nils-herrmann/clean_scirepeval huggingface dataset:
Glucagon-like peptide-1 (7–36) amide response to low versus high glycaemic index preloads in overweight subjects with and without type II diabetes mellitus

Glucagon-like-peptide-1 (7–36) amide (GLP-1) is an insulin secretagogue and potential treatment for type II diabetes mellitus. An alternative to GLP-1 administration is endogenous dietary stimulation. We described a greater GLP-1 release following ingestion of liquids versus solids. We add to this work studying the effect of fluid preloads with differing glycaemic indices (GI) on the metabolic response to a meal.GLP-1, insulin and glucose responses were measured in six overweight individuals and six subjects with type II diabetes on three occasions, after preload (milk, low GI; Ovaltine Light, high GI; or water, non-nutritive control) and meal ingestion.In people with and without diabetes, the high GI preload produced the greatest glucose incremental area under the curve (IAUC)0–20, followed by the low GI preload, and water (P<0.001). In both groups, insulin IAUC0–20 was higher following high and low GI preloads compared with water (NS). In people without diabetes, the GLP-1 response was higher when high and low GI preloads were consumed compared with water (P=0.041), with no significant difference between nutritive preloads. GLP-1 response did not differ between preloads in people with diabetes. Despite initial differences, total IAUCs0–200 for biochemical variables did not differ by preload.We confirm that nutritive liquids stimulate GLP-1 to a greater extent than water in subjects without diabetes; however, this does not influence subsequent meal-induced response. The GI of preloads does not influence the degree of GLP-1 stimulation.
One-year cost-effectiveness of tiotropium versus ipratropium to treat chronic obstructive pulmonary disease.

The aim of this paper is to assess the health economic consequences of substituting ipratropium with the new, once-daily bronchodilator tiotropium in patients with a diagnosis of chronic obstructive pulmonary disease (COPD). This prospective cost-effectiveness analysis was performed alongside two 1-yr randomised, double-blind clinical trials in the Netherlands and Belgium. Patients had a diagnosis of COPD and a forced expiratory volume in one second (FEV1) < or = 65% predicted normal. Patients were randomised to tiotropium (18 microg once daily) or ipratropium (2 puffs of 20 microg administered four times daily) in a ratio of 2:1. The mean number of exacerbations was reduced from 1.01 in the ipratropium group (n = 175) to 0.74 in the tiotropium group (n = 344). The percentages of patients with a relevant improvement on the St. George's Respiratory Questionnaire (SGRQ) were 34.6% and 51.2%, respectively. Compared to ipratropium, the number of hospital admissions, hospital days and unscheduled visits to healthcare providers was reduced by 46%, 42% and 36% respectively. Mean annual healthcare costs including the acquisition cost of the study drugs were 1721 Euro (SEM 160) in the tiotropium group and 1,541 Euro (SEM 163) in the ipratropium group (difference 180 Euro). Incremental cost-effectiveness ratios were 667 Euro per exacerbation avoided and 1084 Euro per patient with a relevant improvement on the SGRQ. Substituting tiotropium for ipratropium in chronic obstructive pulmonary disease patients offers improved health outcomes and is associated with increased costs of 180 Euro per patient per year.
Development of the Therapist Empathy Scale.

Few measures exist to examine therapist empathy as it occurs in session.



A 9-item observer rating scale, called the Therapist Empathy Scale (TES), was developed based on Watson's (1999) work to assess affective, cognitive, attitudinal, and attunement aspects of therapist empathy. The aim of this study was to evaluate the inter-rater reliability, internal consistency, and construct and criterion validity of the TES.



Raters evaluated therapist empathy in 315 client sessions conducted by 91 therapists, using data from a multi-site therapist training trial (Martino et al., 2010) in Motivational Interviewing (MI).



Inter-rater reliability (ICC = .87 to .91) and internal consistency (Cronbach's alpha = .94) were high. Confirmatory factor analyses indicated some support for single-factor fit. Convergent validity was supported by correlations between TES scores and MI fundamental adherence (r range .50 to .67) and competence scores (r range .56 to .69). Discriminant validity was indicated by negative or nonsignificant correlations between TES and MI-inconsistent behavior (r range .05 to -.33).



The TES demonstrates excellent inter-rater reliability and internal consistency. RESULTS indicate some support for a single-factor solution and convergent and discriminant validity. Future studies should examine the use of the TES to evaluate therapist empathy in different psychotherapy approaches and to determine the impact of therapist empathy on client outcome.
Impact of traffic related air pollution indicators on non-cystic fibrosis bronchiectasis mortality: a cohort analysis

Mortality in non-cystic fibrosis bronchiectasis (NCFB) is known to be influenced by a number of factors such as gender, age, smoking history and Pseudomonas aeruginosa, but the impact of traffic related air pollution indicators on NCFB mortality is unknown.



We followed 183 patients aged 18 to 65 years with a HRCT proven diagnosis of NCFB and typical symptoms, who had visited the outpatient clinic at the University Hospital of Leuven, Belgium, between June 2006 and October 2012. We estimated hazard ratios (HR) for mortality in relation to proximity of the home to major roads and traffic load, adjusting for relevant covariables (age, gender, disease severity, chronic macrolide use, smoking history, socioeconomic status and Pseudomonas aeruginosa colonization status).



Fifteen out of the 183 included patients died during the observation period. Residential proximity to a major road was associated with the risk of dying with a HR 0.28 (CI 95% 0.10-0.77; p = 0.013) for a tenfold increase in distance to a major road. Mortality was also associated with distance-weighted traffic density within 100 meters (HR for each tenfold increase in traffic density 3.80; CI 95% 1.07-13.51; p = 0.04) and 200 meters from the patient's home address (HR for each tenfold increase in traffic density 4.14; CI 95% 1.13-15.22; p = 0.032).



Traffic-related air pollution appears to increase the risk of dying in patients with NCFB.
Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial.

Noninvasive ventilation (NIV) with a face mask is relatively ineffective at preventing endotracheal intubation in patients with acute respiratory distress syndrome (ARDS). Delivery of NIV with a helmet may be a superior strategy for these patients.



To determine whether NIV delivered by helmet improves intubation rate among patients with ARDS.



Single-center randomized clinical trial of 83 patients with ARDS requiring NIV delivered by face mask for at least 8 hours while in the medical intensive care unit at the University of Chicago between October 3, 2012, through September 21, 2015.



Patients were randomly assigned to continue face mask NIV or switch to a helmet for NIV support for a planned enrollment of 206 patients (103 patients per group). The helmet is a transparent hood that covers the entire head of the patient and has a rubber collar neck seal. Early trial termination resulted in 44 patients randomized to the helmet group and 39 to the face mask group.



The primary outcome was the proportion of patients who required endotracheal intubation. Secondary outcomes included 28-day invasive ventilator-free days (ie, days alive without mechanical ventilation), duration of ICU and hospital length of stay, and hospital and 90-day mortality.



Eighty-three patients (45% women; median age, 59 years; median Acute Physiology and Chronic Health Evaluation [APACHE] II score, 26) were included in the analysis after the trial was stopped early based on predefined criteria for efficacy. The intubation rate was 61.5% (n = 24) for the face mask group and 18.2% (n = 8) for the helmet group (absolute difference, -43.3%; 95% CI, -62.4% to -24.3%; P < .001). The number of ventilator-free days was significantly higher in the helmet group (28 vs 12.5, P < .001). At 90 days, 15 patients (34.1%) in the helmet group died compared with 22 patients (56.4%) in the face mask group (absolute difference, -22.3%; 95% CI, -43.3 to -1.4; P = .02). Adverse events included 3 interface-related skin ulcers for each group (ie, 7.6% in the face mask group had nose ulcers and 6.8% in the helmet group had neck ulcers).



Among patients with ARDS, treatment with helmet NIV resulted in a significant reduction of intubation rates. There was also a statistically significant reduction in 90-day mortality with helmet NIV. Multicenter studies are needed to replicate these findings.
Hyperoxia-induced alterations in cardiovascular function and autonomic control during return to normoxic breathing

Hyperoxia causes hemodynamic alterations. We hypothesized that cardiovascular and autonomic control changes last beyond the end of hyperoxic period into normoxia. Ten healthy volunteers were randomized to breathe either medical air or 100% oxygen for 45 min in a double-blind study design. Measurements were performed before (baseline) and during gas exposure, and then 10, 30, 60, and 90 min after gas exposure. Hemodynamic changes were studied by Doppler echocardiography. Changes in cardiac and vasomotor autonomic control were evaluated through changes in spectral power of heart rate variability and blood pressure variability. Cardiac baroreflex sensitivity was assessed by the sequence method. Hyperoxia significantly decreased heart rate and increased the high frequency power of heart rate variability, suggesting a chemoreflex increase in vagal activity since the slope of cardiac baroreflex was significantly decreased during hyperoxia. Hyperoxia increased significantly the systemic vascular resistances and decreased the low frequency power of blood pressure variability, suggesting that hyperoxic vasoconstriction was not supported by an increase in vascular sympathetic stimulation. These changes lasted for 10 min after hyperoxia (p < 0.05). After the end of hyperoxic exposure, the shift of the power spectral distribution of heart rate variability toward a pattern of increased cardiac sympathetic activity lasted for 30 min (p < 0.05), reflecting a resuming of baseline autonomic balance. Cardiac output and stroke volume were significantly decreased during hyperoxia and returned to baseline values (10 min) later than heart rate. In conclusion, hyperoxia effects continue during return to normoxic breathing, but cardiac and vascular parameters followed different time courses of recovery.
Intraoperative computed tomographic angiography in cerebral aneurysm surgery: a pilot feasibility study.

To assess the feasibility and potential utility of intraoperative computed tomographic angiography (iCTA) in identifying unexpected residual aneurysms and major cerebral artery occlusion after cerebral aneurysm surgery.



We prospectively studied 6 consecutive patients with ruptured anterior circulation aneurysms who underwent craniotomy and clipping. iCTA was performed in all cases after the surgeon was satisfied that the aneurysm was completely obliterated and the clip did not occlude a major artery. We analyzed the iCTA images with regard to residual aneurysm and major arterial occlusion and compared them with the postoperatively acquired angiographic images, which served as a control. Patient age and sex, aneurysm location and size, clinical presentation after rupture, and postoperative course, as well as postoperative modified Rankin Scale scores, were also recorded.



One of the 6 patients had a residual aneurysm detected on the iCTA images, and it was confirmed on the immediate postoperative digital subtraction angiography. There were no cases of major arterial occlusion on iCTA imaging or postoperatively acquired angiographic imaging.



iCTA is both feasible and potentially useful in identifying unexpected residual aneurysms and major arterial occlusion after surgical clipping of aneurysms.
For the common good: measuring residents' efforts to protect their community from drug- and sex-related harm.

People in high-risk neighbourhoods try to protect their friends, neighbours, relatives and others from the social and physical risks associated with sex and drug use. This paper develops and validates a community-grounded questionnaire to measure such 'intravention' (health-directed efforts to protect others). An initial ethnography, including life-history interviews and focus groups, explored the forms of intravention activities engaged in by residents of Bushwick (a high-risk New York City neighbourhood). Grassroots categories of intraventions were derived and questions developed to ask about such behaviours. Face validity and adequacy of the questions were assessed by independent experts. Pre-testing was conducted, and reliability and validity were assessed. An instrument including 110 intravention items was administered to 57 community-recruited residents. Analysis focused on 57 items in 11 domain-specific subscale. All subscales had good to very good reliability; Cronbach's alpha ranged from .81 to .95. The subscales evidenced both convergent and discriminant validity. Although further testing of this instrument on additional populations is clearly warranted, this intravention instrument seems valid and reliable. It can be used by researchers in comparative and longitudinal studies of the causes, prevalence and affects of different intravention activities in communities. It can benefit public health practitioners by helping them understand the environments in which they are intervening and by helping them find ways to cooperate with local neighbourhood-level health activists.
Conservative methods for reducing lateral translation postures of the head: a nonrandomized clinical control trial.

Fifty-one retrospective, consecutive patients were compared to twenty-six prospective volunteer controls in a nonrandomized clinical control trial. Both groups had chronic neck pain and lateral head translation posture. For treatment subjects, beginning and follow-up pain scales and anteroposterior (AP) cervical radiographs were obtained after 12.8 weeks of care (average of 37 visits), while the duration was a mean of 12 months for control subjects. Digitized radiographs were analyzed for Risser-Ferguson angles and a horizontal translation distance of C2 from a vertical line through T3. For treatment, patients received the Harrison mirror-image postural methods, which include mechanically assisted manipulation, opposite head posture exercise, and opposite head translation posture traction. While no significant differences were found in the control group subjects' pain scores and AP radiographic measurements, statistically significant improvements were observed in the treatment group subjects' pain scores and lateral translation displacements of C2 compared to T3 (pretrial score: 13.7 mm, posttrial score: 6.8 mm) and in angle measurements.
Long-term survival and late effects among one-year survivors of second allogeneic hematopoietic cell transplantation for relapsed acute leukemia and myelodysplastic syndromes.

We analyzed the outcomes of patients who survived disease-free for 1 year or more after a second allogeneic hematopoietic cell transplantation (HCT) for relapsed acute leukemia or myelodysplastic syndromes between 1980 and 2009. A total of 1285 patients received a second allogeneic transplant after disease relapse; among these, 325 were relapse free at 1 year after the second HCT. The median time from first to second HCT was 17 and 24 months for children and adults, respectively. A myeloablative preparative regimen was used in the second transplantation in 62% of children and 45% of adult patients. The overall 10-year conditional survival rates after second transplantation in this cohort of patients who had survived disease-free for at least 1 year was 55% in children and 39% in adults. Relapse was the leading cause of mortality (77% and 54% of deaths in children and adults, respectively). In multivariate analyses, only disease status before second HCT was significantly associated with higher risk for overall mortality (hazard ratio, 1.71 for patients with disease not in complete remission before second HCT, P < .01). Chronic graft-versus-host disease (GVHD) developed in 43% and 75% of children and adults after second transplantation. Chronic GVHD was the leading cause of nonrelapse mortality, followed by organ failure and infection. The cumulative incidence of developing at least 1 of the studied late effects within 10 years after second HCT was 63% in children and 55% in adults. The most frequent late effects in children were growth disturbance (10-year cumulative incidence, 22%) and cataracts (20%); in adults they were cataracts (20%) and avascular necrosis (13%). Among patients with acute leukemia and myelodysplastic syndromes who receive a second allogeneic HCT for relapse and survive disease free for at least 1 year, many can be expected to survive long term. However, they continue to be at risk for relapse and nonrelapse morbidity and mortality. Novel approaches are needed to minimize relapse risk and long-term transplantation morbidity in this population.
Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study.

A wide variety of operational issues were encountered with the planning and implementation of an adaptive, dose-finding, seamless phase 2/3 trial for a diabetes therapeutic. Compared with a conventional design, significant upfront planning was required, as well as earlier, more integrated cross-functional coordination. The existing infrastructure necessitated greater flexibility to meet the needs of the adaptive design. Rapid data acquisition, analysis, and reporting were essential to support the successful implementation of the adaptive algorithm. Drug supply for nine treatment arms had to be carefully managed across many sites worldwide. Details regarding these key operational challenges and others will be discussed along with resolutions taken to enable successful implementation of this adaptive, seamless trial.
The International Stroke Trial database

We aimed to make individual patient data from the International Stroke Trial (IST), one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.



For each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point (14-days after randomisation or prior discharge) and at 6-months and provide them as an analysable database.



The IST dataset includes data on 19 435 patients with acute stroke, with 99% complete follow-up. Over 26.4% patients were aged over 80 years at study entry. Background stroke care was limited and none of the patients received thrombolytic therapy.



The IST dataset provides a source of primary data which could be used for planning further trials, for sample size calculations and for novel secondary analyses. Given the age distribution and nature of the background treatment given, the data may be of value in planning trials in older patients and in resource-poor settings.
Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD

Clinical manifestations of chronic obstructive pulmonary disease (COPD), including airflow limitation, dyspnea, and activity limitation, ultimately lead to impaired health-related quality of life (HRQoL). This 9-month, randomized, double-blind, multicenter study compared the effect of once-daily tiotropium 18 microg and placebo on HRQoL, spirometric parameters, and exacerbations in 554 patients with moderate-to-severe COPD. HRQoL was assessed using the St. George's Respiratory Questionnaire (SGRQ) and the new 8-item Visual Simplified Respiratory Questionnaire (VSRQ), which is currently being validated. The primary efficacy endpoint was the proportion of patients achieving a reduction of at least 4 units in the SGRQ total score at study end (Month 9). Mean +/- SD baseline SGRQ total score was 47.4 +/- 18.1. Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score vs placebo at study end (59.1% vs 48.2%, respectively; p = 0.029). Tiotropium significantly improved spirometric parameters (forced expiratory volume in 1 second [FEV1]: 0.11 +/- 0.02 L vs 0.01 +/- 0.02 L; between-group difference: 0.10 +/- 0.03 L, p = 0.0001) and reduced exacerbations vs placebo. Maintenance treatment with tiotropium provided significant and clinically relevant improvements in HRQoL, as measured by the SGRQ.
Evaluation of the Fight Asthma Now (FAN) program to improve asthma knowledge in urban youth and teenagers.

School-based asthma education programs targeting disadvantaged youth and teens with asthma are lacking.



To assess the impact of the Fight Asthma Now (FAN) educational program among 2 populations of predominantly low-income minority students: youth (3(rd)-6(th) graders) and teens (7(th)-8(th) graders).



Chicago-area elementary schools were invited to participate in this stratified 2-arm study. Eligible schools were assigned to participate either in the intervention or in the control arm. Within each participating school, eligible students were recruited and grouped (stratified by grade and age) to form teen or youth classes. Participants completed a pre- and post-intervention asthma knowledge questionnaire and observation for spacer technique competency. The treatment group received the FAN curriculum between the evaluations.



A sample of 26 low-income, predominantly minority-serving schools was recruited. Most participating schools were randomized in a 3:1 ratio to form 25 youth classes (19 intervention and 6 control group) and 16 teen classes (11 intervention and 5 control group), resulting in 275 vs 69 youth and 141 vs 51 teens in the intervention and control groups, respectively. Stratified analyses were performed, and clustering within the school and class was taken into consideration in analyses. Multilevel models adjusting for school, class, ethnicity, sex, and pretest score indicate that the FAN intervention significantly increased both knowledge and spacer competency test scores, among both the youth and teen participants (P = .011 with respect to knowledge score among teen students, P < .0001 for all other cases).



This study suggests that FAN significantly increases asthma knowledge and spacer technique competency within this high-risk population.