| 1. |
- Ruperto, N., et al.
(author)
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The Pediatric Rheumatology International Trials Organization/American College of Rheumatology provisional criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus : prospective validation of the definition of improvement
- 2006
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In: Arthritis and Rheumatism. - : Wiley. - 0004-3591 .- 1529-0131. ; 55:3, s. 355-363
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To use the Pediatric Rheumatology International Trials Organization (PRINTO) core set of outcome measures to develop a validated definition of improvement for the evaluation of response to therapy in juvenile systemic lupus erythematosus (SLE).METHODS: Thirty-seven experienced pediatric rheumatologists from 27 countries, each of whom had specific experience in the assessment of juvenile SLE patients, achieved consensus on 128 patient profiles as being clinically improved or not improved. Using the physicians' consensus ratings as the gold standard measure, the chi-square, sensitivity, specificity, false-positive and false-negative rates, area under the receiver operating characteristic curve, and kappa level of agreement for 597 candidate definitions of improvement were calculated. Only definitions with a kappa value greater than 0.7 were retained. The top definitions were selected based on the product of the content validity score multiplied by its kappa statistic.RESULTS: The definition of improvement with the highest final score was at least 50% improvement from baseline in any 2 of the 5 core set measures, with no more than 1 of the remaining worsening by more than 30%.CONCLUSION: PRINTO proposes a valid and reproducible definition of improvement that reflects well the consensus rating of experienced clinicians and that incorporates clinically meaningful change in core set measures in a composite end point for the evaluation of global response to therapy in patients with juvenile SLE. The definition is now proposed for use in juvenile SLE clinical trials and may help physicians to decide whether a child with SLE responded adequately to therapy.
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| 2. |
- Aapro, M, et al.
(author)
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Guidance on the use of bisphosphonates in solid tumours: recommendations of an international expert panel
- 2008
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In: Annals of Oncology. - : Elsevier BV. - 1569-8041 .- 0923-7534. ; 19:3, s. 420-432
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Journal article (peer-reviewed)abstract
- Bisphosphonates (BP) prevent, reduce, and delay cancer-related skeletal complications in patients, and have substantially decreased the prevalence of such events since their introduction. Today, a broad range of BP with differences in potency, efficacy, dosing, and administration as well as approved indications is available. In addition, results of clinical trials investigating the efficacy of BP in cancer treatment-induced bone loss (CTIBL) have been recently published. The purpose of this paper is to review the current evidence on the use of BP in solid tumours and provide clinical recommendations. An interdisciplinary expert panel of clinical oncologists and of specialists in metabolic bone diseases assessed the widespread evidence and information on the efficacy of BP in the metastatic and nonmetastatic setting, as well as ongoing research on the adjuvant use of BP. Based on available evidence, the panel recommends amino-bisphosphonates for patients with metastatic bone disease from breast cancer and zoledronic acid for patients with other solid tumours as primary disease. Dosing of BP should follow approved indications with adjustments if necessary. While i.v. administration is most often preferable, oral administration (clodronate, IBA) may be considered for breast cancer patients who cannot or do not need to attend regular hospital care. Early-stage cancer patients at risk of developing CTIBL should be considered for preventative BP treatment. The strongest evidence in this setting is now available for ZOL. Overall, BP are well-tolerated, and most common adverse events are influenza-like syndrome, arthralgia, and when used orally, gastrointestinal symptoms. The dose of BP may need to be adapted to renal function and initial creatinine clearance calculation is mandatory according to the panel for use of any BP. Subsequent monitoring is recommended for ZOL and PAM, as described by the regulatory authority guidelines. Patients scheduled to receive BP (mainly every 3-4 weeks i.v.) should have a dental examination and be advised on appropriate measures for reducing the risk of jaw osteonecrosis. BP are well established as supportive therapy to reduce the frequency and severity of skeletal complications in patients with bone metastases from different cancers.
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| 4. |
- Carducci, Michael A., et al.
(author)
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A phase 3 randomized controlled trial of the efficacy and safety of atrasentan in men with metastatic hormone-refractory prostate cancer
- 2007
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In: Cancer. - : Wiley. - 1097-0142 .- 0008-543X. ; 110:9, s. 1959-1966
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Journal article (peer-reviewed)abstract
- BACKGROUND. The objective of this study was to evaluate the efficacy and safety of atrasentan (Xinlay), a selective endothelin-A receptor antagonist, in patients with metastatic hormone- refractory prostate cancer (HRPC). METHODS. This multinational, double-blind, placebo-controlled trial enrolled 809 men with metastatic HRPC. Patients were randomized 1:1 to receive either atrasentan 10 mg per day or placebo. The primary endpoint was time to disease progression (TTP), which was determined according to radiographic and clinical measures. Analyses of overall survival and changes in biomarkers also were performed. RESULTS. Atrasentan did not reduce the risk of disease progression relative to placebo (hazards ratio, 0.89; 95% confidence interval, 0.76-1.04; P =.136). Most patients progressed radiographically at the first 12-week bone scan without concomitant clinical progression. In exploratory analyses, increases from baseline to final bone alkaline phosphatase (BAP) and prostate-specific antigen (PSA) levels were significantly lower with atrasentan treatment (P <.05 for each). The median time to BAP progression (> 50% increase from nadir) was twice as long with atrasentan treatment (505 days vs 254 days; P <.01). The delay in time to PSA progression did not reach statistical significance. Atrasentan generally was tolerated well, and the most common adverse events associated with treatment were headache, rhinitis, and peripheral edema, reflecting the vasodilatory and fluid-retention properties of endothelin-A receptor antagonism. CONCLUSIONS. Atrasentan did not delay disease progression in men with metastatic HRPC despite evidence of biologic effects on PSA and BAP as markers of disease burden.
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| 5. |
- Ougazzaden, A., et al.
(author)
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Growth of GaN by metal organic vapor phase epitaxy on ZnO-buffered c-sapphire substrates
- 2008
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In: Journal of Crystal Growth. - : Elsevier BV. - 0022-0248 .- 1873-5002. ; 310:5, s. 944-947
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Journal article (peer-reviewed)abstract
- The materials quality and availability of large-area bulk GaN substrates is currently considered a key problem for the continuing development of improved GaN-based devices. Since industrial fabrication of bulk GaN substrates with suitable materials quality has proven very difficult, the opto-GaN industry is currently based on heteroepitaxy using either c-sapphire or 6H SiC substrates. ZnO is promising as a substrate material for GaN because it has the same wurtzite structure and a relatively small lattice mismatch (similar to 1.8%). In this study, we have successfully grown GaN by MOVPE on ZnO-buffered c-sapphire. The growth conditions required to both prevent ZnO degradation and grow monocrystal thin film of GaN have been obtained. SEM, HRXRD and micro-Raman characterizations underlined the presence of the two layers GaN and ZnO with high structural quality.
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| 7. |
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| 8. |
- Ougazzaden, A., et al.
(author)
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Progress on new wide bandgap materials BGaN, BGaAlN and their potential applications
- 2007
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In: Quantum Sensing and Nanophotonic Devices IV. - : SPIE. - 9780819465924 ; , s. G4791-G4791
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Conference paper (peer-reviewed)abstract
- The development of wide band gap semiconductors extends their applications in optoelectronics devices to the UV domain. Compact lasers and high sensitivity APD detectors in UV range are currently needed for different applications such as, purification, covert communication and real time detection of airborne pathogens. Until now, the full exploitation of these potential materials has been limited by the lack of suitable GaN substrates. Recently, a novel class of materials has been reported based on BGaN and BAlN, potentially reducing the crystal defect densities by orders of magnitude compared to existing wide band gap heterostructures. Characteristics of these new alloys are similar to those of AlGaN materials with the advantage that these can be lattice matched to AlN and SiC substrates. In addition, these materials offer the possibility of using quaternary BAlGaN alloys at Ultra Violet (UV) wavelengths and hence lead to more degrees of freedom in designing sophisticated device structures. In this paper we describe the MOVPE growth conditions used to incorporate boron in GaN and AlGaN. Detailed characterization and analysis in terms of structural and electrical properties are discussed.
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| 9. |
- Salim, Sa'ad, et al.
(author)
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CD83(+)CCR7(-) Dendritic Cells Accumulate in the Subepithelial Dome and Internalize Translocated Escherichia coli HB101 in the Peyers Patches of Heal Crohns Disease
- 2009
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In: American Journal of Pathology. - : Elsevier BV. - 0002-9440 .- 1525-2191. ; 174:1, s. 82-90
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Journal article (peer-reviewed)abstract
- Recurrent Crohns disease originates with small erosions in the follicle-associated epithelium overlying the Peyers patches. Animal studies have illustrated mucosal immune regulation by dendritic cells located in the subepithelial dome. The aim of this study was to characterize the dendritic cells at this specific site in patients with Crohns disease. Heal tissues were obtained after surgery performed on Crohns patients; ileal samples from noninflammatory bowel disease and ulcerative colitis served as standard and inflammatory controls, respectively. Flow cytometry of isolated intestinal mononuclear cells showed a larger subset of dendritic cells in Crohns samples compared with controls. This finding was corroborated by confocal microscopy, showing enhanced infiltrates of cells positive for the dendritic cell markers, DC-SIGN(+) and CD83(+), in the subepithelial dome. Moreover, the CD83(+) cells in Crohns tissues showed reduced expression of the lymph node migratory receptor, CCR7, possibly contributing to the high numbers of dendritic cells. After exposure to nonpathogenic Escherichia coli in Ussing chambers, dendritic cells in the subepithelial dome of Crohns disease demonstrated increased co-localization with translocated bacteria. Immunohistochemical results revealed that DC-SIGN(+) cells in Crohns tissues were found to express toll-like receptor 4 and produce tumor necrosis factor-a. In conclusion, nonmigrating dendritic cells that accumulate in the subepithelial dome and internalize nonpathogenic bacteria may be important for the onset and perpetuation of mucosal inflammation in Crohns disease.
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