Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0085631 (agitation)
 12,064 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Between 1981 and 1994, 58 bioequivalence studies (b.s.) were performed in 885 healthy volunteers. 93.1 per cent were single-dose, mainly of two way cross-over design. According to ATC groups, 13 were of cardiovascular drugs(C), 11 musculoskeletal (M), nine alimentary (A), seven urogenital (G), seven antimicrobial (J), six haematological (B), three nervous (N) and two respiratory (R). 97.2 per cent of volunteers finished the studies. Out of 25 withdrawals, 14 did it by their own will, seven were excluded because of lack of compliance with the protocol, one because of an adverse drug reaction (ADR) (preputial oedema), one because of intercurrent illness, and two for other objective reasons. In 35 studies the probants have been males, in 23 both sexes. Subjects were between 18 and 40 years. 209 adverse events were reported in 18 studies (31 per cent). From 885 volunteers that came to first session at the time, 115 (13 per cent) had ADRs. The association of the drug and ADRs was defined as probable in 91 ADRs (45.9 per cent), definite in 66 (33.4 per cent) and possible in 41 (20.7 per cent). 73 (63.5 per cent) volunteers had one ADR, 22 (19.1 per cent) had two and 20 (17.4 per cent) more than two ADRs. The majority -117 (56 per cent)-of ADRs were mild, 78 (37.3 per cent) moderate and 14 (6.7 per cent) severe. The most frequent ADR was headache (22.9 per cent), followed by nasal congestion (12.9 per cent), sweating (12.4 per cent), nausea (6.7 per cent), restlessness (6.7 per cent), deafness and tinnitus (6.2 per cent), change of biochemical or haematological parameters (5.3 per cent) and other. An unusual and rare ADR was impotence and preputial oedema (two volunteers on frusemide). All studies of G group (7-100 per cent) had ADRs, followed by C group (5-38 per cent) and A (3-33 per cent). Glipizide (5 mg) had highest number of ADRs (64-30.6 per cent), bromocriptine (10 mg) had 31 (14.8 per cent) and frusemide (500 mg) 22 (10.6 per cent). The largest number of subjects with ADRs were on frusemide (13-72 per cent), glipizide (17-68 per cent) and bromocriptine (15-52 per cent). At a time when generic drugs are of increasing importance, the safety of b.s. is of considerable interest. Our data confirm their safety and indicate that the majority of ADRs are mild.
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PMID:How safe are bioequivalence studies in healthy volunteers? 895 18

The aim of this study was to determine oxidative stress status as well as blood lead (Pb) and zinc (Zn) levels and clinical markers in workers of a Zn-Pb mine. A comparative cross-sectional analysis was performed in 67 mine workers who have been in contact with Zn and Pb in comparison to a control group containing 67 healthy subjects with the same age and sex. Lipid peroxidation, superoxide dismutase, catalase, glutathione reductase, myleoperoxidase, DNA damage, total antioxidant capacity, Zn, and Pb levels were measured in blood of workers and controls. Clinical examination was accomplished to record any abnormal sign or symptoms. Comparing with controls, the workers showed higher blood levels of superoxide dismutase, myleoperoxidase, glutathione reductase, lipid peroxidation, Pb, and Zn. Workers showed lower DNA-damage as compared with controls. Workers showed clinical symptoms such as memory impairment, less of concentration, insomnia, headache, claudication, epigasteric, inappetence, agitation, tremor, decreasing of reflection of deep tendon, conduction deafness of ear, and fatigue. The workers had extra normal levels of Pb (0.9-3 microg/dL) and showed oxidative stress. Taken together, the results indicate that exposure to combination of Pb and Zn in mine elevates total antioxidant capacity of body in a reflex to overcome to oxidative stress. Especially, in the present case, it seems that toxic effect of Pb has been greater than positive effects of Zn, but the combination exposure has resulted in not such a critical toxicity situation.
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PMID:Study on clinical and biochemical toxicity biomarkers in a zinc-lead mine workers. 2037 35

Cochlear implant is a commonly performed surgery for hearing loss in pre-school and school children. However, data on anesthesia management and anesthesia-related complications are sparse. We retrospectively reviewed the data of our institute from January, 2007 to December, 2012. Medical records and anesthesia charts of all the patients who had undergone cochlear implant under general anesthesia between this period were reviewed. Information related to the demographic profile, preoperative evaluation, anesthetic techniques, and perioperative complications were collected and analyzed. A total of 190 patients underwent cochlear implant surgery for pre-lingual (175) and post-lingual (15) deafness. General endotracheal anesthesia with inhalational agents was used in all the cases. Difficult intubation was encountered in three patients. Anesthesia-related complications were laryngospasm at extubation (4.73 %), emergence agitation (2.63 %), and postoperative nausea and vomiting (1.05 %). Major surgical complications were CSF leak without meningitis (3.15 %), device migration/failure (1.05 %), and flap infection (1.57 %). Cochlear implant under general anesthesia in small children is safe and anesthesia-related complications were minimal. Surgical complications, although more frequent, were predominantly minor and self-limiting.
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PMID:Perioperative complications of cochlear implant surgery in children. 2498 54