bluuebunny/crossref_metadata_2025_split huggingface dataset:
Delayed-Release Oral Mesalamine 4.8 g/day (800 mg tablets) Compared with 2.4 g/day (400 mg tablets) for the Treatment of Mildly to Moderately Active Ulcerative Colitis: The ASCEND I Trial
Authors: Hanauer Stephen B , Sandborn William J , Dallaire Christian , Archambault André , Yacyshyn Bruce , Yeh Chyon , Smith-Hall Nancy 
Published: March 2016

BACKGROUND: Delayed-release oral mesalamine 2.4 g/day to 4.8 g/day has been shown to be effective in treating mildly to moderately active ulcerative colitis (UC), but it is unknown whether an initial dose of 4.8 g/day is more effective than 2.4 g/day in patients with mildly to moderately active UC and in the subgroup with moderate disease.PATIENTS AND METHODS: A six-week, multicentre, randomized, double-blind, controlled trial assessing the safety and clinical efficacy of a new dose (ASCEND I) of medication randomly assigned 301 adults with mildly to moderately active UC to delayed-release oral mesalamine 2.4 g/day (400 mg tablet [n=154]) or 4.8 g/day (800 mg tablet [n=147]). The primary efficacy end point was overall improvement (ie, treatment success), defined as complete remission or response to therapy from baseline to week 6. Primary safety end points were adverse events and laboratory evaluations. Data were also analyzed separately for the prespecified subgroup of patients with moderate UC at baseline.RESULTS: Treatment success was not statistically different between the treatment groups at week 6; 51% of the group (77 of 150) who received delayed-release oral mesalamine 2.4 g/day and 56% of the group (76 of 136) who received 4.8 g/day reached the efficacy end point (P=0.441). Among the moderate disease subgroup, however, the higher initial dose was more effective; 57% of patients (53 of 93) given delayed-release oral mesalamine 2.4 g/day and 72% of patients (55 of 76) given 4.8 g/day achieved treatment success (P=0.0384). Both regimens were well tolerated.CONCLUSIONS: Delayed-release oral mesalamine is an effective and well-tolerated initial therapy in patients with mildly to moderately active UC, and a 4.8 g/day dose may enhance treatment success rates in patients with moderate disease compared with mesalamine 2.4 g/day.
The Effect of Sham Feeding on Neurocardiac Regulation in Healthy Human Volunteers
Authors: Kamath Markad V , Spaziani Robert , Ullal Sangeeta , Tougas Gervais , Guzman Juan C , Morillo Carlos , Capogna Joshua , Al-Bayati Mohammed , Armstrong David 
Published: March 2016

BACKGROUND: Distension and electrical stimuli in the esophagus alter heart rate variability (HRV) consistent with activation of vagal afferent and efferent pathways. Sham feeding stimulates gastric acid secretion by means of vagal efferent pathways. It is not known, however, whether activation of vagal efferent pathways is organ- or stimulus-specific.OBJECTIVE: To test the hypothesis that sham feeding increases the high frequency (HF) component of HRV, indicating increased neurocardiac vagal activity in association with the known, vagally mediated, increase in gastric acid secretion.METHODS: Continuous electrocardiography recordings were obtained in 12 healthy, semirecumbent subjects during consecutive 45 min baseline, 20 min sham feeding (standard hamburger meal) and 45 min recovery periods. The R-R intervals and beat-to-beat heart rate signal were determined from digitized electrocardiography recordings; power spectra were computed from the heart rate signal to determine sympathetic (low frequency [LF]) and vagal (HF) components of HRV.RESULTS: Heart rate increased during sham feeding (median 70.8 beats/min, 95% CI 66.0 to 77.6; P<0.001), compared with baseline (63.6, 95% CI 60.8 to 70.0) and returned to baseline levels within 45 min. Sham feeding increased the LF to HF area ratio (median: 1.55, 95% C.I 1.28 to 1.77; P<0.021, compared with baseline (1.29, 95% CI 1.05 to 1.46); this increase in LF to HF area ratio was associated with a decrease in the HF component of HRV.CONCLUSIONS: Sham feeding produces a reversible increase in heart rate that is attributable to a decrease in neurocardiac parasympathetic activity despite its known ability to increase vagally mediated gastric acid secretion. These findings suggest that concurrent changes in cardiac and gastric function are modulated independently by vagal efferent fibres and that vagally mediated changes in organ function are stimulus- and organ-specific.
Anxiety Sensitivity, Fear of Pain and Pain‐Related Disability in Children and Adolescents with Chronic Pain
Authors: Martin Andrea L , McGrath Patricia A , Brown Stephen C , Katz Joel 
Published: March 2016

BACKGROUND: Converging lines of evidence suggest that anxiety sensitivity and fear of pain may be important vulnerability factors in the development of avoidance behaviours and disability in adults with chronic pain. However, these factors have not been evaluated in children with chronic pain.OBJECTIVES: To examine the relationships among anxiety sensitivity, fear of pain and pain‐related disability in children and adolescents with chronic pain.METHODS: An interview and five questionnaires (Childhood Anxiety Sensitivity Index, Pain Anxiety Symptoms Scale, Functional Disability Inventory, Multidimensional Anxiety Scale for Children, and Reynolds Child or Adolescent Depression Scale) were administered to 21 children and adolescents eight to 17 years of age (mean ± SD 14.24±2.21 years) who continued to experience pain an average of three years after discharge from a specialized pain clinic for children.RESULTS: Anxiety sensitivity accounted for 38.6% of the variance in fear of pain (F[1,20]=11.30; P=0.003) and fear of pain accounted for 39.9% of the variance in pain‐related disability (F[1,20]=11.95; P=0.003), but anxiety sensitivity was not significantly related to pain disability (R2=0.09; P>0.05).CONCLUSIONS: These findings indicate that children with high levels of anxiety sensitivity had a higher fear of pain, which, in turn, was linked to increased pain disability. The results of this study suggest that anxiety sensitivity and fear of pain may play important and distinct roles in the processes that maintain chronic pain and pain‐related disability in children.
N-acetyltransferase 2 Slow Acetylator Genotype Associated with Adverse Effects of Sulfasalazine in the Treatment of Inflammatory Bowel Disease
Authors: Chen Min , Xia Bing , Chen Bixiao , Guo Qiusha , Li Jin , Ye Mei , Hu Zhengguo 
Published: March 2016

AIM:N-acetyltransferase 2 (NAT2) is an important enzyme catalyzingN-acetylation of sulfasalazine (SASP). The aim of the present study was to investigate associations of the genotypes ofNAT2with inflammatory bowel disease (IBD), and with adverse effects of SASP, which is used as the first-line treatment of IBD.PATIENTS AND METHODS: The wildtype allele (NAT2*4) and three variant alleles (NAT2*5B, NAT2*6AandNAT*7B) of theNAT2gene were determined in 101 patients with IBD (84 patients with ulcerative colitis and 17 patients with Crohn’s disease) and 109 healthy controls by the polymerase chain reaction-restriction fragment length polymorphism method. Sixty-eight patients with IBD treated with SASP were followed, and their adverse reactions were recorded.RESULTS: Eleven patients (16%) experienced adverse effects from SASP, including nine cases of sulfapyridine (SP) dose-related adverse effects and two cases of hypersensitivity (skin rash). Patients with the slow acetylator genotypes without theNAT2*4allele experienced adverse effects more frequently (36%) than those with the fast acetylator genotypes with at least oneNAT2*4allele (11%), but the results were not significantly different (OR of 0.26, 95% CI 0.065 to 1.004; P=0.051). However, those with the slow acetylator genotypes experienced more SP dose-related adverse effects than those with the fast acetylator genotypes (36% versus 8%, OR of 0.17, 95% CI 0.039 to 0.749; P=0.019).CONCLUSIONS: TheNAT2gene polymorphism was not associated with susceptibility to IBD in Chinese populations, but theNAT2slow acetylator genotypes were significantly associated with SP dose-related adverse effects of SASP in the treatment of IBD.
Airflow Obstruction in Young Adults in Canada
Authors: Al-Hazmi Manal , Wooldrage Kate , Anthonisen Nicholas R , Becklake Margaret R , Bowie Dennis , Chan-Yeung Moira , Dimich-Ward Helen , Ernst Pierre , Manfreda Jure , Sears Malcolm R , Siersted Hans C , Sweet Lamont , Van Til Linda 
Published: March 2016

OBJECTIVE: Airflow obstruction is relatively uncommon in young adults, and may indicate potential for the development of progressive disease. The objective of the present study was to enumerate and characterize airflow obstruction in a random sample of Canadians aged 20 to 44 years.SETTING: The sample (n=2962) was drawn from six Canadian sites.DESIGN: A prevalence study using the European Community Respiratory Health Survey protocol was conducted. Airflow obstruction was assessed by spirometry. Bronchial responsiveness, skin reactivity to allergens and total serum immunoglobulin E were also measured. Logistic regression was used for analysis.RESULTS: Airflow obstruction was observed in 6.4% of the sample, not associated with sex or age. The risk of airflow obstruction increased in patients who had smoked and in patients who had lung trouble during childhood. Adjusted for smoking, the risk of airflow obstruction was elevated for subjects with past and current asthma, skin reactivity to allergens, elevated levels of total immunoglobulin E and bronchial hyper‐responsiveness. Of the subjects with airflow obstruction, 21% were smokers with a history of asthma, 50% were smokers without asthma, 12% were nonsmokers with asthma and 17% were nonsmokers with no history of asthma. Bronchial hyper‐responsiveness increased the prevalence of airflow obstruction in each of these groups.CONCLUSION: Smoking and asthma, jointly and individually, are major determinants of obstructive disorders in young adults. Bronchial hyper‐responsiveness contributes to obstruction in both groups.
Acceptance of Colonoscopy Requires more than Test Tolerance
Authors: Condon Amanda , Graff Lesley , Elliot Lawrence , Ilnyckyj Alexandra 
Published: March 2016

BACKGROUND: Colon cancer screening, including colonoscopy, lags behind other forms of cancer screening for participation rates. The intrinsic nature of the endoscopic procedure may be an important barrier that limits patients from finding this test acceptable and affects willingness to undergo screening. With colon cancer screening programs emerging in Canada, test characteristics and their impact on acceptance warrant consideration.OBJECTIVES: To measure the acceptability of colonoscopy and define factors that contribute to procedural acceptability, in relation to another invasive gastrointestinal scope procedure, gastroscopy.PATIENTS AND METHODS: Consecutive patients undergoing a colonoscopy (n=55) or a gastroscopy (n=33) were recruited. Their procedural experience was evaluated and compared pre-endoscopy, immediately before testing and postendoscopy. Questionnaires were used to capture multiple domains of the endoscopy experience and patient characteristics.RESULTS: Patient scope groups did not differ preprocedurally for general or procedure-specific anxiety. However, the colonoscopy group did anticipate more pain. Those who had a gastroscopy demonstrated higher preprocedural acceptance than those who had a colonoscopy. The colonoscopy group had a significant decrease in scope concerns and anxiety postprocedurally. As well, they reported less pain than they anticipated. Regardless, postprocedurally, the colonoscopy group’s acceptance did not increase significantly, whereas the gastroscopy group was almost unanimous in their test acceptance. The best predictor of pretest acceptability of colonoscopy was anticipated pain.CONCLUSIONS: The findings indicate that concerns that relate specifically to colonoscopy, including anticipated pain, influence acceptability of the procedure. However, the experience of a colonoscopy does not lead to improved test acceptance, despite decreases in procedural anxiety and pain. Patients’ preprocedural views of the test are most important and should be addressed directly to potentially improve participation in colonoscopy.
A Comparison of Self-Perceived Health Status in Inflammatory Bowel Disease and Irritable Bowel Syndrome Patients from a Canadian National Population Survey
Authors: Tang Linda YL , Nabalamba Alice , Graff Leslie A , Bernstein Charles N 
Published: March 2016

OBJECTIVE: To determine whether differences exist in perceptions of physical health, mental health and stress levels between patients with inflammatory bowel disease (IBD) and patients with irritable bowel syndrome (IBS).METHODS: Data were obtained from the 2005 Canadian Community Health Survey, which had a sample size of 132,947 Canadians. Information on 4441 participants aged 19 years or older who reported that they had been diagnosed with Crohn’s disease (n=474), ulcerative colitis (n=637) or IBS (n=3330) was analyzed regarding perceptions of their physical health, mental health, stress levels and activity levels.RESULTS: Overall, IBD patients reported being in fair to poor health (P<0.01) more often than IBS patients. In addition, IBS patients were more likely than IBD patients to report poor mental health status (P<0.01) and greater stress levels (P<0.01). In multivariate analyses, having IBS or IBD along with another chronic disease significantly increased the odds of reporting poorer health status.CONCLUSIONS: People with IBD were more likely to experience fair or poor general health. IBS patients reported higher levels of stress and poorer mental health than IBD patients. When IBS or IBD coexisted with another chronic condition, activity participation at home and at work was significantly more likely to be impaired.
Effect of Maintenance Azithromycin on Established Bronchiolitis Obliterans Syndrome in Lung Transplant Patients
Authors: Porhownik Nancy R , Batobara Wael , Kepron Wayne , Unruh Helmut W , Bshouty Zoheir 
Published: March 2016

BACKGROUND: Bronchiolitis obliterans syndrome (BOS), the main cause of late mortality following lung transplantation, is defined as an irreversible decline in forced expiratory volume in 1 s (FEV1).Previous studies using azithromycin for BOS in lung transplant patients have demonstrated a potential reversibility of the decline in FEV1.OBJECTIVES: To examine whether initiating azithromycin reverses decline in FEV1 in lung transplant recipients with established BOS of at least three months.METHODS: Pulmonary function tests were performed every three months in seven lung transplant recipients with established BOS of at least three months. FEV1 was recorded at six and three months before initiation, at time of initiation, and three, six, nine and 12 months postazithromycin initiation. The primary end point was change in FEV1. During the study, no immunosuppressive medication changes or acute rejection episodes occurred.RESULTS: Mean time from transplant to azithromycin initiation was 64 months (range 17 to 117 months). Mean time from BOS diagnosis to azithromycin initiation was 22 months (range three to 67 months). Rate of FEV1 decline from six months before azithromycin initiation, and rates of FEV1 increase from initiation to three and 12 months post‐treatment initiation, were not statistically significant (P=0.32, P=0.16 and P=0.18, respectively). Following a trend toward improvement in the first three months after treatment initiation, FEV1 tended to stabilize.DISCUSSION: Although several studies address the possible benefit of maintenance azithromycin in lung transplant patients with BOS, the role of the drug remains unproven in these patients, and would best be addressed by a large randomized controlled trial.
Economic Evaluation of Voriconazole for the Treatment of Candidemia in Canadian Adults
Authors: Rotstein Coleman , Cragin Lael , Laverdière Michel , Garber Gary , Bow Eric J , Scalera Alissa , Roberts Craig , Sorenson Sonja V , the Canadian Expert Panel  
Published: March 2016

BACKGROUND: Candidemia is a common cause of nosocomial bloodstream infection. When selecting therapeutic treatments for candidemia, cost‐effectiveness is an important consideration. The present study assessed the cost‐effectiveness of voriconazole for the treatment of candidemia.METHODS: A decision‐analytical model was used for evaluating the cost‐effectiveness of voriconazole compared with a regimen of conventional amphotericin B (CAB) followed by fluconazole (FLU) in the treatment of non‐neutropenic patients diagnosed with candidemia in the Canadian setting, based on the Global Candidemia Study. The time frame of the model was 98 days (14 weeks). Model parameters were based primarily on clinical outcome, and resource use data collected from the clinical trial were used. Supplemental data were obtained from an independent panel of 12 Canadian experts for parameters not available from the clinical trial. Unit costs were collected from Canadian sources. The outcome variables selected in the study were the number of patients cured within 98 days, the number of patients surviving at 98 days and the number of patients avoiding toxicity. Incremental costs per outcome were calculated to compare the cost‐effectiveness analyses (both probabilistic and one‐way sensitivity analyses were performed).RESULTS: The cost‐effectiveness analysis demonstrated a difference of $1,121 in the total average cost of treatment with voriconazole ($70,489) versus CAB/FLU ($69,368). While the costs of voriconazole exceeded the costs of CAB/FLU, these costs were almost completely offset by lower hospitalization costs. While patients in both treatment arms experienced cure rates of 41%, both the percentage of patients surviving at day 98 (64.5% versus 58.2%) and the percentage of patients avoiding toxicity (64.5% versus 52.5%) were higher in the voriconazole arm. Accounting for differences in total costs and clinical outcomes, this analysis estimated an incremental cost per patient surviving at day 98 of $17,739, and an incremental cost per patient avoiding toxicity of $9,298. In the case of cost per patient cured, voriconazole had a higher cost ($1,121) than CAB/FLU. The results of the deterministic and probabilistic sensitivity analyses indicated that the model was robust.CONCLUSIONS: Results of the decision‐analytical model provided evidence to support the cost‐effectiveness of voriconazole relative to a regimen of CAB/FLU in the treatment of non‐neutropenic patients diagnosed with candidemia in the Canadian setting.
A Randomized, Double‐Blind, Crossover Comparison of the Efficacy and Safety of Oral Controlled‐Release Tramadol and Placebo in Patients with Painful Osteoarthritis
Authors: Thorne Carter , Beaulieu André D , Callaghan Denis J , O’Mahony William F , Bartlett John M , Knight Richard , Kraag Gunnar R , Akhras Ronald , Piraino Paula S , Eisenhoffer John , Harsanyi Zoltan , Darke Andrew C 
Published: March 2016

OBJECTIVE: To compare the efficacy and safety of controlled‐release (CR) tramadol (Zytram XL, Purdue Pharma, Canada) and placebo in patients with painful osteoarthritis.METHODS: Patients underwent analgesic washout for two to seven days before random assignment to 150 mg daily of CR tramadol or placebo, and were titrated weekly to 200 mg, 300 mg or a maximum of 400 mg once daily. After four weeks, patients crossed over to the alternate treatment for another four weeks. Plain acetaminophen was provided as a rescue analgesic. All patients who completed the crossover study were eligible to receive open label CR tramadol for six months.RESULTS: Seventy‐seven of 100 randomly assigned patients were evaluable for efficacy. CR tramadol resulted in significantly lower visual analogue scale pain intensity scores (37.4±23.9 versus 45.1±24.3, P=0.0009). Western Ontario and McMaster Universities osteoarthritis index subscale scores for pain (189.0±105.0 versus 230.0±115.4; P=0.0001) and physical function (632.4±361.3 versus 727.4±383.4; P=0.0205) were significantly better with CR tramadol. Total pain and disability (22.8±14.5 versus 27.2±14.8; P=0.0004), and overall pain and sleep (104.7±98.0 versus 141.0±108.2; P=0.0005) scores in the Pain and Sleep Questionnaire were significantly lower for CR tramadol. Short‐form 36 Health Survey scores were significantly better during CR tramadol treatment for the pain index (38.8±10.8 versus 35.6±9.0; P=0.0100), general health perception (46.5±11.2 versus 44.4±11.6; P=0.0262), vitality (43.1±13.2 versus 40.2±13.7; P=0.0255) and overall physical components (40.8±8.9 versus 37.8±7.7; P=0.0002). CR tramadol treatment was preferred by 55.8% of patients (P=0.0005) versus 20.8% and 23.4% of patients who chose placebo or had no preference, respectively. These improvements were sustained for up to six months, and 86.5% of patients reported at least moderate benefit from CR tramadol during long‐term treatment.CONCLUSION: CR tramadol is effective for the management of painful osteoarthritis.
Does Blood Urea Nitrogen Level Predict Severity and High-Risk Endoscopic Lesions in Patients with Nonvariceal Upper Gastrointestinal Bleeding?
Authors: Al-Naamani Khalid , Alzadjali Nabil , Barkun Alan N , Fallone Carlo A 
Published: March 2016

BACKGROUND: Nonvariceal upper gastrointestinal bleeding (UGIB) is a serious medical condition requiring prompt resuscitation and early endoscopic therapy in those with high-risk endoscopic lesions (HRLs). There are little or no data correlating sole blood urea nitrogen (BUN) level with the severity of nonvariceal UGIB or the presence of HRLs in the adult population.OBJECTIVES: To determine if the BUN level on presentation correlates with parameters of severity of UGIB (need for blood transfusion or intensive care unit [ICU] admission) or to the subsequent finding of HRL, and in so doing identify patients who will require early endoscopic intervention.METHODS: The Canadian Registry of patients with Upper Gastrointestinal Bleeding undergoing Endoscopy was used to identify patients enrolled from the McGill University Health Centre (Montreal, Quebec) who presented with or developed acute nonvariceal UGIB while admitted. All comparisons were performed using Student’sttest or Wilcoxon’s signed rank test, as appropriate. Logistic regression modelling using a stepwise method was performed to identify independent predictors of severe nonvariceal UGIB and HRL.RESULTS: Two hundred nine patients were enrolled in the study. The mean age was 67±18 years and 59.8% were male. The mean BUN level was 13.4±9.4 mmol/L. Univariate analysis demonstrated that the BUN level was a significant predictor of ICU admission (BUN 14.7±10.4 mmol/L versus 12.0±8.0 mmol/L, P=0.035). However, when adjusted for systolic blood pressure, BUN level became a weaker predictor of ICU admission, just failing to achieve statistical significance (OR 1.03, 95% CI 1.00 to 1.06; P=0.08). Univariate analysis also demonstrated that BUN level was not a statistically significant predictor of blood transfusion requirement (BUN 14.1±10.6 mmol/L versus 13.6±8.6 mmol/L, P=0.508), nor of HRL (BUN 14.2±10.7 mmol/L versus 12.9±8.6 mmol/L, P=0.605).CONCLUSION: In patients with nonvariceal UGIB, the BUN level at initial presentation is a weak predictor of the severity of UGIB as defined by ICU admission, but is not helpful in identifying patients with a HRL.