nils-herrmann/clean_scirepeval huggingface dataset:
The decline in blood glucose levels is less with intermittent high-intensity compared with moderate exercise in individuals with type 1 diabetes.

To compare the response of blood glucose levels to intermittent high-intensity exercise (IHE) and moderate-intensity exercise (MOD) in individuals with type 1 diabetes.



Seven healthy individuals with type 1 diabetes were tested on two separate occasions, during which either a 30-min MOD or IHE protocol was performed. MOD consisted of continuous exercise at 40% Vo(2peak), while the IHE protocol involved a combination of continuous exercise at 40% Vo(2peak) interspersed with 4-s sprints performed every 2 min to simulate the activity patterns of team sports.



Both exercise protocols resulted in a decline in blood glucose levels. However, the decline was greater with MOD (-4.4 +/- 1.2 mmol/l) compared with IHE (-2.9 +/- 0.8 mmol/l; P < 0.05), despite the performance of a greater amount of total work with IHE (P < 0.05). During 60 min of recovery from exercise, glucose levels remained higher in IHE compared with MOD (P < 0.05). Furthermore, glucose levels remained stable during recovery from IHE, while they continued to decrease after MOD (P < 0.05). The stabilization of blood glucose levels with IHE was associated with elevated levels of lactate, catecholamines, and growth hormone during early recovery from exercise (P < 0.05). There were no differences in free insulin, glucagon, cortisol, or free fatty acids between MOD and IHE.



The decline in blood glucose levels is less with IHE compared with MOD during both exercise and recovery in individuals with type 1 diabetes.
Two randomized trials of linaclotide for chronic constipation.

Linaclotide is a minimally absorbed peptide agonist of the guanylate cyclase C receptor. In two trials, we aimed to determine the efficacy and safety of linaclotide in patients with chronic constipation.



We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation. Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks. The primary efficacy end point was three or more complete spontaneous bowel movements (CSBMs) per week and an increase of one or more CSBMs from baseline during at least 9 of the 12 weeks. Adverse events were also monitored.



For Trials 303 and 01, respectively, the primary end point was reached by 21.2% and 16.0% of the patients who received 145 μg of linaclotide and by 19.4% and 21.3% of the patients who received 290 μg of linaclotide, as compared with 3.3% and 6.0% of those who received placebo (P<0.01 for all comparisons of linaclotide with placebo). Improvements in all secondary end points were significantly greater in both linaclotide groups than in the placebo groups. The incidence of adverse events was similar among all study groups, with the exception of diarrhea, which led to discontinuation of treatment in 4.2% of patients in both linaclotide groups.



In these two 12-week trials, linaclotide significantly reduced bowel and abdominal symptoms in patients with chronic constipation. Additional studies are needed to evaluate the potential long-term risks and benefits of linaclotide in chronic constipation. (Funded by Ironwood Pharmaceuticals and Forest Research Institute; ClinicalTrials.gov numbers, NCT00765882 and NCT00730015.).
Effects of Community-Based Cardiac Rehabilitation on Body Composition and Physical Function in Individuals with Stable Coronary Artery Disease: 1.6-Year Followup

To examine long-term changes in physical function and body composition in coronary artery disease (CAD) patients participating in ongoing community-based cardiac rehabilitation (CR).



Thirty-four individuals (69.7 ± 8.2 years; 79% men) participated in this longitudinal observational study. Baseline and follow-up assessments included incremental shuttle walk, short physical performance battery, handgrip strength, chair stands, body composition, last year physical activity, and CR attendance.



Participants attended 38.5 ± 30.3% sessions during 1.6 ± 0.2 year followup. A significant increase in 30-second chair stands (17.0 ± 4.7 to 19.6 ± 6.4, P < 0.001), body weight (75.8 ± 11.1 to 77.2 ± 12.1 kg, P = 0.001), and body fat (27.0 ± 9.5 to 29.1 ± 9.6%, P < 0.001) and a decline in handgrip strength (36.4 ± 9.4 to 33.0 ± 10.6 kg·f, P < 0.001) and muscle mass (40.8 ± 5.6 to 39.3 ± 5.8%, P < 0.001) were observed during followup. There was no significant change in shuttle walk duration. CR attendance was not correlated to observed changes.



Elderly CAD patients participating in a maintenance CR program improve lower-body muscle strength but experience a decline in handgrip strength and unfavourable changes in body composition, irrespective of CR attendance.
Phase I study to determine the safety and pharmacokinetics of the novel Raf kinase and VEGFR inhibitor BAY 43-9006, administered for 28 days on/7 days off in patients with advanced, refractory solid tumors.

BAY 43--9006, an oral multi-kinase inhibitor, targets serine-threonine kinases and receptor tyrosine kinases, and affects the tumor and vasculature in preclinical models. Based on its pharmacologic effect, it may be a useful cancer treatment. This study determined the maximum tolerated dose (MTD) of BAY 43-9006 in 42 patients with advanced, refractory metastatic or recurrent solid tumors. Dose-limiting toxicities (DLTs), safety, pharmacokinetics and tumor response were also evaluated.



In this open-label, phase I, dose-escalation study, BAY 43--9,006 was administered orally in repeated cycles of 35 days (28 days on/7 days off). Eight doses were investigated: from 50 mg every fourth day to 600 mg twice daily. Treatment continued until unacceptable toxicity, tumor progression or death.



The MTD was 400 mg twice daily. BAY 43-9006 was well tolerated, with mild to moderate toxicities; only six patients discontinued study therapy due to adverse events. DLTs consisted of hand-foot skin reaction in three of seven patients receiving 600 mg twice daily. Stable disease was achieved in 22% of patients; median duration of stable disease was 7.2 months. Consistent with its observed half-life of approximately 27 h, BAY 43-9, 006 accumulated on multiple dosing. Increases in exposure were less than proportional to the increases in dose.



Results indicate that further clinical investigation of BAY 43--9006 is warranted, and suggest it could be a promising future therapy for patients with cancer.
A randomized controlled trial comparing manipulation with mobilization for recent onset neck pain.

A randomized controlled trial comparing manipulation with mobilization for recent onset neck pain.



To determine whether neck manipulation is more effective for neck pain than mobilization.



Randomized controlled trial with blind assessment of outcome.



Primary care physiotherapy, chiropractic, and osteopathy clinics in Sydney, Australia.



Patients (N=182) with nonspecific neck pain less than 3 months in duration and deemed suitable for treatment with manipulation by the treating practitioner.



Participants were randomly assigned to receive treatment with neck manipulation (n=91) or mobilization (n=91). Patients in both groups received 4 treatments over 2 weeks.



The number of days taken to recover from the episode of neck pain.



The median number of days to recovery of pain was 47 in the manipulation group and 43 in the mobilization group. Participants treated with neck manipulation did not experience more rapid recovery than those treated with neck mobilization (hazard ratio=.98; 95% confidence interval, .66-1.46).



Neck manipulation is not appreciably more effective than mobilization. The use of neck manipulation therefore cannot be justified on the basis of superior effectiveness.
A Healthy Balance of Plasma Cholesterol by a Novel Annurca Apple-Based Nutraceutical Formulation: Results of a Randomized Trial

Cardiovascular diseases are nowadays preferential targets of preventive medicine through a straightforward therapy on lipid profile. However, statins, the first-line lipid-lowering drug therapy, specifically act on low-density lipoprotein cholesterol (LDL-C), having a modest effect on plasma high-density lipoprotein cholesterol (HDL-C) concentrations. Today, a number of novel HDL-targeted therapies are emerging, along with unexpected side effects. Thus, novel and possibly safe substances, able to correct impaired lipid profile in humans, are still in great demand. Herein, based on encouraging clinical data, we formulated a nutraceutical product (AppleMetS®, AMS), based on a polyphenolic extract from Annurca apple, and demonstrated that two capsules a day of AMS, after one month, have a LDL-C lowering outcome equivalent to 40 mg of simvastatin or 10 mg of atorvastatin. Nevertheless, different from statin-based therapy, AMS exerted a notable effect on HDL (+49.2%). Based on the trial results, we can assert that AMS formulation could effectively integrate the current therapeutic arsenal to correct impaired lipid profile in humans. Specifically, AMS may be considered a complementary and/or alternative safe substance suitable for the treatment of mildly hypercholesterolemic subjects who do not present occurrence of atheromatous plaques yet.
Evaluating positional accuracy using megavoltage cone-beam computed tomography for IMRT with head-and-neck cancer

Accurate dose delivery is essential for the success of intensity-modulated radiation therapy (IMRT) for patients with head-and-neck (HN) cancer. Reproducibility of IMRT dose delivery to HN regions can be critically influenced by treatment-related changes in body contours. Moreover, some set-up margins may not be adaptable to positional uncertainties of HN structures at every treatment. To obtain evidence for appropriate set-up margins in various head and neck areas, we prospectively evaluated positional deviation (δ values) of four bony landmarks (i.e. the clivus and occipital protuberance for the head region, and the mental protuberance and C5 for the neck region) using megavoltage cone-beam computed tomography during a treatment course. Over 800 δ values were analyzed in each translational direction. Positional uncertainties for HN cancer patients undergoing IMRT were evaluated relative to the body mass index. Low positional accuracy was observed for the neck region compared with the head region. For the head region, most of the δ was distributed within ± 5 mm, and use of the current set-up margin was appropriate. However, the δ values for the neck region were within ± 8 mm. Especially for overweight patients, a few millimeters needed to be added to give an adequate set-up margin. For accurate dose delivery to targets and to avoid excess exposure to normal tissues, we recommend that the positional verification process be performed before every treatment.
Sustained Viral Response to Pegylated Interferon α-2b and Ribavirin in Chronic Hepatitis C Refractory to Prior Treatment

Hepatitis C virus (HCV) infection refractory to previous therapy is common. Treatment of patients with refractory disease is difficult and less studied. Pegylated interferon α-2b plus ribavirin is used for treatment of HCV patients naïve to therapy. We conducted a randomized study for refractory HCV patients using a high- vs. a low-dose pegylated interferon α-2b and ribavirin protocol. Our aim was (1) to determine the efficacy of pegylated interferon α-2b plus ribavirin to eradicate HCV in previously treated individuals and (2) to compare a low-dose to a high-dose regimen. One hundred fifty-two patients were initiated in the study, 112 (74%) were male and 40 (26%) female. Nineteen percent of patients obtained a sustained viral response (SVR) in the high-dose arm. Prior relapsers had the highest SVR rates: 50% in non-genotype 1 and 34% in genotype 1. The odds of achieving a SVR were six times higher in previous relapsers. The rate of SVR in genotype 1 patients who were nonresponders to prior therapy was only 8%. All patients who achieved a SVR had no detectable virus at week 24. However, only half of those who had undetectable viral titers at week 24 achieved a SVR. In conclusion, retreatment of patients with refractory hepatitis C infection with interferon α-2b and ribavirin combination therapy is well tolerated and gives modest response rates. The most important factor in predicting response to therapy is the manner of response to previous treatment. The likelihood of response to treatment can be predicted from the viral titers at 24 weeks.
Eff ectiveness and cost-eff ectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence ( PREVENT ) : a randomised controlled trial

Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence. Maintenance antidepressants for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to medication. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce risk of relapse or recurrence compared with usual care, but has not yet been compared with maintenance antidepressant treatment in a defi nitive trial. We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment (MBCT-TS) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months.
Ligament reconstruction/tendon interposition arthroplasty for thumb basal joint osteoarthritis preliminary results of a prospective outcome study.

Ligament reconstruction/tendon interposition arthroplasty (LRTIA) is a common procedure for basal joint osteoarthritis of the thumb. We evaluated 31 operations in 30 patients, 28 females, 2 males with a mean age of 57 years. The mean follow-up was 24 months (range 8 to 46 months). Pain reduction was 75% on average, with good preservation of motion and of first web space. Twenty-six patients were satisfied or very satisfied; five were not. The grip strength and key-pinch strength increased post-operatively, albeit not significantly.
Role of antioxidant property of carvedilol in mild to moderate hypertensive patients: A prospective open-label study

Carvedilol is a nonselective third generation β-blocker that does not display the negative effects of traditional β-blockers. Regarding the antioxidant, anti-inflammatory and distinct metabolic properties of carvedilol which are similar to that of high-density lipoprotein (HDL) and paraoxonase 1 (PON1), the present study intends to investigate the effects of carvedilol treatment on malondialdehyde (MDA) and soluble lectin-like ox-low-density lipoprotein (LDL) receptor (sLOX-1) as markers of oxidative stress in association to lipid profiles, apolipoproteins (apo), and PON1 activity in hypertensive patients.



This clinical trial study was performed on forty patients with mild to moderate essential hypertension. Subjects were studied before and after 2 months treatment with carvedilol, 25 mg daily. Lipids and lipoproteins were measured using a biochemistry analyzer. PON and arylesterase activity were assayed using paraoxon and phenyl acetate as substrates, respectively. MDA was quantified using a chemical colorimetric assay. ELISA was used to measure sLOX-1.



Our results showed that carvedilol treatment decreased systolic and diastolic blood pressure as much as forty and 16 mmHg, respectively (P < 0.001). It also increased HDL, total cholesterol, and serum PON1 activity (P < 0.05), but the levels of triglyceride, LDL, apo A-I, and apo B did not significantly change. There was an inverse correlation between serum PON1 activity and serum MDA.



This study confirmed the antihypertensive effect of the drug and its beneficial metabolic effects through augmenting HDL and PON1 activity. We propose that the antioxidant effects of carvedilol can be partially attributed to increased PON-1 activity.
Effect of endogenous nitric oxide inhibition on airway responsiveness to histamine and adenosine-5'-monophosphate in asthma.

Nitric oxide (NO) may be bronchoprotective in asthma, possibly due to a direct action on airway smooth muscle or through mast cell stabilisation. To investigate this the effects of two doses of nebulised NG-nitro-L-arginine methyl ester (L-NAME), a non-selective NO synthase (NOS) inhibitor, on exhaled NO levels and airway responsiveness to histamine, a direct smooth muscle spasmogen, and adenosine-5'-monophosphate (AMP), an indirect spasmogen which activates mast cells, were evaluated in patients with mild asthma.



The study consisted of two phases each with a double blind, randomised, crossover design. In phase 1, 15 subjects inhaled either L-NAME 54 mg or 0.9% saline 30 minutes before histamine challenge. Nine of these subjects were studied in a similar fashion but were also challenged with AMP. In phase 2, 13 subjects (eight from phase 1) performed the same protocol but inhaled L-NAME in a dose of 170 mg or 0.9% saline before being challenged with histamine and AMP.



The mean (95% CI) reduction in exhaled NO levels after L-NAME 54 mg was 78% (66 to 90) but this did not alter airway responsiveness; the geometric mean (SE) concentration provoking a fall of 20% or more in forced expiratory volume in one second (PC20) after L-NAME and saline was 0.59 (1.26) and 0.81 (1.26) mg/ml, respectively, for histamine and 20.2 (1.7) and 17.2 (1.6) mg/ml, respectively, for AMP. In contrast, L-NAME 170 mg reduced NO levels to a similar extent (81% (95% CI 76 to 87)) but increased airway responsiveness by approximately one doubling dose to both spasmogens; the geometric mean (SE) PC20 for histamine after L-NAME 170 mg and saline was 0.82 (1.29) and 1.78 (1.19) mg/ml, respectively (p < 0.001), and for AMP was 11.8 (1.5) and 24.3 (1.4) mg/ml, respectively (p < 0.001).



These results suggest that L-NAME increases airway responsiveness in asthma. This may occur through mechanisms separate from NO inhibition or through pathways independent of those responsible for production of NO measured in exhaled air.
Multiple antigen concentrations in delayed-type hypersensitivity (DTH) and response diversity during and after immunization with a peptide-based HIV-1 immunotherapy candidate (Vacc-4x).

Delayed-type hypersensitivity (DTH) testing represents a simple in vivo method for monitoring cellular immune responses. In a phase II clinical trial on HIV-infected patients (n = 38) of the peptide-based HIV-1 immunotherapy candidate Vacc-4x, we monitored DTH responses to three antigen concentrations of Vacc-4x. We have shown that DTH can be used quantitatively to measure immune reactions to Vacc-4x and its individual peptide components. Our data stress the qualities and differences of induration and erythema, both in discriminating individual antigens and in monitoring immunizations over time. The data also indicate that DTH baseline-status might have important impact on immunization kinetics.
Patient-reported outcomes in relapsed ovarian cancer: results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone.

Trabectedin in combination with PLD improves progression-free survival (PFS) and overall response rate (ORR) in comparison to PLD alone in patients with relapsed ovarian cancer (. Here we report the impact of the treatment combination on patient-reported functional status and symptoms.



Patient-reported outcome (PRO) questionnaires, EORTC-QLQ C30, OV28, and EQ-5D were completed by patients at screening and on Day 1 of every other treatment cycle starting with Cycle 1, and at the end-of-treatment visit.



Of the 672 patients randomized in this study, 663 treated patients completed at least one of the baseline questionnaires. Median cycles of treatment was 6 (131 days) for the combination arm and 5 (143 days) for the monotherapy arm. Longitudinal data analyses showed no significant differences between the treatment arms for any of the pre-specified scales. Similar analyses of other scales, including Health Index scores and Health State on the Visual Analog Scale, support these findings. Start of subsequent therapy was significantly delayed in the combination arm compared with the monotherapy arm (p=0.0032).



The addition of trabectedin to PLD led to little or no decrement in patient-reported functional status and symptoms in patients with relapsed ovarian cancer, as compared to treatment with PLD alone. The combination led to manageable and non-cumulative overall toxicity with a fewer PLD-associated adverse events, and a significant improvement in PFS and ORR compared to single agent.
Randomized trial of a comprehensive asthma education program after an emergency department visit.

Patients with asthma who visit the emergency department (ED) may benefit from education that optimizes self-management and treatment.



To conduct a randomized trial of asthma education (AE) after an ED visit.



Patients who present with acute asthma and history consistent with moderate to severe persistent asthma or recent ED visits were stratified by age (adult, child) and randomly assigned to intervention or usual care during the ED visit. The intervention was conducted by trained asthma educators and included a facilitated office visit with the primary care physician followed by a home visit. Intention-to-treat analysis was conducted, with time to first asthma relapse (either ED or unscheduled urgent office visit) during the 6-month follow-up period used as the primary outcome.



Of the 239 patients analyzed, 46% were adults, 46% were male, 30% were African American, and 56% had moderate to severe persistent asthma. Follow-up information was obtained on 191 patients (80%) at 6 months; 23.1% of the intervention group vs 31.1% of the usual care group had an urgent asthma visit (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.48-1.29). Overall, 39% of the 117 patients assigned to the intervention group did not comply with any of the post-ED activities. Subgroup analysis suggested greater benefit among children (HR, 0.62; 95% CI, 0.33-1.19) than adults (HR, 1.08; 95% CI, 0.50-2.33).



Delivery of a comprehensive AE program after an ED visit was ineffective in adult patients; however, it may be effective in children. Further research on alternative AE delivery strategies appears warranted to reduce the burden of asthma visits to the ED.
Colorectal cancer screening in Korean workers: using a stage model approach to examine the ecological predictors of behavior.

Early detection is important for reducing mortality by colorectal cancer. Workplaces have access to a large number of people, approximately half of the Korean population. For cancer prevention, it is necessary to approach cancer screening through the workplace.



In this cross-sectional study, we aimed to identify colorectal cancer screening (CRCS) stages and to predict factors that affect the respective stages.



Data were collected from 314 manual workers at 32 medium-sized and small workplaces located in Korea. The dependent variable was the stage of CRCS, and independent variables were intrapersonal, interpersonal, and organizational levels.



At the intrapersonal level, workers who increased work hours per week or who felt stress were less likely to be in the acting/maintenance stage than in the decided to act stage of CRCS. At the organizational level, workers in medium-sized workplaces, those whose administrators secured health checkup and cancer screening budget for their workplace, and those considering health checkup and cancer screening were more likely to be in the acting/maintenance stage, compared with the decided to act stage.



Our findings suggest that the respective stages are affected by different intrapersonal, interpersonal, and organizational factors.



The workplace environment and organizational predictors before the implementation of CRCS promotion programs may produce better results.