nils-herrmann/clean_scirepeval huggingface dataset:
Comparison of fluticasone propionate and beclomethasone dipropionate on direct and indirect measurements of bronchial hyperresponsiveness in patients with stable asthma.

Fluticasone propionate is a new inhaled corticosteroid with a 2:1 efficacy ratio compared with beclomethasone dipropionate with regard to lung function and symptom scores, without increased systemic activity. The aim of this study was to investigate whether this was also the case for bronchial hyperresponsiveness, assessed by both a direct (histamine) and an indirect (ultrasonically nebulised distilled water (UNDW)) provocation test.



Fluticasone propionate, 750 micrograms/day, and beclomethasone dipropionate, 1500 micrograms/day, were compared in a randomised, double blind, crossover study consisting of two six week treatment periods, each preceded by a three week single blind placebo period. Twenty one non-smoking asthmatics (mean forced expiratory volume in one second (FEV1) 74.7% predicted, mean PC20histamine 0.36 mg/ml) completed the study.



Fluticasone propionate and beclomethasone dipropionate improved FEV1, peak flow rates, asthma symptoms, and bronchial hyperresponsiveness to the same extent. Both fluticasone propionate and beclomethasone dipropionate caused an increase in PC20histamine (mean 2.29 [95% confidence interval 1.45 to 3.13] and 1.95 [1.07 to 2.84] doubling doses, respectively) and in PD20UNDW (1.12 [0.55 to 1.70] and 1.28 [0.88 to 1.70] doubling doses, respectively). Neither treatment changed morning serum cortisol levels, but fluticasone propionate decreased the number of peripheral blood eosinophils less than beclomethasone dipropionate, indicating smaller systemic effects of fluticasone propionate.



These findings show that fluticasone propionate is as effective as twice the dose of beclomethasone dipropionate on bronchial hyperresponsiveness, assessed by provocation with both histamine and UNDW, without increased systemic activity.
Improvement in clinical markers in CF patients using a reduced glutathione regimen: an uncontrolled, observational study.

CFTR mutation, which causes cystic fibrosis (CF), has also recently been identified as causing glutathione system dysfunction and systemic deficiency of reduced glutathione (GSH). Such dysfunction and deficiency regarding GSH may contribute to the pathophysiology of CF. We followed 13 patients (age range 1-27 years) with cystic fibrosis who were using a regimen of reduced glutathione (GSH), including oral glutathione and inhaled buffered glutathione in an uncontrolled, observational study. Dosage ranged from 66-148 mg/kg/day in divided doses, and the term examined was the initial 5.5 months of GSH use (45 days of incrementally adjusted dose, plus 4 months of use at full dosage). Baseline and post-measurements of FEV1 percent predicted, BMI percentile, and weight percentile were noted, in addition to bacterial status and pulmonary exacerbations. Significant improvement in the following clinical parameters was observed: average improvement in FEV1 percent predicted (N=10) was 5.8 percentage points (p<0.0001), average weight percentile (N=13) increased 8.6 points (p<0.001), BMI percentile (N=11) improved on average 1.22 points (p<0.001). All patients improved in FEV1 and BMI, if measured in their case; 12 of 13 patients improved in weight percentile. Positive sputum cultures of bacteria in 11 patients declined from 13 to 5 (p<0.03) with sputum cultures of Pseudomonas aeruginosa becoming negative in 4 of 5 patients previously culturing PA, including two of three patients chronically infected with PA as determined by antibody status. Use of a daily GSH regimen appears to be associated in CF patients with significant improvement in lung function and weight, and a significant decline in bacteria cultured in this uncontrolled study. These findings bear further clinical investigation in larger, randomized, controlled studies.
Prognostic Impact of Anemia in Patients With Chronic Heart Failure- With Special Reference to Clinical Background: Report From the CHART-2 Study.

We aimed to elucidate the prognostic impact of anemia with special reference to the clinical background of patients with chronic heart failure (CHF).



We examined 4,646 consecutive patients with Stage C/D CHF registered in the Chronic Heart Failure Analysis and Registry in the Tohoku District-2 (CHART-2) Study (n=10,219). Among them, 1,627 (35%) had anemia and were characterized by higher age (74 vs. 66 years), lower estimated glomerular filtration rate (52.8 vs. 66.1 ml/min/1.73 m(2)) and higher B-type natriuretic peptide levels (154.5 vs. 81.8 pg/ml) (all P<0.001) but comparable left ventricular ejection fraction (LVEF; 57.5 vs. 56.7%). Anemic patients were more frequently treated with diuretics (55.1 vs. 42.3%) but less often treated with β-blockers (45.4 vs. 51.1%) (both P<0.001). During a median follow-up of 3.8 years, 371 and 272 patients died with and without anemia, respectively (22.8 vs. 9.0%, adjusted hazard ratio 1.40; 95% confidence interval 1.15-1.71, P=0.001). Subgroup analysis revealed that the prognostic impact of anemia was comparable in terms of age, sex, renal function and double product, but differed by LVEF level and CHF etiology (both, P for interaction <0.001). In particular, a difference in the prognostic impact of LVEF level was noted in patients with ischemic heart disease.



These results indicate that the prognostic impact of anemia is evident in CHF patients with preserved EF and it differs by CHF etiology.
An interactive workshop plus locally adapted guidelines can improve General Practitioners asthma management and knowledge: A cluster randomised trial in the Australian setting

A cluster randomised trial was conducted to determine the effectiveness of locally adapted practice guidelines and education about paediatric asthma management, delivered to general practitioners (GPs) in small group interactive workshops.



Twenty-nine practices were randomly allocated to one of three study arms. Australian asthma management guidelines were adapted to accommodate characteristics of the local area. GPs in the intervention arm (Group 1, n = 18 GPs) participated in a small group based education program and were provided with the adapted guidelines. One control arm (Group 2, n = 18 GPs) received only the adapted guidelines, while the other control arm (Group 3, n = 15 GPs) received an unrelated education intervention. GPs' knowledge, attitudes and management of paediatric asthma was assessed.



Post intervention, intervention arm GPs were no more likely to provide a written asthma action plan, but were better able to assess the severity of asthma attack (Group 1vs Group 2 p = 0.05 and Group 1 vs Group 3 p = 0.01), better able to identify patients at high risk of severe attack (Group 1vs Group 3 p = 0.06), and tended to score higher on the asthma knowledge questionnaire (Group 1 vs Group 2 p = 0.06 and Group 1 vs Group 3 p = 0.2). Most intervention arm GPs felt more confident than control GPs to manage acute asthma attack and ongoing management of infrequent episodic asthma.



Using interactive small group workshops to disseminate locally adapted guidelines was associated with improvement in GP's knowledge and confidence to manage asthma, but did not change GP's self-reported provision of written action plans.
Aged garlic extract reduces blood pressure in hypertensives: a dose–response trial

Hypertension affects about 30% of adults worldwide. Garlic has blood pressure-lowering properties and the mechanism of action is biologically plausible. Our trial assessed the effect, dose–response, tolerability and acceptability of different doses of aged garlic extract as an adjunct treatment to existing antihypertensive medication in patients with uncontrolled hypertension.A total of 79 general practice patients with uncontrolled systolic hypertension participated in a double-blind randomised placebo-controlled dose–response trial of 12 weeks. Participants were allocated to one of three garlic groups with either of one, two or four capsules daily of aged garlic extract (240/480/960 mg containing 0.6/1.2/2.4 mg of S-allylcysteine) or placebo. Blood pressure was assessed at 4, 8 and 12 weeks and compared with baseline using a mixed-model approach. Tolerability was monitored throughout the trial and acceptability was assessed at 12 weeks by questionnaire.Mean systolic blood pressure was significantly reduced by 11.8±5.4 mm Hg in the garlic-2-capsule group over 12 weeks compared with placebo (P=0.006), and reached borderline significant reduction in the garlic-4-capsule group at 8 weeks (−7.4±4.1 mm Hg, P=0.07). Changes in systolic blood pressure in the garlic-1-capsule group and diastolic blood pressure were not significantly different to placebo. Tolerability, compliance and acceptability were high in all garlic groups (93%) and highest in the groups taking one or two capsules daily.Our trial suggests aged garlic extract to be an effective and tolerable treatment in uncontrolled hypertension, and may be considered as a safe adjunct treatment to conventional antihypertensive therapy.
Risk factors and predictive clinical scores for asthma exacerbations in childhood.

Asthma is a major public health problem that affects millions of children worldwide, and exacerbations account for most of its morbidity and costs. Primary-care providers lack efficient tools to identify children at high risk for exacerbations. We aimed to construct a clinical score to help providers to identify such children.



Our main outcome was severe asthma exacerbation, which was defined as any hospitalization, urgent visit, or systemic steroid course for asthma in the previous year, in children. A clinical score, consisting of a checklist questionnaire made up of 17 yes-no questions regarding asthma symptoms, use of medications and health-care services, and history, was built and validated in a cross-sectional study of Costa Rican children with asthma. It was then evaluated using data from the Childhood Asthma Management Program (CAMP), a longitudinal trial cohort of North American children.



Compared with children at average risk for an exacerbation in the Costa Rican validation set, the odds of an exacerbation among children in the low-risk (OR, 0.2; 95% CI, 0.1-0.4) and high-risk (OR, 5.4; 95% CI, 1.5-19.2) score categories were significantly reduced and increased, respectively. In CAMP, the hazard ratios for an exacerbation after 1-year follow-up in the low-risk and high-risk groups were 0.6 (95% CI, 0.5-0.7) and 1.9 (95% CI, 1.4-2.4), respectively, with similar results at 2 years.



The proposed Asthma Exacerbation Clinical Score is simple to use and effective at identifying children at high and low risk for asthma exacerbations. The tool can easily be used in primary-care settings.
High-dose inhaled versus intravenous salbutamol combined with theophylline in severe acute asthma. Swedish Society of Chest Medicine.

In a multicentre parallel group study we studied 176 adult patients (53% men) with severe acute asthma (peak expiratory flow (PEF), 15-50% of predicted values). The effect of two doses of inhaled salbutamol (0.15 mg.kg-1 x 2; 30 min apart) (n = 87) was compared with that of one dose of salbutamol given intravenously (5 micrograms.kg-1) (n = 89). There was a significantly larger increase in peak expiratory flow after the first inhaled dose in the group that received inhalation treatment than in the i.v. treated group (69 vs 41 l.min-1, p less than 0.05), but there was no difference in systemic side-effects between the groups. After the second inhaled dose there was a further increase in PEF, but also in systemic side-effects. These treatments were also compared in a cross-over study on 18 of the patients who returned with a second attack of severe acute asthma. The cross-over evaluation produced similar results, with a significantly larger increase in PEF after the first inhaled dose than after the i.v. treatment. Fifteen of the 18 patients found the inhalations more effective than the i.v. treatment. Theophylline (3-6 mg.kg-1) was infused i.v. 60 min after the start of salbutamol treatment, and a significant increase in PEF was observed in both groups. A correlation between the increase in PEF and the increase in plasma theophylline concentration was only found in the group that had received i.v. salbutamol.(ABSTRACT TRUNCATED AT 250 WORDS)
A comparison of functional and impairment-based robotic training in severe to moderate chronic stroke: a pilot study.

To compare the outcome of training the functional movement of transport of the arm and grasping an object with the alternative of training the transport of the arm in isolation.



Pretest-posttest comparison.



Rehabilitation hospitals, outpatient care.



Volunteer sample of forty-seven persons with persistent hemiparesis from a single, unilateral stroke within the past one to five years.



Robotic therapy 3 x/week for 6 weeks for the paretic upper limb consisted of either a) sensorimotor, active-assistive impairment-based exercise during repetitive planar reaching tasks, or b) a "free-hand" approach, in which the robot assisted subjects employing the sensorimotor active-assistive exercise to transport the hand to a series of targets, where it stopped to allow the person to interact with actual objects (functional approach 1), or c) transport and manipulation, in which the robot assisted subjects employing active-assistive exercise during repetitive planar reaching tasks while grasping a simulated object and releasing it at the target or followed by grasp and release of a simulated object (functional approach 2).



Fugl-Meyer Assessment.



All three groups improved from pre- to post-treatment with the sensorimotor impairment based approach demonstrating the best outcome of the three approaches.



Short-term, goal-directed robotic therapy can significantly improve motor abilities of the exercised limb segments in persons with chronic stroke, but contrary to expectation, training both the transport of the arm and manipulation of an object (functionally-based approaches) did not confer any advantage over training solely transport of the arm (impairment-based approach).
A Phase I pharmacokinetic and biological correlative study of oblimersen sodium (genasense, g3139), an antisense oligonucleotide to the bcl-2 mRNA, and of docetaxel in patients with hormone-refractory prostate cancer.

To assess the feasibility of administering oblimersen sodium, a phosphorothioate antisense oligonucleotide directed to the Bcl-2 mRNA, with docetaxel to patients with hormone-refractory prostate cancer; to characterize the pertinent pharmacokinetic parameters, Bcl-2 protein inhibition in peripheral blood mononuclear cell(s) (PBMC) and tumor; and to seek preliminary evidence of antitumor activity.



Patients were treated with increasing doses of oblimersen sodium administered by continuous i.v. infusion on days 1 to 6 and docetaxel administered i.v. over 1 h on day 6 every 3 weeks. Plasma was sampled to characterize the pharmacokinetic parameters of both oblimersen and docetaxel, and Bcl-2 protein expression was measured from paired collections of PBMCs pretreatment and post-treatment.



Twenty patients received 124 courses of the oblimersen and docetaxel combination at doses ranging from 5 to 7 mg/kg/day oblimersen and 60 to 100 mg/m(2) docetaxel. The rate of severe fatigue accompanied by severe neutropenia was unacceptably high at doses exceeding 7 mg/kg/day oblimersen and 75 mg/m(2) docetaxel. Nausea, vomiting, and fever were common, but rarely severe. Oblimersen mean steady-state concentrations were 3.44 +/- 1.31 and 5.32 +/- 2.34 at the 5- and 7-mg/kg dose levels, respectively. Prostate-specific antigen responses were observed in 7 of 12 taxane-naïve patients, but in taxane-refractory patients no responses were observed. Preliminary evaluation of Bcl-2 expression in diagnostic tumor specimens was not predictive of response to this therapy.



The recommended Phase II doses for oblimersen and docetaxel on this schedule are 7 mg/kg/day continuous i.v. infusion days 1 to 6, and 75 mg/m(2) i.v. day 6, respectively, once every 3 weeks. The absence of severe toxicities at this recommended dose, evidence of Bcl-2 protein inhibition in PBMC and tumor tissue, and encouraging antitumor activity in HPRC patients warrant further clinical evaluation of this combination.
Autistic traits in a population-based ADHD twin sample.

Most diagnostic nomenclatures do not allow for the concurrent diagnosis of autism and attention-deficit/hyperactivity disorder (ADHD). Clinic-based studies suggest autistic symptoms are common in children with ADHD, but such studies are prone to referral bias. This study assesses whether children with ADHD selected from the general twin population have elevated levels of autistic traits.



Nine hundred forty-six twins identified by Missouri birth records were assigned to DSM-IV ADHD diagnoses and seven population-derived ADHD subtypes defined through latent class analysis of DSM-IV ADHD symptoms. The Social Responsiveness Scale (SRS) was used as a quantitative measure of autistic traits. Linear regression was used to evaluate whether mean SRS scores differed between ADHD diagnostic groups.



Mean SRS scores for DSM-IV predominantly inattentive subtype and combined subtype ADHD groups were significantly higher than for subjects without DSM-IV ADHD (p < .001, both comparisons). Five of the population-derived ADHD subtypes (talkative-impulsive, mild and severe inattentive, mild and severe combined) had significantly higher mean SRS scores compared to the latent class subtype with few ADHD symptoms (p < .001, all comparisons). DSM-IV combined subtype and the population-derived severe combined subtype had the highest mean total SRS scores and the highest mean scores for each of the three autism symptom domains, with a substantial proportion of individuals scoring in the clinically significant range.



This study provides population-based evidence for clinically significant elevations of autistic traits in children meeting diagnostic criteria for ADHD. These results have implications for the design and interpretation of studies of both disorders.
Comparison of bioreplaceable interposition arthroplasty with metatarsal head resection of the rheumatoid forefoot.

Interposition arthroplasty with bioreplaceable poly-L/D-lactic acid (PLDLA) implants has been studied in Finland with promising results in reconstruction of the rheumatoid hand. We evaluated this material in a series of patients with rheumatoid forefoot deformities.



Thirty-five patients were randomized to either PLDLA metatarsophalangeal joint interposition arthroplasty group (16 patients) or to conventional metatarsal head resection group (19 patients).



At 3 months after surgery, the function VAS was significantly better in the control group (p = 0.003). The difference disappeared by 12 months. Otherwise, comparison between the two groups did not reveal any statistically significant differences in the AOFAS scores or the pain VAS at 3 or 12 months.



Early results after PLDLA interposition arthroplasty of metatarsophalangeal joints were not as promising as previously reported with rheumatoid metacarpophalangeal reconstruction.
Anabolic steroids in athletics.

puerperium is a time of special danger, as the rapid involution of the uterus may tear apart adhesions which wall-off abscess cavities thus leading to spreading peritonitis. In view of these risks I feel therefore that a small but definite place exists for termination of pregnancy in certain patients with active Crohn's disease. Sterilization is, of course, a different matter, as alternative methods of contraception will often suffice or vasectomy may be performed on the husband.-I am, etc.,
Telephone case management reduces both distress and psychiatric hospitalization.

The aim of the present study was to improve the health care of people repeatedly admitted to private hospitals.



An open trial in which frequent utilizers were offered telephone case management over a 12 month period, was conducted.



An average of 24 phone calls were made to the 99 who remained in the programme for the 12 months. Psychological distress declined significantly over the 12 months, and the number of days in hospital was reduced compared to the previous year. The cost benefit ratio was 1:8.4.



The changes in well-being and hospitalization over the 12 months were substantial and are unlikely to be due to regression to the mean. A prospective randomized controlled trial comparing telephone case management with treatment as usual is indicated.
Self-Esteem and Its Relationship to Mental Health and Quality of Life in Adults with Cystic Fibrosis

Research from the general population indicates an important role for self-esteem in mental health, but limited research in this area exists in the cystic fibrosis (CF) literature. This study aimed to explore the predictive value of self-esteem and health-related quality of life (HRQoL) in mental health symptoms in adults with CF. Seventy-four participants, recruited online, completed the Clinical Outcomes in Routine Evaluation-Outcome Measure 34 (CORE-OM), Rosenberg Self-esteem Scale and Cystic Fibrosis Questionnaire-Revised (CFQ-R). Comparably high levels of self-esteem were found, but HRQoL was lower than previous research. Thirty percent of participants scored within the clinical range for mental health difficulty. Hierarchical regression, controlling for gender, explored the value of four CFQ-R subscales (physical, social, emotional and role functioning) and self-esteem in predicting CORE-OM total score. Gender accounted for 8.2 % of the variance in mental health scores while the five independent variables accounted for a further 73.0 % of variance. Of the five variables, CFQ-R emotional functioning and self-esteem were significant predictors of mental health symptoms. Results are discussed in relation to clinical implications and potential uses for internet technologies to promote socialisation.
A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes.

This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D).



Twenty MDI-treated individuals with T2D with HbA(1c) ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed.



Nineteen participants transitioned to PaQ treatment and demonstrated competency in assembling, placing, and using the device. Self-monitored blood glucose and blinded continuous glucose-monitoring data showed glycemic control similar to MDI. Study participants reported high satisfaction and device acceptance.



PaQ treatment is both feasible and acceptable in individuals with T2D. Transition from MDI is easy and safe. PaQ treatment might lead to better therapy adherence and improvements in glycemic control and clinical outcomes.