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Nausea
Kinds of Nausea Terms modified by Nausea Selected AbstractsGastric Stasis in Migraine: More Than Just a Paroxysmal Abnormality During a Migraine AttackHEADACHE, Issue 1 2006Objective.,The aim of this article is to evaluate gastric motility and emptying in the ictal and interictal period in migraine. Background.,Nausea is a predominant symptom of migraine and the basis of it is thought to be gastric stasis. Objective methods to establish this are however lacking. We utilized gastric scintigraphy studies to determine gastric motility in the ictal and interictal period of migraine. Methods.,Ten migraine subjects were compared to equal number of age and sex matched controls. Gastric scintigraphy using a standard meal was performed in all control subjects once and in all 10 migraine subjects in the interictal period and nine studies were performed in the ictal period migraine. Results.,The time to half emptying was delayed in migraine ictally (78%) and interictal period (80%) using normative data at this institution. Gastric stasis was less pronounced ictally (149.9 minutes) compared to interictal period (188.8 minutes). There was a significant delay compared to nonmigrainous controls (migraine 188.8 minutes vs normal controls 111.8 minutes; P < .05). These data were replicated in percentage of radioactive material remaining in the stomach at 2 hours. Conclusions.,Contrary to previous belief, this study has demonstrated that migraineurs suffer from gastric stasis both during and outside an acute migraine attack. This may suggest that migraineurs may have an abnormal autonomic function compared to nonmigrainous controls. The potential role of this in pathophysiology of migraine is discussed and avenues for further investigations are explored. [source] Helicobacter Status Does Not Relate to Postanesthetic NauseaHELICOBACTER, Issue 5 2005Simon D. S. Woods No abstract is available for this article. [source] Merimepodib, pegylated interferon, and ribavirin in genotype 1 chronic hepatitis C pegylated interferon and ribavirin nonresponders,,HEPATOLOGY, Issue 6 2009Vinod K. Rustgi Merimepodib (MMPD) is an orally administered, inosine monophosphate dehydrogenase inhibitor that has shown antiviral activity in nonresponders with chronic hepatitis C (CHC) when combined with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV). We conducted a randomized, double-blind, multicenter, phase 2b study to evaluate the antiviral activity, safety, and tolerability of MMPD in combination with Peg-IFN-alfa-2a and RBV in patients with genotype 1 CHC who were nonresponders to prior therapy with Peg-IFN and RBV. Patients received 50 mg MMPD, 100 mg MMPD, or placebo every 12 hours, in addition to Peg-IFN-alfa-2a and RBV, for 24 weeks. Patients with a 2-log or more decrease from baseline or undetectable hepatitis C virus (HCV) RNA levels at week 24 were then eligible to continue Peg-IFN-alfa-2a and RBV for a further 24 weeks, followed by 24 weeks of follow-up. The primary efficacy endpoint was sustained virological response (SVR) rate at week 72 in all randomized patients who received at least one dose of study drug and had a history of nonresponse to standard therapy. A total of 354 patients were randomized to treatment (117 to placebo; 119 to 50 mg MMPD; 118 to 100 mg MMPD), and 286 completed the core study. The proportion of patients who achieved SVR was similar among the treatment groups: 6% (6/107) for 50 mg MMPD, 4% (5/112) for 100 mg MMPD, and 5% (5/104) for placebo (P = 0.8431). Adverse-event profiles for the MMPD combination groups were similar to that for Peg-IFN-alfa and RBV alone. Nausea, arthralgia, cough, dyspnea, neutropenia, and anemia were more common in patients taking MMPD. Conclusion: The addition of MMPD to Peg-IFN-alfa-2a and RBV combination therapy did not increase the proportion of nonresponder patients with genotype 1 CHC achieving an SVR. (HEPATOLOGY 2009.) [source] Evaluation of Interventions Proposed for Altered Tissue Perfusion: Cardiopulmonary in Patients Hospitalized With Acute Myocardial InfarctionINTERNATIONAL JOURNAL OF NURSING TERMINOLOGIES AND CLASSIFICATION, Issue 2003Ivanise Maria Gomes PURPOSE To evaluate the effectiveness and efficacy of the interventions proposed for patients with altered tissue perfusion: cardiopulmonary, according to NIC and NOC taxonomies. METHODS Prospective and descriptive study carried out in the cardiology unit of a school hospital with patients under clinical treatment followed from admission until discharge. Patient data were collected using the unit's assessment tool and nursing diagnoses were established. Daily activities were proposed for these patients based on NIC interventions "cardiac care: acute,""cardiac care," and "cardiac care: rehabilitative." Results were evaluated according to indicators selected from NOC's Tissue Perfusion: Cardiac. FINDINGS The sample comprised 25 patients (12 males, 13 females), age range 39 to 83 years. Days hospitalized averaged 3.5 in the coronary unit and 3.5 in the cardiology infirmary, for a total of 7 hospital days. The nursing diagnosis was made based on defining characteristics: enzymatic and ECG changes were found in 100% of the patients, chest pain (96%), diaphoresis (80%), and nausea (72%). The related factor in evidence for 100% of the sample was coronary arterial flow interruption. Patients were evaluated according to NOC outcomes both before starting activities and daily, with the following results: chest pain , 64% of patients initially presented pain with score 1, most (72%) presented scores 4 and 5 on day 2; on days 3, 5, 6, and 7 of hospitalization, all patients reported absence of pain (score 5). On day 4 only, 4% of patients reported pain with intensity 7 (score 2). Profuse diaphoresis was found in 80% of the sample on day 1 of hospitalization, and that disappeared in the course of the remaining days. Nausea was found in 44% of the population with score 1 on day 1 of hospitalization, and disappeared subsequently. Most the patients (84%) did not present with vomiting. Also, no evidence was found of vital sign changes in most of the sample. ECG presented score 1 in 72% of the sample on day 1, greatly decreasing from day 2. Cardiac enzymes appeared in 100% of the sample, decreasing in subsequent days. Heart ejection fraction, pulmonary artery pressure, heart rate, and myocardial scanning indicators were not measured. CONCLUSIONS Indicators evaluated achieved score 5 (no compromise) on hospital discharge in 100% of patients, which evidences effectiveness of the interventions performed. [source] Effect of P6 acustimulation on post-operative nausea and vomiting in patients undergoing a laparoscopic cholecystectomyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 10 2009U. H. FREY Background Non-pharmacologic techniques such as electrical acustimulation may mitigate post-operative nausea and vomiting (PONV). The primary purpose of this study was to investigate the effectiveness of acustimulation on attenuating PONV. Moreover, we tested whether a pre- or a post-induction application of acustimulation results in differences in PONV reduction. Methods In this prospective, double-blind, randomized, controlled trial, we studied 200 patients undergoing a laparoscopic cholecystectomy during propofol (induction) fentanyl/isoflurane/atracurium (maintenance) anaesthesia. In the acustimulation group (n=101), subdivided into groups with pre-induction (n=57) and post-induction (n=44) acustimulation, an active ReliefBand® device was placed at the P6 acupoint. In the sham group (n=99), also subdivided into pre-induction (n=55) or post-induction (n=44) groups, an inactive device was applied instead. The ReliefBand® remained in place for 24 h after surgery. Nausea and vomiting/retching were recorded at 2, 6, and 24 h post-operatively. Results The incidence of early nausea (up to 2 h) was significantly lower in the acustimulation than in the sham group (29% vs. 42%; P=0.043). No significant effect could be detected for retching/vomiting. Moreover, acustimulation showed no effect on PONV after 6 and 24 h. Risk factor analysis (female gender, non-smoker, history of PONV/motion sickness, and post-operative morphine usage) revealed a relative reduction in risk of 40% for nausea (P=0.021) and 55% for retching/vomiting (P=0.048) in patients with three or four risk factors present. The timing of (pre- vs. post-induction) acustimulation had no significant effect on PONV reduction. Conclusion Acustimulation at the P6 acupoint reduces early nausea, but not vomiting, after laparoscopic cholecystectomy, irrespective of its pre- or post-induction application. [source] Effect of Teriparatide {rhPTH(1-34)} on BMD When Given to Postmenopausal Women Receiving Hormone Replacement TherapyJOURNAL OF BONE AND MINERAL RESEARCH, Issue 2 2006Louis G Ste-Marie Abstract The effects of teriparatide when given in combination with HRT were studied in postmenopausal women with low bone mass or osteoporosis. The data provide evidence that the adverse event profile for combination therapy with teriparatide + HRT together is consistent with that expected for each treatment alone and that the BMD response is greater than for HRT alone. Introduction: Teriparatide {rhPTH(1-34)}, given as a once-daily injection, activates new bone formation in patients with osteoporosis. Hormone replacement therapy (HRT) prevents osteoporosis by reducing bone resorption and formation. Combination therapy with these two compounds, in small clinical trials, increased BMD and reduced vertebral fracture burden. The purpose of this study was to determine whether teriparatide provided additional effect on BMD when given in combination with HRT. Materials and Methods: A randomized, double-blind, placebo-controlled study was conducted in postmenopausal women with either low bone mass or osteoporosis. Patients were randomized to placebo subcutaneous plus HRT (n = 125) or teriparatide 40 ,g/day (SC) plus HRT (TPTD40 + HRT; n = 122) for a median treatment exposure of 13.8 months. Approximately one-half of the patients in each group were pretreated with HRT for at least 12 months before randomization. Patients received 1000 mg calcium and 400,1200 IU of vitamin D daily as oral supplementation. BMD was measured by DXA. Results: Compared with HRT alone, TPTD40 + HRT produced significant (p < 0.001) increases in spine BMD (14% versus 3%), total hip (5.2% versus 1.6%), and femoral neck (5.2% versus 2%) at study endpoint. BMD, in whole body and ultradistal radius, was higher, and in the one-third distal radius was lower, in the combination therapy but not in the HRT group. Serum bone-specific alkaline phosphatase and urinary N-telopeptide/Cr were increased significantly (p < 0.01) in the women receiving TPTD40 + HRT compared with HRT. A similar profile of BMD and bone markers was evident in both randomized patients as well as in subgroups of patients not pretreated or pretreated with HRT. Patients tolerated both the treatments well. Nausea and leg cramps were more frequently reported in the TPTD40 + HRT group. Conclusions: Adding teriparatide, a bone formation agent, to HRT, an antiresorptive agent, provides additional increases in BMD beyond that provided by HRT alone. The adverse effects of teriparatide when added to HRT were similar to the adverse effects described for teriparatide administered alone. Whether teriparatide was initiated at the same time as HRT or after at least 1 year on HRT, the incremental increases over HRT alone were similar. [source] Outpatient versus inpatient laparoscopic cholecystectomy: a prospective randomized study of symptom occurrence, symptom distress and general state of health during the first post-operative weekJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 4 2008Cajsa Barthelsson Abstract Background, Few randomized clinical trials focus on patients' symptoms of the first post-operative week following outpatient (OPS) versus inpatient (IPS) laparoscopic cholecystectomy (LC). The objective was to compare these treatment modalities with regard to patients' perceptions of pain and other post-operative symptoms, amount of distress, level of anxiety and general state of health during the first post-operative week. Methods, One hundred patients were randomized. Seventy-three LC patients were valid for efficacy (OPS n = 34, IPS n = 39). Data were collected by means of questionnaires. Results, The main result was that no differences were seen between the groups regarding the occurrence of post-operative symptoms or symptom distress. Approximately 90% of the patients in both groups perceived pain, reduced mobility and tiredness on day 1. Nausea and loss of appetite were reported by half of the patients. Post-operative day 1, both groups reported much or very much distress related to pain and reduced mobility (approximately 40%) and nausea (approximately 20%). Although both groups reported less symptoms on day 7, one-third still experienced pain, but only one patient reported this to be distressing. Conclusion, Laparoscopic cholecystectomy patients in both groups recover equally well, indicating that a greater proportion of LC patients should be offered the outpatient modality. [source] Comparison of spinal anesthesia with general anesthesia on morphine requirement after abdominal hysterectomyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 5 2009L. MASSICOTTE Purpose: The aim of this study was to compare morphine consumption with patient-controlled analgesia (PCA) between spinal anesthesia (SA) (bupivacaine, morphine and fentanyl) and general anesthesia (GA) (sufentanil) after an abdominal hysterectomy. Methods: Forty women were randomly assigned to receive SA with bupivacaine 15 mg, 0.15 mg of intrathecal morphine and 15 ,g of fentanyl or GA with sufentanil, both combined with PCA. The primary outcome was morphine consumption with the PCA device. The secondary outcomes were post-operative pain at rest and under stress on a visual analog scale, nausea, pruritus and respiratory depression on a standardized scale. Outcome measures were recorded at 6, 12, 18, 24 and 48 h post-anesthesia. The duration of post-anesthesia care unit (PACU) and hospital stay were recorded. Results: Patients in the SA group consumed at least two times less morphine at each time interval than the GA group: at 48 h, they used 19 ± 17 vs. 81 ± 31 mg (P<0.0001). Post-operative pain at rest was lower in the SA group until the 18th hour and under stress until the 48th. There was more sedation in the GA group until the 18th hour. Little difference was observed in the incidence of pruritus. Nausea was more intense at the 6th hour in the GA group. There was no difference in the respiratory rate. The duration of PACU stay was shorter for the SA group (52 ± 9 vs. 73 ± 11 min, P<0.0001) as was the duration of hospital stay (2.2 ± 0.4 vs. 3.3 ± 0.7 days, P=0.01). Conclusions: It is concluded that intrathecal morphine 0.15 mg with 15 ,g of fentanyl decreases post-operative pain and morphine consumption by PCA without increasing adverse reactions for women undergoing an abdominal hysterectomy. [source] Morphological Substrate of the Catecholaminergic Input of the Vasopressin Neuronal System in HumansJOURNAL OF NEUROENDOCRINOLOGY, Issue 12 2006B. Dudás It has been postulated that the stress response is associated with water balance via regulating vasopressin release. Nausea, surgical stress and insulin-induced hypoglycaemia were shown to stimulate vasopressin secretion in humans. Increased vasopressin release in turn induces water resorption through the kidneys. Although the mechanism of the stress-mediated vasopressin release is not entirely understood, it is generally accepted that catecholamines play a crucial role in influencing water balance by modulating the secretion of vasopressin. However, the morphological substrate of this modulation has not yet been established. The present study utilised double-label immunohistochemistry to reveal putative juxtapositions between tyrosine hydroxylase (TH)-immunoreactive (IR) catecholaminergic system and the vasopressin systems in the human hypothalamus. In the paraventricular and supraoptic nuclei, numerous vasopressin-IR neurones received TH-IR axon varicosities. Analysis of these juxtapositions with high magnification combined with oil immersion did not reveal any gaps between the contacted elements. In conclusion, the intimate associations between the TH-IR and vasopressin-IR elements may be functional synapses and may represent the morphological basis of vasopressin release modulated by stressors. Because certain vasopressin-IR perikarya receive no detectable TH innervations, it is possible that additional mechanisms may participate in the stress-influenced vasopressin release. [source] Pregabalin and dexamethasone in combination with paracetamol for postoperative pain control after abdominal hysterectomy.ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 2 2009A randomized clinical trial Background: Multimodal analgesia may be important for optimal postoperative pain treatment and facilitation of early mobilization and recovery. We investigated the analgesic effect of pregabalin and dexamethasone in combination with paracetamol after abdominal hysterectomy. Methods: One hundred and sixteen patients were randomly assigned to either group A (paracetamol+placebo × 2), group B (paracetamol+pregabalin+placebo) or group C (paracetamol+pregabalin+dexamethasone). According to randomization and preoperatively, patients received paracetamol 1000 mg, pregabalin 300 mg, dexamethasone 8 mg or placebo. General anaesthesia was performed. Postoperative pain treatment was paracetamol 1000 mg × 4 and patient-controlled intravenous morphine, 2.5 mg bolus. Nausea was treated with ondansetron. Morphine consumption, pain score (visual analogue scale) at rest and during mobilization, nausea, sedation, dizziness, number of vomits and consumption of ondansetron were recorded 2, 4 and 24 h after the operation. P<0.05 was considered statistically significant. Results: The 24-h morphine consumption and pain score, both at rest and during mobilization, were not significantly different between treatment groups. The mean nausea score (P=0.002) was reduced in group C vs. A. The number of vomits was significantly reduced in both group B (P=0.041) and C (P=0.001) vs. A. Consumption of ondansetron was reduced in group C vs. A and B (P<0.001). Other side effects were not different between groups. Conclusion: Combinations of paracetamol and pregabalin, or paracetamol, pregabalin and dexamethasone did not reduce morphine consumption and pain score compared with paracetamol alone for patients undergoing abdominal hysterectomy. Dexamethasone reduced nausea, vomiting and use of ondansetron. [source] Intractable Nausea, Vomiting and Diarrhea in a Mexican Woman with No Recent Travel HistoryJOURNAL OF TRAVEL MEDICINE, Issue 1 2000Clare Dimaunahan No abstract is available for this article. [source] Clinical trial: sodium phosphate tablets are preferred and better tolerated by patients compared to polyethylene glycol solution plus bisacodyl tablets for bowel preparationALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2007G. R. LICHTENSTEIN Summary Background, Patient acceptance of bowel preparation can affect colon cancer screening compliance. Aim, To compare patient acceptance, preference and tolerability of 32-sodium phosphate tablets vs. 2L polyethylene glycol solution plus 4 bisacodyl tablets for bowel preparation. Methods, A prospective, randomized, investigator-blinded, multicentre trial was performed. Results were based on responses to a patient questionnaire. Results, 411 patients (205 sodium phosphate; 206 polyethylene glycol plus bisacodyl) completed the study preparation and patient questionnaire prior to colonoscopy. More patients receiving sodium phosphate vs. polyethylene glycol plus bisacodyl found it easy to take (77% vs. 42%), reported it to be without taste (47% vs. 6%), found it easy to take with respect to volume of liquid prescribed (72% vs. 27%) and indicated they would take the same preparation again in the future (96% vs. 74%, P < 0.0001 for all). Fewer patients receiving sodium phosphate vs. polyethylene glycol plus bisacodyl had to take time off work or change ordinary activities to take the study preparation (18% vs. 52%, P < 0.0001). Nausea, vomiting, bloating and abdominal pain were reported less frequently with sodium phosphate (P < 0.0013). Conclusion, The 32-tablet sodium phosphate dosing regimen was easier to take and better tolerated, when compared to 2L polyethylene glycol plus bisacodyl tablets for bowel preparation. [source] Pilot study of pentoxifylline in hepatopulmonary syndrome,LIVER TRANSPLANTATION, Issue 8 2008Rajasekhar Tanikella Hepatopulmonary syndrome (HPS) results when chronic liver disease or portal hypertension causes intrapulmonary microvascular dilatation with hypoxemia. In experimental HPS, tumor necrosis factor alpha (TNF-,) overproduction contributes to vasodilatation, which is improved by pentoxifylline, a TNF-, inhibitor. The effectiveness of pentoxifylline in humans is unknown. The aim of this open-label, single-arm clinical trial was to assess the efficacy and tolerability of pentoxifylline in patients with cirrhosis and advanced HPS undergoing liver transplantation evaluation. Nine adults with cirrhosis and moderate to severe HPS were enrolled. All patients had an initial 2-week titration to a target dose of pentoxifylline of 400 mg by mouth every 8 hours, which was continued for 6 weeks. Baseline and follow-up arterial blood gases and TNF-, levels were evaluated. Adverse effects and tolerability were assessed. The 9 patients had a mean age of 55 ± 10 years, and 67% were female. The most common causes of cirrhosis were hepatitis C virus and alcohol (55%). The mean Model for End-Stage Liver Disease score was 11 (range, 6-19), and patients had advanced hypoxemia [mean partial pressure of arterial oxygen (PaO2) = 54 ± 12 mm Hg, mean alveolar-arterial oxygen gradient (A-a PaO2) = 57 ± 15 mm Hg]. Of the 9 patients enrolled, follow-up blood gases were done in 7. There was no significant change in PaO2 (P = 0.3) or A-a PaO2 (P = 0.3) with treatment. Pentoxifylline was poorly tolerated. Nausea (100%) and vomiting (56%) were the predominant side effects, and only a single patient was able to complete full-dose therapy. Treatment with pentoxifylline did not improve arterial oxygenation in advanced HPS, and tolerance was limited by gastrointestinal toxicity. Liver Transpl 14:1199,1203, 2008. © 2008 AASLD. [source] Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease,MOVEMENT DISORDERS, Issue 6 2010Juliana Bronzova MD Abstract This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9,45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; ,7.3 points), as compared with placebo (,3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (,30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by ,10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD. © 2010 Movement Disorder Society [source] Use of the Visual Analog Scale to Rate and Monitor Severity of Nausea in the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 12 2009FACEM, M Clin Epi, Robert Meek MBBS Abstract Objectives:, The objective was to describe the association between verbal descriptors of nausea severity and visual analog scale (VAS) ratings in an undifferentiated emergency department (ED) population and to calculate the minimum clinically significant difference (MCSD) in VAS rating of nausea severity in this population. Methods:, A prospective observational study was conducted at three EDs on a convenience sample of stable, consenting adult patients presenting with nausea as part of their symptom complex. Data included demographics, adjectival description of nausea severity (none, mild, moderate, or severe), and VAS rating (standard 100-mm line) at enrollment, 30 minutes, and 60 minutes. At 30 and 60 minutes they were also asked to describe any change in nausea severity from the previous rating ("a lot less,""a little less,""the same,""a little more,""a lot more"). The MCSD was defined as the average VAS change when a patient reported "a little less" or "a little more" nausea. Results:, A total of 247 patients provided 693 matched adjectival ratings and VAS scores. Median age was 45 years, and 100 (40%) were male. The median VAS measures for none, mild, moderate, and severe nausea were 2, 23, 53, and 83 mm, respectively. VAS distributions in the verbal categories were statistically different from each other (Spearman rank correlation coefficient = 0.90; p < 0.0001). The MCSD was 22 mm (95% CI = 20 to 24 mm). Conclusions:, There is very good correlation between verbal descriptors of nausea and VAS ratings. The MCSD for VAS nausea ratings in an ED population is 22 mm. [source] Electrical stimulation of the vestibular system prevents postoperative nausea and vomitingACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 9 2000F. Pusch Background: Electrical stimulation of the vestibular system may prevent nausea and vomiting. We studied the influence of transcutaneous impulse stimulation in prevention of postoperative nausea and vomiting (PONV) following gynaecological surgery. Methods: In this randomised study 70 women undergoing elective gynaecological surgery under general anaesthesia were assigned to receive either the activated (stimulation group) or the inactivated (non-stimulation group) impulse stimulator. The stimulator comprises the stimulator itself, two negative electrodes on a headset applied over both mastoid processes and a nuchal positive electrode. The device yielded a pulse frequency of 5 Hz direct current, individually adjustable between 0.5 and 4 mA. A trapezoid stimulation of 50 ms was applied. Nausea, vomiting, dizziness and the amount of antiemetic drugs used were assessed during the first 4 h postoperatively. Results: Lower postoperative nausea scores with a lower incidence of vomiting and postoperative dizziness were found in the stimulation group. A lower amount of antiemetic drugs was needed in the stimulation group when compared to the non-stimulation group (P<0.01 between groups). Conclusion: This study suggests that electrical stimulation of the vestibular system may be useful in prevention of PONV. [source] Nausea and vomiting in pregnancy: maternal characteristics and risk factorsPAEDIATRIC & PERINATAL EPIDEMIOLOGY, Issue 4 2006Carol Louik Summary Nausea with or without vomiting (NVP) is probably the most frequently reported medical complaint of pregnancy, but few studies have considered risk factors for its development. We used data from an ongoing epidemiological study of pregnancies in four regional centres. Mothers of infants with congenital malformations (n = 17 158) and a sample of normal infants (n = 5329) were interviewed within 6 months of delivery by trained nurse-interviewers using a standardised questionnaire. For all risk factors investigated, odds ratios and 95% confidence intervals were calculated using multiple logistic regression, controlling for potential confounders. The cumulative incidence (risk) of NVP was 67%. The risk of NVP and its timing during pregnancy were similar for mothers of malformed and normal infants, so data were combined. No changes in the NVP risk were observed over the 20-year study period. The risk decreased with increasing age, but increased with increasing gravidity. The risk also increased with increasing number of prior miscarriages. Further, within each gravidity category, the risk was higher for twin births than for singletons. Women who reported onset of NVP after the first trimester differed demographically from women whose NVP began earlier: they were less-well educated, had lower incomes, and were more likely to be black. The finding that the number of prior pregnancies, both complete and incomplete, and number of fetuses independently appear to increase the risk of NVP suggests a fetal ,dose' effect. Together with selected demographic characteristics that differentiate early- vs. late-onset NVP, these findings warrant further investigation. [source] Ondansetron has similar clinical efficacy against both nausea and vomitingANAESTHESIA, Issue 2 2009R. M. Jokela Summary Ondansetron is widely believed to prevent postoperative vomiting more effectively than nausea. We analysed data from 5161 patients undergoing general anaesthesia who were randomly stratified to receive a combination of six interventions, one of which was 4 mg ondansetron vs placebo. For the purpose of this study a 20% difference in the relative risks for the two outcomes was considered clinically relevant. Nausea was reduced from 38% (969/2585) in the control to 28% (715/2576) in the ondansetron group, corresponding to a relative risk of 0.74, or a relative risk reduction of 26%. Vomiting was reduced from 17% (441/2585) to 11% (293/2576), corresponding to a relative risk of 0.67, or a relative risk reduction of 33%. The relative risks of 0.67 and 0.74 were clinically similar and the difference between them did not reach statistical significance. We thus conclude that ondansetron prevents postoperative nausea and postoperative vomiting equally well. [source] A study of airway management using the ProSeal LMA® laryngeal mask airway compared with the tracheal tube on postoperative analgesia requirements following gynaecological laparoscopic surgeryANAESTHESIA, Issue 9 2007M. Hohlrieder Summary In a randomised double blind prospective study, we tested the hypothesis that postoperative pain is lower in patients who receive an ProSeal LMAÔ laryngeal mask airway compared with a tracheal tube. One hundred consecutive female patients (ASA I,II, 18,75 years) undergoing laparoscopic gynaecological surgery were divided into two equal-sized groups for airway management with the ProSeal LMA or tracheal tube. Anaesthesia management was identical for both groups and included induction of anaesthesia using propofol/fentanyl, and maintenance with propofol/remifentanil, muscle relaxation with rocuronium, positive pressure ventilation, gastric tube insertion, dexamethasone/tropisetron for anti-emetic prophylaxis, and diclofenac for pain prophylaxis. All types of postoperative pain were treated using intravenous patient-controlled analgesia (PCA) morphine. Patients and postoperative staff were unaware of the airway device used. Data were collected by a single blinded observer. We found that pain scores were lower for the ProSeal LMA at 2 h and 6 h but not at 24 h. Morphine requirements were lower for the ProSeal LMA by 30.4%, 30.6% and 23.3% at 2, 6 and 24 h, respectively. Nausea was less common with the ProSeal LMA than with the tracheal tube at 2 h and 6 h but not at 24 h. There were no differences in the frequency of vomiting, sore throat, dysphonia or dysphagia. We conclude that postoperative pain is lower for the ProSeal LMA than the tracheal tube in females undergoing gynaecological laparoscopic surgery. [source] Evaluation of the safety, pharmacokinetics and treatment effects of an ,,,3 integrin inhibitor on bone turnover and disease activity in men with hormone-refractory prostate cancer and bone metastasesASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 1 2010Mark A ROSENTHAL Abstract Aim: This study aimed to evaluate the safety, pharmacokinetics and treatment effects of an ,,,3 integrin inhibitor on bone turnover and disease activity in men with hormone-refractory prostate cancer (HRPC) and bone metastases. Methods: A total of 21 patients with bone metastases and HRPC were randomized to receive MK-0429 200 mg b.i.d. or 1600 mg b.i.d. for 4 weeks. Toxicity, pharmacokinetics and markers of bone turnover and tumor activity were examined. Results: Nausea was the most common adverse event: one (200-mg group) and 11 (1600-mg group) patients. At 4 weeks, mean AUC0,12 h was 210 mmol*h (200-mg group) and 673 mmol*h (1600-mg group); mean Cmax values were 42 mmol/L (200-mg group) and 154 mmol/L (1600-mg group). Urinary cross-linked N-telopeptides of type I collagen to creatinine ratio (uNTx), a bone turnover biomarker, showed a change from baseline of ,43.4 percent (200-mg group) and ,34.1 percent (1600-mg group). There was an increase in serum prostate specific antigen (PSA), a marker for disease activity, of 54.1 percent (200-mg group) and 44.5 percent (1600-mg group). Conclusion: MK-0429 was generally well tolerated, with the most common side-effect being nausea. There was some evidence of an early reduction of bone turnover, indicating a potential for clinical use in the treatment of MBD although serum PSA was unexpectedly increased during the study. [source] Oxytocin,ergometrine co-administration does not reduce blood loss at caesarean delivery for labour arrest,BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 5 2008M Balki Objective, To determine if intravenous infusion of a combination of oxytocin and ergometrine maleate is better than oxytocin alone to decrease blood loss at caesarean delivery for labour arrest. Design, Prospective, double-blinded, randomised controlled trial. Setting, Mount Sinai Hospital, Toronto, Canada. Population, Women undergoing caesarean deliveries for labour arrest. Methods, Forty-eight women were randomised to receive infusion of either ergometrine maleate 0.25 mg + oxytocin 20 iu or oxytocin 20 iu alone, diluted in 1 l of lactated Ringer's Solution, immediately after delivery of the infant. Unsatisfactory uterine contractions after delivery were treated with additional boluses of the study solution or rescue carboprost. Blood loss was estimated based on the haematocrit values before and 48 hours after delivery. Main outcome measures, The primary outcome was the estimated blood loss, while the secondary outcomes included the use of additional uterotonics, need for blood transfusion and the incidence of adverse effects. Results, The estimated blood loss was similar in the oxytocin,ergometrine and oxytocin-only groups; 1218 ± 716 ml and 1299 ± 774 ml, respectively (P= 0.72). Significantly fewer women required additional boluses of the study drug in the oxytocin,ergometrine group (21 and 57%; P= 0.01). Nausea (42 and 9%; P= 0.01) and vomiting (25 and 4%; P= 0.05) were significantly more prevalent in the oxytocin,ergometrine group. Conclusions, In women undergoing caesarean delivery for labour arrest, the co-administration of ergometrine with oxytocin does not reduce intraoperative blood loss, despite apparently superior uterine contraction. [source] Comparison of outcomes for elderly patients treated with weekly paclitaxel in combination with carboplatin versus the standard 3-weekly paclitaxel and carboplatin for advanced nonsmall cell lung cancer,CANCER, Issue 3 2008Suresh Ramalingam MD Abstract BACKGROUND. The purpose of this study was to compare the outcomes between elderly (aged ,70 years) patients treated with paclitaxel on a weekly basis and with carboplatin (every 4 weeks) versus the standard 3-weekly regimen of carboplatin and paclitaxel for first-line therapy of advanced nonsmall cell lung cancer. METHODS. Of the 444 patients enrolled, 136 (31%) were aged ,70 years. Seventy-two patients were randomized to the weekly schedule (paclitaxel, 100 mg/m2 weekly for 3 of 4 weeks; carboplatin, area under the curve [AUC] = 6 mg/mL·min on Day 1 every 4 weeks), and 64 patients were randomized to the standard schedule (paclitaxel, 225 mg/m2; carboplatin, AUC = 6 mg/mL·min on Day 1 every 21 days). Patients with stable disease or objective response after 4 cycles of therapy were eligible for maintenance therapy with weekly paclitaxel (70 mg/m2, 3 of 4 weeks). RESULTS. The response rate for elderly patients was 26% on the weekly regimen and 19% on the standard schedule. The median survival duration for the weekly and the standard schedules was 37 weeks and 31 weeks, respectively. The 1-year survival rates were similar at 31% and 33%. Grade 3 to 4 anemia was more common on the weekly schedule (16% vs 6%), whereas grade 3 neuropathy was less common (5.5% vs 9.5%). Nausea and emesis were also less frequent on the weekly schedule. CONCLUSIONS. Efficacy was similar between the weekly regimen and the standard regimen of carboplatin and paclitaxel for elderly patients with advanced NSCLC and may be advantageous based on its favorable tolerability profile. Cancer 2008. © 2008 American Cancer Society. [source] Ondansetron versus Promethazine to Treat Acute Undifferentiated Nausea in the Emergency Department: A Randomized, Double-blind, Noninferiority TrialACADEMIC EMERGENCY MEDICINE, Issue 3 2008Darren Braude MD Abstract Objectives:, The authors sought to compare ondansetron and promethazine among emergency department (ED) patients with undifferentiated nausea. The hypothesis was that ondansetron was not inferior to promethazine and that rates of adverse effects were similar. Methods:, This was a randomized double-blind noninferiority clinical trial conducted in an urban academic ED. A convenience sample of nonpregnant adults with at least 40 mm of self-reported nausea measured on a 100-mm visual analog scale (VAS) were enrolled. Patients who had already received more than 1 L of intravenous fluid or an antiemetic agent were excluded. Subjects were block-randomized in groups of 10 to either 4 mg of ondansetron or 25 mg of promethazine delivered intravenously. The primary outcome was change in nausea over 30 minutes. The authors used a 15-mm margin of noninferiority. Secondary endpoints included changes in anxiety, sedation, and other adverse effects. Analyses included t-tests, tests for proportions, and 95% confidence intervals (CIs). Results:, A total of 120 subjects completed the study, 60 in each arm. Baseline nausea, anxiety, and sedation scores were similar. Ondansetron and promethazine reduced nausea similarly (ondansetron ,34 mm, promethazine ,36 mm; difference ,2 mm; 95% CI = ,13 to 8 mm). The reduction in anxiety was similar (ondansetron ,13 mm, promethazine ,14 mm; difference ,1 mm; 95% CI = ,10 to 10 mm). Promethazine was associated with significantly more sedation than ondansetron (ondansetron 5 mm, promethazine 19 mm; difference 14 mm; 95% CI = 5 to 24 mm). There were no cases of akathisia in the ondansetron group and 2 cases in the promethazine group. Conclusions:, Promethazine and ondansetron have similar efficacy in reducing nausea among ED patients. Change in anxiety was similar, but promethazine was associated with greater sedation. [source] Measuring Nausea in Emergency Department Patients via the Use of Exploratory Factor AnalysisACADEMIC EMERGENCY MEDICINE, Issue 6 2010Robert L. Cloutier MD Abstract Objectives:, The objective was to evaluate the applicability of a previously studied multifactorial nausea scale in the emergency department (ED) setting via exploratory factor analysis (EFA). Methods:, Two studies evaluated the validity and factor structure of 18 nausea descriptors scored on 11-point Likert scales. Trained research volunteers administered the scale to 83 men and 123 women in the first sample and to 100 men and 230 women in the second sample. All patients were assessed at enrollment and again at 90 minutes to detect changes in symptom severity. An EFA in the first study used a maximum likelihood estimation method with a principal factor analysis. The second study narrowed the descriptors and evaluated the factor structure with a confirmatory factor analysis (CFA). Results:, Two factors were retained in the solution; one contained five items with descriptors of physical symptoms, and a second contained five items with psychological symptoms. CFA determined that the two five-item scales were stable and reliable measures of patient nausea experience. Conclusions:, The scales measure both physical and psychological symptoms of nausea, indicating that the experience is multidimensional. ACADEMIC EMERGENCY MEDICINE 2010; 17:e33,e39 © 2010 by the Society for Academic Emergency Medicine [source] P43 Acute urticaria to infliximabCONTACT DERMATITIS, Issue 3 2004Ana Giménez-Arnau Infliximab is a chimeric antitumor necrosis factor-alpha monoclonal antibody used to treat Crohn's disease and rheumatoid arthritis. Acute infusion reactions, headache, fever, chills, urticaria and chest pain were seen in 17% of patients with infliximab compared with 7% of those receiving placebo. Other adverse cutaneous reactions are fungal dermatitis, eczema, seborrhoea, hordeolum, bullous eruption, furunculosis, periorbital oedema, hyperkeratosis, rosacea, verruca, skin pigmentation, alopecia, leukocytoclastic vasculitis, lichenoid drug eruption, erythema multiforme, perniosis-like eruption, granuloma annulare and acute folliculitis. Any pathogenic mechanism has been suggested. Patch test with infliximab can induce flare-up of lesions, nausea and malaise and suggest a percutaneous absortion. A sixty years-old man with atopy background and rheumatoid arthritis treated with Remicare®, infliximab who developed a severe acute urticaria with angioedema is presented. The lesions appearance after previous endovenous administrations and the worsening spreading wheals days after the injection clinically suggested an hypersensitivity mechanism. The protocolized study drug hypersensitivity performed showed only the Prick Test positivity with infliximab at 30/60 minutes. Patch test with infliximab was negative and any adverse event was reported. Actually the patient is treated with etanercept and this drug is well tolerated. This result suggested a type I hypersensitivity mediated reaction. Urticaria could be induced as immunologic reaction of the host against the murine part of infliximab, just as it hapens with other antichimeric antibodies. [source] Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder and comorbid social anxiety disorderDEPRESSION AND ANXIETY, Issue 3 2009Lenard A. Adler M.D. Abstract Background: To evaluate the effect of atomoxetine (ATX) on attention-deficit/hyperactivity disorder (ADHD) and comorbid social anxiety disorder in adults. Methods: Randomized, double-blind, placebo-controlled, conducted in adults with ADHD and social anxiety disorder. Patients received 40,100,mg ATX (n=224) or placebo (n=218) for 14 weeks following a 2-week placebo lead-in period. Efficacy measures included the Conners' Adult ADHD Rating Scale: Investigator-Rated: Screening Version (CAARS:Inv:SV), Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression-Overall-Severity (CGI-O-S), State-Trait Anxiety Inventory (STAI), Social Adjustment Scale-Self Report (SAS), and Adult ADHD Quality of Life Scale-29 (AAQoL). Safety and tolerability were also assessed. Results: ATX mean change (,8.7±10.0) from baseline (29.6±10.4) on CAARS:Inv:SV Total ADHD Symptoms score was significantly greater than placebo mean change (,5.6±10.2) from baseline (31.2±9.4; P<.001). ATX mean change (,22.9±25.3) from baseline (85.3±23.6) on LSAS Total score was significant compared to placebo mean change (,14.4±20.3) from baseline (82.1±21.3; P<.001). The visit-wise analysis revealed greater improvement on the CAARS:Inv:SV Total ADHD Symptoms score and LSAS Total score for ATX at every time point throughout the study (P values ,.012). Mean changes in CGI-O-S, STAI-Trait Anxiety scores, and AAQoL Total score were significantly greater for ATX compared to placebo. Mean change for both groups on STAI-State Anxiety scores was comparable. Improvement on SAS for ATX compared to placebo was not significant. Rates of insomnia, nausea, dry mouth, and dizziness were higher with ATX than with placebo. Discontinuation rates due to treatment-emergent adverse events were similar between groups. Conclusions: ATX monotherapy effectively improved symptoms of ADHD and comorbid social anxiety disorder in adults and was well tolerated. Depression and Anxiety, 2009. Published 2009 Wiley-Liss, Inc. [source] Efficacy and safety of duloxetine in the treatment of generalized anxiety disorder: a flexible-dose, progressive-titration, placebo-controlled trialDEPRESSION AND ANXIETY, Issue 3 2008Moira Rynn M.D. Abstract Generalized anxiety disorder (GAD), a prevalent and chronic illness, is associated with dysregulation in both serotonergic and noradrenergic neurotransmission. Our study examined the efficacy, safety, and tolerability of duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and norepinephrine, for short-term treatment of adults with GAD. In a 10-week, double-blind, progressive-titration, flexible-dose trial, 327 adult outpatients with a DSM-IV,defined GAD diagnosis were randomized to duloxetine 60,120,mg (DLX, N=168) or placebo (PLA, N=159) treatment. The primary efficacy measure was mean change from baseline to endpoint in Hamilton Anxiety Scale (HAMA) total score. Secondary outcome measures included response rate (HAMA total score reduction ,50% from baseline), Clinician Global Impression,Improvement (CGI-I) scores, and Sheehan Disability Scale (SDS) scores. Patients who received duloxetine treatment demonstrated significantly greater improvement in HAMA total scores (P=.02); a higher response rate (P=.03), and greater improvement (P=.04) than patients who received placebo. Duloxetine-treated patients were also significantly more improved than placebo-treated patients on SDS global functional (P<.01) and work, social, and family/home impairment scores (P<.05). The rate of discontinuation due to adverse events (AEs) was higher for the duloxetine group compared with the placebo group (P=.002). The AEs most frequently associated with duloxetine were nausea, dizziness, and somnolence. Duloxetine was an efficacious, safe, and well-tolerated treatment that resulted in clinically significant improvements in symptom severity and functioning for patients with GAD. Depression and Anxiety 0:1,8, 2007. © 2007 Wiley-Liss, Inc. [source] Exenatide: a review from pharmacology to clinical practiceDIABETES OBESITY & METABOLISM, Issue 6 2009R. Gentilella Background:, Exenatide is an incretin mimetic that activates glucagon-like-peptide-1 receptors. It blunts the postprandial rise of plasma glucose by increasing glucose-dependent insulin secretion, suppressing inappropriately high glucagon secretion and delaying gastric emptying. Methods:, In seven clinical trials performed in 2845 adult patients with type 2 diabetes mellitus who were inadequately controlled by a sulphonylurea and/or metformin (glycosylated haemoglobin, HbA1c ,11%), or by thiazolidinediones (with or without metformin) and treated for periods from 16 weeks to 3 years, exenatide (5 ,g b.i.d. s.c. for the first 4 weeks of treatment and 10 ,g b.i.d. s.c. thereafter) reduced HbA1c, fasting and postprandial glucose, and body weight dose dependently, and was similar to insulin glargine and biphasic insulin aspart in reducing HbA1c. Body weight diminished with exenatide, whereas it increased with both insulin preparations. Positive effects on the lipid profile and a reduction in C-reactive protein were also recorded with exenatide. Treatment extensions up to 3 years showed that benefits were maintained in the long term. Adverse events were usually mild to moderate in intensity, and generally the frequency decreased with continued therapy. The most common was nausea (whose incidence may be reduced by gradual dose escalation from 5 ,g b.i.d. to 10 ,g b.i.d.), vomiting, diarrhoea, headache and hypoglycaemia (almost exclusively in patients treated with a sulphonylurea). Results and conclusions:, Exenatide is a new, promising therapeutic option for type 2 diabetic patients inadequately controlled by oral agents, before insulin therapy, offering the added benefits of body weight reduction and tight postprandial glucose control. [source] Prophylactic use of anti-emetic medications reduced nausea and vomiting associated with exenatide treatment: a retrospective analysis of an open-label, parallel-group, single-dose study in healthy subjectsDIABETIC MEDICINE, Issue 10 2010C. Ellero Diabet. Med. 27, 1168,1173 (2010) Abstract Aims, Transient nausea and, to a lesser extent, vomiting are common adverse effects of exenatide that can be mitigated by dose titration and usually do not result in treatment discontinuation. This retrospective analysis of data from a phase 1, open-label, parallel-group, single-dose study in healthy subjects evaluated the effect of oral anti-emetics on exenatide-associated nausea and vomiting and on the pharmacokinetics of exenatide. Methods, A single subcutaneous dose (10 ,g) of exenatide was administered to 120 healthy subjects (19,65 years, BMI 23,35 kg/m2). Incidences of nausea and vomiting were compared between 60 subjects premedicated with two oral anti-emetics 30 min before the exenatide dose and 60 non-premedicated subjects. Similarly, the area under the concentration-time curve (AUC) and the maximum observed concentration (Cmax) of plasma exenatide concentrations over 8 h post-dose were compared. Results, Among all subjects [61% male, 32 ± 12 years, body mass index (BMI) 29.1 ± 3.4 kg/m2 (mean ± sd)], mild to moderate nausea was the most frequent adverse event after exenatide dosing. Vomiting was also observed. Subjects premedicated with anti-emetics experienced significantly less nausea and vomiting (16.7 and 6.7%, respectively) vs. non-premedicated subjects (61.7 and 38.3%, respectively; P -value < 0.0001 for both nausea and vomiting). The mean area under the concentration-time curve and the maximum observed concentration AUC and Cmax of plasma exenatide concentrations during 8 h post-dose were not significantly different between groups. Conclusion, Administration of oral anti-emetics before a single 10-,g exenatide dose was associated with significant reductions in treatment-emergent nausea and vomiting, with no discernible effect on the pharmacokinetics of exenatide. Use of anti-emetic therapy may provide a short-term strategy to minimize the nausea and vomiting associated with exenatide treatment. [source] Original Article: Treatment: Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with Type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled trialDIABETIC MEDICINE, Issue 9 2010R. E. Ratner Diabet. Med. 27, 1024,1032 (2010) Abstract Aims, To evaluate the dose,response relationship of lixisenatide (AVE0010), a glucagon-like peptide-1 (GLP-1) receptor agonist, in metformin-treated patients with Type 2 diabetes. Methods, Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA1c) , 7.0 and < 9.0% (, 53 and < 75 mmol/mol)] on metformin (, 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 ,g once daily or twice daily or placebo. The primary end-point was change in HbA1c from baseline to 13 weeks in the intent-to-treat population. Results, Lixisenatide significantly improved mean HbA1c from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 ,g doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo). Target HbA1c < 7.0% (53 mmol/mol) at study end was achieved in 68% of patients receiving 20 and 30 ,g once-daily lixisenatide vs. 32% receiving placebo (P < 0.0001). Dose-dependent improvements were observed for fasting, postprandial and average self-monitored seven-point blood glucose levels. Weight changes ranged from ,2.0 to ,3.9 kg with lixisenatide vs. ,1.9 kg with placebo. The most frequent adverse event was mild-to-moderate nausea. Conclusions, Lixisenatide significantly improved glycaemic control in mildly hyperglycaemic patients with Type 2 diabetes on metformin. Dose,response relationships were seen for once- and twice-daily regimens, with similar efficacy levels, with a 20 ,g once-daily dose of lixisenatide demonstrating the best efficacy-to-tolerability ratio. This new, once-daily GLP-1 receptor agonist shows promise in the management of Type 2 diabetes to be defined further by ongoing long-term studies. [source] | ||||||||||||||||||||||||||||||||||||||||||||||