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At least 1,621 records · Page 90Linked to original sources
PubMed2000

U.S. clinical investigation of the Artisan myopia lens for the correction of high myopia in phakic eyes. Report of the results of phases 1 and 2, and interim phase 3.

PURPOSE: The purpose of this article is to present the results of the U.S. Clinical investigation of the Artisan anterior chamber iris fixed lens implant for the correction of myopia in phakic eyes. METHODS: A prospective, multi-center, FDA-supervised trial was designed and undertaken in the United States by Ophtec USA, Inc., Boca Raton, Florida to determine the safety and efficacy of the Artisan lens as a potential refractive treatment for patients with high myopia. During the trial, two different models of the Artisan lens were used: one with a 5-mm optical zone (model 206) and the other with a 6-mm optical zone (model 204). RESULTS: The data presented comprise 176 enrolled subjects and 264 implant procedures. The most frequently chosen Artisan lens power was -13.00 D (average, -12.76 D; SD, 3.24). The postoperative results at 6 months for all eyes (n = 135) showed 100% of patients were 20/40 or better best-corrected while 72% gained one or more lines and 22% gained two or more lines regardless of degree of astigmatism or postoperative goal. Through the course of the study, intraocular pressure maintained a level with a mean below 16 mmHg. In general, total reported complications in the patient cohort decreased over time, dropping from 39% at the initial visit to 10% at visit four and 0% at visit seven. CONCLUSIONS: On the basis of the interim results of the U.S. Clinical Investigation of the Artisan Myopia Lens for the Correction of High Myopia in Phakic Eyes, the Artisan anterior chamber phakic IOL may offer an option for correction of high degrees of myopia. Refractive outcomes were exceptional and complications were minimal and amenable to treatment.

Adult↗
PubMed2003

Are asthma and allergies in children and adolescents increasing? Results from ISAAC phase I and phase III surveys in Münster, Germany.

OBJECTIVE: To assess time trends in symptoms of asthma, allergic rhinitis, and atopic eczema among children in Münster, Germany. METHODS: Two cross-sectional surveys 5-years apart (1994/1995, 1999/2000) using ISAAC core written and video questionnaires and applying the ISAAC protocol. Two main age groups (6-7 and 13-14 year olds) were designated with information collected by parental and self-report for both age groups, respectively. A school-based sample of 7744 participants in the 1994/1995 survey and 7962 participants in the 1999/2000 survey was recruited. In the first and second surveys, response rates for the 6-7 year olds were 81 and 82%, respectively, while for the 13-14 year olds response rates were 94% in both. Analyses focus on the change in 12-month prevalence of symptoms of asthma, rhinitis, and eczema. RESULTS: There is a tendency towards an increase in current symptoms for all three conditions and in both age groups, but more so among girls. Indices of diagnosis either remained the same or increased in parallel to the increase in symptoms. Indices of severity also showed a homogenous increase in the 5-year study period. CONCLUSIONS: Our study shows that symptoms of asthma, rhinitis, and eczema are increasing, reflecting a change in the morbidity of these conditions in our population.

Adolescent↗
PubMed1999

Use of predictive probabilities in phase II and phase III clinical trials.

Predictive probability is particularly useful in aiding a decision-making process related to drug development. This is especially true for decisions occurring as the result of interim analyses of clinical trials. Examples of clinical trial applications of Bayesian predictive probability and the use of the beta-binomial distribution are described.

Bayes Theorem↗
PubMed1997

Pharmacokinetic profile of ABELCET (amphotericin B lipid complex injection): combined experience from phase I and phase II studies.

Amphotericin B (AmB) has been the most effective systemic antifungal agent, but its use is limited by the dose-limiting toxicity of the conventional micellar dispersion formulation (Fungizone). New formulations with better and improved safety profiles are being developed and include ABELCET (formerly ABLC), but their dispositions have not been well characterized; hence, the reason for their improved profiles remains unclear. This report details the pharmacokinetics of ABELCET examined in various pharmacokinetic and efficacy studies by using whole-blood measurements of AmB concentration performed by high-pressure liquid chromatography. The data indicated that the disposition of AmB after administration of ABELCET is different from that after administration of Fungizone, with a faster clearance and a larger volume of distribution. It exhibits complex and nonlinear pharmacokinetics with wide interindividual variability, extensive distribution, and low clearance. The pharmacokinetics were unusual. Clearance and volume of distribution were increased with dose, peak and trough concentrations after multiple dosings increased less than proportionately with dose, steady state appeared to have been attained in 2 to 3 days, despite an estimated half-life of up to 5 days, and there was no evidence of significant accumulation in the blood. The data are internally consistent, even though they were gathered under different conditions and circumstances. The pharmacokinetics of ABELCET suggest that lower concentrations in blood due to higher clearance and greater distribution may be responsible for its improved toxicity profile compared to those of conventional formulations.

Amphotericin B↗
PubMed2000

Phase 1 and phase 2 studies of Salmonella enterica serovar paratyphi A O-specific polysaccharide-tetanus toxoid conjugates in adults, teenagers, and 2- to 4-year-old children in Vietnam.

Salmonella enterica serovar Paratyphi A O-specific polysaccharide (O-SP) was activated with 1-cyano-4-dimethylaminopyridinium tetrafluoroborate (CDAP) and bound to tetanus toxoid (TT) with adipic acid dihydrazide as a linker (SPA-TT(1)) or directly (SPA-TT(2)). In mice, these two conjugates elicited high levels of immunoglobulin G (IgG) anti-lipopolysaccharide (LPS) in serum with bactericidal activity (E. Konadu, J. Shiloach, D. A. Bryla, J. B. Robbins, and S. C. Szu, Infect. Immun. 64:2709-2715, 1996). The safety and immunogenicity of the two conjugates were then evaluated sequentially in Vietnamese adults, teenagers, and 2- to 4-year-old children. None of the vaccinees experienced significant side effects, and all had preexisting LPS antibodies. At 4 weeks after injection, there were significant increases of the geometric mean IgG and IgM anti-LPS levels in the adults and teenagers: both conjugates elicited a greater than fourfold rise in the IgG anti-LPS level in serum in >/=80% of the volunteers. SPA-TT(2) elicited slightly higher, though not statistically significantly, levels of IgG anti-LPS than did SPA-TT(1) in these age groups. Accordingly, only SPA-TT(2) was evaluated in the 2- to 4-year-old children. On a random basis, one or two injections were administered 6 weeks apart to the children. No significant side effects were observed, and the levels of preexisting anti-LPS in serum were similar in children of all ages. A significant rise in the IgG anti-LPS titer was elicited by the first injection (P = 0.0001); a second injection did not elicit a booster response. Representative sera from all groups had bactericidal activity that could be adsorbed by S. enterica serovar Paratyphi A LPS.

Adolescent↗
PubMed2003

[Changes in the activity of cyclin-kinase complexes governing cell transition from G1 phase to DNA replication phase in E1A + c-Ha-ras transformants transfected with the bcl-2 gene].

The antiproliferative effect of human bcl-2 gene transferred to E1A + c-Ha-ras-transformed rat embryo fibroblasts, which are characterized by the absence of cell cycle checkpoints after damage and by a high proapoptotic sensitivity was studied. Ionizing irradiation, adriamycin treatment, and serum starvation were shown to induce G1/S arrest in E1A + c-Ha-ras-transformants. Bcl-2 antiproliferative effect in E1A + c-Ha-ras-transformants was not associated with alterations in Cdk2, cyclin E and A contents. G1/S arrest following irradiation or serum starvation was accompanied by a decrease in kinase activity associated with cyclin E-cdk2, whereas G1/S arrest in tetraploid subpopulation after adriamycin treatment did not correlate with a decrease in cyclin E-associated kinase activity. Cyclin A-associated kinase activity did not decrease after any used treatment. Transfection of bcl-2 in E1A + c-Ha-ras-transformants resulted in elevated expression of cyclin-cdk complexes inhibitor p21/Waf-1, but not p27/Kip. Damaging agents caused p21/Waf-1 and p27/Kip accumulation, but bcl-2 overexpression did not restore functions of these inhibitors, since p21/Waf-1 and p27/Kip were unable to suppress cyclin-cdk complexes activity after damage. These results suggest that bcl-2 transfection in E1A + c-Ha-ras-transformants is likely to result in irradiation- or serum starvation-induced G1/S arrest accomplished by a selective decrease in cyclin E-associated kinase activity. Adriamycin-induced G1/S arrest seems to be realized via cyclin-cdk complexes activity-independent way involving antiproliferative targets downstream of cyclin E-cdk2 and cyclin A-cdk2 complexes.

Adenovirus E1A Proteins↗
PubMed1993

[Are phase II or phase II antidepressive drug studies still feasible considering currently required inclusion and exclusion criteria?].

The present policy of pharmaceutical companies to aim at perfectionistic, and therefore inflexible protocols for clinical drug-trials renders patient recruitment increasingly difficult or even impossible, and may result in an increasing number of non-completed studies. It appears that many of today's inclusion and exclusion criteria are not sufficiently assessed in terms of their scientific basis and clinical usefulness. Sense and nonsense of these criteria are discussed. The tendency to adhere to streamlined protocols to certify the needs of drug regulators will severely impair the feasibility and validity of antidepressant drug trials in psychiatric in-patients.

Adolescent↗