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At least 181 records · Page 10Linked to original sources
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↗
PubMedDate not supplied

Ketamine psychedelic therapy (KPT): a review of the results of ten years of research.

Ketamine is a prescription drug used for general anesthesia. In subanesthetic doses, it induces profound psychedelic experiences and hallucinations. The subanesthetic effect of ketamine was the hypothesized therapeutic mechanism in the authors' use of ketamine-assisted psychotherapy for alcoholism. The results of a controlled clinical trial demonstrated a considerable increase in efficacy of the authors' standard alcoholism treatment when supplemented by ketamine psychedelic therapy (KPT). Total abstinence for more than one year was observed in 73 out of 111 (65.8%) alcoholic patients in the KPT group, compared to 24% (24 out of 100 patients) of the conventional treatment control group (p < 0.01). The authors' studies of the underlying psychological mechanisms of KPT have indicated that ketamine-assisted psychedelic therapy of alcoholic patients induces a harmonization of the Minnesota Multiphasic Personality Inventory (MMPI) personality profile, positive transformation of nonverbalized (mostly unconscious) self-concept and emotional attitudes to various aspects of self and other people, positive changes in life values and purposes, important insights into the meaning of life and an increase in the level of spiritual development. Most importantly, these psychological changes were shown to favor a sober lifestyle. The data from biochemical investigations showed that pharmacological action of KPT affects both monoaminergic and opioidergic neurotransmitter metabolism, i.e., those neurochemical systems which are involved in the pathogenesis of alcohol dependence. The data from EEG computer-assisted analysis demonstrated that ketamine increases theta activity in cerebrocortical regions of alcoholic patients. This is evidence of the reinforcement of limbic cortex interaction during KPT session.

Adult↗
PubMed2000

Cytomegalovirus immune globulin after liver transplantation: a cost-effectiveness analysis.

OBJECTIVE: Cytomegalovirus (CMV) immune globulin (CMVIG) has been shown to significantly reduce severe CMV-associated disease complicating orthotopic liver transplant (OLT). We evaluated the economic impact of severe CMV-associated disease and calculated the marginal cost-effectiveness (C/E) of routine prophylaxis with CMVIG after OLT. DESIGN: C/E analysis. SETTING: Four teaching hospitals in Boston. PATIENTS: Patients who underwent OLT from January 1988 through June 1990. MEASUREMENTS: We gathered actual cost data of hospital care for patients enrolled in a clinical trial of CMVIG prophylaxis in OLT. We calculated average outpatient expenses from a separate group of patients undergoing OLT and developed a regression model to estimate costs during the first year post-transplant (R2 = 0.77). Based on this model, we calculated variable costs (in 1999 US dollars) for all patients in the randomized trial. From the published literature we obtained the probability of CMV outcomes and of long-term survival after OLT. We then developed a decision analytical model to determine an incremental C/E ratio, using a Markov simulation to estimate long-term survival and long-term costs. We discounted costs and life-years at 3% and 5% per yr. RESULTS: Based on the efficacy rate of 54% in the controlled trial, we estimate that CMVIG will increase life expectancy by 0.65 discounted years at an additional cost of $11,600, providing a marginal C/E ratio of $17,900/yr life saved. Examining the confidence limits of efficacy, we estimate that CMVIG will have a marginal C/E ratio of $66,200 gained/yr at an efficacy of 11% and $14,000 gained/yr at an efficacy of 83%. CONCLUSION: After OLT, prophylactic CMVIG has an incremental C/E ratio comparable to that of other well-accepted medical therapies and should be used routinely in these patients.

Cost-Benefit Analysis↗
PubMed2000

Target volume definition in conformal radiotherapy for prostate cancer: quality assurance in the MRC RT-01 trial.

BACKGROUND AND PURPOSE: Prior to randomization of patients into the UK Medical Research Council multicentre randomized trial (RT-01) of conformal radiotherapy (CFRT) in prostate cancer, clinicians at participating centres were required to complete a quality assurance (QA) clinical planning exercise to enable an investigation of inter-observer variability in gross target volume (GTV) and normal structure outlining. MATERIALS AND METHODS: Thirteen participating centres and two investigators completed the clinical planning exercise of three practice planning cases. Clinicians were asked to draw outlines of the GTV, rectum and bladder on hard-copy computerized tomography (CT) films of the pelvis, which were transferred onto the Cadplan computer planning system by a single investigator. Centre, inferior and superior CT levels of GTV, rectum and bladder were noted, and volume calculations performed. Planning target volumes (PTV) were generated using automatic volume expansion of GTVs by a 1 cm margin. Anterior, right and left lateral beam eye views (BEV) of the PTVs were generated. Using a common central point, the BEV PTVs were superimposed for each beam direction of each case. Radial PTV variation was investigated by measurement of a novel parameter, termed the radial line measurement variation (RLMV). RESULTS: GTV central slice and length were defined with reasonable consistency. The RLMV analysis showed that the main part of the prostate gland, bladder and inferior rectum were outlined with good consistency among clinicians. However, the outlining of the prostatic apex, superior aspect of the prostate projecting into the bladder, seminal vesicles, the base of seminal vesicles and superior rectum were more variable. CONCLUSION: This exercise has demonstrated adequate consistency of GTV definition. The RLMV method of analysis indicates particular regions of clinician uncertainty. Appropriate feedback has been given to all participating clinicians, and the final RT-01 trial protocol has been modified to accommodate these findings.

Humans↗
PubMed2000

Radiotherapy versus follow-up in the treatment of pathological stage Ia and Ib non-small cell lung cancer. Early stopped analysis of a randomized controlled study.

OBJECTIVE: This is an analysis of a randomized controlled clinical trial planned to evaluate the effects of adjuvant radiotherapy (AR) on the local recurrence rate in patients with non-small cell lung cancer (NSCLC) with pathological stage (pStage) Ia (pT1N0) and Ib (pT2N0). The effects of AR on the long-term survival have also been marginally evaluated. MATERIALS AND METHODS: This clinical trial was planned with the hypothesis that AR on pStage Ia and Ib, R0 NSCLCs was effective on local recurrence rate. From July 1989 through March 1997, 104 patients with NSCLC who presented with pStage Ia and Ib have been observed and treated and entered the study. Male/female ratio was 91:13; the mean age was 62 years (range 41-75 years). All patients underwent major pulmonary resection and homolateral standard hilar and mediastinal lymph node dissection. pStage was T1N0 in 29 and T2N0 in 75 cases. Patients have been randomized 'by chance' into two groups (G1 and G2). G1 received radiotherapy, G2 did not receive any adjuvant treatment. Fifty-two patients entered G1 and 52 entered G2. RESULTS: Post-operative mortality was nil. Seven patients have been excluded from the study (four in G1 and three in G2), due to incomplete follow-up data. We do not report any radiotherapy-related complication or deterioration of lung function. The treatment effect on the local recurrence rate demonstrated a clearly significant protective effect of the AR. No statistically significant difference was found from the comparison of the 5-year survival rate of the treated (83%) versus untreated (70%) patients. No detrimental effect of the radiotherapy has been assessed. CONCLUSIONS: AR in the treatment of pStage Ia and Ib NSCLC has been well tolerated and had a significant relative effect on the local recurrence rate but did not significantly modify overall survival even if a positive trend in the group of treated patients is reported.

Adult↗
PubMed1995

Chemo-endocrine therapy in patients with stage D2 prostate cancer.

There have only been a few studies of chemo-endocrine therapy compared with endocrine therapy alone in newly diagnosed prostate cancer patients. We assessed the effects of these two therapies by comparing long-term survival rates. One hundred and twenty-nine patients were entered in this study between November 1977 and March 1992. Seventy-seven patients were treated with endocrine therapy alone. Other 52 patients received chemo-endocrine therapy, which included orchiectomy and/or diethylstilbestrol diphosphate (DES-DP) plus Cisplatin, with or without other cytotoxic agents. All patients had bone metastasis at the beginning of the study. There was a significant difference in survival between patients who received endocrine therapy and chemo-endocrine therapy (P = 0.0078). That is, survival rate was superior for the chemoendocrine therapy patients throughout the entire follow-up period. These data suggest that early chemo-endocrine therapy containing Cisplatin, with or without maintenance chemotherapy, is a potentially effective treatment for newly diagnosed metastatic prostate cancer and is worth further investigation via a randomized trial.

Aged↗
PubMed1993

Cisplatin and radiotherapy in the management of locally advanced head and neck cancer.

PURPOSE: This manuscript traces the results of combined modality head and neck cancer trials, with reference to survival and rates of local-regional control and distant metastases, that have led to current Phase III trials testing concomitant cisplatin and radiotherapy. METHODS AND MATERIALS: The toxicity, local control rates, and survival results of pilot trials and small randomized trials using concomitant cisplatin based chemotherapy and radiotherapy are reviewed. RESULTS: Enhanced mucosal toxicity and myelosuppression occur which affect patient compliance and tolerance of planned chemotherapy, but do not appear to affect delivery of standard fractionation radiotherapy. The encouraging results of single agent cisplatin and radiotherapy trials and those using cisplatin-5-FU and split course radiotherapy have led to the activation of three randomized Head and Neck Intergroup trials. These trials are for Stage III & IV carcinoma of the nasopharynx, Stage III & IV resectable carcinoma of the larynx (organ preservation) and Stage III & IV unresectable carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx. CONCLUSION: The three Intergroup study designs should allow for a definitive evaluation of concomitant treatment.

Cisplatin↗
PubMed2002

Double placebo design in a prevention trial for Alzheimer's disease.

The Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) is designed to compare two nonsteroidal anti-inflammatory agents against placebo. A placebo control for two active treatments can be achieved in several ways, each of which may have different implications for the logistics of drug supply, enrollment, adherence to treatment, and the validity of specific treatment comparisons. The authors outline the placebo designs considered in ADAPT, discuss their advantages and disadvantages, and provide their rationale for and the consequences of the selection of the double placebo design.

Aged↗
PubMed1989

Advanced cryptogenic fibrosing alveolitis: preliminary report on treatment with cyclosporin A.

Seven patients with fibrosing alveolitis who failed to respond to prednisolone and cyclophosphamide and were deteriorating, were treated with cyclosporin A. An initial favourable response was seen but was not maintained. When compared to a control population, matched for the extremely severe disease present in the treated group, survival was doubled from 2.5 to 5 months. With growing awareness of the possibility of heart-lung transplantation in this disease, even this trivial increase in survival may be of crucial importance in individual patients.

Cyclosporins↗
PubMed2000

Fatty acid composition of serum cholesterol esters as a reflector of low-saturated-fat, low-cholesterol diet in young children: the STRIP project. The Special Turku coronary Risk factor Intervention Project.

STRIP (the Special Turku coronary Risk factor Intervention Project) is an ongoing intervention trial which aims at a permanent reduction in the intake of saturated fat and cholesterol starting in childhood. A total of 75 intervention and 63 control children was studied consecutively at the ages of 7 and 13 mo, and 2, 3 and 5 y to evaluate the influence of such intervention on serum cholesterol ester (CE) fatty acid composition, a widely used biomarker of fatty acid intake. Analysis of 4-d food records showed that total intake of fat and of saturated fat increased with age in both groups of children but was constantly lower in intervention than in control children, e.g. at the age of 5 y the mean intakes of total fat and of saturated fatty acids were 31.1 E% and 33.9 E% and 12.1 E% and 14.6 E% in intervention and control children, respectively (p = 0.009 and 0.0001, respectively). Serum CE fatty acid compositions did not differ between the 2 groups at any age; the mean proportion of CE linoleic acid was 52.4% and 52.0% in 5-y-old intervention and control children, respectively. Correlation analysis showed, however, that the percentage of linoleic acid and of polyunsaturated fatty acids in CE reflected well the respective dietary intakes (r = 0.36; p = 0.0001 for both coefficients). In conclusion, CE fatty acid composition did not differ between the intervention and control groups, whereas CE linoleic and total polyunsaturated fatty acids reflected well the differences in their intakes at the individual level.

Child, Preschool↗
PubMed1992

Management of the non-descended testis: doubtful value of luteinizing-hormone-releasing-hormone (LHRH). A double-blind, placebo-controlled multicentre study.

In a double-blind, placebo-controlled multicentre study, the effect of luteinizing-hormone-releasing-hormone (LHRH) in 141 boys was analysed after 4-week treatment period with 0.4 mg LHRH nasal spray or placebo nasal spray three times daily. Data from 123 boys was analysed, with 62 boys in the treatment group and 61 in the placebo group. Full response i.e. the testis at the bottom of the scrotum on both sides in boys with bilaterally undescended testes, was found in six patients, one of them in the placebo group [Therapeutic gain of LHRH with 95% CI: 8.1% (0.1-16.6%, P = 0.12)]. Only in these boys could surgery be avoided. Considering the number of testes (and not the number of boys) a significant effect was found on at least one testis in 25% of boys with bilaterally undescended testes [Therapeutic gain with 95% CI: 24.0% (13.2-34.8%, P = 0.001)]. In unilateral undescended testes, the LHRH treatment showed no effect (P = 1.00). The inclusion of retractile testes did not affect our results. In our opinion LHRH has a limited place in treatment of the non-descended testis.

Administration, Inhalation↗