nils-herrmann/clean_scirepeval huggingface dataset:
Absence of cochleotoxicity measured by standard and high-frequency pure tone audiometry in a trial of once- versus three-times-daily tobramycin in cystic fibrosis patients.

We undertook assessment of hearing in patients with cystic fibrosis who were taking part in a large randomized controlled trial of once- versus three-times-daily tobramycin for pulmonary exacerbations of cystic fibrosis (the TOPIC study). All patients were eligible to have standard pure tone audiometry performed across the frequency range of 0.25 to 8 kHz. High-frequency pure tone audiometry over 10 to 16 kHz was also performed with a subset of patients. Audiometry was undertaken at the start of tobramycin treatment, at the end of a 14-day course of treatment, and at follow-up 6 to 8 weeks later. We enrolled 244 patients, of whom 219 (125 children and 94 adults) completed treatment. Nineteen patients were excluded from analysis due to abnormal baseline audiometry. Complete pre- and posttreatment standard audiological data were obtained for 168/219 patients. We found no significant differences in hearing thresholds when they were assessed at the baseline, at the end of treatment, and at follow-up 6 to 8 weeks later were compared. In addition, no significant differences in hearing thresholds were detected between treatment regimens. Similar results were obtained for the subset of 63/168 patients who underwent high-frequency audiometry. We conclude that for a single 14-day course of tobramycin treatment in patients with cystic fibrosis with no preexisiting auditory deficit, no measurable effect on hearing was apparent with either once- or three-times-daily treatment. Estimation of the cumulative cochleotoxic risk in cystic fibrosis patients due to repeated aminoglycoside therapy, as evidenced by the patients excluded from this study due to hearing loss, also requires further characterization.
Favorable outcome for children and adolescents with T-cell lymphoblastic lymphoma with an intensive ALL-type therapy without local radiotherapy

In study NHL-BFM 90 we investigated the efficacy of an ALL-type treatment without local radiotherapy for childhood T-cell lymphoblastic lymphoma (T-LBL). In particular, the prognostic impact of the speed of tumor regression was evaluated. From April 1990 to March 1995, 105 evaluable patients, 1.1–16.4 years of age, with T-LBL were enrolled into study NHL-BFM 90. Patients with stage I and II received an 8-drug induction followed by a consolidation including high-dose-methotrexate (MTX) and maintenance therapy up to a total therapy duration of 24 months. Patients with stage III and IV received an additional reinduction and cranial radiotherapy (CRT) (12 Gy for prophylaxis) between consolidation and maintenance. Residual tumor after completion of induction had to be resected. No local RT was applied. Patients received intensified chemotherapy if tumor regression on day 33 of induction was < 70% or when vital residual tumor was present after the induction phase. With a median follow-up of 6,41 years, pEFS at 5 years is 91,4% (SE±2.7%). 101 patients were evaluable for the speed of tumor response. Two patients received intensified therapy due to < 70% tumor regression on day 33. Of 19 patients with tumor residues after induction, 2 relapsed as compared to 4 of 80 patients with complete tumor regression. Our data demonstrate that, with intensive ALL-type chemotherapy but no local radiotherapy, an event-free survival rate of 90% can be achieved in childhood T-LBL. Providing tumor regression within 5 weeks is sufficient, tumor remnants after induction have weak prognostic impact.
[The effects of a support group intervention on the burden of primary family caregivers of stroke patients].

The purpose of this study was to develop and evaluate the effects of a support group intervention on the burden of primary family caregivers of stroke patients.



A nonequivalent control group pretest-posttest design was used. The subjects were 36 primary family caregivers of stroke patients [experimental(N=18) and control(N=18) groups] in a neurosurgery ward of a university hospital. The experimental group members participated in six sessions of a support group intervention for two weeks and the degree of their caregiving burden was evaluated. Data was analyzed by Chi-square tests, t-tests, and paired t-tests using SPSS 10.0.



The experimental group had a significantly lower total burden score (t=2.061, p= .047)and sub-scales of emotional(t=-3.319, p= .002), time-dependent(t=-2.045, p= .049) and developmental(t=-2.656, p= .012) burden scores than the control group, while no significant differences were found in physical, social or financial burden scores between the two groups. Within the experimental group, there was a significant decrease in physical(t=2.507, p= .023), emotional(t=4.754, p= .000), social(t=2.932, p= .009), time- dependent(t=5.015, p= .000) and developmental(t=7.541, p= .000) burden scores but not the financial burden score.



The results suggest that a support group intervention can be utilized as an effective nursing program to reduce the burden of primary family caregivers of stroke patients.
Comparative efficacy of fingolimod vs natalizumab: A French multicenter observational study.

To compare natalizumab and fingolimod on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from 27 multiple sclerosis centers participating in the French follow-up cohort Observatoire of Multiple Sclerosis.



Patients with RRMS included in the study were aged from 18 to 65 years with an Expanded Disability Status Scale score of 0-5.5 and an available brain MRI performed within the year before treatment initiation. The data were collected for 326 patients treated with natalizumab and 303 with fingolimod. The statistical analysis was performed using 2 different methods: logistic regression and propensity scores (inverse probability treatment weighting).



The confounder-adjusted proportion of patients with at least one relapse within the first and second year of treatment was lower in natalizumab-treated patients compared to the fingolimod group (21.1% vs 30.4% at first year, p = 0.0092; and 30.9% vs 41.7% at second year, p = 0.0059) and supported the trend observed in nonadjusted analysis (21.2% vs 27.1% at 1 year, p = 0.0775). Such statistically significant associations were also observed for gadolinium (Gd)-enhancing lesions and new T2 lesions at both 1 year (Gd-enhancing lesions: 9.3% vs 29.8%, p < 0.0001; new T2 lesions: 10.6% vs 29.6%, p < 0.0001) and 2 years (Gd-enhancing lesions: 9.1% vs 22.1%, p = 0.0025; new T2 lesions: 16.9% vs 34.1%, p = 0.0010) post treatment initiation.



Taken together, these results suggest the superiority of natalizumab over fingolimod to prevent relapses and new T2 and Gd-enhancing lesions at 1 and 2 years.



This study provides Class IV evidence that for patients with RRMS, natalizumab decreases the proportion of patients with at least one relapse within the first year of treatment compared to fingolimod.
The Sacramento Neighborhood Alcohol Prevention Project: outcomes from a community prevention trial.

This article reports the results of the Sacramento Neighborhood Alcohol Prevention Project (SNAPP). SNAPP set as its goal the reduction of alcohol access, drinking, and related problems in two low-income, predominantly ethnic minority neighborhoods, focusing on individuals between the ages 15 and 29, an age group identified with high rates of alcohol-involved problems.



Two neighborhoods in Sacramento were selected to be the intervention sites because they were economically and ethnically diverse and had high rates of crime and other drinking-related problems. The quasi-experimental design of the study took a "phased" approach to program implementation and statistical examination of outcome data. Outcome-related data were collected in the intervention sites as well as in the Sacramento community at large. Five project interventions included a mobilization component to support the overall project, a community awareness component, a responsible beverage-service component, an underage-access law enforcement component, and an intoxicated-patron law enforcement component. Archival data were collected to measure and evaluate study outcomes and to provide background and demographic information for the study.



Overall, we found significant (p < .05) reductions in assaults as reported by police, aggregate emergency medical services (EMS) outcomes, EMS assaults, and EMS motor vehicle accidents.



Results from the Sacramento Neighborhood Alcohol Prevention Project demonstrate the effectiveness of neighborhood-based interventions in the reduction of alcohol-related problems such as assaults, motor vehicle crashes, and sale of alcohol to minors.
Daily morning running for 3 weeks improved sleep and psychological functioning in healthy adolescents compared with controls.

To compare sleep electroencephalographic patterns and psychological functioning of healthy adolescents running regularly in the mornings with those of control subjects. Although several studies have shown that regular moderate-to-vigorous exercise is related to favorable sleep and psychological functioning in adolescents, research on the effectiveness of short interventions is more limited.



Fifty-one adolescents (mean age = 18.30 years; 27 female [53%]) took part in the study; they were randomly assigned either to a running or to a control group. The running group went running every morning for 30 minutes at moderate intensity during weekdays for 3 consecutive weeks. Sleep electroencephalographic patterns and psychological functioning were assessed in both groups before and after the 3-week period. All participants also kept a sleep log for 3 weeks.



Objective sleep improved (slow-wave sleep increased; sleep onset latency decreased) in the running group compared with the control group. Subjective sleep quality, mood, and concentration during the day improved, whereas sleepiness during the day decreased.



Thirty minutes of running in the morning during weekdays for 3 consecutive weeks impacted positively on sleep and psychological functioning in healthy adolescents compared with control subjects. Running is inexpensive and easy to implement during school schedules, and as both objective and subjective improvements were observed within 3 weeks, regular physical exercise should be promoted.
Interference by sulphinpyrazone with the antihypertensive effects of oxprenolol

The interfering effect of sulphinpyrazone, a uricosuric agent which reduces the activity of cyclo-oxygenase, with the antihypertensive activity of oxprenolol, a non-cardioselective beta-blocker with sympathomimetic activity, has been evaluated. Ten patients with primary arterial hypertension of mild to moderate degree entered a randomized doubleblind cross-over study versus placebo. They were given oxprenolol + placebo or oxprenolol + sulphinpyrazone for 15 days, and then the treatments were crossed-over for a further 15 days. Oxprenolol significantly reduced blood pressure (161±3/101±1 vs 149±4/96±2 mmHg) and heart rate (72±3 vs 66±3 beats/min). During administration of the combination with sulphinpyrazone the blood pressure increased to its pretreatment level (156±5/101±2 mmHg). The effect of oxprenolol on heart rate was not influenced by the combined treatment (67±6 beats/min). The results may be explained by 1) sulphinpyrazone-induced inhibition of prostaglandin synthesis, which could interfere with the antihypertensive activity of oxprenolol, or 2) sulphinpyrazone-induced acceleration of the metabolism of oxprenolol.
Effectiveness of targeted intervention and maintenance pharmacotherapy in conjunction with family intervention in schizophrenia

A sample of 85 patients with schizophrenia, of whom 34 later dropped out, received randomised treatment. There were no significant differences between treatment-takers and drop-outs in the variables assessed. Patients received either standard-dose maintenance neuroleptic treatment or targeted maintenance pharmacotherapy and all patients received behavioural family therapy. Measures of psychopathology, social adjustment, side-effects, family burden, and expressed emotion were assessed at baseline and then periodically over an 18-month period. The study was designed to compare the two alternative pharmacological maintenance approaches, each of them supported by psychosocial intervention. Any evaluation of the impact of behavioural family treatment on relapse rates and other outcome criteria is exclusively descriptive. A significantly higher rate of relapse was observed at 18 months in patients randomised to targeted treatment compared to those randomised to standard-dose treatment (35 % vs 4 %). Although patients assigned to the targeted maintenance group received significantly lower mean doses of neuroleptics, there were no significant differences between the two groups with regard to side-effects, global measures of social function, and overall psychopathology. Family burden was higher in the targeted-treatment group at six months, but did not differ at the one-year and eighteen-month time points. However, both groups improved significantly from baseline to 12 or 18 months in almost all variables assessed. Thus, the behavioural family approach did not compensate for the problems associated with the targeted medication strategy.
Effect of focal/grid photocoagulation on visual acuity and retinal thickening in eyes with non-center-involved diabetic macular edema.

To report visual acuity and anatomic changes from baseline to 12 months after modified Early Treatment Diabetic Retinopathy Study (ETDRS)-style (focal/grid) photocoagulation in eyes with non-center-involved (non-CI) clinically significant macular edema.



Visual acuity, optical coherence tomography, fluorescein angiography, and fundus photography data were analyzed from eyes with non-CI clinically significant macular edema treated with modified ETDRS-style (focal/grid) photocoagulation in a Diabetic Retinopathy Clinical Research Network trial.



Among the 22 eyes (of 22 patients) with 12-month follow-up, median visual acuity letter score remained within 1 letter of baseline over 12 months. The median central subfield retinal thickness decreased by 10 mum, median total macular volume decreased by 0.2 mm, and median fluorescein leakage area within the grid decreased by 0.7 disk areas.



We are unaware of any other systematic evaluation of eyes with non-CI clinically significant macular edema since the ETDRS. Focal/grid laser in these non-CI eyes was associated with relatively stable visual acuity and retinal thickness measurements, and decreased fluorescein leakage area at 1 year. One-year visual acuity results are consistent with those published by the ETDRS, despite the intervening significant differences in the management of diabetes. Although this was a small study without a concurrent control group, the ETDRS recommendation to consider focal/grid laser in eyes with non-CI clinically significant macular edema still seems appropriate.
Non-invasive determination of cardiac output: comparison of a novel CW Doppler ultrasonic technique and inert gas rebreathing.

Cardiac Output (CO) is an important parameter in the diagnosis and therapy of heart diseases. Inert gas rebreathing (IGR) and continuous wave Doppler ultrasound (CWD) are among the most promising newer techniques aiming at a non-invasive, point of care measurement of CO. A direct comparison of the two methods has not yet been carried out.



63 consecutive patients were included in the study. CO was measured twice with both CWD and IGR to assess inter-method agreement and reproducibility. The statistical comparisons were performed as proposed by Bland and Altman.



There was a significant correlation between the CO measurements by both methods (r=0.53, p<0.001). Bland-Altman analysis showed a good agreement of measurements with a bias of 0.4+/-1.0 l/min (mean+/-standard deviation). Both methods showed a good reproducibility. CWD measurements were not possible in 14% of patients while IGR measurements were not possible in 5% of patients (p=0.13).



The determination of CO by IGR and CWD revealed a good agreement and reproducibility with a low rate of impossible measurements, suggesting that IGR and CWD can be used interchangeably in the clinical setting.
Agreement among measurements and estimations of glomerular filtration in children with cancer.

Glomerular filtration is an important route of elimination for many types of chemotherapy. Accurate estimation of glomerular filtration at the bedside is essential in the management of children with cancer. Bedside formulae for the estimation of glomerular filtration have not been validated in children with cancer. We investigated the accuracy of three formulae (the original Schwartz, Counahan-Barratt, and revised Schwartz equations) against measurement of the glomerular filtration rate (GFR) in a cohort of children with cancer.


PROCEDURE
This was a retrospective review of existing data from a single institution. The electronic medical record was queried for subjects meeting inclusion criteria during a 3.5 year time frame. Bland-Altman analyses were used to assess agreement among current formulae and estimating the GFR compared to the measured, or index GFR. Logistic regression was performed to identify potential variables with an effect on the estimation of GFR.



None of the three estimation formulae provided a reliable estimate of the index GFR. The mean difference was lowest between the revised Schwartz and the index GFR compared to the other two formulae and the index GFR. For the original Schwartz equation, age and prior receipt of chemotherapy were significant predictors of under- and overestimation. For the revised Schwartz equation, one age group (6-12 years) and a diagnosis of neuroblastoma actively receiving chemotherapy were positive risk factors for overestimation of the GFR.



Currently available estimation formulae for GFR may not be appropriate for children with cancer.
The Efficacy and Limitations of Sirolimus Conversion in Liver Transplant Patients Who Develop Renal Dysfunction on Calcineurin Inhibitors

This study evaluates sirolimus in preserving renal function in 28 patients who developed renal insufficiency after liver transplantation. Patients with a creatinine level higher than 1.8 mg/ml were eligible for conversion. Of the 28 patients, 7 (25%) did not tolerate sirolimus, 6 (21%) progressed to end-stage renal disease (ESRD), and 14 (50%) have been maintained on sirolimus with stable renal function. The 28 patients overall had a decline in creatinine of 0.38 mg/dl (P D 0:029) at week 4, with a small increase by week 24. However, the subset of 14 patients who did not develop ESRD had a decline in creatinine that persisted to week 48. While the differences between those who developed ESRD and those with stable renal function were not statistically significant, the patients who developed ESRD had a higher creatinine at conversion (2.8 vs 2.3) and a lower creatinine clearance (36 vs 53 ml/min). Patients receiving sirolimus had a persistent rise in cholesterol (P < 0:05). The use of sirolimus to preserve renal function was limited by patients unable to tolerate drug (25%) and patients who developed ESRD (21%). A subgroup of patients (50%) had an improvementin creatinine that persisted for 48 weeks.
Influence of Age and Race on 24-Hour Ambulatory Blood Pressure Responses to Valsartan, Hydrochlorothiazide, and Their Combination: Implications for Clinical Practice.

The effects of race and age on 24-hour mean ambulatory systolic blood pressure (maSBP) responses to sequential 4-week periods of angiotensin receptor blocker therapy (valsartan [VAL] 160 mg/d then 320 mg/d and combination VAL/hydrochlorothiazide [HCTZ] 320/12.5 mg/d) were compared in 304 patients with stage 1 or 2 hypertension. There were lesser blood pressure (BP) responses from baseline with VAL monotherapy in black than Caucasian patients (-2.9 and -4.0 mm Hg vs -8.2 and -9.3 mm Hg, respectively; P<.001 each) but VAL/HCTZ BP responses were similar in both groups (-12 vs -15 mm Hg). Participants 65 years and older had lower BP responses with VAL 160 mg/d and 320 mg/d than those younger than 65 years (-2.8 and -4.5 mm Hg vs -6.5 and -7.5 mm Hg, respectively; P<.001) but similar responses to VAL/HCTZ (-14 vs -17 mm Hg). No BP response differences were found between those older than and those younger than 55 years. The authors conclude that: (1) adding low-dose HCTZ (12.5 mg daily) to VAL is more effective than VAL titration, irrespective of age or race, (2) VAL BP efficacy is lower in blacks than Caucasians, and (3) ARB responses are diminished in patients older than 65 years. Guidelines for stage 1 or 2 hypertension that suggest age 55 should determine initial monotherapy choice (eg, ARB vs thiazide diuretic) or that fail to recommend initial ARB-thiazide combination therapy should be reconsidered.
Large variation between hospitals in immediate breast reconstruction rates after mastectomy for breast cancer in the Netherlands.

The present study aimed to describe the use of immediate breast reconstruction (IBR) after mastectomy for invasive breast cancer and ductal carcinoma in situ (DCIS) in hospitals in the Netherlands and determine whether patient and tumor factors account for the variation.



Patients undergoing mastectomy for primary invasive breast cancer or DCIS diagnosed between January 1, 2011 and December 31, 2013 were selected from the NABON Breast Cancer Audit. All the 92 hospitals in the Netherlands were included. The use of IBR in all hospitals was compared using unadjusted and adjusted analyses. Patient and tumor factors were evaluated by univariate and multivariate analyses.



In total, 16,953 patients underwent mastectomy: 15,072 for invasive breast cancer and 1881 for DCIS. Unadjusted analyses revealed considerable variation between hospitals in postmastectomy IBR rates for invasive breast cancer (mean 17%; range 0-64%) and DCIS (mean 42%; range 0-83%). For DCIS, younger age and multifocal disease were factors that significantly increased IBR rates. For patients diagnosed with invasive breast cancer, IBR was more often used in younger patients, multifocal tumors, smaller tumors, tumors with a lower grade, absence of lymph node involvement, ductal carcinomas, or hormone-receptor positive/HER2-positive tumors. After case-mix adjustments for these factors, the variation in the use of IBR between hospitals remained large (0-43% for invasive breast cancer and 0-74% for DCIS).



A large variation between hospitals was found in postmastectomy IBR rates in the Netherlands for both invasive breast cancer and DCIS even after adjustment for patient and tumor factors.