nils-herrmann/clean_scirepeval huggingface dataset:
Transdiaphragmatic pressure and neural respiratory drive measured during inspiratory muscle training in stable patients with chronic obstructive pulmonary disease

Inspiratory muscle training (IMT) is a rehabilitation therapy for stable patients with COPD. However, its therapeutic effect remains undefined due to the unclear nature of diaphragmatic mobilization during IMT. Diaphragmatic mobilization, represented by transdiaphragmatic pressure (Pdi), and neural respiratory drive, expressed as the corrected root mean square (RMS) of the diaphragmatic electromyogram (EMGdi), both provide vital information to select the proper IMT device and loads in COPD, therefore contributing to the curative effect of IMT. Pdi and RMS of EMGdi (RMSdi%) were measured and compared during inspiratory resistive training and threshold load training in stable patients with COPD.



Pdi and neural respiratory drive were measured continuously during inspiratory resistive training and threshold load training in 12 stable patients with COPD (forced expiratory volume in 1 s ± SD was 26.1%±10.2% predicted).



Pdi was significantly higher during high-intensity threshold load training (91.46±17.24 cmH2O) than during inspiratory resistive training (27.24±6.13 cmH2O) in stable patients with COPD, with P<0.01 for each. Significant difference was also found in RMSdi% between high-intensity threshold load training and inspiratory resistive training (69.98%±16.78% vs 17.26%±14.65%, P<0.01).



We concluded that threshold load training shows greater mobilization of Pdi and neural respiratory drive than inspiratory resistive training in stable patients with COPD.
Comparing exercise interventions to increase persistence with physical exercise and sporting activity among people with hypertension or high normal blood pressure: study protocol for a randomised controlled trial

Increasing physical activity is known to have health benefits for people with hypertension and related conditions. Current general practitioner referrals for gym-based exercise increase physical activity but meta-analyses show that while these are effective the absolute health risk reduction is small due to patients failing to maintain activity levels over time. This study assesses the effectiveness of two sports-oriented interventions that are intended to bridge the intention-behaviour gap and thus increase the likelihood of sustained increases in physical activity.



Four-arm randomised controlled trial. The study tests two types of intervention that are intended to increase physical activity among currently inactive 18- to 74-year-old people with hypertension or high-normal blood pressure. This study will assess the effectiveness of a 12-week sports-oriented exercise programme, the efficacy of a web-delivered self-help tool to promote and support sports participation and healthy behaviour change and the effect of these interventions in combination. The control arm will be a standard care general practitioner referral for gym-based exercise. Participants will be allocated using block randomisation. The first author and primary analyst is blinded to participant allocation. The primary outcome measures will be time spent in physical activity assessed in metabolic equivalent minutes per week using the International Physical Activity Questionnaire 1 year after commencement of the intervention. Secondary outcomes include increased involvement in sporting activity and biomedical health outcomes including change in body mass index, and waist and hip measurement and reductions in blood pressure.



If proven to be superior to general practitioner referrals for gym-based exercise, these sports-oriented interventions would constitute low-cost alternatives. The next stage would be a full economic evaluation of the interventions.
Does smoking habit affect the randomized comparison of 6 versus 24-month dual antiplatelet therapy duration? Insights from the PRODIGY trial.

a Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands b Cardiothoracic Department, Spedali Civili, University of Brescia, Italy c Department of Clinical and Experimental Medicine, Policlinico “G. Martino”, University of Messina, Italy d Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium e Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy f Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Düsseldorf, Germany g Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network, Düsseldorf, Germany h Cardialysis, Rotterdam, The Netherlands
Ultrasound-guided intratumoral indigo carmine injection for intraoperative, surgeon-performed tumor localization.

The purpose of this study was to evaluate the feasibility of ultrasound-guided intratumoral indigo carmine injections for intraoperative localization of small head and neck tumors and to introduce our surgeon-performed technique.



In total, 23 patients who had tumors ≤1.5 cm that were not palpable by 2 head and neck surgeons were enrolled in this prospective study.



Ultrasound-guided intratumoral indigo carmine injections successfully targeted tumors in 22 patients (95.7%). The mean preinjection target tumor size was 0.8 cm. After an average injection of 0.7 mL indigo carmine, the mean target tumor size increased to 1.0 cm, which enhanced visual demarcation because of the increased tumor size. In these patients, we successfully and uneventfully resected the target tumors with ultrasound-guided intratumoral indigo carmine injection assistance.



Ultrasound-guided intratumoral indigo carmine injections were technically feasible as an intraoperative procedure and were performed safely by a head and neck surgeon to facilitate localization of small head and neck tumors, even in revision cases.
Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population.

Excess weight gain tends to occur in young adulthood. However, research examining effective weight-related interventions for this age group has been limited. As one of seven trials in the EARLY Trials consortium (Early Adult Reduction of weight through LifestYle intervention), the CHOICES Study (Choosing Healthy Options in College Environments and Settings) tested effects of a technology-integrated, young adult weight gain prevention intervention. It was a randomized controlled trial with assessments at baseline (2011) and 4-, 12- and 24-months post-intervention initiation and included 441 participants (ages 18-35) who were students at three Minnesota community colleges. The 24-month intervention included a 1-credit academic course and social networking and support online intervention. This analysis examined effects on 12 secondary behavioral outcomes across three domains: diet (fast food, sugary beverages, breakfast, at-home meal preparation), physical activity/screen time (minutes and energy expenditure in leisure time physical activity, television viewing, leisure time computer use) and sleep (hours of sleep, time required to fall asleep, days not getting enough rest, difficulty staying awake). The intervention resulted in significant reductions in fast food (p=0.007) but increases in difficulty staying awake (p=0.015). There was limited evidence of other behavior changes at 4months (0.05<p<0.1) in the expected direction but differences by treatment condition dissipated over time. Analyses examining summary treatment effects (i.e., modeling effects on all behavioral outcomes simultaneously) indicated significant overall effects (p=0.014), largely driven by 4-month results (p=0.005). Additional research is needed to understand effective obesity prevention among young adults, particularly when addressing multiple weight-related outcomes.
Minimally-diluted blood cardioplegia supplemented with potassium and magnesium for combination of 'initial, continuous and intermittent bolus' administration.

The present study was designed to examine the hypothesis that minimally-diluted blood cardioplegia (BCP) supplemented with potassium and magnesium provides superior myocardial protection in comparison with the standard-diluted BCP for a combination of 'initial, continuous, and intermittent bolus' BCP administration.



Seventy patients undergoing elective coronary revascularization between 1997 and 2001 (M : F =55:15, mean age 67.6+/-7.5 years) were randomly divided into 2 groups: Group C (n=35) was given the standard 4:1-diluted blood-crystalloid BCP, and Group M (n=35) was given minimally-diluted BCP supplemented with potassium-chloride and magnesium-sulfate. The BCP temperature was maintained at 30 degrees C. Cardioplegic arrest was induced with 2 min of initial antegrade BCP infusion, followed by continuous retrograde BCP infusion. Intermittent antegrade BCP was infused every 30 min for 2 min. The time required for achieving cardioplegic arrest was significantly shorter in Group M (47.5+/-16.3 vs 62.5+/-17.6 s, p<0.0001). The number of patients showing spontaneous heart beat recovery after reperfusion was significantly larger in Group M (28 vs 15, p=0.0029), and the number of patients suffering from atrial fibrillation during the postoperative period was significantly smaller in Group M (n=3 vs 11, p=0.034). Both the postoperative maximum dopamine dose (3.57+/-2.46 vs 5.44+/-2.23 microg/kg per min, p=0.0014) and peak creatine kinase-MB (19.5+/-8.5 vs 25.8+/-11.9 IU/L, p=0.0128) were significantly less in Group M. The number of patients showing paradoxical movement of the ventricular septum in the early postoperative echocardiography was significantly smaller in Group M (9 vs 24, p=0.0007).



These results suggest that 'initial, continuous and intermittent bolus' administration of minimally-diluted BCP supplemented with potassium and magnesium is a reliable and effective technique for intraoperative myocardial protection.
Electrical stimulation plus progressive resistance training for leg strength in spinal cord injury: A randomized controlled trial

A randomized controlled trial.To determine the effectiveness of electrical stimulation (ES)-evoked muscle contractions superimposed on progressive resistance training (PRT) for increasing voluntary strength in the quadriceps muscles of people with spinal cord injuries (Sydney, Australia.A total of 20 people with established SCI and neurologically induced weakness of the quadriceps muscles participated in the trial. Participants were randomized between experimental and control groups. Volunteers in the experimental group received ES superimposed on PRT to the quadriceps muscles of one leg thrice weekly for 8 weeks. Participants in the control group received no intervention. Assessments occurred at the beginning and at the end of the 8-week period. The four primary outcomes were voluntary strength (Nm) and endurance (fatigue ratio) as well as the performance and satisfaction items of the Canadian Occupational Performance Measure (COPM; The between-group mean differences (95% confidence interval (CI)) for voluntary strength and endurance were 14 Nm (1–27; P=0.034) and 0.1 (−0.1 to 0.3; P=0.221), respectively. The between-group median differences (95% CI) for the performance and satisfaction items of the COPM were 1.7 points (−0.2 to 3.2; P=0.103) and 1.4 points (−0.1 to 4.6; P=0.058), respectively.ES superimposed on PRT improves voluntary strength, although there is uncertainty about whether the size of the treatment effect is clinically important. The relative effectiveness of ES and PRT is yet to be determined.
Real-world effectiveness of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide in high-risk patients and other subgroups

The clinical EXCITE (EXperienCe of amlodIpine and valsarTan in hypErtension) study reported clinically relevant blood pressure (BP) reductions across all doses of amlodipine/valsartan (Aml/Val) and Aml/Val/hydrochlorothiazide (HCT) single-pill combinations. The study prospectively observed a multiethnic population of hypertensive patients for 26 weeks who were treated according to routine clinical practice. Here, we present the results in high-risk subgroups including the elderly, obese patients, and patients with diabetes or isolated systolic hypertension. In addition, we present a post hoc analysis as per prior antihypertensive monotherapy and dual therapy.



Patients prescribed Aml/Val or Aml/Val/HCT were assessed in this 26±8 week, noninterventional, multicenter study across 13 countries in the Middle East and Asia. Changes in mean sitting systolic BP, mean sitting diastolic BP, and overall safety were assessed.



Of a total of 9,794 patients analyzed, 8,603 and 1,191 patients were prescribed Aml/Val and Aml/Val/HCT, respectively. Among these, 15.5% were elderly, 32.5% were obese, 31.3% had diabetes, and 9.8% had isolated systolic hypertension. Both Aml/Val and Aml/Val/HCT single-pill combinations, respectively, were associated with clinically relevant and significant mean sitting systolic/diastolic BP reductions across all subgroups: elderly patients (-32.2/-14.3 mmHg and -38.5/-16.5 mmHg), obese patients (-32.2/-17.9 mmHg and -38.5/-18.4 mmHg), diabetic patients (-30.3/-16.1 mmHg and -34.4/-16.6 mmHg), and patients with isolated systolic hypertension (-25.5/-4.1 mmHg and -30.2/-5.9 mmHg). Incremental BP reductions with Aml/Val or Aml/Val/HCT single-pill combinations were also observed in patients receiving prior monotherapy or dual therapy for hypertension. Overall, both Aml/Val and Aml/Val/HCT were generally well tolerated.



This large, multiethnic study supports the evidence that Aml/Val and Aml/Val/ HCT single-pill combinations are effective in diverse and clinically important subgroups of patients with hypertension.
Rapid response team and hospital mortality in hospitalized patients

Although rapid response systems are known to reduce in-hospital cardiac arrest rate, their effect on mortality remains debated. The present study aimed to evaluate the effect of implementing an intensivist-led rapid response team (RRT) on mortality in hospitalized patients. An implementation of an intervention and a comparison with retrospective data analysis were performed in the four hospitals of Montpellier regional healthcare centre, in France. An intensivist-led RRT was implemented on a 24/7 basis along with educational modules, publicity and bedside simulation-based training in only one of the four hospitals from January 2012 to June 2012. A single activation criterion (heart rate below 40/min or above 140/min, systolic blood pressure below 80 mmHg, cardiac arrest, respiratory rate below 8/min or above 30/min, pulse oximetry below 90 % with O2 above 6 l/min, respiratory distress in a tracheotomised patient, respiratory arrest, coma or sudden change in level of consciousness, seizure) allowed any caregiver to directly contact the RRT using a dedicated cell phone number. Patients over 18 years admitted for more than 24 h in the medical-surgical wards from July 2010 to December 2011 (pre-RRT period) and from July 2012 to December 2013 (RRT period) were included. The main outcome was unexpected mortality. Analyses of data from one RRT hospital and three control hospitals (no RRT hospital) were performed. RRT implementation was associated with a decrease in unexpected mortality rate in the hospital that implemented RRT (from 21.9 to 17.4 per 1000 discharges; p = 0.002). Reduction in unexpected mortality associated with RRT implementation could be estimated at 1.5 lives saved per week in the RRT hospital. In the three other hospitals, mortality rate was not significantly modified (from 19.5 to 19.9 per 1000 discharges; p = 0.69). Overall mortality decreased from 39.6 to 34.6 per 1000 discharges between the pre-RRT and RRT period in the RRT hospital (p = 0.012), but did not significantly change in the other hospitals. Patients in the RRT hospital were more frequently admitted to the intensive care unit (ICU) during the RRT period (45.8 vs 52.9 per 1000; p = 0.002), and their sequential organ failure assessment (SOFA) score upon ICU admission significantly decreased from 7 (4–10) to 5 (2–9); p < 0.001. In the present retrospective study, implementation of an intensivist-led RRT along with educational modules, publicity and bedside simulation-based training was associated with a significant decrease in unexpected and overall mortality of inpatients.
The optimal dose of 5-aminosalicylic acid in active ulcerative colitis: a dose-finding study with newly developed mesalamine.

5-Aminosalicylate is the gold standard for inducing remission in patients with mildly to moderately active ulcerative colitis. The optimal dose is as yet not defined. Despite some recent developments, the ideal formulation for 5-aminosalicylic acid is still awaited. A new pellet preparation was designed combining slow and delayed release properties. Aims of the study were to find the optimal dose and to test efficacy and safety of a new 5-aminosalicylic acid formulation.



Three hundred twenty-one patients were included in a double-blind multicenter trial. Inclusion criteria were active ulcerative colitis (Clinical Activity Index [CAI] and Endoscopic Index [EI] according to Rachmilewitz, CAI 6-12; EI >/=4). Three different doses of 5-aminosalicylic acid (0.5 g 3 times a day, 1.0 g 3 times a day, and 1.5 g 3 times a day) were studied for 8 weeks.



Clinical remission rate (CAI </=4) was highest in the 1.0 g 3 times a day group (66 %), 50% in the 0.5 g 3 times a day group, and 55% in the 1.5 g 3 times a day group. Hierarchical testing showed no significance, indicating a lack of dose response across the 3 mesalamine doses. In addition, times to first clinical response were similar: 26.5 days (1.0 g 3 times a day), 27.5 days (0.5 g 3 times a day), and 21.5 days (1.5 g 3 times a day). Endoscopic improvement was better with 1.0 g mesalamine 3 times a day than with 0.5 g 3 times a day, but overall endoscopic and histologic improvement was not different between treatment groups. Baseline activity, duration, and localization of ulcerative colitis did have some influence on the therapeutic activity, but there was no significant interaction with the dose of the study drug. Safety, with special focus on kidney function, was excellent in all 3 groups.



There is no significant dose response between mesalamine 1.5 g/day, 3.0 g/day, and 4.5 g/day. The optimal dose to induce remission of ulcerative colitis is 0.5 g 5-aminosalicylic acid 3 times a day. Patients failing with this dose may benefit from an increase of the dose up to 1.0 g 3 times a day, but should also be considered for alternative treatment. A newly developed pellet formulation of 5-aminosalicylic acid has promising efficacy and excellent safety.
There is no association between the circadian clock gene HPER3 and cognitive dysfunction after noncardiac surgery.

The specific clock-gene PERIOD3 is important with regard to circadian rhythmicity, sleep homeostasis, and cognitive function. The allele PER3(5/5) has been associated with worse cognitive performance in response to sleep deprivation. We hypothesized that patients with the PER3(5/5) genotype would have an increased risk of postoperative cognitive dysfunction (POCD) 1 week after noncardiac surgery.



Blood samples were analyzed from 93 patients with POCD and 186 patients without POCD from a completed multicenter study. The study population comprised patients ages 40 years and older undergoing noncardiac surgery who were tested preoperatively and 1 week after surgery with a neuropsychological test battery comprising 7 subtests. PER3 genotypes were determined by polymerase chain reaction analysis of DNA from blood samples (Clinicaltrials.gov identifier NCT01088100).



The frequencies of the 3 genotypes were 11.8% (32 patients) PER3(5/5), 41.7% (113 patients) PER3(4/5), and 46.5% (126 patients) PER3(4/4). No significant difference was found in the distribution of the 3 genotypes according to POCD at 1 week (P = 0.68). Twelve percent (6% to 21%) of the patients with POCD and 12% (7% to 17%) of the patients without POCD had the PER3(5/5) genotype. The difference of the incidence of POCD/-POCD for the PER3(5/5) genotype was 1% (-7% to 10%). A significantly higher Z score was found in patients having the PER3(4/4) in 1 of the neuropsychological tests (error score of the Concept Shifting Test) (Bonferroni corrected P = 0.042).



No significant association was found between the clock-gene PER3(5/5) genotype and POCD at 1 week after noncardiac surgery. If PER3(5/5) does worsen cognitive performance, the incidence is <10% of patients.
Isometric Exercise for the Cervical Extensors Can Help Restore Physiological Lordosis and Reduce Neck Pain: A Randomized Controlled Trial.

The aim of this study was to investigate whether isometric neck extension exercise restores physiological cervical lordosis and reduces pain.



Sixty-five patients with loss of cervical lordosis were randomly assigned to exercise (27 women, 7 men; mean age, 32.82 ± 8.83 yrs) and control (26 women, 5 men; mean age, 33.48 ± 9.67 yrs) groups. Both groups received nonsteroidal anti-inflammatory drugs for 10 days. The exercise group received additional therapy as a home exercise program, which consisted of isometric neck extension for 3 mos. Neck pain severity and cervical lordosis were measured at baseline and at 3 mos after baseline.



Compared with baseline levels, cervical lordosis angle was significantly improved in the exercise group (P < 0.001) but not in the control group (P = 0.371) at the end of 3 mos. Moreover, the exercise group was significantly superior to the control group considering the number of patients in whom cervical lordosis angle returned to physiological conditions (85.2% vs. 22.5%; P < 0.001). At the end of 3 mos, pain intensity was significantly reduced in both groups compared with baseline levels (for all, P < 0.001). Nevertheless, considering the change from baseline to month 3, the reduction in pain was about twice in the exercise group compared with the control group (P < 0.001).



Isometric neck extension exercise improves cervical lordosis and pain.
Treatment with metadoxine and its impact on early mortality in patients with severe alcoholic hepatitis.

Despite treatment with glucocorticoids, mortality remains high in patients with severe alcoholic hepatitis. Oxidative stress and depletion of mitochondrial glutathione are implicated factors in liver injury. The aim of this study was to evaluate the impact of the addition of metadoxine, a drug which possesses a multifactorial mechanism of action, including antioxidant properties, to standard treatment with glucocorticoids in patients with severe alcoholic hepatitis.



This randomized open label clinical trial was performed in Mexico's General Hospital (Registry Key DIC/10/107/03/043). We randomized 70 patients with severe alcoholic hepatitis. The first group received prednisone (40 mg/day), and the second group received prednisone (40 mg/day) plus metadoxine tablets (500 mg three times daily). The duration of treatment in both groups was 30 days. Survival at 30 and 90 days, development of complications, adverse events and response to treatment (Lille model) were assessed.



In the group receiving metadoxine, significant improvements were observed, as follows: survival at 30 days (74.3 vs. 45.7%, P = 0.02); survival at 90 days (68.6 vs. 20.0%, P = 0.0001). There was less development or progression of encephalopathy (28.6 vs. 60.0%, P = 0.008) and hepatorenal syndrome (31.4 vs. 54.3%, P = 0.05), and the response to treatment (Lille model) was higher in the metadoxine group (0.38 vs. 0.63, P = 0.001; 95% CI 0.11 to 0.40). There were no differences between groups regarding the development or progression of variceal hemorrhage or infection. The incidence of adverse events, mainly gastrointestinal, was similar in both groups.



Addition of metadoxine to glucocorticoid treatment improves the short-term survival of patients with severe alcoholic hepatitis and diminishes the development or progression of encephalopathy and hepatorenal syndrome.