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Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 127 records · Page 7Linked to original sources
PubMed2005

Intranasal lysine-aspirin in aspirin-sensitive nasal polyposis: a controlled trial.

OBJECTIVES/HYPOTHESIS: Intranasal lysine-aspirin has been used as a method of desensitization in patients with aspirin-sensitive nasal polyps to control their recurrence and prevent frequent surgical intervention. However, the studies are limited in number, and their design is open to criticisms. Thus, we conducted a controlled trial to study the clinical effectiveness of topical lysine-aspirin in patients with aspirin-sensitive nasal polyposis. STUDY DESIGN: Prospective, randomized, double blind, placebo controlled, crossover trial. METHODS: Aspirin-sensitive patients confirmed by intranasal challenge were enrolled and randomized to receive 16 mg of topical lysine-aspirin every 48 hours or placebo for 6 months before crossover. Polyp growth and nasal and chest symptoms were monitored using acoustic rhinometry, nasal inspiratory peak flow, peak expiratory flow rate, and a daily diary of symptom scores. RESULTS: Twenty-two patients were enrolled. After withdrawals and drop outs, data were available on 11 patients for analysis. Multivariate analysis of measured parameters did not reveal a significant clinical benefit to patients receiving topical lysine-aspirin compared with placebo. Deterioration was similar while on lysine-aspirin or placebo. CONCLUSIONS: This is the first controlled clinical trial of topical desensitization in aspirin-sensitive nasal polyp patients. Despite the failure to demonstrate clinical benefit, tissue studies have shown a significant improvement at the microscopic level. Further work with larger numbers of patients along with conventional treatment may show a clinical improvement in these patients.

Administration, Intranasal↗
PubMedDate not supplied

The effect of hemodiafiltration with on-line endogenous reinfusion (on-line HFR) on anemia: design of a European, open, randomised, multicentre trial. European Collaborative Study.

The lack of backfiltration reduces plasma levels of C-reactive protein and interleukin-6. Paired filtration dialysis is the hemodialfitration technique that abolishes backfiltration. By physically separating convection from diffusion, it allows pure ultrafiltrate to be available during the entire session, so the ultrafiltrate can be regenerated and used as infusion fluid. On these premises, we have developed a European, open, randomised, multicentre study aimed at evaluating the effect of hemodiafiltration with on-line endogenous reinfusion (on-line HFR) on anemia. At least 130 chronically uremic hemodialysed (bicarbonate hemodialysis) stable patients with mild anemia (Hb between 9 and 11 g/dL) will be enrolled and normalized for iron stores by concomitantly repleting iron deposits (if ferritin <300 microg/L) and reducing the dose of erythropoietin to maintain Hb values within the range at enrollment (9-11 g/dL). Patients will be included in the study, randomized to the two treatments (test treatment: on-line HFR; control treatment: hemodiafiltration or modified forms) and followed up for nine months. Iron stores will be maintained within normal levels and the dose of erythropoietin will be kept constant. The primary question and response variable will be the mean monthly changes in hemoglobin levels over the period of nine months. As secondary questions and response variables, we will measure the nutritional status using a subjective global assessment, protein catabolic rate, urea generation rate and the dietician's assessment, serum concentrations of vitamins A, C, E and serum C-reactive protein.

Anemia↗
PubMed1995

Bypass Angioplasty Revascularization Investigation (BARI): baseline clinical and angiographic data.

This report presents baseline clinical and angiographic data from the Bypass Angioplasty Revascularization Investigation (BARI), a multicenter international trial assessing the relative efficacy of percutaneous transluminal coronary angioplasty (PTCA) versus coronary artery bypass graft surgery (CABG) in selected patients with multivessel coronary artery disease. PTCA is commonly performed in patients with multivessel coronary artery disease, yet its long-term efficacy in comparison to CABG is unknown. From August 1988 through August 1991, 1,829 qualifying patients with multivessel disease suitable for either procedure were randomized to PTCA or CABG; sample size estimates were based on anticipated 5-year mortality. Two registry populations were also defined for follow-up: (1) 2,013 patients eligible for randomization but not randomized; and (2) 422 patients considered by angiography as unsuitable for randomization. Patients randomized in BARI were at relatively high risk for subsequent cardiac events: 39% were > or = 65 years old, 55% had prior myocardial infarction, 69% presented with unstable angina or non-Q wave myocardial infarction, and 43% had 3-vessel coronary artery disease. Patients randomized to PTCA and CABG were equally matched in all the important baseline variables. The randomized and the eligible but not randomized groups were similar in most respects. However, the nonrandomized group had a higher proportion with college education; fewer with a history of myocardial infarction, heart failure, diabetes, and smoking; and a somewhat better average ejection fraction. At the 3-month follow-up, PTCA had been performed more commonly in the nonrandomized eligible patients, especially those with 2-vessel disease.(ABSTRACT TRUNCATED AT 250 WORDS)

Angioplasty, Balloon, Coronary↗
PubMed2000

Economic analysis of a phase III study of G-CSF vs placebo following allogeneic blood stem cell transplantation.

Hematopoietic colony-stimulating factors (CSF) decrease the duration of neutropenia following stem cell transplantation (SCT). With CSF-mobilized allogeneic blood SCT (alloBSCT), the yields of CD34+ cells are several-fold higher than in other SCT settings, raising concern that post-transplant CSF use may be unnecessary. In this study, we estimate the resource and cost implications associated with CSF use following alloBSCT. A cost identification analysis was conducted for 44 patients on a randomized, double-blind placebo-controlled trial of G-CSF following alloBSCT. Study drug was given daily until an absolute neutrophil count (ANC) > or = 1000 cells/microl. Billing information from the time of transplant to day +100 was analyzed. The median number of days to an ANC > or = 500 cells/microl was shorter in the G-CSF arm, 10.5 days vs 15 days (P < 0.001), while platelet recovery and rates of acute graft-versus-host disease (GVHD) and survival were similar. Resource use was similar, including days hospitalized, days on antibiotics, blood products transfused and outpatient visits. Total median post-transplant costs were $76577 for G-CSF patients and $78799 for placebo patients (P = 0.93). G-CSF following allogeneic blood SCT decreased the median duration of absolute neutropenia and did not incur additional costs, but did not result in shorter hospitalizations, or less frequent antibiotic use.

Adolescent↗
PubMed1999

Oseltamivir.

Oseltamivir is the oral prodrug of GS4071, a selective inhibitor of influenza A and B viral neuraminidase. After absorption from the gastrointestinal tract oseltamivir is efficiently converted to GS4071, which is maintained at high and sustained concentrations in plasma. Based on studies in rats and ferrets, GS4071 appears to be effectively distributed to all tissues, including major sites of infection in the upper and lower respiratory tracts. Oral oseltamivir was an effective treatment in naturally occurring influenza when administered within 36 hours of symptom onset, reducing both the duration and severity of symptoms and the incidence of secondary complications in influenza-infected patients enrolled in 2 large placebo-controlled, double-blind trials. Prophylactic oral administration of oseltamivir was effective in reducing the incidence of influenza illness according to pooled data from 2 large placebo-controlled, double-blind trials of healthy nonimmunised volunteers during periods of seasonal influenza activity. The reported incidence of viral resistance to GS4071 was low in clinical isolates from oseltamivir treatment studies. All known GS4071 resistant genotypes are growth disadvantaged and display significantly reduced infectivity in animals. Oseltamivir was well tolerated in human volunteers and patients in clinical trials. Treatment-related adverse events (primarily gastrointestinal) were mild and transient in nature.

Acetamides↗
PubMed2000

Use of the World Wide Web in research: randomization in a multicenter clinical trial of treatment for twin-twin transfusion syndrome.

OBJECTIVE: To describe the process involved in using the World Wide Web to coordinate a randomized, multicenter international trial of treatment for twin-twin transfusion syndrome. METHOD: A Web site was designed by members of the research team, a Web consultant, and a senior computer programmer. The original intent was to provide patient randomization only, but the Web site later was designed so that centers could download a data collection form. Data could be entered directly into the Web site and subsequently imported into a database at the coordinating center. EXPERIENCE: The Web site has been active for 3 years, with 13 participating centers and 31 patients enrolled. COMMENT: Use of the World Wide Web to coordinate an international, multicenter trial is an efficient method. Although there are many benefits, the most obvious is the capability to initiate and conduct a large international trial at minimal cost.

Communication↗
PubMed1994

Evaluating the accuracy of citations in drug promotional brochures.

OBJECTIVE: To evaluate the accuracy of statements cited in 3 x 5 inch promotional cards for the 50 most frequently prescribed drugs. MEASUREMENTS: The 50 most frequently prescribed drugs were identified in the April 1992 issue of Pharmacy Times. File cards were requested from the pharmaceutical companies. References in the file card were retrieved and cited statements identified. Criteria used to evaluate reference accuracy were: type of study design, use of peer review journals, retrievability of references in area libraries, and reference documentation as no error, major error, or minor error. Referenced statements were classified as correct, incorrect, misleading, or taken from the abstract, discussion, or conclusion section of a study. RESULTS: Of the 50 most frequently prescribed products, 21 file cards were obtained. One hundred forty-two cited references were retrieved (average +/- SD per file card 6.9 +/- 8.4). Three hundred thirty-four cited statements were verified (average per file card 15.9 +/- 24.7). Forty-two percent of references were human controlled trials, 17 percent not available, 11 percent review articles, 10 percent manufacturer information, 8 percent human uncontrolled, 4 percent nonhuman controlled, 3 percent retrospective, 2 percent tertiary literature, 1 percent epidemiologic studies, 1 percent prospective, and 1 percent editorial. Thirty-three percent of references were found in peer-review journals. Of all cited references, 73 percent were retrievable. Thirty-nine references were not retrievable: 24 were not held by local libraries and 15 were manufacturers' information. Eighty-five percent of references contained no errors in reference documentation. For accuracy of statements, 46.1 percent were correct, 29 percent not available, 15.3 percent misleading, 4.2 percent incorrect, and 5.4 percent were cited from the abstract, discussion, or conclusion section of the study. CONCLUSIONS: Most references cited in pharmaceutical promotional brochures referenced controlled studies that are retrievable. However, incorporation of more adequately controlled studies, more references from peer review journals, and careful evaluation of referenced statements by the pharmaceutical company, journals' editorial board. Food and Drug Administration, and healthcare professionals may be beneficial.

Bibliographies as Topic↗
PubMed2000

Association of muscle power with functional status in community-dwelling elderly women.

BACKGROUND: Identification of the physiologic factors most relevant to functional independence in the elderly population is critical for the design of effective interventions. It has been suggested that muscle power may be more directly related to impaired physical performance than muscle strength in elderly persons. We tested the hypothesis that peak muscle power is closely associated with self-reported functional status in sedentary elderly community-dwelling women. METHODS: We used baseline data that were collected as part of a 1-year randomized controlled clinical trial of a combined program of strength, power, and endurance training in 80 elderly women (mean age 74.8 +/- 5.0 years) with 3.2 +/- 1.9 chronic diseases, selected for baseline functional impairment and/or falls. RESULTS: Functional status at baseline was related in univariate analyses to physiologic capacity, habitual physical activity level, neuropsychological status, and medical diagnoses. Leg power had the strongest univariate correlation to self-reported functional status (r = -.47, p < .0001) of any of the physiologic factors we tested. In a forward stepwise regression model, leg press power and habitual physical activity level were the only two factors that contributed independently to functional status (r = .64, p < .0001), accounting for 40% of the variance in functional status. CONCLUSIONS: Leg power is a strong predictor of self-reported functional status in elderly women.

Activities of Daily Living↗
PubMed1999

Calcium antagonists in the post-myocardial infarction setting.

At present, the use of calcium antagonists for the secondary prevention of cardiac events following an acute myocardial infarction (MI) is not recommended. This advice is based on several large mortality studies using short-acting calcium antagonists in the absence of coronary reperfusion therapy. Even in these studies, discrepancies between the different pharmacological classes of calcium antagonists were recognised. When separated from the dihydropyridine calcium antagonists, the rate-lowering calcium antagonists, verapamil and diltiazem, do appear to provide some benefit in reduction of recurrent MI. Three large trials using verapamil post-MI demonstrated a significant reduction in reinfarction with a favourable trend towards reducing death as well. Similarly, the effects of diltiazem post-MI have been evaluated in 3 large trials. In 2 earlier trials, diltiazem lessened cardiac events in patients with nonQ-wave infarctions and those without pulmonary congestion upon presentation. Overall, there was a significant benefit in lessening reinfarction with no effect on mortality. The recently completed Incomplete Infarction Trial of European Research Collaborators Evaluating Prognosis Post-Infarction (INTERCEPT) trial found that sustained-release diltiazem given after thrombolytic therapy for acute MI lessened cardiac events by 23% (a nonsignificant difference) without worsening congestive symptoms. Overall, there is adequate data to support the use of heart-rate-lowering calcium antagonists for secondary prevention post-MI provided the patient is intolerant of beta-blocker therapy. These trials are reviewed in detail, and suggestions for clinical practice are provided in this article.

Animals↗
PubMed2002

A summary of the findings from the Post-CABG trial.

The Post-CABG trial was designed to assess the effects of 2 different lipid lowering strategies and low dose warfarin vs placebo (2 x 2 factorial) design on the progression of atherosclerosis in saphenous vein grafts. Atherosclerotic progression was determined by comparing baseline and follow-up angiograms (mean interval: 4.3 years) using quantitative angiography. Significant progression of disease in SVG's was reduced with the aggressive lipid lowering strategy compared to the moderate strategy; significant progression in SVG's was not altered by low dose warfarin. The beneficial effects on angiographic changes were demonstrated in multiple subgroups of participants in the trial. The composite clinical end point of death, MI, stroke, PTCA or repeat CABG was analyzed at the end of the trial and 3 years (extended follow-up) after closure of the angiographic trial. At the time of the extended follow-up the aggressive lipid strategy was associated with reduced clinical events; low dose warfarin was also associated with reduced clinical events.

Coronary Artery Bypass↗
PubMed1992

[Clinical experience with long-term administration of "essential" phospholipids in chronic active hepatitis. Review of 3 double-blind studies].

The results from three double-blind studies, obtained after a 12-month treatment with Essentiale or placebo in patients (n = 85) with HBsAg positive or HBsAg negative chronic active hepatitis provide evidence of the clear improvement of the clinical and histological picture in the majority of the patients treated with Essentiale forte.

Double-Blind Method↗
PubMed1996

Combined androgen blockade.

Combined androgen blockade (CAB), the addition of an antiandrogen to castration (medical or surgical), is becoming a well-established option for advanced prostate cancer. CAB with leuprolide and flutamide was found to improve both progression-free and overall survival, compared with leuprolide alone, particularly in patients with minimal metastatic disease. These findings have led to an intergroup study in more than 1,300 men, including 300 with minimal disease, of orchidectomy with flutamide versus orchidectomy with placebo, which will examine which patient subgroups benefit most from CAB. This intergroup study has already provided important information regarding prostate-specific antigen as a surrogate marker for response and progression. The success with CAB in lengthening survival and improving quality of life in metastatic prostate cancer has stimulated enthusiasm for broadening the base of clinical studies for the management of this disease.

Androgen Antagonists↗
PubMed1996

Fluvastatin in combination with other lipid-lowering agents.

Fluvastatin, a new synthetic inhibitor of HMGCoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, has been studied in several models to examine its effects when used in combination with other lipid-modifying agents such as derivatives of fibric acid (bezafibrate), resins (cholestyramine), and niacin. The combination of fluvastatin with bezafibrate has been studied in a double-blind trial involving patients with well-documented familial hypercholesterolaemia. Fluvastatin 40 mg/day, combined with either bezafibrate 400 mg/day or cholestyramine 8 g/day, resulted in reductions in levels of low-density lipoprotein cholesterol (LDL-C), these being indistinguishable between the groups; however, significantly greater increases in levels of high-density lipoprotein cholesterol (21.3%) and reductions in levels of triglycerides (25.1%) were seen with the fluvastatin-bezafibrate combination. No notable increases were seen in levels of serum creatine kinase, aspartate aminotransferase, or alanine aminotransferase, and no cases of myopathy were observed. In a study model that examined low-dose combinations of fluvastatin with cholestyramine, reductions in levels of LDL-C of 15.8% and 19.3% were seen with fluvastatin 10 mg and 20 mg, respectively. After an 8-week interval in which a daily dosage of cholestyramine 8 g was added, from baseline, reductions of 26.3% in the 10 mg fluvastatin-cholestyramine group and 31.2% in the 20 mg fluvastatin-cholestyramine group were observed, whereas the placebo-cholestyramine group displayed a reduction of 14.9%. Doubling the resin dosage to 16 g/day for the final 8 weeks of the study provided little additional benefit. Myotoxicity has been observed when lovastatin is coadministered with niacin, and so the combination of niacin with fluvastatin has also been studied to examine the possibility of this effect occurring. Patients were randomised to either fluvastatin 20 mg or placebo for 6 weeks, after which time open-label niacin was administered to all patients and titrated to a final dosage of 3 g/day. After 6 weeks, fluvastatin produced a 20.8% reduction in LDL-C levels from baseline. When combined with niacin, a 43.7% reduction was noted at the week 15 endpoint, against the 26.5% reduction seen with niacin monotherapy. The combination was well tolerated, with no reports of myopathy or of significant elevations in creatine kinase or liver transaminase levels. Combinations of fluvastatin with a variety of other agents have been shown to have significant effects on lipid profiles, with no evidence to date of clinically remarkable safety findings. Thus, the use of combination therapies may result in optimal management of patients with moderately severe hypercholesterolaemia and mixed dyslipidaemic profiles.

Anticholesteremic Agents↗