nils-herrmann/clean_scirepeval huggingface dataset:
Changes in Body Fat Distribution and Fitness Are Associated With Changes in Hemoglobin A1c After 9 Months of Exercise Training

To investigate the associations between changes in body composition and fitness after exercise training and changes in hemoglobin A1c (HbA1c) in individuals with type 2 diabetes.



Participants (n = 201) were randomized to aerobic, resistance, or combined training for 9 months. HbA1c, waist circumference, total and trunk fat mass, appendicular fat mass, lean body mass, isokinetic leg muscle strength, peak O2 uptake, and estimated METs were assessed at baseline and follow-up. Change in HbA1c was evaluated across quartiles of change in body composition and fitness.



Change in HbA1c was associated with changes in body weight (r = 0.13, P = 0.052), waist circumference (r = 0.17, P = 0.013), trunk fat mass (r = 0.19, P = 0.005), and estimated METs (r = -0.16, P = 0.023). There was a trend in change in HbA1c across quartiles of waist circumference (P = 0.011), trunk fat mass (P = 0.020), and estimated METs (P = 0.011). Participants with increased estimated METs and reduced trunk fat mass had greater odds of having reduced HbA1c after training (3.48, 1.46-8.31). Finally, participants with increased estimated METs and reduced waist circumference were 2.81 (1.13-6.98) times more likely to have reduced HbA1c and type 2 diabetes medication use than those without improved fitness and central adiposity.



In patients with type 2 diabetes, a reduction in central adiposity and increase in fitness were the most prominent predictors of the change in HbA1c in response to exercise training.
Two years of continued early treatment for recent-onset schizophrenia: a randomised controlled study.

This random-controlled study evaluated benefits derived from continued integrated biomedical and psychosocial treatment for recent-onset schizophrenia.



Fifty cases of schizophrenia of less than 2 years duration were allocated randomly to integrated or standard treatment (ST) for 2 years. ST comprised optimal pharmacotherapy and case management, while IT also included cognitive-behavioural family treatment, that incorporated skills training, cognitive-behavioural strategies for residual psychotic and non-psychotic problems and home-based crisis management. Psychopathology, functioning, hospitalisation and suicidal behaviours were assessed two monthly and a composite index, reflecting overall clinical outcome was derived.



IC proved superior to ST in reducing negative symptoms, minor psychotic episodes and in stabilising positive symptoms, but did not reduce hospital admissions or major psychotic recurrences. The composite index showed that significantly more IC patients (53%) had excellent 2-year outcomes than ST (25%).



Evidence-based treatment achieves greater clinical benefits than pharmacotherapy and case management alone for recent-onset schizophrenia.
Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial

Pain is frequent and distressing in people with dementia, but no randomized controlled trials have evaluated the effect of analgesic treatment on pain intensity as a key outcome.



Three hundred fifty-two people with dementia and significant agitation from 60 nursing home units were included in this study. These units, representing 18 nursing homes in western Norway, were randomized to a stepwise protocol of treating pain (SPTP) or usual care. The SPTP group received acetaminophen, morphine, buprenorphine transdermal patch and pregabalin for 8 weeks, with a 4-week washout period. Medications were governed by the SPTP and each participant's existing prescriptions. We obtained pain intensity scores from 327 patients (intervention n = 164, control n = 163) at five time points assessed by the primary outcome measure, Mobilization-Observation-Behaviour-Intensity-Dementia-2 (MOBID-2) Pain Scale. The secondary outcome was activities of daily living (ADL). We used a linear intercept mixed model in a two-way repeated measures configuration to assess change over time and between groups.



The SPTP conferred significant benefit in MOBID-2 scores compared with the control group [average treatment effect (ATE) -1.388; p < 0.001] at week 8, and MOBID-2 scores worsened during the washout period (ATE = -0.701; p = 0.022). Examining different analgesic treatments, benefit was conferred to patients receiving acetaminophen compared with the controls at week 2 (ATE = -0.663; p = 0.010), continuing to increase until week 8 (ATE = -1.297; p < 0.001). Although there were no overall improvements in ADL, an increase was seen in the group receiving acetaminophen (ATE = +1.0; p = 0.022).



Pain medication significantly improved pain in the intervention group, with indications that acetaminophen also improved ADL function.
The Willowbrook futures project: a longitudinal analysis of person-centered planning.

We conducted a longitudinal comparative evaluation of person-centered planning processes and outcomes for 20 individuals with intellectual disabilities and problem behavior (former residents of Willowbrook) and a matched contrast group, who received traditional interdisciplinary service planning (ISP). At the inception of the study, all participants were living in one of four other developmental centers (institutions) in New York City. Process and outcome data obtained from questionnaires completed by team members approximately every 8 months at four time periods showed that the rate of improvement in both person-centered planning process and outcomes for the intervention group was significantly greater than that of the comparison group. Eighteen of 19 person-centered planning participants moved to community living arrangements, as did 5 of 18 in the contrast group.
Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS).

Large randomized trials have shown that beta-blockers reduce mortality and hospital admissions in patients with heart failure. The effects of beta-blockers in elderly patients with a broad range of left ventricular ejection fraction are uncertain. The SENIORS study was performed to assess effects of the beta-blocker, nebivolol, in patients >/=70 years, regardless of ejection fraction.



We randomly assigned 2128 patients aged >/=70 years with a history of heart failure (hospital admission for heart failure within the previous year or known ejection fraction </=35%), 1067 to nebivolol (titrated from 1.25 mg once daily to 10 mg once daily), and 1061 to placebo. The primary outcome was a composite of all cause mortality or cardiovascular hospital admission (time to first event). Analysis was by intention to treat. Mean duration of follow-up was 21 months. Mean age was 76 years (SD 4.7), 37% were female, mean ejection fraction was 36% (with 35% having ejection fraction >35%), and 68% had a prior history of coronary heart disease. The mean maintenance dose of nebivolol was 7.7 mg and of placebo 8.5 mg. The primary outcome occurred in 332 patients (31.1%) on nebivolol compared with 375 (35.3%) on placebo [hazard ratio (HR) 0.86, 95% CI 0.74-0.99; P=0.039]. There was no significant influence of age, gender, or ejection fraction on the effect of nebivolol on the primary outcome. Death (all causes) occurred in 169 (15.8%) on nebivolol and 192 (18.1%) on placebo (HR 0.88, 95% CI 0.71-1.08; P=0.21).



Nebivolol, a beta-blocker with vasodilating properties, is an effective and well-tolerated treatment for heart failure in the elderly.
Parent and Emergency Physician Comfort with a System of On-Line Emergency-Focused Medical Summaries for Infants with Significant Cardiac Disease

Surveys were developed and administered to assess parental comfort with emergency care for children with special health care needs (CSHCN) with cardiac disease and the impact of a web-based database of emergency-focused clinical summaries (emergency information forms-EIF) called Midwest Emergency Medical Services for Children Information System (MEMSCIS) on parental attitudes regarding emergency care of their CSHCN. We hypothesized that MEMSCIS would improve the parent and provider outlook regarding emergencies of young children with heart disease in a randomized controlled trial. Children under age 2 were enrolled in MEMSCIS by study nurses associated with pediatric cardiac centers in a metropolitan area. Parents were surveyed at enrollment and 1 year on a 5-Point Likert Scale. Validity and reliability of the survey were evaluated. Study nurses formulated the emergency-focused summaries with cardiologists. One-hundred-seventy parent subjects, 94 study and 76 control, were surveyed at baseline and 1 year. Parents felt that hospital personnel were well-prepared for emergencies of their children and this improved from baseline 4.07 ± 1.03 to 1 year 4.24 ± 1.04 in study parents who had an EIF for their child and participated in the program (p = 0.0114) but not control parents. Parents perceived an improved comfort level by pre-hospital (p = 0.0256) and hospital (p = 0.0031) emergency personnel related to the MEMSCIS program. The MEMSCIS Program with its emergency-focused web-based clinical summary improved comfort levels for study parents. We speculate that the program facilitated normalization for parents even if the EIF was not used in an emergency during the study. The MEMSCIS program helps to prepare the family and the emergency system for care of CSHCN outside of the medical home.
Phase III evaluation of octreotide versus chemotherapy with 5-fluorouracil or 5-fluorouracil plus leucovorin in advanced exocrine pancreatic cancer: a North Central Cancer Treatment Group study.

There continues to be a need for new systemic approaches for the treatment of advanced pancreatic cancer. The purpose of this study was to compare the antitumor activity of the somatostatin analogue octreotide to 5-fluorouracil chemotherapy in a Phase III setting. Eighty-four patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 and limited tumor volume were randomized to receive octreotide 200 microg three times daily or 5-fluorouracil with or without leucovorin. After the first 12 patients had been randomized to octreotide, we increased the dose in the remaining patients to 500 microg three times daily. This change was based on early reports in other studies, suggesting that our original dose may not have been effective and that higher doses of octreotide were well tolerated. A planned interim analysis performed after 84 patients were enrolled demonstrated inferior time to progression and survival for the patients randomized to octreotide. Further accrual to the octreotide arm of this protocol was therefore terminated. Octreotide in doses of 200-500 microg three times daily does not delay progression or extend survival in patients with advanced pancreatic cancer compared with treatment with 5-fluorouracil with or without leucovorin.
Hydrolyzed casein and whey protein meals comparably stimulate net whole-body protein synthesis in COPD patients with nutritional depletion without an additional effect of leucine co-ingestion.

Muscle wasting commonly occurs in COPD, negatively affecting outcome. The aim was to examine the net whole-body protein synthesis response to two milk protein meals with comparable absorption rates (hydrolyzed casein (hCAS) vs. hydrolyzed whey (hWHEY)) and the effects of co-ingesting leucine.



Twelve COPD patients (GOLD stage II-IV) with nutritional depletion, were studied following intake of a 15 g hCAS or hWHEY protein meal with or without leucine-co-ingestion, according to a double-blind randomized cross-over design. The isotopic tracers L-[ring-(2)H5]-Phenylalanine, L-[ring-(2)H2]-Tyrosine, L-[(2)H3]-3-Methylhistidine (given via continuous intravenous infusion), and L-[(15)N]-Phenylalanine (added to the protein meals) were used to measure endogenous whole-body protein breakdown (WbPB), whole-body protein synthesis (WbPS), net protein synthesis (NetPS), splanchnic extraction and myofibrillar protein breakdown (MPB). Analyses were done in arterialized-venous plasma by LC/MS/MS.



WbPS was greater after intake of the hCAS protein meal (P < 0.05) whereas the hWHEY protein meal reduced WbPB more (P < 0.01). NetPS was stimulated comparably, with a protein conversion rate greater than 70%. Addition of leucine did not modify the insulin, WbPB, WbPS or MPB response.



Hydrolyzed casein and whey protein meals comparably and efficiently stimulate whole-body protein anabolism in COPD patients with nutritional depletion without an additional effect of leucine co-ingestion.
Ambulatory oesophageal pH monitoring: a comparison between antimony, ISFET, and glass pH electrodes.

Ambulatory oesophageal pH-impedance monitoring is a widely used test to evaluate patients with reflux symptoms. Several types of pH electrodes are available: antimony, ion sensitive field effect transistor (ISFET), and glass electrodes. These pH electrodes have not been compared directly, and it is uncertain whether these different types of pH electrodes result in similar outcome.



In an in-vitro model the response time, sensitivity, and drift of an antimony, ISFET, and glass pH electrode were assessed simultaneously after calibration at 22 degrees C and at 37 degrees C. All measurements were performed at 37 degrees C and repeated five times with new catheters of each type. Fifteen patients with reflux symptoms underwent 24-h pH monitoring off PPI therapy using antimony, ISFET, and glass pH electrodes simultaneously.



After calibration at 22 degrees C, pH electrodes had similar response times, sensitivity and drift. In contrast to glass electrodes, antimony electrodes performed less accurately after calibration at 37 degrees C than after calibration at 22 degrees C. Calibration temperature did not affect ISFET electrodes significantly. During in-vivo experiments, significant differences were found in acid exposure times derived from antimony (4.0+/-0.8%), ISFET (5.7+/-1.1%), and glass pH electrodes (9.0+/-1.7%).



In vitro, antimony and glass pH electrodes are affected by different buffer components and temperature, respectively. In vivo, significant higher acid exposure times are obtained with glass electrodes compared with antimony and ISFET pH electrodes. ISFET electrodes produce stable in-vitro measurements and result in the most accurate in-vivo measurements of acid exposure time.
Clinical course of recent-onset atrial fibrillation treated with oral propafenone.

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias in the adult population. Propafenone is a class 1c antiarrhythmic agent that has an electrophysiologic profile suggesting that it might be potentially effective in recent-onset AF. The present study was undertaken, therefore, to examine the time course as well as the frequency of successful conversion in patients with recent-onset AF treated with propafenone administered orally. Fifty patients with recent-onset AF were recruited into 2 groups: 25 patients were given propafenone, 150 mg every 4 h, and 25 patients served as a control group and received verapamil (a drug known to slow the ventricular response but not to restore sinus rhythm) 40 mg, every 4 h and up to 48 h or until conversion to sinus rhythm occurred. Of the 50 patients, 2 refused to continue the study and another 2 were excluded because of left heart failure. Conversion to sinus rhythm occurred in 21 of 24 patients (87 percent) in the propafenone group as compared with 9 of 22 (41 percent) in the verapamil group (p < 0.001). In 10 patients in the propafenone group, conversion occurred within 12 h, within 24 h in another 9 patients, and between 24 and 48 h in the remaining 2 patients. There was no correlation between the duration of AF prior to entry into the study and the subsequent incidence of and time to conversion with propafenone. With respect to cause of AF, all groups showed a high incidence of conversion. Two patients developed heart failure during treatment and one patient (in the verapamil group) developed embolic stroke while still having atrial fibrillation. We conclude that in patients with AF, the prognosis for conversion to sinus rhythm within 48 h, with propafenone, is excellent (87 percent) and safe.
Effect on cerebral vasospasm of coil embolization followed by microcatheter intrathecal urokinase infusion into the cisterna magna: a prospective randomized study.

Vasospasm remains the leading cause of death and permanent neurological disability in patients with aneurysmal subarachnoid hemorrhage (SAH). The objective of our prospective randomized trial of coil embolization followed by intrathecal urokinase infusion into the cisterna magna (ITUKI therapy) was to test its effectiveness in preventing or alleviating the severity of ischemic neurological deficits caused by vasospasm.



We enrolled 110 patients with ruptured intracranial aneurysms eligible for coil embolization and randomly assigned them to embolization with (n=57) or without (n=53) ITUKI therapy performed within 24 hours of aneurysmal SAH. The incidence of symptomatic vasospasms and the clinical outcomes, based on the Glasgow Outcome Scale, 6 months after SAH onset were assessed.



There were no side effects or adverse reactions attributable to ITUKI therapy. Symptomatic vasospasm occurred in 5 patients (8.8%) with and 16 (30.2%) without ITUKI therapy; the difference was significant (P=0.012). Although the mortality rate did not differ between the groups, patients with ITUKI therapy had significantly better outcomes than those without (P=0.036).



Our results demonstrate that ITUKI therapy significantly reduced the occurrence of symptomatic vasospasm. Although it did not completely prevent vasospasms, ITUKI therapy resulted in a lower rate of permanent neurological deficits.
Intravascular ultrasound guidance improves angiographic and clinical outcome of stent implantation for long coronary artery stenoses: final results of a randomized comparison with angiographic guidance (TULIP Study).

Long coronary lesions treated with stents have a poor outcome. This study compared the 6-month outcome of stent implantation for long lesions in patients randomized to intravascular ultrasound (IVUS; n=73) or angiographic guidance (n=71).



Stenoses >20 mm in length and a reference diameter that permitted a stent diameter > or =3 mm were eligible. Primary end points were 6-month minimal lumen diameter (MLD) and the combined end point of death, myocardial infarction, and target-lesion revascularization (TLR). Baseline clinical and angiographic data were comparable in both groups. At 6 months, MLD in the IVUS group (1.82+/-0.53 mm) was larger than in the angiography group (1.51+/-0.71 mm; P=0.042). TLR and combined end-point rates at 6 months were 4% (n=3) and 6% (n=4) in the IVUS group and 14% (n=10) and 20% (n=14) in the angiography group, respectively (P=0.037 for TLR and P=0.01 for combined events). Restenosis (>50% diameter stenosis) was found in 23% of the IVUS group and 45% of the angiography group (P=0.008). At 12 months, TLR and the combined end point occurred in 10% (n=7) and 12% (n=9) of the IVUS group and 23% (n=17) and 27% (n=19) of the angiography group (P=0.018 and P=0.026), respectively.



Angiographic and clinical outcome up to 12 months after long stent placement guided by IVUS is superior to guidance by angiography.
Endovascular treatment of ruptured thoracic aortic aneurysm in patients older than 75 years.

To investigate the outcomes of thoracic endovascular aortic repair (TEVAR) for ruptured descending thoracic aortic aneurysm (rDTAA) in patients older than 75 years.



We retrospectively identified all patients treated with TEVAR for rDTAA at seven referral centres between 2002 and 2009. The cohort was stratified according to age ≤75 and >75 years, and the outcomes after TEVAR were compared between both groups.



Ninety-two patients were identified of which 73% (n = 67) were ≤75 years, and 27% (n = 25) were older than 75 years. The 30-day mortality was 32.0% in patients older than 75 years, and 13.4% in the remaining patients (p = 0.041). Patients older than 75 years suffered more frequently from postoperative stroke (24.0% vs. 1.5%, p = 0.001) and pulmonary complications (40.0% vs. 9.0%, p = 0.001). The aneurysm-related survival after 2 years was 52.1% for patients >75 years, and 83.9% for patients ≤75 years (p = 0.006).



Endovascular treatment of rDTAA in patients older than 75 years is associated with an inferior outcome compared with patients younger than 75 years. However, the mortality and morbidity rates in patients above 75 years are still acceptable. These results may indicate that endovascular treatment for patients older than 75 years with rDTAA is worthwhile.
Effects of consuming foods containing oat β-glucan on blood pressure, carbohydrate metabolism and biomarkers of oxidative stress in men and women with elevated blood pressure

To assess the effects of consuming foods containing oat β-glucan on blood pressure, carbohydrate homeostasis and biomarkers of oxidative stress.A randomized, double-blind, controlled clinical trial.The trial was conducted at two clinics.Ninety-seven men and women with resting systolic blood pressure 130–179 mm Hg and/or diastolic blood pressure 85–109 mm Hg were randomly assigned to consume foods containing oat β-glucan or control foods for 12 weeks. Resting blood pressures, insulin and glucose values before and after standard breakfast meals, and four biomarkers of oxidative stress were measured before and at the end of the treatment period.Changes from baseline to week 12 in mean peak insulin and incremental area under the insulin curve differed significantly between groups (P=0.037 and 0.034, respectively), with the β-glucan group showing declines and the control group remaining essentially unchanged. Blood pressure responses were not significantly different between groups overall. However, in subjects with body mass index above the median (31.5 kg/m2), both systolic (8.3 mm Hg, P=0.008) and diastolic (3.9 mm Hg, P=0.018) blood pressures were lowered in the β-glucan group compared to controls. No significant differences in biomarkers of oxidative stress were observed between treatments.The results of the present trial suggest beneficial effects of foods containing β-glucan from oats on carbohydrate metabolism, and on blood pressure in obese subjects.Funding for this study was provided by the Quaker Oats Company.