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Author Mark S. BLUMENKRANZ,; PALANKER, D.V.; MORDAUNT, D.H.; ANDERSEN, D.E. openurl 
  Title Method And Apparatus For Patterned Plasma-Mediated Laser Trephination Of The Lens Capsule And Three Dimensional Phaco-Segmentation Type Patent
  Year 2006 Publication Abbreviated Journal  
  Volume Issue Pages  
  Keywords Pct6074469; Pctus06000873; Wo06074469; Wous2006000873  
  Abstract System and method for making incisions in eye tissue at different depths. The system and method focuses light, possibly in a pattern, at various focal points which are at various depths within the eye tissue. A segmented lens can be used to create multiple focal points simultaneously. Optimal incisions can be achieved by sequentially or simultaneously focusing lights at different depths, creating an expanded column of plasma, and creating a beam with an elongated waist.  
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  Notes Approved no  
  Call Number (up) 13052 Serial 6929  
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Author openurl 
  Title ADALIMUMAB (HUMIRAr) PLUS METHOTREXATE IS SAFE AND EFFICACIOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS INTO THE 7TH YEAR OF THERAPY Type Journal Article
  Year 2005 Publication Ann Rheum Dis Abbreviated Journal  
  Volume 64  Issue Suppl III Pages 438  
  Keywords analysis; Antibodies; Arthritis; Clinical Trials; Joints; methods; Methotrexate; Patients; Safety; therapy  
  Abstract Background: In clinical trials, adalimumab, a fully human anti-TNF monoclonal antibody, has been shown to reduce the signs and symptoms and to inhibit radiographic progression of disease in patients with active, moderate to severe rheumatoid arthritis (RA). Objectives: To assess the sustainability of the safety profile and efficacy outcomes of adalimumab 40 mg every other week (eow) plus methotrexate (MTX) in patients with long-standing, moderate to severe RA in two long-term, open-label extension (OLE) studies. Methods: Patients who enrolled in five randomized, controlled trials (RCT) and received adalimumab 40 mg eow plus MTX were evaluated in this analysis. After these trials, patients were eligible to enroll in two separate OLE studies: DE020 (ARMADA, STAR, DE005, DE037) and DE010. Patients were evaluated for efficacy and safety every 3 months. Results: A total of 921 patients received adalimumab 40 mg eow plus MTX and enrolled in the RCTs leading into the DE020 OLE. At the time of this analysis, 617 (66%) patients remain on therapy in the OLE. A total of 304 (33%) patients withdrew: 74 (8%) for lack of efficacy, 106 (11%) for adverse events, and 124 (14%) for other reasons. Eighty-nine patients are into their 5th year of treatment and have demonstrated sustained and consistent clinical improvement over time, as supported by efficacy outcomes and by achievement of clinical remission based on DAS28<2.6. At the last visits of all 921 patients, 23% had 0 tender joints (TJC68), 20% had 0 swollen joints (SJC66), and 42% had a HAQ score ?0.5-all are parameters of clinical remission. Forty-three patients randomized in the Phase I RCT leading into the DE010 OLE study received adalimumab 40 mg eow plus MTX are included in this analysis. At the time of this evaluation, 31 (72%) patients remain in the OLE and 12 (28%) patients withdrew: 1 (2%) for lack of efficacy, 3 (7%) for adverse events, and 8 (19%) for other reasons. At last visits, 9% had 0 tender joints (TJC68), 23% had 0 swollen joints (SJC66), and 26% had a HAQ score ?0.5. Sustained response is supported by efficacy outcomes in 15 patients who are into their 7th year of adalimumab therapy. In both OLE trials, adalimumab plus MTX was well-tolerated and rates of adverse events, including serious infections, were consistent with those observed in the RCTs. Long-term Efficacy in Patients Treated with Adalimumab plus MTXEfficacy Criteria DE020 – Year 5 n=89 DE010 – Year 7 n=15 ACR20 (%) 72 87 ACR50 (%) 55 60 ACR70 (%) 38 33 DAS28<2.6 (%) 41 43 DAS28* 2.9 2.7 DAS28 change from baseline* 2.9 3.6 HAQ* 0.5 0.9 HAQ change from baseline* 0.8 0.6 * Median values * Median values Conclusion: Patients with long-standing RA treated with adalimumab 40 mg eow plus MTX achieved sustained and consistent improvements, into their 7th year of continuous therapy, with more than 40% achieving clinical remission (DAS28<2.6). Long-term adalimumab therapy is safe and well-tolerated. Rheumatoid Arthritis Treatment  
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  Notes Approved no  
  Call Number (up) 132 Serial 895  
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Author Andersen, D.E.; Mordaunt, D.H.; Wiltberger, M.W. openurl 
  Title Method and device for optical ophthalmic therapy Type Patent
  Year 2005 Publication Abbreviated Journal  
  Volume Issue Pages  
  Keywords 11170005; Us20050288745; Usa170005; Usb170005  
  Abstract Optical scanning system and method for performing therapy on trabecular meshwork of a patient's eye, including a light source for producing alignment and therapeutic light, a scanning device for deflecting the alignment and therapeutic light to produce an alignment therapeutic patterns of the alignment and therapeutic light, and an ophthalmic lens assembly for placement over a patient's eye that includes a reflective optical element for reflecting the light patterns onto the trabecular meshwork of the patient's eye. The reflective optical element can be a continuous annular mirror (e.g. smooth or with multiple facets) to image the entire trabecular meshwork, or a reflective optical element that moves in coordination with the deflection of the beam. Visualization of the alignment and therapeutic patterns of light on the eye can be implemented by reflection thereof off a visualization mirror that transmits a portion of light emanating from the trabecular meshwork.  
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  Notes Approved no  
  Call Number (up) 13210 Serial 6930  
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Author openurl 
  Title SAFETY OF ADALIMUMAB (HUMIRAr) IN GLOBAL CLINICAL TRIALS OF PATIENTS WITH EARLY VS. LONG-STANDING RHEUMATOID ARTHRITIS (RA) Type Journal Article
  Year 2005 Publication Ann Rheum Dis Abbreviated Journal  
  Volume 64  Issue Suppl III 422 Pages  
  Keywords Arthritis; Clinical Trials; methods; Patients; Safety; Syndrome  
  Abstract Objectives: To assess the safety of adalimumab in the treatment of patients with early vs. long-standing RA who received adalimumab in randomized pivotal trials, open-label trials, or in phase IIIb studies. Methods: All patients with RA participating in pivotal, randomized and controlled trials of adalimumab were eligible to enroll in open-label trials in which they received 40 mg adalimumab every other week. DE013 (PREMIER) was a 2-year randomized controlled trial in patients with early RA (disease duration<3years). Participants in these clinical trials and in phase IIIb studies, Act (US) and ReAct (EU), were routinely evaluated for safety. Reports of serious adverse events (SAE) were tabulated using MedDRA coding by events per 100-patient-years (E/100PY). SAE rates were compared with respect to disease duration between patients with early (<3 yrs) and long-standing RA. Results: As of August 31, 2004, 10,050 patients (12,066 PY exposure) with long-standing RA had enrolled in adalimumab clinical trials world-wide; 271 of these had been treated with adalimumab for ?5 years. Patients in pivotal trials had baseline characteristics indicative of moderate to severe RA. Rates (E/100PY) of selected SAE among patients with long-standing RA as of August 31, 2004 were comparable to an earlier report of global safety in adalimumab RA clinical trials (1). The overall rate of serious infections observed in patients with long-standing RA was comparable to rates in published reports of RA patients treated with DMARDs, including TNF antagonists (2,3). Rates for serious infections and other SAE of interest were lower in the early RA trial (Table 1). There were no cases of histoplasmosis, demyelinating disease, lymphoma, lupus-like syndrome or pancytopenia in adalimumab-treated patients with early RA. Serious Adverse Event Rates in Patients Treated with Adalimumab (E/100PY)Serious Events of Interest Long-standing RA 31-Aug-2004 Early RA PREMIER N 10,050 542 PY 12,066 917 Serious Infections 4.79 1.85 Pneumonia 0.87 0.55 Urinary Tract Infections 0.38 0.11 Septic Arthritis 0.46 0.22 Tuberculosis 0.24 0.11 Histoplasmosis 0.03 0.00 Demyelinating Diseases 0.07 0.00 Lymphoma 0.11 0.00 SLE/Lupus-like Syndrome 0.06 0.00 Congestive Heart Failure 0.26 0.11 Pancytopenia 0.02 0.00 Conclusion: The safety profile of adalimumab has been stable over time-no new safety signals have been identified. Overall safety outcomes in patients with early RA demonstrated fewer serious adverse events than have been reported for patients with long-standing RA. References: 1. Schiff MH, et al. Global Safety in Adalimumab (HUMIRAr) Rheumatoid Arthritis Clinical Trials. Poster presented at ACR 2004, San Antonio, TX. 2. Doran MF, et al. Arthritis Rheum 2002;46:2287-93. 3. Moreland LW, et al. J Rheumatol 2001;28:1238-44. Rheumatoid Arthritis Treatment  
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  Notes Approved no  
  Call Number (up) 133 Serial 896  
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Author Kapany, N.S.; Peppers, N.A.; Zweng, H.C.; Flocks, M. openurl 
  Title Retinal Photocoagulation By Lasers Type Journal Article
  Year 1963 Publication Nature Abbreviated Journal Nature  
  Volume 199 Issue Pages 146-149  
  Keywords Cats; Lasers; Light Coagulation; Rabbits; Research; Retinal Detachment  
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  ISSN 00280836 ISBN Medium  
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  Notes Approved no  
  Call Number (up) 1337 Serial 6811  
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Author Teiwes, W.; Huppertz, M.; Weise, R.; Jacobs, J. openurl 
  Title Methods and apparatus for determination and decrease of dynamic positioning errors of an ablating laser during refractive laser surgery Type Patent
  Year 2003 Publication Abbreviated Journal  
  Volume Issue Pages  
  Keywords 10276768; Us20030144651; Usa276768; Usb276768  
  Abstract The above described apparatus and methods provide the possibility to reduce or even eliminate the effects of delay between image acquisition and laser ablation. Thus this will lead to less positioning errors and therefore to better ablation results in laser refractive surgery. The importance of this invention will increase with decreasing ablating beam diameter. The use of synchronization leads to shorter delay times. Hence it follows that the duration of the whole treatment decreases as well.  
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  Notes Approved no  
  Call Number (up) 1338 Serial 6812  
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Author openurl 
  Title Global Safety in Adalimumab (HUMIRAr) Rheumatoid Arthritis Clinical Trials Type Journal Article
  Year 2005 Publication nn Abbreviated Journal  
  Volume Issue Pages  
  Keywords Arthritis; Clinical Trials; Incidence; methods; Patients; Randomized Controlled Trials; Safety; Syndrome; therapy  
  Abstract PURPOSE: To assess the safety of adalimumab in the long-term treatment of patients with rheumatoid arthritis (RA) who received adalimumab in randomized pivotal trials, open-label extensions (OLE), or in Act (US) and ReAct (EU) early access programs. METHODS: All patients with RA participating in the pivotal randomized controlled trials of adalimumab were eligible to enroll in OLE trials during which they received 40 mg adalimumab sc every other week. Participants in these clinical trials and in the Act/ReAct programs were evaluated for safety at regular intervals. Safety data were reported via routine clinical trial methodology. Reports of OLE/Act/ReAct trial serious adverse events (SAE) were tabulated by events per 100 patient-years (E/100 pt-yrs) and compared with those observed in adalimumab arms of the pivotal trials. RESULTS: As of December 31, 2003, 9460 patients (9894 pt-yrs of exposure) had enrolled in all adalimumab clinical trials, and 194 of these had been treated with adalimumab for more than 5 years. Patients in the pivotal trials had long-standing disease duration (~11 years), had failed ~3 prior DMARDs, and had a mean baseline HAQ score of 1.6--all characteristics indicative of patients with moderate to severe RA. The data table compares various adverse event rates in the OLE/Act/ReAct trials with rates found in adalimumab pivotal trials. In the OLE/Act/ReAct trials, rates of serious infections were comparable to those observed both in adalimumab pivotal trials and in published reports of patients with RA treated with DMARDs, including anti-TNF therapy (1, 2). Initiation of screening for TB resulted in a 9-fold reduction in rates of TB reactivation, from 1.3/100 pt-yrs pre-screening to 0.15/100 pt-yrs post-screening. Cases of histoplasmosis were observed in endemic areas. With the exception of lymphoma, the rates of cancers were similar to those predicted by the SEER cancer database. A total of 15 cases of lymphoma were reported (Standardized Incidence Ratio = 4.3), consistent with the rate expected in a comparable population with RA. Rate of Events/100 pt-yrs Events of Interest Pivotal Trials (adalimumab arms) (N=1380) 793 pt-yr All Trials (OLE, Act, ReAct) (N=9460) 9894 pt-yr Serious infections 4.3 4.3* Tuberculosis# 0.13 0.15 Histoplasmosis 0.13 0.03 Multiple Sclerosis 0.25 0.07 All non-cutaneous cancers 1.01 0.98 Lymphoma 0.25 0.15 Lupus-like syndrome 0.13 0.10 *Data from open-label extension trials only #Since screening initiated CONCLUSIONS: The safety profile of adalimumab in open-label extension and early access programs is similar to what has been seen in randomized controlled trials and to what has been reported in comparable populations with RA. The rates of adverse events are stable over time, and no new safety signals have been identified. (1) Doran MF et al. Arthritis Rheum 2002;46:2287-93 (2) Moreland LW et al. J Rheumatol 2001;28:1238-44 Commercial Relationship: M.H. Schiff, Abbott Laboratories 2, 5, 8; Amgen 2, 5, 8; Centocor 2, 5, 8; Aventis 2, 5, 8; Wyeth-Ayerst 2, 5, 8; G.R. Burmester, Abbott Laboratories 2, 5, 8; Novartis 2, 5, 8; Essex 2, 5, 8; Aventis 5, 8; Wyeth 5, 8; A.L. Pangan, Abbott Laboratories 3; H. Kupper, Abbott Laboratories 1, 3; G.T. Spencer-Green, Abbott Laboratories 3. OASIS – Online Abstract Submission and Invitation SystemT c1996-2007, Coe-Truman Technologies, Inc.  
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  Notes Table not correct!! use print version!! Approved no  
  Call Number (up) 134 Serial 897  
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Author TEIWES, W.; GRECU, H. openurl 
  Title Multidimensional Eye Tracking And Position Measurement System Type Patent
  Year 2003 Publication Abbreviated Journal  
  Volume Issue Pages  
  Keywords 02700222.9; Ep1357831; Epa02700222  
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  Notes Approved no  
  Call Number (up) 13423 Serial 6931  
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Author Schroder, R. openurl 
  Title Beam position monitoring for laser eye surgery Type Patent
  Year 2005 Publication Abbreviated Journal  
  Volume Issue Pages  
  Keywords 10128130; Us06864478; Us6864478; Usa128130; Usb128130  
  Abstract Improved methods, apparatus and systems for monitoring laser beam position enhance the safety and efficacy of laser eye surgery systems. The present invention will advantageously be used in laser eye surgery where accurate control of the laser beam is crucial for patient safety and successful vision correction. In one embodiment, a first beam of laser energy is directed through a scanning mechanism toward an eye to ablate the eye, and a second beam of laser energy is directed through the scanning mechanism toward a sensor. When the scanning mechanism is moved by a laser eye surgery system to move the first beam across the eye, the scanning mechanism also moves the second beam across the sensor. Movement of the beam across the sensor can be used to monitor movement of the first beam across the eye. If actual movement of the first beam across the eye does not match desired movement of the beam, one or more components of the laser surgery system will shut down in order to stop the laser eye surgery procedure, thus preventing undesirable ablation of the eye.  
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  Notes Approved no  
  Call Number (up) 13472 Serial 6932  
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Author Brinkmann, R.; Schuele, G. openurl 
  Title Method for operation of laser Type Patent
  Year 2006 Publication Abbreviated Journal  
  Volume Issue Pages  
  Keywords 11327939; Us20060111697; Usa327939; Usb327939  
  Abstract This invention relates to a method for operation of an irradiation laser whereby laser pulse sequences or pulses of varying length are modified during application such that the comparability of recorded transients is retained.  
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  Notes Approved no  
  Call Number (up) 13548 Serial 6933  
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