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In June 1983, an outbreak of waterborne giardiasis occurred in a group of 93 university students and faculty participating in a geology field course in Colorado. All cases occurred in one subgroup of persons who were heavily exposed to untreated stream water on a field trip, and the risk of illness was strongly related to the amount of untreated stream water consumed. The median incubation period from a brief exposure to the first symptom was 7 days. The authors compared symptoms and stool sample results among 31 Giardia-positive persons in the exposed group and 36 Giardia-negative participants in an unexposed group to assess several case definitions for acute giardiasis. Diarrhea, abdominal cramps, flatulence, foul-smelling stools, nausea, excessive tiredness, bloating, anorexia, and chills were each significantly more common in the first group than in the second. A giardiasis case definition of 5 days or more of diarrhea--the definition used in many epidemiologic studies of giardiasis--had a specificity of 100 percent but a sensitivity of only 32.2 percent compared with a definition based on results of stool examinations. When a case was defined as an illness lasting 7 days or more, with a combination of two or more of six symptoms (diarrhea, flatulence, foul-smelling stools, nausea, abdominal cramps, and excessive tiredness), sensitivity rose to 73 percent, with a specificity of 88 percent. Such a case definition may be an improvement over that of 5 days of diarrhea, especially in outbreaks where there is good laboratory documentation that Giardia is the etiologic agent. The definition should be validated in other outbreaks and in situations where giardiasis must be distinguished from gastrointestinal disease caused by other agents.
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PMID:Acute giardiasis: an improved clinical case definition for epidemiologic studies. 199 3

A multicenter phase I-II trial of intravenous (IV) human recombinant interferon beta (rIFN-beta; Betaseron; Triton Bioscience Inc, Almeda, CA) was conducted in children with recurrent or progressive primary brain and spinal cord tumors. A total of 29 patients were enrolled: high-grade astrocytoma (12), brainstem glioma (nine), and primitive neuroectadermal tumor (three), ependymoma (two), germ cell (two), and spinal cord astrocytoma (one). Betaseron was given by IV infusion over 30 minutes 3 times per week (Monday-Wednesday-Friday [MWF]). Four dose levels were studied, and at least three patients were entered at each dose level. The treatment plan began with a three-step dose escalation for each patient over 6 weeks (initiation phase). The dose-escalation schema for the four dose levels was: 50-100-200, 100-200-400, 200-300-500, and 300-400-600 x 10(6) (M) IU/m2. Patients experiencing an objective response or stable disease after 6 weeks entered the maintenance phase at the final escalated dose, ie, 200, 400, 500, or 600 mlU/m2 (MWF). Common transient effects included chills, fever, and fatigue. Dose-limiting toxicities were hematologic, hepatic, and CNS. The maintenance maximum-tolerable dose (MTD) was 500 mlU/m2, ie, dose level 3. Response was assessed at completion of the initiation phase and at 2-month intervals during the maintenance phase. Objective partial responses were seen in patients with high-grade astrocytoma (two) and brain-stem glioma (two). Thus, four of 21 (19%) assessable patients had partial responses for a median of 4 months. Eight patients had stable disease for a median of 5+ (2 to 14+) months. Antineoplastic activity has been identified in children with high-grade astrocytomas and brainstem gliomas in a dose-intensive regimen.
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PMID:Recombinant interferon beta: a phase I-II trial in children with recurrent brain tumors. 201 20

Since it is very rare that cardiac tamponade due to myocardial rupture caused by infective endocarditis, occurs we are reporting this case. A 62 year old man, who had underlying diseases of pneumoconiosis and hypertensive heart disease, visited Chikuho Rosai Hospital complaining of chest oppression and general fatigue on Feb. 7, 1987. He was diagnosed as having ischemic heart disease by electrocardiogram. Two days later, he suddenly had chills and a fever, and the laboratory data showed leukocytosis and a positive C-reactive protein (CRP). The echo cardiogram showed mitral regurgitation (MR) and aortic regurgitation (AR), but neither vegetation nor pericardial effusion was observed. On Feb. 16, he was admitted with shock, and he died the next day. The blood cultures grew gram-positive cocci, respectively. From the clinical symptoms, chest roentgenogram and electrocardiogram, we suspected a cardiac tamponade. On autopsy findings, though coronary arteries were intact, the aortic valves had severe valvular adhesions, calcifications and hypertrophies. The rupture hole was observed in the left ventricles, which was just under the aortic valve through the pericardiac space. It seemed that he died of a cardiac tamponade due to the outflow of blood from this hole. On histopathologic findings of the cardiac wall, gram-positive cocci and many of neutrophils were observed.
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PMID:[An autopsied case of infective endocarditis with cardiac tamponade due to myocardial rupture]. 207 73

We demonstrated the clinical effectiveness of recombinant interferon-gamma (rIFN gamma) (Biogen) in 18 patients with Philadelphia-positive chronic myeloid leukemia. Sequential cytogenetic studies and molecular analyses of the breakpoint cluster region and for immunoglobulin and T cell rearrangements were performed every 3-4 months. In 13 patients who received treatment for a minimum of 3 months, the majority were treated with 1.5 mg/m2, t.i.w., i.v. Nonhematologic effects--particularly chills, rigors, myalgia, fatigue, headaches, and nausea--were significant. Complete or partial hematologic responses were observed in six patients, two of whom had approximately 20% normal metaphases after an average of 74 weeks of treatment. However, reversion to 100% Ph+ cells occurred 30 weeks later. In these two patients, in whom normal metaphases were found, no changes were observed in the presence of rearrangements of the breakpoint cluster region. In addition, the marrows remained hypercellular, and the leukocyte alkaline phosphatase score and B12 levels remained abnormal. No immunoglobulin or T cell beta-chain gene rearrangements were found. These data indicate the clinical effectiveness of rIFN gamma in some patients with chronic myeloid leukemia, although the fundamental nature of the disease is unaltered by this form of treatment.
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PMID:Recombinant gamma-interferon has activity in chronic myeloid leukemia. 215 24

The total porosity and mean pore sizes of various bone cement preparations were measured using image analysis. The porosity in different commercial bone cements varied from 5% to 16% when these cements were prepared in the usual fashion. Centrifugation for 30 seconds resulted in a substantial reduction in the overall porosity of Simplex P, AKZ, Zimmer Regular, and CMW bone cements by reducing both the mean pore size and the number of pores per unit area. In contrast, the porosity of LVC, Palacos R, and Palacos R with gentamicin bone cements was not significantly decreased by centrifugation. Chilling the monomer before mixing resulted in higher porosity of both the centrifuged and uncentrifuged Simplex P, Zimmer Regular, and CMW bone cements. Simplex P mixed with chilled monomer and centrifuged for 120 seconds has one of the lowest porosities of the various cements, while retaining good handling characteristics and excellent fatigue strength.
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PMID:Porosity of various preparations of acrylic bone cements. 220 46

Reactogenicity of trivalent influenza vaccine prepared for the 1988-89 season was assessed as part of a first-time voluntary influenza prevention program among hospital staff. Of approximately 500 full-time workers in areas with the highest concentrations of patients at high risk for influenza complications offered the vaccine 288 accepted. Of these, 266 (92%) returned a questionnaire regarding any symptoms experienced within 48 hours after vaccination; 238 (90%) of the respondents reported adverse effects. Soreness at the injection site was described by 229 subjects, 58 (25%) of whom had constant aching and 123 (54%) soreness with arm movement. Symptoms resolved in 1 to 2 days, and only 21 (9%) of those who reported symptoms said they took analgesic medication. Systemic adverse effects were described by 130 subjects (49%). Intercurrent illness accounted for some of these complaints, but 65 people (24%) described at least two of the following symptoms: generalized aching, tiredness, nausea, chills or onset of fever within 12 hours after vaccination (a symptom complex previously attributed to influenza vaccine). Systemic symptoms resolved within 0.5 to 2 days. Thirteen subjects (5%) reported missing work because of arm soreness (1 subject) or systemic symptoms (12). Adverse effects were encountered more often than expected, probably because most of the workers were young and lacked immunity to influenza. Acceptability of the program could likely be improved by using a split-virus vaccine.
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PMID:Evaluation of adverse events after influenza vaccination in hospital personnel. 229 29

In 1981 and 1982, two US citizens died from Japanese encephalitis (JE) acquired in China. In 1983, the Centers for Disease Control initiated an evaluation of a purified, inactivated, mouse-brain-derived JE vaccine produced and used in Japan since 1966. Two doses of this vaccine given 1-2 weeks apart evoked neutralizing antibody titers greater than or equal to 8 in only 77% of recipients. After three JE vaccine doses administered 1-2 weeks apart, 99% developed titers greater than or equal to 8. When a third dose was given to 29 participants 6-12 months after the primary series, all developed titers greater than or equal to 16. Reported adverse reactions included injection site tenderness (18%), erythema (6%), or swelling (3%); headache (9%); and dizziness, fatigue, sleepiness, nausea, chills, fever, or lower back pain (less than or equal to 5%). On the basis of this study, three doses of BIKEN JE vaccine are recommended for US citizens who may be at risk of exposure to JE virus.
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PMID:Evaluation of the potency and safety of inactivated Japanese encephalitis vaccine in US inhabitants. 232 39

All major types of human interferons (IFNs) have been purified and clinically administered as antitumor agents. We summarize here experience to date with toxicity of IFNs in cancer patients. The acute syndrome consists of fever, chills, myalgias, arthralgias, and headache, with some variation according to type of IFN, route of administration, schedule, and dose. Fatigue, perhaps reflecting CNS toxicity, is the most prevalent nonacute symptom. At high doses, IFNs are neurotoxic; the abnormalities seen by EEG resemble those in diffuse encephalitis. Hematologic toxicity consists mainly of leukopenia, but anemia and thrombocytopenia occur in some patients. Nausea, vomiting, and diarrhea are the main gastrointestinal symptoms. Elevation of serum transaminases seems to reflect liver toxicity. Renal function is well preserved, except for rare instances of acute renal failure. Cardiac toxicity remains questionable, although heart failure and arrhythmias have been associated with the administration of IFNs. Most, if not all, of these effects are reversible or can be ameliorated. With IFN alpha, the type most widely used in clinical studies, doses of 1 million to 9 million units (MU) are generally well tolerated, but doses greater than or equal to 18 MU yield moderate to severe toxicity. Doses greater than or equal to 36 MU can induce severe toxicity and significantly alter the performance status of the patient.
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PMID:Clinical toxicity of interferons in cancer patients: a review. 241 69

The present investigation was undertaken to establish the relation between climacteric symptoms, ovarian function, ageing, and psychological factors. The subjects were as follows; 1,270 women who received a screening test for cervical cancer and 247 women following hysterectomy. The methods of investigation were Kupperman menopausal index (K-index), Cornell Medical Index (CMI) and YG character questionnaire (YG test). The following results were obtained: 1) the K-index increased until 39 years of age and was constant after 40 years. Five symptoms (chills, nervousness, melancholia, excitability and vertigo) were not influenced by ageing, and seven symptoms (panting, hypesthesia, insomnia, wakefulness, fatigue, palpitation and formication) increased with age. Hot flushes, perspiration, numbness, shoulder stiffness, lumbago, and headache, occurred at peak frequency in the climacteric period. 2) In hot flushes, perspiration, numbness, hypesthesia, shoulder stiffness, lumbago, and formication, a significant difference was found between the control and those patients who had received bilateral oophorectomy. 3) The K-index and CMI score were significantly correlated, and six symptoms (palpitation, panting, excitability, vertigo, wakefulness and formication) in particular were related to CMI. 4) The K-index was lowest in the patients indicated to be the D type by the YG test, and was highest in the patients of the B.E type. Six symptoms (excitability, palpitation, panting, melanchoria, hypesthesia and formication) were thought to be associated with the character of the patients. Results showed that four symptoms (hot flushes, perspiration, numbness, shoulder stiffness and lumbago) were closely related to ovarian function, and three symptoms (panting, excitability, and palpitation) depended largely on mental factors. The relationship between vasomortor symptoms and gonadotropin was investigated.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Study on climacteric symptoms in relation to ovarian function ageing and psychologic factors]. 249 39

Combinations of tumor necrosis factor-alpha (TNF-alpha) and interferon-gamma (IFN-gamma) demonstrate synergistic antiproliferative activity in vitro. Therefore, we initiated a clinical study of recombinant TNF-alpha (rTNF-alpha) and rIFN-gamma combination therapy in humans. Twenty-five patients with metastatic cancer received both rTNF-alpha and rIFN-gamma by intramuscular injection for 5 consecutive days every 2 weeks for a total of 4 weeks. The dose levels were 5/5, 10/5, 10/10, 25/10, 25/25, 50/25, 50/50, 75/50, and 75/75 micrograms/m2 per day of rTNF-alpha/rIFN-gamma. A minimum of 2 patients were entered sequentially at each dose level. If the first 2-week cycle of therapy was well tolerated, the dose was increased to the next highest dose level during the second 2-week cycle. Fever, chills, and fatigue were observed at all doses. Severity of symptoms corresponded to increasing dose levels. Although TNF is identical to a molecule known as "cachectin," the vast majority of our patients did not lose weight while on study. However, alterations in lipid metabolism occurred and were manifested by a median change in triglyceride values of +40 mg/dl (range, -130 to +318 mg/dl), and in cholesterol values of -30 mg/dl (range, -103 to +2 mg/dl). The maximum tolerated dose was 75 micrograms/m2 of rTNF-alpha combined with 50 micrograms/m2 of rIFN-gamma, with dose-limiting side effects being mainly constitutional symptoms. A dose-related suppression in granulocyte and platelet counts was observed. Hematologic parameters returned to baseline within 72 h after therapy was discontinued, and neither infection nor bleeding occurred. Ten of 22 evaluable patients had stable disease for a median of 8 weeks (range, 4-21 weeks); 12 patients showed progressive disease. This study will form the framework for phase II trials of rTNF-alpha and rIFN-gamma combination therapy.
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PMID:Phase I study of a combination of recombinant tumor necrosis factor-alpha and recombinant interferon-gamma in cancer patients. 250 84


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