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Biomedical subjects

R M Goldberg

Publications and source records attributed to R M Goldberg.

At least 55 records · Page 3Linked to original sources
PubMed1996

Drug-drug and drug-disease interactions in the ED: analysis of a high-risk population.

A study was undertaken to determine the potential for adverse drug interactions (ADIs) and drug-disease interactions (DDIs) in a high-risk population of emergency department (ED) patients and to characterize drug-drug and drug-disease interactions in terms of percentage of patients at risk from existing drug regimens, percentage of patients at risk from ED treatment, relation between number of drugs and potential for interactions, types of drugs and diseases posing greatest potential for interaction, and the differences in a general versus community hospital population with respect to these parameters. Records of 205 consecutive patients, 111 from a general hospital teaching facility ED (Facility 1) and 94 from a community hospital ED (Facility 2) were retrospectively reviewed. The records of all patients receiving three or more medications and all patients older than 50 years of age receiving two or more medications were analyzed by two computer programs for the presence of potential drug-drug and drug-disease interactions. A total of 226 potential ADIs were found in 89 patients (47%), with 50% of ADIs being related to ED treatment. A total of 94 potential DDIs were found in 44 patients (21%), with 34% of DDIs being related to ED treatment. The risk of an ADI rose from 13% for patients taking 2 medications to 82% for patients taking 7 or more medications. Eleven medications and four disease categories were identified as having particular potential for interactions. No significant differences were found between the general and the community hospital populations in these respects. ED patients taking three or more medications and patients older than 50 years of age taking two or more medications are at substantial risk for adverse drug-drug and drug-disease interactions. The risk is increased in patients taking particular drugs or having particular disease states.

Adolescent↗
PubMed1996

Learning preference and personality type: their association in paediatric residents.

The objective of this study was to determine if there is a relationship between the learning preferences and personality types of residents in paediatrics. As part of a study to teach residents in paediatrics how to teach, the authors administered the Learning Preference Inventory (LPI) and Fundamental Interpersonal Relationship Orientation (FIRO-B) instruments to 55 residents in paediatrics at all three levels of training. The instruments provided data that were used to provide feedback to residents on their learning preferences and interaction styles, as well as how these factors might affect teaching and learning in the clinical setting. The Pearson correlation coefficient was used to determine relationships between the LPI and the FIRO-B. Fifty-two of the 55 residents (95%) completed the instruments. The results revealed that residents' learning preferences were significantly related to their personality types. For example, residents with high inclusion and affection scores on the FIRO-B preferred learning with others, which was significantly related to their high interpersonal scores on the LPI. Residents with low inclusion and affection scores were more likely to prefer independent learning (high individual and student-structured scores on the LPI) and abstract learning at statistically significant levels. The scores obtained by residents in paediatrics on the LPI were strongly correlated with those obtained on the FIRO-B. These data may have important implications for the way in which staff recruit, counsel and teach residents. The fact that the LPI is easy to administer and does not purport to measure personality styles makes it an acceptable educational tool that can be used in many areas of training.

Attitude↗
PubMed1995

A phase III evaluation of a somatostatin analogue (octreotide) in the treatment of patients with asymptomatic advanced colon carcinoma. North Central Cancer Treatment Group and the Mayo Clinic.

BACKGROUND: The purpose of this study was to determine by randomized, controlled, double-blind evaluation whether therapy with the somatostatin analogue, octreotide, would delay tumor progression and improve survival of patients with metastatic colorectal carcinomas who were ambulatory with no significant symptoms. METHODS: Two hundred sixty patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 and without symptoms related to colon cancer were randomized to receive 150 micrograms of octreotide subcutaneously three times daily or, initially, no treatment. After 91 patients were entered in the double-blind study, saline placebo injections were used for patients in the control arm. RESULTS: The randomization culminated in balanced assignment of patients with respect to disease site(s), presence or absence of measurable or evaluable disease, and interval from diagnosis of metastasis to protocol entry. Steatorrhea and diarrhea, usually mildly severe, resulted more often from treatment than from the placebo. The major end points were time to progression and survival. Curves for both parameters overlapped in the blind and open trial segments. CONCLUSION: Octreotide at a dose of 150 micrograms given three times daily is not effective therapy for patients with advanced asymptomatic colon carcinoma.

Aged↗
PubMed1995

Phase II study of amonafide in patients with recurrent glioma.

Amonafide, a novel imide derivative with broad preclinical antitumor activity, achieves significant cerebrospinal fluid levels in animal models. In order to test its antitumor activity in patients with recurrent diffuse infiltrative glioma of the astrocytic and oligodendroglial type, we performed a phase II clinical trial. Of the 22 eligible and evaluable patients treated, 2 (9%) experienced tumor regression lasting more than one year. No other patients experienced tumor regression; one remained stable more than six months. Toxicities consisted primarily of myelosuppression, vomiting, and venous irritation at the infusion site. We conclude that amonafide has minimal activity in recurrent glioma patients. Further investigations are not warranted in this study population.

Adenine↗
PubMed1995

Cost analysis of stapling versus suturing for skin closure.

A randomized, prospective study was performed to test the null hypothesis that there is no difference between the cost of stapling and suturing for skin closure of selected linear lacerations. Appropriate wounds were randomly assigned to be closed by staples or sutures. Wound lengths, skin closure times, and the number of staples or the number and types of sutures used were recorded. Costs for materials and labor were calculated. The average total cost per case was $17.69 (with suture kit) and $7.84 (without suture kit) for the staple Group compared with $21.58 for the suture Group (P = .0001 for each). It is concluded that stapling is less costly than suturing and that the advantage appears to increase as laceration length increases.

Adult↗
PubMed1995

Pentoxifylline for treatment of cancer anorexia and cachexia? A randomized, double-blind, placebo-controlled trial.

PURPOSE: Based on evidence that suggests pentoxifylline can inhibit tumor necrosis factor, we set out to evaluate the activity and toxicity of this drug in patients with cancer-associated anorexia and/or cachexia. PATIENTS AND METHODS: Seventy patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 with cancer anorexia and/or cachexia (defined by a weight loss of > or = 5 lb in the preceding 2 months or a caloric intake < 20 kcal/kg/d) were stratified and then randomly assigned to receive pentoxifylline or identical-appearing placebo tablets in a double-blind fashion. Patients' weights were monitored and patient questionnaires were used to assess appetite, toxicity, and perception of benefit. RESULTS: Pentoxifylline failed to improve the appetites of study patients. Pentoxifylline did not appear to cause any toxicity. CONCLUSION: This study failed to demonstrate any benefit of pentoxifylline at this dose and schedule as therapy for cancer anorexia and/or cachexia.

Aged↗
PubMed1994

Randomized trial of cyclophosphamide, methotrexate, and 5-fluorouracil with or without estrogenic recruitment in women with metastatic breast cancer.

BACKGROUND: The fraction of breast cancer cells undergoing DNA synthesis at any one time is relatively low, which is problematic because most chemotherapeutic agents are most effective against dividing cells. Estrogens administered in vitro and in vivo can increase breast cancer cell proliferation. A randomized clinical trial was performed to determine if estrogenic recruitment could increase the effectiveness of combination chemotherapy. METHODS: One hundred sixty-five women were randomized, with two excluded from these analyses, to either an intravenous cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) regimen alone (cyclophosphamide, 600 mg/m2; methotrexate, 40 mg/m2; 5-fluorouracil, 600 mg/m2) or CMF preceded by 3 days of diethylstilbestrol (DES) at a dose of 1 mg orally per day. The planned cycle length was 3 weeks. RESULTS: Objective responses were seen in 20 of 80 patients (25%) treated with CMF and 32 of 83 patients (39%) treated with DES-CMF, and this difference almost achieved statistical significance (chi-square, two-sided P = 0.06). However, duration of response, time to disease progression, and survival time were similar for the two regimens. CONCLUSIONS: Estrogenic recruitment with DES as used in this study does not substantially increase the efficacy of a CMF regimen administered intravenously every 3 weeks.

Adult↗
PubMed1994

Phase II evaluation of 5-fluorouracil and low-dose leucovorin in cisplatin-refractory advanced ovarian carcinoma.

Thirty-nine women with advanced, recurrent epithelial ovarian carcinoma who failed prior treatment with a platinum-based regimen were treated with leucovorin, 20 mg/m2 intravenously followed by 5-fluorouracil, 425 mg/m2 intravenously, daily for 5 consecutive days every 5 weeks in a phase II trial. Partial regressions were seen in 3 of 15 (20%) measurable disease patients, and objective regressions were seen in 3 of 14 (21%) evaluable/nonmeasurable disease patients. A 50% or greater decrease in CA-125 level was observed in 3 of 10 (30%) patients with no objectively evaluable or measurable disease. Overall objective response rate was 23% (95% confidence interval: 11 to 39%) in all 39 patients evaluated, with a median time to progression of 3 months and overall median survival of 7 months. Toxicities were acceptable and consisted of neutropenia, thrombocytopenia, stomatitis, and mild diarrhea. 5-Fluorouracil, as administered in this protocol, had modest antitumor activity in cisplatin-refractory ovarian carcinoma of short duration and minimal toxicity.

Adenocarcinoma↗
PubMed1994

Cyclophosphamide, cisplatin, and leuprolide acetate in patients with debulked stage III or IV ovarian carcinoma.

A phase II study of cyclophosphamide, cisplatin, and leuprolide acetate after debulking of stage III or IV ovarian carcinoma was conducted in 33 patients through a cooperative group study involving 11 institutions. The intent was to determine whether the addition of a gonadotropin-releasing hormone analogue would alter the response rates and toxicity profile of cyclophosphamide and cisplatin in patients with advanced ovarian cancer. Twenty-nine patients completed all 6 planned cycles. Of the 19 patients who had second-look laparotomy, 12 had persistent disease and 7 were negative for disease. The use of a gonadotropin-releasing hormone with combined chemotherapy did not alter the toxicity profile or the effectiveness of chemotherapy when comparisons were made with historical controls.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1994

Transdermal clonidine for ameliorating post-orchiectomy hot flashes.

To determine the efficacy of transdermal clonidine for alleviating post-orchiectomy hot flashes, a randomized, double-blind, crossover clinical trial was designed including 70 men with a history of prostate cancer who had undergone a medical or surgical orchiectomy and were suffering from hot flashes. The results of this study demonstrated that clonidine did not significantly decrease hot flash frequency or severity. Future research is necessary to find effective means of alleviating hot flashes in post-orchiectomy patients.

Adult↗
PubMed1994

A comparison of drug interaction software programs: applicability to the emergency department.

STUDY OBJECTIVE: To compare the features of available drug interaction software programs in terms of general applicability to an emergency department setting. DESIGN: Prospective evaluation of drug interaction software programs based on presence or absence of a variety of performance features. SETTING: University and community hospital EDs. PARTICIPANTS: Eight commercially available drug interaction software programs. RESULTS: Programs were evaluated according to designated performance and data base features. Tabulated results were compiled for purposes of comparison. CONCLUSION: Although no computer program tested completely met the specific needs of a busy ED, many programs have features with at least some general applicability.

Drug Information Services↗
PubMed1994

Transdermal clonidine for ameliorating tamoxifen-induced hot flashes.

PURPOSE: To determine the efficacy of transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer. PATIENTS AND METHODS: A randomized, double-blind, crossover design was used in this prospective study. Women with a history of breast cancer who were receiving tamoxifen and suffering from hot flashes were potentially eligible for this protocol study. RESULTS: Clonidine did reduce hot-flash frequency to a degree that was statistically impressive (P < .0001), but clinically moderate (20% reduction from baseline). It also decreased hot-flash severity (P = .02, 10% reduction from baseline). Clonidine was related to increased mouth dryness (P < .001), constipation (P < .02), itchiness under the patch (P < .01), and drowsiness (P < .05). CONCLUSION: Better means are needed to alleviate hot flashes among patients in whom estrogen therapy is contraindicated.

Administration, Cutaneous↗
PubMed1994

Measurable or assessable disease in lung cancer trials: does it matter?

PURPOSE: The goals of this study were to analyze and compare the major clinical response rates and survival of patients with either measurable or assessable disease status to treatment with systemic chemotherapy. PATIENTS AND METHODS: All patients had stage IIIB or IV non-small-cell lung cancer (NSCLC) and were enrolled onto three consecutive phase III clinical trials. Patients were stratified by disease status (measurable or assessable) before randomization to systemic chemotherapy. The three trials were conducted in the setting of a multicenter cooperative oncology group. Composite data were obtained for the three trials. Major clinical responses, time to progression, and survival were analyzed and compared in patients with measurable or assessable disease using standard statistical methods. RESULTS: Four hundred twenty-six patients were enrolled onto the three trials from June 1981 through August 1990. Measurable disease was present in 236 patients (55%) and assessable disease in 190 (45%). Each study was well balanced for the number of patients with measurable or assessable disease on either treatment regimen. A major clinical response was observed in 71 patients with measurable disease (30%; 95% confidence interval [CI], 24 to 36). Forty patients with assessable disease responded to treatment (21%; 95% CI, 16 to 28) (P = .04). The time to progression for all patients (P = .23) and for responders only (P = .10) was not significantly different based on disease status. Overall survival and survival of responders only was not significantly different, but patients with assessable disease tended to do better. Using multivariate analysis, sex and disease status had a borderline influence on the major response rate (P = .05). Performance score (PS) was the only factor that was significantly correlated with survival. CONCLUSION: NSCLC patients with assessable disease have major clinical response rates, time to progression, and survival that are similar to those of NSCLC patients with measurable disease. This study supports the inclusion of patients with assessable-disease lung cancer in both phase II and III trials conducted in the cooperative group setting.

Adult↗
PubMed1994

Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer.

PURPOSE: Hydrazine sulfate is a controversial agent that was originally studied in cancer patients approximately 20 years ago. Based on a series of recent trials that suggested that this drug might have utility in cancer patients, we conducted this study. PATIENTS AND METHODS: Patients with metastatic colorectal cancer were randomized to receive hydrazine sulfate or placebo in a double-blinded manner. Protocol patients did not concurrently receive any other systemic antineoplastic treatment. RESULTS: There were 127 assessable patients entered onto this clinical trial. Data from the study showed trends both for poorer survival and for poorer quality of life (QL) in the hydrazine group. There were no significant differences in the two study arms with regard to anorexia or weight loss. CONCLUSION: This trial failed to demonstrate any benefit for hydrazine sulfate.

Aged↗