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At least 199 records · Page 11Linked to original sources
PubMed2000

Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group.

OBJECTIVE: To compare the efficacy and safety of cyclosporin A ([CsA] 0.05% and 0.1% ophthalmic emulsions) to vehicle in patients with moderate to severe dry eye disease. DESIGN: Multicenter, randomized, double-masked, parallel-group, 6-month, vehicle-controlled. PARTICIPANTS: A total of 877 patients with defined moderate to severe dry eye disease (292 to 293 in each treatment group). METHODS: Two identical clinical trials; patients were treated twice daily with either CsA, 0.05% or 0.1%, or vehicle. The results of these two trials were combined for analysis. MAIN OUTCOME MEASURES EFFICACY: corneal and interpalpebral dye staining, Schirmer tear test (with and without anesthesia), tear break-up time, Ocular Surface Disease Index (OSDI), facial expression, patient subjective rating scale, symptoms of dry eye, investigator's evaluation of global response to treatment, treatment success, and daily use of artificial tears. SAFETY: occurrence of adverse events, best-corrected visual acuity, intraocular pressure, biomicroscopy, and blood trough CsA concentrations. RESULTS: Treatment with CsA, 0.05% or 0.1%, gave significantly (P < or = 0.05) greater improvements than vehicle in two objective signs of dry eye disease (corneal staining and categorized Schirmer values). CsA 0.05% treatment also gave significantly greater improvements (P < 0.05) in three subjective measures of dry eye disease (blurred vision, need for concomitant artificial tears, and the physician's evaluation of global response to treatment). There was no dose-response effect. Both CsA treatments exhibited an excellent safety profile, and there were no significant topical or systemic adverse safety findings. CONCLUSIONS: The novel ophthalmic formulations CsA 0.05% and 0.1% were safe and effective in the treatment of moderate to severe dry eye disease yielding improvements in both objective and subjective measures. Topical CsA represents a new pharmacologically based treatment for dry eye disease that may provide significant patient benefits.

Cornea↗
PubMed2005

Excited-state double-proton transfer in the 7-azaindole dimer in the gas phase. 3. Reaction mechanism studied by picosecond time-resolved REMPI spectroscopy.

The excited-state double-proton-transfer (ESDPT) reaction in the jet-cooled 7-azaindole dimer (7AI2) has been investigated with picosecond time-resolved resonance-enhanced multiphoton ionization spectroscopy. The observed decay profiles of 7AI2 by exciting the origin and the intermolecular stretch fundamental in the S1 state are well reproduced by single-exponential functions with time constants of 1.9 +/- 0.9 ps and 860 +/- 300 fs, respectively. This result provides clear evidence of the concerted mechanism of ESDPT in 7AI2.

Gases↗
PubMed2004

Increasing prevalence of allergic rhinitis but not asthma among children in Hong Kong from 1995 to 2001 (Phase 3 International Study of Asthma and Allergies in Childhood).

There is a worldwide belief that the prevalence of asthma and other allergic diseases is increasing but the measures used in many studies are susceptible to systematic errors. We examined the trend of asthma, allergic rhinitis and eczema prevalence in school children aged 6-7 years in Hong Kong from 1995 to 2001 using standardized ISAAC methodology. There were 4448 and 3618 children participating in 2001 and 1995, respectively. The prevalence of life-time rhinitis (42.4% vs. 38.9%, p < 0.01), current rhinitis (37.4% vs. 35.1%, p < 0.03), current rhinoconjunctivitis (17.2 vs. 13.6%, p < 0.01) and life-time eczema (30.7% vs. 28.1%, p = 0.01) increased significantly. There was no significant change in prevalence of life-time asthma, life-time wheeze and current wheeze albeit a significant increase in severe asthma symptoms. We investigated a number of potential risk factors including sex, family history of atopy, sibship size, birth weight, respiratory tract infections, pet ownership and exposure to tobacco smoke. However, the increases in prevalence of rhinitis and eczema could not be entirely explained by the change of prevalence of these risk factors. The odds ratio OR for the study period remained significantly associated with current rhinitis (OR 1.31, 95% confidence intervals CI 1.17-1.46), current rhinoconjunctivitis (OR 1.63, 95% CI 1.41-1.87) and life-time eczema (OR 1.30, 95% CI 1.16-1.45) after adjustment for these confounding variables using logistic regression model. Further study is warranted to elucidate the factors contributing to the observable change in the prevalence of rhinitis in our population.

Asthma↗
PubMed2000

The British Association of Dermatologists audit of atopic eczema management in secondary care. Phase 3: audit of service outcome.

Service outcome was examined by a preconsultation (part 1) and a 6-week postconsultation (part 2) patient questionnaire in 29 hospital dermatology departments randomly selected from an original sample of 187 centres across the U.K. The outcome measures were: quality of life as measured by the Dermatology Life Quality Index (DLQI) and Children's DLQI (CDLQI), improvement in sleep loss, improvement in worse aspect of skin disease and return to work or school. Three hundred and fifty-two questionnaires (115 adults, 237 children) were completed for part 1, and 235 (67%) replied to part 2. The mean DLQI at initial consultation was 12.5, dropping to 9.7 at 6 weeks (P = 0.001). The mean CDLQI at initial consultation was 10.5, dropping to 8.7 at 6 weeks (P < 0.001). Forty-nine per cent of adults and 44% of children had a > 25% relative improvement in score, which did not meet the 60% working standard. Forty-four per cent of adults and 47% of children had an improvement in sleep loss at 6 weeks, falling short of the 70% working standard. Sixty-one per cent of adults and 59% of children had an improvement in the worst aspect of their skin condition at 6 weeks, falling short of the 80% working standard. Of the 20 adults and eight children off work/school during part 1, 70% of adults and 87.5% of children had returned to work/school by 6 weeks. This met the 80% working standard for children but not for adults. On a national scale, only one of the eight working standards for service outcome was met, although most of the working standards were met by at least one of the 11 National Health Service administrative areas. This study presents the first national data on the outcomes of a representative sample of atopic eczema patients seen in secondary care. Small sample sizes, instruments which may be insensitive to change, as well as local factors such as case-mix, baseline severity and staff to patient ratios need to be taken into account when interpreting these results. Nevertheless, the results of this baseline audit suggest that the outcome of patients with atopic eczema following secondary care consultation may not be as good as some doctors believe. This suggests that an improvement in practice, a re-evaluation of the working standards, or both, is needed and should be examined in future audit cycles.

Adolescent↗
PubMed1999

[3-phase bone scintigraphy of microsurgically attached bone transplants as early graft survival assessment].

Vascularized bone grafts do not allow direct graft monitoring during the early postoperative period. The first two weeks are critical for the blood supply and viability of the graft. Three-phase bone scintigraphy, performed between the 7th and 14th postoperative day, was valuable in predicting the survival of vascularized bone grafts. It is a simple and safe method for the evaluation of blood supply of both the graft and the graft-surrounding tissue. Clinical data, obtained from studying 17 patients,/led to the conclusion that three-phase bone scintigraphy plays an important role in the process of decision-making on surgical reexploration.

Adult↗
PubMed1996

[The value of 3-phase skeletal scintigraphy for early diagnosis of Sudeck disease].

PURPOSE: In a prospective study the value of the three-phase bone scintigraphy in the early diagnosis of Sudeck's atrophy was analysed. MATERIAL AND METHODS: 137 patients with the clinical suspicion on Sudeck's atrophy in stage I were examined. By means of the clinical course and additional examinations (block response), pain experts confirmed the diagnosis separately. RESULTS: With the findings of hyperperfusion of all 5 phalanges, homogeneous hyperaemia of the affected hand or the foot and periarticular increased uptake of the whole extremity a reliable diagnosis of Sudeck's atrophy was possible. The sensitivity was 95.9%, the specificity 100%. With bone scintigraphy Sudeck's atrophy could be clearly differentiated from an inactivity atrophy. CONCLUSION: Three-phase bone scintigraphy is an excellent tool for the objective diagnosis of Sudeck's atrophy in stage I.

Adult↗
PubMed1986

[Functional heterogeneity of liver metastases in 3-phase computerized tomograms].

Ninety patients with liver metastases (68 colorectal carcinomas, 22 breast carcinomas) were examined by triphasic angio-CT. This included demonstration of the entire liver after a bolus-like injection of contrast. Originally, the metastases were hypodense, but showed four patterns of contrast enhancement. Quantitative evaluation of the mammary carcinomas showed a marked increase in density during the bolus phase, with similar contrast values in the liver and at the centre and edge of the metastasis at ten minutes after the injection. Colorectal carcinomas showed only slight increase in density after contrast injection. The difference in density between the centre and the periphery of the metastasis was still present on later images. This finding indicates that there are differences in the vascularisation of these metastases.

Breast Neoplasms↗
PubMed1982

[3-phase scintigraphy in the Sudeck syndrome. Comparison with the results of roentgenologic and clinical studies].

37 patients with clinically and radiologically proved reflex sympathetic dystrophy syndrome were scintigraphed by 99mTc-MDP (three-phase-scintigraphy). In 87% of the examinations (all three-phases) an increased tracer accumulation in the region of the affected limb could be seen scintigraphically. The majority of the positive results (92% resp. 87%) were found in the interval phase (phase II) and the late phase (phase III) of the scintigraphic examinations.--We recommend a staging of the increase of the tracer accumulation when examining the reflex sympathetic dystrophy syndrome. This staging doesn't significantly correlate with the familiar clinical and radiological stagings. However it may be useful when assessing the course of the syndrome.--Increased tracer accumulations could be observed in the case of clinically, radiologically and scintigraphically manifest reflex sympathetic dystrophy syndrome in the region of the foot, frequently in the ipsilateral knee region, rarely in the ipsilateral hip joint region, although clinically the syndrome could not be observed in these regions.

Adult↗
PubMed2005

Correlation between immunologic responses to a recombinant glycoprotein 120 vaccine and incidence of HIV-1 infection in a phase 3 HIV-1 preventive vaccine trial.

BACKGROUND: An objective of the first efficacy trial of a candidate vaccine containing recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein 120 (rgp120) antigens was to assess correlations between antibody responses to rgp120 and the incidence of HIV-1 infection. METHODS: Within the randomized trial (for vaccinees, n=3598; for placebo recipients, n=1805), binding and neutralizing antibody responses to rgp120 were quantitated. A case-cohort design was used to study correlations between antibody levels and HIV-1 incidence. RESULTS: Peak antibody levels were significantly inversely correlated with HIV-1 incidence. The relative risk (RR) of infection was 0.63 (95% confidence interval, 0.45-0.89) per log(10) higher neutralization titer against HIV-1(MN), and the RRs of infection for second-, third-, and fourth-quartile responses of antibody blocking of gp120 binding to soluble CD4 versus first-quartile responses (the lowest responses) were 0.35, 0.28, and 0.22, respectively. CONCLUSIONS: Despite inducing a complex, robust immune response, the vaccine was unable to reduce the incidence of HIV-1. Two interpretations of the correlative results are that the levels of antibodies (i) caused both an increased (low responders) and decreased (high responders) risk of HIV-1 acquisition or (ii) represented a correlate of susceptibility to HIV-1 but had no causal effect on susceptibility. Although the data cannot definitively discriminate between these 2 explanations, (ii) appears to be more likely.

AIDS Vaccines↗
PubMed1992

Differential reduction of plasma cholesterol by the American Heart Association Phase 3 Diet in moderately hypercholesterolemic, premenopausal women with different body mass indexes.

The ability of a low-fat, low-cholesterol diet to improve the risk-factor profiles of moderately hypercholesterolemic, premenopausal women was evaluated. Nineteen women were fed a typical American diet for 1 mo, after which a low-fat diet consisting of 21% of total energy (en%) as fat, 59 en% carbohydrates, 19 en% protein, and 96 mg cholesterol/d (P:S 1.8) was given. After 5 months, total and low-density lipoprotein (LDL) cholesterol was decreased by 7% and 11%, respectively, and total triglycerides increased by approximately 30%. High-density-lipoprotein (HDL) cholesterol was decreased by 12% at month 2 and 5% at month 5 (P less than 0.05). Although HDL2 cholesterol decreased progressively throughout the diet period to -35% by month 5, HDL3 cholesterol, which decreased to -5% at month 1, increased to +7% by month 5. Of the plasma apolipoproteins only apo A-II was altered (+15%) by the diet. Body mass index correlated to baseline values and affected response to diet; only the leanest women had significant decreases in total, LDL, and HDL2 cholesterol in response to the low-fat diet.

Adult↗
PubMed2002

Use of perflubron emulsion to decrease allogeneic blood transfusion in high-blood-loss non-cardiac surgery: results of a European phase 3 study.

BACKGROUND: This single-blind randomized study in general surgery evaluated the efficacy of perflubron emulsion (PFC) as an artificial oxygen carrier being used to augment preoperative acute normovolemic hemodilution to reduce and avoid transfusion of both allogeneic erythrocytes and erythrocytes from preoperative autologous donation compared with standard of care. METHODS: Subjects (N = 492) with hemoglobin concentrations of 12-15 g/dl undergoing noncardiac surgical procedures with 20 ml/kg or greater expected blood loss were randomized into two groups. Control patients were transfused intraoperatively at a hemoglobin concentration less than 8.0 +/- 0.5 g/dl or at protocol-defined, physiologic triggers. PFC-treated patients first underwent acute normovolemic hemodilution to hemoglobin of 8.0 +/- 0.5 g/dl, followed by dosing with perflubron emulsion (1.8 g/kg). When hemoglobin reached less than 6.5 +/- 0.5 g/dl, an additional 0.9-g/kg dose was given. PFC patients were transfused at hemoglobin less than 5.5 +/- 0.5 g/dl or at predefined physiologic triggers. After surgery, hemoglobin was maintained at 8.5 +/- 0.5 g/dl or greater in all patients until discharge. Efficacy endpoints included the number of allogeneic and preoperative autologous donation units transfused and the percentage of subjects avoiding transfusion. RESULTS: Both groups had similar hemoglobin concentrations at screening (13.5 +/- 1.0 g/dl) and at discharge: 10.8 +/- 1.2 g/dl (PFC) and 11.1 +/- 1.3 g/dl (control). At 24 h, more patients in the PFC group avoided allogeneic and preoperative autologous donation erythrocyte transfusions (53% vs. 43%, < 0.05), and fewer erythrocytes were transfused (1.5 +/- 4.8 vs. 2.1 +/- 3.9 units; median, 0 vs. 1 unit; P = 0.013). By day of discharge, these differences were not significant in the intent-to-treat population, but overall there were less allogeneic and preoperative autologous donation erythrocyte transfusions in the PFC group (696 vs. 846 units). In the protocol-defined target population (n = 330 subjects with blood loss > or = 20 ml/kg), significantly greater avoidance of any erythrocyte transfusion was maintained through day of hospital discharge (26% vs. 16% in the PFC and control groups, respectively; P < 0.05), and there was also a significant reduction in the number of erythrocyte units transfused (3.4 +/- 2.9 vs. 4.9 +/- 2.4 units; median 2 vs. 4 units; P < 0.001). Adverse events rates were similar in the PFC (86%) and control (81%) groups; however, more serious adverse events were reported in the PFC group (32%) than in controls (21%; P < 0.05). Overall mortality was 3%, and the difference between groups (PFC, 4% vs. controls, 2%) was not statistically significant. CONCLUSIONS: Augmented acute normovolemic hemodilution with PFC reduces transfusion needs in patients undergoing noncardiac surgical procedures with blood loss 20 ml/kg or greater.

Adult↗