nils-herrmann/clean_scirepeval huggingface dataset:
Course length of 30 metres versus 10 metres has a significant influence on six-minute walk distance in patients with COPD: an experimental crossover study.

Do patients with chronic obstructive pulmonary disease (COPD) achieve a different distance on the six minute walk test (6MWT) conducted on a 10m course versus on a 30m course? When assessing the distance on a 6MWT conducted on a 10m course, is it valid to use existing reference equations that were generated on longer courses?



A randomised double-crossover experimental study.



Forty-five patients with COPD in primary physiotherapy care.



All patients performed a 6MWT twice over a 10m course and twice over a 30m course. The 6MWTs were performed in accordance with the American Thoracic Society guidelines.



6MWD was assessed and predicted distance was calculated based on a range of reference equations.



The 6MWD on the 10m course was 49.5m shorter than on the 30m course, which was statistically significant (95% CI 39.4 to 59.6). By using existing reference equations for a 6MWT conducted on the 10m course, the predicted distance is highly overestimated (with a range of 30% to 33%) and the average distance as a percentage of the predicted value is 8%pred lower compared to a 6MWT conducted on the 30m course, resulting in a worse representation of a COPD patient's functional exercise capacity.



This study shows that the impact of course length on the 6MWD and on the use of reference equations in patients with COPD is substantial and clinically relevant (based on the most conservative published minimum clinically important difference). Therefore, existing reference equations established for a 6MWT conducted over a 30m (or longer) course cannot be applied to predict the distance achieved on the 6MWT on a 10m course, which is frequently used in primary care physiotherapy practices for patients with COPD.
Nortriptyline plus nicotine replacement versus placebo plus nicotine replacement for smoking cessation: pragmatic randomised controlled trial.

To test the efficacy of nortriptyline plus nicotine replacement therapy compared with placebo plus nicotine replacement therapy for smoking cessation.



Pragmatic randomised controlled trial.



National Health Service stop smoking service clinics.



901 people trying to stop smoking.



Participants chose their nicotine replacement product, including combinations of nicotine replacement therapy, and received behavioural support. Nortriptyline was started one to two weeks before quit day, with the dose increased from 25 mg to 75 mg daily for eight weeks and reduced if not tolerated.



Primary outcome was prolonged confirmed abstinence at six months. Secondary outcomes were prolonged abstinence at 12 months, drug use, severity of side effects, nicotine withdrawal symptoms, and urges to smoke.



72 of 445 (16%) people using nortriptyline and 55 of 456 (12%) using placebo achieved prolonged abstinence at six months (relative risk 1.34, 95% confidence interval 0.97 to 1.86). At 12 months the corresponding values were 49 (11%) for nortriptyline and 40 (9%) for placebo (1.26, 0.84 to 1.87). 337 (79%) people in the nortriptyline arm and 325 (75%) in the placebo arm were taking combination treatment on quit day, median 75 mg per day in both groups. More people in the nortriptyline arm than in the placebo arm took lower doses. The nortriptyline arm had noticeably higher severity ratings for dry mouth and constipation than the placebo arm, with slightly higher ratings for sweating and feeling shaky. Both groups had similar urges to smoke, but nortriptyline reduced depression and anxiety. Overall, withdrawal symptom scores did not differ.



Nortriptyline and nicotine replacement therapy are both effective for smoking cessation but the effect of the combination is less than either alone and evidence is lacking that combination treatment is more effective than either alone.
Cost-Effectiveness Analysis of Lamivudine for the Treatment of Chronic Hepatitis B

To estimate the short term and long term cost effectiveness, from a healthcare perspective, associatedwith the introduction of lamivudine for chronic hepatitis B. The analysis used a 2-step modelling approach. A decision tree was used to estimate clinical outcomes and costs after 1 year. The 1-year results were then extrapolated to 70 years using a Markov model.  The study population comprised hypothetical cohorts of patients with chronic hepatitis B, representative of those likely to receive treatment in clinical practice in Australia. Main outcome measures and results: In the short term, more patients seroconvertedwhen lamivudinewas available, with an incremental cost-effectiveness ratio of 3341 Australian dollars ($A) per additional seroconversion. In the long term, the introduction of lamivudine increased life expectancy by 3.9 years [3.2 quality-adjusted life-years (QALYs)] compared with when interferon-α was the only treatment, or 4.6 years (3.8 QALYs) comparedwith no treatment. There were reductions in lifetime risk of developing compensated cirrhosis, decompensated cirrhosis and hepatocellular carcinoma of 5, 11 and 11%, respectively, when lamivudine was available. The incremental cost of having lamivudine available, as opposed to interferon-α only, was $A633 per year of life saved or $A735 per QALY.  The introduction of lamivudine is expected to reduce and delay the progression of chronic hepatitis B, increasing the life expectancy and quality of life of patients for a small overall increase in healthcare costs.
Effect of Different Antipsychotic Drugs on Short-Term Mortality in Stroke Patients

The safety, tolerability, and efficacy data for antipsychotic drugs used in the acute phase of stroke are limited. The primary aim of this study was to examine the effectiveness and safety of typical and atypical antipsychotics on acute ischemic stroke mortality.This observational study was conducted in a retrospective cohort of patients selected from the 2010-2011 National Health Research Institute database in Taiwan. Patients were tracked for 1 month from the time of their first hospitalization for acute ischemic stroke. A nested case-control analysis was used to estimate the odds ratio (OR) of 30-day mortality associated with antipsychotic drug, adjusted for age, gender, disease severity, and comorbidities.The study cohort included 47,225 subjects with ischemic stroke, including 9445 mortality cases and 37,780 matched controls. After adjustment for the covariates, antipsychotics users before ischemic stroke are associated with a 73% decrease in the rate of mortality (OR 0.27; 95% CI 0.23-0.31). After ischemic stroke, the use of antipsychotics is associated with 87% decrease in the rate of mortality (OR 0.13; 95% CI 0.1-0.16). The users of conventional antipsychotics are associated with a 78% decrease in the rate of mortality (OR 0.22; 95% CI 0.18-0.26). The users of atypical antipsychotics are also associated with a 86% decrease in the rate of mortality (OR 0.14; 95% CI 0.12-0.17).We found that 1-month mortality among acute stroke patients treated with antipsychotics is significantly lower. The benefit on lower mortality was found not only among ischemic stroke patients who had received antipsychotics previously but also among patients who start antipsychotics after their stroke.
Safety of the Malaria Vaccine Candidate, RTS,S/AS01E in 5 to 17 Month Old Kenyan and Tanzanian Children

The malaria vaccine candidate, RTS,S/AS01(E), showed promising protective efficacy in a trial of Kenyan and Tanzanian children aged 5 to 17 months. Here we report on the vaccine's safety and tolerability. The experimental design was a Phase 2b, two-centre, double-blind (observer- and participant-blind), randomised (1∶1 ratio) controlled trial. Three doses of study or control (rabies) vaccines were administered intramuscularly at 1 month intervals. Solicited adverse events (AEs) were collected for 7 days after each vaccination. There was surveillance and reporting for unsolicited adverse events for 30 days after each vaccination. Serious adverse events (SAEs) were recorded throughout the study period which lasted for 14 months after dose 1 in Korogwe, Tanzania and an average of 18 months post-dose 1 in Kilifi, Kenya. Blood samples for safety monitoring of haematological, renal and hepatic functions were taken at baseline, 3, 10 and 14 months after dose 1. A total of 894 children received RTS,S/AS01(E) or rabies vaccine between March and August 2007. Overall, children vaccinated with RTS,S/AS01(E) had fewer SAEs (51/447) than children in the control group (88/447). One SAE episode in a RTS,S/AS01(E) recipient and nine episodes among eight rabies vaccine recipients met the criteria for severe malaria. Unsolicited AEs were reported in 78% of subjects in the RTS,S/AS01(E) group and 74% of subjects in the rabies vaccine group. In both vaccine groups, gastroenteritis and pneumonia were the most frequently reported unsolicited AE. Fever was the most frequently observed solicited AE and was recorded after 11% of RTS,S/AS01(E) doses compared to 31% of doses of rabies vaccine. The candidate vaccine RTS,S/AS01(E) showed an acceptable safety profile in children living in a malaria-endemic area in East Africa. More data on the safety of RTS,S/AS01(E) will become available from the Phase 3 programme.
Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial.

Insulin initiation in patients with type 2 diabetes is often delayed because of concerns about injections. Our objective was to compare the effects of AIR inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) with those of injectable insulin on glycemic control and safety.



This was planned as a 24-month, open-label, randomized study in adults with diabetes inadequately controlled by one or more oral antihyperglycemic medications (OAMs). Following a 2-week baseline period, patients continued OAMs and were randomized to AIR insulin (n = 208) or insulin lispro (n = 203) before meals. The primary end point was hemoglobin A1C (A1C) change from baseline to 6 months. Noninferiority was established if the upper limit of the 95% confidence interval of the difference in A1C change was < or =0.4%.



Early termination of the study diminished the number of patients for the 12- and 24-month analyses, but not for the primary 6-month end point analyses. AIR insulin and injectable insulin groups had comparable baseline A1C values (8.18% vs. 8.21%, respectively). Change in A1C from baseline to 6-month end point was similar (least squares mean, -0.81 +/- 0.09% and -0.87 +/- 0.09%; 95% confidence interval for the difference -0.117, 0.234; P = 0.51) and so were final A1C values of 7.36% and 7.31% for AIR insulin and injectable insulin, respectively. At 6 months, no differences were observed in eight-point profiles, overall and nocturnal hypoglycemia, and weight gain. Greater decreases in spirometry were observed in the AIR insulin group at 12 months. Cough was the most frequently reported adverse event (20% [AIR insulin] vs. 10% [insulin lispro]; P = 0.002).



Treatment with AIR insulin resulted in similar improvement in glycemic control compared with insulin lispro. More frequent cough and greater decrease in spirometry were observed with AIR insulin.
Tolerability to high doses of formoterol and terbutaline via Turbuhaler for 3 days in stable asthmatic patients.

This randomized, double-blind, crossover study in two parts compared tolerability to high doses of formoterol (Oxis Turbuhaler) with that of high doses of terbutaline (Bricanyl Turbuhaler). After Holter monitoring at home, 12 patients were treated with 4+4+4 doses of formoterol Turbuhaler, 6 microg x dose(-1), (total daily metered dose 72 microg) or 4+4+4 doses of terbutaline Turbuhaler, 0.5 mg x dose(-1) (daily dose 6 mg) given in the morning, after lunch and in the evening, for 3 consecutive days. After a one week washout period at home, patients received the alternative treatment. Thereafter, 15 other patients received 8+6+6 doses of formoterol Turbuhaler (total daily metered dose 120 microg) or 8+6+6 doses of terbutaline Turbuhaler (daily dose 10 mg). Pulse, cardiac frequency, blood pressure, serum potassium, electrocardiogram and forced expiratory volume in one second (FEV1) were registered at regular intervals and Holter monitoring was applied during all 4 treatment days. Terbutaline 6 mg showed significantly greater systemic effects than formoterol 72 microg on pulse, blood pressure, cardiac frequency and QTc (QT interval corrected for heart rate). Terbutaline 10 mg had significantly greater effects than formoterol 120 microg on serum potassium levels, pulse, cardiac frequency and QTc. No differences in FEV1 levels were found. Both drugs were safe and generally well tolerated on both dose levels. In conclusion, high doses of formoterol Turbuhaler over 3 days were generally safe and well tolerated. Daily doses of 6 mg and 10 mg terbutaline Turbuhaler were systemically more potent than 72 microg and 120 microg formoterol, respectively. The safety margin thus appears to be wide if patients happen to use extra doses of formoterol in addition to those prescribed for regular use.
Psychological maladjustment and quality of life in adolescents with constipation.

To assess psychological maladjustment in adolescents with functional constipation.



We conducted a cross-sectional survey in five schools. Adolescents aged between 13 and 18 years were included in the study. Validated questionnaires were used to collect bowel habits and demographic data, health-related quality of life (HRQoL) and psychological maladjustment. Rome III criteria were used to diagnose constipation.



1697 adolescents were recruited (boys 779 (45.9%), mean age 15.06 years and SD 1.6 years). Prevalence of constipation was 6.7%, of whom 52 were boys (45.6%) and 62 were girls (54.4%). 38 adolescents (33.3%) with constipation and 230 controls (14.5%) had significant psychological maladjustment. Among seven different personality dimensions used to assess psychological maladjustment, children with constipation had significantly more deficits than controls in hostility and aggression (14.2 vs 12.6 in controls (mean difference 1.54, 95% CI (0.89 to 2.19) p<0.001), negative self-esteem (12.0 vs 10.5 in controls, mean difference 1.54 95% CI (0.96 to 2.06) p<0.001), negative self-adequacy (11.9 vs 9.8 controls, mean difference 2.07 95% CI (1.46 to 2.67) p<0.001), emotional unresponsiveness (12.9 vs 11.5 controls, mean difference 1.44 95% CI (0.84 to 2.04) p<0.001), emotional instability (17.1 vs 15.6, mean difference 1.53 95% CI (0.86 to 2.2) p<0.001) and negative world view (12.1 vs 10.2 controls, mean difference 1.91 95% CI (1.24 to 2.59) p<0.001). The total HRQoL of adolescents with constipation was lower than controls (70.6 vs 79.0 mean difference 9.48 95% CI (1.4 to 6.7) p<0.05).



A significant proportion of children with constipation are suffering from psychological maladjustment.
Endoscopic submucosal dissection for cancers of the remnant stomach after distal gastrectomy.

Endoscopic submucosal dissection (ESD) of early gastric cancer is less invasive than surgical resection, and if technically feasible, it may result in less long-term morbidity than does incisional surgery. However, ESD is technically difficult in patients who have had a previous distal gastrectomy.



Our purpose was to retrospectively assess the results of ESD of early gastric cancer in the remnant stomach.



Case series.



A total of 31 lesions in 30 patients with early remnant gastric cancer were treated with ESD at Okayama University Hospital, Tsuyama Central Hospital, Hiroshima City Hospital, Kagawa Prefectural Central Hospital, and Mitoyo General Hospital from March 2001 to January 2007.



ESD.



En bloc resection rate, complete resection rate, operation time, and complications.



En bloc resection and complete resection were achieved in 30 (97%) and in 23 (74%) lesions, respectively. The median operation time required for ESD in the remnant stomach was 113 minutes (range 45-450 minutes). Perforation occurred in 4 (13%). The incidence of delayed bleeding requiring blood transfusion was 0%.



Short duration of follow-up.



ESD is feasible in the remnant stomach but has a relatively high complication rate and should only be performed by experienced endoscopists.
Simulation of merge junctions in a dynamically entrained automated guideway transit system

Merge junctions and intersections are the principal capacity limiters and sources of delay in automated guideway transit (AGT) networks. The capacity and delay performance of the merge junctions must be thoroughly understood before an AGT network can be designed. This paper describes the modeling and event-structured Monte Carlo simulation of a single merge junction, having two input lanes and one output lane, operating in a quasi-synchronous network. The simulation described here differs from previous merging models by permitting slots to be of variable length to accommodate trains of different lengths, and allowing unlimited maneuvering of trains (if needed). It has the unique ability to represent the operation of a special, newly devised concatenating merge, which permits trains arriving on separate input lanes to combine themselves into a longer train at the merge.
 The simulation logic which is used to represent special features of merge performance (flow compressibility, upstream propagation of disturbances, etc.) is explained, and the implementation using GASP IIA is described. The statistical considerations underlying the experimental design are discussed and some sample diagnostic outputs displayed.
Cognitive function in hypertensives treated with atenolol or propranolol

To test reports that beta blockers, particularly lipopbilic forms, impair cognitive function and cause psychiatric disturbances. Randomized, double-blind, controlled crossover trial with eight-week treatment periods. Sequential sample of 43 male veterans, with untreated diastolic blood pressures (DBP) between 90 and 110 mmHg, aged 35–64 years. Propranolol-LA, 80-mg tablets, or atenolol, 50-mg tablets, were given daily, incremented by one tablet at weekly intervals until DBP ≤90 mmHg. Hydrochlorothiazide was added, if necessary. Repeated-measures ANOVA was performed on all cognitive tests. Cognitive test performance was not affected by beta blocker therapy in seven of nine tests and was enhanced on Trail Making Test. Performance was impaired only on Digit Cancellation. Neither Speilberger’s State Trait Anxiety Inventory nor the Beck Depression Inventory was affected by either beta blocker. Atenolol or propranolol therapy does not impair cognitive function or contribute significantly to psychiatric side effects.
Prednisone lowers serum uric acid levels in patients with decompensated heart failure by increasing renal uric acid clearance.

Clinical studies have shown that large doses of prednisone could lower serum uric acid (SUA) in patients with decompensated heart failure (HF); however, the optimal dose of prednisone and underlying mechanisms are unknown. Thirty-eight patients with decompensated HF were randomized to receive standard HF care alone (n = 10) or with low-dose (15 mg/day, n = 8), medium-dose (30 mg/day, n = 10), or high-dose prednisone (60 mg/day, n = 10), for 10 days. At the end of the study, only high-dose prednisone significantly reduced SUA, whereas low- and medium-dose prednisone and standard HF care had no effect on SUA. The reduction in SUA in high-dose prednisone groups was associated with a significant increase in renal uric acid clearance. In conclusion, prednisone can reduce SUA levels by increasing renal uric acid clearance in patients with decompensated HF.
Hypotensive resuscitation strategy reduces transfusion requirements and severe postoperative coagulopathy in trauma patients with hemorrhagic shock: preliminary results of a randomized controlled trial.

Trauma is a leading cause of death worldwide and is thus a major public health concern. Previous studies have shown that limiting the amount of fluids given by following a strategy of permissive hypotension during the initial resuscitation period may improve trauma outcomes. This study examines the clinical outcomes from the first 90 patients enrolled in a prospective, randomized controlled trial of hypotensive resuscitation, with the primary aim of assessing the effects of a limited transfusion and intravenous (IV) fluid strategy on 30-day morbidity and mortality.



Patients in hemorrhagic shock who required emergent surgery were randomized to one of the two arms of the study for intraoperative resuscitation. Those in the experimental (low mean arterial pressure [LMAP]) arm were managed with a hypotensive resuscitation strategy in which the target mean arterial pressure (MAP) was 50 mm Hg. Those in the control (high MAP [HMAP]) arm were managed with standard fluid resuscitation to a target MAP of 65 mm Hg. Patients were followed up for 30 days. Intraoperative fluid requirements, mortality, postoperative complications, and other clinical data were prospectively gathered and analyzed.



Patients in the LMAP group received a significantly less blood products and total i.v. fluids during intraoperative resuscitation than those in the HMAP group. They had significantly lower mortality in the early postoperative period and a nonsignificant trend for lower mortality at 30 days. Patients in the LMAP group were significantly less likely to develop immediate postoperative coagulopathy and less likely to die from postoperatively bleeding associated with coagulopathy. Among those who developed coagulopathy in both groups, patients in the LMAP group had significantly lower international normalized ratio than those in the HMAP group, indicating a less severe coagulopathy.



Hypotensive resuscitation is a safe strategy for use in the trauma population and results in a significant reduction in blood product transfusions and overall IV fluid administration. Specifically, resuscitating patients with the intent of maintaining a target minimum MAP of 50 mm Hg, rather than 65 mm Hg, significantly decreases postoperative coagulopathy and lowers the risk of early postoperative death and coagulopathy. These preliminary results provide convincing evidence that support the continued investigation and use of hypotensive resuscitation in the trauma setting.
Population pharmacokinetics of hydroxyurea in cancer patients

The pharmacokinetics of hydroxyurea (HU) were investigated in cancer patients after intravenous infusion or oral administration. On the basis of the minimal value of the objective function (MVOF) and prior knowledge of the disposition of HU in animals and man, the data were best described by a one-compartment pharmacokinetic model with parallel Michaelis-Menten metabolism and first-order renal excretion. The computer program NONMEM (nonlinear mixed effects model) was used to perform the nonlinear regression and provide estimates of the population parameters. For the combined intravenous and oral data set, these parameters were estimated to be: maximal elimination rate (V max), 0.097 mmolh−1 l−1; Michaelis constant for HU elimination (K M), 0.323 mmol/1; renal clearance (Cl R), 90.8 ml/min; volume of distribution (V d), 0.186× (body weight) + 25.41; absorption rate constant (K a), 2.92 h−1; and availability to the systemic circulation (F), 0.792. The principal findings of the investigation are that HU undergoes nonlinear elimination in cancer patients and that HU is reasonably well absorbed following oral administration.