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During the period from September 8 to October 2, 1970, 44 of the 120 children and 78 of 141 adults questioned at the Children's Asthma Research Institute and Hospital experienced gastroenteritis characterized by nausea, vomiting, and fever and/or chills. Diarrhea was rare in children (4.5%) and common in adults (74%). The median duration of illness for children, 18 hours, was significantly shorter than the 48 hours for adults. All viral and bacterial cultures of 30 stool specimens were negative for viruses and bacterial pathogens. A retrospective survey of 28 ill employees revealed a secondary attach rate of 46% of 76 family contacts. A bacteria-free filtrate prepared from stool swab specimens of 2 ill adults by a team at the National Institute of Allergy and Infectious Diseases was administered orally to 3 adult volunteers. One of the 3 vomited and had 4 watery diarrheal stools on the third post-inoculation day. Diarrheal stool filtrates from this person were then given orally to 8 others; 1 became ill. Although the epidemiologic features point to the respiratory route of infection, the probably successful serial transmission of disease via bacteria-free stool filtrates through 2 generations of volunteers also suggests that the "Denver agent" is a virus-sized particle that replicates in the gastrointestinal tract.
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PMID:Epidemic acute infectious nonbacterial gastroenteritis at the Children's Asthma Research Institute and Hospital. 116 30

This multicenter, randomized, investigator-blinded, parallel group study compared the effects of converting patients from a q12h extended-release theophylline preparation (Theo-Dur) to a q24h extended-release product (Uni-Dur). Patients (n = 133) first received open-label Theo-Dur treatment with dosage titrated to achieve peak serum theophylline concentrations of 10-20 micrograms/ml. Patients then were randomized to continue Theo-Dur (n = 64) or to convert to Uni-Dur (n = 60) with peak serum theophylline concentrations maintained in the desired range. Pulmonary function tests were performed during the open-label and blinded periods; patients maintained diaries and performed peak flow measurements before each dose of study treatment. Adverse events were recorded throughout the study. Respiratory status during blinded treatment was rated as the same or improved compared with open-label treatment by > 87% of evaluable patients and physicians, regardless of treatment group. There were no significant differences in mean peak serum theophylline concentrations at baseline, at the final evaluation, or at any point during the study. Few dosage adjustments were necessary (5/52, Uni-Dur; 9/57, Theo-Dur). There were no significant changes in pulmonary function test results or patient diary entries between the open-label and blinded periods. Headache and nausea were the most commonly reported adverse events. In conclusion, converting patients from twice- to once-daily theophylline treatment resulted in no significant changes in any measures of pulmonary function, and there were no significant differences between the groups during the blinded treatment period.
J Asthma 1995
PMID:Conversion from twice- to once-daily extended-release theophylline treatment in patients with reversible airway obstruction. 762 3

It has been difficult to confirm that a given building is responsible for allergic symptomatology, exacerbation of asthma, or immunological dysfunction. In fact, in most studies, few objective immunological parameters have been studied and only rarely has there been any quantitation of IgE or secondary mediators. Furthermore, although many studies deal with rhinitis or respiratory tract irritation, there is a misconception that all such symptoms are allergic in nature, and studies attempting to prove that allergies are caused by buildings frequently neglect to prove that these are indeed true allergic responses. In addition, many of the symptoms that people attribute to sick building syndrome (SBS) or building-related illness, such as headaches, dizziness, fatigue, nausea, cough, and eye irritation, are subjective, and studies often fail to take into account other possible causes that may be inherent in the subjects, such as sinusitis, hyperventilation syndrome, or psychosomatic illness. Unfortunately, most clinical studies on SBS pay little attention to the preexisting conditions that a subject may have and discount the possibility that the inciting agent does not cause symptoms, but merely exacerbates a preexisting condition. Moreover, they offer no information about the nature of the mechanisms of action or pathophysiological relationships. Clearly, further studies are necessary to further explain the complexity of complaints that currently exist. Indeed, SBS might properly be paraphrased as "what is it?--if it is!"
J Asthma 1993
PMID:The sick building syndrome. I. Definition and epidemiological considerations. 833 Oct 40

There have been reports of increased prevalence of certain food allergies in patients with Type I latex allergy (LA). A detailed food allergy history was obtained from 137 patients with LA. Latex allergy was defined by positive history of IgE mediated reactions to contact with latex and positive skin prick test to latex and/or positive in vitro test (AlaSTAT and/or Pharmacia CAP). Food allergy was diagnosed by a convincing history of possible IgE mediated symptoms occurring within 60 minutes of ingestion. We identified 49 potential allergic reactions to foods in 29 (21.1%) patients. Foods responsible for these reactions include banana 9 (18.3%), avocado 8 (16.3%), shellfish 6 (12.2%), fish 4 (8.1%), kiwi 6 (12.2%), tomato 3 (6.1%), watermelon, peach, carrot 2 (4.1%) each, and apple, chestnut, cherry, coconut, apricot, strawberry, loquat, one (2.0%) each. Reactions to foods included local mouth irritation, angioedema, urticaria, asthma, nausea, vomiting, diarrhea, rhinitis, or anaphylaxis. Our study confirms the earlier reports of increased prevalence of food allergies in patients with LA. We also report increased prevalence of shellfish and fish allergy not previously reported. The nature of cross reacting epitopes or independent sensitization between latex and these foods is not clear.
Allergy Asthma Proc
PMID:Prevalence of food allergy in 137 latex-allergic patients. 1020 85

Two randomized, placebo-controlled, double-blind studies have shown clinical benefit with omalizumab (Xolair), a recombinant humanized monoclonal anti-immunoglobulin E (IgE) antibody, at a dose of 300 mg every 3 or 4 weeks in patients with seasonal allergic rhinitis. The present open-label, 12-week study was designed to assess the safety and tolerability of retreatment with omalizumab in 287 patients previously treated with this agent in one of the latter studies. Omalizumab, 300 mg, was administered subcutaneously every 4 weeks (three injections) to patients with IgE levels < or = 150 IU/mL (n = 182) and every 3 weeks (four injections) to patients with IgE levels > 150 IU/mL (n = 105) at screening before retreatment. Reported adverse events were monitored and blood samples were analyzed for laboratory safety (hematology and serum chemistry) and IgE levels. Urinalysis also was completed as part of the laboratory safety evaluation. The overall incidence and pattern of adverse events were similar to those reported in the primary study. There were no severe or serious adverse events related to omalizumab treatment and no anti-omalizumab antibodies were detected in any patient. Two patients withdrew from treatment because of adverse events (skin rash and nausea; facial erythema and edema) related to study treatment. Free IgE levels decreased to the levels associated with symptom reduction in the core study. In summary, retreatment during a second pollen season with omalizumab, 300 mg every 3 or 4 weeks, was well tolerated and was not associated with any significant immunologic reactions.
Allergy Asthma Proc
PMID:Tolerability of retreatment with omalizumab, a recombinant humanized monoclonal anti-IgE antibody, during a second ragweed pollen season in patients with seasonal allergic rhinitis. 1461 32

Buckwheat, which has been abundantly consumed in Asian countries and has been increasingly popular in the United States, Canada, and Europe, can be a potent allergen when ingested or inhaled. A case is reported of a 36-year-old man who experienced nausea, vomiting, urticaria, a sensation of throat closing, inability to speak, dyspnea, and dizziness shortly after ingesting a large portion of buckwheat that required emergency room treatment. In the previous 2 years he had experienced asthma, contact urticaria, allergic conjunctivitis, and allergic rhinitis from sleeping with a buckwheat pillow. Six months after the first ingestion reaction, the patient again experienced anaphylaxis requiring emergency treatment when he accidentally ate crackers with a small amount of buckwheat. Skin-prick testing showed a strong positive response to buckwheat, and a radioallergosorbent assay test was highly positive to buckwheat. It is possible that inhaled buckwheat provoking asthma sensitized the patient before his two episodes of ingestion anaphylaxis. Buckwheat is a potent allergen that can induce various clinical manifestations in the same individual.
Allergy Asthma Proc
PMID:Buckwheat allergy. 1694 56

The i.v. immunoglobulin (IVIG) therapy is one of the mainstays of treatment for humoral immunodeficiencies, but there is limited knowledge of the adverse reactions associated with this therapy, especially reactions occurring in the postinfusion period. The purpose of this prospective, observational, multicenter study was to identify and quantify the adverse reactions that can occur both during and after IVIG infusions (Gamimune N) in patients with humoral immunodeficiency. Patients with primary immunodeficiencies requiring IVIG therapy were followed over a 6-month period, and data regarding adverse events, particularly the time of onset, duration, and type of reaction associated with IVIG infusions wzas collected via direct observation and patient interviews. Data were obtained during and up to 72 hours after the completion of infusions. Sixty-five patients were recruited and received a total of 447 infusions over a 6-month period. Four hundred fifty-one adverse reactions were noted, with 17% of infusions associated with an intrainfusion reaction and 41% associated with a postinfusion reaction. Most postinfusion reactions occurred within 24 hours of the infusion and consisted mainly of headaches, fatigue, and nausea. Adverse reactions to Gamimune N infusions are common and occur primarily in the postinfusion period. Estimates of the rate of adverse reactions to Gamimune N infusions currently are underestimated because they do not account for postinfusion reactions. In addition, once recognized, effective treatment of postinfusion reactions may improve patient compliance and quality of life.
Allergy Asthma Proc
PMID:Intrainfusion and postinfusion adverse events related to intravenous immunoglobulin therapy in immunodeficiency states. 1717 91

Long-term intravenous immunoglobulin (IVIG) infusion is an effective treatment for children with humoral immunodeficiencies, already be complicated by systemic adverse effects. In order to determine the adverse effects of intravenous immunoglobulin in patients with antibody deficiency, 45 immunodeficient patients receiving intravenous immunoglobulin were studied during a 36 month period at Children's Medical Center. The investigated group included 25 patients with common variable immunodeficiency, 14 patients with X-linked agammaglobulinemia and 6 patients with IgG subclass deficiency. A total of fifty adverse effects occurred through 955 infusions (5.2%). The most frequent immediate adverse effects were mild (40 infusions out of 955) in 22 cases, including: chills, flushing, fever, nausea and headache. Three patients experienced moderate effects (10 infusions out of 955) such as rash, severe headache, joint pain and chest tightness. None of the effects was anaphylactic type. It can be concluded that intravenous immunoglobulin is generally a well-tolerated medical agent for patients with antibody deficiency, but all patients should be monitored by a physician who is familiar with its indications, risks, adverse effects and their appropriate management.
Iran J Allergy Asthma Immunol 2003 Sep
PMID:Adverse effects of intravenous immunoglobulin therapy in patients with antibody deficiency. 1730 67

Sodium fluorescein (SF) is widely used to assess chorioretinal disorders. Adverse reactions are well documented but the underlying mechanism is still uncertain. The aim of this study was the evaluation of skin testing to predict SF reaction, the identification of possible predisposing factors, and the objective record of the reported reactions. All patients with adequate indication for SF angiography (SFA) during an 18-month period were evaluated as follows: (a) detailed personal history of atopy, diabetes, previous SFA, and/or diagnostic procedures with radiocontrast media (RCM) and possible side effect; (b) skin testing with SF 10% diluted preparations; (c) SFA with 5 mL of SF, objective record of any reaction. Two hundred twenty-four patients (108 men and 116 women) with a mean age of 65.2 years (SD, 12.86; range, 16-92 years) underwent SFA. The overall rate of adverse reactions was 3.6% (8/224), which consists of 5 (2.2%) individuals with transient mild nausea; 2 (0.9%) subjects with face and upper trunk flushing that appeared in one case after 60 minutes and in the other case 24 hours later and both resolved without treatment, and I subject with transient bilateral frontal headache and dizziness. None of the 224 patients had positive skin or intradermal testings. One hundred thirty-six of 224 (60.7%) patients stated no previous SFA and 74.1% had not performed RCM injection. None of the recorded variables correlated with increased risk of reaction. SFA is a safe procedure with minor adverse effects. Although in vivo testing can not identify reactors it may help to exclude an underlying IgE-mediated mechanism in susceptible individuals.
Allergy Asthma Proc
PMID:Skin testing and adverse reactions in fluorescein: a prospective study. 1788 17

A need exists for safe, effective therapy for the relief of the symptoms of allergic rhinitis (AR) that also consistently relieves nasal congestion, the most common and bothersome symptom. This study was performed to assess efficacy and safety of a once-daily tablet containing 10 mg of loratadine, an antihistamine, and 10 mg of montelukast, a leukotriene antagonist (SCH 445761) versus placebo and pseudoephedrine (PSE; 240 mg once-daily formulation; active comparator). In a multicenter, parallel-group, double-blind, double-dummy, randomized study, 1095 subjects with documented history of seasonal AR and positive skin-prick test to a prevailing aeroallergen were treated for 15 days with fixed-dose combination loratadine/montelukast (L/M), PSE, or placebo. After randomization, subjects rated severity of nasal congestion and measured peak nasal inspiratory flow (PNIF) rate in the morning and evening. The change in quality of life from baseline was also assessed. L/M and PSE were significantly more effective than placebo in alleviating nighttime and daytime nasal congestion and improving PNIF rate, an objective measure of nasal obstruction. There were no significant differences between L/M and PSE for any efficacy analysis including improvement in the quality of life. Subjects treated with L/M experienced a similar incidence of total adverse events versus placebo and a lower incidence of total adverse events (including dizziness, insomnia, jitteriness, nausea, and dry mouth) versus PSE. Nasal decongestant activity of L/M was significantly higher than that of placebo and similar to that of PSE in symptomatic AR subjects. L/M showed a safety profile similar to placebo and was better tolerated than PSE. Thus, L/M offers a safe and efficacious alternative to PSE for the treatment of nasal congestion associated with AR.
Allergy Asthma Proc
PMID:Efficacy and safety of fixed-dose loratadine/montelukast in seasonal allergic rhinitis: effects on nasal congestion. 1954 27


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