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Burlington, MA, United States

Codsi M.J.,The Everett Clinic | Rodeo S.A.,Hospital for Special Surgery | Scalise J.J.,The CORE Institute | Moorehead T.M.,inVentiv Health | Ma C.B.,University of California at San Francisco
Journal of Shoulder and Elbow Surgery | Year: 2014

This study compared ultrasound and magnetic resonance imaging (MRI) evaluation of the repaired rotator cuff to determine concordance between these imaging studies. Methods: We performed a concordance study using the data from a prospective nonrandomized multicenter study at 13 centers. A suture bridge technique was used to repair 113 rotator cuff tears that were between 1 and 4 cm wide. Repairs were evaluated with MRI and ultrasound at multiple time points after surgery. The MRI scans were read by a central radiologist and the surgeon, and the ultrasounds were read by a local radiologist or the surgeon who performed the ultrasound. Results: The concordance between the central radiologist's MRI reading and the investigator's MRI readings at all time points was 89%, with a κ coefficient of 0.60. The concordance between the central radiologist's MRI and ultrasound readings at all time points was 85%, with a κ coefficient of 0.40. The concordance between the investigator's MRI and ultrasound readings was 92%, with a κ coefficient of 0.70. Conclusions: In the community setting, ultrasound may be used to evaluate the integrity of a repaired rotator cuff tendon and constitutes a comparable alternative to MRI when evaluating the integrity of a rotator cuff repair. Clinical investigators should compare their postoperative ultrasound results with their postoperative MRI results for a certain time period to establish the accuracy of ultrasound before relying solely on ultrasound imaging to evaluate the integrity of their rotator cuff repairs. © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees.

Tikkanen I.,University of Helsinki | Narko K.,Boehringer Ingelheim | Zeller C.,Boehringer Ingelheim | Green A.,inVentiv Health | And 3 more authors.
Diabetes Care | Year: 2015

OBJECTIVE To investigate the efficacy, safety, and tolerability of empagliflozin in patients with type 2 diabetes and hypertension. RESEARCH DESIGN AND METHODS Patients (N = 825) with type 2 diabetes and hypertension (mean seated systolic blood pressure [SBP] 130-159 mmHg and diastolic blood pressure [DBP] 80-99 mmHg) were randomized (double blind) to 10 mg or 25 mg empagliflozin or placebo once daily for 12 weeks. RESULTS At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h SBP (ambulatory blood pressure monitoring [ABPM]) was 23.44 mmHg (95% CI 24.78, 22.09) with 10 mg empagliflozin and 24.16 mmHg (25.50, 22.83) with 25 mg empagliflozin (both P < 0.001). At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h DBP (ABPM) was 21.36 mmHg (95% CI 22.15, 20.56) with 10 mg empagliflozin and 21.72 mmHg (95% CI 22.51, 20.93) with 25 mg empagliflozin (both P < 0.001). Changes in office BP were consistent with ABPM. Adjustedmean difference versus placebo in change from baseline in HbA1c at week 12 was 20.62% (95% CI 20.72, 20.52) (26.8mmol/mol [95% CI27.9,25.7]) with 10 mg empagliflozin and20.65% (95% CI 20.75, 20.55) (27.1 mmol/mol [95% CI 28.2, 26.0]) with 25 mg empagliflozin (both P < 0.001). Empagliflozin was well tolerated.One patient on placebo and one patient on 10 mg empagliflozin reported events consistent with volume depletion. CONCLUSIONS Empagliflozin was associated with significant and clinically meaningful reductions in BP and HbA1c versus placebo and was well tolerated in patients with type 2 diabetes and hypertension. © 2015 by the American Diabetes Association.

Eriksen E.F.,University of Oslo | Keaveny T.M.,University of California at Berkeley | Gallagher E.R.,inVentiv Health | Krege J.H.,Lilly United States LLC
Bone | Year: 2014

Teriparatide is a skeletal anabolic treatment for patients with osteoporosis at high risk for fracture. Because adequate clinical trials have not yet been conducted to assess the efficacy of teriparatide for reducing the risk of hip fracture, we review here the literature regarding how treatment with teriparatide affects the hip in patients with osteoporosis. Teriparatide increases cancellous bone volume, improves bone architecture, and - uniquely among osteoporosis treatments - increases cortical thickness and cortical porosity. By bone scan and positron emission tomography, teriparatide increases bone formation throughout the skeleton, including the hip. Consistent with these findings, studies using dual-energy X-ray absorptiometry and quantitative computed tomography for longitudinal assessment of changes at the hip have consistently shown increases in areal and volumetric bone mineral density, cortical thickness, and finite element-estimated hip strength in patients treated with teriparatide. Finally, in clinical fracture-outcome trials, treatment with teriparatide has been shown to reduce the risk of nonvertebral fracture, a composite endpoint that includes hip fracture. Taken together, this body of evidence suggests that teriparatide positively affects the hip in patients with osteoporosis. © 2014 Elsevier Inc.

inVentiv Health | Date: 2015-05-11

A computer network system and method for printing accompanying information and prescription labels in pharmacies, comprises: a central CS; a PMS; a data transmission network through which said PMS and said central CS can communicate; wherein said PMS includes an I/O terminal, a scanner, and a first printer; wherein said PMS includes a PMS SO and a Catalina SO; said PMS SO is configured to receive and store prescription information for a prescription, and to associate a prescription identification with said prescription; said Catalina SO is configure to select accompanying information for said prescription, to format and save said accompanying information in an accompanying information print file; and said PMS is configured to print a prescription label for said prescription and said accompanying information print file.

inVentiv Health | Date: 2014-05-06

The invention provides a network computer system and novel pharmacy printers and their methods of use wherein the local CS includes a pharmacy printer for printing pharmacy orders including prescriptions, and the pharmacy printer includes a pharmacy printer database storing drug information and association of a drug identifier with information about a corresponding drug, and additional information, and obtains and uses instructions for printing the additional information in association with printing of a prescription label from characters contained in a prescription label print file for the prescription label.

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