Schuster A.,Heinrich Heine University Dusseldorf |
Haliburn C.,Data Management |
Doring G.,University of Tubingen |
Goldman M.H.,Forest Laboratories
Thorax | Year: 2013
Purpose To assess efficacy and safety of a new dry powder formulation of inhaled colistimethate sodium in patients with cystic fibrosis (CF) aged ≥6 years with chronic Pseudomonas aeruginosa lung infection. Study design and methods A prospective, centrally randomised, phase III, open-label study in patients with stable CF aged ≥6 years with chronic P aeruginosa lung infection. Patients were randomised to Colobreathe dry powder for inhalation (CDPI, one capsule containing colistimethate sodium 1 662 500 IU, twice daily) or three 28-day cycles with twice-daily 300 mg/5 ml tobramycin inhaler solution (TIS). Study duration was 24 weeks. Results 380 patients were randomised. After logarithmic transformation of data due to a non-normal distribution, adjusted mean difference between treatment groups (CDPI vs TIS) in change in forced expiratory volume in 1 s (FEV1% predicted) at week 24 was -0.98% (95% CI -2.74% to 0.86%) in the intentionto-treat population (n=373) and -0.56% (95% CI -2.71% to 1.70%) in the per protocol population (n=261). The proportion of colistin-resistant isolates in both groups was ≤1.1%. The number of adverse events was similar in both groups. Significantly more patients receiving CDPI rated their device as 'very easy or easy to use' (90.7% vs 53.9% respectively; p<0.001). Conclusion CDPI demonstrated efficacy by virtue of non-inferiority to TIS in lung function after 24 weeks of treatment. There was no emergence of resistance of P aeruginosa to colistin. Overall, CDPI was well tolerated. Source
Lebwohl M.,Mount Sinai School of Medicine |
Swanson N.,Oregon Health And Science University |
Anderson L.L.,Dermatology Associates of Tyler |
Melgaard A.,Data Management |
And 2 more authors.
New England Journal of Medicine | Year: 2012
BACKGROUND: Actinic keratosis is a common precursor to sun-related squamous-cell carcinoma. Treating actinic keratoses and the surrounding skin area (i.e., field therapy) can eradicate clinical and subclinical actinic keratoses. Topical field therapy currently requires weeks or months of treatment. We investigated the efficacy and safety of a new topical field therapy for actinic keratosis, ingenol mebutate gel (0.015% for face and scalp and 0.05% for trunk and extremities). METHODS: In four multicenter, randomized, double-blind studies, we randomly assigned patients with actinic keratoses on the face or scalp or on the trunk or extremities to receive ingenol mebutate or placebo (vehicle), self-applied to a 25-cm 2 contiguous field once daily for 3 consecutive days for lesions on the face or scalp or for 2 consecutive days for the trunk or extremities. Complete clearance (primary outcome) was assessed at 57 days, and local reactions were quantitatively measured. RESULTS: In a pooled analysis of the two trials involving the face and scalp, the rate of complete clearance was higher with ingenol mebutate than with placebo (42.2% vs. 3.7%, P<0.001). Local reactions peaked at day 4, with a mean maximum composite score of 9.1 on the local-skin-response scale (which ranges from 0 to 4 for six types of reaction, yielding a composite score of 0 to 24, with higher numbers indicating more severe reactions), rapidly decreased by day 8, and continued to decrease, approaching baseline scores by day 29. In a pooled analysis of the two trials involving the trunk and extremities, the rate of complete clearance was also higher with ingenol mebutate than with placebo (34.1% vs. 4.7%, P<0.001). Local skin reactions peaked between days 3 and 8 and declined rapidly, approaching baseline by day 29, with a mean maximum score of 6.8. Adverse events were generally mild to moderate in intensity and resolved without sequelae. CONCLUSIONS: Ingenol mebutate gel applied topically for 2 to 3 days is effective for field treatment of actinic keratoses. (Funded by LEO Pharma; ClinicalTrials.gov numbers, NCT00742391, NCT00916006, NCT00915551, and NCT00942604.) Copyright © 2012 Massachusetts Medical Society. Source
Cherala S.S.,Data Management
Preventing Chronic Disease | Year: 2012
Introduction: Obesity is a national epidemic. Gastric bypass surgery may be the only option that provides significant long-term weight loss for people who are morbidly obese (body mass index [BMI] ≥40 kg/m) or for people who have a BMI of 35 or higher and have an obesity-related comorbidity. The objective of this study was to assess trends in gastric bypass surgery in New Hampshire. Methods: Data from 1996 to 2007 from the New Hampshire Inpatient Hospital Discharge data set were analyzed. Records for patients with a gastric bypass surgery code were identified, and data on patients and hospitalizations were collected. A joinpoint regression model was used to analyze trends in surgery rates. Differences between patients and payer types were analyzed by using the Cochran-Mantel-Haenszel χ test. Results: The annual rate of gastric bypass surgery increased significantly from 3.3 to 22.4 per 100,000 adults between 1996 and 2007. The in-hospital death rate decreased significantly from 11% in 1996 to 1% in 2007. A greater proportion of women (78.1% during the study period) than men had this surgery. The average charge of a surgery decreased significantly from $44,484 in 1996 to $43,907 in 2007; by 2007, total annual charges were $13.9 million. Since 1996, private or "other" payers have been charged for nearly 80% of the total discharges. Conclusion: The number of gastric bypass surgeries has increased in New Hampshire, and so have their cost. These increases may reflect a shortage in effective primary care and preventive measures to address the obesity epidemic. Source
Data Management | Date: 2010-08-09
Disclosed is a system for, and method of, determining whether records and entity representations should be delinked. The system and method need no human interaction in order to calculate parameters and utilizing formulas used for the delinking decisions.
Data Management | Date: 2011-01-31
Disclosed is a system for, and method of, calculating parameters used to determine whether records and entity representations should be linked. The system and method use a symmetric and reflexive function to allow for linking records and entity representations whose field values differ. The system and method apply iterative techniques such that parameters from each linking iteration are used in the next linking iteration. The system and method need no human interaction in order to calibrate and utilize record matching formulas used for the linking decisions. These techniques may be used for geographic location proximity matching.