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1. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection

Author

Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, and Nelson DR

Subjects
Chronic hepatitis C, NS3 protease inhibitor, non-nucleoside polymerase inhibitor, cirrhosis, antiviral, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Christoph Sarrazin,1 Francesco Castelli,2 Pietro Andreone,3 Maria Buti,4 Massimo Colombo,5 Stanislas Pol,6 Filipe Calinas,7 Massimo Puoti,8 Antonio Olveira,9 Mitchell Shiffman,10 Jerry O Stern,11 George Kukolj,12 Michael Roehrle,13 Stella Aslanyan,11 Qiqi Deng,11 Richard Vinisko,11 Federico J Mensa,11 David R Nelson,14 on behalf of the HCVerso1 and 2 study groups 1Department of Internal Medicine 1, JW Goethe University Hospital, Frankfurt, Germany; 2Department of Infectious and Tropical Diseases, University of Brescia, Brescia, 3Department of Medical and Surgical Sciences, Università di Bologna and Azienda Ospedaliero-Universitaria, Policlinico Sant‘Orsola-Malpighi, Bologna, Italy; 4Department of Internal Medicine, Hospital Universitari Vall d’Hebron and CIBERehd del Instituto Carlos III, Barcelona, Spain; 5Division of Gastroenterology and Hepatology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy; 6University Paris Descartes, Department of Hepatology, Hospital Cochin, APHP and INSERM UMS-20, Institut Pasteur, Paris, France; 7Department of Gastroenterology, Centro Hospitalar de Lisboa Central, Lisbon, Portugal; 8Department of Infectious Diseases, AO Ospedale Niguarda Cà Granda, Milan, Italy; 9Liver Unit, Hospital Universitario La Paz, CIBERehd, Madrid, Spain; 10Liver Institute of Virginia, Bon Secours Health System, Richmond, VA, USA; 11Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 12Boehringer Ingelheim Ltd/Ltée, Burlington, ON, Canada; 13Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; 14Clinical and Translational Science Institute, University of Florida, Gainesville, FL, USA Abstract: The interferon-free combination of once-daily faldaprevir 120 mg, twice-daily deleobuvir 600 mg, and weight-based ribavirin was evaluated in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotype-1b-infected, treatment-naïve patients, including those ineligible for peginterferon (HCVerso2). Patients without cirrhosis were randomized to 16 weeks (Arm 1; n=208 HCVerso1, n=213 HCVerso2) or 24 weeks (Arm 2; n=211 in both studies) of faldaprevir + deleobuvir + ribavirin. Patients with compensated cirrhosis received open-label faldaprevir + deleobuvir + ribavirin for 24 weeks (Arm 3; n=51, n=72). Primary endpoints were comparisons of adjusted sustained virologic response (SVR) rates with historical rates: 71% (HCVerso1) and 68% (HCVerso2). Adjusted SVR12 rates were significantly greater than historical controls for Arms 1 and 2 in HCVerso2 (76%, 95% confidence interval [CI] 71–81, P=0.002; 81%, 95% CI 76–86, P

Published
2016

2. Mammograms in cosmetic breast surgery

Author

Shiffman M

Subjects
Mammograms, Cosmetic Surgery, Breast, Surgery, RD1-811
Abstract

Mammograms are necessary as preoperative preparation for breast surgery in certain patients. There is a definite need for mammograms preoperatively in patients over 40 who should be obtaining mammograms on an annual basis. Under the age of 40 mammograms are up to the discretion of the surgeon. Postoperative mammograms should be obtained as a baseline 6-12 months after breast surgery.

Published
2005

3. Randomized placebo-controlled trial of emricasan for non-alcoholic steatohepatitis-related cirrhosis with severe portal hypertension

Author

Abdelmalek, M., Bhamidimarri, K., Borg, B., Caldwell, S., Fenkel, J., Freilich, B., Fuchs, M., Ghabril, M., Ghalib, R., Gonzalez, S., Gordon, S., Hameed, B., Harrison, S., Kayali, Z., Kemmer, N., Korenblat, K., Lai, M., Landis, C., Lawitz, E., Lee, W., Lidofsky, S., Mena, E., Noureddin, M., Paredes, A., Pyrsopoulos, N., Reddy, R., Rinella, M., Rockey, D., Rodriguez, M., Ryan, M., Sarkar, S., Satapathy, S., Scanga, A., Shiffman, M., Siddiqui, M., Simonetto, D., Syn, W., Thuluvath, P., Vemulapalli, R., Vierling, J., Younes, Z., Albillos, A., Ruiz-Tapiador, J. Arenas, Augustin, S., Calleja, J., Garcia, J. Crespo, Buey, L. Garcia, Garcia-Pagan, J.C., Villanueva, C., Bureau, C., Carbonell, N., Leroy, V., Rautou, P.-E., Heinzow, H., Schiefke, I., Zipprich, A., Berzigotti, A., Muellhaupt, B., Garcia-Tsao, Guadalupe, Bosch, Jaime, Kayali, Zeid, Harrison, Stephen A., Abdelmalek, Manal F., Lawitz, Eric, Satapathy, Sanjaya K., Ghabril, Marwan, Shiffman, Mitchell L., Younes, Ziad H., Thuluvath, Paul J., Berzigotti, Annalisa, Albillos, Agustin, Robinson, James M., Hagerty, David T., Chan, Jean L., and Sanyal, Arun J.

Published
2020
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5. Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis

Author

Pares, A, Shiffman, M, Vargas, V, Invernizzi, P, Malecha, E, Liberman, A, Macconell, L, Hirschfield, G, Pares A., Shiffman M., Vargas V., Invernizzi P., Malecha E. S., Liberman A., MacConell L., Hirschfield G., Pares, A, Shiffman, M, Vargas, V, Invernizzi, P, Malecha, E, Liberman, A, Macconell, L, Hirschfield, G, Pares A., Shiffman M., Vargas V., Invernizzi P., Malecha E. S., Liberman A., MacConell L., and Hirschfield G.

Abstract

Background & Aims: Total bilirubin is a predictor of survival in primary biliary cholangitis, with the main elevated component being direct bilirubin. The purpose of this post hoc analysis was to assess the efficacy and safety of obeticholic acid across quartiles of varying baseline levels of direct bilirubin in the phase 3, randomized, placebo-controlled Primary Biliary Cholangitis Obeticholic Acid International Study of Efficacy. Methods: This analysis assessed patients on the basis of their baseline direct bilirubin level (divided by quartile). Biochemistry and safety outcomes were evaluated within each quartile over time. Results: In the quartile with the highest baseline direct bilirubin (>5.47 µmol/L), there was a significant reduction in both direct and total bilirubin at Month 12 compared with placebo. Least squares mean (standard error) change from baseline in direct bilirubin at Month 12 was 4.17 (1.42) µmol/L for placebo, −3.48 (1.63) µmol/L for obeticholic acid 5-10 mg and −3.66 (1.51) µmol/L for obeticholic acid 10 mg (P <.0001, obeticholic acid vs placebo); the corresponding values for total bilirubin at Month 12 were 4.38 (1.55) µmol/L for placebo, −4.53 (1.83) µmol/L for obeticholic acid 5-10 mg and −5.06 (1.64) µmol/L for obeticholic acid 10 mg (P <.0001, obeticholic acid vs placebo). Conclusions: Obeticholic acid treatment was associated with significant reductions in total and direct bilirubin, particularly in patients with high baseline direct bilirubin. Because raised direct bilirubin levels, even within the normal range, are predictive of survival in primary biliary cholangitis, these results suggest substantial benefits of obeticholic acid in at-risk patients.

Published
2020

6. 223: Development of a CF primary palliative care intervention: Perceptions and preferences of individuals with CF and family caregivers

Author

Basile, M., primary, Dhingra, L., additional, DiFiglia, S., additional, Portenoy, R., additional, Wang, J., additional, Walker, P., additional, Shiffman, M., additional, Pollinger, S., additional, Middour-Oxler, B., additional, Markovitz, M., additional, Linnemann, R., additional, Kier, C., additional, Hardcastle, M., additional, Hadjiliadis, D., additional, Friedman, D., additional, Fischer, F., additional, Berdella, M., additional, Abdullah, R., additional, Yonker, L., additional, and Georgiopoulos, A., additional

Published
2021
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7. 219: Improving assessment for CF pediatric palliative care: Initial development of the ADAPT-CF communication guide with children and caregivers

Author

Middour-Oxler, B., primary, Dhingra, L., additional, Georgiopoulos, A., additional, Wang, J., additional, Friedman, D., additional, Shiffman, M., additional, Portenoy, R., additional, DiFiglia, S., additional, Fischer, F., additional, Abdullah, R., additional, Berdella, M., additional, Hadjiliadis, D., additional, Kier, C., additional, Markovitz, M., additional, Walker, P., additional, Yonker, L., additional, and Linnemann, R., additional

Published
2021
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8. The Immune Landscape of Molecular Bacterial Vaginosis and HPV Natural History

Author

Anne Nucci-Sack, Williams L, Sarah Pickering, Shiffman M, Mykhaylo Usyk, Robert D. Burk, Nicolas F. Schlecht, R Herrero, Ligia A. Pinto, Ana Gradissimo, Safian M, Shankar Viswanathan, Angela Diaz, Christopher C. Sollecito, and Carolina Porras

Subjects
Natural history, Immune system, Immunology, medicine, Biology, Bacterial vaginosis, medicine.disease
Abstract

Bacterial vaginosis (BV) is a highly prevalent condition that is associated with acquisition of sexually transmitted infections and adverse reproductive outcomes. It has been proposed that BV’s role as a pathogenic condition is mediated via bacteria-induced local inflammation. However, the complex interplay between vaginal microbes and host immune factors has yet to be clearly elucidated. We demonstrate that 16S rRNA amplicon sequencing and a novel pipeline can be used to generate a molecular Nugent BV score (molBV) corresponding to the Nugent score 0 - 10. This algorithm is independent of the region of 16S rRNA amplified, the sequencing platform and source population. We further identify two local immune cytokine patterns associated with this molecular Nugent score (q-values

Published
2021
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10. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis

Author

Nevens, F, Andreone, P, Mazzella, G, Strasser, S, Bowlus, C, Drenth, J, Pockros, P, Regula, J, Beuers, U, Trauner, M, Jones, D, Floreani, A, Hohenester, S, Luketic, V, Shiffman, M, van Erpecum, K, Vargas, V, Vincent, C, Hirschfield, G, Shah, H, Hansen, B, Lindor, K, Marschall, H, Kowdley, K, Hooshmand Rad, R, Marmon, T, Sheeron, S, Pencek, R, Macconell, L, Pruzanski, M, Shapiro, D. Collaborator: Carbone, INVERNIZZI, PIETRO, DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, Facolta' di MEDICINA e CHIRURGIA, AREA MIN. 06 - Scienze mediche, Gastroenterology & Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, Graduate School, Other departments, Nevens, F., Andreone, P., Mazzella, G., Strasser, S.I., Bowlus, C., Invernizzi, P., Drenth, J.P.H., Pockros, P.J., Regula, J., Beuers, U., Trauner, M., Jones, D.E., Floreani, A., Hohenester, S., Luketic, V., Shiffman, M., Van Erpecum, K.J., Vargas, V., Vincent, C., Hirschfield, G.M., Shah, H., Hansen, B., Lindor, K.D., Marschall, H.-U., Kowdley, K.V., Hooshmand-Rad, R., Marmon, T., Sheeron, S., Pencek, R., Macconell, L., Pruzanski, M., Shapiro, D., Nevens, F, Andreone, P, Mazzella, G, Strasser, S, Bowlus, C, Invernizzi, P, Drenth, J, Pockros, P, Regula, J, Beuers, U, Trauner, M, Jones, D, Floreani, A, Hohenester, S, Luketic, V, Shiffman, M, van Erpecum, K, Vargas, V, Vincent, C, Hirschfield, G, Shah, H, Hansen, B, Lindor, K, Marschall, H, Kowdley, K, Hooshmand Rad, R, Marmon, T, Sheeron, S, Pencek, R, Macconell, L, Pruzanski, M, Shapiro, and D., C

Subjects
Liver Cirrhosis, Male, 0301 basic medicine, Cirrhosis, Fibroblast Growth Factor, medicine.medical_treatment, Clinical Trial, Phase III, Placebo-controlled study, Liver transplantation, Gastroenterology, Pruritu, chemistry.chemical_compound, 0302 clinical medicine, Primary biliary cirrhosis, Bone Density, Chenodeoxycholic acid, Adult, Aged, Alkaline Phosphatase, Bile Acids and Salts, Chenodeoxycholic Acid, Double-Blind Method, Female, Fibroblast Growth Factors, Humans, Liver Cirrhosis, Biliary, Middle Aged, Pruritus, Non-U.S. Gov't, Medicine (all), Research Support, Non-U.S. Gov't, Biliary, Obeticholic acid, General Medicine, Clinical Trial, Bile Acids and Salt, Multicenter Study, Randomized Controlled Trial, 030211 gastroenterology & hepatology, Human, medicine.medical_specialty, Randomization, Liver Cirrhosi, Research Support, Placebo, 03 medical and health sciences, Phase III, Internal medicine, Journal Article, medicine, business.industry, medicine.disease, Surgery, Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11], 030104 developmental biology, chemistry, business
Abstract

none 32 BACKGROUND Primary biliary cholangitis (formerly called primary biliary cirrhosis) can progress to cirrhosis and death despite ursodiol therapy. Alkaline phosphatase and bilirubin levels correlate with the risk of liver transplantation or death. Obeticholic acid, a farnesoid X receptor agonist, has shown potential benefit in patients with this disease. METHODS In this 12-month, double-blind, placebo-controlled, phase 3 trial, we randomly assigned 217 patients who had an inadequate response to ursodiol or who found the side effects of ursodiol unacceptable to receive obeticholic acid at a dose of 10 mg (the 10-mg group), obeticholic acid at a dose of 5 mg with adjustment to 10 mg if applicable (the 5-10-mg group), or placebo. The primary end point was an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% from baseline, and a normal total bilirubin level. RESULTS Of 216 patients who underwent randomization and received at least one dose of obeticholic acid or placebo, 93% received ursodiol as background therapy. The primary end point occurred in more patients in the 5-10-mg group (46%) and the 10-mg group (47%) than in the placebo group (10%; P

Published
2016
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13. Contributions to the Theory of Games (AM-28), Volume II

Author

ARROW, K. J., BARANKIN, E. W., BLACKWELL, D., BOTT, R., DALKEY, N., DRESHER, M., GALE, D., GILLIES, D. B., GLICKSBERG, I., GROSS, O., KARLIN, S., KUHN, H. W., MAYBERRY, J. P., MILNOR, J. W., MOTZKIN, T. S., VON NEUMANN, J., RAIFFA, H., SHAPLEY, L. S., SHIFFMAN, M., STEWART, F. M., THOMPSON, G. L., THRALL, R. M., Kuhn, H. W., Tucker, A. W., ARROW, K. J., BARANKIN, E. W., BLACKWELL, D., BOTT, R., DALKEY, N., DRESHER, M., GALE, D., GILLIES, D. B., GLICKSBERG, I., GROSS, O., KARLIN, S., KUHN, H. W., MAYBERRY, J. P., MILNOR, J. W., MOTZKIN, T. S., VON NEUMANN, J., RAIFFA, H., SHAPLEY, L. S., SHIFFMAN, M., STEWART, F. M., THOMPSON, G. L., THRALL, R. M., Kuhn, H. W., and Tucker, A. W.

Published
2016
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16. Long-term clearance of hepatitis C virus following interferon α-2b or peginterferon α-2b, alone or in combination with ribavirin

Author

Manns, M. P., Pockros, P. J., Norkrans, G., Smith, C. I., Morgan, T. R., Häussinger, D., Shiffman, M. L., Hadziyannis, S. J., Schmidt, W. N., Jacobson, I. M., Bárcena, R., Schiff, E. R., Shaikh, O. S., Bacon, B., Marcellin, P., Deng, W., Esteban-Mur, R., Poynard, T., Pedicone, L. D., Brass, C. A., Albrecht, J. K., and Gordon, S. C.

Published
2013
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18. P254 Development of a primary palliative care model that includes a novel approach to address the needs of caregivers of adults with cystic fibrosis - improving life with cystic fibrosis: a primary palliative care partnership

Author

Georgiopoulos, A.M., primary, Glajchen, M., additional, Markovitz, M., additional, Portenoy, R., additional, DiFiglia, S., additional, Wang, J., additional, Walker, P., additional, Shiffman, M., additional, Pollinger, S., additional, Middour-Oxler, B., additional, Linnemann, R.W., additional, Kier, C., additional, Hardcastle, M., additional, Hadjiliadis, D., additional, Friedman, D., additional, Fischer, F., additional, Berdella, M., additional, Basile, M., additional, Abdullah, R., additional, Yonker, L., additional, and Dhingra, L., additional

Published
2021
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19. Randomized placebo-controlled trial of emricasan for non-alcoholic steatohepatitis-related cirrhosis with severe portal hypertension

Author

Garcia-Tsao, Guadalupe, primary, Bosch, Jaime, additional, Kayali, Zeid, additional, Harrison, Stephen A., additional, Abdelmalek, Manal F., additional, Lawitz, Eric, additional, Satapathy, Sanjaya K., additional, Ghabril, Marwan, additional, Shiffman, Mitchell L., additional, Younes, Ziad H., additional, Thuluvath, Paul J., additional, Berzigotti, Annalisa, additional, Albillos, Agustin, additional, Robinson, James M., additional, Hagerty, David T., additional, Chan, Jean L., additional, Sanyal, Arun J., additional, Abdelmalek, M., additional, Bhamidimarri, K., additional, Borg, B., additional, Caldwell, S., additional, Fenkel, J., additional, Freilich, B., additional, Fuchs, M., additional, Ghabril, M., additional, Ghalib, R., additional, Gonzalez, S., additional, Gordon, S., additional, Hameed, B., additional, Harrison, S., additional, Kayali, Z., additional, Kemmer, N., additional, Korenblat, K., additional, Lai, M., additional, Landis, C., additional, Lawitz, E., additional, Lee, W., additional, Lidofsky, S., additional, Mena, E., additional, Noureddin, M., additional, Paredes, A., additional, Pyrsopoulos, N., additional, Reddy, R., additional, Rinella, M., additional, Rockey, D., additional, Rodriguez, M., additional, Ryan, M., additional, Sarkar, S., additional, Satapathy, S., additional, Scanga, A., additional, Shiffman, M., additional, Siddiqui, M., additional, Simonetto, D., additional, Syn, W., additional, Thuluvath, P., additional, Vemulapalli, R., additional, Vierling, J., additional, Younes, Z., additional, Albillos, A., additional, Ruiz-Tapiador, J. Arenas, additional, Augustin, S., additional, Calleja, J., additional, Garcia, J. Crespo, additional, Buey, L. Garcia, additional, Garcia-Pagan, J.C., additional, Villanueva, C., additional, Bureau, C., additional, Carbonell, N., additional, Leroy, V., additional, Rautou, P.-E., additional, Heinzow, H., additional, Schiefke, I., additional, Zipprich, A., additional, Berzigotti, A., additional, and Muellhaupt, B., additional

Published
2020
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39. Hcverso1 and 2: Faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection

Author

Sarrazin, C, Castelli, F, Andreone, P, Buti, M, Colombo, M, Pol, S, Calinas, F, Puoti, M, Olveira, A, Shiffman, M, Stern, J, Kukolj, G, Roehrle, M, Aslanyan, S, Deng, Q, Vinisko, R, Mensa, F, Nelson, D, Sarrazin C., Castelli F., Andreone P., Buti M., Colombo M., Pol S., Calinas F., Puoti M., Olveira A., Shiffman M., Stern J. O., Kukolj G., Roehrle M., Aslanyan S., Deng Q., Vinisko R., Mensa F. J., Nelson D. R., Sarrazin, C, Castelli, F, Andreone, P, Buti, M, Colombo, M, Pol, S, Calinas, F, Puoti, M, Olveira, A, Shiffman, M, Stern, J, Kukolj, G, Roehrle, M, Aslanyan, S, Deng, Q, Vinisko, R, Mensa, F, Nelson, D, Sarrazin C., Castelli F., Andreone P., Buti M., Colombo M., Pol S., Calinas F., Puoti M., Olveira A., Shiffman M., Stern J. O., Kukolj G., Roehrle M., Aslanyan S., Deng Q., Vinisko R., Mensa F. J., and Nelson D. R.

Abstract

The interferon-free combination of once-daily faldaprevir 120 mg, twice-daily deleobuvir 600 mg, and weight-based ribavirin was evaluated in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotype-1b-infected, treatment-naïve patients, including those ineligible for peginterferon (HCVerso2). Patients without cirrhosis were randomized to 16 weeks (Arm 1; n=208 HCVerso1, n=213 HCVerso2) or 24 weeks (Arm 2; n=211 in both studies) of faldaprevir + deleobuvir + ribavirin. Patients with compensated cirrhosis received open-label faldaprevir + deleobuvir + ribavirin for 24 weeks (Arm 3; n=51, n=72). Primary endpoints were comparisons of adjusted sustained virologic response (SVR) rates with historical rates: 71% (HCVerso1) and 68% (HCVerso2). Adjusted SVR12 rates were significantly greater than historical controls for Arms 1 and 2 in HCVerso2 (76%, 95% confidence interval [CI] 71–81, P=0.002; 81%, 95% CI 76–86, P<0.0001) and Arm 2 in HCVerso1 (81%, 95% CI 77–86, P<0.0001), but not for Arm 1 of HCVerso1 (72%, 95% CI 66–77, P=0.3989). Unadjusted SVR12 rates in Arms 1, 2, and 3 were 71.6%, 82.5%, and 72.5%, respectively, in HCVerso1 and 75.6%, 82.0%, and 73.6%, respectively, in HCVerso2. Virologic breakthrough and relapse occurred in 24-week arms in 8%–9% and 1% of patients, respectively, and in 16-week arms in 7%–8% and 9%–11% of patients, respectively. The most common adverse events were nausea (46%–61%) and vomiting (29%–35%). Adverse events resulted in discontinuation of all medications in 6%–8% of patients. In treatmentnaïve patients with hepatitis C virus genotype-1b infection, with or without cirrhosis, faldaprevir + deleobuvir + ribavirin treatment for 24 weeks resulted in adjusted SVR12 rates significantly higher than historical controls. Both studies were registered in ClinicalTrials. gov (NCT01732796, NCT01728324).

Published
2016

40. Negative-Pressure Wound Therapy as Prevention Measure After Cardiac Surgery: Principles and Techniques

Author

Valen, Richard, Domingues, Carina, Bogers, Ad, Shiffman, M., Low, M., and Cardiothoracic Surgery

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Treatment duration, Psychological intervention, Surgical wound, Cardiac surgery, Intervention (counseling), Negative-pressure wound therapy, Perioperative care, Medicine, business, Intensive care medicine, Surgical site infection
Abstract

Reduction of surgical site infection (SSI) rates after (cardiac) surgery remains an important topic for all involved in the surgical domain. These infections lead to a higher risk for mortality and an increased morbidity in the individual patient. Despite many advances in perioperative care, however, the percentage of SSI has not declined. On a macrolevel, the costs associated with SSI are enormous, and all possible interventions to reduce SSI should be investigated. A possible new intervention is negative topical pressure therapy on clean, closed surgical wounds. In this chapter the theory behind this technique is explored, advice on patient selection is given, and treatment duration is discussed.

Published
2018

43. Prospective evaluation of serum gamma-glutamyl transferase (GGT) for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis (PSC)

Author

Levy, C., primary, Shiffman, M., additional, Janssen, H., additional, Montano-Loza, A., additional, Caldwell, S., additional, Luketic, V., additional, Ding, D., additional, Mccolgan, B., additional, Myers, R., additional, Eksteen, B., additional, Chapman, R.W.G., additional, Manns, M.P., additional, Goodman, Z., additional, Bowlus, C., additional, Muir, A., additional, and Hirschfield, G., additional

Published
2018
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44. Pharmacokinetics and pharmacodynamics of seladelpar, a potent and selective PPAR-delta, in patients with primary biliary cholangitis

Author

Boudes, P., primary, Michael, G., additional, Bowlus, C., additional, Hirschfield, G., additional, Jones, D., additional, Odin, J., additional, Sheridan, D., additional, Gitlin, N., additional, Harrison, S., additional, Hassanein, T., additional, Levy, C., additional, Shiffman, M., additional, Thorburn, D., additional, Thuluvath, P.J., additional, Vierling, J., additional, Choi, Y.-J., additional, Varga, M., additional, (Sasha) Steinberg, A., additional, Mcwherter, C., additional, and Martin, R., additional

Published
2018
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45. Treatment efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor delta agonist, in primary biliary cholangitis patients: 12- and 26-week analysis from an ongoing international, randomized, dose raging phase 2 study

Author

Hirschfield, G., primary, Boudes, P., additional, Bowlus, C., additional, Gitlin, N., additional, Michael, G., additional, Harrison, S., additional, Gordon, S.C., additional, Aspinall, R., additional, Doerffel, Y., additional, Kremer, A.E., additional, Sheridan, D., additional, Bacon, B., additional, Berg, C., additional, Borg, B., additional, Hassanein, T., additional, Odin, J., additional, Shiffman, M., additional, Thuluvath, P.J., additional, Thorburn, D., additional, Bernstein, D., additional, Buggisch, P., additional, Corless, L., additional, Levy, C., additional, Mayo, M.J., additional, Swain, M.G., additional, Vierling, J., additional, Wörns, M.-A., additional, Steinberg, A.(S.), additional, Bergheanu, S., additional, Choi, Y.-J., additional, Varga, M., additional, Martin, R., additional, Mcwherter, C., additional, and Jones, D., additional

Published
2018
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47. A phase 3b, open-label, randomized, pragmatic study of glecaprevir/pibrentasvir +/− ribavirin (RBV) for HCV genotype 1 subjects who previously failed an NS5A Inhibitor + sofosbuvir (SOF) therapy

Author

Lok, A., primary, Willner, I., additional, Reddy, R., additional, Hassan, M., additional, Hinestrosa, F., additional, Shiffman, M., additional, Sulkowski, M., additional, Brown, R., additional, Morelli, G., additional, Peter, J., additional, Fried, M.W., additional, Vainorius, M., additional, Michael, L., additional, Wang, G., additional, Hu, Y., additional, Kort, J., additional, and Nelson, D.R., additional

Published
2018
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