tbuckley/cabot-search huggingface dataset:
Better Reporting of Adverse Drug Reactions
Authors: ELIAS ABRUTYN
Journal: Annals of Internal Medicine (1985)

Editorials1 February 1985Better Reporting of Adverse Drug ReactionsELIAS ABRUTYN, M.D.ELIAS ABRUTYN, M.D.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-102-2-264 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptDespite the safety of most drugs for most patients, physicians, pharmaceutical manufacturers, and the Food and Drug Administration (FDA) are constantly alert for new adverse drug reactions. This vigilance is justified by recalling the serious effects induced by thalidomide and, more recently, by ticrynafen. New adverse drug reactions are currently identified through two major sources: cases reported by physicians directly to the industry and regulatory agencies, and reports published in the medical literature. These sources will probably be the main sources for the foreseeable future.Last September an international group representing industry, regulatory agencies, medical journals, and the popular press...References1. VENULETBERNEKERCIUCCI JGA, eds. Assessing Causes of Adverse Drug Reactions. New York: Academic Press; 1982. Google Scholar2. VENULETBLATTNERVON BULOWBERNEKER JRJG. How good are articles on adverse drug reactions? Br Med J. 1982;284:252-4. CrossrefMedlineGoogle Scholar3. BERNEKERCIUCCIJOYCE GAJ. Standards for reporting adverse drug reactions [Letter]. Br Med J. 1983;287:1720. CrossrefMedlineGoogle Scholar4. JONES J. Criteria for journal reports of suspected drug reactions. Clin Pharm. 1982;1:554-5. MedlineGoogle Scholar This content is PDF only. To continue reading please click on the PDF icon. Author, Article, and Disclosure InformationAffiliations: Veterans Administration Hospital Medical College of Pennsylvania Philadelphia, Pennsylvania PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited ByAppendix 2: Guidelines and a Checklist for Reporting Suspected Adverse Drug Reactions Anecdotally in JournalsGuidelines for Submitting Adverse Event Reports for PublicationGuidelines for Submitting Adverse Event Reports for PublicationGuidelines for submitting adverse event reports for publicationGuidelines for Submitting Adverse Event Reports for PublicationSelected References on Adverse Drug Reaction ReportingPostmarketing Surveillance MethodologiesRepetitive Publication: A Clinical Trial of NorfloxacinAccurate Case Counts: The Problem and a ProposalELIAS ABRUTYN, M.D.Adverse-Drug-Reaction Monitoring 1 February 1985Volume 102, Issue 2Page: 264-265KeywordsAdverse reactionsDrug administrationDrug safetyFood and Drug AdministrationForecasting Issue Published: 1 February 1985 PDF DownloadLoading ...
VIRILIZING ADRENAL HYPERPLASIA; A GENETIC AND HORMONAL STUDY 1
Authors: Barton Childs, Melvin M. Grumbach, Judson J. Van Wyk
Journal: Journal of Clinical Investigation (1956)

It is not at all unusual to find other affected children among the brothers and sisters of pa- tients with virilizing adrenal hyperplasia.Such familial aggregations of affected children suggest, at least, a genetic basis for the condition at hand, and when the affected individuals are distributed in one generation only, there is a possibility that the condition is due to a mutant gene which finds obvious expression in the homozygote.This mode of inheritance for a possible gene responsible for virilizing adrenal hyperplasia has been sug- gested (1-3).Knudson (2) obtained information on 8 families, including 11 affected children.To these he added 26 families taken from the literature in which there were 32 affected children.Com- parison of the observed number of affected sibs of index cases with that expected indicated suffi- cient agreement to favor the hypothesis of a reces- sive gene.All of Knudson's cases, however, were patients who showed evidence of electrolyte dis- turbance, and there appears to be no study which includes all types of cases which fall into this syn- drome.This paper consists of information per- taining to a possible genetic etiology of this dis- ease, obtained from 56 families containing one or more affected individuals, and an hormonal study of a group of parents of affected children.An exhaustive review of the literature is not relevant here, since our interpretations are based only upon the results of the analysis of our own data and not upon information from families that has been presented in other articles.
Co-development of autoimmune hepatitis and Sjögren's syndrome triggered by the administration of herbal medicines
Authors: Hyo Jeong Oh, Young Mi Mok, Moon Seong Baek, Ji Kyeong Lee, Bong Soo Seo, Tae Hyeon Kim, Keum Ha Choi, In Kyeom Hwang, Ji Eun Ra, Yong-Reol Oh, Yong Sung Kim, Eun Young Cho, Haak Cheoul Kim, Young Woo Sohn
Journal: Clinical and Molecular Hepatology (2013)

Autoimmune hepatitis (AIH) has been reported in association with SjÃ¶gren's syndrome (SS). Drug-induced AIH has been rarely reported. A rare case of the co-development of AIH and SS in a 53-year-old woman after the consumption of herbal medicines is described. After admission, the patient complained of dryness in her mouth, and she was subsequently diagnosed with SS, which had not been detected previously. The patient's bilirubin and aminotransferase levels initially decreased following conservative management; however, they later began to progressively increase. A diagnosis of AIH was made based on the scoring system proposed by the International Autoimmune Hepatitis Group. The patient was administered a combination of prednisolone and azathioprine, and the results of follow-up liver-function tests were found to be within the normal range. This is an unusual case of AIH and SS triggered simultaneously by the administration of herbal medicines. Keywords: Autoimmune hepatitis; SjÃ¶gren's syndrome; Herbal medicine
Training for Effective Patient Communication
Authors: Diane B. Wayne, William C. McGaghie
Journal: JAMA (2014)

In a recent report, Dr Curtis and colleagues1 found that simulation-based education did not improve patient-reported quality of communication. We disagree with the authors’ conclusion that “these findings raise questions about skills transfer from simulation training to actual patient care and the adequacy of communication skills assessment.” Instead, we propose a different explanation: the educational intervention was neither powerful nor assessed rigorously, which would prevent transfer of training outcomes to measured patient care practices or patient outcomes.
Effectiveness of high-dose methotrexate in T-cell lymphoblastic leukemia and advanced-stage lymphoblastic lymphoma: a randomized study by the Children's Oncology Group (POG 9404)
Authors: Barbara L. Asselin, Meenakshi Devidas, Chenguang Wang, Jeanette Pullen, Michael J. Borowitz, Robert Hutchison, Steven E. Lipshultz, Bruce M. Camitta
Journal: Blood (2011)
Petriellidium boydii Sinusitis
Authors: C. Jack Bark
Journal: JAMA (1978)

<h3>To the Editor.—</h3> The recent description (239:2368, 1978) of<i>Petriellidium boydii</i>involving the sinuses, reported to be the first known such infection at this site, has prompted us to add an additional case. <h3>Report of a Case.—</h3> A 28-year-old diabetic woman was seen in October 1977 with a history of pain over the right antrum radiating into the ear. Roentgenograms showed an acute sinusitis with opacification of the right antrum. She was treated conservatively with sinus irrigation and antibiotics, without response. Because of the persistence of roentgenographic findings and symptoms, a Caldwell-Luc procedure was performed two months later. Irregular soft tissue aggregating 4 cm was removed and showed edema with intense chronic inflammation. In addition large fungal particles were seen, the exact nature of which could not be determined on the material fixed in formaldehyde solution. The cultures grew two strains of light<i>Klebsiella pneumoniae</i>, scant<i>Enterobacter cloacae</i>, heavy anaerobic
Common pattern of two distinct types of colony-stimulating factor in human tissues and cultured cells.
Authors: M C Wu, A A Yunis
Journal: Journal of Clinical Investigation (1980)

Conditioned media prepared from human lung, placenta, peripheral leukocytes, cultured human pancreatic carcinoma cells, and cultured cervical carcinoma cells exhibit a common pattern of two distinct colony-stimulating factors (CSF) separable by isoelectrofocusing. Type I CSF appears polydisperse on isoelectrofocusing, showing multiple peaks with an isoelectric point of 3.6-4.7 and mol wt 50,000. It has a much higher activity in mouse than in human bone marrow, and stimulates the formation of predominately macrophage colonies. Type II CSF has an isoelectric point of 5.7 and mol wt 27,000 and exhibits higher activity in human than in mouse marrow, yielding predominately granulocytic colonies.
High 18F-Fluorothymidine Uptake for Invasive Thymoma
Authors: Chia-Ju Liu, Jane Wang, Wen-Hung Kuo, Ruoh-Fang Yen
Journal: Clinical Nuclear Medicine (2012)

We report an invasive thymoma discovered incidentally by an 18F-FLT (fluorothymidine) PET study on a 48-year-old woman. The patient had equivocal breast lesions in her bilateral breasts. She entered a clinical 18F-FLT PET trial in our hospital to differentiate malignant breast tumors from benign ones. No 18F FLT-avid lesions in her breasts were revealed. But an intense 18F-FLT uptake lesion was noted in her right anterior mediastinum. However, an F-FDG PET scan showed only mild F-FDG uptake in the lesion. Video-assisted thoracic surgery thymectomy was subsequently performed, and the final pathology showed invasive thymoma.
Screening for renovascular hypertension. Is renal digital-subtraction angiography the preferred noninvasive test?
Authors: Robert J. Havey, Frank Krumlovsky, Francesco delGreco, Helen Gartner Martin
Journal: JAMA (1985)

RENOVASCULAR hypertension is responsible for approximately 1% of all cases of hypertension,<sup>1-4</sup>and affects as many as 600,000 people in this country alone.<sup>5</sup>The current diagnostic approach to the clinically suspect patient involves identification of a renal artery stenotic lesion and determination of its functional significance. The stenotic lesion is usually first detected by a noninvasive screening study, such as radioisotope. renography, intravenous (IV) pyelography, or renal digital-subtraction angiography. Its presence is then confirmed with renal arteriography, and its significance determined by renal vein renin studies. Renal digital-subtraction angiography has become the noninvasive screening test of choice in many centers<sup>6,7</sup>though others<sup>8</sup>maintain that the hypertensive IV pyelography is still preferred. Since this controversy is important, we undertook a critical review of the available published data concerning the use of these various noninvasive tests in screening for renovascular hypertension. <h3>Radioisotope Renogram</h3> In
Response to Letter Regarding Article, “ST-Elevation Myocardial Infarction Diagnosed After Hospital Admission”
Authors: Ross F. Garberich, Jay H. Traverse, Michael T. Claussen, Gabriel Rodriguez, Anil K. Poulose, Ivan J. Chavez, Stephanie Rutten-Ramos, David A. Hildebrandt, Timothy D. Henry
Journal: Circulation (2015)
Autocrine stimulation of interleukin 1 beta in acute myelogenous leukemia cells.
Authors: K Sakai, T Hattori, M Matsuoka, N Asou, S Yamamoto, K Sagawa, K Takatsuki
Journal: The Journal of Experimental Medicine (1987)

A significant increase in CD25 antigen-positive cells by IL-1 was observed in cells of a patient with M7 acute myelogenous leukemia. Basal proliferation and expression of CD25 antigen by the M7 leukemic cells were inhibited by addition of anti-IL-1 beta antibody in a dose-dependent manner, but not by rabbit anti-IL-1 alpha antibody. Culture supernatants of these leukemic cells contained IL-1 activity, which was specifically inhibited by addition of anti-IL-1 beta antibody, and Northern blot analysis detected intracellular IL-1 beta mRNA. These results indicated that autocrine secretion of IL-1 beta was involved in proliferation of some myelogenous leukemic cells.
Wellcome Trust backs campaign for open access to research
Authors: N. Hawkes
Journal: BMJ (2012)

The Wellcome Trust, one of the world’s biggest funders of biomedical research, is to throw its weight behind the campaign to open up access to scientific papers.

Mark Wallport, director of the trust, told the Guardian (10 April, p 1) that in future it would insist on the scientists it funds publishing their results in such a way that the public could have free access to them within six months of publication. Those who disregard the policy could find it impossible to obtain future grants.

The trust is in the final stage of launching its own journal, eLife, in cooperation with the Howard Hughes Medical Institute and the Max …
Recurrent post-partum pulmonary eosinophilia
Authors: C. W. Davies, C. I. Mackinlay, C. G. Wathen
Journal: Thorax (1997)

In 1980 a 23 year old woman developed idiopathic eosinophilic pneumonia which was successfully treated with corticosteroids. She subsequently developed two identical relapses in the post-partum period.
Effects of Prior Intensive Insulin Therapy on Cardiac Autonomic Nervous System Function in Type 1 Diabetes Mellitus
Authors: Rodica Pop-Busui, Phillip A. Low, Barbara H. Waberski, Catherine L. Martin, James W. Albers, Eva L. Feldman, Catherine Sommer, Patricia A. Cleary, John M. Lachin, William H. Herman
Journal: Circulation (2009)

Background— The Epidemiology of Diabetes Interventions and Complications (EDIC) study, a prospective observational follow-up of the Diabetes Control and Complications Trial (DCCT) cohort, reported persistent benefit of prior intensive therapy on retinopathy and nephropathy in type 1 diabetes mellitus. We evaluated the effects of prior intensive insulin therapy on the prevalence and incidence of cardiac autonomic neuropathy (CAN) in former DCCT intensive and conventional therapy subjects 13 to 14 years after DCCT closeout. Methods and Results— DCCT autonomic measures (R-R variation with paced breathing, Valsalva ratio, postural blood pressure changes, and autonomic symptoms) were repeated in 1226 EDIC subjects in EDIC year 13/14. Logistic regression models were used to calculate the odds of incident CAN by DCCT treatment group after adjustment for DCCT baseline covariates, duration in the DCCT, and quantitative autonomic measures at DCCT closeout. In EDIC year 13/14, the prevalence of CAN using the DCCT composite definition was significantly lower in the former intensive group versus the former conventional group (28.9% versus 35.2%; P =0.018). Adjusted R-R variation was significantly greater in the former DCCT intensive versus the former conventional group (29.9 versus 25.9; P &lt;0.001). Prior DCCT intensive therapy reduced the risks of incident CAN by 31% (odds ratio, 0.69; 95% confidence interval, 0.51 to 0.93) and of incident abnormal R-R variation by 30% (odds ratio, 0.70; 95% confidence interval, 0.51 to 0.96) in EDIC year 13/14. Conclusions— Although CAN prevalence increased in both groups, the incidence was significantly lower in the former intensive group compared with the former conventional group. The benefits of former intensive therapy extend to measures of CAN up to 14 years after DCCT closeout.
Many drugs used for rheumatic disease cause neutropenia
Authors: C. Fox, R. Hull
Journal: BMJ (2014)

We agree with Hay and colleagues that, although neutropenia worries clinicians, it is often an unimportant finding and rarely requires treatment.1

Drug induced neutropenia is common in patients with rheumatic disease. We recognise that this is an increasing problem in primary care. It rarely leads to an alteration in the patient’s management, although it causes concern to non-specialists. We would like …
Adrenal Collision Tumor Diagnosed by F-18 Fluorodeoxyglucose PET/CT
Authors: Shane B. Anderson, Matthew D. Webb, Kevin P. Banks
Journal: Clinical Nuclear Medicine (2010)

Collision tumor is a rare condition in which 2 neoplasms develop in the same area and become intermingled. It is comprised of 2 distinct tissues, with one frequently being a benign entity and the second a malignant metastasis. While uncommonly encountered, collision tumors have been reported in a variety of sites to include the meninges, lungs, liver, bowel, genitourinary tract, and lymph nodes. Their origin is debated with some hypothesizing that the 2 lesions simply occur in contiguity by chance while others propose that the presence of one tumor alters the local environment, making development of a second tumor more likely. We present a 68-year-old woman with a history of left upper lobe adenocarcinoma and ipsilateral hilar lymph node spread of disease (stage IIb). Staging identified an incidental adenoma in the left adrenal gland, which was subsequently confirmed by magnetic resonance imaging (MRI). Several years later, the lesion developed anatomic and metabolic features typical for malignancy, consistent with a collision tumor.
Diabetes-Induced Changes in the Alternative Splicing of the Slo Gene in Corporal Tissue
Authors: Kelvin P. Davies, Weixin Zhao, Moses Tar, Johanna C. Figueroa, Pratik Desai, Vytas K. Verselis, Jack Kronengold, Hong-Zhan Wang, Arnold Melman, George J. Christ
Journal: European Urology (2006)
Responses of blood vessels in the rabbit knee to acute joint inflammation.
Authors: A Khoshbaten, W R Ferrell
Journal: Annals of the Rheumatic Diseases (1990)

These experiments examined the responses of articular blood vessels in the rabbit knee to induction of acute joint inflammation by intraarticular injection of 4% kaolin suspension. This produced an inflammatory response, which became evident about four hours after injection. Electrical stimulation of the nerve supply to the knee joint before induction of inflammation produced a biphasic response--an initial vasoconstriction during the stimulation phase followed by dilatation after stimulation stopped. These responses were followed up for eight hours and it was noted that the constrictor response became progressively greater, producing a further 19% decrease in blood flow during nerve stimulation about three hours after the injection of kaolin. The sensitivity of postjunctional alpha adrenoceptors, however, showed still greater increase in the inflamed joint as close intraarterial injection of 10(-6) M adrenaline produced an additional 30% reduction in blood flow four hours after kaolin injection compared with the control response. Possibly, the smaller enhancement of the constrictor response to nerve stimulation in the inflamed joint may reflect sensitisation of prejunctional alpha adrenoceptors in addition to the effects exerted on postjunctional alpha adrenoceptors by the inflammatory process. The dilator response also increased over eight hours, though this rise was less marked. These findings indicate that even over the limited time span of the experiments, significant alterations occurred in factors which influence the calibre of articular blood vessels.
How to read a Kaplan-Meier survival plot
Authors: P. Sedgwick
Journal: BMJ (2014)

Researchers investigated the effectiveness of larval therapy for the treatment of sloughy or necrotic leg ulcers. A three armed randomised controlled trial study design was used. The intervention consisted of loose larvae or bagged larvae. The control treatment was the standard debridement technique of hydrogel. Participants had at least one venous or mixed venous and arterial ulcer, with at least 25% coverage of slough or necrotic tissue. The outcome measures included time to healing of the largest eligible ulcer and time to debridement (defined as a cosmetically clean wound) after the ulcer healed. The maximum length of follow-up was 12 months.1 In total, 267 participants were recruited and randomised to loose larvae (n=94), bagged larvae (n=86), or hydrogel (n=87). Healing rates did not differ between the loose and the bagged larvae arms, so the results were presented for larvae overall (loose and bagged larvae arms combined). Time to healing was not significantly different between the larvae groups (combined) and hydrogel treatment groups (hazard ratio for healing using larvae v hydrogel 1.13, 95% confidence interval 0.76 to 1.68; P=0.54). Larval therapy significantly reduced the time to debridement compared with hydrogel (hazard ratio 2.31, 1.65 to 3.2; P<0.001; figure⇓). It was concluded that larval therapy did not improve the rate of healing of sloughy or necrotic leg ulcers compared with hydrogel but did significantly reduce the time to debridement. Kaplan-Meier plot of time to debridement of ulcer using larval therapy (loose and bagged combined) compared with hydrogel. The median survival time for each treatment group is the length of time corresponding to the probability of 0.5 Which of the following statements, if any, are true?
Conference on health consequences of environmental controls: impact of mobile emissions controls. Conference objectives.
Authors: J B Moran
Journal: Environmental Health Perspectives (1975)

The past and current EPA research and regulatory programs as they relate to non-regulated emissions from light-duty motor vehicles are reviewed. Provisions of Sections 202(a) and 211 of the 1970 Clean Air Act Amendments are discussed and their relationships to the nonregulated emissions issue detailed. The EPA position regarding non-regulated emissions from oxidation catalyst-equipped vehicles is discussed and related to technical papers presented in this symposium. The planned EPA research programs addressing the "catalyst" issue are reviewed.
The MELD score in patients awaiting liver transplant: Strengths and weaknesses
Authors: Mauro Bernardi, Stefano Gitto, Maurizio Biselli
Journal: Journal of Hepatology (2010)

Adoption of the Model for End-stage Liver Disease (MELD) to select and prioritize patients for liver transplantation represented a turning point in organ allocation. Prioritization of transplant recipients switched from time accrued on the waiting list to the principle of "sickest first". The MELD score incorporates three simple laboratory parameters (serum creatinine and bilirubin, and INR for prothrombin time) and stratifies patients according to their disease severity in an objective and continuous ranking scale. Concordance statistics have demonstrated its high accuracy in stratifying patients according to their risk of dying in the short-term (three months). Further validations of MELD as a predictor of survival at various temporal end-points have been obtained in independent patient cohorts with a broad spectrum of chronic liver disease. The MELD-based liver graft allocation policy has led to a reduction in waitlist new registrations and mortality, shorter waiting times, and an increase in transplants, without altering overall graft and patient survival rates after transplantation. MELD limitations are related either to the inter-laboratory variability of the parameters included in the score, or to the inability of the formula to predict mortality accurately in specific settings. For some conditions, such as hepatocellular carcinoma, widely accepted MELD corrections have been devised. For others, such as persistent ascites and hyponatremia, attempts to improve MELD's predicting power are currently underway, but await definite validation.
Drug company fails to stop publication of report
Authors: D. Spurgeon
Journal: BMJ (1998)

A legal dispute over the publication of a report on cholesterol lowering drugs has been won by the Canadian Coordinating Office for Health Technology Assessment (CCOHTA).

Bristol-Myers Squibb Canada tried to prevent publication of a report on statins produced by the independent technology assessment body, claiming that it would negatively affect the sales of their drug pravastatin (Pravachol). The company lost both its original case last December and an appeal in May.

CCOHTA, a non-profit corporation founded and funded by …