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Investigational drug tracking: Phases I-III and NDA submissions--Part I.

The author catalogs over 800 investigational drugs/biologicals currently in Phase I, II or III clinical trials or drugs/biologicals submitted to the FDA as new drug applications. The list assists in predicting when new drugs will be marketed. The entries include generic/chemical name, investigational drug number, synonyms, trade names, manufacturers, clinical trial status, predicted approval year, indications or drug class, whether the drug has been developed through biotechnology, and references. Entries were gleaned from medical journals, stock market analysis publications, and the Pharmaceutical Manufacturers Association's Medicines in Development Series. The list is alphabetized by the generic/chemical name or investigational drug number and cross-indexed by the trade name and synonyms. The list reflects those drugs which were not FDA approved as of April 15, 1994. Part I includes the trade name and synonym cross-indexes and the beginning of the main alphabetical listing by generic/chemical name or investigational drug number.

Catalogs, Drug as Topic↗

UCMP and the Internet help hospital libraries share resources.

The Medical Library Center of New York (MLCNY), a medical library consortium founded in 1959, has specialized in supporting resource sharing and fostering technological advances. In 1961, MLCNY developed and continues to maintain the Union Catalog of Medical Periodicals (UCMP), a resource tool including detailed data about the collections of more than 720 medical library participants. UCMP was one of the first library tools to capitalize on the benefits of computer technology and, from the beginning, invited hospital libraries to play a substantial role in its development. UCMP, beginning with products in print and later in microfiche, helped to create a new resource sharing environment. Today, UCMP continues to capitalize on new technology by providing access via the Internet and an Oracle-based search system providing subscribers with the benefits of: a database that contains serial holdings information on an issue specific level, a database that can be updated in real time, a system that provides multi-type searching and allows users to define how the results will be sorted, and an ordering function that can more precisely target libraries that have a specific issue of a medical journal. Current development of a Web-based system will ensure that UCMP continues to provide cost effective and efficient resource sharing in future years.

Catalogs as Topic↗

The SUNY biomedical communication network: six years of progress in on-line bibiographic retrieval.

The SUNY Biomedical Communication Network became operational in 1968 as the first on-line bibliograhpic retrieval service for biomedical literature. Since 1968, the SUNY/BCN has grown in size from nine to thirty-two medical and university libraries and has expanded its data base coverage to include the ERIC and Psychological Abstracts data bases in addition to the full ten-year retrospective MEDLARS data base. Aside from the continuous provision of an on-line searching system, the SUNY experience over the last six years has yielded valuable information in the following areas of: (1) monograph indexing and retrieval, (2) shared cataloging, (3) user interaction and education in on-line systems, and (4) member participation in Network policy-making processes. The continued success of the SUNY/BCN is evidence that it is possible to provide a high quality on-line bibliographic retrieval system at cost to academic institutions. SUNY's success in this effort is the result of centralized resource sharing and effective regional networking, combined with thoughtful planning by user advisory committees.

Cataloging↗

Computer-stored faculty publication file using the MT/ST in a medium-sized medical center library.

The Bowman Gray School of Medicine Library has implemented a computerized faculty publication file adapted from an existing system that utilized a Magnetic Tape/Selectric Typewriter for catalog card production and computer storage. The faculty publication file has provided printouts for the school's annual report and monthly faculty bulletins. After the data for all faculty bibliographies have been stored in the file, it will be possible to retrieve complete author and departmental listings. The file will be continuously updated by adding current citations and the bibliographies of new faculty members and by deleting data when faculty members leave the staff.

Cataloging↗

[Draft of a compilation of diagnoses in otorhinolaryngology (author's transl)].

Here we report an attempt to make out a catalog of diagnoses in otorhinolaryngology for intern-clinical interests, which appears suitable to electronic data-processing by its modified six-figure ICD-code. In a supplement to this compilation we make allowance for the overlapping with our neighbouring medical specialities.

Catalogs as Topic↗

MEDLARS: PERFORMANCE, PROBLEMS, POSSIBILITIES.

Operational experience during the first year of MEDLARS is described in relation to the Library's primary objectives of index publication, recurring bibliographies, and demand search services. Progress toward the implementation of two secondary objectives-the input of cataloging copy and the decentralization of the system-is also reported. MEDLARS has been intensively tested during its first operational year, its strengths and weaknesses have been identified, and it is now prepared to develop its service potential.

Bibliographies as Topic↗

Online medical books: their availability and an assessment of how health sciences libraries provide access on their public Websites.

OBJECTIVE: The objective of this study was to determine the number and topical range of available online medical books and to assess how health sciences libraries were providing access to these resources on their public Websites. METHOD: The collection-based evaluative technique of list checking was used to assess the number and topical range of online medical books of the six largest publishers. Publisher inventory lists were downloaded over a two-day period (May 16-17, 2004). Titles were counted and compared with the 2003 Brandon/Hill list. A sample of health sciences libraries was subsequently derived by consulting the 2004 "Top Medical Schools-Research" in U.S. News & World Report. Bibliographic and bibliothecal access methods were evaluated based on an inspection of the publicly available Websites of the sample libraries. RESULTS: Of 318 currently published online medical books, 151 (47%) were Brandon/Hill titles covering 42 of 59 Brandon/Hill topics (71%). These 151 titles represented 22% (N = 672) of the Brandon/Hill list, which further broke down as 52 minimal core, 41 initial purchase, and 58 other recommended Brandon/Hill titles. These numbers represented 50%, 28%, and 12%, respectively, of all Brandon/Hill titles corresponding to those categories. In terms of bibliographic access, 20 of 21 of sampled libraries created catalog records for their online medical books, 1 of which also provided analytical access at the chapter level, and none provided access at the chapter section level. Of the 21 libraries, 19 had library Website search engines that provided title-level access and 4 provided access at the chapter level and none that at the chapter section level. For bibliothecal access, 19 of 21 libraries provided title-level access to medical books, 8 of which provided classified and alphabetic arrangements, 1 provided a classified arrangement only, and 10 provided an alphabetic arrangement only. No library provided a bibliothecal arrangement for medical book chapters or chapter sections. CONCLUSIONS: This study shows that the number and topical range of online medical books is reaching a point where collection-level consideration is warranted to facilitate efficient use and to prevent the problem of split files. However, the results also show that few efforts are underway on the publicly available Websites of the surveyed health sciences libraries to provide the analytical access necessary to meet the structural needs of clinical information seekers.

Access to Information↗

Comparison of holdings of NLM (CATLINE) with those of resource libraries.

The collection development practices of the National Library of Medicine (NLM), with the goal of comprehensive acquisition of biomedical monographs, are compared with those of the resource libraries of the TALON (Region IX) Regional Medical Library. Holdings of two resource libraries in the TALON region, The University of Texas Health Science Center at San Antonio and The University of Texas Medical Branch at Galveston, and of the TALON Union Catalog of Monographs were compared with the NLM CATLINE data base for four subject classes and selected imprint years. Foreign-language coverage is lacking in Region IX, with English-language coverage is lacking in Region IX, with English-language coverage ranging between 70 and 88% of titles listed in CATLINE. Absent English-language material tends to be ephemeral or otherwise out of scope for the resource libraries. Between 7.1 and 18.8% of monographs acquired in each subject class by the two recource libraries are lacking in CATLINE; this represents between 2 and 8% of the CATLINE titles for each class.

Book Collecting↗

Union list development: control of the serial literature.

The discussion covers the development of a national union list or finding tool for biomedical serial holdings and its integration into the National Serials Data Program, which is being developed under the auspices of the three National Libraries. Specific topics which are covered include: (1) Selection of the Union Catalog of Medical Periodicals (UCMP) as the basis for a biomedical list and the status of that activity; (2) discussion of the various methods of recording holdings; (3) status of the National Serials Data Program and a discussion of its relationship to the UCMP file; and (4) status of the Standard Serial Number and its relationship to other existing coding schemes for serial titles.

Catalogs, Union as Topic↗

A regional medical library network.

The raison d'être for cooperative networks is discussed, and the development of the SUNY Biomedical Communication Network is traced briefly; a description of the system and its products is given. The cooperative cataloging program engaged in with the Francis A. Countway Library of Medicine and the National Library of Medicine is described, as are the efforts of the Network in the production of regional and state-wide union lists of serials.

Cataloging↗

The Medical Library and Media Center of Keio University in Tokyo: report on a visit.

The Medical Library and Media Center at Keio University in Tokyo offers many facilities to its users: access to medical information within a large catalog of monographs and journals, online searching and CD-ROM databases, and a dynamic interlibrary loan service. This article is a report of a professional visit to the library on September 30, 1993.

Catalogs, Library↗

Audiovisuals and non-print learning resources in a health sciences library.

The MD undergraduate program at McMaster University, based entirely on self-instruction, requires the provision of all kinds of learning resources. How these are assembled and made available is described. Emphasis is placed on the practical library problems of cataloging, shelving, maintenance, and distribution of audiovisual materials including pathology specimens and 'problem boxes' as well as the more usual films, videotapes and slide/tape sets. Evaluation is discussed briefly.

Audiovisual Aids↗

The genetics of psoriasis 2001: the odyssey continues.

Accumulating evidence indicates that psoriasis is a multifactorial disorder caused by the concerted action of multiple disease genes in a single individual, triggered by environmental factors. Some of these genes control the severity of multiple diseases by regulating inflammation and immunity (severity genes), whereas others are unique to psoriasis. Various combinations of these genes can occur even within a single family, accounting in large measure for the many clinical manifestations of psoriasis. The disease-causing variants (alleles) of these genes probably arose early in the history of modern humans. As a result, psoriasis disease alleles are common in the general population, have a worldwide distribution, and often share the same ancestral chromosome with neutral alleles at adjacent loci. This phenomenon, called linkage disequilibrium, explains why psoriasis is strongly associated with HLA-Cw6 worldwide, although HLA-Cw6 is unlikely to be the disease allele. Many unaffected individuals carry 1 or more disease alleles, but lack other genetic and/or environmental factors necessary to produce disease. This explains why psoriasis develops in only about 10% of HLA-Cw6-positive individuals, and why genome-wide linkage scans for psoriasis and other multifactorial genetic disorders have not been uniformly successful. The Human Genome Project is rapidly generating a catalog of human DNA sequence variations. This resource has already allowed precise linkage disequilibrium mapping of the major histocompatibility complex psoriasis gene to just beyond HLA-C, toward HLA-A. This gene is likely to be identified soon. Further development and use of linkage disequilibrium resources will provide a powerful tool for the identification of the remaining psoriasis genes.

Genetic Heterogeneity↗

Radiofrequency tissue volume reduction: multilesion vs single-lesion treatments for snoring.

OBJECTIVE: To compare the safety and efficacy of single-lesion and multilesion radiofrequency tissue reduction (RFTR) of the soft palate for the treatment of snoring. DESIGN: Prospective, nonrandomized clinical trial. SETTING: University hospital outpatient clinic. PATIENTS: Nonrandomized patients undergoing RFTR to treat socially unacceptable snoring. Of 47 patients, 16 received single-lesion treatments and 31 received multilesion treatments. INTERVENTION: Soft-palate RFTR was performed using a radiofrequency generator. Patients required 1 to 3 treatments based on improvement or withdrawal from the study, and each received 1, 3, or 4 lesions per treatment. Patients who received single-lesion therapy did not cross over into the multilesion group; however, 5 patients in the multilesion group received 4-lesion therapy after a treatment with 3 lesions. MAIN OUTCOME MEASURES: Outcome measures were determined using visual analog scale questionnaires assessing level of snoring (snoring index) and level of pain (pain index) associated with the procedure. Adverse events and complications during treatment were cataloged. Data were collected before the procedure, 6 weeks after each treatment, and an average of 16 months after the last procedure. RESULTS: Single-lesion and multilesion groups showed significant improvement in snoring after RFTR treatments (P<.01 for both). However, compared with the single-lesion group, the multilesion group required fewer treatments (1.94 vs 2.38; P =.05) and was more than twice as likely to be cured after 2 treatments (61% vs 25%; P =.02). A trend toward improved clinical outcomes with increased number of lesions and total energy per treatment was observed when patients treated with 1, 3, or 4 lesions were compared. The 4-lesion group had the most pronounced improvement in snoring index score per treatment, the lowest number of treatments required for cure, and the greatest percentage of patients cured after 2 treatment sessions. Follow-up demonstrated minimal relapse of snoring in the multilesion group at a mean of 16 months. Although there was a statistically significant increase in pain in the multilesion group vs the single-lesion group, this increase did not increase narcotic use or time off work and was considered minimal by reporting patients. CONCLUSION: Multilesion RFTR using higher energy levels per treatment is safe and has increased efficacy without increased complications relative to single-lesion therapy.

Adult↗

Symptom outcomes after endoscopic sinus surgery for chronic rhinosinusitis.

OBJECTIVE: To determine the effectiveness of endoscopic sinus surgery (ESS) for individual symptoms, medication use, and related factors in patients with chronic rhinosinusitis (CRS). DESIGN: Nonrandomized, prospective, clinical trial. INTERVENTIONS: Adult patients with medically refractory CRS were examined before ESS with the Rhinosinusitis Symptom Inventory to catalog major and minor symptoms, medication use, physician visits, and missed workdays due to CRS. After a minimum 6-month follow-up after ESS, patients were examined to determine response to therapy. After computation of Rhinosinusitis Symptom Inventory domains, comparisons were conducted and effect sizes were computed for the change in symptoms after surgery. RESULTS: One hundred adults completed the examination, with a mean follow-up of 19.0 months. Before surgery, the mean major symptom scores ranged from 2.5 to 3.5 (Likert scale, from 0 [symptom absent] to 5 [maximum severity]) and the minor symptom scores ranged from 0.8 to 2.8. After surgery, statistically significant decreases in major and minor symptoms were noted (P<.001 for all). The largest effect sizes were noted for the decreases in facial pressure, congestion, nasal obstruction, rhinorrhea, and headache (absolute value of effect size >0.85 for all). Similarly, large effect sizes were noted for decreases in symptoms in the nasal (-1.30), facial (-1.13), and total (-1.25) symptom domains of the Rhinosinusitis Symptom Inventory. Medication use actually increased for topical nasal corticosteroids, but decreased for prescription antihistamines. A mean reduction of 1.1 antibiotic courses (mean decrease of 2.3 weeks taking antibiotics) was noted after ESS. CONCLUSIONS: Endoscopic sinus surgery provides significant symptom relief for the nasal and facial symptoms associated with CRS. Patients will often still require topical nasal corticosteroids for the management of their CRS, but can expect decreases in antibiotic requirements after ESS.

Absenteeism↗

The abnormally patent eustachian tube. Alterations in psychological status resulting from polytef paste injections.

Several authors have noted that patients with an abnormally patent Eustachian tube (APET) seem to be psychologically disturbed. We investigated the psychological status of these patients before and after treatment with polytef paste (Teflon) injections. Twelve women were evaluated by a series of tests designed to catalog the nature and intensity of the symptoms, the degree to which symptoms affected the patient, psychopathological trends, and an assessment by the patients of improvement. Results prior to treatment indicated that the patients' symptoms were quite disturbing and were moderately disabling; such symptoms affected concentration, and a marked decrease in the enjoyment of life was noted. After treatment, a notable decrease in APET symptoms was reported, with a parallel decline in emotional disturbances. Patients felt less depressed, anxious, and angry, and they reported that the quality of life was much improved. These findings indicate that physical symptoms can have profound effects on emotional status. In such cases, the most effective psychological treatment is control of physical symptoms rather than psychiatric referral.

Adult↗

Skin lesions of the spinal axis and spinal dysraphism. Fifteen cases and a review of the literature.

OBJECTIVE: To catalog the paraspinal skin lesions of early childhood that are associated with occult spinal dysraphism. RESEARCH DESIGN: Retrospective review of a series of patients. SETTING: Tertiary care referral center. PATIENTS: Fifteen patients who had significant paraspinal skin lesions were identified from the personal files of the authors who saw them. RESULTS: The skin lesions included various combinations of hyperpigmentation, hypopigmentation, hypertrichosis, acrochordons, dimples, lipomas, hemangiomas, or teratomas. Not all lesions were evaluated with the same tests, which included plain roentgenography, ultrasonography, myelography, computed tomography, and magnetic resonance imaging. Of the 15 patients, six had spinal anomalies, eight had no apparent spinal dysraphism, and one had insufficient results of the evaluation to assess the spinal column. CONCLUSIONS: Early recognition of paraspinal skin lesions is essential to prevent neurologic damage. Urinary or fecal incontinence, recurrent urinary infections, muscle atrophy, foot deformities, weakness, pain, or decreased sensation in the lower extremities may eventually develop in these patients. Magnetic resonance imaging appears to be the single best screening test for dysraphism.

Back↗

Cigarette promotional items in public schools.

OBJECTIVES: To assess the prevalence of ownership of cigarette promotional items (CPIs) by rural northern New England students and to examine the association between CPI ownership and smoking behavior. DESIGN AND SETTING: Voluntary, self-administered survey of 1265 sixth- through 12th-grade students representing 79% to 95% of all students attending 5 rural New Hampshire and Vermont public schools in October 1996. We examined the association between ownership of a CPI and smoking behavior through regression models and conducted a sensitivity analysis on the findings. MAIN OUTCOME MEASURES: Adjusted odds of being a smoker (lifetime use of > or = 100 cigarettes) and, among never smokers and experimental smokers, adjusted cumulative odds of having higher levels of smoking uptake given CPI ownership. RESULTS: One third of students owned a CPI. Prevalence of ownership did not vary by grade or sex, but was higher among poor-to-average school performers (45.0% vs 21.0% for excellent school performers, P < .001) and children whose friends and family members smoked (43.4% vs 13.8% for students with no family members or friends smoking, P < .001). Cigarette promotional items included articles of clothing (T-shirts, hats, backpacks, and jackets), smoking paraphernalia (lighters and ashtrays), camping gear, and electronics. More than half of CPIs (58.2%) bore the Marlboro logo, and almost one third (31.7%) bore the Camel logo. These items were obtained directly from catalogs or vendors 22.4% of the time. Whereas only 4.5% of students reported bringing a CPI to school with them the day of the survey, 44.5% reported seeing such an item at school the day of the survey. After controlling for confounding factors, such as having friends who smoke, students who owned CPIs were 4.1 times more likely to be smokers than those who did not own CPIs (95% confidence interval [CI], 3.1-5.5). Never and experimental smokers (n = 1008) who owned CPIs were more likely to be in a higher category on the smoking uptake index in grades 6 (cumulative odds ratio [OR = 5.7, 95% CI, 1.9-16.8), 7 (OR = 1.8, 95% CI, 0.9-3.7), 8 (OR = 2.3, 95% CI, 1.1-4.8), and 9 (OR = 2.1, 95% CI, 1.1-3.9), periods when children are most vulnerable to initiating cigarette use. A sensitivity analysis indicated that an unmeasured confounder of CPI ownership and smoking was unlikely to alter our conclusions. CONCLUSIONS: Cigarette promotional items are owned by one third of students in these rural northern New England schools. These items are highly visible in the public school setting, and their ownership is strongly associated with initiation and maintenance of smoking behavior. These data lend support to a ban on CPIs to be included in US Food and Drug Administration regulations to prevent tobacco use among US youth.

Adolescent↗