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Biomedical subjects

Michael Goldstein

Publications and source records attributed to Michael Goldstein.

12 recordsLinked to original sources
PubMed2006

Safety and colon-cleansing efficacy of a new residue-free formulation of sodium phosphate tablets.

OBJECTIVE: A residue-free sodium phosphate tablet (RF-NaP) was formulated that lacks microcrystalline cellulose, which can appear as a whitish residue in the colon. A multicenter, randomized, investigator-blinded study was conducted to compare the colon-cleansing efficacy of 40 or 32 tablets of RF-NaP with the marketed 40-tablet NaP treatment regimen. METHODS: Eight hundred sixteen patients were randomized prior to colonoscopy to receive either 40 tablets (60 g) of NaP or RF-NaP or 32 tablets (48 g) of RF-NaP. Colon cleansing was assessed using a 4-point scale based on retained "colonic contents." The primary end point was overall colon-cleansing response rate to treatment (score of excellent/good) versus nonresponse (fair/inadequate). RESULTS: Seven hundred four patients were included in the efficacy analysis. The overall colon-cleansing response rates were comparable among treatment arms (94.5%, 97.0%, and 95.3% for NaP, RF-NaP 40, and RF-NaP 32 tablets, respectively). Ascending colon-cleansing response rates for RF-NaP 40 (95.7%) and 32 tablets (93.6%) were significantly better than for NaP tablets (88.5%, p < 0.03 for both). Patients treated with RF-NaP 32 tablets experienced less pronounced changes in electrolyte levels and fewer adverse events (138/239, 58%) compared with patients receiving NaP (161/238, 68%, p= 0.07) and RF-NaP 40 tablets (156/236, 66%, p= 0.03). The most common adverse events reported were abdominal distention, nausea, abdominal pain, and vomiting. CONCLUSIONS: Based on the safety, efficacy, and patient preferences, the 32-tablet RF-NaP regimen was superior to the 40-tablet RF-NaP and NaP regimen for colon cleansing prior to colonoscopy.

Adolescent↗
PubMed2006

Immunohistochemical localization of EGF, TGF-alpha, TGF-beta, and their receptors in rat corneas during healing of excimer laser ablation.

PURPOSE: Members of the epidermal growth factor (EGF) and transforming growth factor beta (TGF-beta) families of growth factors and receptors are known to regulate key aspects of corneal wound healing, including epithelial migration and scar formation. To further understand their roles, mRNA levels were measured and proteins were immunolocalized in rat corneas at multiple time points during healing of excimer laser ablation injury. METHODS: Excimer laser photoablation was performed to a depth of 50 microm on rat corneas. Levels of mRNAs for EGF, TGF-alpha, TGF-beta isoforms 1, 2, and 3, and their receptors (EGF-R and TGFbeta-IIR) were measured by quantitative RT-PCR on days 0, 1.5, 7, 21, 42, and 91 after ablation. Immunohistochemical localization of the growth factors and their receptors was performed on days 0, 7, and 21 in corneal sections. RESULTS: Levels of EGF mRNA remained stable in rat corneas after ablation (68 +/- 12 copies/cell, mean +/- SD), whereas levels of TGF-alpha mRNA progressively increased sixfold to a maximum at day 42 (300 copies/cell) then slightly decreased on day 91. Levels of EGF-R mRNA rapidly increased 60-fold on day 7 compared with day 0 (571 vs. 9 copies/cell) then decreased sixfold above baseline at day 91. Levels of TGF-beta1 mRNA remained stable (36 +/- 10 copies/cell), whereas levels of TGF-beta2 and TGF-beta3 mRNAs peaked on day 21 (300-fold and 25-fold increase) and remained elevated through day 91. Levels of TGFbeta-IIR mRNA showed a similar pattern. Immunostaining of all the growth factors and receptors was primarily in basal layers of epithelial cells in uninjured cornea and during healing. Intensity of immunostaining for TGF-beta1, TGFbeta-IR, and TGFbeta-IIR increased appreciably in the basal epithelial layers after ablation. CONCLUSIONS: Levels of mRNAs for several key members of the EGF and TGF-beta systems increase during corneal wound healing. In addition, the proteins are primarily localized in basal layers of epithelial cells, which suggest these cells are active in synthesizing autocrine and paracrine growth factors that modulate corneal wound healing.

Animals↗
PubMed2006

Phase II trial of sequential chemotherapy followed by chemoradiation, surgery, and postoperative chemotherapy for the treatment of stage IIIA/IIIB non-small-cell lung cancer.

BACKGROUND: The optimal treatment of locally advanced non-small-cell lung cancer remains a challenge. Although the benefit of combined chemoradiation has been established, the optimal chemotherapy regimen, timing of full-dose chemotherapy, and how best to combine chemotherapy with radiation to maximize systemic and radiosensitizing effects remain unclear. PATIENTS AND METHODS: Twenty-nine patients with pathologically confirmed stage IIIA/IIIB non-small-cell lung cancer were included in a phase II trial of sequential carboplatin/paclitaxel followed by chemoradiation, surgery, and postoperative gemcitabine. Twenty-five patients (86%) completed the concurrent chemotherapy and radiation therapy phase and were eligible for surgery. At restaging, 7 patients (21%) showed disease progression. Seventeen patients (59%) went on to surgery. Few were able to tolerate full postoperative chemotherapy. RESULTS: The 1-year overall survival rate was 61%, with a 2-year survival rate of 56%. Median overall survival was 25.2 months. Seven of the patients are alive and without recurrence at the time of this writing. Our median follow-up time was 22.2 months. Reversible grade 3/4 toxicities were fairly common, experienced in 45% of patients. CONCLUSION: Our results with this combined modality approach are comparable with those of previous, similar studies. Postoperative chemotherapy after initial combined modality therapy is often not feasible, reinforcing the value of initial systemic therapy. Long-term results are still suboptimal and await studies adding targeted therapies to our usual chemotherapy/radiation approaches.

Adult↗
PubMed2005

The lack of social gradient of health behaviors and psychosocial factors in Northern Italy.

OBJECTIVES: To examine inequalities in health behaviors and psychosocial factors in Northern Italy. METHODS: The study was based on a computer-assisted telephone interview (CATI) of 4 002 non-institutionalized adults living in the Veneto region of Italy. RESULTS: Cigarette smoking, binge drinking, fruit and vegetables consumption and stress failed to show a social gradient. Only physical activity was significantly associated with social class. Stress was a significant predictor of physical inactivity, smoking and low fruit and vegetable intake. Lack of emotional support was associated with smoking and physical inactivity among males, and low fruit and vegetable intake for both genders. CONCLUSIONS: Three proposed explanations may account for the lack of consistent social gradient of health behaviors in Northern Italy: a) socio-economic context; b) uncompleted epidemiological transition of behavioral risk factors across social classes; c) lack of systematic health promotion efforts. Future research is needed to examine the plausibility of such explanations.

Adolescent↗
PubMed2005

Stage-based expert systems to guide a population of primary care patients to quit smoking, eat healthier, prevent skin cancer, and receive regular mammograms.

BACKGROUND: Treating multiple health behavior risks on a population basis is one of the most promising approaches to enhancing health and reducing health care costs. Previous research demonstrated the efficacy of expert system interventions for three behaviors in a population of parents. The interventions provide individualized feedback that guides participants through the stages of change for each of their risk behaviors. This study extended that research to a more representative population of patients from primary care practice and to targeting of four rather than three behaviors. METHODS: Stage-based expert systems were applied to reduce smoking, improve diet, decrease sun exposure, and prevent relapse from regular mammography. A randomized clinical controlled trial recruited 69.2% of primary care patients (N = 5407) at home via telephone. Three intervention contacts were delivered for each risk factor at 0, 6, and 12 months. The primary outcome measures were the percentages of at-risk patients at baseline who progressed to the action or maintenance stages at 24-month follow-up for each of the risk behaviors. RESULTS: Significant treatment effects were found for each of the four behaviors, with 25.4% of intervention patients in action or maintenance for smoking, 28.8% for diet, and 23.4% for sun exposure. The treatment group had less relapse from regular mammography than the control group (6% vs. 10%). CONCLUSION: Proactive, home-based, and stage-matched expert systems can produce relatively high population impacts on multiple behavior risks for cancer and other chronic diseases.

Adult↗
PubMed2005

Utilization of extended donor criteria liver allografts maximizes donor use and patient access to liver transplantation.

OBJECTIVE: The objective of this study was to evaluate the effect of systematic utilization of extended donor criteria liver allografts (EDC), including living donor allografts (LDLT), on patient access to liver transplantation (LTX). SUMMARY BACKGROUND DATA: Utilization of liver allografts that do not meet traditional donor criteria (EDC) offer immediate expansion of the donor pool. EDC are typically allocated by transplant center rather than regional wait-list priority (RA). This single-institution series compares outcomes of EDC and RA allocation to determine the impact of EDC utilization on donor use and patient access to LTX. METHODS: The authors conducted a retrospective analysis of 99 EDC recipients (49 deceased donor, 50 LDLT) and 116 RA recipients from April 2001 through April 2004. Deceased-donor EDC included: age >65 years, donation after cardiac death, positive viral serology (hepatitis C, hepatitis B core antibody, human T-cell lymphotrophic), split-liver, hypernatremia, prior carcinoma, steatosis, and behavioral high-risk donors. Outcome variables included patient and graft survival, hospitalization, initial graft function, and complication categorized as: biliary, vascular, wound, and other. RESULTS: EDC recipients were more frequently diagnosed with hepatitis C virus or hepatocellular carcinoma and had a lower model for end-stage liver disease (MELD) score at LTX (P < 0.01). Wait-time, technical complications, and hospitalization were comparable. Log-rank analysis of Kaplan-Meier survival estimates demonstrated no difference in patient or graft survival; however, deaths among deceased-donor EDC recipients were frequently the result of patient comorbidities, whereas LDLT and RA deaths resulted from graft failure (P < 0.01). EDC increased patient access to LTX by 77% and reduced pre-LTX mortality by over 50% compared with regional data (P < 0.01). CONCLUSION: Systematic EDC utilization maximizes donor use, increases access to LTX, and significantly reduces wait-list mortality by providing satisfactory outcomes to select recipients.

Adolescent↗
PubMed2004

Cardiac events in patients with negative maximal versus negative submaximal dobutamine echocardiograms undergoing noncardiac surgery: importance of resting wall motion abnormalities.

OBJECTIVES: This study sought to evaluate the negative predictive value (NPV) of preoperative dobutamine stress echocardiography (DSE) in patients who fail to achieve target heart rate (HR) and assess the influence of resting wall motion abnormalities (WMAs) without demonstrable ischemia on perioperative events. BACKGROUND: The prognostic value of a negative-submaximal DSE study before noncardiac surgery is unknown. METHODS: Consecutive patients (n = 429) who underwent surgery over a three-year period, preceded by DSE, were included. We compared perioperative event rates among those without inducible ischemia according to whether or not 85% age-adjusted maximum HR was achieved, and whether WMAs were present at rest. RESULTS: Of 397 negative DSEs, peak HR was <85% maximum predicted in 62 (16%). Most were receiving beta-blockers (77%). The average dobutamine and atropine doses were 48 microg/kg/min and 1.2 mg, respectively. Average HR was 115 beats/min (74% maximum predicted). Perioperative myocardial infarctions occurred more frequently in patients with positive tests (3 of 32 [9.4%] vs. 7 of 397 [1.8%]; p = 0.03), but with similar frequency among the negative-maximal and negative-submaximal groups (6 of 335, 1.8% vs. 1 of 62, 1.6%, respectively). Accordingly, the NPV was 98% in both subgroups. Events occurred exclusively in patients with WMAs at rest: 7 of 100 (7%) versus 0 of 297 (0%) (p < 0.0001). CONCLUSIONS: In patients undergoing preoperative DSE, failure to achieve target HR is not uncommon despite an aggressive DSE regimen. A negative DSE without resting WMAs has excellent NPV regardless of the HR achieved. Patients with resting WMAs appear to be at increased risk for perioperative events even without provokable ischemia.

Adrenergic beta-Agonists↗
PubMed2004

Blockade of receptor for advanced glycation end product (RAGE) attenuates ischemia and reperfusion injury to the liver in mice.

Hepatic ischemia/reperfusion (I/R) injury associated with liver transplantation and hepatic resection is characterized by hepatocellular damage and a deleterious inflammatory response. In this study, we examined whether receptor for advanced glycation end product (RAGE) activation is linked to mechanisms accentuating inflammation on I/R in a murine model of total hepatic ischemia. Animals treated with soluble RAGE (sRAGE), the extracellular ligand-binding domain of RAGE, displayed increased survival after total hepatic I/R compared with vehicle treatment. TUNEL assay and histologic analysis revealed that blockade of RAGE was highly protective against hepatocellular death and necrosis on I/R; in parallel, proliferating cell nuclear antigen was enhanced in livers of mice treated with sRAGE. Rapid activation of p38, p44/42, stress-activated protein kinase and c-Jun N-terminal kinase mitogen-activated protein kinases, signal transducer and activator of transcription-3, and nuclear translocation of activator protein-1 was evident at early times on I/R. In the remnants of sRAGE-treated livers, however, activation of each of these signaling and transcription factor pathways was strikingly decreased. sRAGE-treated remnants displayed enhanced activation of nuclear factor kappaB, in parallel with increased transcripts for the proregenerative cytokine, tumor necrosis factor-alpha. In conclusion, these data suggest that RAGE modulates hepatic I/R injury, at least in part by activation of key signaling pathways linked to proinflammatory and cell death-promoting responses. We propose that blockade of this pathway may represent a novel strategy to attenuate injury in hepatic I/R and to facilitate regeneration.

Animals↗
PubMed2003

Evidence-based behavioral medicine: what is it and how do we achieve it?

The goal of evidence-based medicine is ultimately to improve patient outcomes and quality of care. Systematic reviews of the available published evidence are required to identify interventions that lead to improvements in behavior, health, and well-being. Authoritative literature reviews depend on the quality of published research and research reports. The Consolidated Standards for Reporting Trials (CONSORT) Statement (www.consort-statement.org) was developed to improve the design and reporting of interventions involving randomized clinical trials (RCTs) in medical journals. We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence-based practice. Additional behavioral medicine-specific guidelines (e.g., treatment adherence) are also presented. Use of these guidelines by clinicians, educators, policymakers, and researchers who design, report, and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice.

Behavioral Medicine↗
PubMed2002

The effect of a stage-matched and tailored intervention on repeat mammography(1).

BACKGROUND: Our objective was to determine whether a tailored, stage-matched educational intervention, guided by the transtheoretical model (TTM), would increase rates of repeat-screening mammography. DESIGN SETTING/PARTICIPANTS: A total of 1324 women (N=1026 after attrition) aged 50 to 74 years were recruited from a staff-model health maintenance organization. Some of the women were not due for mammograms at the time of recruitment. INTERVENTION: Women were randomly assigned to one of three intervention conditions: Group 1, no educational materials (usual care); Group 2, standard materials; and Group 3, stage-matched/tailored materials. Women in Groups 2 and 3 received a mailed education packet after both a baseline and a follow-up telephone interview. All women in Group 2 received the same materials regardless of differences in baseline mammography-related attitudes and behaviors. Each woman in Group 3 received materials based on her stage of adoption for mammography and TTM constructs. MAIN OUTCOME: Using clinical records, repeat screening was defined as receipt of a second mammogram within 14 months after obtaining an initial postbaseline mammogram. RESULTS: Women in Group 3 were more likely to obtain repeat-screening mammograms than women in Group 1 (44.2% vs 35.8%; adjusted rate ratio = 1.29, 95% confidence interval [CI]=1.11-1.46; adjusted rate difference = 0.06, 95% CI=-0.01-0.13). The screening percentage in Group 2 was intermediate (39.3%), and did not differ from either Group 3 or Group 1. CONCLUSIONS: The effect of the stage-matched/tailored intervention was sustained for repeat screening, although no educational materials were delivered to coincide with the timing for a second mammogram. However, the stage-matched/tailored intervention was not sufficient to have a substantial impact on screening beyond the effect of standard educational materials. Future interventions may need to administer "booster" sessions to increase repeat screenings.

Aged↗