nils-herrmann/clean_scirepeval huggingface dataset:
Growth and neurodevelopmental outcomes after early low-dose hydrocortisone treatment in extremely low birth weight infants.

Low cortisol concentrations in premature infants have been correlated with increased severity of illness, hypotension, mortality, and development of bronchopulmonary dysplasia. A total of 360 mechanically ventilated infants with a birth weight of 500 to 999 g were enrolled in a randomized, multicenter trial of prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia. Mortality and bronchopulmonary dysplasia were decreased in the hydrocortisone-treated patients exposed to chorioamnionitis. We now report outcomes at 18 to 22 months' corrected age.



Surviving infants were evaluated with standardized neurologic examination and Bayley Scales of Infant Development-II. Neurodevelopmental impairment was defined as a Mental Developmental Index or Psychomotor Developmental Index of <70, cerebral palsy, blindness or deafness.



A total of 252 (87%) of 291 survivors were evaluated. Cerebral palsy was diagnosed in 13% of hydrocortisone-treated versus 14% of placebo-treated infants. Fewer hydrocortisone-treated infants had a Mental Development Index <70, and more of the hydrocortisone-treated infants showed evidence of awareness of object permanence. Incidence of neurodevelopmental impairment was not different (39% [hydrocortisone] vs 44% [placebo]). There were no differences in physical growth measures. Chorioamnionitis-exposed infants treated with hydrocortisone were shorter and weighed less than controls but had no evidence of neurodevelopmental impairment. Among infants not exposed to chorioamnionitis, hydrocortisone-treated patients were less likely to have a Mental Development Index of <70 or to be receiving glucocorticoids at follow-up.



Early, low-dose hydrocortisone treatment was not associated with increased cerebral palsy. Treated infants had indicators of improved developmental outcome. Together with the short-term benefit previously reported, these data support additional studies of hydrocortisone treatment of adrenal insufficiency in extremely premature infants.
Development of an E-learning System for the Endoscopic Diagnosis of Early Gastric Cancer: An International Multicenter Randomized Controlled Trial

In many countries, gastric cancer is not diagnosed until an advanced stage. An Internet-based e-learning system to improve the ability of endoscopists to diagnose gastric cancer at an early stage was developed and was evaluated for its effectiveness.



The study was designed as a randomized controlled trial. After receiving a pre-test, participants were randomly allocated to either an e-learning or non-e-learning group. Only those in the e-learning group gained access to the e-learning system. Two months after the pre-test, both groups received a post-test. The primary endpoint was the difference between the two groups regarding the rate of improvement of their test results.



515 endoscopists from 35 countries were assessed for eligibility, and 332 were enrolled in the study, with 166 allocated to each group. Of these, 151 participants in the e-learning group and 144 in the non-e-learning group were included in the analysis. The mean improvement rate (standard deviation) in the e-learning and non-e-learning groups was 1·24 (0·26) and 1·00 (0·16), respectively (P<0·001).



This global study clearly demonstrated the efficacy of an e-learning system to expand knowledge and provide invaluable experience regarding the endoscopic detection of early gastric cancer (R000012039).
Predict Risk of Relapse for Patients with Multiple Stages of Treatment of Depression

Depression is a serious mood disorder afflicting millions of people around the globe. Medications of different types and with different effects on neural activity have been developed for its treatments during the past few decades. Due to the heterogeneity of the disorder, many patients cannot achieve symptomatic remission from a single clinical trial. Instead they need multiple clinical trials to achieve remission, resulting in a multiple stage treatment pattern. Furthermore those who indeed achieve symptom remission are still faced with substantial risk of relapse. One promising approach to predicting the risk of relapse is censored regression. Traditional censored regression typically applies only to situations in which the exact time of event of interest is known. However, follow-up studies that track the patients' relapse status can only provide an interval of time during which relapse occurs. The exact time of relapse is usually unknown. In this paper, we present a censored regression approach with a truncated $l_1$ loss function that can handle the uncertainty of relapse time. Based on this general loss function, we develop a gradient boosting algorithm and a stochastic dual coordinate ascent algorithm when the hypothesis in the loss function is represented as (1) an ensemble of decision trees and (2) a linear combination of covariates, respectively. As an extension of our linear model, a multi-stage linear approach is further proposed to harness the data collected from multiple stages of treatment. We evaluate the proposed algorithms using a real-world clinical trial dataset. Results show that our methods outperform the well-known Cox proportional hazard model. In addition, the risk factors identified by our multi-stage linear model not only corroborate findings from recent research but also yield some new insights into how to develop effective measures for prevention of relapse among patients after their initial remission from the acute treatment stage.
Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial

Care for people with dementia and their informal caregivers is a challenging aim in healthcare. There is an urgent need for cost-effective support programs that prevent informal caregivers of people with dementia from becoming overburdened, which might result in a delay or decrease of patient institutionalization. For this reason, we have developed the Systematic Care Program for Dementia (SCPD). The SCPD consists of an assessment of caregiver's sense of competence and suggestions on how to deal with competence deficiencies. The efficiency of the SCPD will be evaluated in our study.



In our ongoing, cluster, randomized, single-blind, controlled trial, the participants in six mental health services in four regions of the Netherlands have been randomized per service. Professionals of the ambulatory mental health services (psychologists and social psychiatric nurses) have been randomly allocated to either the intervention group or the control group. The study population consists of community-dwelling people with dementia and their informal caregivers (patient-caregiver dyads) coming into the health service. The dyads have been clustered to the professionals. The primary outcome measure is the patient's admission to a nursing home or home for the elderly at 12 months of follow-up. This measure is the most important variable for estimating cost differences between the intervention group and the control group. The secondary outcome measure is the quality of the patient's and caregiver's lives.



A novelty in the SCPD is the pro-active and systematic approach. The focus on the caregiver's sense of competence is relevant to economical healthcare, since this sense of competence is an important determinant of delay of institutionalization of people with dementia. The SCPD might be able to facilitate this with a relatively small cost investment for caregivers' support, which could result in a major decrease in costs in the management of dementia. Implementation on a national level will be started if the SCPD proves to be efficient.
Do baseline client characteristics predict the therapeutic alliance in the treatment of schizophrenia?

This study examined clinical predictors of client and therapist alliance ratings early in therapy, the relationship between client and therapist alliance ratings, and the psychometric properties of the Working Alliance Inventory in individuals with schizophrenia receiving manual-based treatment. Assessment of clinical symptoms and social functioning were conducted at baseline, and alliance ratings were obtained at 5 weeks. The Working Alliance Inventory had high internal consistency, but there were low correlations between client and therapist ratings. Results also indicated that social functioning and the activation and autistic preoccupation factors on the Positive and Negative Syndrome Scale were significant predictors of therapists' alliance ratings. There were no significant relationships between clinical predictors and clients' therapeutic alliance ratings. The findings indicate that client interpersonal factors are significant predictors of the therapist-rated alliance in the treatment of schizophrenia. Low correlations between clients' and therapists' ratings of the alliance should be examined in future research.
Assessing the association of appropriateness of coronary revascularization and clinical outcomes for patients with stable coronary artery disease.

The study assessed the appropriateness of coronary revascularization in Ontario, Canada, and examined its association with longer-term outcomes.



Although appropriate use criteria for coronary revascularization have been developed to improve the rational use of cardiac invasive procedures, it is unknown whether greater adherence to appropriateness guidelines is associated with improved clinical outcomes in stable coronary artery disease.



A population-based cohort of stable patients undergoing cardiac catheterization was assembled from April 1, 2006, to March 31, 2007. The appropriateness for coronary revascularization at the time of coronary angiography was retrospectively adjudicated using the appropriate use criteria. Clinical outcomes between coronary revascularization and medical treatment without revascularization, stratified by appropriateness categories, were compared.



In 1,625 patients with stable coronary artery disease, percutaneous coronary intervention or coronary artery bypass grafting was only performed in 69% who had an appropriate indication for coronary revascularization. Coronary revascularization was associated with a lower adjusted hazard of death or acute coronary syndrome (hazard ratio [HR]: 0.61; 95% confidence interval [CI]: 0.42 to 0.88) at 3 years compared with medical therapy in appropriate patients. The rate of coronary revascularization was 54% in the uncertain category and 45% in the inappropriate category. No significant difference in death or acute coronary syndrome between coronary revascularization and no revascularization in the uncertain category (HR: 0.57; 95% CI: 0.28 to 1.16) and the inappropriate category (HR: 0.99; 95% CI: 0.48 to 2.02) was observed.



Using the appropriateness use criteria, we identified substantial underutilization and overutilization of coronary revascularization in contemporary clinical practice. Underutilization of coronary revascularization is associated with significantly increased risks of adverse outcomes in patients with appropriate indications.
Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke.

Cerebrolysin is a neuropeptide preparation with neuroprotective and neurorestorative effects. Combining Cerebrolysin treatment with a standardized rehabilitation program may have a potential synergistic effect in the subacute stage of stroke. This study aims to evaluate whether Cerebrolysin provides additional motor recovery on top of rehabilitation therapy in the subacute stroke patients with moderate to severe motor impairment.



This phase IV trial was designed as a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. A total of 70 patients (Cerebrolysin n = 35, placebo n = 35) with moderate to severe motor function impairment were included within 7 days after stroke onset and were randomized to receive a 21-day treatment course of either Cerebrolysin or placebo, given in addition to standardized rehabilitation therapy. Assessments were performed at baseline, immediately after treatment as well as 2 and 3 months after stroke onset. The plasticity of motor system was assessed by diffusion tensor imaging and with resting state functional magnetic resonance imaging.



Both groups demonstrated significant improvement in motor function (p < 0.05); however, no significant difference was found between the two groups. In the stroke patients with severe motor impairment, the Cerebrolysin group exhibited significantly more improvement in motor function compared with the placebo group (p < 0.05). Effects of Cerebrolysin were demonstrated as restricted increments of corticospinal diffusivity and as recovery of the sensorimotor connectivity.



The combination of standard rehabilitation therapy with Cerebrolysin treatment in the subacute stroke has shown additional benefit on motor recovery and plastic changes of the corticospinal tract in patients with severe motor impairment.


 2013).
Cognitive therapy vs medications in the treatment of moderate to severe depression.

There is substantial evidence that antidepressant medications treat moderate to severe depression effectively, but there is less data on cognitive therapy's effects in this population.



To compare the efficacy in moderate to severe depression of antidepressant medications with cognitive therapy in a placebo-controlled trial.



Random assignment to one of the following: 16 weeks of medications (n = 120), 16 weeks of cognitive therapy (n = 60), or 8 weeks of pill placebo (n = 60).



Research clinics at the University of Pennsylvania, Philadelphia, and Vanderbilt University, Nashville, Tenn.



Two hundred forty outpatients, aged 18 to 70 years, with moderate to severe major depressive disorder.



Some study subjects received paroxetine, up to 50 mg daily, augmented by lithium carbonate or desipramine hydrochloride if necessary; others received individual cognitive therapy.



The Hamilton Depression Rating Scale provided continuous severity scores and allowed for designations of response and remission.



At 8 weeks, response rates in medications (50%) and cognitive therapy (43%) groups were both superior to the placebo (25%) group. Analyses based on continuous scores at 8 weeks indicated an advantage for each of the active treatments over placebo, each with a medium effect size. The advantage was significant for medication relative to placebo, and at the level of a nonsignificant trend for cognitive therapy relative to placebo. At 16 weeks, response rates were 58% in each of the active conditions; remission rates were 46% for medication, 40% for cognitive therapy. Follow-up tests of a site x treatment interaction indicated a significant difference only at Vanderbilt University, where medications were superior to cognitive therapy. Site differences in patient characteristics and in the relative experience levels of the cognitive therapists each appear to have contributed to this interaction.



Cognitive therapy can be as effective as medications for the initial treatment of moderate to severe major depression, but this degree of effectiveness may depend on a high level of therapist experience or expertise.
Clinical pharmacology and antiarrhythmic efficacy of encainide in patients with chronic ventricular arrhythmias.

We determined the pharmacokinetics, efficacy and therapeutic plasma concentration of encainide, a new antiarrhythmic drug that affects His-Purkinje conduction but not ventricular refractoriness. Nine patients with frequent and complex premature ventricular complexes were studied in a 3-day double-blind protocol. Each day, each patient received 75 mg of i.v. or oral encainide or placebo. Frequent blood samples for encainide plasma concentration determination and continuous ambulatory ECGs were obtained. There was a marked intersubject variation in bioavailability (mean 42 +/- 24%, range 7.4-82%), clearance (13.2 +/- 5.6 ml/min/kg, range 3.75-22.1 ml/min/kg) and half-life (3.4 +/- 1.7 hours i.v., 2.5 +/- 0.8 hours oral). Eight of nine patients had more than 90% suppression of premature ventricular complexes for 3-36 hours. Minimal antiarrhythmic plasma concentration was higher (39 +/- 54 ng/ml, range 3.5-170 ng/ml) after i.v. dosing than after oral dosing (14 +/- 16 ng/ml, range 1.5-48 ng/ml), suggesting an active metabolite after oral dosing in many patients. Minimal side effects were seen despite high peak plasma concentrations (range 794-1556 ng/ml i.v., 36-495 ng/ml oral). The minimal ratio of toxic to therapeutic plasma concentration ranged from 4.3-326 (median 23) after oral dosing. Antiarrhythmic action was associated with an 11-44% widening of the QRS complex that was not associated with other adverse effects. We conclude that encainide effectively suppresses ventricular arrhythmias. Despite a variable bioavailability, high clearance and short half-life, its wide ratio of toxic to therapeutic concentration and probable active metabolite permit a long duration of action, which should allow a reasonable dose schedule in most patients during chronic oral dosing.
Simultaneous use of non-medical ADHD prescription stimulants and alcohol among undergraduate students.

Use of prescription stimulants used to treat Attention Deficit/Hyperactivity Disorder (ADHD) for reasons other than prescribed, known as non-medical use, is a growing problem among undergraduates. Previous studies show that non-medical prescription stimulant (NMPS) users consume more alcohol than individuals who do not use NMPS. However, research on simultaneous use of NMPS and alcohol is limited. The objectives of this study were to: (1) determine the prevalence of simultaneous use of alcohol and NMPS; (2) examine predictors and consequences of simultaneous NMPS and alcohol use among undergraduates.



In fall 2009, 4090 students from eight North Carolina universities completed a web-based survey.



Past year prevalence of NMPS use among this sample was 10.6% and simultaneous use of NMPS with alcohol was 4.9%. Among NMPS users, 46.4% used NMPS simultaneously with alcohol within the past year. Multivariable analysis revealed that simultaneous NMPS and alcohol use was associated with low grade point averages, use of other substances, and increased alcohol-related consequences. Simultaneous NMPS and alcohol users reported experiencing significantly more negative consequences than either past year drinkers who did not use prescription stimulants and concurrent NMPS and alcohol users (use over the past year but not at the same time).



Simultaneous use of NMPS and alcohol is high among NMPS users in our sample of undergraduate students. Simultaneous users are at increased risk of experiencing negative consequences. Thus, prevention and intervention efforts should include a focus on simultaneous NMPS and alcohol use.
Routine use of intravenous low-dose recombinant tissue plasminogen activator in Japanese patients: general outcomes and prognostic factors from the SAMURAI register.

A retrospective, multicenter, observational study was conducted to document clinical outcomes and to identify outcome predictors in patients treated with low-dose intravenous recombinant tissue plasminogen activator (0.6 mg/kg alteplase), which was approved in Japan in 2005, within 3 hours of stroke onset.



Consecutive patients with stroke treated with recombinant tissue plasminogen activator in 10 Japanese stroke centers were included.



A total of 600 patients (377 men, 72+/-12 years old) were studied. Median National Institutes of Health Stroke Scale scores decreased from 13 before recombinant tissue plasminogen activator to 8 at 24 hours later. Symptomatic intracerebral hemorrhage within 36 hours with a >or=1-point increase from the baseline National Institutes of Health Stroke Scale score developed in 23 patients (3.8%; 95% CI, 2.6% to 5.7%). At 3 months, 43 patients had died (7.2%; 5.4% to 9.5%), and 199 patients (33.2%; 29.5% to 37.0%) had a modified Rankin Scale score <or=1. Analysis of 399 patients with a premorbid modified Rankin Scale score <or=1 who met the criteria of the European license (<or=80 years old, an initial National Institutes of Health Stroke Scale score <or=24, etc) showed that 40.6% (35.9% to 45.5%) had a 3-month modified Rankin Scale score <or=1. After multivariate adjustment, younger age, lower initial National Institutes of Health Stroke Scale score, absence of internal carotid artery occlusion, higher Alberta Stroke Program Early CT Score on CT, and absence of intravenous antihypertensives just before recombinant tissue plasminogen activator were independently related to a 3-month modified Rankin Scale score <or=1. Congestive heart failure and hyperglycemia were independently related to mortality.



Three-month outcomes of patients receiving low-dose intravenous recombinant tissue plasminogen activator therapy in the present study were similar to those from postmarketing surveys using 0.9 mg/kg alteplase.
Assessment of burden in partners of stroke patients with the sense of competence questionnaire.

The burden of caregiving can be harmful to both carers' and patients' functional health, but a specific instrument to assess the burden of caregiving as experienced by carers of stroke patients is not yet available. The Sense of Competence Questionnaire (SCQ), reliable and valid among caregivers of dementia patients, was evaluated on its metric properties in a population of partners of stroke patients.



As part of a multicenter study on quality of care, SCQ burden scores of partners and functional health of patients were assessed 6 months after stroke (group A; n=166). In this study group, the reliability in terms of homogeneity, the construct validity, and the clinical validity of the SCQ were evaluated. The test-retest reliability was assessed in a separate group (group B; n=47). The feasibility was examined in both study groups.



The reliability of the total SCQ score was good (Chronbach's alpha coefficient=0.83; intraclass correlation coefficient=0.93). Statistical support for construct validity was shown by principal-components analysis. Clinical validity was supported by the association between higher SCQ burden scores and patients' impaired functional health: cognitive function (P=.03), disability (P=.10), handicap (P<.01), and quality of life (P=.02).



The SCQ is a reliable and valid instrument for assessing burden of caregiving as experienced by partners of stroke patients. It is suitable for use in cross-sectional stroke studies and may help to identify partners at risk for high levels of burden and caregiving-related problems.