nils-herrmann/clean_scirepeval huggingface dataset:
Prospective randomized crossover study of simulation vs. didactics for teaching medical students the assessment and management of critically ill patients.

Simulation (SIM) allows medical students to manage high-risk/low-frequency cases in an environment without patient risk. However, evidence for the efficacy of SIM-based training remains limited.



To compare SIM-based training to traditional didactic lecture (LEC) for teaching medical students to assess and manage critically ill patients with myocardial infarction (MI) and anaphylaxis.



Prospective, randomized, non-blinded crossover study of 28 fourth-year medical students. Students were oriented to the human patient simulator, then randomized to SIM or LEC between August and December 2007. The SIM group learned to manage MI using SIM training and the LEC group learned via PowerPoint lecture. All subjects' assessment and management skills were then evaluated during a simulation session of MI. During a second instruction session, the students crossed over and were taught anaphylaxis using the opposite modality and similar assessments were conducted. Completion of critical actions for each case were scored, converted to percentages, and analyzed via signed rank test.



Of 28 subjects, 27 performed better when trained with SIM compared with LEC (p < 0.0001). Mean scores were 93% (95% confidence interval [CI] 91-95%) of critical actions completed for SIM and 71% (95% CI 66-76%) for LEC. Absolute increase for simulation was 22% (95% CI 18-26%). For three domains common to MI and anaphylaxis, simulation scores were higher for history (27%, 95% CI 21-38%), physical examination (26%, 95% CI 20-33%), and management (16%, 95% CI 11-21%).



SIM training is superior to didactic lecture for teaching fourth-year medical students to assess and manage simulated critically ill MI and anaphylaxis patients.
Intracoronary brachytherapy, a promising treatment option for diabetic patients: Results from a European multicenter registry (RENO).

Despite advances in the interventional treatment of coronary disease, diabetics still have double the case fatality rate as nondiabetics. The purpose of this analysis from the Radiation in Europe With Novoste (RENO) registry was to assess the clinical and angiographic 6-month outcome of diabetic patients in comparison to nondiabetic patients after localized beta-radiation. A total of 1,098 patients (83.8% with in-stent restenosis) treated with the Novoste Beta-Cath system in Europe were enrolled in the RENO registry. Diabetes was, irrespective of the type of lesion treated, no significant risk factor for major adverse cardiac events or target vessel revascularization. Individuals with diabetes (n = 256) and without diabetes (n = 833) displayed no significant differences concerning clinical or angiographic endpoints. Vascular brachytherapy appears to be the first technique to even out the increased risk of diabetic patients undergoing percutaneous coronary interventions in the routine clinical setting. Thus, intracoronary brachytherapy represents a promising treatment option for diabetic patients.
Picotamide, a combined inhibitor of thromboxane A2 synthase and receptor, reduces 2-year mortality in diabetics with peripheral arterial disease: the DAVID study.

Patients with diabetes are at excessive risk of mortality and cardiovascular morbidity. Previous studies suggest that aspirin may be less effective in diabetic patients. In this multi-centre, randomized, double blind trial picotamide, a dual inhibitor of thromboxane A2 synthase and receptor, was compared with aspirin for the prevention of mortality and major cardiovascular events in diabetics with peripheral arterial disease (PAD).



A total of 1209 adults aged 40-75 years with type 2 diabetes and PAD were randomized to receive picotamide (600 mg bid) or aspirin (320 mg od) for 24 months. The cumulative incidence of the 2 years overall mortality was significantly lower amongst patients who received picotamide (3.0%) than in those who received aspirin (5.5%) with a relative risk ratio for picotamide versus aspirin of 0.55 (95% CI: 0.31-0.98%). Events were reported in 43 patients (7.1%) on picotamide and 53 (8.7%) on aspirin. The combined endpoint of mortality and morbidity had a slightly lower incidence in the picotamide group but this difference did not reach statistical significance.



Picotamide is significantly more effective than aspirin in reducing overall mortality in type 2 diabetic patients with associated PAD.
Teaching subjects with type 2 diabetes how to incorporate sugar choices into their daily meal plan promotes dietary compliance and does not deteriorate metabolic profile.

To determine whether teaching free-living subjects with type 2 diabetes how to incorporate added sugars or sweets into their daily meal plan results in a greater consumption of calories (fat or sugar) and deteriorates their glycemic or lipid profiles but improves their perceived quality of life.



In an 8-month randomized controlled trial, 48 free-living subjects with type 2 diabetes were taught either a conventional (C) meal plan (no concentrated sweets) or one permitting as much as 10% of total energy as added sugars or sweets (S). Mean individual nutrient intake was determined using the average of six 24-h telephone recalls per 4 months. Metabolic control and quality of life were evaluated every 2 months. Quality of life was assessed using the Medical Outcome Survey and the Diabetes Quality of Life questionnaire.



The S group did not consume more calories (fat or sugar) and in fact ate significantly less carbohydrate (-15 vs. 10 g) and less starch (-7 vs. 8 g) and had a tendency to eat fewer calories (-77 vs. 81 kcal) than the C group. Weight remained stable, and there was no evidence that consuming more sugar worsened metabolic profile or improved their perceived quality of life.



Giving individuals with type 2 diabetes the freedom to include sugar in their daily meal plan had no negative impact on dietary habits or metabolic control. Health professionals can be reassured and encouraged to teach the new "sugar guidelines," because doing so may result in a more conscientious carbohydrate consumption.
Prophylactic vesical instillations with 0.2% chondroitin sulfate may reduce symptoms of acute radiation cystitis in patients undergoing radiotherapy for gynecological malignancies

We studied the feasibility and efficacy of intravesical instillations with 40 ml chondroitin sulfate 0.2% solution to prevent or reduce acute radiation cystitis in women undergoing pelvic radiotherapy. In a comparative pilot study in 20 patients, half of the patients received instillations. Instillations' bother was measured with visual analog scores (VAS, 0–10); bladder pain, with VAS; micturition-related quality of life, with the urogenital distress inventory (UDI). One of the instilled patients discontinued the instillations. The first median “acceptability”-VAS was 0 (range, 0–3); the last median was 1 (range, 0–3). “Bladder pain”-VAS peaked halfway in the treatment among controls (median, 1; range, 0–5) and after treatment in the instilled patients (median, 1; range, 1–3). UDI scores showed over time median follow-up scores at or above median baseline scores in controls and at or below median baseline scores in instilled patients. Intravesical instillations with chondroitin sulfate 0.2% solution may decrease the bother related to bladder symptoms and are well tolerated.
Predicting asthma in preschool children with asthma symptoms: study rationale and design

In well-child care it is difficult to determine whether preschool children with asthma symptoms actually have or will develop asthma at school age. The PIAMA (Prevention and Incidence of Asthma and Mite Allergy) Risk Score has been proposed as an instrument that predicts asthma at school age, using eight easy obtainable parameters, assessed at the time of first asthma symptoms at preschool age. The aim of this study is to present the rationale and design of a study 1) to externally validate and update the PIAMA Risk Score, 2) to develop an Asthma Risk Appraisal Tool to predict asthma at school age in (specific subgroups of) preschool children with asthma symptoms and 3) to test implementation of the Asthma Risk Appraisal Tool in well-child care.



The study will be performed within the framework of Generation R, a prospective multi-ethnic cohort study. In total, consent for postnatal follow-up was obtained from 7893 children, born between 2002 and 2006. At preschool age the PIAMA Risk Score will be assessed and used to predict asthma at school age. Discrimination (C-index) and calibration will be assessed for the external validation. We will study whether the predictive ability of the PIAMA Risk Score can be improved by removing or adding predictors (e.g. preterm birth). The (updated) PIAMA Risk Score will be converted to the Asthma Risk Appraisal Tool- to predict asthma at school age in preschool children with asthma symptoms. Additionally, we will conduct a pilot study to test implementation of the Asthma Risk Appraisal Tool in well-child care.



Application of the Asthma Risk Appraisal Tool in well-child care will help to distinguish preschool children at high- and low-risk of developing asthma at school age when asthma symptoms appear.This study will increase knowledge about the validity of the PIAMA risk score and might improve risk assessment of developing asthma at school age in (specific subgroups of) preschool children, who present with asthma symptoms at well-child care.
Effects of iron supplementation on attention deficit hyperactivity disorder in children.

Iron deficiency has been suggested as a possible contributing cause of attention deficit hyperactivity disorder (ADHD) in children. This present study examined the effects of iron supplementation on ADHD in children. Twenty-three nonanemic children (aged 5-8 years) with serum ferritin levels <30 ng/mL who met DSM-IV criteria for ADHD were randomized (3:1 ratio) to either oral iron (ferrous sulfate, 80 mg/day, n = 18) or placebo (n = 5) for 12 weeks. There was a progressive significant decrease in the ADHD Rating Scale after 12 weeks on iron (-11.0 +/- 13.9; P < 0.008), but not on placebo (3.0 +/- 5.7; P = 0.308). Improvement on Conners' Parent Rating Scale (P = 0.055) and Conners' Teacher Rating Scale (P = 0.076) with iron supplementation therapy failed to reach significance. The mean Clinical Global Impression-Severity significantly decreased at 12 weeks (P < 0.01) with iron, without change in the placebo group. Iron supplementation (80 mg/day) appeared to improve ADHD symptoms in children with low serum ferritin levels suggesting a need for future investigations with larger controlled trials. Iron therapy was well tolerated and effectiveness is comparable to stimulants.
The rehabilitation of gait in patients with hemiplegia: a comparison between conventional therapy and multichannel functional electrical stimulation therapy.

Gait rehabilitation in patients with severe hemiplegia requires substantial effort. Preliminary studies indicate potential beneficial effects of using multichannel functional electrical stimulation (MFES) for gait rehabilitation in these patients. In this study, a new method of gait rehabilitation for nonambulatory patients with hemiplegia by means of MFES added to conventional therapy was introduced. The results of the method's application were evaluated by comparing it with conventional therapeutic methods.



The proposed rehabilitation method was tested on a group of 20 patients with severe hemiplegia secondary to cerebrovascular accident. Subjects were randomly assigned to one of two groups. One group received 3 weeks of MFES followed by 3 weeks of conventional therapy. The other group received 3 weeks of conventional therapy followed by 3 weeks of MFES.



The effects of each therapeutic method were evaluated by measurements of temporal-distance variables and ground reaction forces and by assessment of each subject's physical status according to the Fugl-Meyer evaluation scale.



There was improved performance of the subjects during MFES combined with conventional therapy as compared with conventional therapy alone.



The superiority of the MFES method as compared with conventional therapy was mainly attributed to the enhanced motor learning accomplished by application of MFES. These results, however, are preliminary, and further research is needed.
Early dysfunction and long-term improvement in endothelium-dependent vasodilation in the infarct-related artery after thrombolysis.

This study assessed the degree of endothelial dysfunction in post-acute myocardial infarction (AMI) and its subsequent status in the infarct-related artery (IRA) in patients treated with thrombolysis.



Coronary flow reserve alterations in the IRA after thrombolysis have been described, but the endothelium-dependent vasomotion has not been investigated, to date.



Endothelial function in patients after thrombolysis was assessed by infusion of acetylcholine (ACh) at increasing doses in the IRA. Diameter changes in the distal segments were evaluated using quantitative coronary angiography. Patients with coronary atherosclerosis constituted the control group. Clinical variables, electrocardiography and biochemical markers were used to determine the timing of reperfusion and the extent of the infarct. Patients in the AMI group were re-evaluated one year later.



In the initial assessment, 16 patients showed a vasoconstriction response to ACh in the IRA compared to the control group (-20 +/- 21% vs. 4 +/- 4%; p < 0.01). Significant correlations between the degree of vasoconstriction and maximum value of the creatine kinase-MB fraction and number of new Q waves were observed. Of the 12 patients re-evaluated, 4 had complete occlusion of the IRA. In the remaining eight patients with patent artery, an improvement in response to ACh was observed relative to the initial study (+3 +/- 11%, vs. -19 +/- 15%, p < 0.05).



In patients with AMI treated with thrombolysis, severe endothelial dysfunction in the IRA is observed early. In patients who retain patency of the IRA, the endothelial dysfunction improves during the follow-up and suggests a component of stunned endothelium in the first few days post-AMI.
Mutations in HIV-1 reverse transcriptase potentially associated with hypersusceptibility to nonnucleoside reverse-transcriptase inhibitors: effect on response to efavirenz-based therapy in an urban observational cohort.

Hypersusceptibility to nonnucleoside reverse-transcriptase inhibitors (NNRTIs) was described in association with reverse-transcriptase (RT) mutations conferring resistance to nucleoside reverse-transcriptase inhibitors (NRTIs). We evaluated the effect of RT mutations associated with hypersusceptibility to NNRTIs on the response to efavirenz-based therapy.



We analyzed an observational database of patients for whom highly active antiretroviral therapy failed and who received genotypic resistance testing-guided therapy, either efavirenz or protease inhibitor (PI) based. Study end points were achievement of virus load <80 copies/mL, achievement of virus load <80 copies/mL without rebound to >500 copies/mL, and changes in CD4 cell counts.



The baseline RT mutations M41L, M184V, L210W, and T215Y and the M41L/T215Y and M41L/T215Y/M184V combinations were associated with virological suppression for efavirenz-treated patients, whereas, for PI-treated patients, only the M184V mutation was associated with virological suppression, and the L210W mutation showed a negative correlation; no correlation was found between any mutation and virological response without rebound.



The M41L, M184V, L210W, and T215Y mutations were associated with a better, although transient, virological outcome in patients treated with efavirenz-based regimens.
Phase I and pharmacokinetic study of BMS-188797, a new taxane analog, administered on a weekly schedule in patients with advanced malignancies.

The purpose of this study was to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and preliminary activity of BMS-188797 administered weekly.



Patients with advanced malignancies were treated with escalating doses of BMS-188797 on a weekly schedule as a 1-h i.v. infusion. Plasma sampling was performed to characterize the pharmacokinetics of BMS-188797.



Eighteen patients with advanced malignancies were enrolled at three dose levels ranging from 35 to 65 mg/m(2). The number of patients evaluated at each dose level was as follows: 35 mg/m(2) (n = 3); 50 mg/m(2) (n = 9); and 65 mg/m(2) (n = 6). At 65 mg/m(2), three of six patients had a DLT (one had grade 4 neutropenia lasting >7 days, and two had grade 3 diarrhea). Expansion of the 50-mg/m(2) dose cohort to nine patients established this dose as the MTD, with one patient experiencing a DLT (grade 4 neutropenia with fever). Two partial responses were observed (lung cancer, 7+ months; ovarian cancer, 6+ months durations), as well as two minor responses (esophageal cancer, 5 months; ovarian cancer, 5 months). Both patients with partial responses had been clinically resistant to paclitaxel. Plasma pharmacokinetic mean values of maximum concentration (C(max)) and area under the curve (AUC(0-48)) increased in a dose-dependent manner within the range of doses used in this study, and in three of four patients, the DLTs correlated with AUC.



The MTD and the recommended Phase II dose of weekly BMS-188797 is 50 mg/m(2). The drug demonstrates antitumor activity in taxane-refractory solid tumors and is now being evaluated in combination with carboplatin.
Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial

To assess whether a manual based coping strategy compared with treatment as usual reduces depression and anxiety symptoms in carers of family members with dementia.



Randomised, parallel group, superiority trial.



Three mental health community services and one neurological outpatient dementia service in London and Essex, UK.



260 carers of family members with dementia.



A manual based coping intervention comprising eight sessions and delivered by supervised psychology graduates to carers of family members with dementia. The programme consisted of psychoeducation about dementia, carers' stress, and where to get emotional support; understanding behaviours of the family member being cared for, and behavioural management techniques; changing unhelpful thoughts; promoting acceptance; assertive communication; relaxation; planning for the future; increasing pleasant activities; and maintaining skills learnt. Carers practised these techniques at home, using the manual and relaxation CDs.



Affective symptoms (hospital anxiety and depression total score) at four and eight months. Secondary outcomes were depression and anxiety caseness on the hospital anxiety and depression scale; quality of life of both the carer (health status questionnaire, mental health) and the recipient of care (quality of life-Alzheimer's disease); and potentially abusive behaviour by the carer towards the recipient of care (modified conflict tactics scale).



260 carers were recruited; 173 were randomised to the intervention and 87 to treatment as usual. Mean total scores on the hospital anxiety and depression scale were lower in the intervention group than in the treatment as usual group over the eight month evaluation period: adjusted difference in means -1.80 points (95% confidence interval -3.29 to -0.31; P=0.02) and absolute difference in means -2.0 points. Carers in the intervention group were less likely to have case level depression (odds ratio 0.24, 95% confidence interval 0.07 to 0.76) and there was a non-significant trend towards reduced case level anxiety (0.30, 0.08 to 1.05). Carers' quality of life was higher in the intervention group (difference in means 4.09, 95% confidence interval 0.34 to 7.83) but not for the recipient of care (difference in means 0.59, -0.72 to 1.89). Carers in the intervention group reported less abusive behaviour towards the recipient of care compared with those in the treatment as usual group (odds ratio 0.47, 95% confidence interval 0.18 to 1.23), although this was not significant.



A manual based coping strategy was effective in reducing affective symptoms and case level depression in carers of family members with dementia. The carers' quality of life also improved.
Low versus high radioiodine dose in postoperative ablation of residual thyroid tissue in patients with differentiated thyroid carcinoma: a large randomized clinical trial.

Radioiodine ablation of thyroid tissue remains the cornerstone of treatment for patients with differentiated thyroid carcinoma after thyroidectomy. Selecting an optimal dose of radioiodine for successful ablation is a continuous challenge in these patients.



We compared the treatment response of 341 patients with thyroidectomy randomly allocated to the high-dose group, 3700 MBq (170 patients), versus the low-dose group, 1110 MBq (171 patients), for radioiodine ablation therapy in a double-blind randomized clinical trial. The response to treatment was defined as successful or unsuccessful according to post-therapy ultrasonography of the neck, serum thyroglobulin (Tg), anti-Tg, and functioning residual tissue after 6-month and 12-month intervals. The major criteria of successful ablation were Tg<2 ng/ml, anti-Tg<100 IU/ml, and absent remnant in the off-levothyroxine state. Additional radioiodine doses were administered in cases showing no significant response to the first therapy. Finally, the initial outcome, the total hospitalization time, and the cumulative I-131 doses during the 12-month course of the study were compared between the subgroups.



The rate of initial successful ablation was 51.6% in all patients, 39.2% in the low-dose group, and 64.1% in the high-dose group. The corresponding success rates at the end of the 12-month follow-up without additional treatment were 55.1, 41.5, and 68.8%, respectively. The relative risk (RR) of unsuccessful ablation for the low-dose versus the high-dose group was 1.695 [95% confidence interval (CI), 1.34-2.14]. In the low-dose group, more patients needed a second dose of I-131, resulting in a higher cumulative activity (median, 4810 vs. 3700 MBq, P<0.0001) and more inpatient time (median 4 vs. 3 days) in comparison with the high-dose group. The covariate factors predicting the treatment response, in order of significance, were radioiodine dose, baseline Tg, baseline thyroid stimulating hormone (TSH) level, efficiency of TSH suppressive therapy, and sex.



The higher dose of I-131 (3700 MBq) resulted in successful ablation more often than the low dose (1110 MBq).