Gene/Protein Disease Symptom Drug Enzyme Compound
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Cholesterol granulomas of the head are relatively rare. Isolated lesions of the cerebellopontine angle are even more uncommon. In this report, 17 cases of petrous apex cholesterol granulomas are presented and management is discussed. Symptoms at presentation included dizziness (14 patients), pressure (nine patients), tinnitus (eight patients), hearing loss (eight patients), otalgia (six patients), headache (six patients), nausea (three patients), drainage from ear (two patients), facial pain (two patients), seizure (two patients), lightheadedness (one patient), hemifacial spasm (one patient), and facial numbness (one patient). Six cases were managed without surgery and 11 patients underwent operative procedures. The approaches used included the infralabyrinthine (eight patients), transcanal-infracochlear (two patients), and translabyrinthine (one patient). The mean follow-up period for all cases was 29.5 months. Of those patients managed without surgery, symptoms improved in all except one, whose tinnitus was slightly worse. Of surgically treated patients, symptoms improved or remained the same except in one with worsened dizziness. There were nine patients with hearing present presurgery and seven whose hearing was preserved postsurgery. The authors present a case that was managed at another center where an attempt at surgical resection through a subtemporal middle fossa approach was unsuccessful. This lesion was successfully treated using an infralabyrinthine approach with drainage into the mastoid cavity. Cholesterol granulomas of the petrous apex can be managed without surgery when symptoms are stable or improve. Otherwise, a transmastoid extradural approach with simple drainage into the mastoid sinus or middle ear produces symptomatic improvement with low morbidity. Resection of petrous apex cholesterol granulomas is not necessary.
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PMID:Cholesterol granulomas of the petrous apex: combined neurosurgical and otological management. 881 66

Lesopitron, a 5-hydroxytryptamine 1A agonist, is a new potential anxiolytic of the azapirone class. It has greater potency in animal models of anxiety than buspirone, gepirone, or ipsapirone, and it lacks the antidopaminergic effects associated with buspirone. Lesopitron has been tolerated at single doses up to 50 mg and repeated dosages of 45 mg/day in healthy volunteers. Forty-two patients with generalized anxiety disorder (GAD) were enrolled in this double-blind bridging study to determine the safety and tolerability of fixed doses of lesopitron (20, 25, 30, 40, 45, 50, and 60 mg two times a day) over a 6 1/2-day inpatient administration period. Each of the seven panels included six patients (four drug/two placebo). One patient in the 25-mg, two-times-a-day panel voluntarily withdrew because of increased anxiety symptoms. One patient experienced severe orthostatic hypotension at 60 mg two times a day, and moderate to severe adverse events (dizziness, lightheadedness, nausea, headache) occurred in two other patients at this dosage. The most commonly reported adverse events in all the panels were headache, dizziness, and nausea. Lesopitron is rapidly absorbed in patients, having a time to maximum concentration (Tmax) ranging from 0.5 to 1 hour, and its elimination half-life ranged from 1.1 to 5.6 hours. Peak plasma concentrations showed high interindividual variability for lesopitron, but increased linearly with dose for the main metabolite, 5-hydroxylesopitron. We defined the maximum tolerated dose in GAD patients as 50 mg two times a day, twice as high as the highest dose tested in healthy volunteers.
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PMID:Establishing the maximum tolerated dose of lesopitron in patients with generalized anxiety disorder: a bridging study. 895 72

Butyrates have been studied as cancer differentiation agents in vitro and as a treatment for hemoglobinopathies. Tributyrin, a triglyceride with butyrate molecules esterified at the 1, 2, and 3 positions, induces differentiation and/or growth inhibition of a number of cell lines in vitro. When given p.o. to rodents, tributyrin produces substantial plasma butyrate concentrations. We treated 13 patients with escalating doses of tributyrin from 50 to 400 mg/kg/day. Doses were administered p.o. after an overnight fast, once daily for 3 weeks, followed by a 1-week rest. Intrapatient dose escalation occurred after two courses without toxicity greater than grade 2. The time course of butyrate in plasma was assessed on days 1 and 15 and after any dose escalation. Grade 3 toxicities consisted of nausea, vomiting, and myalgia. Grades 1 and 2 toxicities included diarrhea, headache, abdominal cramping, nausea, anemia, constipation, azotemia, lightheadedness, fatigue, rash, alopecia, odor, dysphoria, and clumsiness. There was no consistent increase in hemoglobin F with tributyrin treatment. Peak plasma butyrate concentrations occurred between 0.25 and 3 h after dose, increased with dose, and ranged from 0 to 0.45 mM. Peak concentrations did not increase in three patients who had dose escalation. Butyrate pharmacokinetics were not different on days 1 and 15. Because peak plasma concentrations near those effective in vitro (0.5-1 mM) were achieved, but butyrate disappeared from plasma by 5 h after dose, we are now pursuing dose escalation with dosing three times daily, beginning at a dose of 450 mg/kg/day.
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PMID:Phase I study of the orally administered butyrate prodrug, tributyrin, in patients with solid tumors. 953 30

A randomized double-blind dose-titration crossover trial of the safety and efficacy of oral fampridine-SR (sustained release 4-aminopyridine) was conducted on spinal cord injured (SCI) patients at two centers. Twenty-six patients (n = 26) with incomplete lesions completed the trial. These patients all had chronic (>2 years) and stable neurological deficits. They received fampridine-SR 12.5 and 17.5 mg b.i.d. over a 2-week treatment period, followed by a 1-week washout and 2 weeks of placebo, or vice versa. Patients reported significant benefit of fampridine-SR over placebo on patient satisfaction (McNemar's test, p2 < 0.05) and quality of life scores (p2 < 0.01). Sensory scores (p1 < 0.01), including both pin prick (p1 = 0.059) and light touch (p1 = 0.058), and motor scores (adjusted to reflect only paretic segments) (p1 < 0.01) all yielded evidence of benefit of fampridine-SR over placebo. The Ashworth scale of spasticity was significantly (p2 < 0.05) reduced when patients received fampridine-SR. There were no statistically significant benefits of the drug on measures of pain or bowel, bladder and sexual function, or functional independence. Side effects of lightheadedness and nausea were transient and trivial relative to efficacy, and approximately 30% of patients reported a wish to continue to use fampridine-SR. The clinical benefits most likely derive from the K+ channel blocking action of the drug. Potassium channel blockade enhances axonal conduction across demyelinated internodes and enhances neuroneuronal and neuromuscular transmission in preserved axons. These results provide the first evidence of therapeutic benefit of fampridine-SR in SCI patients.
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PMID:Randomized double-blind crossover trial of fampridine-SR (sustained release 4-aminopyridine) in patients with incomplete spinal cord injury. 981 39

This Phase II study was designed to determine the efficacy and tolerability of vorozole (R83842), a new nonsteroidal aromatase inhibitor, in postmenopausal women with advanced breast cancer in progression being treated with tamoxifen, and to correlate these effects with the hormonal profile and plasma drug levels. Twenty-nine eligible women with estrogen receptor-positive or unknown disease were treated with 2.5 mg vorozole once daily p.o. until disease progression. All 29 are evaluable for toxicity and 27 for response as assessed by International Union Against Cancer (UICC) criteria. After a median follow-up of 8 months, 3 patients (11%) had partial remission of their disease for 14, 15, and 16 months and 14 patients had disease stabilization for 7-24 months (median, 12). Patients with a normal carcinoembryonic antigen level (</=3 mm/liter), those without bone metastases, older women, and those with a long disease-free interval were most likely to benefit from treatment. Estradiol decreased from pretreatment levels of 9. 2-85 pm/liter (mean, 24) to below detection (9.2 pm/liter) and estrone from 64-311 pm/liter (mean, 144.3) to 19-116 pm/liter (mean, 57) after 1 month. Serum follicle-stimulating and luteinizing hormone levels rose from 9-74 IU/liter (mean, 35.3) and 3.3-38 IU/liter (mean, 17.8) to 10-102 IU/liter (mean, 44.6) and 1.6-70 IU/liter (mean, 24.2) and sex hormone-binding globulin fell from 27-138 nm/liter (mean, 65.4) to 15-109 nm/liter (mean, 53.8) after 1 month of treatment. Corresponding levels of androstenedione, dehydroepiandrosterone, free testosterone, and 17alpha-hydroxyprogesterone were unaffected. An adrenocorticotropic hormone stimulation test was normal in 18 patients 1 month after treatment commenced. Trough drug levels (measured by gas chromatography) ranged from 6.5-95 ng/ml (median, 24.5) at 1 month of treatment. Possible treatment-related side effects were mild and included malaise, anorexia and nausea, hot flashes, fluid retention, vaginal infection, alopecia, lightheadedness, and one allergic reaction which caused lip swelling. Vorozole, given orally, is a clinically active well-tolerated new treatment for breast cancer. Selective suppression of estrogen confirms its action as a specific aromatase inhibitor. Further trials to confirm its relative efficacy in postmenopausal disease and to explore its application in other settings are indicated.
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PMID:Phase II study of vorozole (R83842), a new aromatase inhibitor, in postmenopausal women with advanced breast cancer in progression on tamoxifen. 981 84

Lignocaine has been used successfully to treat burn pain and neuropathic pain. We have conducted a randomized, double-blind trial to assess the morphine-sparing effect of intravenous lignocaine in patients with acute pain. After major abdominal surgery, patients were treated with post-operative patient-controlled intravenous analgesia in two groups: group M (n = 25, morphine 0.2 mg mL-1) and group ML (n = 25, morphine 0.2 mg mL-1 plus lignocaine 3.2 mg mL-1). The patient-controlled analgesia system was programmed to deliver a 5 mL bolus with a 50 mL per 4 h limit; the lockout time was 10 min. Both groups closely resembled each other in terms of demographic data, pain intensity, cumulative morphine dose and the morphine-associated nausea, vomiting and pruritus. However, the sedation scores in group ML patients during the first post-operative day were significantly greater than those in group M. The incidence of lignocaine-related lightheadedness and dry mouth was also significantly greater in group ML than in group M. It was concluded that the addition of lignocaine 3.2 mg mL-1 to morphine 0.2 mg mL-1 given via patient-controlled analgesia system does not provide a post-operative morphine-sparing analgesic effect.
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PMID:Lignocaine plus morphine in bolus patient-controlled intravenous analgesia lacks post-operative morphine-sparing effect. 988 51

Smoking is protective against developing ulcerative colitis. Nicotine may be the cause of this protective effect. Controlled trials have demonstrated efficacy of transdermal nicotine for active ulcerative colitis. Side effects observed with transdermal nicotine include contact dermatitis, nausea, and lightheadedness. Topical administration of nicotine to the colon reduces nicotine blood concentrations and side effects, and may be of clinical benefit.
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PMID:Nicotine therapy for ulcerative colitis: a review of rationale, mechanisms, pharmacology, and clinical results. 1023 87

A previously healthy 42-year-old man presented to the emergency department with progressive weakness, lightheadedness, nausea, and lower extremity edema. Evaluation revealed hypotension, pulsus paradoxus, leukocytosis, hepatic and renal dysfunction, and an air-fluid level in the mediastinum. Emergency department ultrasound confirmed the presence of a large pericardial fluid collection. The patient was admitted to the medical intensive care unit with a diagnosis of pyopneumopericardium for emergent pericardiocentesis.
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PMID:Spontaneous pyopneumopericardium. 1033 81

Preclinical studies indicate that dihydropyridine-type calcium channel antagonists modulate dopamine neurotransmitter function and can reduce cocaine-reinforced behaviors. Amlodipine, a long-acting dihydropyridine-type calcium channel antagonist related to isradipine and nifedipine, was administered in open label fashion for 12 weeks to 26 cocaine-dependent patients. In subjects expressing cocaine craving, craving significantly declined during the course of the 12 weeks. Five individuals reported flushing, headache, fatigue, nocturia, nausea, and lightheadedness. No conclusions regarding efficacy can be made due to the small number of subjects and the open-label design.
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PMID:Amlodipine treatment of cocaine dependence. 1043 93

Neurally mediated syncope is a disorder of the autonomic regulation of postural tone, which results in hypotension, bradycardia, and loss of consciousness. A wide variety of stimuli can trigger this reflex, the most common stimulus being orthostatic stress. Typically, a patient with neurally mediated syncope experiences nausea, lightheadedness, a feeling of warmth, and pallor before abruptly losing consciousness. If the cause of syncope is unclear, a stepwise approach is necessary to arrive at the diagnosis. The diagnosis of neurally mediated syncope can be confirmed by a head-up tilt-table test. Treatment options include behavioral modification and several pharmacologic therapies. For severe recurrent syncope unresponsive to conventional treatment, a pacemaker can be implanted.
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PMID:Neurally mediated syncope. 1109 11


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