candesartan increased PAI-1 (+6.5 ng ml−1, P<0.05 vs. baseline and P<0.01 vs. imidapril). Imidapril significantly decreased Ang II levels (−14.6 pg ml−1 at week 16, P<0.05 vs. baseline), whereas candesartan increased them (+24.2 pg ml−1, P<0.01 vs. baseline and vs. imidapril). In both groups there was a positive correlation between Ang II and PAI-1 changes (r=0.61, P<0.001 at week 16 for imidapril, and r=0.37, P<0.005 at week 16 for candesartan). Imidapril reduced plasma PAI-1 and Ang II levels, whereas candesartan increased them. This suggests that the different effect of angiotensin-converting enzyme inhibitors and Ang II blockers on Ang II production has a role in their different influence on fibrinolysis.
Factors that influence cancer patients' anxiety following a medical consultation: impact of a communication skills training programme for physicians.

No study has yet assessed the impact of physicians' skills acquisition after a communication skills training programme on the evolution of patients' anxiety following a medical consultation. This study aimed to compare the impact, on patients' anxiety, of a basic communication skills training programme (BT) and the same programme consolidated by consolidation workshops (CW), and to investigate physicians' communication variables associated with patients' anxiety.



Physicians, after attending the BT, were randomly assigned to CW or to a waiting list. The control group was not a non-intervention group. Consultations with a cancer patient were recorded. Patients' anxiety was assessed with the State Trait Anxiety Inventory before and after a consultation. Communication skills were analysed according to the Cancer Research Campaign Workshop Evaluation Manual.



No statistically significant change over time and between groups was observed. Mixed-effects modelling showed that a decrease in patients' anxiety was linked with screening questions (P = 0.045), physicians' satisfaction about support given (P = 0.004) and with patients' distress (P < 0.001). An increase in anxiety was linked with breaking bad news (P = 0.050) and with supportive skills (P = 0.013). No impact of the training programme was observed.



This study shows the influence of some communication skills on the evolution of patients' anxiety. Physicians should be aware of these influences.
Is adjuvant chemotherapy indicated in stage I pure immature ovarian teratoma (IT)? A multicentre Italian trial in ovarian cancer (MITO-9).

Conservative surgery followed by platinum-based chemotherapy is considered the standard approach for stage I immature ovarian teratoma (IT), except for stage IA G1. Nevertheless the use of chemotherapy in stage IA G2-3 and IB-IC is controversial. The aim of this study was to evaluate the outcome of patients with IT in order to define the role of chemotherapy in stage I disease.



Twenty-eight patients with stage I IT treated in MITO centers were retrospectively reviewed. Grade, stage, age, surgical and postoperative treatment were analyzed using χ(2) test and T test looking for association with recurrence.



Median age was 25.5. Twenty-four patients underwent fertility-sparing surgery. FIGO stages were 19 IA, 2 IB, and 7 IC. Nine patients had grade 1 tumor, 12 grade 2, and 7 grade 3. Nine patients received adjuvant chemotherapy. Overall recurrence rate was 21.4% (2 in chemotherapy group and 4 in the group without treatment). No patients with G1 had recurrence, whereas 25% of G2 and 42.9% of G3 relapsed. Recurrence rate was not significantly different according to stage, grade or adjuvant chemotherapy, whereas it was greater in the group not operated in a MITO center, not staged and of age lower than 20 years, with statistical significance. At recurrence 4 patients presenting with mature teratoma were treated with surgery alone, whereas 2 recurring with IT were treated with surgery plus chemotherapy. After a median follow-up of 59 months all patients are NED.



Our study suggests that chemotherapy may be withheld for primary therapy and utilized only for recurrence.
Relationship between PCO2 and unfavorable outcome in infants with moderate-to-severe hypoxic ischemic encephalopathy

Abnormal PCO2 is common in infants with hypoxic ischemic encephalopathy (HIE). The objective was to determine whether hypocapnia was independently associated with unfavorable outcome (death or severe neurodevelopmental disability at 18 mo) in infants with moderate-to-severe This was a post hoc analysis of the CoolCap Study in which infants were randomized to head cooling or standard care. Blood gases were measured at prespecified times after randomization. PCO2 and follow-up data were available for 196 of 234 infants. Analyses were performed to investigate the relationship between hypocapnia in the first 72 h after randomization and unfavorable outcome.After adjusting for pH, amplitude-integrated electroencephalogram background and seizures, birth weight, Apgar score at 5 min, cooling status, and Sarnat stage, PCO2 was inversely associated with unfavorable outcome (P < 0.001). The probability of unfavorable outcome was 0.20 ± 0.1 (point estimate ± SE), 0.53 ± 0.23 and 0.89 ± 0.16 for a PCO2 of 40, 30, and 20 mm Hg respectively and was greater in infants with severe HIE than with moderate HIE.Conclusions:Hypocapnia in infants with moderate-to-severe HIE was independently associated with unfavorable outcome. Future studies of controlled normocapnia will be important.