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At least 19 recordsLinked to original sources
PubMed2000

The drug thief at Georgetown University Medical Center: anatomy of a $2 billion class-action lawsuit.

Separate lawsuits filed on behalf of plaintiff patients at Georgetown University Medical Center, Washington, DC, have been consolidated under a District of Columbia judge who is scheduled to rule soon on whether to certify them as a class-action suit against the medical center. The case involves a drug-abusing worker in the interventional radiology unit at Georgetown University Hospital who may have exposed up to 500 patients to HIV, hepatitis, and other viruses during his period of employment from September 8, 1999 to February 2, 2000. The lawsuits allege that the med center failed to protect patients by not adopting American Hospital Association guidelines that call for universal pre-employment drug screening. The hospital currently is in the final stages of being sold to Medstar Health, Columbia, MD, which may eventually change the drug-screening policy. The episode not only has been embarrassing for the prestigious medical center, but also has focused attention on the potential consequences for hospitals that do not screen employees for drug use.

Academic Medical Centers↗
PubMed1988

Implementing RECONSIDER, a diagnostic prompting computer system, at the Georgetown University Medical Center.

RECONSIDER, a computer program for diagnostic prompting developed at the University of California, San Francisco, has been implemented at the Georgetown University Medical Center as part of the Integrated Academic Information Management System Model Development grant project supported by the National Library of Medicine. The system is available for student use in the Biomedical Information Resources Center of the Dahlgren Memorial Library. Instruction on use of the computer system is provided by the library and instruction on medical use of the knowledge base is directed by the faculty. The implementation, capabilities, enhancements such as the addition of Current Medical Information and Terminology (5th ed.), and evaluation of the system are reported.

Computer User Training↗
PubMed2000

GEM-231 (Hybridon).

GEM-231 is an 18-mer hybrid oligonucleotide under development by Hybridon for the potential treatment of cancer. This compound was initially developed for colon cancer [256660], and progressed to phase II trials in October 1998 [301009]. Hybridon initiated a phase I dose-escalation study enrolling up to 25 patients with refractory solid tumors, in January 1998 at the Lombardi Cancer Center, Georgetown University Medical Center [275860]. GEM-231 was well tolerated in multiple, escalating doses, and that high plasma levels could be safely achieved [301009]. In addition to antitumor effects, when used as a single agent in animal tumor models, GEM-231 has also demonstrated potentiation of the effects of certain conventional cytotoxic chemotherapy drugs [230699]. Hybridon is conducting studies of the DNA methyltransferase gene and has identified specific sequences on mRNA as targets for chemically-modified antisense oligonucleotides. Hybridon has synthesized compounds that alter methylation of cultured human cancer cells and inhibit their ability to grow in cell culture and inhibit tumor formation in mice [191303]. The work is being carried out in collaboration with McGill University in Montreal and as part of a joint venture called MethylGene, set up by Hybridon and private investors. GEM-231 and other oligonucleotides were claimed in WO- 09515378. Hybridon has been issued with two US patents, US- 05652355 and US-05562356, claiming chemically advanced, mixed-backbone oligonucleotides. The first claims mixed backbone 'hybrid' oligonucleotides, which are second generation chemistries, comprising an internal segment of modified DNA flanked by segments of modified RNA (2'-O-methyl substituted). The other claims mixed backbone 'inverted hybrid' oligonucleotides, which comprises an internal segment of naturally-linked, 2'-O-substituted RNA flanked by modified DNA segments [257135].

Journal Article↗
PubMed2000

Software development for registration of digital subtraction angiography (DSA) images in uterine fibroid embolization.

The ISIS Center at Georgetown University Medical Center has developed a comprehensive program for image-guided procedures in the spine. As part of this program, ISIS has developed a software application known as I-SPINE (ISIS's Spine Procedure Imaging Navigation Engine). I-SPINE is a Windows NT application, which is based on the Analyze/AVM libraries. The software architecture follows the Microsoft Foundation Classes (MFC) single document, multiple view paradigm. This has allowed the developers to add new visualization modules to I-SPINE that aid physicians in procedures outside the spine. One such procedure I-SPINE has been expanded for is uterine fibroid embolization. The idea is that by registering and subtracting post-embolization angiographic images from pre-treatment images the resulting image can be used to quantify the embolization effect on the fibroid circulation and predict the treatment response. The I-SPINE digital subtraction angiography (DSA) module allows the interventional radiologist to open a series of pre and post-embolization DSA images that shows the vascular structures of the uterus and the fibroid or fibroids. From these images, the radiologist selects an appropriate image from each series. The selected images are then hand registered using pixel shifting. Once the images are registered, the pixels are subtracted resulting in an image that shows the embolized arteries that were supplying the fibroids.

Angiography, Digital Subtraction↗
PubMed1999

Technology evaluation: G-3139.

G-3139 is an antisense phosphorothioate oligodeoxynucleotide (AS PS ON) which suppresses bcl-2 expression and is being developed by Genta Inc for the potential treatment of various cancers [308375]. G-3139 is in various stages of phase I/lIa trials. One study, initiated in May 1999, at the Lombardi Cancer Center at Georgetown University Medical Center, US, will examine G-3139 in conjunction with docetaxel. In a phase I/IIa dose-escalating trial to treat non-Hodgkin's lymphoma (NHL), at the Royal Marsden NHS Trust, UK, no serious, clearly drug-attributable or doselimiting adverse effects were noted and in some patients encouraging signs of potential drug activity were observed. The responses included one patient in whom cancer mass was reduced and one who developed a complete response for over 38 weeks in duration [239159,291608,325262]. A new phase II protocol using G-3139 combined with standard chemotherapies in relapsed NHL patients has also begun [325262]. Other phase I/lIa studies include: the safety and efficacy of G-3139 in the treatment of hormone-resistant, metastatic prostate cancer, when administered with mitoxantrone [305822]; the treatment of relapsed follicular NHL, when administered with cyclophosphamide [311217]; the treatment of Stage III and IV metastatic malignant melanoma in combination with dacarbazine [289755]; the treatment of hormone-resistant, metastatic prostate cancer when administered over a significantly longer duration than studied previously and in combination with an androgen-receptor blocking agent [291608]. The National Cancer Institute (NCI) funded and conducted preclinical studies of G-3139 in July 1996 and in June 1998, the NCI and Genta entered into a Cooperative Research and Development Agreement (CRADA) for the development of G-3139 [290153]. Clinical trials,focusing on colorectal cancer, small cell lung cancer and leukemia, were underway as of April 1999. The company licensed the rights for the use of bcl-2 as a target for antisense and gene therapy-based treatments from the University of Pennnsylvania. In June 1998, Genta received two patents relating to its antisense compounds [289685].

Androgen Antagonists↗
PubMed2005

Comparison of valve structure, valve weight, and severity of the valve obstruction in 1849 patients having isolated aortic valve replacement for aortic valve stenosis (with or without associated aortic regurgitation) studied at 3 different medical centers in 2 different time periods.

BACKGROUND: Aortic valve replacement (AVR) for patients with aortic stenosis (AS) has now been available for 45 years. During this period, indications for the procedure have changed. METHODS AND RESULTS: Operatively excised stenotic aortic valves (with or without associated aortic regurgitation and without associated mitral valve disease) from 3 different medical centers (National Institutes of Health, Georgetown University Medical Center, and Baylor University Medical Center) were examined during 2 different time periods by the same physician to compare aortic valve structure, valve weight, age at operation, preoperative transvalvular peak pressure gradient, calculated aortic valve area, and whether simultaneous coronary artery bypass grafting (CABG) was performed. Compared with the first 3 decades (1961-1990) of AVR, patients having this operation during the fourth and fifth decades (1991-2004) had a lower frequency of congenitally malformed aortic valves, a higher frequency of tricuspid aortic valves, an older age, valves of lighter weight and lower transvalvular peak pressure gradients, and more often simultaneous CABG. CONCLUSIONS: Although patients having isolated AVR for AS in the present and last decade were older than in the first 3 decades of valve replacement surgery, congenitally malformed aortic valves continue to be more common than tricuspid aortic valves, but the degree of AS and therefore, valve weight was significantly lower than in the earlier decades.

Adult↗
PubMed1997

Requirements for urology and renal dialysis PC-based telemedicine applications: comparative analysis.

The Imaging Science and Information Systems (ISIS) Center of the Department of Radiology at Georgetown University Medical Center (GUMC) has been developing technical requirements for different telemedicine applications. This paper details the process through which those technical requirements are determined and shows how they may differ substantially, depending on the clinical need. This information is presented in light of two telemedicine applications being undertaken at GUMC: a urology application for the management of patients with surgical stone disease and a nephrology application for monitoring of renal dialysis patients.

Humans↗
PubMed1995

Knowledge, confidence, and attitudes regarding medical ethics: how do faculty and housestaff compare?

BACKGROUND: It has been suggested that faculty members' inadequate knowledge of and unfavorable attitudes toward ethics may present barriers to effective education in ethics for house officers. METHOD: To test this hypothesis, the authors administered a questionnaire assessing the knowledge, confidence, and attitudes regarding ethics of the 73 house officers and 73 full-time faculty members in the Department of Medicine at the Georgetown University Medical Center in 1992-93. Statistical analysis of the responses was performed using chi-square, two-tailed t-tests, and linear regression. RESULTS: Fifty-five house officers (75%) and 57 faculty (78%) responded. The knowledge scores were similarly low for both groups (53% correct for the faculty and 50% for the house officers). However, the faculty were significantly more confident than the house officers regarding ability to address ethical issues (mean ratings of 3.9 vs 3.4 on a scale from 1, very low, to 5, very high; p = .0001). Seventy-five percent of the faculty and 65% of the house officers believed that ethics training should be mandatory during residency. CONCLUSION: The attitudes of the faculty per se do not appear to represent a barrier to teaching ethics. However, the gap between the faculty members' confidence and knowledge could interfere with their abilities to model and teach ethics to house officers.

Academic Medical Centers↗
PubMed1996

Teaching healthcare professionals about drug-induced disease: an innovative clinical therapeutic approach.

An innovative conference on the general principles of recognition and management of drug-induced disease was developed for healthcare professionals (particularly primary care). The full-day conference used a clinical therapeutic approach and was a cooperative effort of the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Staff College and Georgetown University Medical Center (GUMC). Linked with the FDA MedWatch postmarketing surveillance initiative, the conference used multiple formats, including didactic presentations, panel discussions, and case discussions led by faculty from various disciplines (e.g., internal and family medicine, psychiatry, clinical pharmacology, dentistry, clinical pharmacy, nursing, epidemiology). Conference topics included new drug approval, pharmacokinetic/pharmacodynamic considerations, and clinical assessment of adverse drug events. Tests were administered to participants before and after the conference, and participants completed a conference evaluation. Mean scores for the pre- and posttests were compared globally and by professional discipline. Conference evaluations were assessed for responses to eight standardized statements and elicited comments. After the conference, mean and median test scores were improved both globally and by discipline in comparison to protest results, with improvement on almost all individual test questions. Comparison of median scores for the pre- and posttests showed small differences between physicians and pharmacists. Evaluations showed markedly positive response to standardized statements, including enhancement of professional growth; elicited comments were supportive of conference effectiveness and attendee acceptance. This conference, which utilized a combination of educational formats, was designed to present material of an innovative nature. Results indicate that the conference was well-received and fulfilled specified learning objectives, including recognition of populations particularly vulnerable to adverse drug events and understanding of how individual providers can contribute to FDA postmarketing surveillance. Continuing educational efforts using this approach are encouraged.

Drug-Related Side Effects and Adverse Reactions↗
PubMedDate not supplied

Pharmacodynamic effects of three doses of ORG 9426 used for endotracheal intubation in humans.

STUDY OBJECTIVE: To determine the pharmacodynamic characteristics of three incremental doses of ORG 9426 used for endotracheal intubation in patients. DESIGN: Double-blind, randomized administration of one of three doses of intravenous ORG 9426. SETTING: Inpatients requiring surgery at Georgetown University Medical Center. PATIENTS: Thirty-six patients, ages 18 to 65, ASA physical status I, II, and III, scheduled for general surgery. INTERVENTIONS: After Georgetown University Institutional Review Board approval and patient consent, patients were premedicated with midazolam or droperidol. Anesthesia was induced with thiopental sodium and fentanyl. Anesthesia was maintained with 60% nitrous oxide in oxygen. The ulnar nerve was stimulated supramaximally with a 2 Hz train-of-four (TOF) every 20 seconds. Thumb contractions were measured with a force transducer. When TOF and anesthesia were stable, 2, 2.5, or 3 times the ED95 of ORG 9426 (570 micrograms/kg, 710 micrograms/kg, or 850 micrograms/kg) was administered randomly. Tracheal intubation was attempted at maximal depression of the first TOF response (T1). MEASUREMENTS AND MAIN RESULTS: The following parameters were measured: time interval from the injection of ORG 9426 to 90% depression of T1 (T1 90% block), maximal T1 depression (onset time), intubating conditions, clinical duration (time for return of T1 to 25% of control), heart rate (HR), blood pressure (BP), and any adverse clinical experience. ORG 9426 provided adequate intubating conditions in all patients but two, independent of the dose used. Its onset time was rapid, but increasing the dose did not shorten the onset. T1 90% block was achieved rapidly (75 +/- 25 seconds to 78 +/- 18 seconds, means +/- SD). The clinical duration of ORG 9426 was relatively short and lengthened with increasing doses (from 36 +/- 18 minutes at 570 micrograms/kg to 42 +/- 10 minutes at 850 micrograms/kg. Spontaneous twitch recovery from 10% to 25% was similar in all dosage groups (5 +/- 1 minutes to 6 +/- 4 minutes). No clinically significant changes in HR and BP and no adverse clinical experiences were noted in any group. CONCLUSION: These findings warrant further clinical evaluation of ORG 9426 for induction and maintenance of muscle relaxation in humans.

Adolescent↗
PubMed1991

The MAClinical Workstation Project at Georgetown University.

The intent of the MAClinical Workstation Project is to develop computer workstations for medical students of the sort they will use in future medical practice. The idea is to instill information query habits in the daily clinical activities of these young physicians-in-training. The Georgetown University Medical Center Library spearheads the project in conjunction with the School of Medicine. The library handles technical support, including software development, user training, equipment maintenance, and network installations. The project began in 1988 with nine Macintosh computers; today thirty machines are distributed throughout the Georgetown University Hospital conference rooms, faculty and resident offices, and at four affliated hospitals. The Macintosh computers are connected to the medical center's local area network (LAN) with access to the Integrated Academic Information Management System (IAIMS) and Library Information System (LIS) databases. The MAClinical workstations serve multiple educational purposes in the clinical setting. Primarily, students gain experience in medical informatics by using a variety of software systems installed at the stations: the H&P Writer, a history and physical system written in the C programming language, can be used by students to prepare the admission record on patients they examine; also, students can keep patient records, check findings against a diagnostic system, look up drugs and treatment protocols, develop medical sketches, and find additional information when needed in the medical literature.

Computer Systems↗