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Sample records for acute decompensation randomized

  1. Acute Decompensated Heart Failure: Contemporary Medical Management

    Joseph, Susan M.; Cedars, Ari M.; Ewald, Gregory A.; Geltman, Edward M.; Mann, Douglas L.

    2009-01-01

    Hospitalizations for acute decompensated heart failure are increasing in the United States. Moreover, the prevalence of heart failure is increasing consequent to an increased number of older individuals, as well as to improvement in therapies for coronary artery disease and sudden cardiac death that have enabled patients to live longer with cardiovascular disease. The main treatment goals in the hospitalized patient with heart failure are to restore euvolemia and to minimize adverse events. C...

  2. Efficacy and Safety of 1-Hour Infusion of Recombinant Human Atrial Natriuretic Peptide in Patients With Acute Decompensated Heart Failure: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

    Wang, Guogan; Wang, Pengbo; Li, Yishi; Liu, Wenxian; Bai, Shugong; Zhen, Yang; Li, Dongye; Yang, Ping; Chen, Yu; Hong, Lang; Sun, Jianhui; Chen, Junzhu; Wang, Xian; Zhu, Jihong; Hu, Dayi; Li, Huimin; Wu, Tongguo; Huang, Jie; Tan, Huiqiong; Zhang, Jian; Liao, Zhongkai; Yu, Litian; Mao, Yi; Ye, Shaodong; Feng, Lei; Hua, Yihong; Ni, Xinhai; Zhang, Yuhui; Wang, Yang; Li, Wei; Luan, Xiaojun; Sun, Xiaolu; Wang, Sijia

    2016-03-01

    The aim of the study was to evaluate the efficacy and safety of 1-h infusion of recombinant human atrial natriuretic peptide (rhANP) in combination with standard therapy in patients with acute decompensated heart failure (ADHF).This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients with ADHF were randomized to receive a 1-h infusion of either rhANP or placebo at a ratio of 3:1 in combination with standard therapy. The primary endpoint was dyspnea improvement (a decrease of at least 2 grades of dyspnea severity at 12 h from baseline). Reduction in pulmonary capillary wedge pressure (PCWP) 1 h after infusion was the co-primary endpoint for catheterized patients. Overall, 477 patients were randomized: 358 (93 catheterized) patients received rhANP and 118 (28 catheterized) received placebo. The percentage of patients with dyspnea improvement at 12 h was higher, although not statistically significant, in the rhANP group than in the placebo group (32.0% vs 25.4%, odds ratio=1.382, 95% confidence interval [CI]: 0.863-2.212, P = 0.17). Reduction in PCWP at 1 h was significantly greater in patients treated with rhANP than in patients treated with placebo (-7.74 ± 5.95 vs -1.82 ± 4.47 mm Hg, P  0.99).1-h rhANP infusion appears to result in prompt, transient hemodynamic improvement with a small, nonsignificant, effect on dyspnea in ADHF patients receiving standard therapy. The safety of 1-h infusion of rhANP seems to be acceptable. (WHO International Clinical Trials Registry Platform [ICTRP] number, ChiCTR-IPR-14005719.). PMID:26945407

  3. Serum levels of soluble Fas, nitric oxide and cytokines in acute decompensated cirrhotic patients

    Christoph Elsing; Sabine Harenberg; Wolfgang Stremmel; Thomas Herrmann

    2007-01-01

    AIM: To evaluate plasma levels of nitrite/nitrate (NOx),soluble Fas (sFas) antigen, tumor necrosis factor alpha(TNF-α) and interleukin-6 (TL-6) in patients with compensated and acute decompensated cirrhosis and to evaluate mediators causing acute decompensation in liver cirrhosis.METHODS: This prospective study was conducted in the medical intensive care unit of an academic tertiary center. Fifty-five patients with acute decompensation (gastrointestinal hemorrhage, encephalopathy, hydropic decompensation) and twenty-five patients with compensated liver cirrhosis were included. Blood samples were taken for analyses of sfas, Nox, TL-6, TNF-α. Liver enzymes and kidney functions were also tested.RESULTS: In patients with acute decompensation, plasma sfas levels were higher than in non-decompensated patients (15305±4646 vs 12458 ± 4322 pg/mL, P <0.05). This was also true for the subgroup of patients with alcoholic liver cirrhosis (P < 0.05). The other mediators were not different and none of the parameters predicted survival, except for ALT (alanine-aminotransferase). In patients with portal-hypertension-induced acute hemorrhage, NOx levels were significantly lower than in patients with other forms of decompensation (70.8 ±48.3 vs 112.9 ± 74.9 pg/mL, P < 0.05). When NOx levels were normalized to creatinine levels, the difference disappeared. IL-6, TNF-α and sfas were not different between bleeders and non-bleeders. In decompensated patients sfas, IL-6 and NOx levels correlated positively with creatinine levels, while IL-6 levels were dependent on Child class.CONCLUSION: In acute decompensated cirrhotic patients sFas is increased, suggesting a role of apoptosis in this process and patients with acute bleeding have lower NOx levels. However, in this acute complex clinical situation, kidney function seems to have a predominant influence on mediator levels.

  4. Troponin I in acute decompensated heart failure : insights from the ASCEND-HF study

    Felker, G. Michael; Hasselblad, Vic; Tang, W. H. Wilson; Hernandez, Adrian F.; Armstrong, Paul W.; Fonarow, Gregg C.; Voors, Adriaan A.; Metra, Marco; McMurray, John J. V.; Butler, Javed; Heizer, Gretchen M.; Dickstein, Kenneth; Massie, Barry M.; Atar, Dan; Troughton, Richard W.; Anker, Stefan D.; Califf, Robert M.; Starling, Randall C.; O'Connor, Christopher M.

    2012-01-01

    We examined the prognostic importance of cardiac troponin I (cTnI) in a cohort of patients enrolled in the ASCEND-HF study of nesiritide in acute decompensated heart failure (ADHF). Circulating troponins are a prognostic marker in patients with ADHF. Contemporary assays with greater sensitivity requ

  5. Outcomes of patients hospitalized for acute decompensated heart failure: does nesiritide make a difference?

    Hauck Loran D

    2007-11-01

    Full Text Available Abstract Background Nesiritide is indicated in the treatment of acute decompensated heart failure. However, a recent meta-analysis reported that nesiritide may be associated with an increased risk of death. Our goal was to evaluate the impact of nesiritide treatment on four outcomes among adults hospitalized for congestive heart failure (CHF during a three-year period. Methods CHF patients discharged between 1/1/2002 and 12/31/2004 from the Adventist Health System, a national, not-for-profit hospital system, were identified. 25,330 records were included in this retrospective study. Nesiritide odds ratios (OR were adjusted for various factors including nine medications and/or an APR-DRG severity score. Results Initially, treatment with nesiritide was found to be associated with a 59% higher odds of hospital mortality (Unadjusted OR = 1.59, 95% confidence interval [CI]: 1.31–1.93. Adjusting for race, low economic status, APR-DRG severity of illness score, and the receipt of nine medications yielded a nonsignificant nesiritide OR of 1.07 for hospital death (95% CI: 0.85–1.35. Nesiritide was positively associated with the odds of prolonged length of stay (all adjusted ORs = 1.66 and elevated pharmacy cost (all adjusted ORs > 5. Conclusion In this observational study, nesiritide therapy was associated with increased length of stay and pharmacy cost, but not hospital mortality. Randomized trials are urgently needed to better define the efficacy, if any, of nesiritide in the treatment of decompensated heart failure.

  6. Acute metabolic decompensation due to influenza in a mouse model of ornithine transcarbamylase deficiency

    Peter J. McGuire

    2014-02-01

    Full Text Available The urea cycle functions to incorporate ammonia, generated by normal metabolism, into urea. Urea cycle disorders (UCDs are caused by loss of function in any of the enzymes responsible for ureagenesis, and are characterized by life-threatening episodes of acute metabolic decompensation with hyperammonemia (HA. A prospective analysis of interim HA events in a cohort of individuals with ornithine transcarbamylase (OTC deficiency, the most common UCD, revealed that intercurrent infection was the most common precipitant of acute HA and was associated with markers of increased morbidity when compared with other precipitants. To further understand these clinical observations, we developed a model system of metabolic decompensation with HA triggered by viral infection (PR8 influenza using spf-ash mice, a model of OTC deficiency. Both wild-type (WT and spf-ash mice displayed similar cytokine profiles and lung viral titers in response to PR8 influenza infection. During infection, spf-ash mice displayed an increase in liver transaminases, suggesting a hepatic sensitivity to the inflammatory response and an altered hepatic immune response. Despite having no visible pathological changes by histology, WT and spf-ash mice had reduced CPS1 and OTC enzyme activities, and, unlike WT, spf-ash mice failed to increase ureagenesis. Depression of urea cycle function was seen in liver amino acid analysis, with reductions seen in aspartate, ornithine and arginine during infection. In conclusion, we developed a model system of acute metabolic decompensation due to infection in a mouse model of a UCD. In addition, we have identified metabolic perturbations during infection in the spf-ash mice, including a reduction of urea cycle intermediates. This model of acute metabolic decompensation with HA due to infection in UCD serves as a platform for exploring biochemical perturbations and the efficacy of treatments, and could be adapted to explore acute decompensation in other

  7. MR diffusion imaging and MR spectroscopy of maple syrup urine disease during acute metabolic decompensation

    Jan, Wajanat; Wang, Zhiyue J. [Department of Radiology, University of Pennsylvania School of Medicine, Children' s Hospital of Philadelphia, Pennsylvania (United States); Zimmerman, Robert A. [Department of Radiology, University of Pennsylvania School of Medicine, Children' s Hospital of Philadelphia, Pennsylvania (United States); Department of Radiology, Children' s Hospital of Philadelphia, 34th Street and Civic Center Boulevard, PA 19104, Philadelphia (United States); Berry, Gerard T.; Kaplan, Paige B.; Kaye, Edward M. [Department of Pediatrics, University of Pennsylvania School of Medicine, The Children' s Hospital of Philadelphia, Philadelphia, Pennsylvania (United States)

    2003-06-01

    Maple syrup urine disease (MSUD) is an inborn error of amino acid metabolism, which affects the brain tissue resulting in impairment or death if untreated. Imaging studies have shown reversible brain edema during acute metabolic decompensation. The purpose of this paper is to describe the diffusion-weighted imaging (DWI) and spectroscopy findings during metabolic decompensation and to assess the value of these findings in the prediction of patient outcome. Six patients with the diagnosis of MSUD underwent conventional MR imaging with DWI during acute presentation with metabolic decompensation. Spectroscopy with long TE was performed in four of the six patients. Follow-up examinations were performed after clinical and metabolic recovery. DWI demonstrated marked restriction of proton diffusion compatible with cytotoxic or intramyelinic sheath edema in the brainstem, basal ganglia, thalami, cerebellar and periventricular white matter and the cerebral cortex. This was accompanied by the presence of an abnormal branched-chain amino acids (BCAA) and branched-chain alpha-keto acids (BCKA) peak at 0.9 ppm as well as elevated lactate on proton spectroscopy in all four patients. The changes in all six patients were reversed with treatment without evidence of volume loss or persistent tissue damage. The presence of cytotoxic or intramyelinic edema as evidenced by restricted water diffusion on DWI, with the presence of lactate on spectroscopy, could imply imminent cell death. However, in the context of metabolic decompensation in MSUD, it appears that changes in cell osmolarity and metabolism can reverse completely after metabolic correction. (orig.)

  8. MR diffusion imaging and MR spectroscopy of maple syrup urine disease during acute metabolic decompensation

    Maple syrup urine disease (MSUD) is an inborn error of amino acid metabolism, which affects the brain tissue resulting in impairment or death if untreated. Imaging studies have shown reversible brain edema during acute metabolic decompensation. The purpose of this paper is to describe the diffusion-weighted imaging (DWI) and spectroscopy findings during metabolic decompensation and to assess the value of these findings in the prediction of patient outcome. Six patients with the diagnosis of MSUD underwent conventional MR imaging with DWI during acute presentation with metabolic decompensation. Spectroscopy with long TE was performed in four of the six patients. Follow-up examinations were performed after clinical and metabolic recovery. DWI demonstrated marked restriction of proton diffusion compatible with cytotoxic or intramyelinic sheath edema in the brainstem, basal ganglia, thalami, cerebellar and periventricular white matter and the cerebral cortex. This was accompanied by the presence of an abnormal branched-chain amino acids (BCAA) and branched-chain alpha-keto acids (BCKA) peak at 0.9 ppm as well as elevated lactate on proton spectroscopy in all four patients. The changes in all six patients were reversed with treatment without evidence of volume loss or persistent tissue damage. The presence of cytotoxic or intramyelinic edema as evidenced by restricted water diffusion on DWI, with the presence of lactate on spectroscopy, could imply imminent cell death. However, in the context of metabolic decompensation in MSUD, it appears that changes in cell osmolarity and metabolism can reverse completely after metabolic correction. (orig.)

  9. Mechanisms of Disease: detrimental adrenergic signaling in acute decompensated heart failure

    Feldman, David S.; Elton, Terry S; Sun, Benjamin; Martin, Mickey M.; Ziolo, Mark T

    2008-01-01

    Acute decompensated heart failure (ADHF) is responsible for more than 1 million hospital admissions each year in the US. Clinicians and scientists have developed therapeutic strategies that reduce mortality in patients with chronic heart failure (HF). Despite the widely appreciated magnitude of the ADHF problem, there is still a critical gap in our understanding of the cellular mechanisms involved and effective treatment strategies for hospitalized patients. Irrespective of the etiology, pati...

  10. Haemodialysis is an effective treatment in acute metabolic decompensation of maple syrup urine disease

    P.S. Atwal

    2015-09-01

    Full Text Available Acute metabolic decompensation in maple syrup urine disease can occur during intercurrent illness and is a medical emergency. A handful of reports in the medical literature describe the use of peritoneal dialysis and haemodialysis as therapeutic inventions. We report the only patient from our centre to have haemodialysis performed in this setting. Combined with dietary BCAA restriction and calorific support, haemodialysis allows rapid reduction in plasma leucine concentrations considerably faster than conservative methods.

  11. Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

    Wasem, Jürgen; Caspary, Wolfgang; Siebert, Uwe; Schnell-Inderst, Petra; Grabein, Kristin; Hessel, Franz

    2006-01-01

    Background: Conventional diagnostic procedures and therapy of acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) focus on to identify triggering events of the acute deterioration of the liver function and to avoid them. Further objectives are to prevent the development respectively the progression of secondary organ dysfunctions or organ failure. Most of the times the endocrinological function of the liver can to a wide extent be compensated, but the removal of toxins can onl...

  12. Autologous Bone Marrow Mononuclear Cell Transplantation in Patients with Decompensated Alcoholic Liver Disease: A Randomized Controlled Trial

    Spahr, Laurent François Joséph; Chalandon, Yves; Terraz, Sylvain; Kindler, Vincent Lucien; Rubbia-Brandt, Laura; Frossard, Jean-Louis; Breguet, Romain; Lanthier, Nicolas; Farina, Annarita; Passweg, Jakob; Becker, Christoph; Hadengue, Antoine

    2013-01-01

    Objective Impaired liver regeneration is associated with a poor outcome in patients with decompensated alcoholic liver disease (ALD). We assessed whether autologous bone marrow mononuclear cell transplantation (BMMCT) improved liver function in decompensated ALD. Design 58 patients (mean age 54 yrs; mean MELD score 19, all with cirrhosis, 81% with alcoholic steatohepatitis at baseline liver biopsy) were randomized early after hospital admission to standard medical therapy (SMT) alone (n = 30)...

  13. Influence of Spironolactone on Matrix Metalloproteinase-2 in Acute Decompensated Heart Failure

    João Pedro Ferreira

    2015-04-01

    Full Text Available Background: Matrix metalloproteinases (MMPs are a family of enzymes important for the resorption of extracellular matrices, control of vascular remodeling and repair. Increased activity of MMP2 has been demonstrated in heart failure, and in acutely decompensated heart failure (ADHF a decrease in circulating MMPs has been demonstrated along with successful treatment. Objective: Our aim was to test the influence of spironolactone in MMP2 levels. Methods: Secondary analysis of a prospective, interventional study including 100 patients with ADHF. Fifty patients were non-randomly assigned to spironolactone (100 mg/day plus standard ADHF therapy (spironolactone group or standard ADHF therapy alone (control group. Results: Spironolactone group patients were younger and had lower creatinine and urea levels (all p < 0.05. Baseline MMP2, NT-pro BNP and weight did not differ between spironolactone and control groups. A trend towards a more pronounced decrease in MMP2 from baseline to day 3 was observed in the spironolactone group (-21 [-50 to 19] vs 1.5 [-26 to 38] ng/mL, p = 0.06. NT-pro BNP and weight also had a greater decrease in the spironolactone group. The proportion of patients with a decrease in MMP2 levels from baseline to day 3 was also likely to be greater in the spironolactone group (50% vs 66.7%, but without statistical significance. Correlations between MMP2, NT-pro BNP and weight variation were not statistically significant. Conclusion: MMP2 levels are increased in ADHF. Patients treated with spironolactone may have a greater reduction in MMP2 levels.

  14. Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

    Wasem, Jürgen

    2006-04-01

    Full Text Available Background: Conventional diagnostic procedures and therapy of acute liver failure (ALF and acute-on-chronic liver failure (ACLF focus on to identify triggering events of the acute deterioration of the liver function and to avoid them. Further objectives are to prevent the development respectively the progression of secondary organ dysfunctions or organ failure. Most of the times the endocrinological function of the liver can to a wide extent be compensated, but the removal of toxins can only marginally be substituted by conventional conservative therapy. To improve this component of the liver function is the main objective of extracorporal liver support systems. The following principles of liver support systems can be differentiated: Artificial systems, bioartifical systems and extracorporal liver perfusion systems. This HTA report focuses on artificial systems (e.g. BioLogic-DT/-DTPF, MARS, Prometheus, because only these approaches currently are relevant in the German health care system. In 2004 a category "Extracorporal liver assist device" was introduced in the list of "additional payments" in the German DRG-system, which makes reimbursement for hospitals using the technology in inpatient care possible, based on an hospital's individual contract with statutory sickness funds. Objectives: To report the present evidence and future research need on medical efficacy and economic effectiveness of extracorporal liver support devices for treatment of patients with ALF or ACLF based on published literature data. Are artificial liver support systems efficient and effective in the treatment of ALF or ACLF? Methods: An extensive, systematic literature search in medical, economic, and HTA literature data bases was performed. Relevant data were extracted and synthesised. Results: Relevant controlled trials were detected for BioLogic-DT and MARS. No randomised controlled trial on Prometheus was found. None of the included studies on BioLogic-DT showed

  15. Acute decompensated heart failure is routinely treated as a cardiopulmonary syndrome.

    Kumar Dharmarajan

    Full Text Available BACKGROUND: Heart failure as recognized and treated in typical practice may represent a complex condition that defies discrete categorizations. To illuminate this complexity, we examined treatment strategies for patients hospitalized and treated for decompensated heart failure. We focused on the receipt of medications appropriate for other acute conditions associated with shortness of breath including acute asthma, pneumonia, and exacerbated chronic obstructive pulmonary disease. METHODS AND RESULTS: Using Premier Perspective(®, we studied adults hospitalized with a principal discharge diagnosis of heart failure and evidence of acute heart failure treatment from 2009-2010 at 370 US hospitals. We determined treatment with acute respiratory therapies during the initial 2 days of hospitalization and daily during hospital days 3-5. We also calculated adjusted odds of in-hospital death, admission to the intensive care unit, and late intubation (intubation after hospital day 2. Among 164,494 heart failure hospitalizations, 53% received acute respiratory therapies during the first 2 hospital days: 37% received short-acting inhaled bronchodilators, 33% received antibiotics, and 10% received high-dose corticosteroids. Of these 87,319 hospitalizations, over 60% continued receiving respiratory therapies after hospital day 2. Respiratory treatment was more frequent among the 60,690 hospitalizations with chronic lung disease. Treatment with acute respiratory therapy during the first 2 hospital days was associated with higher adjusted odds of all adverse outcomes. CONCLUSIONS: Acute respiratory therapy is administered to more than half of patients hospitalized with and treated for decompensated heart failure. Heart failure is therefore regularly treated as a broader cardiopulmonary syndrome rather than as a singular cardiac condition.

  16. Meta-Analysis of Ultrafiltration versus Diuretics Treatment Option for Overload Volume Reduction in Patients with Acute Decompensated Heart Failure

    Barkoudah Ebrahim

    2015-05-01

    Full Text Available Introduction: Although diuretics are mainly used for the treatment of acute decompensated heart failure (ADHF, inadequate responses and complications have led to the use of extracorporeal ultrafiltration (UF as an alternative strategy for reducing volume overloads in patients with ADHF. Objective: The aim of our study is to perform meta-analysis of the results obtained from studies on extracorporeal venous ultrafiltration and compare them with those of standard diuretic treatment for overload volume reduction in acute decompensated heart failure. Methods: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases were systematically searched using a pre‑specified criterion. Pooled estimates of outcomes after 48 h (weight change, serum creatinine level, and all-cause mortality were computed using random effect models. Pooled weighted mean differences were calculated for weight loss and change in creatinine level, whereas a pooled risk ratio was used for the analysis of binary all-cause mortality outcome. Results: A total of nine studies, involving 613 patients, met the eligibility criteria. The mean weight loss in patients who underwent UF therapy was 1.78 kg [95% Confidence Interval (CI: −2.65 to −0.91 kg; p < 0.001 more than those who received standard diuretic therapy. The post-intervention creatinine level, however, was not significantly different (mean change = −0.25 mg/dL; 95% CI: −0.56 to 0.06 mg/dL; p = 0.112. The risk of all-cause mortality persisted in patients treated with UF compared with patients treated with standard diuretics (Pooled RR = 1.00; 95% CI: 0.64–1.56; p = 0.993. Conclusion: Compared with standard diuretic therapy, UF treatment for overload volume reduction in individuals suffering from ADHF, resulted in significant reduction of body weight within 48 h. However, no significant decrease of serum creatinine level or reduction of all-cause mortality was observed.

  17. Continuous ultrafiltration in acute decompensated heart failure: current issues and future directions.

    Marenzi, Giancarlo; Morpurgo, Marco; Agostoni, Piergiuseppe

    2015-04-01

    Most patients hospitalized for acutely decompensated heart failure (ADHF) present with symptoms and signs of volume overload, which are also associated with high rates of death and re-hospitalization. Several studies have investigated the possible use of extracorporeal ultrafiltration in the management of ADHF, evaluating potential clinical benefits in terms of hospitalization and survival rates versus those of conventional diuretic therapy. Though ultrafiltration remains an extremely appealing therapeutic option for patients with AHDF, some of the most recent studies have reported conflicting results. Differences in the selection of study population, heterogeneity of the indications for the use of ultrafiltration, disparity in the ultrafiltration protocols, and high variability in the pharmacologic therapies used for the control group could explain some of these contradictory findings. The purpose of the present review is to provide an overview and an update on the mechanisms and clinical effects of ultrafiltration and on currently available evidence supporting its use in ADHF. PMID:25650293

  18. Galectin-3: A Link between Myocardial and Arterial Stiffening in Patients with Acute Decompensated Heart Failure?

    Radu Ioan Lala

    2016-01-01

    Full Text Available Abstract Background: Heart failure is accompanied by abnormalities in ventricular-vascular interaction due to increased myocardial and arterial stiffness. Galectin-3 is a recently discovered biomarker that plays an important role in myocardial and vascular fibrosis and heart failure progression. Objectives: The aim of this study was to determine whether galectin-3 is correlated with arterial stiffening markers and impaired ventricular-arterial coupling in decompensated heart failure patients. Methods: A total of 79 inpatients with acute decompensated heart failure were evaluated. Serum galectin-3 was determined at baseline, and during admission, transthoracic echocardiography and measurements of vascular indices by Doppler ultrasonography were performed. Results: Elevated pulse wave velocity and low arterial carotid distensibility are associated with heart failure in patients with preserved ejection fraction (p = 0.04, p = 0.009. Pulse wave velocity, carotid distensibility and Young’s modulus did not correlate with serum galectin-3 levels. Conversely, raised galectin-3 levels correlated with an increased ventricular-arterial coupling ratio (Ea/Elv p = 0.047, OR = 1.9, 95% CI (1.0‑3.6. Increased galectin-3 levels were associated with lower rates of left ventricular pressure rise in early systole (dp/dt (p=0.018 and raised pulmonary artery pressure (p = 0.046. High galectin-3 levels (p = 0.038, HR = 3.07 and arterial pulmonary pressure (p = 0.007, HR = 1.06 were found to be independent risk factors for all-cause mortality and readmissions. Conclusions: This study showed no significant correlation between serum galectin-3 levels and arterial stiffening markers. Instead, high galectin-3 levels predicted impaired ventricular-arterial coupling. Galectin-3 may be predictive of raised pulmonary artery pressures. Elevated galectin-3 levels correlate with severe systolic dysfunction and together with pulmonary hypertension are independent markers of

  19. Post-Exercise Heart Rate Recovery Independently Predicts Clinical Outcome in Patients with Acute Decompensated Heart Failure

    Youn, Jong-Chan; Lee, Hye Sun; Choi, Suk-Won; Han, Seong-Woo; Ryu, Kyu-Hyung; Shin, Eui-Cheol; Kang, Seok-Min

    2016-01-01

    Background Post-exercise heart rate recovery (HRR) is an index of parasympathetic function associated with clinical outcome in patients with chronic heart failure. However, its relationship with the pro-inflammatory response and prognostic value in consecutive patients with acute decompensated heart failure (ADHF) has not been investigated. Methods We measured HRR and pro-inflammatory markers in 107 prospectively and consecutively enrolled, recovered ADHF patients (71 male, 59 ± 15 years, mea...

  20. Efficacy and Safety of 1-Hour Infusion of Recombinant Human Atrial Natriuretic Peptide in Patients With Acute Decompensated Heart Failure

    Wang, Guogan; Wang, Pengbo; Li, Yishi; Liu, Wenxian; Bai, Shugong; Zhen, Yang; Li, Dongye; Yang, Ping; Chen, Yu; Hong, Lang; Sun, Jianhui; Chen, Junzhu; Wang, Xian; Zhu, Jihong; Hu, Dayi; Li, Huimin; Wu, Tongguo; Huang, Jie; Tan, Huiqiong; Zhang, Jian; Liao, Zhongkai; Yu, Litian; Mao, Yi; Ye, Shaodong; Feng, Lei; Hua, Yihong; Ni, Xinhai; Zhang, Yuhui; Wang, Yang; Li, Wei; Luan, Xiaojun; Sun, Xiaolu; Wang, Sijia

    2016-01-01

    Abstract The aim of the study was to evaluate the efficacy and safety of 1-h infusion of recombinant human atrial natriuretic peptide (rhANP) in combination with standard therapy in patients with acute decompensated heart failure (ADHF). This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients with ADHF were randomized to receive a 1-h infusion of either rhANP or placebo at a ratio of 3:1 in combination with standard therapy. The primary endpoint was dyspnea improvement (a decrease of at least 2 grades of dyspnea severity at 12 h from baseline). Reduction in pulmonary capillary wedge pressure (PCWP) 1 h after infusion was the co-primary endpoint for catheterized patients. Overall, 477 patients were randomized: 358 (93 catheterized) patients received rhANP and 118 (28 catheterized) received placebo. The percentage of patients with dyspnea improvement at 12 h was higher, although not statistically significant, in the rhANP group than in the placebo group (32.0% vs 25.4%, odds ratio=1.382, 95% confidence interval [CI]: 0.863–2.212, P = 0.17). Reduction in PCWP at 1 h was significantly greater in patients treated with rhANP than in patients treated with placebo (−7.74 ± 5.95 vs −1.82 ± 4.47 mm Hg, P  0.99). 1-h rhANP infusion appears to result in prompt, transient hemodynamic improvement with a small, nonsignificant, effect on dyspnea in ADHF patients receiving standard therapy. The safety of 1-h infusion of rhANP seems to be acceptable. (WHO International Clinical Trials Registry Platform [ICTRP] number, ChiCTR-IPR-14005719.) PMID:26945407

  1. Temporal Trends in Hospitalization for Acute Decompensated Heart Failure in the United States, 1998-2011.

    Agarwal, Sunil K; Wruck, Lisa; Quibrera, Miguel; Matsushita, Kunihiro; Loehr, Laura R; Chang, Patricia P; Rosamond, Wayne D; Wright, Jacqueline; Heiss, Gerardo; Coresh, Josef

    2016-03-01

    Estimates of the numbers and rates of acute decompensated heart failure (ADHF) hospitalization are central to understanding health-care utilization and efforts to improve patient care. We comprehensively estimated the frequency, rate, and trends of ADHF hospitalization in the United States. Based on Atherosclerosis Risk in Communities (ARIC) Study surveillance adjudicating 12,450 eligible hospitalizations during 2005-2010, we developed prediction models for ADHF separately for 3 International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code 428 discharge diagnosis groups: 428 primary, 428 nonprimary, or 428 absent. We applied the models to data from the National Inpatient Sample (11.5 million hospitalizations of persons aged ≥55 years with eligible ICD-9-CM codes), an all-payer, 20% probability sample of US community hospitals. The average estimated number of ADHF hospitalizations per year was 1.76 million (428 primary, 0.80 million; 428 nonprimary, 0.83 million; 428 absent, 0.13 million). During 1998-2004, the rate of ADHF hospitalization increased by 2.0%/year (95% confidence interval (CI): 1.8, 2.5) versus a 1.4%/year (95% CI: 0.8, 2.1) increase in code 428 primary hospitalizations (P estimated number of hospitalizations with ADHF is approximately 2 times higher than the number of hospitalizations with ICD-9-CM code 428 in the primary position. The trend increased more steeply prior to 2005 and was relatively flat after 2005. PMID:26895710

  2. Bedside lung ultrasound in the evaluation of acute decompensated heart failure.

    Leidi, Federica; Casella, Francesco; Cogliati, Chiara

    2016-06-01

    Dyspnea is a common presenting complaint in the emergency department (ED) and a leading cause of hospitalization in intensive care unit (ICU) and medical wards. Ultrasound (US) has traditionally been considered inadequate to explore the aerated lung. However, in the past 15 years LUS gained broader application, at least in part thanks to the interpretation of the artefacts generated by the interaction of US and lung structures/content. The total reflection of US beam occurring at the pleural level determines the artefactual image of the aerated lung: an homogenous 'foggy-like' picture under the pleural line. As the air content of the lungs decreases due to interstitial imbibition, deposition of collagen or presence of blood, vertical artefacts -arising from the pleural line and moving synchronously with the respiration- called B-lines appear. Multiple and bilateral B-lines identify the alveolar-interstitial syndrome (AIS). The most common cause of AIS is the wet lung: the more the congestion burden, the more the extent of the B-lines, which become confluent until the so-called white lung in case of pulmonary edema. Many studies showed a higher accuracy of LUS in diagnosing acute decompensated heart failure (ADHF) as compared to chest X-ray As recently shown, the integration of LUS to clinical assessment allow to differentiate cardiogenic dyspnea with sensitivity and specificity greater than 95 %. Moreover, LUS can easily detect pleural effusion -frequently present in ADHF-appearing as an anechoic area in the recumbent area of the thorax, delimited inferiorly by the diaphragmatic dome and superiorly by the aerated lung. PMID:26885846

  3. A retrospective characterization of worsening renal function in patients with acute decompensated heart failure receiving nesiritide

    Starr JA

    2009-09-01

    Full Text Available Nesiritide is approved by Food and Drug Administration (FDA for the treatment of patients with acute decompensated heart failure (ADHF due its ability to rapidly reduce cardiac filling pressures and improve dyspnea. Numerous studies have shown that renal dysfunction is associated with unfavorable outcomes in patients with heart failure. In addition, there have been reports suggesting that nesiritide may adversely affect renal function and mortality. Objective: The purpose of this retrospective analysis was to assess the effect of dose and duration of nesiritide use and the dose and duration of diuretic therapy on worsening renal function and increased in-hospital mortality in this patient population.Methods: Seventy-five patients who were hospitalized for ADHF and who were treated with nesiritide for at least 12 hours were reviewed retrospectively. Results: The mean increase in SCr was 0.5 mg/dL (range 0 – 4.4 mg/dL. Thirty-six percent of patients (27/75 met the primary endpoint with an increase in SCr>0.5 mg/dL. Treatment dose and duration of nesiritide did not differ between those patients who had an increase in SCr>0.5 mg/dL and those who did not (p=0.44 and 0.61. Concomitant intravenous diuretics were used in 85% of patients with an increase in SCr >0.5 mg/dL compared to 90% of patients without an increase in SCr>0.5 mg/dL (p=0.57. The in-hospital mortality rate was also higher at 35% in those patients with an increase in creatinine >0.5 mg/dL compared to 11% in those without (p=0.01. Conclusion: Nesiritide was associated with an increase in SCr > 0.5 mg/dL in approximately one-third of patients. The increase occurred independently of dose, duration of nesiritide therapy, blood pressure changes, and concomitant intravenous diuretic use. However, the increase in SCr was associated with an increase in hospital stay and in hospital mortality consistent with previous reports in the literature.

  4. Autologous bone marrow mononuclear cell transplantation in patients with decompensated alcoholic liver disease: a randomized controlled trial.

    Laurent Spahr

    Full Text Available OBJECTIVE: Impaired liver regeneration is associated with a poor outcome in patients with decompensated alcoholic liver disease (ALD. We assessed whether autologous bone marrow mononuclear cell transplantation (BMMCT improved liver function in decompensated ALD. DESIGN: 58 patients (mean age 54 yrs; mean MELD score 19, all with cirrhosis, 81% with alcoholic steatohepatitis at baseline liver biopsy were randomized early after hospital admission to standard medical therapy (SMT alone (n = 30, including steroids in patients with a Maddrey's score ≥32, or combined with G-CSF injections and autologous BMMCT into the hepatic artery (n = 28. Bone marrow cells were harvested, isolated and reinfused the same day. The primary endpoint was a ≥3 points decrease in the MELD score at 3 months, corresponding to a clinically relevant improvement in liver function. Liver biopsy was repeated at week 4 to assess changes in Ki67+/CK7+ hepatic progenitor cells (HPC compartment. RESULTS: Both study groups were comparable at baseline. After 3 months, 2 and 4 patients died in the BMMCT and SMT groups, respectively. Adverse events were equally distributed between groups. Moderate alcohol relapse occurred in 31% of patients. The MELD score improved in parallel in both groups during follow-up with 18 patients (64% from the BMMCT group and 18 patients (53% from the SMT group reaching the primary endpoint (p = 0.43 (OR 1.6, CI 0.49-5.4 in an intention to treat analysis. Comparing liver biopsy at 4 weeks to baseline, steatosis improved (p<0.001, and proliferating HPC tended to decrease in both groups (-35 and -33%, respectively. CONCLUSION: Autologous BMMCT, compared to SMT is a safe procedure but did not result in an expanded HPC compartment or improved liver function. These data suggest either insufficient regenerative stimulation after BMMCT or resistance to liver regenerative drive in patients with decompensated alcoholic cirrhosis. TRIAL REGISTRATION

  5. Therapeutic effects of intravenous urapidil in elderly patients with hypertension and acute decompensated heart failure: A pilot clinical trial

    YANG, WEI; ZHOU, YU-JIE; FU, YAN; QIN, JIAN; TAN, SHU; CHEN, XIAO-MIN; GUO, JIN-CHENG; WANG, DE-ZHAO; ZHAN, HONG; GUAN, WEI; XU, YA-WEI; HE, JING-YU; LI, JING; HUA, QI

    2016-01-01

    Urapidil has been proposed to be an effective vasodilator for the treatment of acute decompensated heart failure (ADHF); however, its effect on cardiac function, as compared with that of nitroglycerin, in elderly patients with hypertension and ADHF has yet to be determined. In the present study, a multicenter, open-label clinical trial was performed, in which 120 elderly patients with hypertension and ADHF were randomly assigned to the treatment (50–400 µg/min intravenous urapidil) or control group (5–40 µg/min intravenous nitroglycerin). The dosages of the medications were adjusted according to the blood pressure of the patients. The systolic and diastolic blood pressure, heart rate and serum level of N-terminal pro B-type natriuretic peptide (NT-proBNP) were evaluated at hospital admission and at days 1, 2, 3 and 7 after treatment. In addition, the left ventricular function was assessed by measuring the left ventricular ejection fraction (LVEF) and left ventricular end-diastolic volume at hospital admission and at days 2 and 7 after treatment. The results indicated that intravenous administration of urapidil and nitroglycerin were effective in lowering the blood pressure and heart rate within 7 days, with no significant differences observed between the two groups (P>0.05). By contrast, greater reduction in the serum NT-proBNP level (2,410.4±546.1 vs. 4,234.1±876.4 pg/ml; P<0.05) and greater improvement in the LVEF (55.3±3.4 vs. 45.2±2.4%; P<0.05) were observed in the urapidil-treated group, as compared with the nitroglycerin-treated group. No adverse events were reported during the treatment period in the two groups. The clinical outcomes at 6 months following discharge were evaluated and were not found to be significantly different between the two groups. In conclusion, the present results of the present study suggested that urapidil was as effective as nitroglycerin in controlling blood pressure and heart rate and was more effective in improving

  6. Comparative effects of recombinant human brain natriuretic peptide and dobutamine on acute decompensated heart failure patients with differsent blood BNP levels

    2014-01-01

    Background Recombinant human B-type natriuretic peptide (rhBNP) has been indicated for the treatment of acute decompensated heart failure (ADHF). However, the therapeutic efficacy of intravenous rhBNP is not always satisfactory in patients with extremely high blood BNP levels. In this study, we evaluated the effects of rhBNP on patients with different BNP levels. Methods One hundred and five patients with ADHF whose left ventricular ejection fraction (LVEF) was  3000 pg/mL) , depending on their admission plasma BNP levels. Each group was then subdivided into rhBNP or dobutamine subgroups according to intravenous administration with either rhBNP or dobutamine for 24-72h. In the high BNP group, 58 patients were randomized to subgroup rhBNP (n = 28) and subgroup dobutamine (n = 30). In the extra-high BNP group, 47 patients were randomized to subgroup rhBNP (n = 24) and subgroup dobutamine (n = 23). The effects of rhBNP and dobutamine on patients in the high and extra-high BNP groups were compared. Results In the high BNP group, rhBNP was more efficient than dobutamine at improving NYHA classification (P 3000 pg/mL). Trial registration ClinicalTrials.gov Identifier: NCT01837849. PMID:24593826

  7. Right ventricular dysfunction as predictor of longer hospital stay in patients with acute decompensated heart failure: a prospective study in Indonesian population

    Yamin, Paskariatne Probo Dewi; Raharjo, Sunu Budhi; Putri, Vebiona Kartini Prima; Hersunarti, Nani

    2016-01-01

    Background Hospital length of stay (LOS) is a key determinant of heart failure hospitalization costs. Longer LOS is associated with lower quality of care measures and higher rates of readmission and mortality. Right ventricular (RV) dysfunction predicted poor outcomes in patients with stable chronic heart failure (CHF), however, its prognostic value in the acute decompensated heart failure (ADHF) patients has not been sufficiently clarified. This study investigated the prognostic value of RV ...

  8. Relaxin for the Treatment of Acute Decompensated Heart Failure: Pharmacology, Mechanisms of Action, and Clinical Evidence.

    Ng, Tien M H; Goland, Sorel; Elkayam, Uri

    2016-01-01

    Acute heart failure remains a major cause of morbidity, and its treatment requires an increasing investment of the health care system. Whereas success in treating chronic heart failure has been achieved over the last decades, several pharmacological approaches for acute heart failure have been introduced but have failed to demonstrate any clinical benefit. Serelaxin is a recombinant human relaxin-2 vasoactive peptide that causes systemic and renal vasodilation. Data suggest that the clinical benefits may be attributable to a potential combination of multiple actions of serelaxin, including improving systemic, cardiac, and renal hemodynamics, and protecting cells and organs from damage via neurohormonal, anti-inflammatory, antiremodeling, antifibrotic, anti-ischemic, and proangiogenic effects. Recently, a number of clinical trials have demonstrated that serelaxin infusion over 48 hours improved dyspnea with more rapid relief of congestion during the first days after admission for heart failure. In addition, administration of serelaxin diminished cardiac, renal, and hepatic damage, which were associated with improved long-term mortality. Available data support substantial clinical benefits and significant promise for serelaxin as a treatment option for patients with acute heart failure. This review focuses on the pharmacology and mechanisms of action of serelaxin and provides a detailed discussion of the clinical evidence for this novel therapy in acute heart failure. PMID:26331289

  9. The predictability of renin-angiotensin-aldosterone system factors for clinical outcome in patients with acute decompensated heart failure.

    Nakada, Yasuki; Takahama, Hiroyuki; Kanzaki, Hideaki; Sugano, Yasuo; Hasegawa, Takuya; Ohara, Takahiro; Amaki, Makoto; Funada, Akira; Yoshida, Akemi; Yasuda, Satoshi; Ogawa, Hisao; Anzai, Toshihisa

    2016-06-01

    Although counter-regulation between B-type natriuretic peptide (BNP) levels and renin-angiotensin-aldosterone system (RAAS) activation in heart failure (HF) has been suggested, whether the regulation is preserved in acute decompensated heart failure (ADHF) patients remains unclear. This study aimed to determine: (1) the relationship between RAAS activation and clinical outcomes in ADHF patients, and (2) the relationships between plasma BNP levels and degrees of activation in RAAS factors. This study included ADHF patients (n = 103, NYHA3-4, plasma BNP > 200 pg/ml). We studied the predictability of RAAS factors for cardiovascular events and the relationships between plasma BNP levels and the degrees of activation in RAAS factors, which were evaluated by plasma renin activity (PRA) and aldosterone concentration (PAC). PRA was a strong predictor of cardiovascular (CV) events over 1 year, even after accounting for plasma BNP levels (hazard ratio (HR): 1.04, CI [1.02-1.06], p analysis, p = 0.06). Cut-off value of PRA (5.3 ng/ml/h) was determined by AUC curve. Of the enrolled patients, higher PRA was found in 40 % of them. Although no correlation between the plasma BNP levels and PRA was found (p = 0.36), after adjusting for hemodynamic parameters, eGFR and medication, a correlation was found between them (p = 0.01). Elevated RAAS factors were found in a substantial number of ADHF patients with high plasma BNP levels in the association with hemodynamic state, which predicts poor clinical outcomes. The measurements of RAAS factors help to stratify ADHF patients at risk for further CV events. PMID:25964073

  10. Post-Exercise Heart Rate Recovery Independently Predicts Clinical Outcome in Patients with Acute Decompensated Heart Failure

    Youn, Jong-Chan; Lee, Hye Sun; Choi, Suk-Won; Han, Seong-Woo; Ryu, Kyu-Hyung; Shin, Eui-Cheol; Kang, Seok-Min

    2016-01-01

    Background Post-exercise heart rate recovery (HRR) is an index of parasympathetic function associated with clinical outcome in patients with chronic heart failure. However, its relationship with the pro-inflammatory response and prognostic value in consecutive patients with acute decompensated heart failure (ADHF) has not been investigated. Methods We measured HRR and pro-inflammatory markers in 107 prospectively and consecutively enrolled, recovered ADHF patients (71 male, 59 ± 15 years, mean ejection fraction 28.9 ± 14.2%) during the pre-discharge period. The primary endpoint included cardiovascular (CV) events defined as CV mortality, cardiac transplantation, or rehospitalization due to HF aggravation. Results The CV events occurred in 30 (28.0%) patients (5 cardiovascular deaths and 7 cardiac transplantations) during the follow-up period (median 214 days, 11–812 days). When the patients with ADHF were grouped by HRR according to the Contal and O’Quigley’s method, low HRR was shown to be associated with significantly higher levels of serum monokine-induced by gamma interferon (MIG) and poor clinical outcome. Multivariate Cox regression analysis revealed that low HRR was an independent predictor of CV events in both enter method and stepwise method. The addition of HRR to a model significantly increased predictability for CV events across the entire follow-up period. Conclusion Impaired post-exercise HRR is associated with a pro-inflammatory response and independently predicts clinical outcome in patients with ADHF. These findings may explain the relationship between autonomic dysfunction and clinical outcome in terms of the inflammatory response in these patients. PMID:27135610

  11. MR spectroscopy-based brain metabolite profiling in propionic acidaemia: metabolic changes in the basal ganglia during acute decompensation and effect of liver transplantation

    McKiernan Patrick J

    2011-05-01

    replenish a compromised Krebs cycle and that this is a marker of compromised aerobic respiration within brain tissue. Thus there is a need for improved brain protective strategies during acute metabolic decompensations. MRS provides a non-invasive tool for which could be employed to evaluate novel treatments aimed at restoring basal ganglia homeostasis. The results from the liver transplantation sub-group supports the hypothesis that liver transplantation provides systemic metabolic stability by providing a hepatic pool of functional propionyl CoA carboxylase, thus preventing further acute decompensations which are associated with the risk of brain infarction.

  12. Evaluation of cardiac sympathetic nerve activity and aldosterone suppression in patients with acute decompensated heart failure on treatment containing intravenous atrial natriuretic peptide

    Kasama, Shu [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Cardiovascular Hospital of Central Japan (Kitakanto Cardiovascular Hospital), Department of Cardiovascular Medicine, Gunma (Japan); Toyama, Takuji; Kurabayashi, Masahiko [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Iwasaki, Toshiya; Sumino, Hiroyuki; Kumakura, Hisao; Minami, Kazutomo; Ichikawa, Shuichi [Cardiovascular Hospital of Central Japan (Kitakanto Cardiovascular Hospital), Department of Cardiovascular Medicine, Gunma (Japan); Matsumoto, Naoya [Nihon University School of Medicine, Department of Cardiology, Tokyo (Japan); Nakata, Tomoaki [Sapporo Medical University School of Medicine, Second (Cardiology) Department of Internal Medicine, Sapporo, Hokkaido (Japan)

    2014-09-15

    Aldosterone prevents the uptake of norepinephrine in the myocardium. Atrial natriuretic peptide (ANP), a circulating hormone of cardiac origin, inhibits aldosterone synthase gene expression in cultured cardiocytes. We evaluated the effects of intravenous ANP on cardiac sympathetic nerve activity (CSNA) and aldosterone suppression in patients with acute decompensated heart failure (ADHF). We studied 182 patients with moderate nonischemic ADHF requiring hospitalization and treated with standard therapy containing intravenous ANP and 10 age-matched normal control subjects. ANP was continuously infused for >96 h. In all subjects, delayed total defect score (TDS), heart to mediastinum ratio, and washout rate were determined by {sup 123}I-metaiodobenzylguanidine (MIBG) scintigraphy. Left ventricular (LV) end-diastolic volume, end-systolic volume, and ejection fraction were determined by echocardiography. All patients with acute heart failure (AHF) were examined once within 3 days and then 4 weeks after admission, while the control subjects were examined only once (when their hemodynamics were normal). Moreover, for 62 AHF patients, plasma aldosterone concentrations were measured at admission and 1 h before stopping ANP infusion. {sup 123}I-MIBG scintigraphic and echocardiographic parameters in normal subjects were more favorable than those in patients with AHF (all p < 0.001). After treatment, all these parameters improved significantly in AHF patients (all p < 0.001). We also found significant correlation between percent changes of TDS and aldosterone concentrations (r = 0.539, p < 0.001) in 62 AHF patients. The CSNA and LV performance were all improved in AHF patients. Furthermore, norepinephrine uptake of myocardium may be ameliorated by suppressing aldosterone production after standard treatment containing intravenous ANP. (orig.)

  13. Evaluation of cardiac sympathetic nerve activity and aldosterone suppression in patients with acute decompensated heart failure on treatment containing intravenous atrial natriuretic peptide

    Aldosterone prevents the uptake of norepinephrine in the myocardium. Atrial natriuretic peptide (ANP), a circulating hormone of cardiac origin, inhibits aldosterone synthase gene expression in cultured cardiocytes. We evaluated the effects of intravenous ANP on cardiac sympathetic nerve activity (CSNA) and aldosterone suppression in patients with acute decompensated heart failure (ADHF). We studied 182 patients with moderate nonischemic ADHF requiring hospitalization and treated with standard therapy containing intravenous ANP and 10 age-matched normal control subjects. ANP was continuously infused for >96 h. In all subjects, delayed total defect score (TDS), heart to mediastinum ratio, and washout rate were determined by 123I-metaiodobenzylguanidine (MIBG) scintigraphy. Left ventricular (LV) end-diastolic volume, end-systolic volume, and ejection fraction were determined by echocardiography. All patients with acute heart failure (AHF) were examined once within 3 days and then 4 weeks after admission, while the control subjects were examined only once (when their hemodynamics were normal). Moreover, for 62 AHF patients, plasma aldosterone concentrations were measured at admission and 1 h before stopping ANP infusion. 123I-MIBG scintigraphic and echocardiographic parameters in normal subjects were more favorable than those in patients with AHF (all p < 0.001). After treatment, all these parameters improved significantly in AHF patients (all p < 0.001). We also found significant correlation between percent changes of TDS and aldosterone concentrations (r = 0.539, p < 0.001) in 62 AHF patients. The CSNA and LV performance were all improved in AHF patients. Furthermore, norepinephrine uptake of myocardium may be ameliorated by suppressing aldosterone production after standard treatment containing intravenous ANP. (orig.)

  14. Acute liver function decompensation in a patient with sickle cell disease managed with exchange transfusion and endoscopic retrograde cholangiography

    Papafragkakis, Haris; Mel A. Ona; Changela, Kinesh; Sadanandan, Swayamprabha; Jelin, Abraham; Anand, Sury; Duddempudi, Sushil

    2014-01-01

    Sickle cell intrahepatic cholestasis is a relatively uncommon complication of homozygous sickle cell anemia, which may lead to acute hepatic failure and death. Treatment is mainly supportive, but exchange transfusion is used as salvage therapy in life threatening situations. We describe a case of a 16-year-old female with homozygous sickle cell anemia who presented to the emergency room with fatigue, malaise, dark urine, lower back pain, scleral icterus and jaundice. She was found to have mar...

  15. CARDIORENAL INTERACTION IN DECOMPENSATED CHRONIC HEART FAILURE

    Zh. D. Kobalava; S. V. Villevalde; M. A. Efremovtseva

    2016-01-01

    Aim. To investigate the prevalence of cardiorenal interactions, predictors of development, variants of clinical course, and outcomes of acute kidney injury (AKI) in patients with acute decompensation of chronic heart failure (ADCHF).Material and methods. Patients (n=278) with clinical manifestations of ADCHF were included into the study. All patients underwent clinical, laboratory and instrumental investigation. Renal function was assessed using the CKD-EPI formula to calculate glomerular fil...

  16. Sex Differences in Patients With Acute Decompensated Heart Failure: Insights From the Heart Function Assessment Registry Trial in Saudi Arabia.

    AlFaleh, Hussam F; Thalib, Lukman; Kashour, Tarek; Hersi, Ahmad; Mimish, Layth; Elasfar, Abdelfatah A; Almasood, Ali; Al Ghamdi, Saleh; Ghabashi, Abdullah; Malik, Asif; Hussein, Gamal A; Al-Murayeh, Mushabab; Abuosa, Ahmed; Al Habeeb, Waleed; Al Habib, Khalid F

    2016-08-01

    We assessed sex-specific differences in clinical features and outcomes of patients with acute heart failure (AHF). The Heart function Assessment Registry Trial in Saudi Arabia (HEARTS), a prospective registry, enrolled 2609 patients with AHF (34.2% women) between 2009 and 2010. Women were older and more likely to have risk factors for atherosclerosis, history of heart failure (HF), and rheumatic heart and valve disease. Ischemic heart disease was the prime cause for HF in men and women but more so in men (P Women had higher rates of hypertensive heart disease and primary valve disease (P women and higher ventricular arrhythmias in men, no differences were observed in hospital outcomes. The overall survival did not differ between men and women (hazard ratio: 1.0, 95% confidence interval: 0.8-1.2, P = .981). Men and women with AHF differ significantly in baseline clinical characteristics and management but not in adverse outcomes. PMID:26438635

  17. Malnutrition as assessed by nutritional risk index is associated with worse outcome in patients admitted with acute decompensated heart failure. An ACAP-HF data analysis

    Marrick L. Kukin

    2011-06-01

    Full Text Available Malnutrition is common at hospital admission and tends to worsen during hospitalization. This controlled population study aimed to determine if serum albumin or moderate and severe nutritional depletion by Nutritional Risk Index (NRI at hospital admission are associated with increased length of hospital stay (LOS in patients admitted with acute decompensated heart failure (ADHF. Serum albumin levels and lymphocyte counts were retrospectively determined at hospital admission in 1740 consecutive patients admitted with primary and secondary diagnosis of ADHF. The Nutrition Risk Score (NRI developed originally in AIDS and cancer populations was derived from the serum albumin concentration and the ratio of actual to usual weight, as follows: NRI = (1.519 × serum albumin, g/dL + {41.7 × present weight (kg/ideal body weight(kg}. Patients were classified into four groups as no, mild, moderate or severe risk by NRI. Multiple logistic regressions were used to determine the association between nutritional risk category and LOS. 381 Patients (34% were at moderate or severe nutritional risk by NRI score. This cohort had lower BMI (24 ± 5.6 kg/m2, albumin (2.8±0.5 g/dL, mean NRI (73.5±9 and Lower eGFR (50±33 mL/min per 1.73 m2. NRI for this cohort, adjusted for age, was associated with LOS of 10.1 days. Using the Multiple Logistic regression module, NRI was the strongest predictor for LOS (OR 1.7, 95% CI: 1.58-1.9; P=0.005, followed by TIMI Risk Score [TRS] (OR 1.33, 95% CI: 1.03-1.71; P=0.02 and the presence of coronary artery disease (OR 2.29, 95%CI: 1.03-5.1; P=0.04. Moderate and severe NRI score was associated with higher readmission and death rates as compared to the other two groups. Nutritional depletion as assessed by Nutritional Risk Index is associated with worse outcome in patients admitted with ADHF. Therefore; we recommend adding NRI to further risk stratify these patients.

  18. Improving Survival in Decompensated Cirrhosis

    Amar Nath Mukerji

    2012-01-01

    Full Text Available Mortality in cirrhosis is consequent of decompensation, only treatment being timely liver transplantation. Organ allocation is prioritized for the sickest patients based on Model for End Stage Liver Disease (MELD score. In order to improve survival in patients with high MELD score it is imperative to preserve them in suitable condition till transplantation. Here we examine means to prolong life in high MELD score patients till a suitable liver is available. We specially emphasize protection of airways by avoidance of sedatives, avoidance of Bilevel Positive Airway Pressure, elective intubation in grade III or higher encephalopathy, maintaining a low threshold for intubation with lesser grades of encephalopathy when undergoing upper endoscopy or colonoscopy as pre transplant evaluation or transferring patient to a transplant center. Consider post-pyloric tube feeding in encephalopathy to maintain muscle mass and minimize risk of aspiration. In non intubated and well controlled encephalopathy, frequent physical mobility by active and passive exercises are recommended. When renal replacement therapy is needed, night-time Continuous Veno-Venous Hemodialysis may be useful in keeping the daytime free for mobility. Sparing and judicious use of steroids needs to be borne in mind in treatment of ARDS and acute hepatitis from alcohol or autoimmune process.

  19. Clinical observation of lyophilized recombinant human brain natriuretic peptide for the treatment of acute decompensated heart failure%冻干重组人脑利钠肽治疗急性失代偿性心力衰竭临床观察

    王沐; 魏盟

    2014-01-01

    目的:研究冻干重组人脑利钠肽治疗急性代偿性心力衰竭的临床效果。方法选择急性失代偿性心力衰竭患者90例,随机分成观察组(45例)和对照组(45例)。对2组患者均进行常规治疗,观察组同时静脉注射冻干重组人脑利钠肽;对照组则静脉注射硝酸甘油。结果治疗前观察组和对照组左心室舒张末期内径(LVEDD)及左心室射血分数(LVEF)差异无统计学意义(P>0.05)。治疗后观察组LVEDD显著小于对照组(P<0.01),LVEF显著高于对照组(P<0.01)。治疗前2组患者动脉血二氧化碳分压(PaCO2)、时间肺活量、收缩压及动脉血氧饱和度比较差异均无统计学意义(P>0.05)。治疗后观察组PaCO2、收缩压显著低于对照组(P<0.01),时间肺活量和动脉血氧饱和度显著高于对照组(P<0.01)。结论冻干重组人脑利钠肽可以有效改善急性失代偿性心力衰竭患者的心脏功能以及呼吸功能。%Objective To study the clinical effect of lyophilized recombinant human brain natriuretic peptide for the treatment of acute decompensated heart failure .Methods 90 patients with acute decompensated heart failure were ran-domly divided into observation group (n=45) and control group (n=45).The patients in both groups received routine treatment .The patients in the observation group received lyophilized recombinant human brain natriuretic peptide intrave -nous injection .The patients in the control group received intravenous injection of nitroglycerin .Results Before treat-ment, the left ventricular end diastolic diameter (LVEDD) and left ventricular ejection fraction (LVEF) between the two groups showed no statistical difference (P>0.05).After treatment, the LVEDD in the observation group were signifi-cantly less than that in the control group (P0.05).After treatment, the PaCO2 and systolic blood pressure were significantly lower in the

  20. The importance of apoptotic activity and plasma NT-proBNP levels in patients with acute exacerbation of decompensated heart failure and their relation to different drugs and comorbidities

    Objective: To demonstrate the presence and importance of apoptotic activity in heart failure during acute exacerbations and to investigate the effects of different drugs used and co-morbidities on levels of N-Terminal pro-Brain Natriuretic Peptide and apoptotic activity on admission and during hospitalisation. Methods: The descriptive study was conducted at the emergency department of Istanbul University Cardiology Institute between October 2010 and May 2011 and comprised patients with complaints of shortness of breath, and who were evaluated as acutely exacerbated decompensated heart failure with an aetiology of ischaemic or dilated cardiomyopathy. Apoptotic activity and N-Terminal pro-Brain Natriuretic Peptide levels were measured on admission and on the seventh day of treatment. SPSS 15 was used for statistical analysis. Results: Of the 89 patients in the study, 67(75%) were males. Overall mean age of the study sample was 61+-12 years. Patients who had N-Terminal pro-Brain Natriuretic Peptide levels higher than 6000 pg/ml on admission had greater in-patient mortality rate (p<0.001). N-Terminal pro-Brain Natriuretic Peptide levels decreased significantly on the seventh day of treatment compared to the admission values (p<0.012). Apoptotic activity levels, although not statistically significant, increased on the seventh day compared with admission values (p<0.12). Apoptotic activity levels on the 7th day were associated with in-patient deaths (p<0.002). Dopamine infusion in the treatment group during hospitalisation significantly increased apoptotic activity (p<0.035), whereas there was a trend towards decreased apoptotic activity levels with spironolactone (p<0.07). Treatment with beta-blockers did not change apoptotic activity levels (p<0.751), whereas lack of beta-blocker therapy increased apoptotic activity (p<0.02). Conclusion: N-Terminal pro-Brain Natriuretic Peptide may be an important risk predictor in decompensated heart failure exacerbations during

  1. Atrial fibrillation associated with a thyroid stimulating hormone-secreting adenoma of the pituitary gland leading to a presentation of acute cardiac decompensation: A case report

    George Jyothis T

    2008-02-01

    Full Text Available Abstract Introduction Hyperthyroidism is a well established cause of atrial fibrillation (AF. Thyroid Stimulating Hormone-secreting pituitary tumours are rare causes of pituitary hyperthyroidism. Whilst pituitary causes of hyperthyroidism are much less common than primary thyroid pathology, establishing a clear aetiology is critical in minimising complications and providing appropriate treatment. Measuring Thyroid Stimulating Hormone (TSH alone to screen for hyperthyroidism may be insufficient to appropriately evaluate the thyroid status in such cases. Case presentation A 63-year-old Caucasian man, previously fit and well, presented with a five-day history of shortness of breath associated with wheeze and dry cough. He denied symptoms of hyperthyroidism and his family, social and past history were unremarkable. Initial investigation was in keeping with a diagnosis of atrial fibrillation (AF with fast ventricular response leading to cardiac decompensation. TSH 6.2 (Normal Range = 0.40 – 4.00 mU/L, Free T3 of 12.5 (4.00 – 6.8 pmol/L and Free T4 51(10–30 pmol/L. Heterophilic antibodies were ruled out. Testosterone was elevated at 43.10 (Normal range: 10.00 – 31.00 nmol/L with an elevated FSH, 18.1 (1.0–7.0 U/L and elevated LH, 12.4 (1.0–8.0 U/L. Growth Hormone, IGF-1 and prolactin were normal. MRI showed a 2.4 cm pituitary macroadenoma. Visual field tests showed a right inferotemporal defect. While awaiting neurosurgical removal of the tumour, the patient was commenced on antithyroid medication (carbimazole and maintained on this until successful trans-sphenoidal excision of the macroadenoma had been performed. AF persisted post-operatively, but was electrically cardioverted subsequently and he remains in sinus rhythm at twelve months follow-up off all treatment. Conclusion This case reiterates the need to evaluate thyroid function in all patients presenting with atrial fibrillation. TSH-secreting pituitary adenomas must be considered

  2. Influence of bilevel positive airway pressure on autonomic tone in hospitalized patients with decompensated heart failure

    Lacerda, Diego; Costa, Dirceu; Reis, Michel; Gomes, Evelim Leal de F. Dantas; Costa, Ivan Peres; Borghi-Silva, Audrey; Marsico, Aline; Stirbulov, Roberto; Arena, Ross; Sampaio, Luciana Maria Malosá

    2016-01-01

    [Purpose] This study evaluated the effect of Bilevel Positive Airway (BiPAP) on the autonomic control of heart rate, assessed by heart rate variability (HRV), in patients hospitalized with decompensated heart failure. [Subjects and Methods] This prospective cross-sectional study included 20 subjects (age: 69±8 years, 12 male, left ventricular ejection fraction: 36 ±8%) diagnosed with heart failure who were admitted to a semi-intensive care unit with acute decompensation. Date was collected fo...

  3. Effects of adding intravenous nicorandil to standard therapy on cardiac sympathetic nerve activity and myocyte dysfunction in patients with acute decompensated heart failure

    Kasama, Shu [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Cardiovascular Hospital of Central Japan (Kitakanto Cardiovascular Hospital), Department of Cardiovascular Medicine, Gunma (Japan); Toyama, Takuji; Funada, Ryuichi; Takama, Noriaki; Koitabashi, Norimichi; Kurabayashi, Masahiko [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Ichikawa, Shuichi [Cardiovascular Hospital of Central Japan (Kitakanto Cardiovascular Hospital), Department of Cardiovascular Medicine, Gunma (Japan); Suzuki, Yasuyuki; Matsumoto, Naoya [Nihon University School of Medicine, Department of Cardiology, Tokyo (Japan); Sato, Yuichi [Health Park Clinic, Department of Imaging, Takasaki, Gunma (Japan)

    2015-04-01

    Nicorandil, an adenosine triphosphate-sensitive potassium channel opener, improves cardiac sympathetic nerve activity (CSNA) in ischemic heart disease or chronic heart failure. However, its effects on CSNA and myocyte dysfunction in acute heart failure (AHF) remain unclear. We investigated the effects of adding intravenous nicorandil to standard therapy on CSNA and myocyte dysfunction in AHF. We selected 70 patients with mild to moderate nonischemic AHF who were treated with standard conventional therapy soon after admission. Thirty-five patients were assigned to additionally receive intravenous nicorandil (4-12 mg/h; group A), whereas the remaining patients continued their current drug regimen (group B). Delayed total defect score (TDS), delayed heart to mediastinum count (H/M) ratio, and washout rate (WR) were determined by {sup 123}I-metaiodobenzylguanidine (MIBG) scintigraphy within 3 days of admission and 4 weeks later. High sensitivity troponin T (hs-TnT) level was also measured at the same time points. After treatment, MIBG scintigraphic parameters significantly improved in both groups. However, the extent of the changes in these parameters in group A significantly exceeded the extent of the changes in group B [TDS -11.3 ± 4.3 in group A vs -4.0 ± 6.0 in group B (p < 0.01); H/M ratio 0.31 ± 0.16 vs 0.14 ± 0.16 (p < 0.01); WR -13.8 ± 7.8 % vs -6.1 ± 8.9 % (p < 0.01)]. The hs-TnT level decreased significantly from 0.052 ± 0.043 to 0.041 ± 0.033 ng/ml (p < 0.05) in group A, but showed no significant change in group B. Moreover, in both groups, no relationships between the extent of changes in MIBG parameters and hs-TnT level were observed. Adding intravenous nicorandil to standard therapy provides additional benefits for CSNA and myocyte dysfunction over conventional therapy alone in AHF patients. Furthermore, the mechanisms of improvement in CSNA and myocyte dysfunction after nicorandil treatment in AHF patients were distinct. (orig.)

  4. Effects of adding intravenous nicorandil to standard therapy on cardiac sympathetic nerve activity and myocyte dysfunction in patients with acute decompensated heart failure

    Nicorandil, an adenosine triphosphate-sensitive potassium channel opener, improves cardiac sympathetic nerve activity (CSNA) in ischemic heart disease or chronic heart failure. However, its effects on CSNA and myocyte dysfunction in acute heart failure (AHF) remain unclear. We investigated the effects of adding intravenous nicorandil to standard therapy on CSNA and myocyte dysfunction in AHF. We selected 70 patients with mild to moderate nonischemic AHF who were treated with standard conventional therapy soon after admission. Thirty-five patients were assigned to additionally receive intravenous nicorandil (4-12 mg/h; group A), whereas the remaining patients continued their current drug regimen (group B). Delayed total defect score (TDS), delayed heart to mediastinum count (H/M) ratio, and washout rate (WR) were determined by 123I-metaiodobenzylguanidine (MIBG) scintigraphy within 3 days of admission and 4 weeks later. High sensitivity troponin T (hs-TnT) level was also measured at the same time points. After treatment, MIBG scintigraphic parameters significantly improved in both groups. However, the extent of the changes in these parameters in group A significantly exceeded the extent of the changes in group B [TDS -11.3 ± 4.3 in group A vs -4.0 ± 6.0 in group B (p < 0.01); H/M ratio 0.31 ± 0.16 vs 0.14 ± 0.16 (p < 0.01); WR -13.8 ± 7.8 % vs -6.1 ± 8.9 % (p < 0.01)]. The hs-TnT level decreased significantly from 0.052 ± 0.043 to 0.041 ± 0.033 ng/ml (p < 0.05) in group A, but showed no significant change in group B. Moreover, in both groups, no relationships between the extent of changes in MIBG parameters and hs-TnT level were observed. Adding intravenous nicorandil to standard therapy provides additional benefits for CSNA and myocyte dysfunction over conventional therapy alone in AHF patients. Furthermore, the mechanisms of improvement in CSNA and myocyte dysfunction after nicorandil treatment in AHF patients were distinct. (orig.)

  5. Role of Nesiritide in Therapy of Patients with Acute Decompensated Heart Failure%奈西立肽在治疗急性失代偿心力衰竭患者中的地位

    胡康新; 陈伊; 胡佩

    2013-01-01

    Nesiritide( rhBNP ) is manufactured from escherichia coli using recombinant DNA technology and has the same chemical structure and biological effects as the BNP produced endogenously by the ventricular myocardium. rhBNP is a potent vasodilator which was approved by US FDA in 2001 for treatment of patients with acute decompensated heart failure( ADHF ). Foreign literatures had showed that rhBNP may rapidly improve hemodynamic status and clinical symptom of ADHF. In prior study, the safety of rhBNP has been questioned, and rhBNP was found to increase 30-day mortality and risk for renal impairments. Recent opinion in this regard is that so long as we use recommend dose ( 0. 01μg · kg-1 · min-1 ± bolus ) rhBNP appear to be safe and effective in patients with ADHF.%柰西立肽为一用重组DNA技术由大肠杆菌制成,具有如心室肌内源性产生的脑利钠肽相同的化学结构和生物学作用.2001年由美国FDA批准的强效扩血管药,最近已用于急性失代偿性心力衰竭患者治疗最新选择.国外文献报道它能短期内改善血流动力学状况和临床症状.在以前研究显示,奈西立肽存在安全性问题,即增高30 d病死率和肾功能损害的危险.最近的意见是,只要我们应用推荐剂量[0.01 μg/( kg·min)±负荷剂量],奈西立肽对急性失代偿性心力衰竭患者似乎是安全有效的.现系统复习奈西立肽的一般知识,它在急性失代偿性心力衰竭患者使用的推荐剂量、临床疗效和安全性.

  6. The outcome of critical illness in decompensated alcoholic liver cirrhosis

    Kavli, M; Strøm, T; Carlsson, M;

    2012-01-01

    %. If respiratory failure was further complicated by shock treated with vasopressor agents, the 90-day mortality increased to 89%. Ninety-day mortality for patients in need of mechanical ventilation, vasoactive medication, and renal replacement therapy because of acute kidney injury was 93%. CONCLUSION......BACKGROUND: The mortality of patients suffering from acute decompensated liver disease treated in the intensive care unit (ICU) varies between 50% and 100%. Previously published data suggest that liver-specific score systems are less accurate compared with the ICU-specific scoring systems acute...... physiology and chronic health evaluation II (APACHE II) and simplified organ failure assessment (SOFA) in predicting outcome. We hypothesized that in a Scandinavian cohort of ICU patients, APACHE II, SOFA, and simplified acute physiology score (SAPS II) were superior to predict outcome compared with the...

  7. Newer treatments for decompensated heart failure: focus on levosimendan

    Ferenc Follath

    2009-03-01

    Full Text Available Ferenc FollathUniversity Hospital Zürich, Steering Group Drug Therapy, Zürich, SwitzerlandAbstract: Acute heart failure (AHF is a major cause of hospitalizations. Severe dyspnea, pulmonary congestion and low cardiac output with peripheral vasoconstriction and renal hypoperfusion is a main form of clinical presentation. Most patients with acute worsening have a pre-existing decompensated chronic heart failure (ADCHF, but AHF may also occur as a first manifestation of a previously unknown heart disease. Myocardial ischemia, cardiac arrhythmias, non-compliance with medication and infections are frequent precipitating factors. Management of AHF depends on the underlying heart disease and cause of decompensation. In patients with ADCHF vasodilators and iv diuretics are first-line drugs for rapid reduction of dyspnea and congestion. In patients with signs of low cardiac output and oliguria, inotropic agents are also often administered to prevent further deterioration. Beta-adrenergic agents and phosphodiesterase inhibitors correct the hemodynamic disturbance, but may also induce arrhythmias and worsen myocardial ischemia. Inotropic therapy therefore remains controversial. A novel class of drugs, the calcium sensitizers, represent a new therapeutic option. Levosimendan was shown to improve myocardial contractility without increasing oxygen requirements and to produce peripheral and coronary vasodilation. Its therapeutic effects and tolerance have been tested in several trials. The present review focuses on the clinical pharmacology and therapeutic utility of levosimendan in patients with ADCHF.Keywords: acute heart failure, inotropic agents, calcium sensitizers, levosimendan

  8. Oral zolpidem prevents acute mountain sickness: a randomized double-blind placebo controlled study

    Yong-tao HUANG; Qin, Jun; Xu-bin GAO; Chen, Guo-Zhu; Zheng, Cheng-Rong; Yang, Jie; Huang, Lan

    2015-01-01

    Objective To study the prophylactic effect of zolpidem on acute mountain sickness (AMS) after acute high-altitude exposure. Methods A randomized double-blind placebo controlled trial was performed on the plateau. Forty subjects were randomly divided into zolpidem group and placebo group. The general clinical data, heart rate, blood pressure, oxygen saturation, the Pittsburgh Sleep Quality Index (PSQI) scores, AMS scores and physical fitness test of the both groups were collected and assessed ...

  9. Treatment of Decompensated Alcoholic Liver Disease

    John Menachery; Ajay Duseja

    2011-01-01

    Alcoholic liver disease (ALD) is a spectrum ranging from simple hepatic steatosis to alcoholic hepatitis and cirrhosis. Patients with severe alcoholic hepatitis can have clinical presentation almost similar to those with decompensated cirrhosis. Scoring with models like Maddrey discriminant function, a model for end-stage liver disease, Glasgow alcoholic hepatitis score, and Lille model are helpful in prognosticating patients with ALD. One of the first therapeutic goals in ALD is to induce al...

  10. Acupuncture in the Inpatient Acute Care Setting: A Pragmatic, Randomized Control Trial

    Jeannette Painovich; Herman, Patricia M.

    2012-01-01

    Purpose. To evaluate the acceptance and effectiveness of acupuncture in a hospital setting. Methods. This 18-month pragmatic randomized controlled trial used a two-tiered consent process for all patients admitted to the acute care unit by study physician groups. The primary study comparison was between those randomized (using biased-coin randomization after initial consent) to be offered acupuncture or not. The primary outcome was length of stay (LOS). Other measures include costs, self-repor...

  11. Acute migraine therapy: recent evidence from randomized comparative trials

    Mett, A.; Tfelt-Hansen, P.

    2008-01-01

    (1) A wide array of data regarding acute migraine treatment are available, but few trials strictly adhere to International Headache Society guidelines for patient inclusion criteria. (2) Triptans appear to have similar efficacy profiles, but among newer triptans, almotriptan offers improved toler...

  12. Prevalência e preditores de embolia pulmonar em pacientes com insuficiência cardíaca agudamente descompensada Prevalence and predictors of pulmonary embolism in patients with acutely decompensated heart failure

    Luís C. L. Correia

    2012-02-01

    Full Text Available FUNDAMENTO: Não existe descrição da prevalência de Embolia Pulmonar (EP em pacientes internados por quadro clássico de Insuficiência Cardíaca descompensada (IC. OBJETIVO: Em pacientes internados por IC, (1 descrever a prevalência de EP, e (2 avaliar a acurácia diagnóstica dos Escores de Wells e de Genebra. MÉTODOS: Pacientes internados primariamente por IC realizaram sistematicamente cintilografia pulmonar de ventilação/perfusão, sendo EP definida por laudo de alta probabilidade. Para fins de interpretação, definimos baixa probabilidade clínica de EP como prevalência BACKGROUND: The prevalence of pulmonary embolism (PE has not been reported in patients hospitalized due to classical findings of decompensated heart failure (HF. OBJECTIVE: To describe the prevalence of PE and to assess the diagnostic accuracy of the Wells and Geneva scores in patients hospitalized due to HF. METHODS: Patients hospitalized primarily due to HF underwent systematic ventilation-perfusion lung scan, and PE was defined by a result of high probability. Aiming at interpreting, low clinical probability of PE was defined as prevalence < 5%, according to the literature. When calculating the sample size, 49 patients were required to provide a 95% confidence interval with ±10% accuracy, estimating an a priori prevalence of 15%. RESULTS: Of 51 patients studied, six had a high probability of PE on lung scan, resulting in 12% prevalence (95% CI = 5% - 23%. The Wells and Geneva scores had an area under the ROC curve of 0.53 (95% CI = 0.27 - 0.80; p = 0.80 and 0.43 (95% CI = 0.13 - 0.73; p = 0.56, respectively, indicating lack of accuracy for the diagnosis of PE. Alternatively, variables related to HF showed a tendency towards association with PE, and an exploratory model formed by that type of variable showed diagnostic accuracy for PE (ROC = 0.81; 95% CI = 0.66 - 0.96; p = 0.01. CONCLUSION: (1 Despite the lack of primary suspicion, patients admitted with HF have

  13. 低糖血症与急性失代偿性肝硬化患者 病死率增加的相关性研究%Correlation between hypoglycemia and increased mortality of patients with acute decompensated liver cirrhosis

    刘润田; 白云; 安聪静; 李秋生; 郑建兴; 张海燕

    2015-01-01

    Objective To explore the correlation between hypoglycemia and the increased mortality of patients with acute decompensated liver cirrhosis.Methods A retrospective study was conducted on the clinical data of 120 patients with acute decompensated liver cirrhosis admitted to the Department of Hepatobiliary Surgery of the Second Hospital of Hebei Medical University from December 2011 to December 2014. The patients were divided into three groups: hypoglycemia group (glucose 10.0 mmol/L, 15 cases). The differences in hepatic carcinoma, decompensation symptoms, the incidence of known glycometabolic disorder, hospitalization situation, indicators of liver function and indexes of blood gas analysis were compared among three groups. The patients' age, hepatic carcinoma, ascites, hepatorenal syndrome, encephalopathy, bleeding, jaundice and glycometabolic disorder, etc were analyzed by the univariate analysis. The resulting risk factors with statistically significant differences were analyzed by multivariate logistic regression method in order to screen out the risk factors of increased mortality.Results The incidences of hepatorenal syndrome [42.9% (9/21) vs. 22.6% (19/84), 33.3% (5/15)] and jaundice [38.1% (7/21) vs. 20.2% (17/84), 13.3% (2/15)], rate of admission into intensive care unit (ICU) [14.3% (3/21) vs. 10.7% (9/84), 13.3% (2/15)] and in-hospital mortality [23.8% (5/21) vs. 10.7% (9/84), 20.0% (3/15)] in the hypoglycemia group were significantly higher than those in the normoglycemia group and hyperglycemia group (P 0.05). Univariate analysis showed that advanced age, hepatic carcinoma, hepatorenal syndrome, bleeding, jaundice and glycometabolic disorder hypoglycemia were the risk factors of the death in patients with acute decompensated liver cirrhosis (P 10.1 mmol/L,15例),比较3组患者肝癌、代偿失调症状、已知糖代谢紊乱发生率及住院情况、肝功能指标和血气分析指标的差异,对患者的年龄、肝癌、腹水、肝肾综合

  14. Sublingual buprenorphine for acute renal colic pain management: a double-blind, randomized controlled trial

    Payandemehr, Pooya; Jalili, Mohammad; Mostafazadeh Davani, Babak; Dehpour, Ahmad Reza

    2014-01-01

    Background The aim of this study was to compare the efficacy and safety of sublingual buprenorphine with intravenous morphine sulfate for acute renal colic in the emergency department. Methods In this double-dummy, randomized controlled trial, we enrolled patients aged 18 to 55 years who had a clinical diagnosis of acute renal colic. Patients received either 2 mg sublingual buprenorphine with an IV placebo, or 0.1 mg/kg IV morphine sulfate with a sublingual placebo. Subjects graded their pain...

  15. Prednisone lowers serum uric acid levels in patients with decompensated heart failure by increasing renal uric acid clearance.

    Liu, Chao; Zhen, Yuzhi; Zhao, Qingzhen; Zhai, Jian-Long; Liu, Kunshen; Zhang, Jian-Xin

    2016-07-01

    Clinical studies have shown that large doses of prednisone could lower serum uric acid (SUA) in patients with decompensated heart failure (HF); however, the optimal dose of prednisone and underlying mechanisms are unknown. Thirty-eight patients with decompensated HF were randomized to receive standard HF care alone (n = 10) or with low-dose (15 mg/day, n = 8), medium-dose (30 mg/day, n = 10), or high-dose prednisone (60 mg/day, n = 10), for 10 days. At the end of the study, only high-dose prednisone significantly reduced SUA, whereas low- and medium-dose prednisone and standard HF care had no effect on SUA. The reduction in SUA in high-dose prednisone groups was associated with a significant increase in renal uric acid clearance. In conclusion, prednisone can reduce SUA levels by increasing renal uric acid clearance in patients with decompensated HF. PMID:27144905

  16. Efficacy of toivaptan for delusional hyponatremia in decompensated liver cirrhosis

    阚晓

    2014-01-01

    Objective To investigate the efficacy and safety of vasopressin receptor antagonist tolvaptan for treating dilutional hyponatremia casused by decompensated liver cir-rhosis.Methods Ninety-six subjects with decompensated liver cirrhosis complicated by dilutional hyponatremia were divided into test group(n=56)and control group(n=40)by double blind method.

  17. Inflammasome activation in decompensated liver cirrhosis

    2016-01-01

    Inflammation participates in the pathogenesis of many liver diseases, including liver cirrhosis. Certaininflammatory citokines, such as interleukin (IL)-1β andIL-18, are produced after the activation of a multiproteincomplex known as the inflammasome. Activation of theinflammasome has been documented in several liverdiseases, but its role in the development and progressionof liver cirrhosis or the complications associated withthis disease is still largely unknown. We have recentlystudied the impact of the inflammasome in the sterileinflammatory response that takes place in the asciticfluid of patients with decompensated cirrhosis, providingevidence that activation of the absent in melanoma2 (AIM2) inflammasome is an important response inthese patients. Ascitic fluid-derived macrophages wereable to mount a very robust AIM2-mediated responseeven in the absence of a priming signal, which is usuallyrequired for the full activation of all the inflammasomes.In addition, high level of inflammasome activation inthese patients was associated with a higher degree ofliver disease and an increased incidence of spontaneousbacterial peritonitis. These results may help explain theexacerbated inflammatory response that usually occursin patients with decompensated cirrhosis in the absenceof detectable infections. Thus, inflammasomes shouldbe considered as possible therapeutic targets in sterileinflammatory complications in patients with cirrhosis.

  18. Treatment of Decompensated Alcoholic Liver Disease

    John Menachery

    2011-01-01

    Full Text Available Alcoholic liver disease (ALD is a spectrum ranging from simple hepatic steatosis to alcoholic hepatitis and cirrhosis. Patients with severe alcoholic hepatitis can have clinical presentation almost similar to those with decompensated cirrhosis. Scoring with models like Maddrey discriminant function, a model for end-stage liver disease, Glasgow alcoholic hepatitis score, and Lille model are helpful in prognosticating patients with ALD. One of the first therapeutic goals in ALD is to induce alcohol withdrawal with psychotherapy or drugs. Most studies have shown that nutritional therapy improves liver function and histology in patients with ALD. The rationale for using glucocorticoids is to block cytotoxic and inflammatory pathways in patients with severe alcoholic hepatitis. Pentoxifylline, a tumor necrosis factor alpha (TNFα suppressor, and infliximab, an anti-TNFα mouse/human chimeric antibody, has been extensively studied in patients with alcoholic hepatitis. Liver transplantation remains the definitive therapy for decompensated cirrhosis/alcoholic hepatitis despite the issues of recidivism, poor compliance with postoperative care, and being a self-inflicted disease.

  19. Randomized controlled trial of oral vs intravenous therapy for the clinically diagnosed acute uncomplicated diverticulitis.

    Ridgway, P F

    2009-11-01

    Despite the high prevalence of hospitalization for left iliac fossa tenderness, there is a striking lack of randomized data available to guide therapy. The authors hypothesize that an oral antibiotic and fluids are not inferior to intravenous (IV) antibiotics and \\'bowel rest\\' in clinically diagnosed acute uncomplicated diverticulitis.

  20. Zinc and copper supplementation in acute diarrhea in children: a double-blind randomized controlled trial

    Mamtani Manju

    2009-05-01

    Full Text Available Abstract Background Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhea. Methods We conducted a double-blind randomized controlled clinical trial in the Department of Pediatrics at Indira Gandhi Government Medical College Nagpur, India. Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually randomized to placebo (Pl, zinc (Zn only, and zinc and copper (Zn+Cu together with standard treatment for acute diarrhea. Results The mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams, respectively, and there were no significant differences in the adjusted means across treatment groups. Similarly, the adjusted means of the amount of oral rehydration solution or intravenous fluids used, the proportion of participants with diarrhea more than 7 days from onset, and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment, did not differ across the three groups. Conclusion The expected beneficial effects of zinc supplementation for acute diarrhea were not observed. Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children. Trial registration The study was registered as an International Standard Randomized Controlled Trial (ISRCTN85071383.

  1. Internal gallbladder drainage prevents development of acute cholecystitis in a pig model: a randomized study

    Kjaer, Daniel W; Mortensen, Frank V; Møller, Jens K; Hamilton-Dutoit, Stephen J; Funch-Jensen, Peter

    2010-01-01

    BACKGROUND: Acute cholecystitis can be the result of retention of bile in the gallbladder with possible secondary infection and ischaemia. The aim of the present study was to investigate whether internal drainage of the gallbladder could protect against the development of acute cholecystitis in a...... pig model. MATERIALS AND METHODS: Twenty pigs were randomized to either internal drainage (drained) or not (undrained). Day 0 acute cholecystitis was induced by ligation of the cystic artery and duct together with inoculation of bacteria. Four days later the pigs were killed and the gallbladders were...... removed and histologically scored for the presence of cholecystitis. Bile and blood samples were collected for bacterial culturing and biochemical analyses. RESULTS: The histological examination demonstrated statistical significant differences in acute cholecystitis development between groups, the degree...

  2. A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

    Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F; Lauritzen, M; Bang, P; Morup, A; Frederiksen, J.L.

    2005-01-01

    OBJECTIVE: To investigate if IV immunoglobulin (IVIG) treatment in the acute phase of optic neuritis (ON) could improve visual outcome and reduce MRI disease activity 6 months after onset of ON. METHODS: Sixty-eight patients with ON were randomized within 4 weeks from onset of symptoms. Thirty...... treatment groups during follow-up. CONCLUSIONS: There was no effect of IV immunoglobulin (IVIG) on long-term visual function following acute optic neuritis, nor was there an effect of IVIG treatment in reducing latency on visual evoked potentials and thus preserving function of axons of the optic nerve......-four patients were randomized to IVIG 0.4 g/kg body wt, and 34 patients were randomized to placebo. Infusions were given at days 0, 1, 2, 30, and 60. Contrast sensitivity, visual acuity, and color vision were measured at baseline and after 1 week, 1 month, and 6 months. Pattern reversal visual evoked potential...

  3. Short term efficacy and safety of low dose tolvaptan in patients with acute decompensated heart failure with hyponatremia: a prospective observational pilot study from a single center in South India

    Soumya Patra

    2014-01-01

    Conclusion: In this small observational study, tolvaptan initiation in patients with ADHF with hyponatremia in addition to standard therapy may hold promise in improvement in NYHA class and serum sodium. At the same time, we observed that serious adverse events such as renal function deterioration and hypernatremia developed after tolvaptan treatment, which needs to be addressed in future by randomized study with larger sample size.

  4. Entecavir for Patients with Hepatitis B Decompensated Cirrhosis in China: a meta-analysis

    Wang, F.Y.; Li, B.; Li, Y.; Liu, H.; Qu, W.D.; Xu, H.W.; Qi, J.N.; Qin, C.Y.

    2016-01-01

    Evidence about the clinical effects of entecavir (ETV) for patients with hepatitis B decompensated cirrhosis remain controversial. Therefore, we perform this meta-analysis to assess the treatment outcomes of ETV in participants with hepatitis B decompensated cirrhosis. Relevant studies were identified by searching databases until the March 2016. A random-effects model was used to estimate summary relative risks (RRs) and 95% confidence intervals (CIs). GRADEprofiler3.6 was used to evaluate the quality of the evidence. A total of 26 studies (involving 2040 patients) were included. The quality of the evidence was classified from very low to high by the GRADED approach for all included RCTs. Meta-analysis showed that patients were more likely to experience HBV-DNA loss (RR:1.85, 95%CIs: 1.41 to 2.43, P < 0.0001 at 48 weeks), have normalized alanine aminotransferase levels (ALT) (P = 0.003 at 24 weeks, P = 0.02 at 48 weeks), and have a low mortality rate at 24 weeks (P = 0.003) when treated with ETV. There was no significant different between ETV and the control groups at the total mortality (P = 0.06) and HBeAg seroconversion (P = 0.14). In conclusion, ETV could be the first line therapy for patients with HBV related decompensated cirrhosis, because ETV could reduce the early mortality and move HBV DNA load down. PMID:27601086

  5. Qing-Yi decoction in participants with severe acute pancreatitis: a randomized controlled trial

    Chen, Weiwei; Yang, Xiaonan; Huang, Lei; Xue, Ping; Wan, Meihua; Guo, Jia; Zhu, Lin; Jin, Tao; Huang, Zongwen; Chen, Guangyuan; Tang, Wenfu; Xia, Qing

    2015-01-01

    Background Qing-Yi Decoction (QYD) has been used for severe acute pancreatitis (SAP) patients in China for many years. There were two kinds of QYD: Num 1. QYD (QYD1) which is used in the acute response stage of SAP and Num 2. QYD (QYD2) which is used in the second stage of SAP. This study aims to evaluate the therapeutic efficacy of QYD in participants with SAP. Methods In this prospective, randomized, double-blind, placebo-controlled trial, participants aged 18–70 years within the first 7 da...

  6. Topical corticosteroids in the treatment of acute sunburn - A randomized, double-blind clinical trial

    Faurschou, A.; Wulf, Hans Chr.

    2008-01-01

    Objective: To examine the effect of topical corticosteroid treatment on acute sunburn. Design: Randomized, double-blind clinical trial. Setting: University dermatology department. Patients: Twenty healthy volunteers with Fitzpatrick skin types I (highly sensitive, always burns easily, tans...... in the acute sunburn reaction when applied 6 or 23 hours after UV exposure. Clinical Trial Registry: clinicaltrials. gov Identifier: NCT00206882 Udgivelsesdato: 2008/5...... or high-potency corticosteroid 6 hours after UV-B exposure were significantly different from SIFs in areas that received no treatment (SIF 1.1-1.7; P clinically relevant. The areas...

  7. Management of hepatitis C patients with decompensated liver disease.

    Hsu, Ching-Sheng; Kao, Jia-Horng

    2016-06-01

    Little is known about the tolerance and effectiveness of novel oral direct acting antivirals (DAA) in hepatitis C patients with decompensated cirrhosis. To examine the studies relevant to the treatment of hepatitis C virus(HCV)-related decompensated liver disease, we performed computer-based searches for English articles between 1947 and August 2015. Fourteen articles including HCV patients with decompensated cirrhosis were reviewed. The combinations of ledipasvir(LDV)/sofosbuvir(SOF)/ribavirin(RBV) for 12 weeks, or daclatasvir/SOF/RBV for 12 weeks are safe and effective for HCV genotype 1 or 4 infection, and daclatasvir/SOF/RBV for 12 weeks or SOF/RBV for 24 weeks might be effective and safe for HCV genotype 2 or 3 infection. In conclusion, current evidence supports the use of all oral DAA regimens in HCV patients with decompensated cirrhosis. PMID:26782619

  8. [Comprehensive therapy of cerebral and cerebrovascular decompensation (author's transl)].

    Hofmann, G

    1980-06-01

    Many psychiatric syndroms in older age are based on cerebral and cerebrovascular decompensation. Diagnosis of metabolic dysfunction or vascular dysregulation--leading to cerebral decompensation--and their therapy is of greater importance than immediate therapy of psychiatric syndroms. We use Strophantin therapy, hemodilation, stabilization of blood pressure, antidiabetics combined with mild sedation by low dose neuroleptics. After achieving metabolic and cerebrovascular equilibrium we start more or less specific psychiatric syndrom therapy like antidepressants. PMID:6109459

  9. Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial

    Gabriella Coruzzi; Emilio Marangio; Cosimo Costantino

    2010-01-01

    Pharmacological therapy of back pain with analgesics and anti-inflammatory drugs is frequently associated with adverse effects, particularly in the elderly. Aim of this study was to compare mesotherapic versus conventional systemic administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in patients with acute low back pain. Eighty-four patients were randomized to receive anti-inflammatory therapy according to the following protocols: (a) mesotherapy group received ...

  10. Graft irradiation in the treatment of acute rejection of renal transplants: a randomized study

    A randomized study of graft irradiation in the treatment of acute rejection of renal transplants was conducted from 1978 to 1981. Patients developing clinical signs of an acute graft rejection received customary antirejection treatment in the form of intravenous administration of high-dose (1 gm per day) of methylprednisolone. They were at the same time randomized to either receive therapeutic irradiation (175 rad every other day to a total of 525 rad) or sham irradiation. Neither the patient nor the Transplant Service surgeons knew at any time whether the radiation treatment had been given. Eighty-three rejection episodes occurring in 64 grafts were entered into the study. Acute rejection was reversed in 84.5% of grafts in the control and 75% in the treated group. The incidence of recurrent rejection was higher in the treated group (66 vs. 46%) and graft survival was lower (22% vs. 54%). The study failed to demonstrate a beneficial effect of graft irradiation in the treatment of acute renal allograft rejection, when used in conjunction with high dose steriods

  11. Graft irradiation in the treatment of acute rejection of renal transplants: a randomized study

    Pilepich, M.V.; Anderson, C.B.; Etheredge, E.E.; Sicard, G.A.; Melzer, J.S.; Blum, J.

    1982-05-01

    A randomized study of graft irradiation in the treatment of acute rejection of renal transplants was conducted from 1978 to 1981. Patients developing clinical signs of an acute graft rejection received customary antirejection treatment in the form of intravenous administration of high-dose (1 gm per day) of methylprednisolone. They were at the same time randomized to either receive therapeutic irradiation (175 rad every other day to a total of 525 rad) or sham irradiation. Neither the patient nor the Transplant Service surgeons knew at any time whether the radiation treatment had been given. Eighty-three rejection episodes occurring in 64 grafts were entered into the study. Acute rejection was reversed in 84.5% of grafts in the control and 75% in the treated group. The incidence of recurrent rejection was higher in the treated group (66 vs. 46%) and graft survival was lower (22% vs. 54%). The study failed to demonstrate a beneficial effect of graft irradiation in the treatment of acute renal allograft rejection, when used in conjunction with high dose steriods.

  12. Influence of bilevel positive airway pressure on autonomic tone in hospitalized patients with decompensated heart failure.

    Lacerda, Diego; Costa, Dirceu; Reis, Michel; Gomes, Evelim Leal de F Dantas; Costa, Ivan Peres; Borghi-Silva, Audrey; Marsico, Aline; Stirbulov, Roberto; Arena, Ross; Sampaio, Luciana Maria Malosá

    2016-01-01

    [Purpose] This study evaluated the effect of Bilevel Positive Airway (BiPAP) on the autonomic control of heart rate, assessed by heart rate variability (HRV), in patients hospitalized with decompensated heart failure. [Subjects and Methods] This prospective cross-sectional study included 20 subjects (age: 69±8 years, 12 male, left ventricular ejection fraction: 36 ±8%) diagnosed with heart failure who were admitted to a semi-intensive care unit with acute decompensation. Date was collected for HRV analysis during: 10 minutes spontaneous breathing in the resting supine position; 30 minutes breathing with BiPAP application (inspiratory pressure = 20 cmH2O and expiratory pressure = 10 cmH2O); and 10 minutes immediately after removal of BiPAP, during the return to spontaneous breathing. [Results] Significantly higher values for indices representative of increased parasympathetic activity were found in the time and frequency domains as well as in nonlinear Poincaré analysis during and after BiPAP in comparison to baseline. Linear HRV analysis: standard deviation of the average of all R-R intervals in milliseconds = 30.99±4.4 pre, 40.3±6.2 during, and 53.3±12.5 post BiPAP. Non-linear HRV analysis: standard deviations parallel in milliseconds = 8.31±4.3 pre, 12.9±5.8 during, and 22.8 ±6.3 post BiPAP. [Conclusion] The present findings demonstrate that BiPAP enhances vagal tone in patients with heart failure, which is beneficial for patients suffering from acute decompensation. PMID:26957719

  13. Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial

    Sidney Glina

    2011-12-01

    Full Text Available PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs. As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174 or ketoprofen 100 mg IV plus placebo (n = 164. 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174 or ketoprofen 100 mg IV(n = 164 plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID at 30 minutes by visual analog scale (VAS (per-protocol population. An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD mPID30 min was 33.84 (24.61 and 35.16 (26.01 for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.

  14. Xyloglucan for the Treatment of Acute Gastroenteritis in Children: Results of a Randomized, Controlled, Clinical Trial

    Pleșea Condratovici, Cătălin; Bacarea, Vladimir; Piqué, Núria

    2016-01-01

    Background. Xyloglucan, a film-forming agent, improves intestinal mucosa resistance to pathologic damage. The efficacy, safety, and time of onset of the antidiarrheal effect of xyloglucan were assessed in children with acute gastroenteritis receiving oral rehydration solution (ORS). Methods. This randomized, controlled, open-label, parallel-group, multicenter, clinical trial included children (3 months–12 years) with acute gastroenteritis of infectious origin. Children were randomized to xyloglucan and ORS, or ORS only, for 5 days. Diarrheal symptoms, including stool number/characteristics, and safety were assessed at baseline and after 2 and 5 days and by fulfillment of a parent diary card. Results. Thirty-six patients (58.33% girls) were included (n = 18/group). Patients receiving xyloglucan and ORS had better symptom evolution than ORS-only recipients, with a faster onset of action. At 6 hours, xyloglucan produced a significantly greater decrease in the number of type 7 stools (0.11 versus 0.44; P = 0.027). At days 3 and 5, xyloglucan also produced a significantly greater reduction in types 6 and 7 stools compared with ORS alone. Xyloglucan plus ORS was safe and well tolerated. Conclusions. Xyloglucan is an efficacious and safe option for the treatment of acute gastroenteritis in children, with a rapid onset of action in reducing diarrheal symptoms. This study is registered with ISRCTN number 65893282.

  15. Prevention of depression in patients with acute coronary syndrome (DECARD) randomized trial

    Hjorthøj, Carsten Rygaard; Hansen, Baiba Hedegaard; Hanash, Jamal Abed;

    2015-01-01

    AIM: Escitalopram may prevent depression following acute coronary syndrome. We sought to estimate the effects of escitalopram on self-reported health and to identify subgroups with higher efficacy. METHODS: This is a secondary analysis of a 12-month double-blind clinical trial randomizing non......-depressed acute coronary syndrome patients to escitalopram (n = 120) or matching placebo (n = 120). The main outcomes were mean scores on Short Form 36 Health Survey (SF-36) domains, and diagnosis of depression was adjusted for baseline SF-36 scores. RESULTS: Escitalopram did not yield different SF-36...... trajectories on any scale compared with placebo (P > 0.28). Efficacy of escitalopram may have been better among those scoring at least the normative score on general health perceptions (hazard ratio (HR) for depression 0.17 (95% confidence interval 0.02-1.42) ) or social functioning (HR = 0.12 (0...

  16. Oral zolpidem prevents acute mountain sickness: a randomized double-blind placebo controlled study

    Yong-tao HUANG

    2015-10-01

    Full Text Available Objective To study the prophylactic effect of zolpidem on acute mountain sickness (AMS after acute high-altitude exposure. Methods A randomized double-blind placebo controlled trial was performed on the plateau. Forty subjects were randomly divided into zolpidem group and placebo group. The general clinical data, heart rate, blood pressure, oxygen saturation, the Pittsburgh Sleep Quality Index (PSQI scores, AMS scores and physical fitness test of the both groups were collected and assessed on plain and plateau, respectively. Results The PSQI scores were obviously lower and the six-minute walk distance was significantly longer in zolpidem group than those in placebo group (P=0.047 and P=0.009, respectively after acute high-altitude exposure. AMS incidence was significantly lower in zolpidem group than in placebo group at different time points (P=0.019, 0.014, 0.025 and 0.026, respectively, and the incidence of severe AMS was also significantly lower in zolpidem group than in placebo group at different time points (P=0.047, 0.044, 0.031 and 0.020, respectively. The symptoms of dizziness, weakness and fatigue were significantly lighter in zolpidem group than in placebo group after acute exposure to high-altitude exposure for 20 hours (P0.05. Conclusion Zolpidem may alleviate AMS symptoms and reduce the incidence of AMS, so it may be promising as a new choice for the prevention of AMS. DOI: 10.11855/j.issn.0577-7402.2015.09.09

  17. Patient Activation through Counseling and Exercise – Acute Leukemia (PACE-AL) – a randomized controlled trial

    Jarden, Mary; Møller, Tom; Kjeldsen, Lars;

    2013-01-01

    treatment related symptoms and side effects. To date, there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy. A randomized controlled trial is needed to determine if patients with acute leukemia can benefit by a structured and...... supervised counseling and exercise program.Methods/design: This paper presents the study protocol: Patient Activation through Counseling and Exercise -- Acute Leukemia (PACE-AL) trial, a two center, randomized controlled trial of 70 patients with acute leukemia (35 patients/study arm) following induction...... chemotherapy in the outpatient setting. Eligible patients will be randomized to usual care or to the 12 week exercise and counseling program. The intervention includes 3 hours + 30 minutes per week of supervised and structured aerobic training (moderate to high intensity 70 - 80%) on an ergometer cycle...

  18. Effect of propranolol on survival in patients with decompensated cirrhosis

    Bang, Ulrich Christian; Benfield, Thomas; Hyldstrup, Lars; Jensen, Jens-Erik Beck; Bendtsen, Flemming

    2016-01-01

    BACKGROUND AND AIMS: We assessed the impact of propranolol on death, risk of hepatorenal syndrome (HRS) and peritonitis in patients with cirrhosis. METHODS: The study was a retrospective observational study and data was retrieved from Danish databases. We used our own criteria to stratify the...... patients into groups of patients with mildly decompensated cirrhosis or severely decompensated cirrhosis. A sub-group of patients with a history of peritonitis was also analyzed. Follow-up time was limited to two years from cohort entry. The reported hazard ratios (HR) with 95% confidence interval (CI......-propranolol was related with a HR of 0.7 (95%CI 0.6-0.9) and among the patients with severely decompensated cirrhosis the HR was 0.6 (95%CI 0.4-0.9). Reduced mortality was found for doses of propranolol lower than 160 mg/d only. Among 361 patients with peritonitis we found reduced mortality in the propranolol...

  19. N-acetylcysteine in Acute Organophosphorus Pesticide Poisoning: A Randomized, Clinical Trial.

    El-Ebiary, Ahmad A; Elsharkawy, Rasha E; Soliman, Nema A; Soliman, Mohammed A; Hashem, Ahmed A

    2016-08-01

    Organophosphorus poisoning is a major global health problem with hundreds of thousands of deaths each year. Research interest in N-acetylcysteine has grown among increasing evidence of the role of oxidative stress in organophosphorus poisoning. We aimed to assess the safety and efficacy of N-acetylcysteine as an adjuvant treatment in patients with acute organophosphorus poisoning. This was a randomized, controlled, parallel-group trial on 30 patients suffering from acute organophosphorus poisoning, who were admitted to the Poison Control Center of Tanta University Emergency Hospital, Tanta, Egypt, between April and September 2014. Interventions included oral N-acetylcysteine (600 mg three times daily for 3 days) as an added treatment to the conventional measures versus only the conventional treatment. Outcome measures included mortality, total dose of atropine administered, duration of hospitalization and the need for ICU admission and/or mechanical ventilation. A total of 46 patients were screened and 30 were randomized. No significant difference was found between both groups regarding demographic characteristics and the nature or severity of baseline clinical manifestations. No major adverse effects to N-acetylcysteine therapy were reported. Malondialdehyde significantly decreased and reduced glutathione significantly increased only in the NAC-treated patients. The patients on NAC therapy required less atropine doses than those who received only the conventional treatment; however, the length of hospital stay showed no significant difference between both groups. The study concluded that the use of N-acetylcysteine as an added treatment was apparently safe, and it reduced atropine requirements in patients with acute organophosphorus pesticide poisoning. PMID:26786042

  20. Effect of IMOD™ on the Inflammatory Process after Acute Ischemic Stroke: a Randomized Clinical Trial

    Homayoun Sadeghi-Bazargani

    2013-03-01

    Full Text Available Background and purpose of the study:Considering the role of inflammation in acute cerebrovascular accidents, anti-inflammatory treatment has been considered as an option in cerebrovascular diseases. Regarding the properties of Setarud (IMOD™ in immune regulation, the aim of the present study was to evaluate the role of this medication in treating patients with acute ischemic stroke.Methods:In this randomized clinical trial, 99 patients with their first ever acute ischemic stroke were divided into two groups of IMOD™ (n = 49 and control (n = 50. The control group underwent routine treatment and the intervention group underwent routine treatment plus daily intermittent infusion of IMOD™ (250mg on the first day and then 375mg into DW5% serum during a 30-minute period for 7 days. The serum levels of inflammatory markers were evaluated on the first day (baseline and on 4th and 7th days. Data were analyzed and the results were compared.Results and major conclusion:58 males (58.6% and 41 females (41.4% with a mean age of 67.00 ± 8.82 years, who had their first ever stroke attack, were enrolled in this trial. Treatment with IMOD™ showed a decreasing trend in IL-6 levels compared to the control group (p = 0.04. In addition, the treatment resulted in the control of increasing serum levels of hsCRP after 7 days compared to the control group (p = 0.02. There was an insignificant decrease in TNF-α and IL-1 levels in the IMOD™ group. Considering the prominent role of inflammation after an ischemic cerebral damage, it appears that treatment with IMOD™ improves the inflammatory profile. Therefore, IMOD™ (Setarud might be considered as a therapeutic option in the acute ischemic stroke. However, future studies are necessary on its long-term results and clinical efficacy

  1. Antiviral therapy of decompensated hepatitis B virus-related cirrhosis

    CHEN Guang-cheng; YU Tao; HUANG Kai-hong; CHEN Qi-kui

    2012-01-01

    Objective To review the development,mechanism,necessity and limitation of antiviral therapy in decompensated hepatitis B virus-related cirrhosis.Data sources Most information was pulled from a literature search (Pubmed 2000 to 2011) using the keywords of antiviral and decompensated hepatitis B virus-related cirrhosis.Relevant book chapters were also reviewed.Study selection Well-controlled,prospective landmark studies and review articles on antiviral therapy in decompesated hepatitis B virus-related cirrhosis were selected.Results Specific antiviral agents not only control viral replication,which permits liver transplantation,but also improve liver function so significantly that patients could be removed from the transplant waiting list.However,the emergence of drug-resistant mutants can result in treatment failure.Combination therapy is a save-strategy in drug-resistant.Conclusions Although the treatment of end-stage liver disease is still a challenge worldwide,antiviral therapy has altered the natural history of hepatitis B patients with decompensated cirrhosis.The approval of the new generation of antivirals is opening new perspectives for finding the optimal antiviral treatment for patients with decompensated cirrhosis and preventing antiviral resistance.A combination of antivirals may be one of the future strategies for fulfilling these goals.

  2. ROLE OF ORAL MONTELUKAST IN ACUTE ASTHMA EXACERBATIONS : A RANDOMIZED PLACEBO CONTROLLED TRIAL

    Gaude

    2015-08-01

    Full Text Available BACKGROUND: Leukotriene receptor antagonists (LTRAs are well established in the management of outpatient asthma. However, there is very little information as to their role in acute asthma exacerbations. The present study was done to evaluate the clinical efficacy of oral Montelukast as an add on therapy to the usual standard therapy of acute attack of bronchial asthma. MATERIALS AND METHODS: A randomized single blinded controlled study was conducted in a tertiary car e teaching hospital. A total of 320 patients with age >18 years of acute exacerbations due to bronchial asthma were included in the study. The patients were randomized into two study and control groups. The study group patients received oral Montelukast (1 0mg once daily for 2 weeks, while the control group received a placebo. All the patients received standard therapy according to GINA guidelines. Improvements in lung function tests, clinical symptoms and relapse rates were monitored at baseline, at discha rge and at 2 weeks. Side effects profile was also monitored. RESULTS: A total of 255 patients were finally assessed. One hundred thirty patients belonged to study group and 125 in the control group. Baseline characteristics were similar and well matched in both the groups. Mean age was 39.9±15.8 years in study group and 42.8±12.8 in the control group and majority were female patients in both the groups. At the end of 2 weeks, it was observed that there were no significant improvements in FEV 1 and FVC as com pared to the control group. However, there was significant improvement in PEFR at 2 weeks (0.4 L/sec, 12% as compared to the control group (p <0.0376. Length of hospital stay was similar in both the groups. No serious adverse effects were noted during th e course of the study. CONCLUSIONS: In acute asthma exacerbations, the present study showed that additional administration of oral Montelukast resulted in significantly higher PEFR at 2 weeks as compared to the standard

  3. Treating Acute Insomnia: A Randomized Controlled Trial of a “Single-Shot” of Cognitive Behavioral Therapy for Insomnia

    Ellis, Jason; Cushing, Toby; Germain, Anne

    2015-01-01

    Study Objectives Despite considerable evidence supporting cognitive behavioral therapy for insomnia (CBT-I) for chronic insomnia, it remains untested within the context of acute insomnia. This study examined the efficacy of a single session of CBT-I, with an accompanying self-help pamphlet, for individuals with acute insomnia. Design A pragmatic parallel group randomized controlled trial. Participants Forty adults (mean age 32.9 + 13.72 y) with Diagnostic and Statistical Manu...

  4. Therapeutic Effects of Oral Zinc Supplementation on Acute Watery Diarrhea with Moderate Dehydration: A Double-Blind Randomized Clinical Trial

    Mohammad Karamyyar; Shahsanam Gheibi; Mehran Noroozi; Ali Kord Valeshabad

    2013-01-01

    Background: To assess the therapeutic effects of oral zinc supplementation on acute watery diarrhea of children with moderate dehydration. Methods: All 9-month to 5-year-old children who were admitted with acute watery diarrhea and moderate dehydration to the Children Ward of Motahari Hospital, Urmia, Iran in 2008 were recruited. After the application of the inclusion and exclusion criteria, the patients were randomly allocated to two groups: one group to receive zinc plus oral rehydration so...

  5. Predicting heart failure decompensation using cardiac implantable electronic devices: a review of practices and challenges.

    Hawkins, Nathaniel M; Virani, Sean A; Sperrin, Matthew; Buchan, Iain E; McMurray, John J V; Krahn, Andrew D

    2016-08-01

    Cardiac implantable electronic devices include remote monitoring tools intended to guide heart failure management. The monitoring focus has been on averting hospitalizations by predicting worsening heart failure. However, although device measurements including intrathoracic impedance correlate with risk of decompensation, they individually predict hospitalizations with limited accuracy. Current 'crisis detection' methods involve repeatedly screening for impending decompensation, and do not adhere to the principles of diagnostic testing. Complex substrate, limited test performance, low outcome incidence, and long test to outcome times inevitably generate low positive and high negative predictive values. When combined with spectrum bias, the generalizability, incremental value, and cost-effectiveness of device algorithms are questionable. To avoid these pitfalls, remote monitoring may need to shift from crisis detection to health maintenance, keeping the patient within an ideal physiological range through continuous 'closed loop' interaction and dynamic therapy adjustment. Test performance must also improve, possibly through combination with physiological sensors in different dimensions, static baseline characteristics, and biomarkers. Complex modelling may tailor monitoring to individual phenotypes, and thus realize a personalized medicine approach. Future randomized controlled trials should carefully consider these issues, and ensure that the interventions tested are generalizable to clinical practice. PMID:26663507

  6. A randomized trial of treatment for acute anterior cruciate ligament tears

    Frobell, Richard B; Roos, Ewa M; Roos, Harald P; Ranstam, Jonas; Lohmander, L Stefan

    2010-01-01

    BACKGROUND: The optimal management of a torn anterior cruciate ligament (ACL) of the knee is unknown. METHODS: We conducted a randomized, controlled trial involving 121 young, active adults with acute ACL injury in which we compared two strategies: structured rehabilitation plus early ACL...... reconstruction and structured rehabilitation with the option of later ACL reconstruction if needed. The primary outcome was the change from baseline to 2 years in the average score on four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) - pain, symptoms, function in sports and recreation...... rehabilitation plus early ACL reconstruction, 1 did not undergo surgery. Of 59 assigned to rehabilitation plus optional delayed ACL reconstruction, 23 underwent delayed ACL reconstruction; the other 36 underwent rehabilitation alone. The absolute change in the mean KOOS(4) score from baseline to 2 years was 39...

  7. A blind, randomized comparison of racecadotril and loperamide for stopping acute diarrhea in adults

    Hwang-Huei Wang; Ming-Jium Shieh; Kuan-Fu Liao

    2005-01-01

    AIM: Racecadotril is a specific enkephalinase inhibitor that exhibits intestinal antisecretory activity without affecting intestinal transit. Loperamide is an effective anti-diarrheal agent, but it usually induces constipation. This study is to compare the efficacy, safety, and tolerability of racecadotril versus Ioperamide in the outpatient treatment of acute diarrhea in adults.METHODS: A two-center, randomized, parallel-group,single-blind study was carried out to compare the efficacy,tolerability, and safety of racecadotril (100 mg thrics daily)and Ioperamide (2.0 mg 2 twics daily) in 62 adult patients suffering from acute diarrhea. The main efficacy criterion used was the duration of diarrhea after beginning the treatment (in hours). Other signs and symptoms were also evaluated.RESULTS: The clinical success rates for these antidiarrheal treatments were 95.7% and 92.0% for racecadotril and Ioperamide respectively. Patients on racecadotril had a median duration of diarrhea of 19.5 h compared with a median of 13 h for patients on Ioperamide.Rapid improvement in anal burn and nausea was found for each drug. However, more patients on Ioperamide suffered from reactive constipation (29.0% vs 12.9%).Itching, another adverse event was notably higher in the racecadotril group (28.6% vs 0%). With regard to other adverse events, the two medications showed similar occurrence rates and similar concomitant medication usage rates.CONCLUSION: Racecadotril and Ioperamide are rapid,equally effective treatments for acute diarrhea in adults,but Ioperamide treatment is associated with a higher incidence of treatment-related constipation.

  8. Lornoxicam versus diclofenac sodium in acute renal colic: a prospective randomized trial

    Sushila Godara

    2013-04-01

    Full Text Available Background: Acute renal colic is excruciatingly painful event, opioid analgesics and nonsteroidal anti-inflammatory drugs remain the mainstay of treatment for acute renal colic. This study compares diclofenac and lornoxicam in their efficacy to relieve pain of renal origin. Methods: Prospective, randomized, double blind clinical study including eighty patients with renal pain admitted in emergency department of a tertiary care teaching hospital. Parameters were observed at baseline and after 15, 30, 60, 180 minutes and 5hrs of drug treatment. The efficacy of the drug was measured by observing: Pain score, onset & duration of action, rescue drug use, global patient and physician impression. Results: Both drugs are effective in relieving pain of renal origin (p<0.05 and maintaining it over time as well. When decrease in value of pain score compared between two groups at various interval there was statistically significant (p<0.05 decrease in pain score only at 15 minutes in lornoxicam group showing this slightly more effective in early phase compared to diclofenac. In either group there is no statistically significant difference regarding onset of action, duration of action and side effect profile. Conclusions: Both the drugs are equally effective and safe in renal colicky pain with added advantage of lornoxicam being more effective in early period. [Int J Basic Clin Pharmacol 2013; 2(2.000: 193-198

  9. Analgesic Effects and Safety of Desmopressin, Tramadol and Indomethacin in Patients with Acute Renal Colic; A Randomized Clinical Trial

    Mehdi Shirazi; Mehdi Salehipour; Mohammad Amin Afrasiabi; Alireza Aminsharifi

    2015-01-01

    Objective: To compare the efficacy of desmopressin (DDAVP), tramadol and indomethacin on pain intensity of patients with acute renal colic caused by urolithiasis. Methods: This prospective, randomized clinical trial was conducted between July 2005 and July 2006 including 120 patients (70 men and 50 women, mean age 38.2±5.8 years) referring to emergency room of Shahid Faghihi hospital with renal colic caused by urolithiasis without any previous treatment. The patients were randomly assigned...

  10. Proton magnetic resonance spectroscopy reflects metabolic decompensation in maple syrup urine disease

    Heindel, W. [Dept. of Diagnostic Radiology, Univ. Koeln (Germany); Kugel, H. [Dept. of Diagnostic Radiology, Univ. Koeln (Germany); Wendel, U. [Children`s Hospital, Univ. Duesseldorf (Germany); Roth, B. [Children`s Hospital, Univ. Koeln (Germany); Benz-Bohm, G. [Dept. of Diagnostic Radiology, Univ. Koeln (Germany)

    1995-06-01

    Using localized proton magnetic resonance spectroscopy ({sup 1}H-MRS), accumulation of branchedchain amino acids (BCAA) and their corresponding 2-oxo acids (BCOA) could be non-invasively demonstrated in the brain of a 9-year-old girl suffering from classical maple syrup urine disease. During acute metabolic decompensation, the compounds caused a signal at a chemical shift of 0.9 ppm which was assigned by in vitro experiments. The brain tissue concentration of the sum of BCAA and BCOA could be estimated as 0.9 mmol/l. Localized {sup 1}H-MRS of the brain appears to be suitable for examining patients suffering from maple syrup urine disease in different metabolic states. (orig.)

  11. Topical Calendula and Betamethasone Valerate in the prevention of acute radiation dermatitis: a randomized prospective trial

    Fotouhi M

    2007-07-01

    Full Text Available Background: Acute radiation dermatitis is a very common side effect of radiation therapy for many cancers, including breast cancer. Despite the high prevalence of acute radiation dermatitis as well as wet desquamation, only a few trials studying the prophylaxis of this complication using topical treatment have been conducted. In spite of these studies, some controversy still exists about regarding treatments for acute radiation dermatitis, as does some concern about their long-term complications. For this reason, we conducted a clinical trial for a new treatment with the same effectiveness as corticosteroids, but fewer complications. Methods: This trial included 60 patients with pathologic diagnoses of breast cancer for whom radiotherapy had been planned. Patients were 30-73 years old. Patients with radical mastectomy received 5000 cGy over five weeks, and those with conservative surgery received 6000 cGy over six weeks divided in 200 cGy fractions. Patients were divided randomly into two groups: one group received a moderately-potent glucocorticoid steroid, 0.1% betamethasone ointment (30, and the other received the new treatment, 0.1% calendula ointment (30. All patients applied their respective drugs twice daily within the tangential field from the first day of radiation treatment until one month after treatment was completed. Starting one week after radiation therapy commenced, patients were monitored weekly for symptoms of dermatitis and the degree of severity as well as possible adverse drug effects, in addition to such monitoring on the days of their appointments. Four weeks after termination of therapy, patients were again examined, at which time they completed a questionnaire about dermatologic complications. Results: The mean time to develop dermatitis was 3.7 weeks for the betamethasone group and 3.87 weeks for the calendula group. Maximal dermatitis intensity during treatment in the betamethasone group was: 0, 6.7%; I, 73.3%; II, 16

  12. The effects of experimentally manipulated social status on acute eating behavior: A randomized, crossover pilot study.

    Cardel, M I; Johnson, S L; Beck, J; Dhurandhar, E; Keita, A D; Tomczik, A C; Pavela, G; Huo, T; Janicke, D M; Muller, K; Piff, P K; Peters, J C; Hill, J O; Allison, D B

    2016-08-01

    Both subjective and objectively measured social status has been associated with multiple health outcomes, including weight status, but the mechanism for this relationship remains unclear. Experimental studies may help identify the causal mechanisms underlying low social standing as a pathway for obesity. Our objective was to investigate the effects of experimentally manipulated social status on ad libitum acute dietary intakes and stress-related outcomes as potential mechanisms relating social status and weight. This was a pilot feasibility, randomized, crossover study in Hispanic young adults (n=9; age 19-25; 67% female; BMI ≥18.5 and ≤30kg/m(2)). At visit 1, participants consumed a standardized breakfast and were randomized to a high social status position (HIGH) or low social status position (LOW) in a rigged game of Monopoly™. The rules for the game differed substantially in terms of degree of 'privilege' depending on randomization to HIGH or LOW. Following Monopoly™, participants were given an ad libitum buffet meal and energy intakes (kcal) were estimated by pre- and post-weighing foods consumed. Stress-related markers were measured at baseline, after the game of Monopoly™, and after lunch. Visit 2 used the same standardized protocol; however, participants were exposed to the opposite social status condition. When compared to HIGH, participants in LOW consumed 130 more calories (p=0.07) and a significantly higher proportion of their daily calorie needs in the ad libitum buffet meal (39% in LOW versus 31% in HIGH; p=0.04). In LOW, participants reported decreased feelings of pride and powerfulness following Monopoly™ (p=0.05) and after their lunch meal (p=0.08). Relative to HIGH, participants in LOW demonstrated higher heart rates following Monopoly™ (p=0.06), but this relationship was not significant once lunch was consumed (p=0.31). Our pilot data suggest a possible causal relationship between experimentally manipulated low social status and

  13. A randomized clinical trial of chiropractic treatment and self-management in patients with acute musculoskeletal chest pain

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner;

    2012-01-01

    We have previously reported short-term follow-up from a pragmatic randomized clinical trial comparing 2 treatments for acute musculoskeletal chest pain: (1) chiropractic treatment and (2) self-management. Results indicated a positive effect in favor of the chiropractic treatment after 4 and 12...

  14. Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial

    Cosimo Costantino

    2011-01-01

    Full Text Available Pharmacological therapy of back pain with analgesics and anti-inflammatory drugs is frequently associated with adverse effects, particularly in the elderly. Aim of this study was to compare mesotherapic versus conventional systemic administration of nonsteroidal anti-inflammatory drugs (NSAIDs and corticosteroids in patients with acute low back pain. Eighty-four patients were randomized to receive anti-inflammatory therapy according to the following protocols: (a mesotherapy group received the 1st and 4th day 2% lidocaine (1 mL + ketoprofen 160 mg (1 mL + methylprednisolone 40 mg (1 mL, then on 7th, 10th, and 13th day, 2% lidocaine (1 mL + ketoprofen 160 mg (1 mL + methylprednisolone 20 mg (1 mL (b conventional therapy group received ketoprofen 80 mg × 2/die and esomeprazole 20 mg/die orally for 12 days, methylprednisolone 40 mg/die intramuscularly for 4 days, followed by methylprednisolone 20 mg/die for 3 days, and thereafter, methylprednisolone 20 mg/die at alternate days. Pain intensity and functional disability were assessed at baseline (T0, at the end of treatment (T1, and 6 months thereafter (T2 by using visual analogic scale (VAS and Roland-Morris disability questionnaire (RMDQ. In both groups, VAS and RMDQ values were significantly reduced at the end of drug treatment and after 6 months, in comparison with baseline. No significant differences were found between the two groups. This suggests that mesotherapy may be a valid alternative to conventional therapy in the treatment of acute low back pain with corticosteroids and NSAIDs.

  15. Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial.

    Costantino, Cosimo; Marangio, Emilio; Coruzzi, Gabriella

    2011-01-01

    Pharmacological therapy of back pain with analgesics and anti-inflammatory drugs is frequently associated with adverse effects, particularly in the elderly. Aim of this study was to compare mesotherapic versus conventional systemic administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in patients with acute low back pain. Eighty-four patients were randomized to receive anti-inflammatory therapy according to the following protocols: (a) mesotherapy group received the 1st and 4th day 2% lidocaine (1 mL) + ketoprofen 160 mg (1 mL) + methylprednisolone 40 mg (1 mL), then on 7th, 10th, and 13th day, 2% lidocaine (1 mL) + ketoprofen 160 mg (1 mL) + methylprednisolone 20 mg (1 mL) (b) conventional therapy group received ketoprofen 80 mg × 2/die and esomeprazole 20 mg/die orally for 12 days, methylprednisolone 40 mg/die intramuscularly for 4 days, followed by methylprednisolone 20 mg/die for 3 days, and thereafter, methylprednisolone 20 mg/die at alternate days. Pain intensity and functional disability were assessed at baseline (T0), at the end of treatment (T1), and 6 months thereafter (T2) by using visual analogic scale (VAS) and Roland-Morris disability questionnaire (RMDQ). In both groups, VAS and RMDQ values were significantly reduced at the end of drug treatment and after 6 months, in comparison with baseline. No significant differences were found between the two groups. This suggests that mesotherapy may be a valid alternative to conventional therapy in the treatment of acute low back pain with corticosteroids and NSAIDs. PMID:20953425

  16. Comparison in continuous or intermittent intravenous injections of furosemide in patients with acute decompensated heart failure%急性失代偿性心力衰竭患者连续与间歇注射呋塞米的对比研究

    陈瑜; 季顺民; 丁卫东

    2013-01-01

    Objective To discuss the curative effects of continuous intravenous injection (cIV) or intermittent intravenous injection (iIV) of furosemide in the patients with acute decompensated heart failure (ADHF). Methods The patients with ADHF (n=56) were chosen from the Nanmo Health Center, Hai’an County of Nantong City of Jiangsu Province from Jun. 2011 to Nov. 2012, and then divided into cIV group (n=26) and iIV group (n=30). The primary end point was net urine output (nUOP)/24 h, and secondary end points included nUOP/furosemide, total urine output (tUOP)/24 h, tUOP/furosemide, weight loss during the study, additional treatment for ADHF, continuing time of drug administration, hospitalization days and safety reviewing (electrolyte loss and hemodynamic instability). Results The levels of nUOP and tUOP [nUOP:(2098±1132) mL vs. (1575±1100) mL, P=0.086;tUOP:(3726± 1121) mL vs. (2955±1267) mL, P=0.019], and tUOP/furosemide [(38.6±31.0) mL/mg vs. (22.2±12.5) mL/mg, P=0.021] were higher in cIV group than those in iIV group. The other indexes, including nUOP/furosemide, weight loss during the study, additional treatment for ADHF, continuing time of drug administration, and safety had no differences between two groups, and average body weight had no significant difference in two groups before and after treatment. The hospitalization time was shorter in cIV group than that in iIV group [(6.9±3.7) vs. (10.9±8.3 days), P=0.006]. Conclusion cIV has better curative effect than iIV on the clinical symptoms such as anhelation in ADHF patients, and patients’ tolerance is higher.%目的:比较连续(cIV)或间歇(iIV)静注给予呋塞米对急性失代偿性心力衰竭(ADHF)患者的疗效和安全性的差异。方法纳入2011年6月~2012年11月江苏省南通市海安县南莫中心卫生院ADHF患者56例,其中26例采用cIV方式给药的患者纳入cIV组,30例采用iIV方式给药的患者纳入iIV组,主要终点为每日净尿量(nUOP)

  17. Efficacy of Two Streptokinase Formulations in Acute Myocardial Infarction: A Double-Blind Randomized Clinical Trial

    Navid Paydari

    2009-03-01

    Full Text Available Background: We sought to evaluate the efficacy and safety of the different trade forms of streptokinase available in our country, namely Heberkinasa (Heberbiotec, Havana, Cuba and Streptase (Aventis Behring GmbH, Marburg, Germany. Methods: We conducted a double-blind randomized clinical trial to compare the two streptokinase formulations, i.e. Heberkinasa (HBK or Streptase (STP, in patients with acute myocardial infarction who needed thrombolysis. Thrombolysis success was evaluated angiographically and/or clinically. Clinical follow-up was done 30 days after thrombolysis. Results: We randomly allocated 221 patients with a mean age of 56.9±10.8 years (males: 88.2% to HBK (n=119 and STP (n=102 groups. Baseline clinical and demographic characteristics were similar between the two groups, and the two groups were not significantly different in terms of door-to-needle and pain-to-needle intervals. The rate of complications was not significantly different between the groups (44.1% [HBK] vs. 42% [STP]. Angiography was done for 158 (71.5 % patients in the first 24 hours (9% and in the first 72 hours (38.8% after thrombolysis. Lesion morphology and lesion/patient ratio were not significantly different between the two groups (1.87[HBK] vs. 1.67[STP]. The two groups were similar with respect to angiographic patency rate (67.5% [HBK] vs. 67.6% [STP]. The study groups were also similar as regards clinical outcome and complications of both streptokinase formulations. Conclusion: The present study demonstrated that Heberkinasa is as effective and as safe as a standard streptokinase, namely Streptase, in a clinical setting.

  18. A Randomized Trial of Behavioral Physical Therapy Interventions for Acute and Sub-Acute Low Back Pain (NCT00373867)

    George, Steven Z.; Zeppieri, Giorgio; Cere, Anthony L.; Cere, Melissa R.; Borut, Michael S.; Hodges, Michael J.; Reed, Dalton M.; Valencia, Carolina; Robinson, Michael E.

    2008-01-01

    Psychological factors consistent with fear-avoidance models are associated with the development of chronic low back pain (LBP). As a result, graded activity (GA) and graded exposure (GX) have been suggested as behavioral treatment options. This clinical trial compared the effectiveness of treatment based classification (TBC) physical therapy alone, to TBC augmented with GA or GX for patients with acute and sub-acute LBP. Our primary hypothesis was that GX would be most effective for those wit...

  19. Duration of bed occupancy as calculated at a random chosen day in an acute care ward. Implications for the use of scarce resources in psychiatric care

    Restan Asbjørn; Berg John E

    2005-01-01

    Abstract Background Psychiatric acute wards are obliged to admit patients without delay according to the Act on Compulsive Psychiatric Care. Residential long term treatment facilities and rehabilitation facilities may use a waiting list. Patients, who may not be discharged from the acute ward or should not wait there, then occupy acute ward beds. Materials and methods Bed occupancy in one acute ward at a random day in 2002 was registered (n = 23). Successively, the length of stay of all patie...

  20. Randomized Study of Ondansetron Versus Domperidone in the Treatment of Children With Acute Gastroenteritis

    Rerksuppaphol, Sanguansak; Rerksuppaphol, Lakkana

    2013-01-01

    Background Acute gastroenteritis (AGE) is a common condition among children that is frequently accompanied by vomiting. Symptomatic control of vomiting is important as it improves patient’s general condition and reduces the need for intravenous therapy and hospitalization. Antiemetic agents including ondansetron and domperidone are used to provide symptomatic relief but the existing studies do not provide enough evidence of better efficacy for one over another. Methods Seventy-six Thai children under the age of 15 with AGE were randomized to receive either ondansetron or domperidone. The primary outcome of the study was the proportion of the patients in each group who had no episode of vomiting 24 hours after the start of treatment. Results Primary outcome was met in 62% of patients in ondansetron group and 44% of patients in domperidone group (P = 0.16). Patients in domperidone group received more doses of the drug within 24 hours after the start of the treatment compared to ondansetron group (P = 0.01). No adverse effect was observed in any of the two groups. Conclusions Ondansetron can be considered a safe comparable alternative to commonly-used domperidone in Thai children who suffer from symptoms of gastroenteritis. Larger clinical trials are needed to further explore the effectiveness of the two medications. PMID:24171058

  1. Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion: a Randomized Clinical Trial

    Alireza Ramezani

    2011-01-01

    Full Text Available Purpose: To evaluate the therapeutic effect of intravitreal triamcinolone (IVT injection for recent branch retinal vein occlusion (BRVO. Methods: In a randomized controlled clinical trial, 30 phakic eyes with recent (less than 10 weeks′ duration BRVO were assigned to two groups. The treatment group (16 eyes received 4 mg IVT and the control group (14 eyes received subconjunctival sham injections. Changes in visual acuity (VA were the main outcome measure. Results: VA and central macular thickness (CMT changes were not significantly different between the study groups at any time point. Within group analysis showed significant VA improvement from baseline in the IVT group up to three months (P 0.05. Significant reduction in CMT was noticed only in the treatment group (‑172 ± 202 μm, P = 0.029 and at 4 months. Ocular hypertension occurred in 4 (25% and 2 (14.3% eyes in the IVT and control groups, respectively. Conclusion: A single IVT injection had a non-significant beneficial effect on VA and CMT in acute BRVO as compared to the natural history of the condition. The 3-month deferred treatment protocol advocated by the Branch Vein Occlusion Study Group may be a safer option than IVT injection considering its potential side effects.

  2. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial.

    Vincent Gajdos

    2010-09-01

    Full Text Available Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET and assisted cough (AC. Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC in previously healthy infants hospitalized for a first episode of acute bronchiolitis.We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n=246 or nasal suction (NS, control group, n=250. Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97-2.73 for the control group and 2.02 days (95% CI 1.96-2.34 for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]=1.09, 95% CI 0.91-1.31, p=0.33. No treatment by age interaction was found (p=0.97. Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]=10.2, 95% CI 1.3-78.8, p=0.005 and RR=5.4, 95% CI 1.6-18.4, p=0.002, respectively. No difference between groups in bradycardia with or

  3. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial

    Connor, Kathryn M; Aurora, Sheena K; Loeys, Tom; Ashina, Messoud; Jones, Christopher; Giezek, Hilde; Massaad, Rachid; Williams-Diaz, Angela; Lines, Christopher; Ho, Tony W

    2011-01-01

    To evaluate the long-term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.- Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine....

  4. Chiropractic Treatment vs Self-Management in Patients With Acute Chest Pain: A Randomized Controlled Trial of Patients Without Acute Coronary Syndrome

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner; Høilund-Carlsen, Poul F; Haghfelt, Torben; Hartvigsen, Jan

    2012-01-01

    ) self-management as an example of minimal intervention. METHODS: In a nonblinded, randomized, controlled trial set at an emergency cardiology department and 4 outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were...... included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to 4 weeks of chiropractic treatment or self-management, with posttreatment questionnaire follow-up 4 and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical...... chiropractic treatment at 4 weeks regarding the primary outcome of self-perceived change in chest pain and at 12 weeks with respect to the primary outcome of numeric change in pain intensity. CONCLUSIONS: To the best of our knowledge, this is the first randomized trial assessing chiropractic treatment vs...

  5. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial.

    Roncalli, Jérôme; Mouquet, Frédéric; Piot, Christophe; Trochu, Jean-Noel; Le Corvoisier, Philippe; Neuder, Yannick; Le Tourneau, Thierry; Agostini, Denis; Gaxotte, Virginia; Sportouch, Catherine; Galinier, Michel; Crochet, Dominique,; Teiger, Emmanuel; Richard, Marie-Jeanne; Polge, Anne-Sophie

    2011-01-01

    International audience AIMS: Intracoronary administration of autologous bone marrow cells (BMCs) leads to a modest improvement in cardiac function, but the effect on myocardial viability is unknown. The aim of this randomized multicentre study was to evaluate the effect of BMC therapy on myocardial viability in patients with decreased left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI) and to identify predictive factors for improvement of myocardial viability....

  6. Efficacy of Fructooligosaccharide Versus Placebo for Treatment of Acute Diarrhea in Children : a Double - Blind Randomized Clinical Trial

    Suryanty, Reni; Supriatmo; Hasibuan, Berlian; Sinuhaji, Atan Baas

    2005-01-01

    Objective To compare the efficacy of fructooligosaccharide (FOS)versus placebo in pediatric patients with acute diarrhea with regard to duration and frequency of diarrhea and the volume and consistency of the stools. Methods This double-blind randomized clinical trial was carried out from July to November 2003 in the pediatric intensive care unit, outpatient clinic, and pediatric ward of Adam Malik Hospital and Pirngadi Hospital, Medan. Subjects were children and infants aged 4 to 24 month...

  7. Efficacy of intravenous ondansetron to prevent vomiting episodes in acute gastroenteritis: a randomized, double blind, and controlled trial

    Sanguansak Rerksuppaphol

    2010-09-01

    Full Text Available Acute gastroenteritis is one of the most common infectious diseases of childhood. Its symptoms are vomiting, diarrhea, and dehydration. In the emergency ward, intravenous rather than oral rehydration is usually preferred because of the high likelihood of emesis. Treatments to reduce emesis are of value in improving the rehydration procedure. Our study is a double-blind randomized trial and proposes the use of ondansetron as an anti-emetic drug to treat children with acute gastroenteritis. Seventy-four in-patients, aged 3 months to 15 years, were enrolled and randomly assigned to an ondansetron or placebo group. Inclusion criteria were the diagnosis of acute gastroenteritis and the absence of other diseases or allergies to drugs. A single bolus (0.15 mg/kg of ondansetron was injected intravenously; normal 0.9% saline solution was used as a placebo. This treatment induced vomiting cessation in the ondansetron group significantly in comparison to the placebo group. The length of the hospital stay and the oral rehydration fluid volume were similar in the two groups and no adverse effects were noticed. Thus, safety, low cost, and overall bene­fit of ondansetron treatment suggests that this drug can be administered successfully to children with acute gastroenteritis.

  8. Efficacy of Rifaximin Compared with Ciprofloxacin for the Treatment of Acute Infectious Diarrhea: A Randomized Controlled Multicenter Study

    Hong, Kyoung Sup; Kim, You Sun; Han, Dong Soo; Choi, Chang Hwan; Jang, Byung-Ik; Park, Young-Sook; Lee, Kang-Moon; Lee, Soo Teik; Kim, Hyun-Soo

    2010-01-01

    Background/Aims Ciprofloxacin has been widely prescribed for acute infectious diarrhea. However, the resistance to this drug is increasing. Rifaximin is a novel but poorly absorbed rifamycin derivative. This study evaluated and compared the efficacies of rifaximin and ciprofloxacin for the treatment of acute infectious diarrhea. Methods We performed a randomized controlled multicenter study in Korea. Patients with acute diarrhea were enrolled and randomized to receive rifaximin or ciprofloxacin for 3 days. The primary efficacy endpoint was the time to last unformed stool (TLUS). Secondary endpoints were enteric wellness (reduction of at least 50% in the number of unformed stools during 24-hour postenrollment intervals), general wellness (subjective feeling of improvement), and proportion of patients with treatment failure. Results Intent-to-treat analysis (n=143) showed no significant difference between the rifaximin and ciprofloxacin groups in the mean TLUS (36.1 hours vs 43.6 hours, p=0.163), enteric wellness (49% vs 57%, p=0.428), general wellness (67% vs 78%, p=0.189), or treatment failure rate (9% vs 12%, p=0.841). The adverse events did not differ significantly between the two groups. Conclusions These results suggest that rifaximin is as safe and effective as ciprofloxacin in the treatment of acute infectious diarrhea. PMID:20981213

  9. Drug-eluting stents for acute coronary syndrome: a meta-analysis of randomized controlled trials.

    Lishan Wang

    Full Text Available Drug-eluting stents (DES are increasingly used for treatment of acute coronary syndrome (ACS. However, clinical efficacy and safety of various types of DES is not well established in these subjects. We therefore evaluated clinical utility of second-generation and first-generation DES in patients with ACS by conducting a meta-analysis.A search of Medline, Embase, the Cochrane databases, and Web of Science was made. Randomized controlled trials (RCTs which compared second-generation DES (everolimus-eluting stents [EES] or zotarolimus-eluting stents [ZES] versus first-generation DES (sirolimus-eluting stents [SES] or paclitaxe-eluting stents [PES] in patients with ACS and provided data on clinical efficacy or safety endpoints were included. Pooled estimates were calculated using random-effects model.A total of 2,757 participants with ACS in 6 RCTs were included. Compared with first-generation one, second-generation DES trended to be associated with the decreased incidence of definite or probable stent thrombosis in ACS patients (risk ratio [RR]  = 0.60, 95% confidence intervals [CI] 0.33 to 1.07, p = 0.09. However, the rate of target lesion revascularization (TLR significantly increased in second-generation DES (RR = 2.08, 95%CI 1.25 to 3.47, p = 0.005. There were no significant differences in the incidence of major adverse cardiac events (MACEs, all-cause death, cardiac death, and recurrent myocardial infarction between the two arms (all p>0.10. The second-generation EES showed a tendency towards lower risk of MACEs (p = 0.06 and a beneficial effect on reducing stent thrombosis episodes (p = 0.009, while the second-generation ZES presented an increased occurrence of MACEs (p = 0.02 and TLR (p = 0.003.Second-generation DES, especially EES, appeared to present a lower risk of stent thrombosis, whereas second-generation ZES might increase the need for repeat revascularization in ACS patients. During coronary

  10. Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial

    Sidney Glina; Ronaldo Damiao; Joao Afif-Abdo; Carlos Francisco Santa Maria; Raúl Novoa; Carlos Eurico Dornelles Cairoli; Dalia Wajsbrot; Gaston Araya

    2011-01-01

    PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs). As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic ...

  11. Dietary nitrate supplementation in COPD: An acute, double-blind, randomized, placebo-controlled, crossover trial.

    Kerley, Conor P

    2014-12-19

    The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity. We hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects.

  12. Probiotics, calcium and acute diarrhea : a randomized trial in Indonesian children

    Agustina, R.

    2012-01-01

    Background
    Acute diarrhea and acute respiratory tract infections (ARTIs) continue to lead the infectious cause of morbidity and mortality among children <5 years of age in developing countries, including Indonesia. Efforts to prevent diarrheal disease by probiotics and milk calcium suppleme

  13. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD)

    Hansen, Baiba Hedegaard; Hanash, Jamal Abed; Rasmussen, Alice;

    2009-01-01

    acute coronary syndrome. METHODS: Two hundred forty non-depressed patients with acute coronary syndrome are randomized to treatment with either escitalopram or placebo for 1 year. Psychiatric and cardiac assessment of patients is performed to evaluate the possibility of preventing depression. Diagnosis...

  14. Rat models of acute inflammation: a randomized controlled study on the effects of homeopathic remedies

    Menniti-Ippolito Francesca

    2007-01-01

    Full Text Available Abstract Background One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in vitro and animal studies aimed at evaluating the pharmacological activity or efficacy of some homeopathic remedies under potentially reproducible conditions. However, in addition to some contradictory results, these studies have also highlighted a series of methodological difficulties. The present study was designed to explore the possibility to test in a controlled way the effects of homeopathic remedies on two known experimental models of acute inflammation in the rat. To this aim, the study considered six different remedies indicated by homeopathic practice for this type of symptom in two experimental edema models (carrageenan- and autologous blood-induced edema, using two treatment administration routes (sub-plantar injection and oral administration. Methods In a first phase, the different remedies were tested in the four experimental conditions, following a single-blind (measurement procedure. In a second phase, some of the remedies (in the same and in different dilutions were tested by oral administration in the carrageenan-induced edema, under double-blind (treatment administration and measurement and fully randomized conditions. Seven-hundred-twenty male Sprague Dawley rats weighing 170–180 g were used. Six homeopathic remedies (Arnica montana D4, Apis mellifica D4, D30, Atropa belladonna D4, Hamamelis virginiana D4, Lachesis D6, D30, Phosphorus D6, D30, saline and indomethacin were tested. Edema was measured using a water-based plethysmometer, before and at different times after edema induction. Data were analyzed by ANOVA and Student t test. Results In the first phase

  15. Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: results from a double-blind, randomized study

    Purpose: Radiation-induced dermatitis is a very common side effect of radiation therapy, and may necessitate interruption of the therapy. There is a substantial lack of evidence-based treatments for this condition. The aim of this study was to investigate the effect of mometasone furoate cream (MMF) on radiation dermatitis in a prospective, double-blind, randomized study. Material and methods: The study comprised 49 patients with node-negative breast cancer. They were operated on with sector resection and scheduled for postoperative radiotherapy using photons with identical radiation qualities and dosage to the breast parenchyma. The patients were randomized to receive either MMF or emollient cream. The cream was applied on the irradiated skin twice a week from the start of radiotherapy until the 12th fraction (24 Gy) and thereafter once daily until 3 weeks after completion of radiation. Both groups additionally received non-blinded emollient cream daily. The intensity of the acute radiation dermatitis was evaluated on a weekly basis regarding erythema and pigmentation, using a reflectance spectrophotometer together with visual scoring of the skin reactions. Results: MMF in combination with emollient cream treatment significantly decreased acute radiation dermatitis (P=0.0033) compared with emollient cream alone. There was no significant difference in pigmentation between the two groups. Conclusions: Adding MMF, a potent topical corticosteroid, to an emollient cream is statistically significantly more effective than emollient cream alone in reducing acute radiation dermatitis

  16. Análise de custos do tratamento de episódios de descompensação aguda de insuficiência cardíaca: levosimendan versus dobutamina Cost analysis of the treatment of acute decompensated heart failure: levosimendan versus dobutamine

    Mucio Tavares Oliveira Jr

    2005-07-01

    Full Text Available OBJETIVO: Verificar se o tratamento com levosimendan seria mais dispendioso que o usual com dobutamina, uma vez que o preço dos medicamentos não representa a maior despesa no tratamento da descompensação cardíaca. MÉTODOS: Comparou-se o custo do tratamento de 18 pacientes hospitalizados devido a descompensação cardíaca, 9 tratados com dobutamina (grupo dobuta e 9 com levosimendan (grupo levo. Os grupos foram semelhantes quanto à idade, sexo, classe funcional e função cardíaca. RESULTADOS: O custo do tratamento foi semelhante para os dois grupos. No grupo levo as despesas com medicamentos foram maiores, mas as relativas ao período de terapia intensiva e do material empregado foram menores. Levo - medicamentos: R$ 5.414,00; materiais: R$ 399,90; diárias hospitalares: R$ 5.061,20; serviços profissionais: R$ 3.241,80; final: R$ 14.117,00. Dobuta - medicamentos: R$ 2.320,10; materiais: R$ 1.665,70; diárias hospitalares: R$ 6.261,90; serviços profissionais: R$ 3.894,30; final: R$ 14.142,00. CONCLUSÃO: Apesar do preço mais elevado da droga, o custo global do tratamento foi semelhante para os pacientes tratados com dobutamina ou levosimendan. O paciente tratado com levosimendan permaneceu menos tempo em terapia intensiva.OBJECTIVE: To assess whether the treatment with levosimendan is more expensive than the usual one with dobutamine, since price of medications does not usually represent the greatest expense in the treatment of cardiac decompensation. METHODS: The cost of treatment of 18 inpatients with cardiac decompensation, 9 of which treated with dobutamine (dobuta group and 9 with levosimendan (levo group, was compared. Groups were similar concerning age, sex, functional class and cardiac function. RESULTS: Treatment costs were similar for both groups. In the levo group, the costs with the drug were higher than in the dobuta group, but those related to the length of stay in intensive care unit and to the material used during

  17. Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial

    Baumbach Sebastian Felix

    2013-01-01

    Full Text Available Abstract Background Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains. Methods/Design 60 patients, aged 18–40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D. Discussion This is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various

  18. Acute pancreatitis complicating severe dengue

    Vishakha Jain; O P Gupta; Tarun Rao; Siddharth Rao

    2014-01-01

    Dengue is an arthropod borne viral infection endemic in tropical and subtropical continent. Severe dengue is life threatening. Various atypical presentations of dengue have been documented. But we present a rare and fatal complication of severe dengue in form of acute pancreatitis. A 27-year-old male had presented with severe dengue in decompensated shock and with pain in abdomen due to pancreatitis. The pathogenesis of acute pancreatitis in dengue is not clearly understood, but various mecha...

  19. Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia : A randomized, double-blind, placebo-controlled study

    Kahn, Rene S.; Schulz, S. Charles; Palazov, Veselin D.; Reyes, Efren B.; Brecher, Martin; Svensson, Ola; Andersson, Henrik M.; Meulien, Didier

    2007-01-01

    Objective: To evaluate the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) in a 6-week, double-blind, randomized study. Method: Patients with a DSM-IV diagnosis of acute schizophrenia were randomly assigned to fixed-dose quetiapine XR 400, 600, or 800 mg/day (once d

  20. Lactobacillus GG (LGG) and smectite versus LGG alone for acute gastroenteritis: a double-blind, randomized controlled trial

    Pieścik-Lech, Małgorzata; Urbańska, Magdalena; Szajewska, Hania (gyermekgyógyász)

    2012-01-01

    Diarrhea treatment with either Lactobacillus GG (LGG) or smectite as an adjuvant to standard rehydration therapy has proven efficacy. In countries where both LGG and smectite are available, concomitant use is frequently practiced. We investigated whether LGG plus smectite is superior to LGG alone in the management of children with acute gastroenteritis (AGE). A double-blind, placebo-controlled, randomized trial was performed. Children aged 4 to 60 months with AGE received LGG 6 × 109 colony f...

  1. Acute and Chronic Effect of Acoustic and Visual Cues on Gait Training in Parkinson's Disease: A Randomized, Controlled Study

    Roberto De Icco; Cristina Tassorelli; Eliana Berra; Monica Bolla; Claudio Pacchetti; Giorgio Sandrini

    2015-01-01

    In this randomized controlled study we analyse and compare the acute and chronic effects of visual and acoustic cues on gait performance in Parkinson’s Disease (PD). We enrolled 46 patients with idiopathic PD who were assigned to 3 different modalities of gait training: (1) use of acoustic cues, (2) use of visual cues, or (3) overground training without cues. All patients were tested with kinematic analysis of gait at baseline (T0), at the end of the 4-week rehabilitation programme (T1), and ...

  2. Meta-analysis of randomized controlled trials on the safety and effectiveness of early versus delayed laparoscopic cholecystectomy for acute cholecystitis

    Gurusamy, K; Samraj, K; Gluud, C; Wilson, E; Davidson, B R

    2010-01-01

    BACKGROUND:: In many countries laparoscopic cholecystectomy for acute cholecystitis is mainly performed after the acute episode has settled because of the anticipated increased risk of morbidity and higher conversion rate from laparoscopic to open cholecystectomy. METHODS:: A systematic review was...... performed with meta-analysis of randomized clinical trials of early laparoscopic cholecystectomy (ELC; performed within 1 week of onset of symptoms) versus delayed laparoscopic cholecystectomy (performed at least 6 weeks after symptoms settled) for acute cholecystitis. Trials were identified from The.......03) days). CONCLUSION:: ELC during acute cholecystitis appears safe and shortens the total hospital stay. Copyright (c) 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd....

  3. A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

    Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F;

    2005-01-01

    -four patients were randomized to IVIG 0.4 g/kg body wt, and 34 patients were randomized to placebo. Infusions were given at days 0, 1, 2, 30, and 60. Contrast sensitivity, visual acuity, and color vision were measured at baseline and after 1 week, 1 month, and 6 months. Pattern reversal visual evoked potential...

  4. Decompensated Liver Cirrhosis Presenting as a Spontaneous Left-Sided Bacterial Empyema.

    Chertoff, Jason; Nathoo, Sunina

    2016-01-01

    Decompensation of cirrhosis presents with ascites, encephalopathy, variceal bleeding, or spontaneous bacterial peritonitis. Infrequently, decompensation can result from spontaneous bacterial empyema. A 38-year-old man presented with fevers, chills, and dyspnea. Labs were significant for leukocytosis, transaminitis, and coagulopathy. Imaging showed liver cirrhosis with ascites and a left pleural effusion. Treatment of the effusion consisted of chest tube drainage and antibiotics. Spontaneous bacterial empyema was diagnosed after pleural fluid cultures were positive for Escherichia coli. Our case demonstrates that spontaneous bacterial empyemas can be left-sided, and the first sign of decompensation. PMID:26958567

  5. Effects of intracutaneous injections of sterile water in patients with acute low back pain: a randomized, controlled, clinical trial.

    Cui, J Z; Geng, Z S; Zhang, Y H; Feng, J Y; Zhu, P; Zhang, X B

    2016-03-01

    Intracutaneous sterile water injection (ISWI) is used for relief of low back pain during labor, acute attacks of urolithiasis, chronic neck and shoulder pain following whiplash injuries, and chronic myofascial pain syndrome. We conducted a randomized, double-blinded, placebo-controlled trial to evaluate the effect of ISWI for relief of acute low back pain (aLBP). A total of 68 patients (41 females and 27 males) between 18 and 55 years old experiencing aLBP with moderate to severe pain (scores ≥5 on an 11-point visual analogue scale [VAS]) were recruited and randomly assigned to receive either ISWIs (n=34) or intracutaneous isotonic saline injections (placebo treatment; n=34). The primary outcome was improvement in pain intensity using the VAS at 10, 45, and 90 min and 1 day after treatment. The secondary outcome was functional improvement, which was assessed using the Patient-Specific Functional Scale (PSFS) 1 day after treatment. The mean VAS score was significantly lower in the ISWI group than in the control group at 10, 45, and 90 min, and 1 day after injection (Ppain and improving function in aLBP patients at short-term follow-up. ISWI might be an alternative treatment for aLBP patients, especially in areas where medications are not available, as well as in specific patients (e.g., those who are pregnant or have asthma), who are unable to receive medications or other forms of analgesia because of side effects. PMID:26840703

  6. The effect of brexpiprazole (OPC-34712) and aripiprazole in adult patients with acute schizophrenia: results from a randomized, exploratory study.

    Citrome, Leslie; Ota, Ai; Nagamizu, Kazuhiro; Perry, Pamela; Weiller, Emmanuelle; Baker, Ross A

    2016-07-01

    The aim of this study was to explore the effects of brexpiprazole and aripiprazole on efficacy, cognitive functioning, and safety in patients with acute schizophrenia. Patients who would benefit from hospitalization/continued hospitalization for acute relapse of schizophrenia were enrolled and randomized (2 : 1) to target doses of open-label brexpiprazole 3 mg/day or aripiprazole 15 mg/day for 6 weeks. Outcomes included change from baseline to week 6 in the Positive and Negative Syndrome Scale total score, Barratt Impulsiveness Scale 11-item score, and Cogstate computerized cognitive test battery scores. Patients treated with brexpiprazole (n=64) or aripiprazole (n=33) showed reductions in symptoms of schizophrenia as assessed by Positive and Negative Syndrome Scale total score (-22.9 and -19.4, respectively). A modest reduction in impulsivity was observed with brexpiprazole, but not aripiprazole (mean change in the Barratt Impulsiveness Scale 11-item total score: -2.7 and 0.1, respectively). No change in Cogstate scores was observed for either treatment. Brexpiprazole was well tolerated and the incidence of akathisia was lower in patients treated with brexpiprazole (9.4%) than aripiprazole (21.2%). Clinically relevant improvements in psychopathology were observed in patients with acute schizophrenia treated with brexpiprazole or aripiprazole. Brexpiprazole was well tolerated, with a lower incidence of akathisia than aripiprazole. PMID:26963842

  7. Chinese Medicine Injection Qingkailing for Treatment of Acute Ischemia Stroke: A Systematic Review of Randomized Controlled Trials

    Fafeng Cheng

    2012-01-01

    Full Text Available Qingkailing (QKL injection was a famous traditional Chinese patent medicine, which was extensively used to treat the acute stages of cerebrovascular disease. The aim of this study was to assess the quantity, quality and overall strength of the evidence on QKL in the treatment of acute ischemic stroke. Methods. An extensive search was performed within MEDLINE, Cochrane, CNKI, Vip and Wan-Fang up to November 2011. Randomized controlled trails (RCTs on QKL for treatment of acute stroke were collected, irrespective of languages. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards, and RevMan5 was used for data analysis. Results. 7 RCTs (545 patients were included and the methodological quality was evaluated as generally low. The pooled results showed that QKL combined with conventional treatment was more effective in effect rate, and the score of MESSS and TNF-α level compared with conventional treatment alone, but there was no significant difference in mortality of two groups. Only one trial reported routine life status. There were four trials reported adverse events, and no obvious adverse event occurred in three trials while one reported adverse events described as eruption and dizziness.

  8. Effect of Intravenous Iron Supplementation on Acute Mountain Sickness: A Preliminary Randomized Controlled Study

    Ren, Xuewen; Zhang, Qiuying; Wang, Hao; Man, Chunyan; Hong, Heng; Chen, Li; Li, Tanshi; Ye, Ping

    2015-01-01

    Background The aim of this study was to assess the role of intravenous iron supplementation in the prevention of AMS. Material/Methods This was a randomized, double-blinded, placebo-controlled study. Forty-one (n=41) healthy Chinese low-altitude inhabitants living in Beijing, China (altitude of about 50 meters) were randomly assigned into intravenous iron supplementation (ISS group; n=21) and placebo (CON group; n=20) groups. Participants in the ISS group received iron sucrose supplement (200...

  9. Chemical pleurodesis for the management of refractory hepatic hydrothorax in patients with decompensated liver cirrhosis

    Lee, Woo Jin; Park, Jung Ho; Park, Dong Il; Cho, Yong Kyun; Sohn, Chong Il; Jeon, Woo Kyu; Kim, Byung Ik

    2011-01-01

    Background/Aims Hepatic hydrothorax in patients with decompensated liver cirrhosis is a challenging problem. Treatment with diuretics and intermittent thoracentesis can be effective in selected patients. However, there are few effective therapeutic options in patients who are intolerant of these therapies. This study investigated the clinical usefulness of chemical pleurodesis with or without video-assisted thoracoscopic surgery (VATS) for patients with refractory hepatic hydrothorax. Methods Eleven consecutive patients with refractory hepatic hydrothorax who underwent chemical pleurodesis with or without VATS between July 2007 and February 2011 were enrolled in this study. The medical records and radiologic imagings of these patients were thoroughly reviewed. Results The median number of chemical pleurodesis sessions performed was 3 (range: 2-10). Successful pleurodesis was achieved in 8 of the 11 patients (72.7%), 5 (62.5%) of whom remained asymptomatic and hydrothorax free for a median follow-up of 16 weeks (range: 2-52 weeks). Complications were low-grade fever/leukocytosis (n=11, 100%), pneumonia (n=1, 9.1%), pneumothorax (n=4, 36.4%), azotemia/acute renal failure (n=6, 54.6%), and hepatic encephalopathy (n=4, 36.4%). Five patients were suspected as having procedure-related mortality (45.5%) due to the occurrence of acute renal failure with hepatic failure. The overall survival was significantly longer in the success group than in the non-success group. Conclusions Although chemical pleurodesis may improve the clinical symptoms and the radiologic findings in as many as 72.7% of patients with refractory hepatic hydrothorax, a significantly high prevalence of procedure-related morbidity and mortality hinders the routine application of this procedure for such patients. PMID:22310793

  10. The effect of acute alcohol intoxication on gut wall integrity in healthy male volunteers; a randomized controlled trial.

    de Jong, W J; Cleveringa, A M; Greijdanus, B; Meyer, P; Heineman, E; Hulscher, J B

    2015-02-01

    The aim of the study is to determine the effect of acute alcohol consumption on enterocytes. Chronic alcohol consumption has been known to induce a decrease in gut wall integrity in actively drinking alcoholics and patients with alcohol-induced liver disease. Data on the extent of the damage induced by acute alcohol consumption in healthy human beings is scarce. Studies show that heavy incidental alcohol consumption is a growing problem in modern society. Data on this matter may provide insights into the consequences of this behavior for healthy individuals. In a randomized clinical trial in crossover design, 15 healthy volunteers consumed water one day and alcohol the other. One blood sample was collected pre-consumption, five every hour post-consumption, and one after 24 h. Intestinal fatty acid binding protein (I-FABP) was used as a marker for enterocyte damage. Liver fatty acid binding protein (L-FABP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) were used as markers for hepatocyte damage. Lipopolysaccharide binding protein (LBP) and soluble CD14 (sCD14) were used as a measure of translocation. Interleukin-6 (IL-6) was used to assess the acute inflammatory response to endotoxemia. Alcohol consumption caused a significant increase in serum I- and L-FABP levels, compared to water consumption. Levels increased directly post-consumption and decreased to normal levels within 4 h. LBP, sCD14, and IL-6 levels were not significantly higher in the alcohol group. Moderate acute alcohol consumption immediately damages the enterocyte but does not seem to cause endotoxemia. PMID:25559494

  11. Economic evaluation of zinc and copper use in treating acute diarrhea in children: A randomized controlled trial

    Dhande Leena A

    2003-08-01

    Full Text Available Abstract Background The therapeutic effects of zinc and copper in reducing diarrheal morbidity have important cost implications. This health services research study evaluated the cost of treating a child with acute diarrhea in the hospital, the impact of micronutrient supplementation on the mean predicted costs and its cost-effectiveness as compared to using only standard oral rehydration solution (ORS, from the patient's and government's (providers perspective. Methods Children aged 6 months to 59 months with acute diarrhea were randomly assigned to receive either the intervention or control. The intervention was a daily dose of 40 mg of zinc sulfate and 5 mg of copper sulfate powder dissolved in a liter of standard ORS (n = 102. The control was 50 mg of standard ORS powder dissolved in a liter of standard ORS (n = 98. The cost measures were the total mean cost of treating acute diarrhea, which included the direct medical, the direct non-medical and the indirect costs. The effectiveness measures were the probability of diarrhea lasting ≤ 4 days, the disability adjusted life years (DALYs and mortality. Results The mean total cost of treating a child with acute diarrhea was US $14 of which the government incurred an expenditure of 66%. The factors that increased the total were the number of stools before admission (p = 0.01, fever (p = 0.01, increasing grade of dehydration (p = 0.00, use of antibiotics (p = 0.00, use of intra-venous fluids (p = 0.00, hours taken to rehydrate a child (p = 0.00, the amount of oral rehydration fluid used (p = 0.00, presence of any complications (p = 0.00 and the hospital stay (p = 0.00. The supplemented group had a 8% lower cost of treating acute diarrhea, their cost per unit health (diarrhea lasting ≤ 4 days was 24% less and the incremental cost-effectiveness ratio indicated cost savings (in Rupees with the intervention [-452; 95%CI (-11306, 3410]. However these differences failed to reach conventional levels

  12. Homeopathic medicine for acute cough in upper respiratory tract infections and acute bronchitis: a randomized, double-blind, placebo-controlled trial.

    Zanasi, Alessandro; Mazzolini, Massimiliano; Tursi, Francesco; Morselli-Labate, Antonio Maria; Paccapelo, Alexandro; Lecchi, Marzia

    2014-02-01

    Cough is a frequent symptom associated to upper respiratory tract infections (URTIs) and, although being self-limiting, it might deeply affect the quality of life. Homeopathic products are often employed by patients to treat cough, but the evidence on their efficacy is scarce. Thus, we tested the efficacy of a homeopathic syrup in treating cough arising from URTIs with a randomized, double blind, placebo controlled clinical trial. Patients were treated with either the homeopathic syrup or a placebo for a week, and recorded cough severity in a diary by means of a verbal category-descriptive score for two weeks. Sputum viscosity was assessed with a viscosimeter before and after 4 days of treatment; patients were also asked to provide a subjective evaluation of viscosity. Eighty patients were randomized to receive placebo (n = 40) or the homeopathic syrup (n = 40). All patients completed the study. In each group cough scores decreased over time, however, after 4 and 7 days of treatment, cough severity was significantly lower in the homeopathic group than in the placebo one (p syrup employed in the study was able to effectively reduce cough severity and sputum viscosity, thereby representing a valid remedy for the management of acute cough induced by URTIs. PMID:23714686

  13. [Critically ill patients with decompensated liver cirrhosis - New aspects and intensive care management].

    Maschmeier, Miriam; Hüsing, Anna; Schmidt, Hartmut; Kabar, Iyad

    2015-10-01

    The prevalence of liver cirrhosis in the German population is about 1 %. Clinically, compensated liver cirrhosis should be distinguished from decompensated cirrhosis with poor prognosis. Decompensated cirrhosis is defined by the occurrence of complications and consequences of portal hypertension (such as ascites, variceal bleeding, hepatic encephalopathy and hepatorenal syndrome) and progressive liver failure. Optimizing the management of these patients in the intensive care unit could essentially improve their outcome. PMID:26445254

  14. Randomized Study of Ondansetron Versus Domperidone in the Treatment of Children With Acute Gastroenteritis

    Rerksuppaphol, Sanguansak; Rerksuppaphol, Lakkana

    2013-01-01

    Background Acute gastroenteritis (AGE) is a common condition among children that is frequently accompanied by vomiting. Symptomatic control of vomiting is important as it improves patient’s general condition and reduces the need for intravenous therapy and hospitalization. Antiemetic agents including ondansetron and domperidone are used to provide symptomatic relief but the existing studies do not provide enough evidence of better efficacy for one over another. Methods Seventy-six Thai childr...

  15. Randomized Controlled Trial of Mindfulness Meditation and Exercise for the Prevention of Acute Respiratory Infection: Possible Mechanisms of Action

    Aleksandra Zgierska

    2013-01-01

    Full Text Available Background. A randomized trial suggests that meditation and exercise may prevent acute respiratory infection (ARI. This paper explores potential mediating mechanisms. Methods. Community-recruited adults were randomly assigned to three nonblinded arms: 8-week mindfulness-based stress reduction (N=51, moderate-intensity exercise (N=51, or wait-list control (N=52. Primary outcomes were ARI illness burden (validated Wisconsin Upper Respiratory Symptom Survey. Potential mediators included self-reported psychophysical health and exercise intensity (baseline, 9 weeks, and 3 months. A Baron and Kenny approach-based mediational analysis model, adjusted for group status, age, and gender, evaluated the relationship between the primary outcome and a potential mediator using zero-inflated modeling and Sobel testing. Results. Of 154 randomized, 149 completed the trial (51, 47, and 51 in meditation, exercise, and control groups and were analyzed (82% female, 94% Caucasian, 59.3 ± SD 6.6 years old. Mediational analyses suggested that improved mindfulness (Mindful Attention Awareness Scale at 3 months may mediate intervention effects on ARI severity and duration (P<0.05; 1 point increase in the mindfulness score corresponded to a shortened ARI duration by 7.2–9.6 hours. Conclusions. Meditation and exercise may decrease the ARI illness burden through increased mindfulness. These preliminary findings need confirmation, if confirmed, they would have important policy and clinical implications. This trial registration was Clinicaltrials.gov: NCT01057771.

  16. Procalcitonin guidance for reduction of antibiotic use in patients hospitalized with severe acute exacerbations of asthma: a randomized controlled study with 12-month follow-up

    Long, Wei; Li, Li-juan; Huang, Gao-zhong; Zhang, Xue-Min; Zhang, Yi-cui; Tang, Jian-Guo; Zhang, Yu; Lu, Gang

    2014-01-01

    Introduction Patients with severe acute exacerbations of asthma often receive inappropriate antibiotic treatment. We aimed to determine whether serum procalcitonin (PCT) levels can effectively and safely reduce antibiotic exposure in patients experiencing exacerbations of asthma. Methods In this randomized controlled trial, a total of 216 patients requiring hospitalization for severe acute exacerbations of asthma were screened for eligibility to participate and 169 completed the 12-month foll...

  17. REASSESSMENT OF DEFIBRASE IN TREATMENT OF ACUTE CEREBRAL INFARCTION: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL

    The Cooperative Group for Reassessment of Defibras

    2005-01-01

    Objective To evaluate the efficacy and safety of defibrase in patients with acute cerebral infarction by a large sample,multicenter, randomized, double-blind, placebo-controlled clinical trial.Methods Patients with acute cerebral infarction within 12 hours of stroke onset were randomly assigned to receive either an initial intravenous infusion of defibrase 15 U plus normal saline 250 Ml or 250 Ml of normal saline only.Subsequent infusions of defibrase 15 U or placebo (normal saline) were given on the 3rd, 5th, 7th, and 9th day, respectively.Both groups received standard care of acute cerebral infarction. The primary efficacy outcome was functional status(Barthel Index) at 3 months after treatment. Safety outcome were bleeding events and mortality rate. Secondary outcome included Chinese Stroke Scale (CSS) score at 14 days and recurrence rate of stroke at 1 year. Results A total of 1053 patients were enrolled at 46 centers from September 2001 to July 2003, and 527 patients were randomly assigned to receive defibrase and 526 to receive placebo. A similar proportion of patients in both groups completed a full course of treatment. There was a significantly greater proportion of favorable functional status (Barthel Index ≥95) in defibrase group than in placebo group at 3 months (52.2% vs. 42.8%, P < 0.01), and the proportion of dependent functional status (Barthel Index ≤60) was a little lower in defibrase group compared with placebo group(27.7%vs. 32.4%). These differences were more obvious among patients who were treated within 6 hours of stroke onset.Patients in defibrase group had better improvement with respect to CSS score than those in placebo group at 14 days (P <0.05). Recurrence rate of stroke at 1 year was lower in the defibrase group compared with placebo group (6.2% vs. 10.1%,P = 0.053). Patients in defibrase group had higher risk of extracranial bleeding events (4.7%vs. 1.5%, P< 0.01) and a tendency of higher risk of symptomatic intracranial hemorrhage

  18. A randomized controlled multicenter trial of actovegin against acute oral mucositis induced by chemo-radiotherapy for nasopharyngeal carcinoma

    Objective: To evaluate the efficacy and safety of actovegin against acute oral mucositis through a randomized controlled multicenter trial for nasopharyngeal carcinoma (NPC) patients treated by chemo-radiotherapy. Methods: From February 2006 to May 2007, a total of 161 patients with newly diagnosed stage II-IVA(1992 Fuzhou Stage) NPC were randomly assigned to the prevention group, the treatment group and the control group. All patients received current chemo-radiotherapy ± neoadjuvant chemotherapy. Radiation technique and dose were similar among the three groups. Intravenous infusion of actovegin was started when radiation started in the prevention group and when grade 2 mucositis occurred in the treatment group, which was given 30 ml daily, 5 times per week until the end of radiotherapy. Criteria of NCI CTC 2.0 and VRS were used to evaluate acute oral mucositis and pain degree, respectively. Results: 154 patients were eligible for the efficacy analysis, including 49 in the prevention group, 53 in the treatment group and 52 in the control group. In the prevention group and the control group, the incidence was 31% and 56% (P= 0.011) for grade 3-4 mucositis, 59% and 83% (P=0.009) for grade 2-3 pain. In the treatment group and the control group, the corresponding number was 38% and 60% (P=0.023), 70% and 90%, (P=0.014). The prevention group had a lower incidence (P=0.021) and longer average interval (P=0.009) of grade 2 mucositis when comparing with the control group. No drug-related adverse event was observed. Conclusions: Prophylactic or therapeutic use of actovegin by intravenous infusion can significantly reduce the severity of chemo-radiotherapy induced oral mucositis and pain. The prophylactic use may also postpone and decrease the incidence of grade 2 mucositis, which deserves clinic application. (authors)

  19. Analgesic Effects and Safety of Desmopressin, Tramadol and Indomethacin in Patients with Acute Renal Colic; A Randomized Clinical Trial

    Mehdi Shirazi

    2015-04-01

    Full Text Available Objective: To compare the efficacy of desmopressin (DDAVP, tramadol and indomethacin on pain intensity of patients with acute renal colic caused by urolithiasis. Methods: This prospective, randomized clinical trial was conducted between July 2005 and July 2006 including 120 patients (70 men and 50 women, mean age 38.2±5.8 years referring to emergency room of Shahid Faghihi hospital with renal colic caused by urolithiasis without any previous treatment. The patients were randomly assigned to three groups: group A received tramadol 50mg intramuscularly (n=40, group B received desmopressin 40 µg intranasally (n=40 and group C received indomethacin 100mg rectally (n=40. The pain was assessed both on admission and 30 minutes after the intervention. The pain intensity and the side effects were compared between two study groups. Results: There was no significant difference between two study groups regarding the baseline characteristics. The intensity of pain of presentation was almost similar in all groups. In group A, 30 patients (75%, in group B, 15 patients (37.5% and in group C, 19 patients (47.5% had complete pain relief. The pain intensity decreased significantly after the intervention within all three groups ( p<0.001. Conclusion: According to the results of the current study, rectal indomethacin, intramuscular tramadol and intranasal desmopressin are effective and safe routs of controlling pain in acute renal colic secondary to urolithiasis. Tramadol was the most effective agent in controlling the pain. Clinical Trial Registry: The current study is registered with Iranian Registry for Clinical Trials (www.irct.ir; IRCT2015030919470N18

  20. Cost-effectiveness of entecavir versus adefovir for the treatment of chronic hepatitis B in patients with decompensated cirrhosis from a third-party US payer perspective

    Tsai N

    2012-08-01

    Full Text Available Naoky Tsai,1 Lennox Jeffers,2 Lael Cragin,3 Sonja Sorensen,3 Wenqing Su,3 Lisa Rosenblatt,4 Hong Tang,4 Tony Hebden,4 Timothy Juday41John A Burns School of Medicine, University of Hawaii, Honolulu, HI, USA; 2University of Miami School of Medicine, Miami, FL, USA; 3United BioSource Corporation, Bethesda, MD, USA; 4Bristol-Myers Squibb Company, Plainsboro, NJ, USABackground: Decompensated cirrhosis is a serious clinical complication of chronic hepatitis B (CHB that places a large economic burden on the US health care system. Although entecavir has been shown to improve health outcomes in a cost-effective manner in mixed populations of CHB patients, the cost-effectiveness of entecavir has not been evaluated in CHB patients with decompensated cirrhosis.Methods: This study assessed the cost-effectiveness of entecavir versus adefovir, from a US payer perspective, in CHB patients with decompensated cirrhosis, using a health-state transition Markov model with four health states: hepatocellular carcinoma (HCC, HCC-free survival, post-liver transplant, and death. The model considered a hypothetical patient population similar to that included in a randomized controlled trial in the target population (ETV-048: predominantly male (74%, Asian (54%, mean age 52 years, hepatic decompensation (Child–Pugh score ≥ seven, hepatitis B e antigen-positive or -negative, treatment-naïve or lamivudine-experienced, and no liver transplant history. Clinical inputs were based on cumulative safety results for ETV-048 and published literature. Costs were obtained from published literature. Costs and outcomes were discounted at 3% per annum.Results: For 1000 patients over a 3-year time horizon, predicted overall survival and HCC-free survival were longer with entecavir than with adefovir (2.35 versus 2.30 years and 2.11 versus 2.03 years, respectively. Predicted total health care costs were $889 lower with entecavir than with adefovir ($91,878 versus $92,768. For

  1. A randomized trial of washed red blood cell and platelet transfusions in adult acute leukemia [ISRCTN76536440

    Rowe Jacob M

    2004-12-01

    Full Text Available Abstract Background Platelet transfusion is universally employed in acute leukemia. Platelet concentrate supernatants contain high concentrations of biologic mediators that might impair immunity. We investigated whether washed platelet and red cell transfusions could improve clinical outcomes in adult patients with acute leukemia. Methods A pilot randomized trial of washed, leukoreduced ABO identical transfusions versus leukoreduced ABO identical transfusions was conducted in 43 adult patients with acute myeloid or lymphoid leukemia during 1991–94. Primary endpoints to be evaluated were platelet transfusion refractoriness, infectious and bleeding complications and overall survival. Results There were no significant differences in infectious or major bleeding complications and only one patient required HLA matched platelet transfusions. Minor bleeding was more frequent in the washed, leukoreduced arm of the study. Confirmed transfusion reactions were more frequent in the leukoreduced arm of the study. Overall survival was superior in the washed arm of the study (40% versus 22% at 5 years, but this difference was not statistically significant (p = 0.36. A planned subset analysis of those ≤50 years of age found that those in the washed, leukoreduced arm (n = 12 had a 75% survival at five years compared with 30% in the leukoreduced arm (n = 10 (p = 0.037 Conclusion This study provides the first evidence concerning the safety and efficacy of washed platelets, and also raises the possibility of improved survival. We speculate that transfusion of stored red cell and platelet supernatant may compromise treatment, particularly in younger patients with curable disease. Larger trials will be needed to assess this hypothesis.

  2. Use of Axillary Deodorant and Effect on Acute Skin Toxicity During Radiotherapy for Breast Cancer: A Prospective Randomized Noninferiority Trial

    Purpose: To prospectively determine the effect of deodorant use on acute skin toxicity and quality of life during breast radiotherapy (RT). Methods and Materials: Before breast RT, 84 patients were randomly assigned to the deodorant group (n = 40) or the no-deodorant group (n = 44). The patients were stratified by axillary RT and previous chemotherapy. Toxicity evaluations were always performed by the principal investigator, who was unaware of the group assignment, at the end of RT and 2 weeks after completion using the Radiation Therapy Oncology Group acute skin toxicity criteria. Symptoms of acute skin toxicity (i.e., discomfort, pain, pruritus, sweating) and quality of life were self-evaluated. For each criterion, the point estimate of rate difference with the 95% one-sided upper confidence limit was computed. To claim noninferiority owing to deodorant use, the 95% one-sided upper confidence limit had to be lower than the noninferiority margin, fixed to 12.8%. Results: In the deodorant vs. no-deodorant groups, Grade 2 axillary radiodermatitis occurred in 23% vs. 30%, respectively, satisfying the statistical criteria for noninferiority (p = .019). Grade 2 breast radiodermatitis occurred in 30% vs. 34% of the deodorant vs. no-deodorant groups, respectively, also satisfying the statistical criteria for noninferiority (p = .049). Similar results were observed for the self-reported evaluations. The deodorant group reported less sweating (18% vs. 39%, p = .032). No Grade 3 or 4 radiodermatitis was observed. Conclusion: According to our noninferiority margin definition, the occurrence of skin toxicity and its related symptoms were statistically equivalent in both groups. No evidence was found to prohibit deodorant use (notwithstanding the use of an antiperspirant with aluminum) during RT for breast cancer.

  3. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial

    Fisher Beth E

    2010-10-01

    Full Text Available Abstract Background Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. Methods/Design We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. Discussion This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. Trial Registration http://www.clinicaltrials.gov identifier NCT00888498.

  4. Precipitating factors leading to decompensation of chronic heart failure in the elderly patient in South-American community hospital

    Alejandro Diaz; Cleto Ciocchini; Mariano Esperatti; Alberto Becerra; Sabrina Mainardi; Alejandro Farah

    2011-01-01

    Background Exacerbations of heart failure appear frequently associated with precipitating factors not directly related to the evolution of cardiac disease. There still a paucity of data on the proportional distribution of precipitating factors specifically in elderly patients. The aim of this study was to examine prospectively the precipitating factors leading to hospitalization in elderly patients with heart failure in our community hospital. Methods We evaluate elderly patients who need admissions for decompensate heart failure. All patients were reviewed daily by the study investigators at the first 24 h and closely followed-up. Decompensafion was defined as the worsening in clinical NYHA class associated with the need for an increase in medical treatment (at minimum intravenously diuretics). Results We included 102 patients (mean age 79 ± 12 years). Precipitating factors were identified in 88.5%. The decompensation was sudden in 35% of the cases.Noncompliance with diet was identified in 52% of the patients, lack of adherence to the prescribed medications amounted to 30%. Others precipitating factors were infections (29%), arrhythmias (25%), acute coronary ischemia (22%), and uncontrolled hypertension (15%),miscellaneous causes were detected in 18% of the cases (progression of renal disease 60%, anemia 30% and iatrogenic factors 10%).Concomitant cause was not recognizable in 11.5%. Conclusions Large proportion heart failure hospitalizations are associated with preventable precipitating factors. Knowledge of potential precipitating factors may help to optimize treatment and provide guidance for patients with heart failure. The presence of potential precipitating factors should be routinely evaluated in patients presenting chronic heart failure.

  5. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial.

    Andrew Zolopa

    Full Text Available BACKGROUND: Optimal timing of ART initiation for individuals presenting with AIDS-related OIs has not been defined. METHODS AND FINDINGS: A5164 was a randomized strategy trial of "early ART"--given within 14 days of starting acute OI treatment versus "deferred ART"--given after acute OI treatment is completed. Randomization was stratified by presenting OI and entry CD4 count. The primary week 48 endpoint was 3-level ordered categorical variable: 1. Death/AIDS progression; 2. No progression with incomplete viral suppression (ie HIV viral load (VL >or=50 copies/ml; 3. No progression with optimal viral suppression (ie HIV VL <50 copies/ml. Secondary endpoints included: AIDS progression/death; plasma HIV RNA and CD4 responses and safety parameters including IRIS. 282 subjects were evaluable; 141 per arm. Entry OIs included Pneumocytis jirovecii pneumonia 63%, cryptococcal meningitis 12%, and bacterial infections 12%. The early and deferred arms started ART a median of 12 and 45 days after start of OI treatment, respectively. THE DIFFERENCE IN THE PRIMARY ENDPOINT DID NOT REACH STATISTICAL SIGNIFICANCE: AIDS progression/death was seen in 20 (14% vs. 34 (24%; whereas no progression but with incomplete viral suppression was seen in 54 (38% vs. 44 (31%; and no progression with optimal viral suppression in 67 (48% vs 63 (45% in the early vs. deferred arm, respectively (p = 0.22. However, the early ART arm had fewer AIDS progression/deaths (OR = 0.51; 95% CI = 0.27-0.94 and a longer time to AIDS progression/death (stratified HR = 0.53; 95% CI = 0.30-0.92. The early ART had shorter time to achieving a CD4 count above 50 cells/mL (p<0.001 and no increase in adverse events. CONCLUSIONS: Early ART resulted in less AIDS progression/death with no increase in adverse events or loss of virologic response compared to deferred ART. These results support the early initiation of ART in patients presenting with acute AIDS-related OIs, absent major contraindications

  6. Double-blind, randomized, controlled trial of zinc or vitamin A supplementation in young children with acute diarrhoea.

    Faruque, A S; Mahalanabis, D; Haque, S S; Fuchs, G J; Habte, D

    1999-02-01

    In a double-blind, controlled trial with a factorial design, 684 patients (aged 6 months to 2 y; excludes 6 early dropouts) with acute watery diarrhoea of 3 d or less and some dehydration, who were attending a hospital, were randomly assigned to 4 groups to receive: (a) vitamin A 4500 microg retinol equivalent daily for 15 d; (b) 14.2 mg elemental zinc as acetate for the first 417 patients and 40 mg of the remaining 273 patients randomized to this group for 15 d; (c) both vitamin A 4500 microg retinol equivalent and zinc at the above doses daily for 15 d; or (d) placebo mixtures for 15 d. Patients were observed in the hospital for 24 h and followed up at home for 15 d. All received ascorbic acid 30 mg with each dose of medicine or placebo. Zinc supplementation was associated with a reduced duration of diarrhoea (13%, p = 0.03) and markedly reduced rate (43%, p = 0.017) of prolonged diarrhoea (>7 d). Vitamin A supplementation was associated with a nonsignificant trend for reduced rate of prolonged diarrhoea (p = 0.089). In conclusion, zinc supplementation as adjunct therapy had a substantial impact on the rate of prolonged diarrhoea and some impact on duration and may be beneficial in children with diarrhoea in developing countries. PMID:10102147

  7. Randomized, Double-Blind Clinical Trial to Assess the Acute Diuretic Effect of Equisetum arvense (Field Horsetail in Healthy Volunteers

    Danilo Maciel Carneiro

    2014-01-01

    Full Text Available In this double-blind, randomized clinical trial, 36 healthy male volunteers were randomly distributed into three groups (n=12 that underwent a three-step treatment. For four consecutive days, we alternately administered a standardized dried extract of Equisetum arvense (EADE, 900 mg/day, placebo (corn starch, 900 mg/day, or hydrochlorothiazide (25 mg/day, separated by a 10-day washout period. Each volunteer served as his own control, and the groups’ results were compared. We repeated the same evaluation after each stage of treatment to evaluate the safety of the drug. The diuretic effect of EADE was assessed by monitoring the volunteers’ water balance over a 24 h period. The E. arvense extract produced a diuretic effect that was stronger than that of the negative control and was equivalent to that of hydrochlorothiazide without causing significant changes in the elimination of electrolytes. There was no significant increase in the urinary elimination of catabolites. Rare minor adverse events were reported. The clinical examinations and laboratory tests showed no changes before or after the experiment, suggesting that the drug is safe for acute use. Further research is needed to better clarify the mechanism of diuretic action and the other possible pharmacological actions of this phytomedicine.

  8. Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial

    LI Ting; CHEN Shun-le; DAI Qing; HAN Xing-hai; LI Zhan-guo; WU Dong-hai; ZHANG Xiao

    2013-01-01

    Background Acute gout is an intensely painful,inflammatory arthritis.Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition,the efficacy is based on only a few studies,particularly in China.We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.Methods A randomized,double-blind,active comparator study was conducted at 10 sites in China.Patients (n=178; ≥18 years of age) with acute gouty attack (<48 hours) were treated for 5 days with etoricoxib (120 mg/d; n=89) or indometacin (75 mg twice daily; n=89).The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2-5.Secondary end points included investigator assessments of tenderness and swelling,patient/ investigator global assessments of response to therapy,and patients discontinuing treatment.Safety was assessed by adverse events (AEs).Results Etoricoxib and indometacin had comparable primary and secondary end points.Mean change difference from baseline from days 2-5 was 0.03 (95% confidence interval (Cl)-0.19 to 0.25; P=0.6364),which fell within the prespecified comparative bounds of-0.5 to 0.5.No severe AEs were associated with etoricoxib use.Non-severe AEs were mainly digestive and general,and most (73.7%) were mild,although they caused withdrawal of two subjects in the etoricoxib group,due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related).Overall,AEs were similar,although the absolute number of AEs in the etoricoxib group (n=31) was less than the indometacin group (n=34).Conclusions Etoricoxib (120 mg once daily) is effective in treating acute gout,is generally safe and well-tolerated,and is comparable in efficacy to indometacin (75 mg twice daily).

  9. A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure

    Ponikowski, Piotr; Mitrovic, Veselin; Ruda, Mikhail; Fernandez, Alberto; Voors, Adriaan A.; Vishnevsky, Alexander; Cotter, Gad; Milo, Olga; Laessing, Ute; Zhang, Yiming; Dahlke, Marion; Zymlinski, Robert; Metra, Marco

    2014-01-01

    The aim of this study was to evaluate the haemodynamic effects of serelaxin (30 g/kg/day 20-h infusion and 4-h post-infusion period) in patients with acute heart failure (AHF). This double-blind, multicentre study randomized 71 AHF patients with pulmonary capillary wedge pressure (PCWP) 18 mmHg, sys

  10. ACUTE TOXICITY PROFILE AND COMPLIANCE TO ACCELERATED RADIOTHERAPY PLUS CARBOGEN AND NICOTINAMIDE FOR CLINICAL STAGE T2-4 LARYNGEAL CANCER : RESULTS OF A PHASE III RANDOMIZED TRIAL

    Janssens, Geert O.; Terhaard, Chris H.; Doornaert, Patricia A.; Bijl, Hendrik P.; van den Ende, Piet; Chin, Alim; Pop, Lucas A.; Kaanders, Johannes H.

    2012-01-01

    Purpose: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. Methods and Materials: From April 2001 to February 2008, 345 patients with

  11. Acute toxicity profile and compliance to accelerated radiotherapy plus carbogen and nicotinamide for clinical stage T2-4 laryngeal cancer: results of a phase III randomized trial.

    Janssens, G.O.R.J.; Terhaard, C.H.J.; Doornaert, P.A.; Bijl, H.P.; Ende, P. van den; Chin, A.; Pop, L.A.M.; Kaanders, J.H.A.M.

    2012-01-01

    PURPOSE: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. METHODS AND MATERIALS: From April 2001 to February 2008, 345 patients with

  12. A randomized trail comparing primary percutaneous coronary intervention with a strategy of short-acting thrombolysis and immediate planned primary percutaneous coronary intervention in acute myocardial infarction

    傅向华

    2003-01-01

    A randomized trail comparing primary percutaneous coronary intervention with a strategy of short-acting thrombolysis and immediate planned primary percutaneous coronary intervention in acute myocardial infarction!050000$河北医科大学第二医院河北医科大学心脏介入中心@傅向华

  13. Immediate and short-term pain relief by acute sciatic nerve press: a randomized controlled trial

    Zhang Wenlong

    2007-05-01

    Full Text Available Abstract Background Despite much research, an immediately available, instantly effective and harmless pain relief technique has not been discovered. This study describes a new manipulation: a "2-minute sciatic nerve press", for rapid short-term relief of pain brought on by various dental and renal diseases. Methods This randomized, single-blind, placebo-controlled trial ran in three hospitals in Anhui Province, China, with an enrollment of 66 out of 111 solicited patients aged 16 to 74 years. Patients were recruited sequentially, by specific participating physicians at their clinic visits to three independent hospitals. The diseases in enrolled dental patients included dental caries, periodontal diseases and dental trauma. Renal diseases in recruits included kidney infections, stones and some other conditions. Patients were randomly assigned to receive the "2-minute sciatic nerve press" or the "placebo press". For the "2-minute sciatic nerve press", pressure was applied simultaneously to the sciatic nerves at the back of the thighs, using the fists while patients lay prone. For the "placebo press", pressure was applied simultaneously to a parallel spot on the front of the thighs, using the fists while patients lay supine. Each fist applied a pressure of 11 to 20 kg for 2 minutes, after which, patients arose to rate pain. Results The "2-minute sciatic nerve press" produced greater pain relief than the "placebo press". Within the first 10 minutes after sciatic pressure, immediate pain relief ratings averaged 66.4% (p Conclusion Two minutes of pressure on both sciatic nerves can produce immediate significant conduction analgesia, providing a convenient, safe and powerful way to overcome clinical pain brought on by dental diseases and renal diseases for short term purposes. Trial registration ACTR 12606000439549

  14. A Randomized Controlled Trial of Intravenous Magnesium Sulphate as an Adjunct to Standard Therapy in Acute Severe Asthma

    Singh Anupam Kumar

    2008-12-01

    Full Text Available Though intravenous (IV Magnesium Sulphate (MgS04 has additive effect to beta-2 agonists, its additive benefit in face of combination therapy with beta-2-agonists and ipratropium (standard therapy of severe acute exacerbation of asthma remains unaddressed. The aim of this investigation was to evaluate the role of IV MgSO4 when used as an adjunct to standard therapy of severe exacerbations of asthma. Randomized, single blinded, placebo-controlled study was carried out in Emergency Department (ED. Patients aged 18-60 years presenting with acute asthma and FEV1 In group1 (controls, patients were nebulised with salbutamol and ipratropium thrice at 20 minutes interval and were given 2g IV MgSO4 at 30 minutes. In group2 patients were nebulised similarly, but were given IV normal saline at 30 minutes for blinding. FEV1 was evaluated at baseline and at 30 minutes intervals. The primary efficacy end point was FEV1%pred. at 120 mins and pooled discharge rate (derived from comparing proportion of groups attaining PEFR >60%pred. and relief in dyspnea at 30, 60, 90, 120 minutes. Both groups of 30 patients each, were matched with respect to demographic and pulmonary parameters (Baseline FEV1% :22.0+5.1% in group2 vs.22.07+5.2% in group1, p=0.87.At 120 minutes, there was a higher mean FEV1 %pred (62.84+4.73% vs. 56.7+4.5% and %improvement from baseline of (40.7+9.2%vs34.77+7.3%, in group 2 as compared to group1 (Mean Difference= 6.07%, C.I.1.87-10.62., pMagnesium sulfate as an adjunct to standard therapy in patients with severe exacerbation of asthma could cause improvement in pulmonary function and decrease in hospital admission.

  15. Acute and second-meal effects of almond form in impaired glucose tolerant adults: a randomized crossover trial

    Considine Robert V

    2011-01-01

    Full Text Available Abstract Background Nut consumption may reduce the risk of developing type 2 diabetes. The aim of the current study was to measure the acute and second-meal effects of morning almond consumption and determine the contribution of different nut fractions. Methods Fourteen impaired glucose tolerant (IGT adults participated in a randomized, 5-arm, crossover design study where whole almonds (WA, almond butter (AB, defatted almond flour (AF, almond oil (AO or no almonds (vehicle - V were incorporated into a 75 g available carbohydrate-matched breakfast meal. Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids (NEFA, glucagon-like peptide-1 (GLP-1 and appetitive sensations were assessed after treatment breakfasts and a standard lunch. Results WA significantly attenuated second-meal and daylong blood glucose incremental area under the curve (AUCI and provided the greatest daylong feeling of fullness. AB and AO decreased blood glucose AUCI in the morning period and daylong blood glucose AUCI was attenuated with AO. WA and AO elicited a greater second-meal insulin response, particularly in the early postprandial phase, and concurrently suppressed the second-meal NEFA response. GLP-1 concentrations did not vary significantly between treatments. Conclusions Inclusion of almonds in the breakfast meal decreased blood glucose concentrations and increased satiety both acutely and after a second-meal in adults with IGT. The lipid component of almonds is likely responsible for the immediate post-ingestive response, although it cannot explain the differential second-meal response to AB versus WA and AO.

  16. Random Lead Time of the acute ghrelin response to a psychological stress

    Geetha.T

    2014-12-01

    Full Text Available Ghrelin is a growth hormone and cortisol secretagogue that plays an important role in appetite and weight regulation. It is not known whether ghrelin is involved in the eating response to stress in humans. In the present study we examined the effects of psychologically induced stress on plasma ghrelin levels in patients with bingeeating disorder (BED and in healthy subjects of normal or increased body mass index (BMI. Volunteers were subjected to the standardized trier social stress test (TSST. Basal ghrelin levels in patients were at an intermediate level between thin and healthy obese subjects, but this difference did not attain statistical significance. There were no differences in ghrelin levels throughout the test among the groups after correction for BMI, age and gender. A significant difference in the trend time of ghrelin was revealed when the three groups were analyzed according to their cortisol response to stress. Ghrelin levels increased in cortisol responders whereas no change or a decrease in ghrelin levels occurred in cortisol non-responders. We also found Optimal time T*, Minimal Repair δ and Random Lead Time g to minimize the ghrelin level.

  17. Comparison of oral montelukast with oral zileuton in acute asthma: A randomized, double-blind, placebo-controlled study

    Rahul Magazine

    2016-01-01

    Full Text Available Background: Leukotriene modifiers have an established role in the management of chronic asthma but their role in acute asthma is still under evaluation. Objective: To study and compare the effects of oral montelukast with oral zileuton in acute asthma. Materials and Methods: This study included 120 asthmatics and was conducted from September 2012 to March 2014. Patients were randomized into three different groups to receive montelukast or zileuton or placebo in addition to standard treatment for asthma exacerbation. Peak expiratory flow rate (PEFR values, details of rescue medication and vital signs were recorded at 6 h, 12 h, 24 h, and 48 h of drug or placebo administration and at discharge. Additional recording was done in the morning (8-10 am following admission. The primary endpoint was the mean PEFR of each group at these time points; the secondary end point being the need for rescue medications. Results: The mean PEFR recordings of the three study groups - placebo, montelukast, and zileuton - respectively, at various time points were as follows: at 6 h (223.25 ± 90.40, 199.00 ± 82.52, 233.75 ± 84.05; P = 0.240; at 12 h (271.00 ± 109.38, 251.50 ± 101.44, 309.50 ± 129.63; P = 0.048; at 24 h (288.25 ± 114.26, 269.00 ± 107.51, 324.50 ± 127.88; P = 0.080; and at 48 h (295.00 ± 114.80, 293.50 ± 113.24, 344.75 ± 119.91; P = 0.015; discharge (305.00 ± 118.56, 305.25 ± 119.51, 361.25 ± 119.70; P = 0.010. The mean PEFR for the three study groups at 8-10 am on the morning following admission was 268.75 ± 111.43, 252.50 ± 99.99, 306.75 ± 114.44; P = 0.047. Total rescue doses needed were 10, 1, and 0, respectively (P = 0.049. Conclusion: Zileuton is better than montelukast as an additional drug in acute asthma and results in significant improvement in lung function, and reduction in the need for rescue medications.

  18. Therapeutic Effects of Oral Zinc Supplementation on Acute Watery Diarrhea with Moderate Dehydration: A Double-Blind Randomized Clinical Trial

    Mohammad Karamyyar

    2013-06-01

    Full Text Available Background: To assess the therapeutic effects of oral zinc supplementation on acute watery diarrhea of children with moderate dehydration.Methods: All 9-month to 5-year-old children who were admitted with acute watery diarrhea and moderate dehydration to the Children Ward of Motahari Hospital, Urmia, Iran in 2008 were recruited. After the application of the inclusion and exclusion criteria, the patients were randomly allocated to two groups: one group to receive zinc plus oral rehydration solution (ORS and the other one to receive ORS plus placebo. All the patients were rehydrated using ORS and then receiving ORS for ongoing loss (10 ml/kg after every defecation. Additionally, the patients in the intervention group received zinc syrup (1 mg/kg/day divided into two doses. A detailed questionnaire was filled daily for each patient by trained pediatrics residents; it contained required demographic characteristics, nutrition and hydration status, and disease progression. The primary outcome (frequency and consistency of diarrhea and the secondary outcomes (duration of hospitalization and change in patients’ weight were compared between the two groups.Results: The mean diarrhea frequency (4.5±2.3 vs. 5.3±2.1; P=0.004 was lower in the group receiving zinc +ORS; however, the average weight was relatively similar between the two groups (10.5±3.1 vs. 10.1±2.3; P=0.14. The qualitative assessment of stool consistency also confirmed earlier improvement in the treatment group in the first three days of hospitalization (P <0.05. The mean duration of hospitalization was significantly lower in the patients receiving zinc supplements (2.5±0.7 vs. 3.3±0.8 days; P=0.001. Conclusion: Our results imply the beneficial effects of therapeutic zinc supplementation on disease duration and severity in patients with acute diarrhea and moderate dehydration in Iran. Trial Registration Number: IRCT201201241580N2

  19. Ninety-day administration of dl-3-n-butylphthalide for acute ischemic stroke: a randomized, double-blind trial

    CUI Li-ying; ZHU Yi-cheng; GAO Shan; WANG Jian-ming; PENG Bing; NI Jun; ZHOU Li-xin

    2013-01-01

    Background DI-3-n-butylphthalide (NBP),first isolated from the seeds of celery,showed efficacy in animal models of stroke.This study was a clinical trial to assess the efficacy and safety of NBP with a continuous dose regimen among patients with acute ischemic stroke.Methods A randomized,double-blind,double-dummy trial enrolled 573 patients within 48 hours of onset of ischemic stroke in China.Patients were randomly assigned to receive a 14-day infusion of NBP followed by an NBP capsule,a 14-day infusion of NBP followed by aspidn,or a 14-day infusion of ozagrel followed by aspidn.The efficacy measures were Barthel index score and the modified Rankin scale (mRS) at day 90.Differences among the three groups on mRS were compared using X2 test of proportions (with two-sided α=0.05) and Logistic regression analysis was conducted to take the baseline National Institutes of Health Stroke Scale (NIHSS) score into consideration.Results Among the 535 subjects included in the efficacy analysis,90-day treatment with NBP was associated with a significantly favorable outcome than 14-day treatment with ozagrel as measured by mRS (P <0.001).No significant difference was found among the three groups on Barthel index at day 90.The rate of adverse events was similar among the three groups.Conclusions The 90-day treatment with NBP could improve outcomes at the third month after stroke.The NBP treatment (both intravenous and oral) is safe (ChiCTR-TRC-09000483).

  20. Early intravenous beta-blockers in patients with acute coronary syndrome–A meta-analysis of randomized trials

    Chatterjee, Saurav; Chaudhuri, Debanik; Vedanthan, Rajesh; Fuster, Valentin; Ibanez, Borja; Bangalore, Sripal; Mukherjee, Debabrata

    2014-01-01

    Background Intravenous (IV) beta-blockade is currently a Class IIa recommendation in early management of patients with acute coronary syndromes (ACS) without obvious contraindications. Methods We searched the PubMed, EMBASE and the Cochrane Register for Controlled Clinical Trials for randomized clinical trials from 1965 through December, 2011, comparing intravenous beta-blockers administered within 12 hours of presentation of ACS with standard medical therapy and/or placebo. The primary outcome assessed was the risk of short-term (in-hospital mortality-with maximum follow up duration of 90 days) all-cause mortality in the intervention group versus the comparator group. The secondary outcomes assessed were ventricular tachyarrhythmias, myocardial reinfarction, cardiogenic shock, and stroke. Pooled treatment effects were estimated using relative risk with Mantel–Haenszel risk ratio, using a random-effects model. Results Sixteen studies enrolling 73,396 participants met the inclusion / exclusion criteria. In- hospital mortality was reduced 8% with intravenous beta-blockers, RR=0.92 (95% CI, 0.86–1.00; p=0.04) when compared with controls. Moreover, intravenous beta-blockade reduced the risk of ventricular tachyarrhythmias (RR=0.61; 95 % CI 0.47–0.79; p=0.0003) and myocardial reinfarction (RR=0.73, 95 % CI 0.59–0.91; p=0.004) without increase in the risk of cardiogenic shock, (RR=1.02; 95% CI 0.77–1.35; p=0.91) or stroke (RR=0.58; 95 % CI 0.17–1.98; p=0.38). Conclusions Intravenous beta-blockers early in the course of appropriate patients with ACS appears to be associated with significant reduction in the risk of short-term cardiovascular outcomes, including a reduction in the risk of all-cause mortality. PMID:23168009

  1. Rapid cessation of acute diarrhea using a novel solution of bioactive polyphenols: a randomized trial in Nicaraguan children

    Arthur Dover

    2015-05-01

    Full Text Available Goal. We assessed the effectiveness of bioactive polyphenols contained in solution (LX to restore normal bowel function in pediatric patients with acute diarrhea. Background. While providing oral rehydration solution (ORS is standard treatment for diarrhea in developing countries, plant-derived products have been shown to positively affect intestinal function. If a supplement to ORS resolves diarrhea more rapidly than ORS alone, it is an improvement to current care. Study. In a randomized, double-blind, placebo-controlled cross-over study, 61 pediatric patients with uncontrolled diarrhea were randomized to receive either ORS + LX on day 1 and then ORS + water on day 2 (study arm or ORS + water on day 1 and then ORS + LX on day 2 (control arm. Time to resolution and number of bowel movements were recorded. Results. On day 1, the mean time to diarrhea resolution was 3.1 h (study arm versus 9.2 h (control arm (p = 0.002. In the study arm, 60% of patients had normal stool at their first bowel movement after consumption of the phenolic redoxigen solution (LX. On day 2, patients in the study arm continued to have normal stool while patients in the control arm achieved normal stool within 24 h after consuming the test solution. Patients in the control arm experienced a reduction in the mean number of bowel movements from day 1 to day 2 after consuming the test solution (p = 0.0001. No adverse events were observed. Conclusions. Significant decreases in bowel movement frequency and rapid normalization of stool consistency were observed with consumption of this novel solution.

  2. Minimal effects of E. coli and Erwinia asparaginase on the coagulation system in childhood acute lymphoblastic leukemia: a randomized study.

    Risseeuw-Appel, I M; Dekker, I; Hop, W C; Hählen, K

    1994-01-01

    A randomized study was done in twenty newly diagnosed children with acute lymphoblastic leukemia. Ten children were treated with Escherichia coli L-asparaginase, and ten with Erwinia chrysanthemi L-asparaginase. L-asparaginase (ASP) treatment started halfway during ALL-induction treatment with vincristine, prednisone, daunorubicin and intrathecal methotrexate. The mean activated partial thromboplastin time (APTT) level in all children demonstrated a significant fall (P II, V, VII and X stayed within the normal range, while F VIII and F IX were elevated. During the entire period of induction therapy, the ATIII activity remained within the normal range in both treatment groups. The protein C values, however, demonstrated a steady decline from 140% at start of ASP treatment to a mean of 81% and 93%, respectively, at the end of the ASP therapy in the E. coli and Erwinia group. Five of the ten children treated with E. coli ASP demonstrated protein C levels below 70% at the end of ASP therapy, opposed to none of the Erwinia treated patients (P = 0.03). We suggest that the effect of ASP resulting in decreased coagulation factor synthesis is in part counterbalanced by the effect of prednisone on the coagulation system, when ASP is administered at the end of ALL induction treatment. The overall effect of ASP either of E. coli or of Erwinia on the hemorrhagic system reveals a slight imbalance towards thrombosis, mainly because of a gradual decrease in protein C activity. This imbalance is less pronounced in the Erwinia group. PMID:8058004

  3. Comparison of Clinical Efficacy of Intravenous Acetaminophen with Intravenous Morphine in Acute Renal Colic: A Randomized, Double-Blind, Controlled Trial

    Kambiz Masoumi; Arash Forouzan; Ali Asgari Darian; Maryam Feli; Hassan Barzegari; Ali Khavanin

    2014-01-01

    The aim of this study was to compare the clinical efficacy of intravenous acetaminophen with intravenous morphine in acute renal colic pain management. In this double-blind controlled trial, patients aged 18–55 years, diagnosed with acute renal colic, who met the inclusion and exclusion criteria, were randomized into two groups. First, using the visual analogue scale (VAS), intensity of pain was assessed in both groups. Then, one gram of intravenous acetaminophen or 0.1 mg/kg morphine was inf...

  4. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial

    Paajanen Hannu

    2013-02-01

    Full Text Available Abstract Background Although the standard treatment of acute appendicitis (AA consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. Methods/design The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy. Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale. A maximum of 610 adult patients (aged 18–60 years with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day for three days continued by oral levofloxacin (500 mg per day plus metronidazole (1.5 g per day for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. Discussion The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75–85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary

  5. Acute Toxicity Profile and Compliance to Accelerated Radiotherapy Plus Carbogen and Nicotinamide for Clinical Stage T2–4 Laryngeal Cancer: Results of a Phase III Randomized Trial

    Purpose: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. Methods and Materials: From April 2001 to February 2008, 345 patients with cT2–4 squamous cell laryngeal cancer were randomized to AR (n = 174) and ARCON (n = 171). Acute toxicity was scored weekly until Week 8 and every 2–4 weeks thereafter. Compliance to carbogen and nicotinamide was reported. Results: Between both treatment arms (AR vs. ARCON) no statistically significant difference was observed for incidence of acute skin reactions (moist desquamation: 56% vs. 58%, p = 0.80), acute mucosal reactions (confluent mucositis: 79% vs. 85%, p = 0.14), and symptoms related to acute mucositis (severe pain on swallowing: 53% vs. 58%, p = 0.37; nasogastric tube feeding: 28% vs. 28%, p = 0.98; narcotic medicines required: 58% vs. 58%, p = 0.97). There was a statistically significant difference in median duration of confluent mucositis in favor of AR (2.0 vs 3.0 weeks, p = 0.01). There was full compliance with carbogen breathing and nicotinamide in 86% and 80% of the patients, with discontinuation in 6% and 12%, respectively. Adjustment of antiemesis prophylaxis was needed in 42% of patients. Conclusion: With the exception of a slight increase in median duration of acute confluent mucositis, the present data reveal a similar acute toxicity profile between both regimens and a good compliance with ARCON for clinical stage T2–4 laryngeal cancers. Treatment outcome and late morbidity will determine the real therapeutic benefit.

  6. Acute Toxicity Profile and Compliance to Accelerated Radiotherapy Plus Carbogen and Nicotinamide for Clinical Stage T2-4 Laryngeal Cancer: Results of a Phase III Randomized Trial

    Janssens, Geert O., E-mail: g.janssens@rther.umcn.nl [Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen (Netherlands); Terhaard, Chris H. [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Doornaert, Patricia A. [Department of Radiation Oncology, VU University Medical Center, Amsterdam (Netherlands); Bijl, Hendrik P. [Department of Radiation Oncology, University Medical Center Groningen, Groningen (Netherlands); Ende, Piet van den [Department of Radiation Oncology, Maastricht University Medical Centre, Maastricht (Netherlands); Chin, Alim [Department of Clinical Oncology, Leiden University Medical Centre, Leiden (Netherlands); Pop, Lucas A.; Kaanders, Johannes H. [Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen (Netherlands)

    2012-02-01

    Purpose: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. Methods and Materials: From April 2001 to February 2008, 345 patients with cT2-4 squamous cell laryngeal cancer were randomized to AR (n = 174) and ARCON (n = 171). Acute toxicity was scored weekly until Week 8 and every 2-4 weeks thereafter. Compliance to carbogen and nicotinamide was reported. Results: Between both treatment arms (AR vs. ARCON) no statistically significant difference was observed for incidence of acute skin reactions (moist desquamation: 56% vs. 58%, p = 0.80), acute mucosal reactions (confluent mucositis: 79% vs. 85%, p = 0.14), and symptoms related to acute mucositis (severe pain on swallowing: 53% vs. 58%, p = 0.37; nasogastric tube feeding: 28% vs. 28%, p = 0.98; narcotic medicines required: 58% vs. 58%, p = 0.97). There was a statistically significant difference in median duration of confluent mucositis in favor of AR (2.0 vs 3.0 weeks, p = 0.01). There was full compliance with carbogen breathing and nicotinamide in 86% and 80% of the patients, with discontinuation in 6% and 12%, respectively. Adjustment of antiemesis prophylaxis was needed in 42% of patients. Conclusion: With the exception of a slight increase in median duration of acute confluent mucositis, the present data reveal a similar acute toxicity profile between both regimens and a good compliance with ARCON for clinical stage T2-4 laryngeal cancers. Treatment outcome and late morbidity will determine the real therapeutic benefit.

  7. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers.

    Vance L Albaugh

    Full Text Available Atypical antipsychotics exhibit metabolic side effects including diabetes mellitus and obesity. The adverse events are preceded by acute worsening of oral glucose tolerance (oGTT along with reduced plasma free fatty acids (FFA and leptin in animal models. It is unclear whether the same acute effects occur in humans.A double blind, randomized, placebo-controlled crossover trial was conducted to examine the potential metabolic effects of olanzapine in healthy volunteers. Participants included male (8 and female (7 subjects [18-30 years old, BMI 18.5-25]. Subjects received placebo or olanzapine (10 mg/day for three days prior to oGTT testing. Primary endpoints included measurement of plasma leptin, oral glucose tolerance, and plasma free fatty acids (FFA. Secondary metabolic endpoints included: triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol, heart rate, blood pressure, body weight and BMI. Olanzapine increased glucose Area Under the Curve (AUC by 42% (2808±474 vs. 3984±444 mg/dl·min; P = 0.0105 during an oGTT. Fasting plasma leptin and triglycerides were elevated 24% (Leptin: 6.8±1.3 vs. 8.4±1.7 ng/ml; P = 0.0203 and 22% (Triglycerides: 88.9±10.1 vs. 108.2±11.6 mg/dl; P = 0.0170, whereas FFA and HDL declined by 32% (FFA: 0.38±0.06 vs. 0.26±0.04 mM; P = 0.0166 and 11% (54.2±4.7 vs. 48.9±4.3 mg/dl; P = 0.0184, respectively after olanzapine. Other measures were unchanged.Olanzapine exerts some but not all of the early endocrine/metabolic changes observed in rodent models of the metabolic side effects, and this suggest that antipsychotic effects are not limited to perturbations in glucose metabolism alone. Future prospective clinical studies should focus on identifying which reliable metabolic alterations might be useful as potential screening tools in assessing patient susceptibility to weight gain and diabetes caused by atypical antipsychotics.ClinicalTrials.gov NCT00741026.

  8. Duration of bed occupancy as calculated at a random chosen day in an acute care ward. Implications for the use of scarce resources in psychiatric care

    Restan Asbjørn

    2005-05-01

    Full Text Available Abstract Background Psychiatric acute wards are obliged to admit patients without delay according to the Act on Compulsive Psychiatric Care. Residential long term treatment facilities and rehabilitation facilities may use a waiting list. Patients, who may not be discharged from the acute ward or should not wait there, then occupy acute ward beds. Materials and methods Bed occupancy in one acute ward at a random day in 2002 was registered (n = 23. Successively, the length of stay of all patients was registered, together with information on waiting time after a decision was made on further treatment needs. Eleven patients waited for further resident treatment. The running cost of stay was calculated for the acute ward and in the different resident follow-up facilities. Twenty-three patients consumed a total of 776 resident days. 425 (54.8% of these were waiting days. Patients waited up to 86 days. Results Total cost of treatment was 0.69 million Euro (0.90 mill. $, waiting costs were 54.8% of this, 0.38 million Euro (0.50 million $. The difference between acute care costs and the costs in the relevant secondary resident facility was defined as the imputed loss. Net loss by waiting was 0.20 million Euro (0.26 million $ or 28.8% of total cost. Discussion This point estimate study indicates that treating patients too sick to be released to anything less than some other intramural facility locks a sizable amount of the resources of a psychiatric acute ward. The method used minimized the chance of financially biased treatment decisions. Costs of frustration to staff and family members, and delayed effect of treatment was set to zero. Direct extrapolation to costs per year is not warranted, but it is suggested that our findings would be comparable to other acute wards as well. The study shows how participant observation and cost effectiveness analysis may be combined.

  9. Unani Treatment Decreased Fibrosis and Improved Liver Functions in Decompensated Cirrhosis of Liver: A Case Series

    Akhtar Siddiqui

    2016-03-01

    Full Text Available At present, liver transplantation remains the only curative option for the patients with cirrhosis and end-stage liver diseases. The survival rate and recurrent diseases remain the major issues in the patient post-transplantation. Unani medicine is one of the oldest traditional systems of medicine which has been treating chronic liver diseases and cirrhosis (Talayyaful-Kabid for centuries. The current study aimed to assess the impact of Unani treatment on decompensated cirrhosis and collect data to warrant further clinical trials. Authors conducted a case series on five patients with decompensated cirrhosis and portal hypertension. The disease was confirmed through FibroScan and ultrasound and treated with Unani treatment orally for seven months. Results were evaluated based on FibroScan, liver function test (LFT, EuroQol-5D (EQ5D, Child-Pugh and TTO-TIME (trade-off question. Significant improvements in LFT, fibrosis and quality of life were achieved in the studied patients. The literature related to the herbal constituents of chief medicines used to treat in this case was reviewed. The herbs proved their potential anti-oxidative, anti-inflammatory, hepato-protective, immuno-modulator and antiviral activities, suggesting plausible mechanisms of action in the cases. The preliminary findings indicated the potential therapeutic role of Unani treatment in decompensated cirrhosis. Clinical trials should be conducted to explore further therapeutic potential of Unani treatment in decompensated cirrhosis.

  10. Prediction of Heart Failure Decompensation Events by Trend Analysis of Telemonitoring Data.

    Henriques, J; Carvalho, P; Paredes, S; Rocha, T; Habetha, J; Antunes, M; Morais, J

    2015-09-01

    This paper aims to assess the predictive value of physiological data daily collected in a telemonitoring study in the early detection of heart failure (HF) decompensation events. The main hypothesis is that physiological time series with similar progression (trends) may have prognostic value in future clinical states (decompensation or normal condition). The strategy is composed of two main steps: a trend similarity analysis and a predictive procedure. The similarity scheme combines the Haar wavelet decomposition, in which signals are represented as linear combinations of a set of orthogonal bases, with the Karhunen-Loève transform, that allows the selection of the reduced set of bases that capture the fundamental behavior of the time series. The prediction process assumes that future evolution of current condition can be inferred from the progression of past physiological time series. Therefore, founded on the trend similarity measure, a set of time series presenting a progression similar to the current condition is identified in the historical dataset, which is then employed, through a nearest neighbor approach, in the current prediction. The strategy is evaluated using physiological data resulting from the myHeart telemonitoring study, namely blood pressure, respiration rate, heart rate, and body weight collected from 41 patients (15 decompensation events and 26 normal conditions). The obtained results suggest, in general, that the physiological data have predictive value, and in particular, that the proposed scheme is particularly appropriate to address the early detection of HF decompensation. PMID:25248206

  11. The first use of N-carbamylglutamate in a patient with decompensated maple syrup urine disease

    S.K. Ucar; M. Coker; S. Habif; E.U. Saz; B. Karapinar; H. Ucar; O. Kitis; M. Duran

    2009-01-01

    Maple syrup urine disease (MSUD) is a defect in the catabolism of the branched-chain amino acids; leucine, isoleucine, and valine. Affected patients may also develop hyperammonaemia of unknown etiology. This report describes a four-year-old girl with MSUD, who presented with decompensated hyperleuci

  12. Hagen-Poiseuille's law: The link between cirrhosis, liverstiffness, portal hypertension and hepatic decompensation

    Gerond Lake-Bakaar; Muneeb Ahmed; Amy Evenson; Alan Bonder; Salomao Faintuch; Vinay Sundaram

    2015-01-01

    The onset of hepatic decompensation in cirrhosisheralds an accelerated downhill course with pooroutcome. The sole predictor of this decompensation in cirrhosis is increased hepatic vein to portal veingradient hepatic venous pressure gradient (HVPG).Surrogate markers of liver function or hepatic reserveappear to be less relevant. The hepatic sinusoidsbecome less elastic and more rigid as liver fibrosisand cirrhosis progress. We propose that the Hagen-Poiseuille's law, which applies to rigid, but not elasticvessels, determines the pressure-flow characteristicsin the sinusoids. In the rigid cirrhotic liver, HVPG risesdramatically with any change in net surface areaor radius, r4 of the vasculature that follows surgicalresection. This review relates liver stiffness to therisk of decompensation in patients with cirrhosis. Theliver has a unique dual blood supply comprising a lowpressure portal vein and high pressure hepatic artery.We compare the complexity of autoregulation in thenormal elastic liver with that in the rigid cirrhotic liver.Therapeutic modalities to reduce portal pressure mayreduce the risk of hepatic decompensation and improveoutcomes in cirrhosis.

  13. Five-day regimen of intramuscular or subcutaneous self-administered adrenocorticotropic hormone gel for acute exacerbations of multiple sclerosis: a prospective, randomized, open-label pilot trial

    Simsarian JP; Saunders C.; Smith DM

    2011-01-01

    James P Simsarian, Carol Saunders, D Michelle SmithNeurology Center of Fairfax Ltd, Fairfax, VA, USABackground: Despite over 50 years of experience with adrenocorticotropic hormone (ACTH) as a treatment for acute exacerbations of multiple sclerosis, there have been no trials examining the options of the 2–3-week dosing regimen or intramuscular injection protocol used in the original trials. At our clinic, we performed a small, prospective, randomized pilot study to examine the effic...

  14. Effectiveness of mirror therapy on lower extremity motor recovery, balance and mobility in patients with acute stroke: A randomized sham-controlled pilot trial

    Uthra Mohan; S Karthik babu; K Vijaya Kumar; Suresh, B. V.; Z K Misri; M Chakrapani

    2013-01-01

    Objective: To evaluate the effectiveness of mirror therapy on lower extremity motor recovery, balance and mobility in patients with acute stroke. Design: A randomized, sham-controlled, assessor blinded, pilot trial. Setting: Inpatient stroke rehabilitation unit. Subjects: First time onset of stroke with mean post-stroke duration of 6.41 days, able to respond to verbal instructions, and Brunnstrom recovery stage 2 and above were enrolled. Intervention: Mirror therapy group performed 30 minutes...

  15. Different postprandial acute response in healthy subjects to three strawberry jams varying in carbohydrate and antioxidant content: a randomized, crossover trial

    Martinez, J. A.; Zulet, M.A. (María Ángeles); I. Abete; S. Navas-Carretero; Cuervo, M.; Ibero-Baraibar, I. (Idoia)

    2013-01-01

    PURPOSE: Dietary food composition influences postprandial glucose homeostasis. Thus, the objective was to investigate the effects of an acute intake of three different types of strawberry jam, differing in carbohydrate and antioxidants content, on postprandial glucose metabolism, lipid profile, antioxidant status, and satiety. METHODS: Sixteen healthy adults participated in a randomized, crossover, double-blind study with three arms, receiving 60 g of three different strawberry jam...

  16. Effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery: a double blind, randomized clinical trial of efficacy and safety

    Kim, Ji-Ho; Shim, Jae-Kwang; Song, Jong-Wook; Song, Young; Kim, Hye-Bin; Kwak, Young-Lan

    2013-01-01

    Introduction Recombinant human erythropoietin (EPO) is known to provide organ protection against ischemia-reperfusion injury through its pleiotropic properties. The aim of this single-site, randomized, case-controlled, and double-blind study was to investigate the effect of pre-emptive EPO administration on the incidence of postoperative acute kidney injury (AKI) in patients with risk factors for AKI undergoing complex valvular heart surgery. Methods We studied ninety-eight patients with preo...

  17. Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial

    Urbino Antonio

    2011-02-01

    Full Text Available Abstract Background Vomiting in children with acute gastroenteritis (AG is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT. Physicians who provide care to paediatric patients in the emergency department (ED usually prescribe intravenous fluid therapy (IVT for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking. Objectives To compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed ORT. Methods/Design Multicentre, double-blind randomized controlled trial conducted in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration will be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to receive: 1 ondansetron syrup (0,15 mg/Kg of body weight; 2 domperidone syrup (0,5 mg/Kg of body weight; 3 placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic oral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study outcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made 48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm will be enrolled. Discussion The trial results would provide evidence on the efficacy of domperidone, which is largely used in

  18. The Role of Omega-3 Fatty Acids in Acute Pancreatitis: A Meta-Analysis of Randomized Controlled Trials

    Qiu Cheng Lei

    2015-03-01

    Full Text Available To determine whether treatment with omega-3 fatty acids (ω-3 FA provides benefits to patients with acute pancreatitis (AP. The Cochrane Library, PubMed, Embase, Web of Science, and Chinese Biomedical Literature Database were searched. Data analysis was performed using Revman 5.2 software. A total of eight randomized controlled trials (RCTs were included. Overall, ω-3 FA treatment resulted in a significantly reduced risk of mortality (RR 0.35; 95% CI 0.16 to 0.75, p < 0.05, infectious complications (RR 0.54; 95% CI 0.34 to 0.85, p < 0.05 and length of hospital stay (MD –6.50; 95% CI −9.54 to −3.46, p < 0.05, but not length of ICU stay (MD −1.98; 95% CI −6.92 to 2.96, p > 0.05. In subgroup analysis, only patients who received ω-3 FA parenterally had some statistically significant benefits in terms of mortality (risk ratio (RR 0.37; 95% confidence interval (CI 0.16 to 0.86, p < 0.05, infectious complications (RR 0.5; 95% CI 0.28 to 0.9, p < 0.05 and length of hospital stay (mean difference (MD −8.13; 95% CI −10.39 to −5.87, p < 0.001. The administration of ω-3 FA may be beneficial for decreasing mortality, infectious complications, and length of hospital stay in AP, especially when used parenterally. Large and rigorously designed RCTs are required to elucidate the efficacy of parenteral or enteral ω-3 FA treatment in AP.

  19. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD

    Hansen Jørgen

    2009-04-01

    Full Text Available Abstract Background The prevalence of depression in patients with acute coronary syndrome, i.e. myocardial infarction and unstable angina, is higher than in the general population. The prevalence of anxiety is higher as well. Both depression and anxiety are associated with poor cardiac outcomes and higher mortality. Comorbid depression in patients with acute coronary syndrome often goes undiagnosed, and it is therefore a challenging task to prevent this risk factor. The study of DEpression in Coronary ARtery Disease (DECARD is designed to examine if it is possible to prevent depression in patients with acute coronary syndrome. Methods Two hundred forty non-depressed patients with acute coronary syndrome are randomized to treatment with either escitalopram or placebo for 1 year. Psychiatric and cardiac assessment of patients is performed to evaluate the possibility of preventing depression. Diagnosis of depression and Hamilton Depression Scale are the primary outcome measures. Discussion This is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor. Trial Registration http://www.ClinicalTrials.gov. Identifier: NCT00140257

  20. Pivmecillinam versus sulfamethizole for short-term treatment of uncomplicated acute cystitis in general practice: a randomized controlled trial

    Bjerrum, Lars; Gahrn-Hansen, Bente; Grinsted, Per

    2009-01-01

    To investigate whether short-term treatment with pivmecillinam was more effective than sulfamethizole in patients with acute uncomplicated urinary tract infection (UTI).......To investigate whether short-term treatment with pivmecillinam was more effective than sulfamethizole in patients with acute uncomplicated urinary tract infection (UTI)....

  1. A Self-Administered Method of Acute Pressure Block of Sciatic Nerves for Short-Term Relief of Dental Pain: A Randomized Study

    Wang, Xiaolin; Zhao, Wanghong; Wang, Ye; Hu, Jiao; Chen, Qiu; Yu, Juncai; Wu, Bin; Huang, Rong; Gao, Jie; He, Jiman

    2014-01-01

    Objectives While stimulation of the peripheral nerves increases the pain threshold, chronic pressure stimulation of the sciatic nerve is associated with sciatica. We recently found that acute pressure block of the sciatic nerve inhibits pain. Therefore, we propose that, the pain pathology-causing pressure is chronic, not acute. Here, we report a novel self-administered method: acute pressure block of the sciatic nerves is applied by the patients themselves for short-term relief of pain from dental diseases. Design This was a randomized, single-blind study. Setting Hospital patients. Patients Patients aged 16–60 years with acute pulpitis, acute apical periodontitis, or pericoronitis of the third molar of the mandible experiencing pain ≥3 on the 11-point numerical pain rating scale. Interventions Three-minute pressure to sciatic nerves was applied by using the hands (hand pressure method) or by having the patients squat to force the thigh and shin as tightly as possible on the sandwiched sciatic nerve bundles (self-administered method). Outcomes The primary efficacy variable was the mean difference in pain scores from the baseline. Results One hundred seventy-two dental patients were randomized. The self-administered method produced significant relief from pain associated with dental diseases (P ≤ 0.001). The analgesic effect of the self-administered method was similar to that of the hand pressure method. Conclusions The self-administered method is easy to learn and can be applied at any time for pain relief. We believe that patients will benefit from this method. PMID:24400593

  2. A conceptual model of compensation/decompensation in lumbar segmental instability.

    Barz, T; Melloh, M; Lord, S J; Kasch, R; Merk, H R; Staub, L P

    2014-09-01

    Lumbar spinal instability (LSI) is a common spinal disorder and can be associated with substantial disability. The concept of defining clinically relevant classifications of disease or 'target condition' is used in diagnostic research. Applying this concept to LSI we hypothesize that a set of clinical and radiological criteria can be developed to identify patients with this target condition who are at high risk of 'irreversible' decompensated LSI for whom surgery becomes the treatment of choice. In LSI, structural deterioration of the lumbar disc initiates a degenerative cascade of segmental instability. Over time, radiographic signs become visible: traction spurs, facet joint degeneration, misalignment, stenosis, olisthesis and de novo scoliosis. Ligaments, joint capsules, local and distant musculature are the functional elements of the lumbar motion segment. Influenced by non-functional factors, these functional elements allow a compensation of degeneration of the motion segment. Compensation may happen on each step of the degenerative cascade but cannot reverse it. However, compensation of LSI may lead to an alleviation or resolution of clinical symptoms. In return, the target condition of decompensation of LSI may cause the new occurrence of symptoms and pain. Functional compensation and decompensation are subject to numerous factors that can change which makes estimation of an individual's long-term prognosis difficult. Compensation and decompensation may influence radiographic signs of degeneration, e.g. the degree of misalignment and segmental angulation caused by LSI is influenced by the tonus of the local musculature. This conceptual model of compensation/decompensation may help solve the debate on functional and psychosocial factors that influence low back pain and to establish a new definition of non-specific low back pain. Individual differences of identical structural disorders could be explained by compensated or decompensated LSI leading to changes

  3. Effect of acute ozone induced airway inflammation on human sympathetic nerve traffic: a randomized, placebo controlled, crossover study.

    Jens Tank

    Full Text Available BACKGROUND: Ozone concentrations in ambient air are related to cardiopulmonary perturbations in the aging population. Increased central sympathetic nerve activity induced by local airway inflammation may be one possible mechanism. METHODOLOGY/PRINCIPAL FINDINGS: To elucidate this issue further, we performed a randomized, double-blind, cross-over study, including 14 healthy subjects (3 females, age 22-47 years, who underwent a 3 h exposure with intermittent exercise to either ozone (250 ppb or clean air. Induced sputum was collected 3 h after exposure. Nineteen to 22 hours after exposure, we recorded ECG, finger blood pressure, brachial blood pressure, respiration, cardiac output, and muscle sympathetic nerve activity (MSNA at rest, during deep breathing, maximum-inspiratory breath hold, and a Valsalva maneuver. While the ozone exposure induced the expected airway inflammation, as indicated by a significant increase in sputum neutrophils, we did not detect a significant estimated treatment effect adjusted for period on cardiovascular measurements. Resting heart rate (clean air: 59±2, ozone 60±2 bpm, blood pressure (clean air: 121±3/71±2 mmHg; ozone: 121±2/71±2 mmHg, cardiac output (clean air: 7.42±0.29 mmHg; ozone: 7.98±0.60 l/min, and plasma norepinephrine levels (clean air: 213±21 pg/ml; ozone: 202±16 pg/ml, were similar on both study days. No difference of resting MSNA was observed between ozone and air exposure (air: 23±2, ozone: 23±2 bursts/min. Maximum MSNA obtained at the end of apnea (air: 44±4, ozone: 48±4 bursts/min and during the phase II of the Valsalva maneuver (air: 64±5, ozone: 57±6 bursts/min was similar. CONCLUSIONS/SIGNIFICANCE: Our study suggests that acute ozone-induced airway inflammation does not increase resting sympathetic nerve traffic in healthy subjects, an observation that is relevant for environmental health. However, we can not exclude that chronic airway inflammation may contribute to sympathetic

  4. Acute and Chronic Mood and Apathy Outcomes from a randomized study of unilateral STN and GPi DBS.

    Michael S Okun

    Full Text Available To study mood and behavioral effects of unilateral and staged bilateral subthalamic nucleus (STN and globus pallidus internus (GPi deep brain stimulation (DBS for Parkinson's disease (PD.There are numerous reports of mood changes following DBS, however, most have focused on bilateral simultaneous STN implants with rapid and aggressive post-operative medication reduction.A standardized evaluation was applied to a subset of patients undergoing STN and GPi DBS and who were also enrolled in the NIH COMPARE study. The Unified Parkinson Disease Rating Scale (UPDRS III, the Hamilton depression (HAM-D and anxiety rating scales (HAM-A, the Yale-Brown obsessive-compulsive rating scale (YBOCS, the Apathy Scale (AS, and the Young mania rating scale (YMRS were used. The scales were repeated at acute and chronic intervals. A post-operative strategy of non-aggressive medication reduction was employed.Thirty patients were randomized and underwent unilateral DBS (16 STN, 14 GPi. There were no baseline differences. The GPi group had a higher mean dopaminergic dosage at 1-year, however the between group difference in changes from baseline to 1-year was not significant. There were no differences between groups in mood and motor outcomes. When combining STN and GPi groups, the HAM-A scores worsened at 2-months, 4-months, 6-months and 1-year when compared with baseline; the HAM-D and YMRS scores worsened at 4-months, 6-months and 1-year; and the UPDRS Motor scores improved at 4-months and 1-year. Psychiatric diagnoses (DSM-IV did not change. No between group differences were observed in the cohort of bilateral cases.There were few changes in mood and behavior with STN or GPi DBS. The approach of staging STN or GPi DBS without aggressive medication reduction could be a viable option for managing PD surgical candidates. A study of bilateral DBS and of medication reduction will be required to better understand risks and benefits of a bilateral approach.

  5. A Randomized Controlled Trial of Puncturing and Bloodletting at Twelve Hand Jing Points to Treat Acute Carbon Monoxide Poisoning as Adjunct to First Aid Treatment: A Study Protocol

    Yue, Ying; Pan, Xingfang; Zhang, Sai; Jin, Jun; Wang, Wei; Wang, Dongqiang; Han, Dexin; Wang, Guirong; Hu, Qunliang; Kang, Jingqing; Ding, Shasha; Yang, Yi; Bu, Huaien; Guo, Yi

    2015-01-01

    Background. Acute carbon monoxide poisoning (ACOP) is a significant cause of morbidity and mortality in many countries. Twelve Hand Jing Points (THJP) have been believed to be effective to treat all kinds of emergency calls in traditional Chinese medicine (TCM) for more than 3000 years. This randomized controlled trial (RCT) is designed to evaluate the effectiveness of THJP in curing acute carbon monoxide poisoning in first aid treatment. This paper reports the protocol of the trial. Methods/Design. This RCT is a multicenter, randomized, controlled study undergoing in China. The compliant patients are divided into the bloodletting group and standard of care group. With first aid treatments given to both of the groups, the bloodletting group is bleeding at THJP upon being hospitalized. Primary outcomes and secondary outcomes will be measured and compared between these two groups. Before treatment, immediately after treatment, and 30 minutes, 1 hour, and 4 hours after treatment, patients' basic vital signs and state of consciousness were observed. Before treatment and 1 and 4 hours after treatment, carboxyhemoglobin concentration in venous blood samples was detected. Discussion. The objective of this study is to provide convincing evidence to clarify the efficacy and safety of THJP for early treatment of acute carbon monoxide poisoning. PMID:26339271

  6. A Randomized Controlled Trial of Puncturing and Bloodletting at Twelve Hand Jing Points to Treat Acute Carbon Monoxide Poisoning as Adjunct to First Aid Treatment: A Study Protocol

    Ying Yue

    2015-01-01

    Full Text Available Background. Acute carbon monoxide poisoning (ACOP is a significant cause of morbidity and mortality in many countries. Twelve Hand Jing Points (THJP have been believed to be effective to treat all kinds of emergency calls in traditional Chinese medicine (TCM for more than 3000 years. This randomized controlled trial (RCT is designed to evaluate the effectiveness of THJP in curing acute carbon monoxide poisoning in first aid treatment. This paper reports the protocol of the trial. Methods/Design. This RCT is a multicenter, randomized, controlled study undergoing in China. The compliant patients are divided into the bloodletting group and standard of care group. With first aid treatments given to both of the groups, the bloodletting group is bleeding at THJP upon being hospitalized. Primary outcomes and secondary outcomes will be measured and compared between these two groups. Before treatment, immediately after treatment, and 30 minutes, 1 hour, and 4 hours after treatment, patients’ basic vital signs and state of consciousness were observed. Before treatment and 1 and 4 hours after treatment, carboxyhemoglobin concentration in venous blood samples was detected. Discussion. The objective of this study is to provide convincing evidence to clarify the efficacy and safety of THJP for early treatment of acute carbon monoxide poisoning.

  7. Predictors of Acute Hemodynamic Decompensation in Early Sepsis: An Observational Study

    Lee, Young Im; Smith, Robert L; Gartshteyn, Yevgeniya; Kwon, Sophia; Caraher, Erin J.; Nolan, Anna

    2016-01-01

    Background The study of sepsis is hindered by its heterogeneous time course and evolution. A subgroup of patients with severe sepsis develops shock soon after the initiation of treatment while others present hypotensive. We sought to determine the incidence of hypotension after the initiation of treatment for sepsis, and characterize their clinical features and course. Methods A retrospective review of electronic medical record of all septic patients (n = 542) that met the definition of septi...

  8. Safety and efficacy of thrombectomy in patients undergoing primary percutaneous coronary intervention for Acute ST elevation MI: A Meta-Analysis of Randomized Controlled Trials

    Grossman P Michael

    2010-02-01

    Full Text Available Abstract Background Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI in patients with acute ST elevation myocardial infarction (STEMI have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI. Methods Seventeen randomized trials (n = 3,909 patients of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG, thrombolysis in myocardial infarction (TIMI grade flow, and post procedural ST segment resolution (STR using random-effects and fixed-effects models. Results There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42 among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007, MBG 3 (730/1526 vs. 486/1513, OR 2.42, P Conclusions Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices.

  9. Colloid osmotic pressure in decompensated cirrhosis. A 'mirror image' of portal venous hypertension

    Henriksen, J H

    1985-01-01

    Colloid osmotic pressure in plasma (IIP) and ascitic fluid (IIA) and hydrostatic pressures in the hepatoportal system were measured simultaneously in 20 patients with decompensated cirrhosis. IIP was significantly decreased (mean, 21 mm Hg, versus normal, 30 mm Hg; P less than 0.01), and IIA was....../IIP (r = -0.77, P less than 0.001). WHV--IVCP was in most patients in the same order as and closely correlated to effective colloid osmotic pressure (IIP--IIA) (r = 0.88, P less than 0.001). No relationship was found between WHV--IVCP and IIP. The results indicate that a fall in colloid osmotic pressure...... in the interstitial space and ascitic fluid is related to and most likely secondary to the elevated portal pressure in decompensated cirrhosis. Effective colloid osmotic pressure may therefore be regarded as a 'mirror image' of transmural portal pressure. The role of colloid osmotic pressure in the...

  10. Corneal decompensation following filtering surgery with the Ex-PRESS® mini glaucoma shunt device

    Tojo N

    2015-03-01

    Full Text Available Naoki Tojo, Atsushi Hayashi, Akio Miyakoshi Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan Purpose: To report a case of corneal decompensation due to the Ex-PRESS® mini glaucoma shunt device (Ex-PRESS.Patient and methods: A 75-year-old man had pseudoexfoliation glaucoma in his right eye. He underwent filtration surgery with Ex-PRESS. His intraocular pressure was 7 mmHg after 9 months.Results: We observed partial decompensation of the corneal endothelium adjacent to the filtering bleb. Specular microscopy revealed a marked decrease in the endothelial cell density at the center of the cornea.Conclusion: Anterior segment optical coherence tomography is very useful for evaluating corneal edema and the position of Ex-PRESS. It is important to follow up with an examination of the corneal endothelial cells. Keywords: Ex-PRESS, bullous keratopathy, trabeculectomy, complication, cornea 

  11. Role of adjunctive thrombectomy and embolic protection devices in acute myocardial infarction : a comprehensive meta-analysis of randomized trials

    Bavry, Anthony A.; Kumbhani, Dharam J.; Bhatt, Deepak L.

    2008-01-01

    Adjunctive thrombectomy and embolic protection devices in acute myocardial infarction have been extensively studied, although outcomes have mainly focused on surrogate markers of reperfusion. Therefore, the effect of adjunctive devices on clinical outcomes is unknown. This study sought to determine

  12. Patient Activation through Counseling and Exercise – Acute Leukemia (PACE-AL) – a randomized controlled trial

    Jarden, Mary; Møller, Tom; Kjeldsen, Lars; Birgens, Henrik; Christensen, Jesper Frank; Bang Christensen, Karl; Diderichsen, Finn; Hendriksen, Carsten; Adamsen, Lis

    2013-01-01

    Background Patients with acute leukemia experience a substantial symptom burden and are at risk of developing infections throughout the course of repeated cycles of intensive chemotherapy. Physical activity in recent years has been a strategy for rehabilitation in cancer patients to remedy disease and treatment related symptoms and side effects. To date, there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy. A r...

  13. Secondary Healing versus Delayed Excision and Direct Closure after Incision and Drainage of Acute Pilonidal Abscess: A Controlled Randomized Trial

    Mahmoud F. Sakr

    2012-02-01

    Conclusions: Although there is more rapid healing and fewer visits for dressing with I and D and DE/DC of an acute pilonidal abscess, this is accompanied by a significantly higher overall complication rate than with I and D and secondary healing. Recurrence of an acute abscess or development of a chronic pilonidal sinus is similar with both procedures. [Arch Clin Exp Surg 2012; 1(1.000: 8-13

  14. A randomized trial of artesunate-amodiaquine versus artemether-lumefantrine in Ghanaian paediatric sickle cell and non-sickle cell disease patients with acute uncomplicated malaria

    Adjei, George O; Goka, Bamenla Q; Enweronu-Laryea, Christabel C;

    2014-01-01

    BACKGROUND: Sickle cell disease (SCD) is a genetic disorder common in malaria endemic areas. In endemic areas, malaria is a major cause of morbidity and mortality among SCD patients. This suggests the need for prompt initiation of efficacious anti-malarial therapy in SCD patients with acute malaria....... However, there is no information to date, on the efficacy or safety of artemisinin combination therapy when used for malaria treatment in SCD patients. METHODS: Children with SCD and acute uncomplicated malaria (n = 60) were randomized to treatment with artesunate-amodiaquine (AA), or artemether....../57) in the SCD group and 96.4% (53/55) in the non-SCD group. The fractional changes in haemoglobin, platelets and white blood cell counts between baseline (day 0) and endpoint (day 42) were 16.9, 40.6 and 92.3%, respectively, for the SCD group, and, 12.3, 48.8 and 7.5%, respectively, for the non...

  15. Hydrocortisone concentration influences time to clinically significant healing of acute inflammation of the ocular surface and adnexa – results from a double-blind randomized controlled trial

    Sergiyenko, Nikolay; Sukhina, Ludmila; Bezdetko, Pavel; Kovalenko, Yuriy; Nikitin, Nikolai; Merzberger, Matthias; Groß, Dorothea; Kohnen, Ralf

    2014-01-01

    Background The efficacy of topical ophthalmic corticosteroids depends upon small modifications in preparations, such as drug concentration. The aim of this study was to confirm that hydrocortisone acetate (HC-ac) ophthalmic ointments of 2.5% and 1% are more effective than a 0.5% eye ointment. Methods In this randomized, double-blind, placebo-controlled, parallel-group clinical study, the change of signs and symptoms of acute inflammation of the ocular surface and adnexa was evaluated in 411 s...

  16. Lithium as add-on to quetiapine XR in adult patients with acute mania: a 6-week, multicenter, double-blind, randomized, placebo-controlled study

    Bourin, Michel S; Severus, Emanuel; Schronen, Juan P; Gass, Peter; Szamosi, Johan; Eriksson, Hans; Chandrashekar, Hongally

    2014-01-01

    Quetiapine extended release (XR) and lithium are treatments with proven efficacy in acute mania. This randomized study evaluated the efficacy and safety of lithium or placebo as add-on to quetiapine XR in adult patients with manic or mixed symptoms of bipolar I disorder. In this 6-week, double-blind study (Trial D144AC00003), adult patients with DSM-IV-TR-diagnosed bipolar I disorder (current episode manic or mixed), a Young Mania Rating Scale (YMRS) total score ≥20, and score ≥4 on two of fo...

  17. Asthma at acute attack stage treated with “Shao’s five needling therapy”: a multi-central randomized controlled study

    邵素菊

    2013-01-01

    Objective To evaluate the clinical efficacy of asthma at acute attack stage treated with"Shao’s five needling therapy".Methods The randomized controlled method was applied to divide 210 cases into an observation group and a control group,105 cases in each one.In the observation group,"Shao’s five needling therapy"[Feishu (BL 13) ,Dazhui (GV 14) ,Fengmen (BL 12) ]and the combined therapy were adopted,including oxygen uptake,aerosol inhalation and oral administration of prednisone.In the control group,the oral administration of theophylline sustained release tablet and the combined ther-

  18. Results of a randomized international study of high-risk central nervous system B non-Hodgkin lymphoma and B acute lymphoblastic leukemia in children and adolescents

    Cairo, Mitchell S; Gerrard, Mary; Sposto, Richard; Auperin, Anne; Pinkerton, C. Ross; Michon, Jean; Weston, Claire; Perkins, Sherrie L.; Raphael, Martine; McCarthy, Keith; Patte, Catherine

    2007-01-01

    The prognosis for higher risk childhood B-cell non-Hodgkin lymphoma has improved over the past 20 years but the optimal intensity of treatment has yet to be determined. Children 21 years old or younger with newly diagnosed B-cell non-Hodgkin lymphoma/B-cell acute lymphoblastic leukemia (B-NHL/B-ALL) with higher risk factors (bone marrow [BM] with or without CNS involvement) were randomized to standard intensity French-American-British/Lymphoma Malignancy B (FAB/LMB) therapy or reduced intensi...

  19. A randomized hypofractionation dose escalation trial for high risk prostate cancer patients: interim analysis of acute toxicity and quality of life in 124 patients

    The α/β ratio for prostate cancer is postulated being in the range of 0.8 to 2.2 Gy, giving rise to the hypothesis that there may be a therapeutic advantage to hypofractionation. To do so, we carried out a randomized trial comparing hypofractionated and conventionally fractionated image-guided intensity modulated radiotherapy (IG-IMRT) in high-risk prostate cancer. Here, we report on acute toxicity and quality of life (QOL) for the first 124 randomized patients. The trial compares 76 Gy in 38 fractions (5 fractions/week) (Arm 1) to 63 Gy in 20 fractions (4 fractions/week) (Arm 2) (IG-IMRT). Prophylactic pelvic lymph node irradiation with 46 Gy in 23 fractions sequentially (Arm 1) and 44 Gy in 20 fractions simultaneously (Arm 2) was applied. All patients had long term androgen deprivation therapy (ADT) started before RT. Both physician-rated acute toxicity and patient-reported QOL using EPIC questionnaire are described. There were no differences in overall maximum acute gastrointestinal (GI) or genitourinary (GU) toxicity. Compared to conventional fractionation (Arm 1), GI and GU toxicity both developed significantly earlier but also disappeared earlier in the Arm 2, reaching significant differences from Arm 1 at week 8 and 9. In multivariate analyses, only parameter shown to be related to increased acute Grade ≥1 GU toxicity was the study Arm 2 (p = 0.049). There were no statistically significant differences of mean EPIC scores in any domain and sub-scales. The clinically relevant decrease (CRD) in EPIC urinary domain was significantly higher in Arm 2 at month 1 with a faster recovery at month 3 as compared to Arm 1. Hypofractionation at 3.15 Gy per fraction to 63 Gy within 5 weeks was well tolerated. The GI and GU physician-rated acute toxicity both developed earlier but recovered faster using hypofractionation. There was a correlation between acute toxicity and bowel and urinary QOL outcomes. Longer follow-up is needed to determine the significance of these

  20. The Effect of Oral Pancreatic Enzyme Supplementation on the Course and Outcome of Acute Pancreatitis: A Randomized, Double-Blind Parallel-Group Study

    Stefan Kahl

    2014-03-01

    Full Text Available Context Pancreatic exocrine insufficiency is a significant problem after acute pancreatitis. Objective To evaluate whetheroral pancreatic enzyme supplementation improves the recovery of pancreatic exocrine function and to explore the efficacy,safety and tolerability of pancreatic enzyme supplementation in patients during the refeeding period after acute pancreatitis.Design Prospective double-blind, placebo controlled, randomized study. Patients The sudy included 56 patients with acutepancreatitis. Main outcome measures Primary efficacy variable was recovery from pancreatic exocrine insufficiency.Secondary objectives were body weight, abdominal pain, course of APACHE II score, patient’s symptoms and quality of life. Results Twenty of the 56 patients showed low fecal elastase values indicating pancreatic exocrine insufficiency after acutepancreatitis. Median time to recovery from exocrine pancreatic insufficiency was 14 days in the enzyme supplementationgroup and 23 days in the placebo group but overall differences for primary and all but one secondary endpoint did not reachstatistical significance. However, a positive tendency in favour of enzyme supplementation was found for quality of lifeparameters (FACT-Pa in all subscores. There were no relevant differences between placebo and oral pancreatic enzymesupplementation detected with respect to safety and tolerability. Conclusion Enzyme supplementation positively effects thecourse of acute pancreatitis if administered during the early refeeding phase after acute pancreatitis. There is evidence thatoral pancreatic enzyme supplementation has a positive impact on the course of the disease and the global health status (lessweight loss, less flatulence, improved quality of life. Oral pancreatic enzyme supplementation was safely administered andcan be added to the treatment regimen of patients in a refeeding status after severe acute pancreatitis.

  1. Prevention of hospital-acquired pneumonia with Yupingfeng Powder in patients with acute cerebral vascular diseases: a randomized controlled trial

    Li YAN

    2010-01-01

    Full Text Available Background: An increase in the incidence rate of hospital-acquired pneumonia (HAP has a direct influence on prognosis and survival of patients with acute cerebral vascular diseases (ACVD, and how to prevent HAP is a growing concern to clinicians.Objective: To study the efficacy of Yupingfeng Powder, a compound traditional Chinese herbal medicine, in preventing HAP in patients with ACVD.Design, setting, participants and interventions: Sixty ACVD patients with lung qi deficiency syndrome without concurrent infections were randomly divided into prevention group (28 cases and control group (32 cases. The 60 cases were all from Shanghai Yueyang Hospital of Integrated Traditional Chinese and Western Medicine. Tough measures were taken to prevent cross-infection based on treatment of the primary diseases, well nutrition and support therapy. Yupingfeng Powder was used in the prevention group to prevent HAP. The patients were treated for 10 days.Main outcome measures: The clinical symptoms, physical signs, body temperature, and chest X-ray were observed. The changes of blood immunoglobulin A (IgA, immunoglobulin G (IgG, immunoglobulin M (IgM and interleukin-6 (IL-6 were detected before and after treatment.Results: The total response rate in the prevention group was higher than that in the control group (P<0.05, and the total response rates were 78.57% (22/28 and 31.25% (10/32 respectively. The incidence rate of HAP in the prevention group was lower than that in the control group. There were no significant differences in white blood cell count, neutrophilic granulocyte count, and the levels of IgA, IgG, IgM and IL-6 between the two groups before treatment. The white blood cell count and neutrophilic granulocyte count in the control group increased after treatment, and there was a significant difference between the two groups (P<0.05. There was no significant difference in IgA level in the two groups after treatment, and the IgM levels in the two groups

  2. The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic study: Multicenter randomized, double-blind, controlled trial of laparoscopic (LC versus open (LTC surgery for acute cholecystitis (AC in adults

    Bassi Uberto A

    2008-01-01

    Full Text Available Abstract Background In some randomized trials successful laparoscopic cholecystectomy for cholecystitis is associated with an earlier recovery and shorter hospital stay when compared with open cholecystectomy. Other studies did not confirm these results and showed that the potential advantages of laparoscopic cholecystectomy for cholecystitis can be offset by a high conversion rate to open surgery. Moreover in these studies a similar postoperative programme to optimize recovery comparing laparoscopic and open approaches was not standardized. These studies also do not report all eligible patients and are not double blinded. Design The present study project is a prospective, randomized investigation. The study will be performed in the Department of General, Emergency and Transplant Surgery St Orsola-Malpighi University Hospital (Bologna, Italy, a large teaching institutions, with the participation of all surgeons who accept to be involved in (and together with other selected centers. The patients will be divided in two groups: in the first group the patient will be submitted to laparoscopic cholecystectomy within 72 hours after the diagnosis while in the second group will be submitted to laparotomic cholecystectomy within 72 hours after the diagnosis. Trial Registration TRIAL REGISTRATION NUMBER ISRCTN27929536 – The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic study. A multicentre randomised, double-blind, controlled trial of laparoscopic versus open surgery for acute cholecystitis in adults.

  3. Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study

    Scholten Pieter

    2007-07-01

    Full Text Available Abstract Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS. Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures

  4. Iron alone or iron and erythropoietin added to acute normovolemic hemodilution in myomectomy patients: A randomized controlled trial

    Abd El Raheem Mostafa Dowidar

    2016-01-01

    Conclusion: Preoperative iron alone or iron and erythropoietin added to acute normovolemic hemodilution help to reduce the need for allogenic blood transfusion in myomectomy patients. Further studies are needed to evaluate their use in older patients with higher risk for thrombosis and hypertension.

  5. The effect of acute alcohol intoxication on gut wall integrity in healthy male volunteers; a randomized controlled trial

    de Jong, Willem-Jan; Cleveringa, A. M.; Greijdanus, B.; Meyer, P.; Heineman, E.; Hulscher, J. B.

    2015-01-01

    The aim of the study is to determine the effect of acute alcohol consumption on enterocytes. Chronic alcohol consumption has been known to induce a decrease in gut wall integrity in actively drinking alcoholics and patients with alcohol-induced liver disease. Data on the extent of the damage induced

  6. Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial

    Arun Jenish J

    2012-03-01

    Full Text Available Abstract Background There are no published studies that have compared bronchodilatory effect of inhaled budesonide/formoterol combination with budesonide/salbutamol delivered by metered dose inhaler with a spacer in acute exacerbation of asthma in children. We, therefore, compared the bronchodilatory effects of inhaled budesonide/formoterol (dose: 200 μg and 12 μg respectively combination with budesonide (200 μg/salbutamol (200 μg administered by metered dose inhaler and spacer in children of 5-15 years with mild acute exacerbation of asthma [Modified Pulmonary Index Score (MPIS between 6-8] in this double-blind, randomized controlled trial. The primary outcome was FEV1 (% predicted in the two groups at 1, 5, 15, 30, 60 min after administration of the study drug. Results We did not observe any significant differences in the % predicted FEV1 and MPIS between formoterol and salbutamol at various time points from 1 min to 60 min post drug administration. There was significant improvement in FEV1 (% predicted from baseline in both the groups as early as 1 min after drug administration. Conclusions Salbutamol or formoterol delivered along with inhaled corticosteroid by metered dose inhaler with spacer in children between 5-15 years of age with mild acute exacerbation of asthma had similar bronchodilatory effects. Trial Registration ClinicalTrials.gov: NCT00900874

  7. Treatment Outcomes of Corticosteroid Injection and Extracorporeal Shock Wave Therapy as Two Primary Therapeutic Methods for Acute Plantar Fasciitis: A Prospective Randomized Clinical Trial.

    Mardani-Kivi, Mohsen; Karimi Mobarakeh, Mahmoud; Hassanzadeh, Zabihallah; Mirbolook, Ahmadreza; Asadi, Kamran; Ettehad, Hossein; Hashemi-Motlagh, Keyvan; Saheb-Ekhtiari, Khashayar; Fallah-Alipour, Keyvan

    2015-01-01

    The outcome of corticosteroid injection (CSI) and extracorporeal shock wave therapy (ESWT) as primary treatment of acute plantar fasciitis has been debated. The purpose of the present study was to evaluate and compare the therapeutic effects of CSI and ESWT in patients with acute (plantar fasciitis. Of the 116 eligible patients, 68 were randomized to 2 equal groups of 34 patients, each undergoing either ESWT or CSI. The ESWT method included 2000 impulses with energy of 0.15 mJ/mm(2) and a total energy flux density of 900 mJ/mm(2) for 3 consecutive sessions at 1-week intervals. In the CSI group, 40 mg of methyl prednisolone acetate plus 1 mL of lidocaine 2% was injected into the maximal tenderness point at the inframedial calcaneal tuberosity. The success and recurrence rates and pain intensity measured using the visual analog scale, were recorded and compared at the 3-month follow-up visit. The pain intensity had reduced significantly in all patients undergoing either technique. However, the value and trend of pain reduction in the CSI group was significantly greater than those in the ESWT group (p  .05). Both ESWT and CSI can be used as the primary and/or initial treatment option for treating patients with acute plantar fasciitis; however, the CSI technique had better therapeutic outcomes. PMID:26215551

  8. the Pathogenesis of acute on Chronic Hepatitis B liver Failure

    Zhao-chun Chi; Quan-jiang Dong; Chang-xin Geng

    2014-01-01

    Acute-on-chronic liver failure is a characteristic clinical liver syndrome, which should be differentiated from acute liver failure, acute decompensated liver cirrhosis and chronic liver failure. The pathogenesis of ACLF is not fully understood yet. Viral factors and immune injury have been reported to be the two major pathogenesis. This paper reviewed the researches on the pathogenesis of acute on chronic hepatitis B liver failure in recent years, to provide theoretical basis for prompt and accurate diagnosis and treatment of this syndrome. This would beneift for the prognosis and raise the survival rate of patients.

  9. Randomized double blind trial of ciprofloxacin prophylaxis during induction treatment in childhood acute lymphoblastic leukemia in the WK-ALL protocol in Indonesia

    Widjajanto PH

    2013-02-01

    Full Text Available Pudjo H Widjajanto,1 Sumadiono Sumadiono,1 Jacqueline Cloos,2,3 Ignatius Purwanto,1 Sutaryo Sutaryo,1 Anjo JP Veerman1,21Pediatric Hematology and Oncology Division, Department of Pediatrics, Dr Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia; 2Pediatric Oncology/Hematology Division, Department of Pediatrics, 3Department of Hematology, VU University Medical Center, Amsterdam, The NetherlandsObjectives: Toxic death is a big problem in the treatment of childhood acute lymphoblastic leukemia (ALL, especially in low-income countries. Studies of ciprofloxacin as single agent prophylaxis vary widely in success rate. We conducted a double-blind, randomized study to test the effects of ciprofloxacin monotherapy as prophylaxis for sepsis and death in induction treatment of the Indonesian childhood ALL protocol.Methods: Patients were randomized to the ciprofloxacin arm (n = 58 and to the placebo arm (n = 52. Oral ciprofloxacin monotherapy or oral placebo was administered twice a day. All events during induction were recorded: toxic death, abandonment, resistant disease, and complete remission rate.Results: Of 110 patients enrolled in this study, 79 (71.8% achieved CR. In comparison to the placebo arm, the ciprofloxacin arm had lower nadir of absolute neutrophil count during induction with median of 62 (range: 5–884 versus 270 (range: 14–25,480 × 109 cells/L (P > 0.01, greater risks for experiencing fever (50.0% versus 32.7%, P = 0.07, clinical sepsis (50.0% versus 38.5%, P = 0.22, and death (18.9% versus 5.8%, P = 0.05.Conclusion: In our setting, a reduced intensity protocol in a low-income situation, the data warn against using ciprofloxacin prophylaxis during induction treatment. A lower nadir of neutrophil count and higher mortality were found in the ciprofloxacin group.Keywords: ciprofloxacin, prophylaxis, childhood acute lymphoblastic leukemia, randomized trial, low-income country

  10. The Belgian trial with azithromycin for acute COPD exacerbations requiring hospitalization: an investigator-initiated study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

    Vermeersch, Kristina; Gabrovska, Maria; Deslypere, Griet; Demedts, Ingel K; Slabbynck, Hans; Aumann, Joseph; Ninane, Vincent; Verleden, Geert M; Troosters, Thierry; Bogaerts, Kris; Brusselle, Guy G; Janssens, Wim

    2016-01-01

    Background Long-term use of macrolide antibiotics is effective to prevent exacerbations in chronic obstructive pulmonary disease (COPD). As risks and side effects of long-term intervention outweigh the benefits in the general COPD population, the optimal dose, duration of treatment, and target population are yet to be defined. Hospitalization for an acute exacerbation (AE) of COPD may offer a targeted risk group and an obvious risk period for studying macrolide interventions. Methods/design Patients with COPD, hospitalized for an AE, who have a smoking history of ≥10 pack-years and had ≥1 exacerbation in the previous year will be enrolled in a multicenter, randomized, double-blind, placebo-controlled trial (NCT02135354). On top of a standardized treatment of systemic corticosteroids and antibiotics, subjects will be randomized to receive either azithromycin or placebo during 3 months, at an uploading dose of 500 mg once a day for 3 days, followed by a maintenance dose of 250 mg once every 2 days. The primary endpoint is the time-to-treatment failure during the treatment phase (ie, from the moment of randomization until the end of intervention). Treatment failure is a novel composite endpoint defined as either death, the admission to intensive care or the requirement of additional systemic steroids or new antibiotics for respiratory reasons, or the diagnosis of a new AE after discharge. Discussion We investigate whether azithromycin initiated at the onset of a severe exacerbation, with a limited duration and at a low dose, might be effective and safe in the highest risk period during and immediately after the acute event. If proven effective and safe, this targeted approach may improve the treatment of severe AEs and redirect the preventive use of azithromycin in COPD to a temporary intervention in the subgroup with the highest unmet needs. PMID:27099485

  11. Baseline MELD score predicts hepatic decompensation during antiviral therapy in patients with chronic hepatitis C and advanced cirrhosis.

    Georg Dultz

    Full Text Available BACKGROUND AND AIMS: In patients with advanced liver cirrhosis due to chronic hepatitis C virus (HCV infection antiviral therapy with peginterferon and ribavirin is feasible in selected cases only due to potentially life-threatening side effects. However, predictive factors associated with hepatic decompensation during antiviral therapy are poorly defined. METHODS: In a retrospective cohort study, 68 patients with HCV-associated liver cirrhosis (mean MELD score 9.18 ± 2.72 were treated with peginterferon and ribavirin. Clinical events indicating hepatic decompensation (onset of ascites, hepatic encephalopathy, upper gastrointestinal bleeding, hospitalization as well as laboratory data were recorded at baseline and during a follow up period of 72 weeks after initiation of antiviral therapy. To monitor long term sequelae of end stage liver disease an extended follow up for HCC development, transplantation and death was applied (240 weeks, ± SD 136 weeks. RESULTS: Eighteen patients (26.5% achieved a sustained virologic response. During the observational period a hepatic decompensation was observed in 36.8%. Patients with hepatic decompensation had higher MELD scores (10.84 vs. 8.23, p14, respectively. Baseline MELD score was significantly associated with the risk for transplantation/death (p<0.001. CONCLUSIONS: Our data suggest that the baseline MELD score predicts the risk of hepatic decompensation during antiviral therapy and thus contributes to decision making when antiviral therapy is discussed in HCV patients with advanced liver cirrhosis.

  12. Economic evaluation of zinc and copper use in treating acute diarrhea in children: A randomized controlled trial

    Dhande Leena A; Patel Archana B; Rawat Manwar S

    2003-01-01

    Abstract Background The therapeutic effects of zinc and copper in reducing diarrheal morbidity have important cost implications. This health services research study evaluated the cost of treating a child with acute diarrhea in the hospital, the impact of micronutrient supplementation on the mean predicted costs and its cost-effectiveness as compared to using only standard oral rehydration solution (ORS), from the patient's and government's (providers) perspective. Methods Children aged 6 mont...

  13. Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial

    Baumbach Sebastian Felix; Fasser Mariette; Polzer Hans; Sieb Michael; Regauer Markus; Mutschler Wolf; Schieker Matthias; Blauth Michael

    2013-01-01

    Abstract Background Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV) is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains. Methods/Design 60 patients, aged 18–40 years...

  14. Skill execution and sleep deprivation: effects of acute caffeine or creatine supplementation - a randomized placebo-controlled trial

    Kilduff Liam P

    2011-02-01

    Full Text Available Abstract Background We investigated the effects of sleep deprivation with or without acute supplementation of caffeine or creatine on the execution of a repeated rugby passing skill. Method Ten elite rugby players completed 10 trials on a simple rugby passing skill test (20 repeats per trial, following a period of familiarisation. The players had between 7-9 h sleep on 5 of these trials and between 3-5 h sleep (deprivation on the other 5. At a time of 1.5 h before each trial, they undertook administration of either: placebo tablets, 50 or 100 mg/kg creatine, 1 or 5 mg/kg caffeine. Saliva was collected before each trial and assayed for salivary free cortisol and testosterone. Results Sleep deprivation with placebo application resulted in a significant fall in skill performance accuracy on both the dominant and non-dominant passing sides (p Conclusion Acute sleep deprivation affects performance of a simple repeat skill in elite athletes and this was ameliorated by a single dose of either caffeine or creatine. Acute creatine use may help to alleviate decrements in skill performance in situations of sleep deprivation, such as transmeridian travel, and caffeine at low doses appears as efficacious as higher doses, at alleviating sleep deprivation deficits in athletes with a history of low caffeine use. Both options are without the side effects of higher dose caffeine use.

  15. Effectiveness of green tea mouthwash in comparison to chlorhexidine mouthwash in patients with acute pericoronitis: a randomized clinical trial.

    Shahakbari, R; Eshghpour, M; Rajaei, A; Rezaei, N M; Golfakhrabadi, P; Nejat, A

    2014-11-01

    The objective of this study was to evaluate the effectiveness of green tea mouthwash in controlling the pain and trismus associated with acute pericoronitis in comparison to chlorhexidine (CHX) mouthwash. Ninety-seven patients with acute pericoronitis underwent debridement and received 5% green tea mouthwash (study group) or 0.12% CHX mouth rinse (control group). Pain (visual analogue scale; VAS), number of analgesics, maximum mouth opening (MMO), and number of patients with trismus were determined. There were no significant differences in demographic variables (P>0.05), or baseline VAS (P>0.006), MMO (P>0.017) or number of patients with trismus (P>0.017) between the two groups. The mean VAS score of the study group was statistically lower than that of the control group between post-treatment days 3 and 5 (P0.017). Fewer of the patients rinsing with green tea had trismus on days 3 and 7, but the difference was non-significant (P>0.017). Hence, green tea mouth rinse could be an appropriate and effective choice for the control of pain and trismus in acute pericoronitis. PMID:24954134

  16. Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

    Silverman, Michael J

    2013-10-01

    Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided. PMID:24070990

  17. Comparison of the effectiveness and safety of cefpodoxime and ciprofloxacin in acute exacerbation of chronic suppurative otitis media: A randomized, open-labeled, phase IV clinical trial

    Arijit Ghosh

    2012-01-01

    Full Text Available Objective : To compare the effectiveness and safety of cefpodoxime and ciprofloxacin for the treatment of mild to moderate cases of acute exacerbation of chronic suppurative otitis media (AECSOM. Materials and Methods : Adult patients diagnosed with AECSOM were screened and patients fulfilling the inclusion criteria were randomized to receive either cefpodoxime 200 mg twice daily or ciprofloxacin 500 mg twice daily orally for 7 days. The primary outcome of this randomized, open-labeled, phase IV clinical trial (Registration Number - CTRI/2011/10/002079 was clinical success rate at day 14 visit and the secondary outcome was incidence of adverse events (AEs. Forty-six patients were enrolled: 23 in the cefpodoxime group and 23 in the ciprofloxacin group. Results : The clinical success rates were 95.6% in the cefpodoxime group versus 90.9% in the ciprofloxacin group. These rates are comparable, but no statistically significant difference was observed between the groups. Few mild and self-limiting AEs were observed and the tolerability of both the drugs was also good. Conclusion : The results of this randomized, open-labeled phase IV clinical trial showed that a 7-day course of cefpodoxime is therapeutically comparable to ciprofloxacin in terms of both clinical effectiveness and safety for the treatment of patients with AECSOM.

  18. The Effect of G-ORS Along With Rice Soup in the Treatment of Acute Diarrhea in Children: A Single-Blind Randomized Controlled Trial

    Kianmehr, Mojtaba; Saber, Ashraf; Moshari, Jalil; Ahmadi, Reza; Basiri-moghadam, Mahdi

    2016-01-01

    Background The world health organization guidelines for treatment of diarrhea in children emphasize on continued feeding together with prescription of oral rehydration solution (ORS) and supplementary zinc therapy. However, conflicting viewpoints exist regarding the optimal diet and dietary ingredients for children with diarrhea. Moreover, few studies have investigated the effect of rice soup along with ORS in the treatment of this disease. Objectives This study aimed to explore effects of simultaneous taking of glucose oral rehydration solution (G-ORS) and rice soup in the treatment of acute diarrhea in 8 to 24-month-old children. Patients and Methods This single-blind controlled clinical trial was conducted in the pediatric ward of 22nd of Bahman hospital, Gonabad, Iran between June 2013 and February 2014. Forty children aged 8-24 months with acute diarrhea were randomly assigned into an intervention group (G-ORS plus rice soup group) comprising 20 babies and a control group (G-ORS) of 20 children based on balanced blocking randomization. The variables under investigation were diarrhea duration, patient hospitalization, need for intravenous (IV) fluids and stool output frequency. Data was analyzed using independent samples t and chi-square test. Results At the end of study, the time for treating acute watery diarrhea in the intervention and control groups were 21.10 ± 8.81 and 34.55 ± 5.82 hours (P < 0.001) and hospital stay were 34.05 ± 6.62 and 40.20 ± 6.32 hours (P = 0.005). Moreover, stool output frequency were 4.20 ± 0.95 and 8.00 ± 1.37 (P < 0.001) in the first 24 hours, and 2.18 ± 0.60 and 2.80 ± 0.76 (P = 0.03) in the second 24 hours of treatment in intervention and control groups, respectively. Conclusions Rice soup regimen was highly effective and inexpensive in the treatment of acute diarrhea in children. Thus, in addition to the common treatment by G-ORS, rice soup can be consumed simultaneously with G-ORS.

  19. Clinical effectiveness and safety of gemifloxacin versus cefpodoxime in acute exacerbation of chronic bronchitis: A randomized, controlled trial

    S Chatterjee

    2011-01-01

    Conclusion : The results of this randomized, single-blind trial demonstrated that a 7-day course of gemifloxacin is therapeutically comparable to cefpodoxime in terms of both clinical effectiveness and safety for the treatment of type II Anthonisen category AECB patients.

  20. Randomized factorial trial of high-dose intravenous streptokinase, of oral aspirin and of intravenous heparin in acute myocardial infarction. ISIS (International Studies of Infarct Survival) pilot study.

    1987-06-01

    619 patients with suspected acute myocardial infarction (MI) were randomized to receive either a high-dose short-term intravenous infusion of streptokinase (1.5 MU over one hour) or placebo. Using a '2 X 2 X 2 factorial' design, patients were also randomized to receive either oral aspirin (325 mg on alternate days for 28 days) or placebo, and separately randomized to receive either intravenous heparin (1000 IU h-1 for 48 hours) or no heparin. Streptokinase (SK) was associated with a nonsignificant (NS) increase in non-fatal reinfarction (3.9% SK vs 2.9% placebo) and decrease in mortality (7.5% vs 9.7% in hospital plus 6.1% vs 8.7% after discharge). After SK, there were significantly fewer strokes (0.5% vs 2.4%; 2P less than 0.05), but significantly more minor adverse events (e.g. hypotension and bradycardia, allergies, bruises or minor bleeds, nausea). Aspirin was associated with fewer non-fatal reinfarctions (3.2% aspirin vs 3.9% placebo; NS), deaths (in hospital: 6.1% vs 10.5%; 2P less than 0.05, and after discharge: 7.0% vs 6.9%; NS), and strokes (0.3% vs 2.0%; NS). Heparin was associated with a decrease in reinfarction (2.2% heparin vs 4.9% no heparin; NS), though not in mortality (in hospital: 8.0% vs 8.5%; NS, and after discharge: 7.0% vs 6.9%; NS), and with a trend towards more strokes (1.6% vs 0.7%; NS) and more bruising and bleeding (14% vs 12%; NS). To assess more reliably the effects of aspirin and of this SK regimen on mortality, about 400 hospitals worldwide are now collaborating in a large (about 20,000 patients planned) randomized trial (ISIS-2), for which the present study was a pilot. PMID:2887430

  1. A randomized study to compare oral fluconazole to amphotericin B in the prevention of fungal infections in patients with acute leukaemia.

    Rozenberg-Arska, M; Dekker, A W; Branger, J; Verhoef, J

    1991-03-01

    In a prospective randomized study the efficacy of fluconazole (50 mg in one single daily dose) was compared with oral amphotericin B in suspension and tablets (each 200 mg four times daily) for prevention of colonization and subsequent infection by yeasts in 50 patients undergoing remission induction treatment for acute leukaemia. All patients received ciprofloxacin for prevention of bacterial infections. Fluconazole was as effective as amphotericin B in preventing severe local and disseminated fungal disease (one documented and one highly suspected infection in each group of patients). Fluconazole effectively prevented yeast colonization of the oropharynx but was less effective than amphotericin B in preventing colonization of the lower alimentary tract. Fifty-two percent of patients receiving fluconazole had persistent positive stool cultures as compared to 4% in the amphotericin B group (P less than 0.01). Fluconazole was better tolerated than amphotericin B. One patient developed an extended rash leading to the termination of fluconazole. PMID:2037541

  2. A phase II randomized study of topical intrarectal administration of amifostine for the prevention of acute radiation-induced rectal toxicity

    Kouloulias, V.E. [Dept. of Radiation Oncology, Aretaieion Univ. Hospital, Univ. of Athens Medical School, Athens (Greece); Dept. of Electrical and Computer Engineering, National Technical Univ. of Athens, Athens (Greece); Center of Radiation Oncology, YGEIA Diagnostic and Therapeutic Center of Athens, Athens (Greece); Kouvaris, J.R.; Kokakis, J.D.; Antypas, C.; Mallas, E.; Vosdoganis, S.P.; Vlahos, L.J. [Dept. of Radiation Oncology, Aretaieion Univ. Hospital, Univ. of Athens Medical School, Athens (Greece); Pissakas, G. [Radiotherapy Dept., Agios Savvas Anticancer Hospital, Athens (Greece); Matsopoulos, G. [Dept. of Electrical and Computer Engineering, National Technical Univ. of Athens, Athens (Greece); Michopoulos, S. [Gastroenterology Unit, Alexandra General Hospital, Athens (Greece); Kostakopoulos, A. [Urology Dept., Sismanoglio Hospital, Univ. of Athens Medical School, Athens (Greece)

    2004-09-01

    Purpose: to investigate the cytoprotective effect of intrarectal amifostine administration on acute radiation-induced rectal toxicity. Patients and methods: 67 patients with T1b-2 NO MO prostate cancer were randomized to receive amifostine intrarectally (group A, n - 33) or not (group B, n = 34) before irradiation. Therapy was delivered using a four-field technique with three-dimensional conformal planning. In group A, 1,500 mg amifostine was administered intrarectally as an aqueous solution in a 40-ml enema. Two different toxicity scales were used: EORTC/RTOG rectal and urologic toxicity criteria along with a Subjective-RectoSigmoid (S-RS) scale based on the endoscopic terminology of the World Organization for Digestive Endoscopy. Objective measurements with rectosigmoidoscopy were performed at baseline and 1-2 days after the completion of radiotherapy. The area under curve for the time course of mucositis (RTOG criteria) during irradiation represented the mucositis index (MI). Results: intrarectal amifostine was feasible and well tolerated without any systemic or local side effects. According to the RTOG toxicity scale, five out of 33 patients showed grade 1 mucositis in group A versus 15 out of 34 patients with grade 1/2 in group B (p = 0.026). Mean rectal MI was 0.3 {+-} 0.1 in group A versus 2.2 {+-} 0.4 in group B (p < 0.001), while S-RS score was 3.9 {+-} 0.5 in group A versus 6.3 {+-} 0.7 in group B (p < 0.001). The incidence of urinary toxicity was the same in both groups. Conclusion: intrarectal administration of amifostine seems to have a cytoprotective efficacy in acute radiation-induced rectal mucositis. Further randomized studies are needed for definitive therapeutic decisions. (orig.)

  3. Effect of a brief outreach educational intervention on the translation of acute poisoning treatment guidelines to practice in rural Sri Lankan hospitals: a cluster randomized controlled trial.

    Lalith Senarathna

    Full Text Available BACKGROUND: In developing countries, including Sri Lanka, a high proportion of acute poisoning and other medical emergencies are initially treated in rural peripheral hospitals. Patients are then usually transferred to referral hospitals for further treatment. Guidelines are often used to promote better patient care in these emergencies. We conducted a cluster randomized controlled trial (ISRCTN73983810 which aimed to assess the effect of a brief educational outreach ('academic detailing' intervention to promote the utilization of treatment guidelines for acute poisoning. METHODS AND FINDINGS: This cluster RCT was conducted in the North Central Province of Sri Lanka. All peripheral hospitals in the province were randomized to either intervention or control. All hospitals received a copy of the guidelines. The intervention hospitals received a brief out-reach academic detailing workshop which explained poisoning treatment guidelines and guideline promotional items designed to be used in daily care. Data were collected on all patients admitted due to poisoning for 12 months post-intervention in all study hospitals. Information collected included type of poison exposure, initial investigations, treatments and hospital outcome. Patients transferred from peripheral hospitals to referral hospitals had their clinical outcomes recorded. There were 23 intervention and 23 control hospitals. There were no significant differences in the patient characteristics, such as age, gender and the poisons ingested. The intervention hospitals showed a significant improvement in administration of activated charcoal [OR 2.95 (95% CI 1.28-6.80]. There was no difference between hospitals in use of other decontamination methods. CONCLUSION: This study shows that an educational intervention consisting of brief out-reach academic detailing was effective in changing treatment behavior in rural Sri Lankan hospitals. The intervention was only effective for treatments with

  4. Efficacy of a children’s procedural preparation and distraction device on healing in acute burn wound care procedures: study protocol for a randomized controlled trial

    Brown Nadia J

    2012-12-01

    Full Text Available Abstract Background The intense pain and anxiety triggered by burns and their associated wound care procedures are well established in the literature. Non-pharmacological intervention is a critical component of total pain management protocols and is used as an adjunct to pharmacological analgesia. An example is virtual reality, which has been used effectively to dampen pain intensity and unpleasantness. Possible links or causal relationships between pain/anxiety/stress and burn wound healing have previously not been investigated. The purpose of this study is to investigate these relationships, specifically by determining if a newly developed multi-modal procedural preparation and distraction device (Ditto™ used during acute burn wound care procedures will reduce the pain and anxiety of a child and increase the rate of re-epithelialization. Methods/design Children (4 to 12 years with acute burn injuries presenting for their first dressing change will be randomly assigned to either the (1 Control group (standard distraction or (2 Ditto™ intervention group (receiving Ditto™, procedural preparation and Ditto™ distraction. It is intended that a minimum of 29 participants will be recruited for each treatment group. Repeated measures of pain intensity, anxiety, stress and healing will be taken at every dressing change until complete wound re-epithelialization. Further data collection will aid in determining patient satisfaction and cost effectiveness of the Ditto™ intervention, as well as its effect on speed of wound re-epithelialization. Discussion Results of this study will provide data on whether the disease process can be altered by reducing stress, pain and anxiety in the context of acute burn wounds. Trial registration ACTRN12611000913976

  5. Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial

    Purpose: Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic radiotherapy? Material and methods: Fifty-six patients with an indication for adjuvant pelvic irradiation after curative surgery were double-blind randomized. All patients took 3x4 capsules study medication daily during radiotherapy. Twenty-eight patients in the enzyme group (EG) received capsules containing papain, trypsin and chymotrypsin, 28 in the placebo group (PG) received placebo capsules. All patients were irradiated with 5x1.8 Gy weekly to 50.4 Gy using four-field-box technique after CT-based planning. Primary objective was the grade of diarrhea, nausea, vomiting, fatigue and epitheliolysis during radiotherapy. Secondary objectives were the number of supportive medications and treatment interruptions due to acute toxicity. Results: None/mild diarrhea: 43% EG, 64% PG. Moderate/severe diarrhea: 57% EG, 36% PG (P=0.11). Mean duration: 11 days in EG, 10 days in PG. None/mild nausea: 93% EG, 93% PG. Moderate/severe nausea: 7% EG, 7% PG. None/mild vomiting: 100% EG, 97% PG. None/mild fatigue: 82% EG, 93% PG. Moderate/severe fatigue: 18% EG, 7% PG (P=0.23). None/mild epitheliolysis: 75% EG, 93% PG. Moderate/severe epitheliolysis: 25% EG, 7% PG (P=0.16). Treatment interruption (mean days): 2.44 in EG, 1.46 in PG. Number of supportive medication: 29 in EG, 19 in PG. Conclusions: The prophylactic use of proteolytic enzymes does not reduce acute toxicities, treatment interruptions and number of supportive medication and therefore does not improve tolerance of adjuvant pelvic radiotherapy

  6. Acute Effect of Topical Menthol on Chronic Pain in Slaughterhouse Workers with Carpal Tunnel Syndrome: Triple-Blind, Randomized Placebo-Controlled Trial

    Emil Sundstrup

    2014-01-01

    Full Text Available Topical menthol gels are classified “topical analgesics” and are claimed to relieve minor aches and pains of the musculoskeletal system. In this study we investigate the acute effect of topical menthol on carpal tunnel syndrome (CTS. We screened 645 slaughterhouse workers and recruited 10 participants with CTS and chronic pain of the arm/hand who were randomly distributed into two groups to receive topical menthol (Biofreeze or placebo (gel with a menthol scent during the working day and 48 hours later the other treatment (crossover design. Participants rated arm/hand pain intensity during the last hour of work (scale 0–10 immediately before 1, 2, and 3 hours after application. Furthermore, global rating of change (GROC in arm/hand pain was assessed 3 hours after application. Compared with placebo, pain intensity and GROC improved more following application of topical menthol (P=0.026 and P=0.044, resp.. Pain intensity of the arm/hand decreased by −1.2 (CI 95%: −1.7 to −0.6 following topical menthol compared with placebo, corresponding to a moderate effect size of 0.63. In conclusion, topical menthol acutely reduces pain intensity during the working day in slaughterhouse workers with CTS and should be considered as an effective nonsystemic alternative to regular analgesics in the workplace management of chronic and neuropathic pain.

  7. Efficacy of Lamivudine Therapy on Decompensated Liver Cirrhosis Due to Chronic Hepatitis B

    Mahmood Yousefi Mashhour

    2007-08-01

    Full Text Available Background and Aims: The aim of this study was to determine the effect of lamivudine on liver function and clinical status of the patients with decompensated cirrhosis arising from hepatitis B virus (HBV.Methods: In a clinical trial on the basis of liver consideration in 55 patients with cirrhosis that had positive HBsAg and HBV DNA, Child-Pugh score more than 8 and some other criteria were treated with lamivudine. In these patients, serumlevel of bilirubin, albumin, ALT, AST and also the PT-INR were controlled at the beginning of study and then at intervals of 2 to 6 months and finally 12 months after the start of treatment.Results: Five patients died in the first 6 months of treatments. The following results are related to 50 patients being under treatment with lamivudine at least for a period of 6 months. In these patients mean Child-Pugh score was decreased from 11 ± 2 to 7 ± 1 (P < 0.0001. All of the patients tolerated this drug very well.Conclusions: Lamivudine can be effective in improvement of liver function in patients with decompensated liver cirrhosis resulting from HBV, but for determination of proper period of treatment, further studies are necessary.

  8. Decompensated porto-pulmonary hypertension in a cirrhotic patient with thrombosis of portocaval shunt

    2007-01-01

    We report a case of decompensated porto-pulmonary hypertension closely associated with the development of intra-portocaval shunt thrombosis. A woman with Laennec's cirrhosis was hospitalized because of severe dyspnea and edema. She underwent surgical portocaval anastomosis ten years ago. Imaging studies showed massive intra-shunt thrombosis, portal hypertension, ascites, pleuro-pericardial effusions and enlargement of right cardiac cavities. Cardiac catheterization allowed to rule out coronary and leftsided heart abnormalities and led to the diagnosis of pre-capillary pulmonary hypertension. Antithrombotic treatment with low molecular weight heparin was instituted. The management also included ACE inhibitors,spironolactone, low-salt diet and lactulose. The patient was discharged and three months later we observed the disappearance of edema, ascites and pleuropericardial effusions, a marked body weight reduction and improved dyspnea and liver function tests. A possible link between the development of intra-shunt thrombosis and clinical decompensation in our patient was hypothesized. In fact, it has been demonstrated that the increased portal pressure, caused by occlusion of portosystemic shunt, reduces renal plasma flow and increases systemic endothelin-1 concentration. In our patient the disappearance of edematous state and improved dyspnea observed after recanalization of the shunt strongly support this hypothesis.

  9. Chronic Hepatitis B with Spontaneous Severe Acute Exacerbation

    Wei-Lun Tsai

    2015-11-01

    Full Text Available Chronic hepatitis B virus (HBV infection is a major global health problem with an estimated 400 million HBV carriers worldwide. In the natural history of chronic hepatitis B (CHB, spontaneous acute exacerbation (AE is not uncommon, with a cumulative incidence of 10%–30% every year. While exacerbations can be mild, some patients may develop hepatic decompensation and even die. The underlying pathogenesis is possibly related to the activation of cytotoxic T lymphocyte-mediated immune response against HBV. An upsurge of serum HBV DNA usually precedes the rise of alanine aminotransferase (ALT and bilirubin. Whether antiviral treatment can benefit CHB with severe AE remains controversial, but early nucleos(tide analogues treatment seemed to be associated with an improved outcome. There has been no randomized study that compared the effects of different nucleos(tide analogues (NA in the setting of CHB with severe AE. However, potent NAs with good resistance profiles are recommended. In this review, we summarized current knowledge regarding the natural history, pathogenetic mechanisms, and therapeutic options of CHB with severe AE.

  10. Controlled randomized study comparing amoxycillin and pivmecillinam in adult out-patients presenting with symptoms of acute urinary tract infection.

    Bresky, B

    1977-07-01

    A comparative study of amoxycillin and pivmecillinam was performed on 298 out-patients with acute urinary tract infection, receiving either 375 mg amoxycillin three times daily or 400 mg pivmecillinam three times daily. The primary cure rate was 90% in the pivmecillinam group compared to 82% in the amoxycillin group. Resistant enterobacteriaceae emerged in approximately 5% of patients receiving amoxycillin but not after treatment with pivmecillinam. No serious side effects were observed in patients receiving picmecillinam and the tolerance was generally good. Upper gastrointestinal side effects were more frequent in the pivmecillinam group whereas lower gastrointestinal side effects predominated in the amoxycillin group. 200 mg pivmecillinam three times daily compared with 400 mg three times daily showed no differences in cure rate and side effects were lower (11% compared to 19%). PMID:330480

  11. The Effect of Bee Venom Acupuncture(BVA on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study

    Song, Ho-Seub

    2005-06-01

    Full Text Available Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC participated in the study, who were divided into two groups (A and B randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41 of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo or BVA was done and then acupuncture at 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41, 足三里(ST36, 陽陵泉(G34 of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS and Visual Analogue Scale(VAS were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective

  12. A prospective, randomized, multi-center trial to investigate Actovegin in prevention and treatment of acute oral mucositis caused by chemoradiotherapy for nasopharyngeal carcinoma

    Purpose: A multi-center prospective randomized trial was conducted to evaluate the efficacy and safety of Actovegin in the prevention and treatment of chemoradiotherapy-induced acute oral mucositis. Methods and materials: Between February 2006 and May 2007, 156 evaluable patients with nasopharyngeal carcinoma were randomized to Group 1 (n = 53) for prevention, Group 2 (n = 51) for treatment, and Group 3 (n = 52) for control. All patients received concomitant chemoradiotherapy ± induction chemotherapy. Radiation technique and dose were similar among 3 groups. Intravenous Actovegin of 30 ml daily (5 days/week) was administrated from day 1 of the radiotherapy for Group 1 and from the onset of grade 2 mucositis for Group 2, until the end of the radiotherapy. Results: The incidence of grade 3 mucositis was lower in Group 1 compared with Group 3 (26.4% vs. 55.8%, P = 0.002). Group 2 had a lower progression rate of mucositis from grade 2 to 3 compared with Group 3 (39.2% vs. 60.4%, P = 0.035). There was no difference in the onset time of grade 3 mucositis among 3 groups. Actovegin was well tolerated and no treatment-related adverse events were observed. Conclusions: Actovegin is effective in the prevention and treatment of chemoradiotherapy-induced oral mucositis.

  13. l-asparaginase loaded red blood cells in refractory or relapsing acute lymphoblastic leukaemia in children and adults: results of the GRASPALL 2005-01 randomized trial.

    Domenech, Carine; Thomas, Xavier; Chabaud, Sylvie; Baruchel, Andre; Gueyffier, François; Mazingue, Françoise; Auvrignon, Anne; Corm, Selim; Dombret, Herve; Chevallier, Patrice; Galambrun, Claire; Huguet, Françoise; Legrand, Faezeh; Mechinaud, Françoise; Vey, Norbert; Philip, Irène; Liens, David; Godfrin, Yann; Rigal, Dominique; Bertrand, Yves

    2011-04-01

    l-asparaginase encapsulated within erythrocytes (GRASPA(®) ) should allow serum asparagine depletion over a longer period than the native form of the enzyme, using lower doses and allowing better tolerance. The GRASPALL 2005-01 study, a multicentre randomized controlled trial, investigated three doses of GRASPA(®) for the duration of asparagine depletion in a phase I/II study in adults and children with acute lymphoblastic leukaemia (ALL) in first relapse. Between February 2006 and April 2008, 18 patients received GRASPA(®) (50 iu/kg: n = 6,100 iu/kg: n = 6, 150 iu/kg: n = 6) after randomization, and six patients were assigned to the Escherichia coli native l-asparaginase (E. colil-ASNase) control group. GRASPA(®) was effective at depleting l-asparagine. One single injection of 150 iu/kg of GRASPA(®) provided similar results to 8 × 10,000 iu/m(2) intravenous injections of E. colil-ASNase. The safety profile of GRASPA(®) showed a reduction in the number and severity of allergic reactions and a trend towards less coagulation disorders. Other expected adverse events were comparable to those observed with E. colil-ASNase and there was also no difference between the three doses of GRASPA(®) . PMID:21332712

  14. A clinical examination of antibiotics in continuous regional arterial infusion (CRAI) therapy for severe acute pancreatitis (SAP). A prospective randomized controlled trial of BIPM and IPM/CS

    Continuous regional arterial infusion (CRAI) therapy using both protease inhibitors and antibiotics are one of the specific therapeutic methods for severe acute pancreatitis (SAP). As for the administered antibiotics, imipenem/cilastatin sodium (IPM/CS) is generally chosen as a first step, but there are only a few reports comparing IPM/CS with other antibiotics. Therefore, we performed a prospective randomized controlled trial between biapenem (BIPM) and IPM/CS as CRAI antibiotics. Twelve patients with SAP were admitted to our institution during April, 2009 since August, 2006, and were randomized into two groups. They were treated with 120 mg/day of nafamostat mesilate and either 1.2 g/day of BIPM (n=6) or 2.0 g/day of IPM/CS (n=6) for CRAI therapy within 48 hours after the administration. The clinical data, inflammatory markers (WBC, CRP), serum pancreatic enzymes (lipase, tripsin, phospholipase A2, elastase 1 and pancreatic secretory trypsin inhibitor (PSTI) and contrast-enhanced abdominal Computed Tomography findings were compared between the two groups and the adverse effects were monitored. CRAI therapy was performed for seven days. The curative effect of this therapy was evaluated at the beginning of the treatment, the day 7 and the day 14. Our results suggested that BIPM was a non-recessive antibiotic which had an equal effect in CRAI therapy in comparison with IPM/CS. (author)

  15. Lactobacillus casei strain GG in the treatment of infants with acute watery diarrhea: A randomized, double-blind, placebo controlled clinical trial [ISRCTN67363048

    Chea-Woo Elsa

    2004-09-01

    Full Text Available Abstract Background Adjuvant therapy to ORT with probiotic bacteria for infants with acute watery diarrhea has been under active investigation. Most studies have been done in the developed world showing benefit only for viral mild gastroenteritis. We evaluated the effect of a milk formula containing one billion (109 cfu/ml of Lactobacillus casei strain GG (LGG upon duration and severity of diarrhea in infants in an environment with more severe acute diarrhea, where etiologic agents other than rotavirus are involved more frequently, and where mixed infections are more prevalent. Methods Male infants aged 3–36 months brought for treatment of acute watery diarrhea of less than 48 hours were eligible. After rehydration was completed with the WHO's oral rehydration solution, patients were randomly assigned to receive a milk formula either containing LGG or not. Stool volume was periodically measured using a devise suited to collect stools separate from urine. Duration of diarrhea was estimated based on stools physical characteristics. Results Eighty nine patients received the placebo milk formula and ninety received the LGG containing formula. Both groups were comparable in their baseline characteristics. Total stool output was significantly larger (p = 0.047 in the LGG group (247.8 ml/kg than in the placebo group (195.0 ml/kg. No significant differences were found in duration of diarrhea (58.5 hours with LGG vs. 50.4 hours with placebo, rate of treatment failure (21.1% with LGG vs. 18.0% with placebo, and proportion of patients with unresolved diarrhea after 120 hours (12.2% with LGG vs. 12.5% with placebo. The rate of stools with reducing substances after 24 hours of treatment increased significantly in both groups (from 41.4% to 72.2% with LGG and from 45.9% to 68.0% with placebo. Conclusion This study did not show a positive effect of LGG on the clinical course of acute watery diarrhea. Positive beneficial effects of LGG, as had been reported

  16. A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial

    Fockens Paul

    2010-07-01

    Full Text Available Abstract Background Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. Methods A randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days. II A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time

  17. Lithium as add-on to quetiapine XR in adult patients with acute mania: a 6-week, multicenter, double-blind, randomized, placebo-controlled study.

    Bourin, Michel S; Severus, Emanuel; Schronen, Juan P; Gass, Peter; Szamosi, Johan; Eriksson, Hans; Chandrashekar, Hongally

    2014-01-01

    Quetiapine extended release (XR) and lithium are treatments with proven efficacy in acute mania. This randomized study evaluated the efficacy and safety of lithium or placebo as add-on to quetiapine XR in adult patients with manic or mixed symptoms of bipolar I disorder. In this 6-week, double-blind study (Trial D144AC00003), adult patients with DSM-IV-TR-diagnosed bipolar I disorder (current episode manic or mixed), a Young Mania Rating Scale (YMRS) total score ≥20, and score ≥4 on two of four core YMRS items were administered quetiapine XR (400 to 800 mg/day) and randomly assigned to receive add-on lithium (600 to 1,800 mg/day) or placebo. The primary efficacy end point was change in the YMRS total score from baseline to day 43, analyzed using a mixed-model for repeated measures (MMRM) approach. Secondary efficacy and safety end points were also measured. Rating scales were administered by trained staff. Three hundred fifty-six patients treated with quetiapine XR were randomized to add-on lithium (n = 173) or placebo (n = 183). Two hundred ninety-one patients (81.7%) completed the study. At day 43, least squares mean change in YMRS total score was -22.8 for add-on lithium and -20.1 for add-on placebo, a statistically significant treatment group difference of -2.69 (p < 0.001). On secondary measures, add-on lithium was associated with significant improvements in response, remission, illness severity, and overall illness versus add-on placebo (p < 0.05). The number needed to treat was 9.1 for response and 7.9 for remission for add-on lithium compared with add-on placebo. Lithium in combination with quetiapine XR was generally well tolerated, with a similar profile to quetiapine XR in combination with placebo. The addition of lithium to quetiapine XR therapy was associated with significantly greater efficacy than placebo as add-on and was generally well tolerated in patients with acute bipolar I mania. This study was registered under Clinicaltrials

  18. A Pragmatic Randomized Controlled Trial of 6-Step vs 3-Step Hand Hygiene Technique in Acute Hospital Care in the United Kingdom.

    Reilly, Jacqui S; Price, Lesley; Lang, Sue; Robertson, Chris; Cheater, Francine; Skinner, Kirsty; Chow, Angela

    2016-06-01

    OBJECTIVE To evaluate the microbiologic effectiveness of the World Health Organization's 6-step and the Centers for Disease Control and Prevention's 3-step hand hygiene techniques using alcohol-based handrub. DESIGN A parallel group randomized controlled trial. SETTING An acute care inner-city teaching hospital (Glasgow). PARTICIPANTS Doctors (n=42) and nurses (n=78) undertaking direct patient care. INTERVENTION Random 1:1 allocation of the 6-step (n=60) or the 3-step (n=60) technique. RESULTS The 6-step technique was microbiologically more effective at reducing the median log10 bacterial count. The 6-step technique reduced the count from 3.28 CFU/mL (95% CI, 3.11-3.38 CFU/mL) to 2.58 CFU/mL (2.08-2.93 CFU/mL), whereas the 3-step reduced it from 3.08 CFU/mL (2.977-3.27 CFU/mL) to 2.88 CFU/mL (-2.58 to 3.15 CFU/mL) (P=.02). However, the 6-step technique did not increase the total hand coverage area (98.8% vs 99.0%, P=.15) and required 15% (95% CI, 6%-24%) more time (42.50 seconds vs 35.0 seconds, P=.002). Total hand coverage was not related to the reduction in bacterial count. CONCLUSIONS Two techniques for hand hygiene using alcohol-based handrub are promoted in international guidance, the 6-step by the World Health Organization and 3-step by the Centers for Disease Control and Prevention. The study provides the first evidence in a randomized controlled trial that the 6-step technique is superior, thus these international guidance documents should consider this evidence, as should healthcare organizations using the 3-step technique in practice. Infect Control Hosp Epidemiol 2016;37:661-666. PMID:27050843

  19. Randomized, controlled trial of a 10-day course of amifloxacin versus trimethoprim-sulfamethoxazole in the treatment of acute, uncomplicated urinary tract infection. Amifloxacin Multi-Center Trial Group.

    Boyko, E. J.; Iravani, A; Silverman, M H; Schelling, D J; Wright, R A

    1990-01-01

    We conducted a randomized controlled trial of orally administered amifloxacin versus trimethoprimsulfamethoxazole (TMP-SMX) as treatments of acute uncomplicated urinary tract infection in women. Amifloxacin at a dosage of 200 mg twice a day appeared as safe and effective as TMP-SMX, but amifloxacin at 400 mg twice a day tended to cause adverse events more frequently than did TMP-SMX.

  20. Efficacy and safety of integrative medical program based on blood cooling and detoxification recipe in treating patients with hepatitis B virus related acute-on-chronic liver failure:a randomized controlled clinical study

    刘慧敏

    2014-01-01

    Objective To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe(BCDR)in treating patients with hepatitis B virus related acute-on-chronic liver failure(HBV-ACLF)of heat-toxicity accumulation syndrome(HTAS).Methods Adopting randomized controlled

  1. Liver dialysis in acute-on-chronic liver failure: current and future perspectives.

    Maiwall, Rakhi; Maras, Jaswinder Singh; Nayak, Suman Lata; Sarin, Shiv Kumar

    2014-09-01

    Patients with acute-on-chronic liver failure (ACLF) are known to have a very high mortality rate as the majority of these patients succumb to multiorgan failure. Liver transplant remains the only option for these patients; however, there are problems with its availability, cost and also the complications and side effects associated with immunosuppression. Unlike advanced decompensated liver disease, there is a potential for hepatic regeneration and recovery in patients with ACLF. A liver support system, cell or non-cell based, logically is likely to provide temporary functional support until the donor liver becomes available or the failing liver survives the onslaught of the acute insult and spontaneously regenerates. Understanding the pathogenesis of liver failure and regeneration is essential to define the needs for a support system. Removal of hepatotoxic metabolites and inhibitors of hepatic regeneration by liver dialysis, a non-cell-based hepatic support, could help to provide a suitable microenvironment and support the failing liver. The current systems, i.e., MARS and Prometheus, have failed to show survival benefits in patients with ACLF based on which newer devices with improved functionality are currently under development. However, larger randomized trials are needed to prove whether these devices can enable restoration of the complex dysregulated immune system and impact organ failure and mortality in these patients. PMID:26201332

  2. Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Patients Receiving Breast Radiation Therapy: Results of a Randomized Trial

    Purpose: We wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study (Boström et al, Radiother Oncol 2001;59:257-265). Methods and Materials: The study was a double-blind comparison of MF with D (Diprobase), administered daily from the start of radiation therapy for 5 weeks in patients receiving breast radiation therapy, 40 Gy in 2.67-Gy fractions daily over 3 weeks. The primary endpoint was mean modified Radiation Therapy Oncology Group (RTOG) score. Results: Mean RTOG scores were significantly less for MF than for D (P=.046). Maximum RTOG and mean erythema scores were significantly less for MF than for D (P=.018 and P=.012, respectively). The Dermatology Life Quality Index (DLQI) score was significantly less for MF than for D at weeks 4 and 5 when corrected for Hospital Anxiety and Depression (HAD) questionnaire scores. Conclusions: MF cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy. For the first time, we have shown a significantly beneficial effect on quality of life using a validated instrument (DLQI), for a topical steroid cream. We believe that application of this cream should be the standard of care where radiation dermatitis is expected

  3. Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Patients Receiving Breast Radiation Therapy: Results of a Randomized Trial

    Hindley, Andrew, E-mail: andrew.hindley@lthtr.nhs.uk [Rosemere Cancer Centre, Royal Preston Hospital, Preston (United Kingdom); Zain, Zakiyah [College of Arts and Sciences, Universiti Utara Malaysia, Kedah (Malaysia); Wood, Lisa [Department of Social Sciences, Lancaster Medical School, Lancaster (United Kingdom); Whitehead, Anne [Medical and Pharmaceutical Statistics Research Unit, Lancaster University, Lancaster (United Kingdom); Sanneh, Alison; Barber, David; Hornsby, Ruth [Rosemere Cancer Centre, Royal Preston Hospital, Preston (United Kingdom)

    2014-11-15

    Purpose: We wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study (Boström et al, Radiother Oncol 2001;59:257-265). Methods and Materials: The study was a double-blind comparison of MF with D (Diprobase), administered daily from the start of radiation therapy for 5 weeks in patients receiving breast radiation therapy, 40 Gy in 2.67-Gy fractions daily over 3 weeks. The primary endpoint was mean modified Radiation Therapy Oncology Group (RTOG) score. Results: Mean RTOG scores were significantly less for MF than for D (P=.046). Maximum RTOG and mean erythema scores were significantly less for MF than for D (P=.018 and P=.012, respectively). The Dermatology Life Quality Index (DLQI) score was significantly less for MF than for D at weeks 4 and 5 when corrected for Hospital Anxiety and Depression (HAD) questionnaire scores. Conclusions: MF cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy. For the first time, we have shown a significantly beneficial effect on quality of life using a validated instrument (DLQI), for a topical steroid cream. We believe that application of this cream should be the standard of care where radiation dermatitis is expected.

  4. Adding ketamine to morphine for intravenous patient-controlled analgesia for acute postoperative pain: a qualitative review of randomized trials

    Carstensen, M; Møller, A M

    2010-01-01

    In experimental trials, ketamine has been shown to reduce hyperalgesia, prevent opioid tolerance, and lower morphine consumption. Clinical trials have found contradictory results. We performed a review of randomized, double-blinded clinical trials of ketamine added to opioid in i.v. patient......-controlled analgesia (PCA) for postoperative pain in order to clarify this controversy. Our primary aim was to compare the effectiveness and safety of postoperative administered ketamine in addition to opioid for i.v. PCA compared with i.v. PCA with opioid alone. Studies were identified from the Cochrane Library 2003...... of 4.5. Pain was assessed using visual analogue scales or verbal rating scales. Six studies showed significant improved postoperative analgesia with the addition of ketamine to opioids. Five studies showed no significant clinical improvement. For thoracic surgery, the addition of ketamine to opioid...

  5. Adding ketamine to morphine for intravenous patient-controlled analgesia for acute postoperative pain: a qualitative review of randomized trials

    Carstensen, M; Møller, A M

    2010-01-01

    -controlled analgesia (PCA) for postoperative pain in order to clarify this controversy. Our primary aim was to compare the effectiveness and safety of postoperative administered ketamine in addition to opioid for i.v. PCA compared with i.v. PCA with opioid alone. Studies were identified from the Cochrane Library 2003......In experimental trials, ketamine has been shown to reduce hyperalgesia, prevent opioid tolerance, and lower morphine consumption. Clinical trials have found contradictory results. We performed a review of randomized, double-blinded clinical trials of ketamine added to opioid in i.v. patient......, MEDLINE (1966-2009), and EMBASE (1980-2009) and by hand-searching reference lists from review articles and trials. Eleven studies were identified with a total of 887 patients. Quality and validity assessment was performed on all trials included using the Oxford Quality Scale with an average quality score...

  6. Indigenous recombinant streptokinase Vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial

    Diwedi S

    2005-05-01

    Full Text Available Background : Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK. Aim: To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK and natural streptokinase (Streptase, n-SK. Settings and Design: Double blind, randomized, non-inferiority, multicentric, parallel study. Materials and Methods: Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V1- V6 or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > 50% ST segment were used to assess reperfusion. Statistical analysis: Difference in the groups was assessed by chi-square or paired t test as required. Probability value Results: Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58 and 69.4% (34 patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%, hypotension in 3 (3.6%, nausea in 2 (2.4% patients. Minor bleeding were seen in 4 (4.8% of patients. Conclusion: Indigenous recombinant Streptokinase (r-SK is as efficacious as natural streptokinase (n-SK in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile..

  7. Quetiapine monotherapy in acute phase for major depressive disorder: a meta-analysis of randomized, placebo-controlled trials

    Maneeton Narong

    2012-09-01

    Full Text Available Abstract Background Schizophrenia and bipolar depression trials suggest that quetiapine may have an antidepressant effect. Objectives This meta-analysis aimed to determine the efficacy, acceptability and tolerability of quetiapine treatment for major depressive disorder (MDD. Only the randomized controlled trials (RCTs comparison between quetiapine and placebo were included. The authors searched such clinical trials carried out between 1991 and February 2012. Data sources MEDLINE, EMBASE, CINHL, PsycINFO and Cochrane Controlled Trials Register were searched in February 2012. Study populations comprised adults with MDD or major depression. Study eligible criteria, participants and interventions Eligible studies were randomized, placebo-controlled trials of quetiapine monotherapy carried out in adults with MDD and presenting endpoint outcomes relevant to: i depression severity, ii response rate, iii overall discontinuation rate, or iv discontinuation rate due to adverse events. No language restriction was applied. Study appraisal and synthesis methods All abstracts identified by the electronic searches were examined. The full reports of relevant studies were assessed, and the data of interest were extracted. Based on the Cochrane methods of bias assessment, risks of bias were determined. The studies with two risks or less were included. The efficacy outcomes were the mean change scores of depression rating scales, the overall response rate, and the overall remission rates. The overall discontinuation rate was considered as a measure of acceptability. The discontinuation rate due to adverse events was a measure of tolerability. Relative risks (RRs and weighted mean differences (WMDs with 95% confidence intervals (CIs were computed by using a random effect model. Results A total of 1,497 participants in three RCTs were included. All trials examined the quetiapine extended-release (XR. The pooled mean change scores of the Montgomery-Asberg Depression

  8. Quetiapine monotherapy in acute treatment of generalized anxiety disorder: a systematic review and meta-analysis of randomized controlled trials

    Maneeton N

    2016-01-01

    Full Text Available Narong Maneeton,1 Benchalak Maneeton,1 Pakapan Woottiluk,2 Surinporn Likhitsathian,1 Sirijit Suttajit,1 Vudhichai Boonyanaruthee,1 Manit Srisurapanont1 1Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; 2Psychiatric Nursing Division, Faculty of Nursing, Chiang Mai University, Chiang Mai, Thailand Background: Some studies have indicated the efficacy of quetiapine in the treatment of generalized anxiety disorder (GAD.Objective: The purpose of this study was to systematically review the efficacy, acceptability, and tolerability of quetiapine in adult patients with GAD.Methods: The SCOPUS, MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched in April 2015. All randomized controlled trials (RCTs of GAD were considered to be included in this meta-analysis. All RCTs of quetiapine in GAD patients providing endpoint outcomes relevant to severity of anxiety, response rate, remission rate, overall discontinuation rate, or discontinuation rate due to adverse events were included. The version reports from suitable clinical studies were explored, and the important data were extracted. Measurement for efficacy outcomes consisted of the mean-changed scores of the rating scales for anxiety, and response rate.Results: A total of 2,248 randomized participants in three RCTs were included. The pooled mean-changed score of the quetiapine-treated group was greater than that of the placebo-treated group and comparable to selective serotonin reuptake inhibitors (SSRIs. Unfortunately, the response and the remission rates in only 50 and 150 mg/day of quetiapine-XR (extended-release were better than those of the placebo. Their response and remission rates were comparable to SSRIs. The rates of pooled overall discontinuation and discontinuation due to adverse events of quetiapine-XR were greater than placebo. Only the overall discontinuation rate of quetiapine-XR at 50 and

  9. The HAC Trial (Harmonic for Acute Cholecystitis Study. Randomized, double-blind, controlled trial of Harmonic(H versus Monopolar Diathermy (M for laparoscopic cholecystectomy (LC for acute cholecystitis (AC in adults

    Coccolini Federico

    2009-05-01

    Full Text Available Abstract Background In the developmental stage of laparoscopic cholecystectomy (LC it was considered 'unsafe' or 'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis (AC. With increasing experience in laparoscopic surgery, a number of centers have reported on the use of laparoscopic cholecystectomy for acute cholecystitis, suggesting that it is technically feasible but at the expense of a high conversion rate, which can be up to 35 per cent and common bile duct lesions. The HARMONIC SCALPEL(R (H is the leading ultrasonic cutting and coagulating surgical device, offering surgeons important benefits including: minimal lateral thermal tissue damage, minimal charring and desiccation. Harmonic Scalpel technology reduces the need for ligatures with simultaneous cutting and coagulation: moreover there is not electricity to or through the patient Harmonic Scalpel has a greater precision near vital structures and it produces minimal smoke with improved visibility in the surgical field. In retrospective series LC performed with H was demonstrated feasible and effective with minimal operating time and blood loss: it was reported also a low conversion rate (3.9%. However there are not prospective randomized controlled trials showing the advantages of H compared to MD (the commonly used electrical scalpel in LC. Methods/Design Aim of this RCT is to demonstrate that H can decrease the conversion rate compared to MD in LC for AC, without a significant increase of morbidity. The patients will be allocated in two groups: in the first group the patient will be submitted to early LC within 72 hours after the diagnosis with H while in the second group will be submitted to early LC within 72 hours with MD. Trial Registration ClinicalTrials.gov Identifier: NCT00746850

  10. Efficacy of Synbiotics to Reduce Acute Radiation Proctitis Symptoms and Improve Quality of Life: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

    Purpose: To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer. Methods and Materials: Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 108 colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis–23 items) questionnaire were the main endpoints. Results: This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance). Conclusions: Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer

  11. Comparison of early enteral nutrition in severe acute pancreatitis with prebiotic fiber supplementation versus standard enteral solution: A prospective randomized double-blind study

    Tarkan Karakan; Meltem Ergun; Ibrahim Dogan; Mehmet Cindoruk; Selahattin Unal

    2007-01-01

    AIM: To compare the beneficial effects of early enteral nutrition (EN) with prebiotic fiber supplementation in patients with severe acute pancreatitis (AP).METHODS: Thirty consecutive patients with severe AP, who required stoppage of oral feeding for 48 h, were randomly assigned to nasojejunal EN with or without prebiotics. APACHE Ⅱ score, Balthazar's CT score and CRP were assessed daily during the study period.RESULTS: The median duration of hospital stay was shorter in the study group [10 ± 4 (8-14) d vs 15 ± 6 (7-26) d] (P<0.05). The median value of days in intensive care unit was also similar in both groups [6 ± 2 (5-8) d vs 6 ± 2 (5-7) d]. The median duration of EN was 8 ± 4 (6-12) d vs 10 ± 4 (6-13) d in the study and control groups, respectively (P>0.05). Deaths occurred in 6 patients (20%), 2 in the study group and 4 in the control group. The mean duration of APACHE Ⅱ normalization (APACHE Ⅱ score < 8) was shorter in the study group than in the control group (4 ± 2 d vs 6.5 ± 3 d, P<0.05). The mean duration of CRP normalization was also shorter in the study group than in the control group (7 ± 2 d vs 10 ± 3 d, P<0.05).CONCLUSION: Nasojejunal EN with prebiotic fiber supplementation in severe AP improves hospital stay, duration nutrition therapy, acute phase response and overall complications compared to standard EN therapy.

  12. Efficacy of Synbiotics to Reduce Acute Radiation Proctitis Symptoms and Improve Quality of Life: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

    Nascimento, Mariana, E-mail: mari1980hemato@yahoo.com.br [Department of Medicine, University Center of Varzea Grande (UNIVAG), Varzea Grande, Mato Grosso (Brazil); Aguilar-Nascimento, José Eduardo [Department of Medicine, University Center of Varzea Grande (UNIVAG), Varzea Grande, Mato Grosso (Brazil); Caporossi, Cervantes; Castro-Barcellos, Heloisa Michelon; Motta, Rodrigo Teixeira [Department of Medicine, Federal University of Mato Grosso (UFMT), Cuiabá, Mato Grosso (Brazil)

    2014-10-01

    Purpose: To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer. Methods and Materials: Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10{sup 8} colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis–23 items) questionnaire were the main endpoints. Results: This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance). Conclusions: Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer.

  13. A 6 week randomized double-blind placebo-controlled trial of ziprasidone for the acute depressive mixed state.

    Ashwin Patkar

    Full Text Available OBJECTIVE: To examine the efficacy of ziprasidone vs. placebo for the depressive mixed state in patients with bipolar disorder type II or major depressive disorder (MDD. METHODS: 73 patients were randomized in a double-blinded, placebo-controlled study to ziprasidone (40-160 mg/d or placebo for 6 weeks. They met DSM-IV criteria for a major depressive episode (MDE, while also meeting 2 or 3 (but not more nor less DSM-IV manic criteria. They did not meet DSM-IV criteria for a mixed or manic episode. Baseline psychotropic drugs were continued unchanged. The primary endpoint measured was Montgomery-Åsberg Depression Rating Scale (MADRS scores over time. The mean dose of ziprasidone was 129.7±45.3 mg/day and 126.1±47.1 mg/day for placebo. RESULTS: The primary outcome analysis indicated efficacy of ziprasidone versus placebo (p = 0.0038. Efficacy was more pronounced in type II bipolar disorder than in MDD (p = 0.036. Overall ziprasidone was well tolerated, without notable worsening of weight or extrapyramidal symptoms. CONCLUSIONS: There was a statistically significant benefit with ziprasidone versus placebo in this first RCT of any medication for the provisional diagnostic concept of the depressive mixed state. TRIAL REGISTRATION: Clinicaltrials.gov NCT00490542.

  14. Are proton pump inhibitors the first choice for acute treatment of gastric ulcers? A meta analysis of randomized clinical trials

    Ward Alexandra

    2002-07-01

    Full Text Available Abstract Background Gastric ulcers are a frequent problem in the United States. Proton pump inhibitors have been shown to increase healing rates and improve clinical symptoms. The objective of this study is to compare gastric ulcer healing rates for patients treated with a proton pump inhibitor (PPI (omeprazole, rabeprazole, pantoprazole, or lansoprazole, an histamine 2- receptor antagonist (ranitidine or placebo. Methods A literature search was conducted to identify randomized, controlled clinical trials that included a PPI in at least one treatment arm and assessed the gastric ulcer healing rates endoscopically. The healing rates were estimated for each treatment at specific time points, and Rate Ratios (RR and 95% confidence intervals (CI were estimated for each trial. Results Sixteen trials met the inclusion criteria: four compared a PPI versus placebo, nine compared a PPI versus ranitidine (no trials of rabeprazole versus ranitidine met the inclusion criteria, and three compared a newer PPI (lansoprazole, pantoprazole or rabeprazole versus omeprazole. In relation to ranitidine, the pooled RR of PPIs (lansoprazole, omeprazole and pantoprazole was 1.33 (95% CI 1.24 to 1.42 at four weeks. In each trial, greater improvement in the studied clinical symptoms was found with the newer PPIs (rabeprazole, pantoprazole and lansoprazole when compared to omeprazole. Conclusion In this study treatment with PPIs resulted in higher healing rates than ranitidine or placebo. This evidence suggests that the first choice for gastric ulcer treatment for the greater relief of symptoms is one of the newer PPIs.

  15. Attentional Bias in Patients with Decompensated Tinnitus: Prima Facie Evidence from Event-Related Potentials.

    Li, Zhicheng; Gu, Ruolei; Zeng, Xiangli; Zhong, Weifang; Qi, Min; Cen, Jintian

    2016-01-01

    Tinnitus refers to the auditory perception of sound in the absence of external sound or electric stimuli. The influence of tinnitus on cognitive processing is at the cutting edge of ongoing tinnitus research. In this study, we adopted an objective indicator of attentional processing, i.e. the mismatch negativity (MMN), to assess the attentional bias in patients with decompensated tinnitus. Three kinds of pure tones, D1 (8,000 Hz), S (8,500 Hz) and D2 (9,000 Hz), were used to induce event-related potentials (ERPs) in the normal ear. Employing the oddball paradigm, the task was divided into two blocks in which D1 and D2 were set as deviation stimuli, respectively. Only D2 induced a significant MMN in the tinnitus group, while neither D1 nor D2 was able to induce MMN in the control group. In addition, the ERPs in the left hemisphere, which were recorded within the time window of 90-150 ms (ERP90-150 ms), were significantly higher than those in the right hemisphere in the tinnitus group, while no significant difference was observed in the control group. Lastly, the amplitude of ERP90-150 ms in the tinnitus group was significantly higher than that in the control group. These findings suggest that patients with decompensated tinnitus showed automatic processing of acoustic stimuli, thereby indicating that these patients allocated more cognitive resources to acoustic stimulus processing. We suggest that the difficulty in disengaging or facilitated attention of patients might underlie this phenomenon. The limitations of the current study are discussed. PMID:26800229

  16. Bone marrow-derived mesenchymal stem cell therapy for decompensated liver cirrhosis: A meta-analysis

    Pan, Xing-Nan; Zheng, Lian-Qiu; Lai, Xiao-Huan

    2014-01-01

    AIM: To assess the efficacy and safety of bone marrow-derived mesenchymal stem cell (BM-MSC) in the treatment of decompensated liver cirrhosis. METHODS: The search terms “bone marrow stem cell” “chronic liver disease” “transfusion” and “injection” were used in the Cochrane Library, Med-Line (Pub-Med) and Embase without any limitations with respect to publication date or language. Journals were also hand-searched and experts in the field were contacted. The studies which used BM-MSC in the treatment of any chronic liver disease were included. Comprehensive Review Manager and Meta-Analyst software were used for statistical analysis. Publication bias was evaluated using Begg’s test. RESULTS: Out of 78 studies identified, five studies were included in the final analysis. The studies were conducted in China, Iran, Egypt and Brazil. Analysis of pooled data of two controlled studies by Review Manager showed that the mean decline in scores for the model for end-stage liver disease (MELD) was -1.23 [95%CI: -2.45-(-0.01)], -1.87 [95%CI: -3.16-(-0.58)], -2.01 [95%CI: -3.35-(-0.68)] at 2, 4 and 24 wk, respectively after transfusion. Meta-analysis of the 5 studies showed that the mean improvement in albumin levels was -0.28, 2.60, 5.28, 4.39 g/L at the end of 8, 16, 24, and 48 wk, respectively, after transfusion. MELD scores, alanine aminotransferase, total bilirubin levels and prothrombin times improved to some extent. BM-MSC injections resulted in no serious adverse events or complications. CONCLUSION: BM-MSC infusion in the treatment of decompensated liver cirrhosis improved liver function. At the end of year 1, there were no serious side effects or complications. PMID:25320545

  17. Randomized and Controlled Clinical Study of Modified Prescriptions of Simiao Pill(四妙丸) in the Treatment of Acute Gouty Arthritis

    SHI Xin-de; LI Guo-chun; QIAN Zu-xi; JIN Ze-qiu; SONG Yan

    2008-01-01

    Objective: To investigate the compatibility of a modified prescription of Simiao Pill (四妙丸) in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial. Methods: A randomized and controlled clinical trial was designed based on clinical epidemiological principles, A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group Ⅰ) included 27 patients taking gout prescription Ⅰ ; the second group (Group Ⅱ) included 27 patients taking gout prescription Ⅱ ; the third group (Group Ⅲ) included 28 patients taking gout prescription Ⅲ; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment, the index of blood uric acid, blood leukocyte count, score of clinical symptoms, etc. were observed and measured. Results: The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%,significantly superior to that of the control group (68%, P<0.05). In terms of the improvement of main symptoms, the scores of four symptoms in all TCM treatment and control groups decreased after treatment, with statistically significant differences (P<0.05). Moreover, the scores markedly fell more so in the three Chinese herb groups than in the control group, and especially in Group Ⅲ (P<0.05). There was a statistically significant difference in blood uric acid values before and after the treatment in the same group but no significant inter-group difference was seen. Conclusion: The modified prescriptions, based on the clinical research, clinical experience and traditional Chinese medicine theory, did show a better effect than Western medicine in this clinical study. Moreover, the prescriptions were precise, with the herbs inexpensive and readily available. The

  18. Unenhanced helical computed tomography vs intravenous urography in patients with acute flank pain: accuracy and economic impact in a randomized prospective trial

    Pfister, S.A. [Department of Radiology, University Hospital, Petersgraben 4, 4031, Basel (Switzerland); Medical Imaging Lucerne, Theaterstrasse 7, 6003, Lucerne (Switzerland); Deckart, A.; Laschke, S.; Gasser, T.C. [Department of Urology, University Hospital, Petersgraben 4, 4031, Basel (Switzerland); Dellas, S.; Otto, U.; Buitrago, C.; Wiesner, W.; Bongartz, G. [Department of Radiology, University Hospital, Petersgraben 4, 4031, Basel (Switzerland); Roth, J. [Department of Radiologic Physics, University Hospital, Petersgraben 4, 4031, Basel (Switzerland)

    2003-11-01

    Unenhanced helical computed tomography (UHCT) has evolved into a well-accepted alternative to intravenous urography (IVU) in patients with acute flank pain and suspected ureterolithiasis. The purpose of our randomized prospective study was to analyse the diagnostic accuracy of UHCT vs IVU in the normal clinical setting with special interest on economic impact, applied radiation dose and time savings in patient management. A total of 122 consecutive patients with acute flank pain suggestive of urolithiasis were randomized for UHCT (n=59) or IVU (n=63). Patient management (time, contrast media), costs and radiation dose were analysed. The films were independently interpreted by four radiologists, unaware of previous findings, clinical history and clinical outcome. Alternative diagnoses if present were assessed. Direct costs of UHCT and IVU are nearly identical (310/309 Euro). Indirect costs are much lower for UHCT because it saves examination time and when performed immediately initial abdominal plain film (KUB) and sonography are not necessary. Time delay between access to the emergency room and start of the imaging procedure was 32 h 7 min for UHCT and 36 h 55 min for IVU. The UHCT took an average in-room time of 23 min vs 1 h 21 min for IVU. Mild to moderate adverse reactions for contrast material were seen in 3 (5%) patients. The UHCT was safe, as no contrast material was needed. The mean applied radiation dose was 3.3 mSv for IVU and 6.5 mSv for UHCT. Alternative diagnoses were identified in 4 (7%) UHCT patients and 3 (5%) IVU patients. Sensitivity and specificity of UHCT and IVU was 94.1 and 94.2%, and 85.2 and 90.4%, respectively. In patients with suspected renal colic KUB and US may be the least expensive and most easily accessable modalities; however, if needed and available, UHCT can be considered a better alternative than IVU because it has a higher diagnostic accuracy and a better economic impact since it is more effective, faster, less expensive and less

  19. Unenhanced helical computed tomography vs intravenous urography in patients with acute flank pain: accuracy and economic impact in a randomized prospective trial

    Unenhanced helical computed tomography (UHCT) has evolved into a well-accepted alternative to intravenous urography (IVU) in patients with acute flank pain and suspected ureterolithiasis. The purpose of our randomized prospective study was to analyse the diagnostic accuracy of UHCT vs IVU in the normal clinical setting with special interest on economic impact, applied radiation dose and time savings in patient management. A total of 122 consecutive patients with acute flank pain suggestive of urolithiasis were randomized for UHCT (n=59) or IVU (n=63). Patient management (time, contrast media), costs and radiation dose were analysed. The films were independently interpreted by four radiologists, unaware of previous findings, clinical history and clinical outcome. Alternative diagnoses if present were assessed. Direct costs of UHCT and IVU are nearly identical (310/309 Euro). Indirect costs are much lower for UHCT because it saves examination time and when performed immediately initial abdominal plain film (KUB) and sonography are not necessary. Time delay between access to the emergency room and start of the imaging procedure was 32 h 7 min for UHCT and 36 h 55 min for IVU. The UHCT took an average in-room time of 23 min vs 1 h 21 min for IVU. Mild to moderate adverse reactions for contrast material were seen in 3 (5%) patients. The UHCT was safe, as no contrast material was needed. The mean applied radiation dose was 3.3 mSv for IVU and 6.5 mSv for UHCT. Alternative diagnoses were identified in 4 (7%) UHCT patients and 3 (5%) IVU patients. Sensitivity and specificity of UHCT and IVU was 94.1 and 94.2%, and 85.2 and 90.4%, respectively. In patients with suspected renal colic KUB and US may be the least expensive and most easily accessable modalities; however, if needed and available, UHCT can be considered a better alternative than IVU because it has a higher diagnostic accuracy and a better economic impact since it is more effective, faster, less expensive and less

  20. A Proof of Concept, Phase II Randomized European Trial, on the Efficacy of ALF-5755, a Novel Extracellular Matrix-Targeted Antioxidant in Patients with Acute Liver Diseases

    Nalpas, Bertrand; Ichaï, Philippe; Jamot, Laure; Carbonell, Nicolas; Rudler, Marika; Mathurin, Philippe; Durand, François; Gerken, Guido; Manns, Michael; Trautwein, Christian; Larrey, Dominique; Radenne, Sylvie; Duvoux, Christophe; Leroy, Vincent; Bernuau, Jacques; Faivre, Jamila; Moniaux, Nicolas; Bréchot, Christian; Amouyal, Gilles; Amouyal, Paul; Samuel, Didier

    2016-01-01

    Objective No efficient medical treatment is available for severe acute hepatitis (SAH) except N-acetylcysteine for acetaminophen-induced acute liver failure. The human C-type lectin Reg3α, referred to as ALF-5755, improved survival in an animal model of acute liver failure and was well tolerated in a phase 1 trial in humans. We performed a phase 2a trial of ALF5755 in non-acetaminophen induced SAH. Design double-blind, randomized, placebo-controlled study. The primary end-point was the improvement in the coagulation protein synthesis assessed by the change of Prothrombin (PR) during the 72 hours following treatment initiation calculated as PRH0 minus PRH72 divided by 72 (PR slope H0H72). Intention to treat (ITT) and per-protocol (PP) analysis of the entire group and the Hepatitis B virus (HBV)/AIH (auto-immune hepatitis) sub-group were done separately. Results 57 patients were included. Twenty-eight received ALF-5755, 29 the placebo. Etiologies were: Hepatitis A (n = 10), HBV (n = 13), AIH (n = 9), drug-induced (n = 8), other (n = 17). On the whole group, nor the PR slope H0H72 (0.18±0.31 vs 0.25±0.32), nor the transplant-free survival rate at day 21 (75 vs 86%) differed between groups. Conversely, in the HBV-AIH subgroup, in which ALF was more severe, PR slope H0-H72 was higher in the ALF-5755 arm, the difference being significant in PP analysis (0.048±0.066 vs -0.040±0.099, p = 0.04); the median length of hospitalization was lower in the ALF-5755 group (8 vs 14 days, p = 0.02). Conclusion ALF-5755 was not efficient in a ITT analysis performed on the whole sample; however it led to a significant, although moderate, clinical benefit in a PP analysis of the sub-group of patients with HBV or AIH related SAH. As HBV is the major cause of SAH in Asia and Africa and AIH a growing cause, this study emphasizes the need to pursuit the evaluation of this novel medical treatment of SAH. Trial Registration ClinicalTrials.gov NCT01318525 PMID:26983031

  1. A Proof of Concept, Phase II Randomized European Trial, on the Efficacy of ALF-5755, a Novel Extracellular Matrix-Targeted Antioxidant in Patients with Acute Liver Diseases.

    Bertrand Nalpas

    Full Text Available No efficient medical treatment is available for severe acute hepatitis (SAH except N-acetylcysteine for acetaminophen-induced acute liver failure. The human C-type lectin Reg3α, referred to as ALF-5755, improved survival in an animal model of acute liver failure and was well tolerated in a phase 1 trial in humans. We performed a phase 2a trial of ALF5755 in non-acetaminophen induced SAH.double-blind, randomized, placebo-controlled study. The primary end-point was the improvement in the coagulation protein synthesis assessed by the change of Prothrombin (PR during the 72 hours following treatment initiation calculated as PRH0 minus PRH72 divided by 72 (PR slope H0H72. Intention to treat (ITT and per-protocol (PP analysis of the entire group and the Hepatitis B virus (HBV/AIH (auto-immune hepatitis sub-group were done separately.57 patients were included. Twenty-eight received ALF-5755, 29 the placebo. Etiologies were: Hepatitis A (n = 10, HBV (n = 13, AIH (n = 9, drug-induced (n = 8, other (n = 17. On the whole group, nor the PR slope H0H72 (0.18±0.31 vs 0.25±0.32, nor the transplant-free survival rate at day 21 (75 vs 86% differed between groups. Conversely, in the HBV-AIH subgroup, in which ALF was more severe, PR slope H0-H72 was higher in the ALF-5755 arm, the difference being significant in PP analysis (0.048±0.066 vs -0.040±0.099, p = 0.04; the median length of hospitalization was lower in the ALF-5755 group (8 vs 14 days, p = 0.02.ALF-5755 was not efficient in a ITT analysis performed on the whole sample; however it led to a significant, although moderate, clinical benefit in a PP analysis of the sub-group of patients with HBV or AIH related SAH. As HBV is the major cause of SAH in Asia and Africa and AIH a growing cause, this study emphasizes the need to pursuit the evaluation of this novel medical treatment of SAH.ClinicalTrials.gov NCT01318525.

  2. Five-day regimen of intramuscular or subcutaneous self-administered adrenocorticotropic hormone gel for acute exacerbations of multiple sclerosis: a prospective, randomized, open-label pilot trial

    Simsarian JP

    2011-07-01

    Full Text Available James P Simsarian, Carol Saunders, D Michelle SmithNeurology Center of Fairfax Ltd, Fairfax, VA, USABackground: Despite over 50 years of experience with adrenocorticotropic hormone (ACTH as a treatment for acute exacerbations of multiple sclerosis, there have been no trials examining the options of the 2–3-week dosing regimen or intramuscular injection protocol used in the original trials. At our clinic, we performed a small, prospective, randomized pilot study to examine the efficacy and safety of, and patient satisfaction with, a short (five-day self-administered ACTH dosing protocol for exacerbations of multiple sclerosis, and to compare the subcutaneous and intramuscular routes of administration.Methods: Patients for this study were recruited from an outpatient treatment clinic. Each patient self-administered natural ACTH gel 80 U/day by subcutaneous or intramuscular injection for five consecutive days and was evaluated at baseline and on days 7 and 14. Patient feedback was collected using the Patient Global Impression of Change (PGI-C, the primary efficacy measure, a patient global visual analog scale, the Expanded Disability Status Scale, a timed walk, the Nine-hole Peg Test, and the Clinical Global Impression of Change.Results: Of the 20 enrolled patients (mean age 39.5 years, 19 completed the study. On day 14, 61.1% of patients (11 of 18 with day 14 scores were treatment responders, and rated their condition as "very much improved" or "much improved" on the PGI-C. The intramuscular group had numerically more responders, but there was no significant difference in the proportion of responders between the intramuscular and subcutaneous groups at day 14 (P = 0.3. The intramuscular route of injection was associated with more injection site pain than the subcutaneous route.Conclusion: A shorter five-day course of intramuscular or subcutaneous ACTH gel may improve symptoms associated with acute exacerbations of multiple sclerosis. Larger

  3. Intravenous lysine clonixinate for the acute treatment of severe migraine attacks: a double-blind, randomized, placebo-controlled study☆

    Krymchantowski, Abouch Valenty; Silva, Marcus Tulius T

    2003-01-01

    Background Several nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to be effective in the treatment of migraine. However, few commercially available NSAIDs can be administered IV. Lysine clonixinate (LC), an NSAID derived from nicotinic acid, has been proved effective in various algesic syndromes (eg, renal colic, muscular pain, nerve compression, odontalgia). The oral formulation of LC has been shown to be effective in the treatment of migraine of moderate severity. Objective The aim of this study was to assess the efficacy and tolerability of the IV formulation of LC in the treatment of severe migraine. Methods This double-blind, randomized, placebo-controlled, prospective study enrolled patients with severe migraine (without aura) as defined by the criteria of the International Headache Society. When patients presented to a neurology hospital with an outpatient headache unit (Instituto de Neurologia Deolindo Couto, Rio de Janeiro, Brazil) with a severe migraine attack that had lasted <4 hours, they were randomized to 1 of 2 groups (IV placebo [25 mL of 0.9% saline] or IV LC [21 mL of 0.9% saline plus 4 mL of LC 200 mg]). Headache intensity and adverse effects (AEs) were assessed before (0 minute) and 30, 60, and 90 minutes after study drug administration. Rescue medication was available 2 hours after study drug administration, and its use was compared between groups. Results Thirty-two patients (23 women, 9 men; mean [SD] age, 32 [2] years; range, 18–58 years) entered the study. Twenty-nine patients (21 women, 8 men; mean [SD] age, 32 [2] years; range, 18–56 years) completed the study. Three patients (all in the placebo group) did not complete the study (1 patient was unable to rate the pain severity after drug administration and 2 patients refused IV drug administration). Among study completers, 17 patients received LC and 12 placebo. At 30 minutes, 1 patient (8.3%) in the placebo group and 5 patients (29.4%) in the LC group were pain free

  4. Chronic and acute effects of walnuts on antioxidant capacity and nutritional status in humans: a randomized, cross-over pilot study

    Lichtenstein Alice H

    2010-05-01

    Full Text Available Abstract Background Compared with other common plant foods, walnuts (Juglans regia are consistently ranked among the highest in antioxidant capacity. In vitro, walnut polyphenols inhibit plasma and LDL oxidation, while in animal models they lower biomarkers of oxidative stress and raise antioxidant capacity. A limited number of human feeding trials indicate that walnuts improve some measures of antioxidant status, but not others. Methods A 19 wk, randomized crossover trial was conducted in 21 generally healthy men and postmenopausal women ≥50 y to study the dose-response effects of walnut intake on biomarkers of antioxidant activity, oxidative stress, and nutrient status. Subjects were randomized to receive either 21 or 42 g raw walnuts/d during each 6 wk intervention phase with a 6 wk washout between phases. Subjects were instructed to consume their usual diet, but refrain from eating any other tree nuts, seeds, peanuts, or ellagitannin-rich foods during the entire study, and other polyphenol-rich foods for 2 d prior to each study visit. Results Compared to baseline levels, red blood cell (RBC linoleic acid and plasma pyridoxal phosphate (PLP were significantly higher after 6 wk with 42 g/d walnuts (P Conclusions Walnut consumption did not significantly change the plasma antioxidant capacity of healthy, well-nourished older adults in this pilot study. However, improvements in linoleic acid and pyridoxal phosphate were observed with chronic consumption, while total plasma thiols were enhanced acutely. Future studies investigating the antioxidant effects of walnuts in humans are warranted, but should include either a larger sample size or a controlled feeding intervention. Trial Registration ClinicalTrials.gov: NCT00626691

  5. Steroids Versus Steroids Plus Additional Agent in Frontline Treatment of Acute Graft-versus-Host Disease: A Systematic Review and Meta-Analysis of Randomized Trials.

    Rashidi, Armin; DiPersio, John F; Sandmaier, Brenda M; Colditz, Graham A; Weisdorf, Daniel J

    2016-06-01

    Despite extensive research in the last few decades, progress in treatment of acute graft-versus-host disease (aGVHD), a common complication of allogeneic hematopoietic cell transplantation (HCT), has been limited and steroids continue to be the standard frontline treatment. Randomized clinical trials (RCTs) have failed to find a beneficial effect of escalating immunosuppression using additional agents. Considering the small number of RCTs, limited sample sizes, and frequent early termination because of anticipated futility, we conducted a systematic review and an aggregate data meta-analysis to explore whether a true efficacy signal has been missed because of the limitations of individual RCTs. Seven reports met our inclusion criteria. The control arm in all studies was 2 mg/kg/day prednisone (or equivalent). The additional agent(s) used in the experimental arm(s) were higher-dose steroids, antithymocyte globulin, infliximab, anti-interleukin-2 receptor antibody (daclizumab and BT563), CD5-specific immunotoxin, and mycophenolate mofetil. Random effects meta-analysis revealed no efficacy signal in pooled response rates at various times points. Overall survival at 100 days was significantly worse in the experimental arm (relative risk [RR], .83; 95% confidence interval [CI], .74 to .94; P = .004, data from 3 studies) and showed a similar trend (albeit not statistically significantly) at 1 year as well (RR, .86; 95% CI, .68 to 1.09; P = .21, data from 5 studies). In conclusion, these results argue against the value of augmented generic immunosuppression beyond steroids for frontline treatment of aGVHD and emphasize the importance of developing alternative strategies. Novel forms of immunomodulation and targeted therapies against non-immune-related pathways may enhance the efficacy of steroids in this setting, and early predictive and prognostic biomarkers can help identify the subgroup of patients who would likely need treatments other than (or in addition to

  6. Early warning and prevention of pneumonia in acute leukemia by patient education, spirometry, and positive expiratory pressure: A randomized controlled trial.

    Møller, Tom; Moser, Claus; Adamsen, Lis; Rugaard, Grith; Jarden, Mary; Bøtcher, Tina S; Wiedenbein, Liza; Kjeldsen, Lars

    2016-03-01

    Long-lasting neutropenia associated with acute myeloid leukemia (AML) and its treatment gives rise to a high risk of pneumonia. The use of broad-spectrum antibiotic prophylaxis during outpatient management has not completely protected patients against admission due to infections and neutropenic fever, emphasizing the need to approach infection protection with complementary efforts. In a randomized controlled design, we examined the applicability of patient-performed daily spirometry [forced expiratory volume in one second (FEV1)] as an early warning tool and explored the effectiveness of positive expiratory pressure (PEP) in preventing pneumonia among 80 AML patients. Twenty-five incidences of pneumonia were detected among 23 patients (6 interventions, 17 controls), giving a prevalence of 28.75% during 5420 days of observation. We found a significant difference in incidence between intervention versus control group (2.17 per 1000 days vs. 6.52 per 1000 days, P = 0.021, respectively). A cross point at 80-76% of the personal FEV1 reference value showed high sensitivity and specificity on pneumonia development. Our data demonstrate the feasibility of educating AML patients in their continuous daily measurement of FEV1 and use of PEP. Daily measures of FEV1 may be an important early warning tool for assessment of pulmonary deterioration during critical phases of neutropenia. We suggest that strategic patient education in the use of spirometry and PEP should be part of standard of care for AML patients undergoing induction chemotherapy. PMID:26661344

  7. Effectiveness of mirror therapy on lower extremity motor recovery, balance and mobility in patients with acute stroke: A randomized sham-controlled pilot trial

    Uthra Mohan

    2013-01-01

    Full Text Available Objective: To evaluate the effectiveness of mirror therapy on lower extremity motor recovery, balance and mobility in patients with acute stroke. Design: A randomized, sham-controlled, assessor blinded, pilot trial. Setting: Inpatient stroke rehabilitation unit. Subjects: First time onset of stroke with mean post-stroke duration of 6.41 days, able to respond to verbal instructions, and Brunnstrom recovery stage 2 and above were enrolled. Intervention: Mirror therapy group performed 30 minutes of functional synergy movements of non-paretic lower extremity, whereas control group underwent sham therapy with similar duration. In addition, both groups were administered with conventional stroke rehabilitation regime. Altogether 90 minutes therapy session per day, six days a week, for two weeks duration was administered to both groups. Outcome Measures: Lower extremity motor subscale of Fugl Meyer Assessment (FMA, Brunnel Balance Assessment (BBA and Functional Ambulation Categories (FAC. Results: Amongst the 22 patients included, equal number of patients participated in mirror group (N = 11 and control group (N = 11. Baseline variables were similar in both groups, except for Brunnstrom recovery stage. There was no statistical difference between groups, except for FAC. (FMA: P = 0.894; BBA: P = 0.358; FAC: P = 0.02. Significance was set at P < 0.05. Conclusion: Administration of mirror therapy early after stroke is not superior to conventional treatment in improving lower limb motor recovery and balance, except for improvement in mobility.

  8. Retrowalking as an adjunct to conventional treatment versus conventional treatment alone on pain and disability in patients with acute exacerbation of chronic knee osteoarthritis: A randomized clinical trial

    Gauri Arun Gondhalekar

    2013-01-01

    Full Text Available Background: Increased external knee adduction moment during walking alters the joint biomechanics; which causes symptoms in chronic knee osteoarthritis patients. Aims: To assess additional effects of Retro-walking over conventional treatment on pain and disability in patients with acute exacerbation of chronic knee osteoarthritis. Materials and Methods: Thirty chronic knee osteoarthritis patients were randomly assigned into 2 groups. Group ′A′ (7 men, 8 women received conventional treatment. Group ′B′ (8 men, 7 women received conventional treatment and Retro-walking. Pain, assessed through visual analogue scale (VAS, and Western Ontario and McMaster Universities Arthritis Index (WOMAC were the primary outcomes and knee range of motion (ROM, hip abductor and extensor strength were secondary outcomes; measured pre-intervention, after 1 week and after 3 weeks of intervention. Results: Two factors analysis of variance for repeated measures was used for all outcomes. At the end of 3 weeks; WOMAC score showed highly significant difference within ( P < 0.0001 and significant difference between groups ( P = 0.040 also by Time × group interaction ( P = 0.024, VAS showed highly significant difference within groups ( P < 0.0001. Knee ROM showed significant difference within groups. Hip abductor and extensor strength showed significant difference by Time × group interaction ( P < 0.05. Conclusion: Retrowalking is an effective adjunct to conventional treatment in decreasing disability in patients with knee osteoarthritis.

  9. Severe acute respiratory failure managed with continuous positive airway pressure and partial extracorporeal carbon dioxide removal by an artificial membrane lung. A controlled, randomized animal study.

    Borelli, M; Kolobow, T; Spatola, R; Prato, P; Tsuno, K

    1988-12-01

    Using an animal model of acute respiratory failure (ARF), we evaluated two treatments: conventional mechanical pulmonary ventilation (MV) and continuous positive airway pressure (CPAP) with extracorporeal removal of CO2 by an artificial membrane lung. We developed a model of "mild" ARF and a model of "severe" ARF after ventilating healthy sheep at a peak inspiratory pressure of 50 cm H2O for various lengths of time. Sheep from either injury models were randomly assigned to one of the above treatment groups. All 16 sheep from the model with "severe" ARF died, with progressive deterioration in pulmonary function and multiorgan failure irrespective of the treatment. Of 11 sheep from the model with "mild" ARF treated by MV, only three survived, whereas all 11 sheep from the model with "mild" ARF treated with CPAP and extracorporeal removal of CO2 responded well, and nine sheep ultimately recovered. We conclude that CPAP with extracorporeal removal of CO2 provided a better environment for the recovery in our model with "mild" ARF than the conventional arrangement centered on MV alone. Our studies also suggest that lung injury can progress (i.e., model with "severe" ARF) to where neither of the two treatments can succeed. PMID:3144216

  10. Acute effects of violent video-game playing on blood pressure and appetite perception in normal-weight young men: a randomized controlled trial.

    Siervo, M; Sabatini, S; Fewtrell, M S; Wells, J C K

    2013-12-01

    Watching television and playing video game being seated represent sedentary behaviours and increase the risk of weight gain and hypertension. We investigated the acute effects of violent and non-violent video-game playing on blood pressure (BP), appetite perception and food preferences. Forty-eight young, normal-weight men (age: 23.1±1.9 years; body mass index: 22.5±1.9 kg/m(2)) participated in a three-arm, randomized trial. Subjects played a violent video game, a competitive, non-violent video game or watched TV for 1 h. Measurements of BP, stress and appetite perception were recorded before a standardized meal (∼300 kcal) and then repeated every 15 min throughout the intervention. Violent video-game playing was associated with a significant increase in diastolic BP (Δ±s.d.=+7.5±5.8 mm Hg; P=0.04) compared with the other two groups. Subjects playing violent video games felt less full (P=0.02) and reported a tendency towards sweet food consumption. Video games involving violence appear to be associated with significant effects on BP and appetite perceptions compared with non-violent gaming or watching TV. PMID:24084510

  11. Selection of Patients and Anesthetic Types for Endovascular Treatment in Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials.

    Fubing Ouyang

    Full Text Available and Purpose Recent randomized controlled trials have demonstrated consistent effectiveness of endovascular treatment (EVT for acute ischemic stroke, leading to update on stroke management guidelines. We conducted this meta-analysis to assess the efficacy and safety of EVT overall and in subgroups stratified by age, baseline stroke severity, brain imaging feature, and anesthetic type.Published randomized controlled trials comparing EVT and standard medical care alone were evaluated. The measured outcomes were 90-day functional independence (modified Rankin Scale ≤2, all-cause mortality, and symptomatic intracranial hemorrhage.Nine trials enrolling 2476 patients were included (1338 EVT, 1138 standard medical care alone. For patients with large vessel occlusions confirmed by noninvasive vessel imaging, EVT yielded improved functional outcome (pooled odds ratio [OR], 2.02; 95% confidence interval [CI], 1.64-2.50, lower mortality (OR, 0.75; 95% CI, 0.58-0.97, and similar symptomatic intracranial hemorrhage rate (OR, 1.12; 95% CI, 0.72-1.76 compared with standard medical care. A higher proportion of functional independence was seen in patients with terminus intracranial artery occlusion (±M1 (OR, 3.16; 95% CI, 1.64-6.06, baseline Alberta Stroke Program Early CT score of 8-10 (OR, 2.11; 95% CI, 1.25-3.57 and age ≤70 years (OR, 3.01; 95% CI, 1.73-5.24. EVT performed under conscious sedation had better functional outcomes (OR, 2.08; 95% CI, 1.47-2.96 without increased risk of symptomatic intracranial hemorrhage or short-term mortality compared with general anesthesia.Vessel-imaging proven large vessel occlusion, a favorable scan, and younger age are useful predictors to identify anterior circulation stroke patients who may benefit from EVT. Conscious sedation is feasible and safe in EVT based on available data. However, firm conclusion on the choice of anesthetic types should be drawn from more appropriate randomized controlled trials.

  12. Acute acquired comitant esotropia of childhood

    Hesgaard, Helena; Vinding, Troels

    2015-01-01

    : In all, 48 cases were recorded. The mean age at onset was 4.7 years, being significantly higher among children with intracranial disease. Seven cause-specific types of AACE in childhood were identified: The acute accommodative (n = 15, 31%), decompensated monofixation syndrome or esophoria (n = 13...... AACE and by review of literature, we identified seven cause-specific types of AACE. Intracranial disease was present in 6%, and four risk factors were identified to guide clinicians when to perform brain imaging. Findings suggest AACE of childhood to be differentiated from AACE of adulthood....

  13. Splanchnic and renal elimination and release of catecholamines in cirrhosis. Evidence of enhanced sympathetic nervous activity in patients with decompensated cirrhosis.

    Henriksen, J H; Ring-Larsen, H; I. L. Kanstrup; Christensen, N J

    1984-01-01

    Plasma noradrenaline (NA) and adrenaline (A) concentrations were determined in different vascular areas in 32 patients with cirrhosis and in nine controls during a right sided heart, liver, and renal vein catheterisation. The patients were divided into four groups: (I) Compensated (without ascites); (II) Recompensated on diuretic treatment because of former ascites; (III) Decompensated (with ascites) without treatment and (IV) Decompensated on diuretic treatment. Median arterial noradrenaline...

  14. Economic evaluation of the artificial liver support system MARS in patients with acute-on-chronic liver failure

    Hessel Franz P

    2006-01-01

    Abstract Background Acute-on-chronic liver failure (ACLF) is a life threatening acute decompensation of a pre-existing chronic liver disease. The artificial liver support system MARS is a new emerging therapeutic option possible to be implemented in routine care of these patients. The medical efficacy of MARS has been demonstrated in first clinical studies, but economic aspects have so far not been investigated. Objective of this study was to estimate the cost-effectiveness of MARS. Methods I...

  15. Safety and Efficacy of Qingre Buyi Decoction(清热补益煎剂)in the Treatment of Acute Radiation Proctitis:A Prospective,Randomized and Controlled Trial

    王烈; 张再重; 涂小煌; 邹忠东; 刘建华; 王瑜

    2009-01-01

    Objective:To investigate the efficiency,safety,and possible mechanisms of Qingre Buyi Decoction(清热补益煎剂,QBD)in the treatment of acute radiation proctitis(ARP).Methods:This study was a single center,prospective,single blind,randomized,and placebo-controlled clinical trial.A total of 60 patients with ARP was equally and randomly distributed into the control group(conventional treatment)and the combination group(conventional treatment plus QBD).The changes of main Chinese medicine clinical symptoms and signs...

  16. Efficacy of a respiratory rehabilitation exercise training package in hospitalized elderly patients with acute exacerbation of COPD: a randomized control trial

    Liao LY

    2015-08-01

    Full Text Available Lin-Yu Liao,1,2 Kuei-Min Chen,2 Wei-Sheng Chung,3 Jung-Yien Chien4 1Department of Nursing, Chest Hospital, Ministry of Health and Welfare, Rende District, Tainan, 2College of Nursing, Kaohsiung Medical University, Sanmin District, Kaohsiung, 3Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, 4Department of Medicine, Chest Hospital, Ministry of Health and Welfare, Rende District, Tainan, Taiwan Clinical trials identifier: NCT02329873 Background: Acute exacerbation (AE of COPD is characterized by a sudden worsening of COPD symptoms. Previous studies have explored the effectiveness of respiratory rehabilitation for patients with COPD; however, no training program specific to acute exacerbation in elderly patients or unstable periods during hospitalization has been developed.Objective: To evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum expectoration among hospitalized elderly patients with AECOPD.Methods: A randomized control trial was conducted. Pretest and posttest evaluations of 61 elderly inpatients with AECOPD (experimental group n=30; control group n=31 were performed. The experimental group received respiratory rehabilitation exercise training twice a day, 10–30 minutes per session for 4 days. The clinical parameters (dyspnea, cough, exercise tolerance, and sputum expectoration were assessed at the baseline and at the end of the fourth day.Results: All participants (median age =70 years, male =60.70%, and peak expiratory flow 140 L completed the study. In the patients of the experimental group, dyspnea and cough decreased and exercise tolerance and sputum expectoration increased significantly compared with those of the patients in the control group (all P<0.05. Within-group comparisons revealed that the dyspnea, cough, and exercise tolerance significantly improved in the experimental group by the end of the fourth

  17. Role of albumin in diseases associated with severe systemic inflammation: Pathophysiologic and clinical evidence in sepsis and in decompensated cirrhosis.

    Artigas, Antonio; Wernerman, Jan; Arroyo, Vicente; Vincent, Jean-Louis; Levy, Mitchell

    2016-06-01

    The metabolism of albumin in inflammatory states such as sepsis or major surgery is complex and still not well characterized. Nevertheless, in inflammatory states, albumin synthesis has been observed to increase. By contrast, in decompensated cirrhosis, a disease characterized by systemic inflammation, albumin synthesis by the liver may decrease to 30% to 50% of normal values. Furthermore, in these conditions, there are high capillary leakage and altered albumin kinetics. The discussion regarding the effect of exogenous albumin administration on intravascular volume in inflammatory states should therefore address albumin turnover. To add complexity to our understanding of the effects of albumin, there are many data indicating that the therapeutic action of albumin is mediated not only through the impact on plasma volume expansion but also through a modulatory effect on inflammation and oxidative stress. All these characteristics are relevant to diseases associated with systemic inflammation including sepsis and decompensated cirrhosis. PMID:26831575

  18. Safety and Efficacy of Low-osmolarity ORS vs. Modified Rehydration Solution for Malnourished Children for Treatment of Children with Severe Acute Malnutrition and Diarrhea: A Randomized Controlled Trial.

    Kumar, Ruchika; Kumar, Praveen; Aneja, S; Kumar, Virendra; Rehan, Harmeet S

    2015-12-01

    World Health Organization-recommended rehydration solution for malnourished children (ReSoMal) for rehydrating severe acute malnourished children is not available in India. In present study, 110 consecutive children aged 6-59 months with severely acute malnourishment and acute diarrhea were randomized to low-osmolarity oral rehydration solution (ORS) (osmolarity: 245, sodium: 75) with added potassium (20 mmol/l) or modified ReSoMal (osmolarity: 300, sodium: 45). In all, 15.4% of modified ReSoMal group developed hyponatremia as compared with 1.9% in low-osmolarity ORS, but none developed severe hyponatremia or hypernatremia. Both groups had equal number of successful rehydration (52 each). Both types of ORS were effective in correcting hypokalemia and dehydration, but rehydration was achieved in shorter duration with modified ReSoMal. PMID:26314308

  19. [Economic aspects of inpatient treatment for decompensated liver cirrhosis: a prospective study employing an evidence-based clinical pathway].

    Hahn, N; Bobrowski, C; Weber, E; Simon, P; Kraft, M; Aghdassi, A; Raetzell, M; Wilke, M; Lerch, M M; Mayerle, J

    2013-03-01

    The introduction of the G-DRG reimbursement system has greatly increased the pressure to provide cost effective treatment in German hospitals. Reimbursement based on diagnosis-related groups, which requires stratification of costs incurred is still not sufficiently discriminating the disease severity and severity in relation to the intensive costs in gastroenterology. In a combined retrospective and prospective study at a tertial referral centre we investigated whether this also applies for decompensated liver cirrhosis. In 2006, 64 retrospective cases (age 57 ± 12.9; ♂ 69.2 %, ♀ 29.8 %) with decompensated liver cirrhosis (ICD code K76.4) were evaluated for their length of hospitalisation, reimbursement as well as Child and MELD scores. In 2008, 74 cases with decompensated liver cirrhosis were treated in a prospective study according to a standardised and evidence-based clinical pathway (age 57 ± 12.2; 73 % ♂, ♀ 27 %). Besides a trend in the reduction of length of hospital stay (retrospective: 13.6 ± 8.6, prospective 13.0 ± 7.2, p = 0.85) overall revenues from patients treated according to a evidence-based clinical pathway were lower than the calculated costs from the InEK matrix. Costs of medication as a percentage of reimbursement amount increased with increasing severity. In both years we could demonstrate an inverse correlation between daily reimbursement and disease severity which precluded cost coverage. For the cost-covering hospital treatment of patients with decompensated liver cirrhosis an adjustment of the DRG based on clinical severity scores such as Child-Pugh or MELD is warranted, if evidence-based treatment standards are to be kept. PMID:23299901

  20. Modeling the effectiveness of nebulized terbutaline for decompensated chronic obstructive pulmonary disease patients in the emergency department.

    Gueho, Florian; Beaune, Sébastien; Devillier, Philippe; Urien, Saik; Faisy, Christophe

    2016-08-01

    Short-acting β2-agonists (SABA) are widely used in the emergency department (ED) to treat patients with decompensated chronic obstructive pulmonary disease (COPD). We sought to model the effectiveness of nebulized SABA (terbutaline) on clinically relevant parameters associated with a reduction in work of breathing or respiratory muscle fatigue in decompensated COPD patients admitted to the ED.Forty consecutive decompensated COPD patients (having received at least one dose of nebulized terbutaline during their stay in the ED) were included in an observational cohort study. The terbutaline dose received at time t was expressed as cumulative dose and as a rate (mg/day). The associations between the terbutaline dose and time-dependent outcome parameters (respiratory rate, heart rate, arterial blood gases, and, as a marker of terbutaline's systemic effect, serum potassium) were analyzed using a nonlinear, mixed-effects model. The effect of various covariates influencing terbutaline's effectiveness (baseline characteristics and concomitant treatments) was assessed on the model.Among the investigated patients, a total of 377 time-dependent observations were available for analysis. Neither the cumulative dose nor the dose rate at time t significantly influenced the arterial blood gas parameters or heart rate. The cumulative dose of terbutaline was associated with a lower serum potassium level (P rate of terbutaline.Overall, the results of our modeling study strongly suggest that terbutaline dose did not influence time-dependent outcomes other than serum potassium, and thus call into question the systematic administration of inhaled SABA to patients admitted to the ED for decompensated COPD. PMID:27512880

  1. Effectiveness, safety and tolerability of a complex homeopathic medicinal product in the prevention of recurrent acute upper respiratory tract infections in children: a multicenter, open, comparative, randomized, controlled clinical trial

    Jong, Miek C.; Buskin, Stephen L.; Ilyenko, Lydia; Kholodova, Irina; Burkart, Julia; Weber, Stephan; Keller, Thomas; Klement, Petra

    2016-01-01

    Background The present study was initiated to investigate the effectiveness, safety and tolerability of complex homeopathic CalSuli-4-02 tablets on prevention of recurrent acute upper respiratory tract infections (URTIs) in children, in comparison to another complex homeopathic product. Methods The study was designed as a prospective, multicenter, randomized, open, clinical trial with two parallel treatment groups at four outpatient pediatric clinics in Russia. Children aged ≤ 6 years with su...

  2. Stem cell mobilization induced by subcutaneous granulocyte-colony stimulating factor to improve cardiac regeneration after acute ST-elevation myocardial infarction: result of the double-blind, randomized, placebo-controlled stem cells in myocardial infarction (STEMMI) trial

    Ripa, Rasmus Sejersten; Jørgensen, Erik; Wang, Yongzhong;

    2006-01-01

    BACKGROUND: Phase 1 clinical trials of granulocyte-colony stimulating factor (G-CSF) treatment after myocardial infarction have indicated that G-CSF treatment is safe and may improve left ventricular function. This randomized, double-blind, placebo-controlled trial aimed to assess the efficacy of......: Bone marrow stem cell mobilization with subcutaneous G-CSF is safe but did not lead to further improvement in ventricular function after acute myocardial infarction compared with the recovery observed in the placebo group....

  3. Effects of Korean White Ginseng (Panax Ginseng C.A. Meyer) on Vascular and Glycemic Health in Type 2 Diabetes: Results of a Randomized, Double Blind, Placebo-controlled, Multiple-crossover, Acute Dose Escalation Trial

    Shishtar, Esra'; Jovanovski, Elena; Jenkins, Alexandra; Vuksan, Vladimir

    2014-01-01

    Korean red ginseng (steam treated Panax ginseng C.A. Meyer), among most prized traditional herbal remedies, has been clinically shown to improve cardiovascular disease (CVD) risk factors. Whether this holds true for the dried non-steamed variety, known as Korean white ginseng (KWG) is unclear. This study therefore, investigated the efficacy and safety of escalating doses of KWG on vascular and glycemic parameters in type 2 diabetes (T2DM). Using an acute, randomized, placebo-controlled, doubl...

  4. Improved outcome with pulses of vincristine and corticosteroids in continuation therapy of children with average risk acute lymphoblastic leukemia (ALL) and lymphoblastic non-Hodgkin lymphoma (NHL): report of the EORTC randomized phase 3 trial 58951

    De Moerloose, Barbara; Suciu, Stefan; Bertrand, Yves; Mazingue, Françoise; Robert, Alain; Uyttebroeck, Anne; Yakouben, Karima; Ferster, Alice; Margueritte, Geneviève; Lutz, Patrick; Munzer, Martine; Sirvent, Nicolas; Norton, Lucilia; Boutard, Patrick; Plantaz, Dominique

    2010-01-01

    The European Organisation for Research and Treatment of Cancer 58951 trial for children with acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL) addressed 3 randomized questions, including the evaluation of dexamethasone (DEX) versus prednisolone (PRED) in induction and, for average-risk patients, the evaluation of vincristine and corticosteroid pulses during continuation therapy. The corticosteroid used in the pulses was that assigned at induction. Overall, 411 patients were ran...

  5. Consumption of red-hot chili pepper increases symptoms in patients with acute anal fissures. A prospective, randomized, placebo-controlled, double blind, crossover trial Efeito da pimenta vermelha nos sintomas de pacientes com fissuras anais agudas

    Pravin J. Gupta

    2008-01-01

    BACKGROUND: Red-hot chili pepper and other spices have been blamed for causing or exacerbating symptoms of anal pathologies like anal fissure and hemorrhoids. AIM: To determine if consumption of chilies increases symptoms of acute anal fissures. METHODS: Individual patients were randomized to receive capsules containing chili or placebo for one week in addition to analgesics and fiber supplement. Patients were asked to note score for symptoms like pain, anal burning, and pruritus during the s...

  6. Probiotics in the treatment of acute rotavirus diarrhoea. A randomized, double-blind, controlled trial using two different probiotic preparations in Bolivian children

    Grandy Giuseppe

    2010-08-01

    Full Text Available Abstract Background Evidence suggests that probiotics reduce rotavirus diarrhoea duration. Although there are several probiotic strains potentially useful, daily practice is often limited by the type and number of products locally available. In general, information about combined products is scarce. In this study we compare the effect of two probiotic products in the treatment of diarrhoea in children less than 2 years of age. Methods A Randomized double-blind controlled clinical trial in children hospitalized for acute rotavirus diarrhoea, in the Paediatric Centre Albina Patino, Cochabamba, Bolivia. Participants were children aged 1 - 23 months, who were randomly assigned to receive one of three treatments: Oral rehydration therapy plus placebo; Oral rehydration solution plus Saccharomyces boulardii; or Oral rehydration solution plus a compound containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii. Sample size was 20 per group and the outcomes were duration of diarrhoea, of fever, of vomiting and of hospitalization. Results 64 cases finished the protocol. On admission, patients' characteristics were similar. Median duration of diarrhoea (p = 0.04 in children who received the single species product (58 hours was shorter than in controls (84.5 hrs. Comparing children that received the single probiotic product and controls showed shorter duration of fever (18 vs 67 hrs (p = 0.0042 and the mixed probiotic of vomiting (0 vs 42.5 hrs (p = 0.041. There was no effect on duration of hospitalization (p = 0.31. When experimental groups were merged, statistical significance of changes increased (total duration of diarrhoea, fever and vomiting P = 0.025, P = 0.025 and P = 0.014, respectively. Conclusions Both products decreased the duration of diarrhoea compared to oral rehydration solution alone. This decrease was significant only for the single species product which also decreased the duration of

  7. An organic khorasan wheat-based replacement diet improves risk profile of patients with acute coronary syndrome: a randomized crossover trial.

    Whittaker, Anne; Sofi, Francesco; Luisi, Maria Luisa Eliana; Rafanelli, Elena; Fiorillo, Claudia; Becatti, Matteo; Abbate, Rosanna; Casini, Alessandro; Gensini, Gian Franco; Benedettelli, Stefano

    2015-05-01

    Khorasan wheat is an ancient grain with previously reported health benefits in clinically healthy subjects. The aim of this study was to examine whether a replacement diet, thereby substituting all other cereal grains, with products made with organic khorasan wheat could provide additive protective effects in reducing lipid, oxidative and inflammatory risk factors, in patients with Acute Coronary Syndromes (ACS) in comparison to a similar replacement diet using products made from organic modern wheat. A randomized double-blinded crossover trial with two intervention phases was conducted on 22 ACS patients (9 F; 13 M). The patients were assigned to consume products (bread, pasta, biscuits and crackers) made either from organic semi-whole khorasan wheat or organic semi-whole control wheat for eight weeks in a random order. On average, patients ingested 62.0 g dry weight (DW) day-1 khorasan or control semolina; and 140.5 g DW day-1 khorasan or control flour, respectively. An eight-week washout period was implemented between the respective interventions. Blood analyses were performed both at the beginning and end of each intervention phase; thereby permitting a comparison of both the khorasan and control intervention phases, respectively, on circulatory risk factors for the same patient. Consumption of products made with khorasan wheat resulted in a significant amelioration in total cholesterol (-6.8%), low-density lipoprotein cholesterol (LDL-C) (-8.1%) glucose (-8%) and insulin (-24.6%) from baseline levels, independently of age, sex, traditional risk factors, medication and diet quality. Moreover, there was a significant reduction in reactive oxygen species (ROS), lipoperoxidation of circulating monocytes and lymphocytes, as well as in the levels of Tumor Necrosis Factor-alpha. No significant differences from baseline in the same patients were observed after the conventional control wheat intervention phase. The present results suggest that a replacement diet with

  8. An Organic Khorasan Wheat-Based Replacement Diet Improves Risk Profile of Patients with Acute Coronary Syndrome: A Randomized Crossover Trial

    Anne Whittaker

    2015-05-01

    Full Text Available Khorasan wheat is an ancient grain with previously reported health benefits in clinically healthy subjects. The aim of this study was to examine whether a replacement diet, thereby substituting all other cereal grains, with products made with organic khorasan wheat could provide additive protective effects in reducing lipid, oxidative and inflammatory risk factors, in patients with Acute Coronary Syndromes (ACS in comparison to a similar replacement diet using products made from organic modern wheat. A randomized double-blinded crossover trial with two intervention phases was conducted on 22 ACS patients (9 F; 13 M. The patients were assigned to consume products (bread, pasta, biscuits and crackers made either from organic semi-whole khorasan wheat or organic semi-whole control wheat for eight weeks in a random order. On average, patients ingested 62.0 g dry weight (DW day−1 khorasan or control semolina; and 140.5 g DW day−1 khorasan or control flour, respectively. An eight-week washout period was implemented between the respective interventions. Blood analyses were performed both at the beginning and end of each intervention phase; thereby permitting a comparison of both the khorasan and control intervention phases, respectively, on circulatory risk factors for the same patient. Consumption of products made with khorasan wheat resulted in a significant amelioration in total cholesterol (−6.8%, low-density lipoprotein cholesterol (LDL-C (−8.1% glucose (−8% and insulin (−24.6% from baseline levels, independently of age, sex, traditional risk factors, medication and diet quality. Moreover, there was a significant reduction in reactive oxygen species (ROS, lipoperoxidation of circulating monocytes and lymphocytes, as well as in the levels of Tumor Necrosis Factor-alpha. No significant differences from baseline in the same patients were observed after the conventional control wheat intervention phase. The present results suggest that a

  9. Early use of non-invasive positive pressure ventilation for acute exacerbations of chronic obstructive pulmonary disease: a multicentre randomized controlled trial

    Collaborative Research Group of Noninvasive Mechan

    2005-01-01

    Background Respiratory muscle fatigue plays an important role in acute exacerbations of chronic obstructive pulmonary disease (AECOPD). In previous clinical studies, non-invasive positive pressure ventilation (NPPV) was proved to be successful only for AECOPD patients with severe respiratory failure. We hypothesized that, the outcomes of AECOPD would be improved if NPPV is early (within 24 to 48 hours of admission) administered in those patients with respiratory muscle fatigue and mild respiratory insufficiency, especially in patients without fulfilling the conventional criteria of mechanical ventilatory support. Methods A prospective multicentre randomized controlled trial was conducted in 19 hospitals in China over 16 months. Three hundred and forty-two AECOPD patients with pH≥7.25 and PaCO2>45 mmHg were recruited on general ward and randomly assigned to standard medical treatment (control group) or early administration of additional NPPV (NPPV group).Results The characteristics of two groups on admission were similar. The number of AECOPD patients requiring intubations in NPPV group was much fewer than that of the control group (8/171 vs 26/71, P=0.002). Subgroup analysis showed the needs for intubation in mildly (pH≥7.35) and severe (pH<7.30) acidotic patients in NPPV group were both decreased (9/80 vs 2/71, P=0.047 and 8/30 vs 3/43, P=0.048, respectively). The mortality in hospital was reduced slightly by NPPV but with no significant difference (7/171 vs 12/171, P=0.345). Respiratory rate (RR),scale for accessory muscle use and arterial pH improved rapidly at the first 2 hours only in patients of NPPV group. After 24 hours, the differences of pH, PaO2, scale for accessory muscle use and RR in NPPV group [(7.36±0.06) mmHg, (72±22) mmHg, (2.5±0.9)/min, (22±4)/min] were statistically significant compared with control group (7.37±0.05) mmHg, (85±34) mmHg, (2.3±1.1)/min, (21±4)/min, P<0.01 for all comparisons].Conclusions The early use of NPPV on

  10. Clinical efficacy and safety of recruitment maneuver in patients with acute respiratory distress syndrome using low tidal volume ventilation: a multicenter randomized controlled clinical trial

    XI Xiu-ming; JIANG Li; ZHU Bo; the RM group

    2010-01-01

    Background The recruitment maneuver (RM) has been shown to improve oxygenation in some patients with acute respiratory distress syndrome. But there is a lack of standardization and lack of clinical studies to prove the improvement on clinical outcome. We conducted this study to evaluate the clinical efficacy and safety of the RM in patients with acute respiratory distress syndrome (ARDS) using Iow tidal volume ventilation.Methods We randomly assigned 110 patients with ARDS from 14 Chinese intensive care units (ICUs) at the tertiary teaching hospitals. Patients with PaO2 ≤200 mmHg at FiO2 1.0 and PEEP ≥10 cmH2O were included in the study.Patients were randomized into two groups: control group and RM group. The tidal volume was set to 6-8 mi per kilogram of predicted body weight (PBW) in both groups. RM was performed by continuous positive airway pressure (CPAP) of 40 cmH2O maintained for 40 seconds. RMs was conducted every eight hours for the first five days, or stopped within five days if the patient reached the weaning standard.Results One hundred and ten patients had completed the requirements for the primary study goals, 55 from the RM group and 55 control patients. Baseline characteristics remained similar in the two groups. In the RM group the PaO2/FiO2 was significantly increased compared to baseline at 120 minutes after RM on day one and day two (P=0.007and P=0.001). There were no significant differences between the RM and control group in hospital mortality (41.8% vs.56.4%, P=0.13), 28-day mortality (29.1% vs. 43.6%, P=0.11) and ventilator-free days at day 28 (10.8±10.1 vs. 7.4±10.0,P=0.08). ICU mortality (32.7% vs. 52.7%, P=0.03), the rate of survival with unassisted breathing for at least 48 consecutive hours at day 28 (58.2% vs. 36.2%, P=0.02), and nonpulmonary organ failure-free days at day 28 (17.4±11.1vs. 13.0±12.0, P=0.03) favored the RM group. There was no significant difference in mean blood pressure and heart rate before RM and at 30, 60

  11. A randomized, 4-week double-blind placebo control study on the efficacy of donepezil augmentation of lithium for treatment of acute mania

    Chen J

    2013-06-01

    Full Text Available Jing Chen,1 Zheng Lu,1,2 Mingyuan Zhang,1 Jie Zhang,1 Xiaodong Ni,1 Xuefeng Jiang,1 Heding Xu,1 Anisha Heeramun-Aubeeluck,2 Qiaoyan Hu,3 Hua Jin,4 John M Davis31Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of China; 2Department of Psychiatry, Tongji Hospital of Tongji University, Shanghai, People’s Republic of China; 3University of Illinois at Chicago, Chicago, IL, USA; 4University of California at San Diego, San Diego, CA, USAIntroduction: A significant number of mania patients fail to respond to current pharmacotherapy, thereby there is need for novel augmentation strategies. The results of some early studies showed the effectiveness of cholinomimetics in the treatment of mania. One open case series suggested the efficacy of donepezil in the treatment of bipolar disorder. Our aim was to explore whether an oral cholinesterase inhibitor, donepezil, administered during a 4-week treatment period,would benefit patients with acute mania.Methods: We conducted a 4-week double-blind, placebo-controlled trial of donepezil as an adjunctive treatment to lithium in patients with acute mania. Eligible subjects were randomly assigned to receive donepezil or placebo in addition to lithium. Donepezil was started at 5 mg/day, and increased to 10 mg/day in the first week. Patients were rated with the Young Mania Rating Scale (YMRS and Brief Psychiatric Rating Scale (BPRS at baseline, day 1, week 1, week 2, and week 4.Results: Out of the 30 patients who were enrolled, 15 were on donepezil and 15 were on placebo. All patients completed the 4-week trial. On the first day, there was a difference of 1.97 units on the psychomotor symptoms scale of the YMRS in the donepezil group as compared to the placebo group (t = 2.39, P = 0.02. There was a difference of 0.57 units (t = 2.09, P = 0.04 in the speech item and a difference of 0.29 units in the sexual interest item (t = 2.11, P = 0.04 in the donepezil

  12. Oral hydration for prevention of contrast-induced acute kidney injury in elective radiological procedures: A systematic review and meta-analysis of randomized controlled trials

    Wisit Cheungpasitporn

    2014-01-01

    Full Text Available Background: The reports on efficacy of oral hydration treatment for the prevention of contrast-induced acute kidney injury (CIAKI in elective radiological procedures and cardiac catheterization remain controversial. Aims: The objective of this meta-analysis was to assess the use of oral hydration regimen for prevention of CIAKI. Materials and Methods: Comprehensive literature searches for randomized controlled trials (RCTs of outpatient oral hydration treatment was performed using MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials Systematic Reviews, and clinicaltrials.gov from inception until July 4 th , 2014. Primary outcome was the incidence of CIAKI. Results: Six prospective RCTs were included in our analysis. Of 513patients undergoing elective procedures with contrast exposures,45 patients (8.8% had CIAKI. Of 241 patients with oral hydration regimen, 23 (9.5% developed CIAKI. Of 272 patients with intravenous (IV fluid regimen, 22 (8.1% had CIAKI. Study populations in all included studies had relatively normal kidney function to chronic kidney disease (CKD stage 3. There was no significant increased risk of CIAKI in oral fluid regimen group compared toIV fluid regimen group (RR = 0.94, 95% confidence interval, CI = 0.38-2.31. Conclusions: According to our analysis,there is no evidence that oral fluid regimen is associated with more risk of CIAKI in patients undergoing elective procedures with contrast exposures compared to IV fluid regimen.This finding suggests that the oral fluid regimen might be considered as a possible outpatient treatment option for CIAKI prevention in patients with normal to moderately reduced kidney function.

  13. Gemifloxacin for the treatment of community-acquired pneumonia and acute exacerbation of chronic bronchitis: a meta-analysis of randomized controlled trials

    ZHANG Lei; WANG Rui; Falagas E. Matthew; CHEN Liang-an; LIU You-ning

    2012-01-01

    Background Gemifloxacin is a fluoroquinolone antibiotic with broad spectrum of antibacterial activity.The aim of the study was to evaluate the comparative effectiveness and safety of gemifloxacin for the treatment of patients with community-acquired pneumonia (CAP) or acute exacerbation of chronic bronchitis (AECB).Methods We performed a meta-analysis of randomized controlled trials (RCTs) comparing gemifloxacin with other approved antibiotics.The PubMed,EMBASE,Chinese Biomedical Literature Database and the Cochrane Central Register of Controlled Trials were searched,with no language restrictions.Results Ten RCTs,comparing gemifloxacin with other quinolones (in 5 RCTs) and β-lactams and/or macrolides (in 5 RCTs),involving 3940 patients,were included in this meta-analysis.Overall,the treatment success was higher for gemifloxacin when compared with other antibiotics (odds ratio 1.39,95% confidence interval 1.15-1.68 in intention-to-treat patients,and 1.33,1.02-1.73 in clinically evaluable patients).There was no significant difference between the compared antibiotics regarding microbiological success (1.19,0.84-1.68) or all-cause mortality (0.82,0.41-1.63).The total drug related adverse events were similar for gemifloxacin when compared with other quinolones (0.89,0.56-1.41),while lower when compared with β-lactams and/or macrolides (0.71,0.57-0.89).In subgroup analyses,administration of gemifloxacin was associated with fewer cases of diarrhoea and more rashes compared with other antibiotics (0.66,0.48-0.91,and 2.36,1.18-4.74,respectively).Conclusions The available evidence suggests that gemifloxacin 320 mg oral daily is equivalent or superior to other approved antibiotics in effectiveness and safety for CAP and AECB.The development of rash represents potential limitation of gemifloxacin.

  14. Treatment of acute radiodermatitis with an oil-in-water emulsion following radiation therapy for breast cancer. A controlled, randomized trial

    A side effect of radiotherapy for breast cancer is acute radiodermatitis. It is a common practice to keep irradiated skin dry on account of data from the 1950s that suggested this regimen limits dermatitis. However, severe dryness of the skin induced by irradiation results in itching and discomfort. Dry skin is characterized by scaliness, epidermal barrier dysfunction, and reduced stratum corneum hydration, and these signs and symptoms are reduced by treatment with an emulsion. We performed a randomized, controlled, open-label study with 66 patients (ITT population), treating the irradiated skin in one group (n = 34) with an oil-in-water emulsion (WO1932), while leaving the other group untreated (n = 32). Clinical scoring (ONS radiation skin reaction scoring, pruritus) and biophysical measurements (stratum corneum hydration and transepidermal water loss (TEWL), as a marker of skin barrier function) were determined at day 1 (directly after termination of the radiation therapy), day 8, and day 47 (± 7). Irradiation increased the ONS score and pruritus, whereas skin hydration and TEWL were reduced. The primary hypothesis that the increase in skin hydration was significantly greater in the emulsion-treated compared to the untreated group as early as after 8 days of treatment could not be confirmed. At the end of the study (day 47 ± 7), however, normalization of stratum corneum hydration was more advanced in the treatment group compared to the untreated group and nearly reached the values of the contralateral healthy breast skin. ONS score and pruritus also revealed an advantage for the emulsion-treated group. TEWL did not show significant changes during emulsion treatment. No adverse events were caused by the treatment regimens. Treatment of radiodermatitis with an oil-in-water emulsion was well tolerated, enhanced stratum corneum hydration, improved clinical indicators, and provided relief from itching. (orig.)

  15. Comparing etoricoxib and celecoxib for preemptive analgesia for acute postoperative pain in patients undergoing arthroscopic anterior cruciate ligament reconstruction: a randomized controlled trial

    Glabglay Prapakorn

    2010-10-01

    Full Text Available Abstract Background The efficacy of selective cox-2 inhibitors in postoperative pain reduction were usually compared with conventional non-selective conventional NSAIDs or other types of medicine. Previous studies also used selective cox-2 inhibitors as single postoperative dose, in continued mode, or in combination with other modalities. The purpose of this study was to compare analgesic efficacy of single preoperative administration of etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior cruciate ligament reconstruction. Methods One hundred and two patients diagnosed as anterior cruciate ligament injury were randomized into 3 groups using opaque envelope. Both patients and surgeon were blinded to the allocation. All of the patients were operated by one orthopaedic surgeon under regional anesthesia. Each group was given either etoricoxib 120 mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain intensity, time to first dose of analgesic requirement and numbers of analgesic used for pain control and adverse events were recorded periodically to 48 hours after surgery. We analyzed the data according to intention to treat principle. Results Among 102 patients, 35 were in etoricoxib, 35 in celecoxib and 32 in placebo group. The mean age of the patients was 30 years and most of the injury came from sports injury. There were no significant differences in all demographic characteristics among groups. The etoricoxib group had significantly less pain intensity than the other two groups at recovery room and up to 8 hours period but no significance difference in all other evaluation point, while celecoxib showed no significantly difference from placebo at any time points. The time to first dose of analgesic medication, amount of analgesic used, patient's satisfaction with pain control and incidence of adverse events were also no significantly difference among three groups. Conclusions

  16. Impact of physical activity on energy balance, food intake and choice in normal weight and obese children in the setting of acute social stress: a randomized controlled trial

    Horsch A.; Wobmann M.; Kriemler S.; Munsch S.; Borloz S.; Balz A.; Marques-Vidal P.; Borghini A.; Puder J. J.

    2015-01-01

    BACKGROUND: Psychological stress negatively influences food intake and food choices, thereby contributing to the development of childhood obesity. Physical activity can also moderate eating behavior and influence calorie intake. However, it is unknown if acute physical activity influences food intake and overall energy balance after acute stress exposure in children. We therefore investigated the impact of acute physical activity on overall energy balance (food intake minus energy expenditure...

  17. A Signal Processing Approach for Detection of Hemodynamic Instability before Decompensation.

    Belle, Ashwin; Ansari, Sardar; Spadafore, Maxwell; Convertino, Victor A; Ward, Kevin R; Derksen, Harm; Najarian, Kayvan

    2016-01-01

    Advanced hemodynamic monitoring is a critical component of treatment in clinical situations where aggressive yet guided hemodynamic interventions are required in order to stabilize the patient and optimize outcomes. While there are many tools at a physician's disposal to monitor patients in a hospital setting, the reality is that none of these tools allow hi-fidelity assessment or continuous monitoring towards early detection of hemodynamic instability. We present an advanced automated analytical system which would act as a continuous monitoring and early warning mechanism that can indicate pending decompensation before traditional metrics can identify any clinical abnormality. This system computes novel features or bio-markers from both heart rate variability (HRV) as well as the morphology of the electrocardiogram (ECG). To compare their effectiveness, these features are compared with the standard HRV based bio-markers which are commonly used for hemodynamic assessment. This study utilized a unique database containing ECG waveforms from healthy volunteer subjects who underwent simulated hypovolemia under controlled experimental settings. A support vector machine was utilized to develop a model which predicts the stability or instability of the subjects. Results showed that the proposed novel set of features outperforms the traditional HRV features in predicting hemodynamic instability. PMID:26871715

  18. [Use of topical non-steroidal anti-inflammatory drugs in aggravated and decompensated arthroses].

    Chlud, K

    1999-01-01

    Pain in osteoarthritis of the big weight bearing joints is either derived from periarticular ligaments, tendons, fascias, muscles, bursae--periarthropathy as sign of decompensation or from the reactive synovitis with or without effusion. NSAIDs (ibuprofen, diclofenac, indometacin, some salicylates, etofenamate and piroxicam) have demonstrated relevant advantages of the percutaneous route over the systemic one in soft tissue rheumatism. NSAIDs, mentioned above, locally administered as cream, gel or spray, quickly penetrate through the corneal layer of the skin and the site of application, reach highly effective concentrations in subcutis, fascias, tendons, ligaments and muscles, less in joint-capsule and -fluid indicating direct penetration. The blood levels of topical NSAIDs are extremely low with no systemic side effects, especially no gastric toxicity; however, local skin irritation is observed (1 to 2%). In contrast to this, systemic (oral) NSAIDs lead primarily via high blood levels to a lower concentration--only one tenth--in periarticular soft tissues with a high incidence of side effects. In conclusion the percutaneous application of certain NSAIDs has become a well established therapeutic regimen in painful osteoarthritis and in all other inflammatory degenerative and posttraumatic alterations of soft tissue structure. PMID:10637963

  19. A Signal Processing Approach for Detection of Hemodynamic Instability before Decompensation

    Belle, Ashwin; Ansari, Sardar; Spadafore, Maxwell; Convertino, Victor A.; Ward, Kevin R.; Derksen, Harm; Najarian, Kayvan

    2016-01-01

    Advanced hemodynamic monitoring is a critical component of treatment in clinical situations where aggressive yet guided hemodynamic interventions are required in order to stabilize the patient and optimize outcomes. While there are many tools at a physician’s disposal to monitor patients in a hospital setting, the reality is that none of these tools allow hi-fidelity assessment or continuous monitoring towards early detection of hemodynamic instability. We present an advanced automated analytical system which would act as a continuous monitoring and early warning mechanism that can indicate pending decompensation before traditional metrics can identify any clinical abnormality. This system computes novel features or bio-markers from both heart rate variability (HRV) as well as the morphology of the electrocardiogram (ECG). To compare their effectiveness, these features are compared with the standard HRV based bio-markers which are commonly used for hemodynamic assessment. This study utilized a unique database containing ECG waveforms from healthy volunteer subjects who underwent simulated hypovolemia under controlled experimental settings. A support vector machine was utilized to develop a model which predicts the stability or instability of the subjects. Results showed that the proposed novel set of features outperforms the traditional HRV features in predicting hemodynamic instability. PMID:26871715

  20. Self-Care, Sense Of Coherence And Depression In Patients Hospitalized For Decompensated Heart Failure

    Viviane Martinelli Pelegrino Ferreira

    2015-06-01

    Full Text Available OBJECTIVE To analyze the self-care behaviors according to gender, the symptoms of depression and sense of coherence and compare the measurements of depression and sense of coherence according to gender. METHOD A correlational, cross-sectional study that investigated 132 patients with decompensated heart failure (HF. Data were collected through interviews and consultation to medical records, and analyzed using the chi-square and the Student's t tests with significance level of 0.05. Participants were 75 men and 57 women, aged 63.2 years on average (SD = 13.8. RESULTS No differences in self-care behavior by gender were found, except for rest after physical activity (p = 0.017. Patients who practiced physical activity showed fewer symptoms of depression (p<0.001. There were no differences in sense of coherence according to self-care behavior and gender. Women had more symptoms of depression than men (p = 0.002. CONCLUSION Special attention should be given to women with HF considering self-care and depressive symptoms.

  1. Plasticity of the central nervous system--a neurosurgeon's experience of cerebral compensation and decompensation.

    Pia, H W

    1985-01-01

    Cerebral plasticity constitutes one of the most decisive factors in recovery and readaptation after cerebral lesions. In contrast to the considerable progress in current studies on normal neuronal plasticity including the idea of "l'homme neuronal", the concept of plasticity postulated by Albrecht Bethe in 1929 received little attention. The author, as a neurosurgeon, has tried to describe cranial morphological plasticity, morphological and functional plasticity in infantile encephalopathies and especially in hemiatrophic lesions. It is supposed that a true morphological substrate exists due to compensatory hyperplasia of the uninvolved hemisphere. Modern neurosurgical techniques have demonstrated that the functional plastic capacity is much larger than has been supposed, even in the elderly. Some aspects of the mechanisms of compensation and decompensation of cortical and subcortical structures as well as of the central regulation systems are discussed. The full extent of the amazing recovery and functional reorganization is reached by plastic capacity, personal motivation, adequate training and sufficient time. The contribution ends with an exposition of a personal philosophy concerning psycho-somatic dualism, the body-mind problem, the future of the human brain and the ethical outlook, based on the progressive biological evolution of the basal neocortex and the immanent functional development (H. Spatz). PMID:4072784

  2. Safety and efficacy of simeprevir plus sofosbuvir with or without ribavirin in patients with decompensated genotype 1 hepatitis C cirrhosis.

    Modi, Apurva A; Nazario, Hector; Trotter, James F; Gautam, Manjushree; Weinstein, Jeffrey; Mantry, Parvez; Barnes, Maisha; Habib, Adil; McAfee, Jean; Teachenor, Olga; Tujague, Lauren; Gonzalez, Stevan

    2016-03-01

    Combination antiviral therapy involving sofosbuvir (SOF) and simeprevir (SIM) is a treatment option in patients with genotype 1 chronic hepatitis C; however, the safety of this regimen in patients with decompensated cirrhosis is not established. Data from a combined treatment cohort of 2 large hepatology referral centers were evaluated to assess for safety and efficacy of SIM plus SOF with or without ribavirin (RBV) in patients with Child B or C cirrhosis. All (n = 42) patients included in the analysis had Child B (n = 35) or C (n = 7) cirrhosis and received 400 mg daily of SOF plus 150 mg daily of SIM, with (n = 7) or without (n = 35) RBV, for 12 weeks. Of the 42 patients in this cohort, 31 (74%) were male, 22 (52%) had failed prior treatments, and 28 (67%) were genotype 1a. Prior decompensating events included encephalopathy (57%), fluid overload (88%), or variceal hemorrhage (24%). Median Model for End-Stage Liver Disease score was 12 (range, 6-25). Treatment was well tolerated overall with more than one-half (57%) reporting no adverse events. In those reporting adverse events, the most common were fatigue (n = 6), insomnia (n = 4), headache (n = 5), nausea (n = 4), and grade 1 rash (n = 1). One patient developed chemical pancreatitis that did not require treatment discontinuation. Three of 7 patients who received RBV developed anemia, with 2 requiring blood transfusions and 1 requiring a dose reduction. No episodes of decompensation requiring hospitalization or deaths occurred on treatment. Of 42 patients, 38 (90%) patients had negative viral load at end of treatment (EOT), and 31 of 42 patients (74%) achieved sustained virological response 12 weeks after EOT; 10 of 10 patients (100%) with HCV genotype 1b achieved sustained virological response for 12 weeks (SVR12). In conclusion, SOF plus SIM was very well tolerated in patients with advanced Child B/C decompensated cirrhosis. Overall, 74% of patients achieved SVR12

  3. Effect of a prostaglandin - given rectally for prevention of radiation-induced acute proctitis - on late rectal toxicity. Results of phase III randomized, placebo-controlled, double-blind study

    Kertesz, Tereza; Herrmann, Markus K.A.; Christiansen, Hans; Hermann, Robert M.; Hess, Clemens F.; Hille, Andrea [Dept. of Radiotherapy and Radiooncology, Univ. of Goettingen (Germany); Zapf, Antonia [Dept. of Medical Statistics, Univ. of Goettingen (Germany); Pradier, Olivier [Dept. of Radiotherapy and Radiooncology, Univ. of Brest (France); Schmidberger, Heinz [Dept. of Radiotherapy and Radiooncology, Univ. of Mainz (Germany)

    2009-09-15

    Background and purpose: to assess the late effect of a prostaglandin, given rectally during irradiation, on late rectal toxicity. In the acute treatment setting no significant differences in reducing the incidence of acute proctitis symptoms in patients receiving misoprostol, however, significantly more rectal bleeding had been reported. Patients and methods: a total of 100 patients who had undergone radiotherapy for prostate cancer had been entered into this phase III randomized, placebo-controlled, double-blind study with misoprostol or placebo suppositories. The toxicity was evaluated yearly after cessation of irradiation by the RTOG/LENT-SOMA scale. Results: the median follow-up was 50 months. 20 patients suffered from grade 1, four patients from grade 2 as well, and three patients only from grade 2 toxicity. Frequency, bleeding and urgency were the most commonly reported symptoms. In keeping with other studies and clinical experience, the symptoms peaked within the first 2 years with a median for grade 1 of 13 months and for grade 2 of 15 months. The presence of acute toxicity grade 2 showed a correlation with the development of any late toxicity (p = 0.03). Any acute rectal bleeding was significant correlated with any late rectal bleeding (p = 0.017). Conclusion: misoprostol given as once-daily suppository for prevention of acute radiation-induced proctitis does neither influence the incidence and severity of radiation-induced acute nor late rectal toxicity. Misoprostol has no negative impact on the incidence and severity of late rectal bleeding, in contrast to acute rectal bleeding. The routine clinical use of misoprostol suppositories cannot be recommended. (orig.)

  4. High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in HCV-infected patients treated with sofosbuvir-containing regimens.

    Perumalswami, P V; Patel, N; Bichoupan, K; Ku, L; Yalamanchili, R; Harty, A; Motamed, D; Khaitova, V; Chang, C; Grewal, P; Liu, L; Schiano, T D; Woodward, M; Dieterich, D T; Branch, A D

    2016-09-01

    To conduct surveillance and determine the safety profile of new hepatitis C virus treatments in real-world clinical practice. Hepatic decompensation and other serious adverse events were investigated in an observational cohort study of 511 patients treated with regimens containing sofosbuvir, December 2013-June 2014. Among 499 previously stable patients (no history of hepatic decompensation during the previous 12 months), a nested case-control study was performed to identify predictors of decompensation/serious adverse event. Cases and controls were matched 1:5 based on treatment regimen and duration. Matched conditional logistic regression was used for analysis. Providers scored the likelihood that events were treatment-related (scale = 0-4). The cumulative incidence of decompensation/events was 6.4% for the total cohort. Among 499 previously stable patients, the incidence of decompensation/events was 4.5%; the mortality rate was 0.6%. Sixteen of the 499 experienced one or more serious complications considered to be at least potentially treatment-related, and the sustained virological response rate was 7/16 (44%). Two cases, both on sofosbuvir/simeprevir (without interferon or ribavirin), had complications consistent with autoimmune events (score 3, 'likely treatment-related'), and one experienced a flare of autoimmune hepatitis. Compared to controls, cases had higher baseline median model for end-stage liver disease scores (14 vs 8, P < 0.01). Decompensation/events was independently associated with lower baseline albumin (OR = 0.12/g/dL, P = 0.01) and higher total bilirubin (OR = 4.31/mg/dL, P = 0.01). Reduced hepatic function at baseline increased the risk of liver decompensation/events. PMID:26989855

  5. Controlled, double-blind, randomized clinical trial to evaluate the impact of fruit juice consumption on the evolution of infants with acute diarrhea

    Mendes Carlos

    2005-08-01

    Full Text Available Abstract In order to assess the effects of juice feedings during acute diarrhea a double-blind, randomized study was performed in 90 children, mean age of 10 ± 4.28 months. Thirty patients with acute diarrhea were fed twice-daily 15 ml/kg of Apple Juice (AJ, 30 received White Grape Juice (WGJ, and 30 were given colored and flavored water (WA as part of their age appropriate dietary intake. The duration and severity of diarrhea were the main endpoint variables of the study performed in a metabolic unit. The patients were similar among the 3 groups, had diarrhea for 50–64 hours prior to admission, and were dehydrated when admitted to the unit for study. Half of the patients in each group were well nourished and the others had mild to moderate degrees of malnutrition. Rotavirus infection was the agent causing the illness in 63% of the patients. The infants fed juice ingested 14–17% more calories than those given WA, (those receiving AJ and WGJ ingested 95 and 98 Calories/Kg/d respectively whereas those receiving WA consumed 81 cal/kg/d. The increased energy intake was not at the expense of other foods or milk formula. The mean body weight gain was greater among patients receiving WGJ (+ 50.7 gm as compared with the patients in the AJ group (+ 18.3 gm or the patients fed WA (- 0.7 gm (p = 0.08. The duration of the illness was longer in the infants fed juice as compared with those given WA (p = 0.006, the mean +/- SD duration in hours was 49.4 ± 32.6, 47.5 ± 38.9 and 26.5 ± 27.4 in patients fed AJ, WGJ and WA respectively. All patients improved while ingesting juice and none of them developed persistent diarrhea; most recovered within 50 hours of the beginning of treatment and less than one fourth had diarrhea longer than 96 hours in the unit. The fecal losses were also increased among the juice fed patients (p = 0.001; the mean ± SD fecal excretion in g/kg/h was 3.94 ± 2.35, 3.59 ± 2.35, and 2.19 ± 1.63 in AJ, WGJ and WA respectively

  6. Assessment of the Results of the Multicenter Randomized Acute Leukemia French Association (ALFA) 9803 Trial%法国急性白血病协会(ALFA)9803多中心随机临床试验结果的评价

    江滨; 凌伟

    2009-01-01

    @@ 1文献来源 Gardin C, Turlure P, Fagot T, et al. Postremission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy: Results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial [J]. Blood, 2007, 109(12) : 5129-5135.

  7. Anogenital HIV RNA in Thai men who have sex with men in Bangkok during acute HIV infection and after randomization to standard vs. intensified antiretroviral regimens

    Nittaya Phanuphak

    2015-05-01

    Full Text Available Introduction: HIV transmission risk is highest during acute HIV infection (AHI. We evaluated HIV RNA in the anogenital compartment in men who have sex with men (MSM during AHI and compared time to undetectable HIV RNA after three-drug versus five-drug antiretroviral therapy (ART to understand risk for onward HIV transmission. Methods: MSM with AHI (n=54 had blood, seminal plasma and anal lavage collected for HIV RNA at baseline, days 3 and 7, and weeks 2, 4, 12 and 24. Data were compared between AHI stages: 1 (fourth-generation antigen-antibody combo immunoassay [IA]–, third-generation IA–, n=15, 2 (fourth-generation IA+, third-generation IA–, n=9 and 3 (fourth-generation IA+, third-generation IA+, western blot–/indeterminate, n=30 by randomization to five-drug (tenofovir+emtricitabine+efavirenz+raltegravir+maraviroc, n=18 versus three-drug (tenofovir+emtricitabine+efavirenz, n=18 regimens. Results: Mean age was 29 years and mean duration since HIV exposure was 15.4 days. Mean baseline HIV RNA was 5.5 in blood, 3.9 in seminal plasma and 2.6 log10 copies/ml in anal lavage (p<0.001. Blood and seminal plasma HIV RNA were higher in AHI Stage 3 compared to Stage 1 (p<0.01. Median time from ART initiation to HIV RNA <50 copies/ml was 60 days in blood, 15 days in seminal plasma and three days in anal lavage. Compared with the three-drug ART, the five-drug ART had a shorter time to HIV RNA <1500 copies/ml in blood (15 vs. 29 days, p=0.005 and <50 copies/ml in seminal plasma (13 vs. 24 days, p=0.048. Conclusions: Among MSM with AHI, HIV RNA was highest in blood, followed by seminal plasma and anal lavage. ART rapidly reduced HIV RNA in all compartments, with regimen intensified by raltegravir and maraviroc showing faster HIV RNA reductions in blood and seminal plasma.

  8. A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury.

    James A Tumlin

    Full Text Available Acute kidney injury (AKI is a highly morbid condition in critically ill patients that is associated with high mortality. Previous clinical studies have demonstrated the safety and efficacy of the Selective Cytopheretic Device (SCD in the treatment of AKI requiring continuous renal replacement therapy in the intensive care unit (ICU.A randomized, controlled trial of 134 ICU patients with AKI, 69 received continuous renal replacement therapy (CRRT alone and 65 received SCD therapy.No significant difference in 60-day mortality was observed between the treated (27/69; 39% and control patients (21/59; 36%, with six patients lost to follow up in the intention to treat (ITT analysis. Of the 19 SCD subjects (CRRT+SCD and 31 control subjects (CRRT alone who maintained a post-filter ionized calcium (iCa level in the protocol's recommended range (≤ 0.4 mmol/L for greater or equal to 90% of the therapy time, 60-day mortality was 16% (3/19 in the SCD group compared to 41% (11/27 in the CRRT alone group (p = 0.11. Dialysis dependency showed a borderline statistically significant difference between the SCD treated versus control CRRT alone patients maintained for ≥ 90% of the treatment in the protocol's recommended (r iCa target range of ≤ 0.4 mmol/L with values of, 0% (0/16 and 25% (4/16, respectively (P = 0.10. When the riCa treated and control subgroups were compared for a composite index of 60 day mortality and dialysis dependency, the percentage of SCD treated subjects was 16% versus 58% in the control subjects (p<0.01. The incidence of serious adverse events did not differ between the treated (45/69; 65% and control groups (40/65; 63%; p = 0·86.SCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.ClinicalTrials.gov NCT01400893 http://clinicaltrials.gov/ct2/show/NCT01400893.

  9. No-reflow protection and long-term efficacy for acute myocardial infarction with Tongxinluo: a randomized double-blind placebo-controlled multicenter clinical trial (ENLEAT Trial)

    ZHANG Hai-tao; YANG Yue-jin; JIA Zhen-hua; ZHANG Jian; YE Zan-kai; YANG Wei-xian; TIAN Yue-qin; JIA Xuan; LI Wei; WU Yi-ling

    2010-01-01

    Background No-reflow after emergency percutaneous coronary intervention (PCI) for acute ST segment elevation myocardial infarction (STEMI) is related to the severe prognosis. The aim of this study was to evaluate the efficacy of Tongxinluo, a traditional Chinese medicine, on no-reflow and the infarction area after emergency PCI for STEMI.Methods A total of 219 patients (female 31, 14%) undergoing emergency PCI for STEMI from nine clinical centers were consecutively enrolled in this randomized, double-blind, placebo-controlled, multicenter clinical trial from January 2007 to May 2009. All patients were randomly divided into Tongxinluo group (n=108) and control group (n=111), given Tongxinluo or placebo in loading dose 2.08 g respectively before emergency PCI with asprin 300 mg and clopidogrel 300 mg together, then 1.04 g three times daily for six months after PCI. The ST segment elevation was recorded by electrocardiogram at hospitalization and 1, 2, 6, 12, 24 hours after coronary balloon dilation to evaluate the myocardial no-flow; myocardial perfusion scores of 17 segments were evaluated on day 7 and day 180 after STEMI with static single-photon emission computed tomography (SPECT) to determine the infarct area.Results There was no statistical significance in sex, age, past history, chest pain, onset-to-reperfusion time, Killip classification, TIMI flow grade just before and after PCI, either in the medication treatment during the follow up such as statin, β-blocker, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) between two groups. There was significant ST segment restoration in Tongxinluo group compared to the control group at 6 hours ((-0.22±0.18) mV vs. (-0.18±0.16) mV, P=0.0394), 12 hours ((-0.24 ± 0.18) mV vs. (-0.18±0.15) mV, P=0.0158) and 24 hours ((-0.27±0.16) mV vs. (-0.20±0.16) mV, P=0.0021) reperfusion; and the incidence of myocardial no-reflow was also reduced significantly at 24-hour reperfusion (34.3% vs

  10. Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial

    Lellouche F

    2016-08-01

    Full Text Available François Lellouche,1 Pierre-Alexandre Bouchard,1 Maude Roberge,1 Serge Simard,1,2 Erwan L’Her,1,3 François Maltais,1 Yves Lacasse1 1Research Centre, 2Biostatistics Department, Quebec Heart and Lung Institute, Laval University, 3Emergency Medicine, Hôtel-Dieu de Lévis, Laval University, Quebec City, QC, Canada Introduction: We developed a device (FreeO2 that automatically adjusts the oxygen flow rates based on patients’ needs, in order to limit hyperoxia and hypoxemia and to automatically wean them from oxygen. Objective: The aim of this study was to evaluate the feasibility of using FreeO2 in patients hospitalized in the respiratory ward for an acute exacerbation of COPD. Methods: We conducted a randomized controlled trial comparing FreeO2 vs manual oxygen titration in the respiratory ward of a university hospital. We measured the perception of appropriateness of oxygen titration and monitoring in both groups by nurses and attending physicians using a Likert scale. We evaluated the time in the target range of oxygen saturation (SpO2 as defined for each patient by the attending physician, the time with severe desaturation (SpO2 <85%, and the time with hyperoxia (SpO2 >5% above the target. We also recorded length of stay, intensive care unit admissions, and readmission rate. Fifty patients were randomized (25 patients in both groups; mean age: 72±8 years; mean forced expiratory volume in 1 second: 1.00±0.49 L; and mean initial O2 flow 2.0±1.0 L/min. Results: Nurses and attending physicians felt that oxygen titration and monitoring were equally appropriate with both O2 administration systems. The percentage of time within the SpO2 target was significantly higher with FreeO2, and the time with severe desaturation and hyperoxia was significantly reduced with FreeO2. Time from study inclusion to hospital discharge was 5.8±4.4 days with FreeO2 and 8.4±6.0 days with usual oxygen administration (P=0.051. Conclusion: FreeO2 was deemed as an

  11. Influence of metabolic dysfunction on cardiac mechanics in decompensated hypertrophy and heart failure.

    Tewari, Shivendra G; Bugenhagen, Scott M; Vinnakota, Kalyan C; Rice, J Jeremy; Janssen, Paul M L; Beard, Daniel A

    2016-05-01

    Alterations in energetic state of the myocardium are associated with decompensated heart failure in humans and in animal models. However, the functional consequences of the observed changes in energetic state on mechanical function are not known. The primary aim of the study was to quantify mechanical/energetic coupling in the heart and to determine if energetic dysfunction can contribute to mechanical failure. A secondary aim was to apply a quantitative systems pharmacology analysis to investigate the effects of drugs that target cross-bridge cycling kinetics in heart failure-associated energetic dysfunction. Herein, a model of metabolite- and calcium-dependent myocardial mechanics was developed from calcium concentration and tension time courses in rat cardiac muscle obtained at different lengths and stimulation frequencies. The muscle dynamics model accounting for the effect of metabolites was integrated into a model of the cardiac ventricles to simulate pressure-volume dynamics in the heart. This cardiac model was integrated into a simple model of the circulation to investigate the effects of metabolic state on whole-body function. Simulations predict that reductions in metabolite pools observed in canine models of heart failure can cause systolic dysfunction, blood volume expansion, venous congestion, and ventricular dilation. Simulations also predict that myosin-activating drugs may partially counteract the effects of energetic state on cross-bridge mechanics in heart failure while increasing myocardial oxygen consumption. Our model analysis demonstrates how metabolic changes observed in heart failure are alone sufficient to cause systolic dysfunction and whole-body heart failure symptoms. PMID:27085901

  12. Comparison between intralesional injection of zinc sulfate 2 % solution and intralesional meglumine antimoniate in the treatment of acute old world dry type cutaneous leishmaniasis: a randomized double-blind clinical trial.

    Farajzadeh, Saeedeh; Hakimi Parizi, Maryam; Haghdoost, Ali Akbar; Mohebbi, Azadeh; Mohammadi, Saman; Pardakhty, Abbas; Eybpoosh, Sana; Heshmatkhah, Amireh; Vares, Behrooz; Saryazdi, Simin; Fekri, Ali Reza; Mohebbi, Elham

    2016-09-01

    Zinc sulfate (ZS) has been used for the treatment of acute cutaneous leishmaniasis (CL) in both forms of in vivo and in vitro recently. The aim of the present study was to compare the efficacy of intralesional injection of ZS 2 % solution with intralesional glucantime in the treatment of acute CL. In this double-blind randomized clinical trial, 80 cases with acute old world dry type CL were enrolled in the study. The treatment protocol in the first group consisted of intralesional injection of ZS 2 % vials once a week for 10 weeks or sooner in case of complete resolution of the lesions. In the second group, intralesional glucantime once a week for 10 weeks or sooner in case of complete resolution of the lesions were used. In both groups cryotherapy was performed once every other week for 10 weeks. In ZS versus second group, partial and complete clinical response was observed with fewer injections although this difference was not statistically significant. In addition, we found that the trend of treatment in second group was faster but again it was not significant [partial treatment: hazard ratio (HR) 1.4, 95 % CI 0.7-2.9; complete treatment: HR 1.3, 95 % CI 0.6-2.8]. The results of this study showed that the intralesional injection of ZS 2 % solution was as effective as glucantime on the healing of the acute old world dry type CL. PMID:27605813

  13. Effect of pneumococcal conjugate vaccination on nasopharyngeal carriage in children with early onset of acute otitis media - a randomized controlled trial.

    Gisselsson-Solén, Marie; Henriksson, Gunnel; Hermansson, Ann; Melhus, Åsa

    2015-01-01

    Abstract Conclusion: Although children vaccinated with heptavalent pneumococcal conjugate vaccine (PCV) had fewer episodes of acute otitis media (AOM), this trial was unable to prove a simultaneous decrease in nasopharyngeal carriage.

  14. Lactobacillus casei strain GG in the treatment of infants with acute watery diarrhea: A randomized, double-blind, placebo controlled clinical trial [ISRCTN67363048

    Chea-Woo Elsa; Campos-Sanchez Miguel; Miranda-Langschwager Percy; Salazar-Lindo Eduardo; Sack R Bradley

    2004-01-01

    Abstract Background Adjuvant therapy to ORT with probiotic bacteria for infants with acute watery diarrhea has been under active investigation. Most studies have been done in the developed world showing benefit only for viral mild gastroenteritis. We evaluated the effect of a milk formula containing one billion (109) cfu/ml of Lactobacillus casei strain GG (LGG) upon duration and severity of diarrhea in infants in an environment with more severe acute diarrhea, where etiologic agents other th...

  15. Plasma-to-ascitic fluid transport rate of albumin in patients with decompensated cirrhosis. Relation to intraperitoneal albumin

    Henriksen, Jens Henrik Sahl; Ring-Larsen, H; Lassen, N A;

    1983-01-01

    Albumin-kinetics and haemodynamic studies were performed in 20 patients with decompensated liver cirrhosis in order to improve the knowledge on genesis and perpetuation of hepatic ascites, especially with respect to determinants of intraperitoneal protein. A positive relationship was found between...... the plasma-to-peritoneal transport rate of albumin (index of 'lymph-imbalance') and the mass of intraperitoneal albumin (rlog = 0.82, P less than 0.001), indicating a significant role of 'lymph-imbalance' to sequestration of protein in the peritoneal cavity. Ascitic fluid albumin concentration was on...

  16. Effect of Text Message, Phone Call, and In-Person Appointment Reminders on Uptake of Repeat HIV Testing among Outpatients Screened for Acute HIV Infection in Kenya: A Randomized Controlled Trial

    Wahome, Elizabeth W.; Gichuru, Evanson N.; Mwashigadi, Grace M.; Thiong’o, Alexander N.; Prins, Henrieke A. B.; Rinke de Wit, Tobias F.; Graham, Susan M.; Sanders, Eduard J.

    2016-01-01

    Background Following HIV-1 acquisition, many individuals develop an acute retroviral syndrome and a majority seek care. Available antibody testing cannot detect an acute HIV infection, but repeat testing after 2–4 weeks may detect seroconversion. We assessed the effect of appointment reminders on attendance for repeat HIV testing. Methods We enrolled, in a randomized controlled trial, 18–29 year old patients evaluated for acute HIV infection at five sites in Coastal Kenya (ClinicalTrials.gov NCT01876199). Participants were allocated 1:1 to either standard appointment (a dated appointment card) or enhanced appointment (a dated appointment card plus SMS and phone call reminders, or in-person reminders for participants without a phone). The primary outcome was visit attendance, i.e., the proportion of participants attending the repeat test visit. Factors associated with attendance were examined by bivariable and multivariable logistic regression. Principal Findings Between April and July 2013, 410 participants were randomized. Attendance was 41% (85/207) for the standard group and 59% (117/199) for the enhanced group, for a relative risk of 1.4 [95% Confidence Interval, CI, 1.2–1.7].Higher attendance was independently associated with older age, study site, and report of transactional sex in past month. Lower attendance was associated with reporting multiple partners in the past two months. Conclusions Appointment reminders through SMS, phone calls and in-person reminders increased the uptake of repeat HIV test by forty percent. This low-cost intervention could facilitate detection of acute HIV infections and uptake of recommended repeat testing. Trial Registration Clinicaltrials.gov NCT01876199 PMID:27077745

  17. Occurrence of hepatocellular carcinoma and decompensation in western European patients with cirrhosis type B. The EUROHEP Study Group on Hepatitis B Virus and Cirrhosis

    Fattovich, G; Giustina, G; Schalm, S W; Hadziyannis, S; Sanchez-Tapias, J; Almasio, P; Christensen, E; Krogsgaard, K; Degos, F; Carneiro de Moura, M

    1995-01-01

    . At entry into the study all patients were tested for hepatitis B e antigen (HBeAg; 34% of patients were HBeAg-positive) and antibody to hepatitis delta virus (anti-HDV; 20% of patients were anti-HDV-positive); 48% of 252 patients tested were hepatitis B virus (HBV)-DNA-positive. During follow-up HCC...... developed in 32 (9%) of the 349 patients and decompensation was observed in 88 (28%) of 317 tumor-free patients. Five years after diagnosis, the probability of HCC appearance was 6% and the probability of decompensation was 23%. After the first episode of decompensation the probability of survival was 35...... factors for HCC reflect an advanced stage of cirrhosis and support the hypothesis that development of a tumor could be the likely consequence of long-standing hepatic disease....

  18. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study

    Rousing, Rikke; Andersen, Mikkel O; Jespersen, Stig M;

    2009-01-01

    STUDY DESIGN: Clinical randomized study. OBJECTIVE: The aim of this study is to compare percutaneous vertebroplasty (PVP) to conservative treatment of patients with osteoporotic vertebral fractures in a clinical randomized study with respect to pain, physical and mental outcome, and to asses the...

  19. Na(+)-K(+)-ATPase alpha(2)-isoform expression in guinea pig hearts during transition from compensation to decompensation.

    Trouve, P; Carre, F; Belikova, I; Leclercq, C; Dakhli, T; Soufir, L; Coquard, I; Ramirez-Gil, J; Charlemagne, D

    2000-10-01

    Disturbance in ionic gradient across sarcolemma may lead to arrhythmias. Because Na(+)-K(+)-ATPase regulates intracellular Na(+) and K(+) concentrations, and therefore intracellular Ca(2+) concentration homeostasis, our aim was to determine whether changes in the Na(+)-K(+)-ATPase alpha-isoforms in guinea pigs during transition from compensated (CLVH) to decompensated left ventricular hypertrophy (DLVH) were concomitant with arrhythmias. After 12- and 20-mo aortic stenosis, CLVH and DLVH were characterized by increased mean arterial pressure (30% and 52.7%, respectively). DLVH differed from CLVH by significantly increased end-diastolic pressure (34%), decreased sarco(endo)plasmic reticulum Ca(2+)-ATPase (-75%), and increased Na(+)/Ca(2+) exchanger (25%) mRNA levels and by the occurrence of ventricular arrhythmias. The alpha-isoform (mRNA and protein levels) was significantly lower in DLVH (2.2 +/- 0.2- and 1. 4 +/- 0.15-fold, respectively, vs. control) than in CLVH (3.5 +/- 0. 4- and 2.2 +/- 0.13-fold, respectively) and was present in sarcolemma and T tubules. Changes in the levels of alpha(1)- and alpha(3)-isoform in CLVH and DLVH appear physiologically irrelevant. We suggest that the increased level of alpha(2)-isoform in CLVH may participate in compensation, whereas its relative decrease in DLVH may enhance decompensation and arrhythmias. PMID:11009487

  20. Defining the role of ultrafiltration therapy in acute heart failure: a systematic review and meta-analysis.

    Jain, Ankur; Agrawal, Nikhil; Kazory, Amir

    2016-09-01

    Ultrafiltration (UF) has emerged as an alternative therapy for acute decompensated heart failure (ADHF) due to its physiological benefits such as improvement in neurohormonal activation. We performed a systematic review and a meta-analysis to evaluate the efficacy, safety, and the impact on outcomes for UF therapy as compared to conventional medical treatment. The PubMed and Cochrane databases were searched from inception to December 2015 for randomized controlled trials that examined UF therapy in ADHF and used diuretic-based regimens as the control group. In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, we explored the impact on weight change, fluid removal, renal function, rehospitalization rate, and mortality. Mantel-Haenszel odds ratio (OR) was calculated for dichotomous data and weighted mean difference (WMD) for continuous data. Seven studies with a total of 771 patients met our selection criteria. UF therapy led to greater weight loss (WMD 1.35, 95 % CI 0.49-2.21, p benefit. PMID:27154520

  1. Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial.

    Jones, Kelsey D J

    2015-01-01

    Ready-to-use therapeutic foods (RUTF) are lipid-based pastes widely used in the treatment of acute malnutrition. Current specifications for RUTF permit a high n-6 polyunsaturated fatty acid (PUFA) content and low n-3 PUFA, with no stipulated requirements for preformed long-chain n-3 PUFA. The objective of this study was to develop an RUTF with elevated short-chain n-3 PUFA and measure its impact, with and without fish oil supplementation, on children\\'s PUFA status during treatment of severe acute malnutrition.

  2. Relaxin: a novel agent for the treatment of acute heart failure.

    Wilson, Suprat S; Ayaz, Syed I; Levy, Phillip D

    2015-03-01

    Acute heart failure (AHF) is defined by a constellation of signs and symptoms that manifest when new or decompensated ventricular dysfunction is triggered by an acute precipitant such as excessive preload, afterload, or myocardial ischemia. Despite being one of the most frequent causes of hospitalization and cardiovascular mortality, little to no progress has been made over the last few decades to advance the treatment of AHF. Current mainstays of pharmacotherapy for AHF including diuretics, vasodilators, and inotropes can improve symptoms; however, no currently approved agent has been shown to provide lasting outcome benefit for patients with AHF. First discovered in pregnant women where it is known to help with growth of the cervix and assist with the maternal cardiovascular and renovascular responses to pregnancy, relaxin is an endogenous neurohormone that has novel vasoactive properties. In particular, relaxin is a potent vasodilator with a number of pleiotropic effects that may affect cardiac remodeling, making relaxin an attractive compound for use in the management of AHF. Indeed, in two randomized controlled trials, a single 48-hour infusion of relaxin relieved symptoms of AHF with no evidence of major adverse effects. A signal of mortality benefit at 180 days was noted in both trials, prompting a third trial of relaxin powered for 180-day mortality that is currently under way. The pharmacology that underscores the potential benefit of relaxin is discussed and insight is provided into future clinical application of this novel drug should it prove to be the first therapy capable of reducing mortality in AHF. PMID:25759289

  3. Acute effect of topical menthol on chronic pain in slaughterhouse workers with carpal tunnel syndrome: triple-blind, randomized placebo-controlled trial

    Sundstrup, Emil; Jakobsen, Markus Due; Brandt, Mikkel;

    2014-01-01

    Topical menthol gels are classified "topical analgesics" and are claimed to relieve minor aches and pains of the musculoskeletal system. In this study we investigate the acute effect of topical menthol on carpal tunnel syndrome (CTS). We screened 645 slaughterhouse workers and recruited 10...

  4. Effect of extended physiotherapy and high-dose vitamin D on rate of falls and hospital re-admission after acute hip fracture: a randomized controlled trial

    Guidelines for post-fracture care of elderly hip fracture patients are not established despite the significant socio-economic burden of post hip fracture morbidity and mortality. Using a factorial design, we studied the effects of extended physiotherapy (supervised 1 hour per day during acute care p...

  5. Double-Blind Randomized Clinical Trial of the Efficacy of Venlafaxine Versus Citalopram in the Treatment of the Acute Phase of Major Depressive Disorder

    Hosseini, Fatemeh; Amini, Fariba; Yassini Ardekani, Seyed Mojtaba; Shariat, Neda; Nadi, Mohammad

    2015-01-01

    Background: There are many antidepressant medications with different side-effects and efficacy profiles. Objectives: In this study, we compared the efficacy of citalopram and venlafaxine in major depression, which has not yet been studied in Iran. Patients and Methods: In this double-blind, randomized controlled trial study, 39 patients aged 18-54 year old with major depressive disorder were randomly allocated into two groups in Yazd City, Iran, between March 2011 and December 2012. A total o...

  6. A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision

    Friis-Møller, Alice; Agren, MS; Ostenfeld, U; Kallehave, F; Gong, Y; Raffn, K; Crawford, ME; Kiss, K; Gluud, Christian; Jørgensen, LN

    2006-01-01

    The purpose of this randomized, double-blind, placebo-controlled multicenter trial was to compare topical zinc oxide with placebo mesh on secondary healing pilonidal wounds. Sixty-four (53 men) consecutive patients, aged 17-60 years, were centrally randomized to either treatment with 3% zinc oxide...... abnormalities by histopathological examination of wound biopsies, or other harmful effects. Larger clinical trials will be required to show definitive effects of topical zinc oxide on wound healing and infection....

  7. EFFECT OF SIMVASTATIN ON THE PROGNOSIS AND THE CHANGES OF THE CLINICAL STATUS IN PATIENTS WITH ACUTE ISCHEMIC STROKE. THE RESULTS OF THE 12 MONTH RANDOMIZED, OPEN COMPARATIVE STUDY

    V. V. Yakusevich

    2015-09-01

    Full Text Available Aim. To evaluate in open 12 month prospective, randomized study the mortality and recurrent cardiovascular events rate, dynamics of neurological deficit, endothelial dysfunc- tion and renal function in patients with the first ischemic stroke of hemispheric localization after prescription of simvastatin 40 mg daily in the acute stage of the disease. Material and methods. Patients (n=210 above 18 years of age (95 men and 115 women with acute ischemic stroke were included into the study. Patients were randomized into two groups. Patients of the group 1 (n=105 received standard treatment for ischemic stroke. Patients of the group 2 (n=105 received simvastatin 40 mg/day additional- ly to standard therapy of stroke. Follow-up duration was 12 months. The lipid profile, a number of desquamated epithelial cells circulating in the blood, glomerular filtration rate (GFR according to MDRD, as well as neurological patient status (Scandinavian Scale, MMSE, NIHSS were monitored.Results. During the follow-up period mortality was 18.1% and 15.2% in group 1 and 2, respectively. Composite end point was achieved in 60.9% and 46.6% of patients, re- spectively (p=0.037. Lipid profile did not change significantly in group 1 while patients in group 2 showed a significant decrease in lipid levels. The positive dynamics of neuro- logical status was observed in both groups, however, the most significant - in group 2. Reduction in a number of endothelial desquamated cells was 45.7% in group 2 and 13.3% in group 1 (p=0.00001. GFR increased significantly in patients of group 2.Conclusion. The long-term treatment with simvastatin in combination with neuroprotective and antihypertensive therapy in patients with acute ischemic stroke leads to decrease in the incidence rate of clinically relevant events, improvement of endothelial function, neurological status and prognosis.

  8. EFFICACY OF MULLIGAN’S TWO LEG ROTATION AND BENT LEG RAISE TECHNIQUES IN HAMSTRING FLEXIBILITY IN SUBJECTS WITH ACUTE NON-SPECIFIC LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL

    Pratik .A. Phansopkar,

    2014-10-01

    Full Text Available Background and objectives: Adequate flexibility of the Hamstring muscles and Core muscle strength is necessary for a healthy lower back. Mulligan’s techniques are fascinating Physiotherapy approach in treatment of hamstrings tightness in NS-LBP such as Mulligan’s Bent Leg Raise (BLR technique, Limited Literature is available on the efficacies of Mulligan’s Two Leg Rotation (TLR technique in Hamstrings flexibility. The objective of the present study was to determine the effectiveness of Mulligan’s TLR and BLR in treatment of acute NS-LBP. Methods: The present randomized clinical trial was conducted among 40 subjects which included both male and female symptomatic subjects between the age of 18 to 35 years with acute NS-LBP and they were randomly allocated into 2 groups namely Group A[SWD, HMP, Mulligan’s TLR, MCE] , Group B[SWD, HMP, Mulligan’s BLR, MCE]. Pre-interventional and 7th day Post-interventional outcome measurements were taken in the form of Visual Analogue Scale (VAS, Modified Oswestry Disability Questionnaire (MODQ, Active Knee Extension (AKE Measurement, Lumbar ROM and Core muscle strength. Results: Intra-group comparison for all the outcome parameters in both the groups showed statistical significance (p<0.001. Inter group comparison for all the outcome parameters had differences but showed no statistical significance. Conclusion: Mulligan’s Two Leg Rotation and Bent Leg Raise techniques are effective in increasing the hamstrings flexibility in subjects with acute non specific low back pain in terms of pain, range of motion and functional disability.

  9. Randomized clinical trial on continuous 7-days-a-week postoperative radiotherapy for high-risk squamous cell head-and-neck cancer: A report on acute normal tissue reactions

    Background and purpose: To analyse acute mucosal reactions in patients treated with continuous accelerated postoperative irradiation (p-CAIR) compared to conventionally fractionated postoperative radiotherapy (p-CF). Patients and methods: The patients were randomly assigned to receive 63 Gy in 1.8 Gy fractions 7-days-a-week given over a period of 5 weeks (n=88), or 63 Gy in 1.8 Gy fractions given 5-days-a-week over 7 weeks (n=87). It represents 65% of an overall trial size. Acute mucosal reactions were scored using modified Dische system. Polychotomous logistic regression was used to estimate the influence of the selected variables on maximum grade of mucositis, and percent of the body weight loss during radiotherapy. Results: The average maximum Dische score and percent of the patients with confluent mucositis were higher in patients treated with p-CAIR, compared to p-CF (13.3 vs. 10.8 and 54 vs. 27%). Polychotomous logistic regression analysis revealed that fractionation scheme and tumour site have significantly influenced maximum Dische score. Tumour site (laryngeal vs. other) had even stronger influence on maximum Dische score than fractionation scheme. The average residual Dische score 8 weeks after radiotherapy was higher in p-CAIR compared to p-CF (2.1 vs. 1.4), and was, most frequently, related to persistent mucosal erythema (70 vs. 57% of pts.). No severe consequential toxicity of radiotherapy was observed, so far, in the trial. Conclusions: While the incidence, intensity and duration of mucosal reactions was higher in p-CAIR than in p-CF the accelerated treatment can be considered tolerable with respect to acute toxicity. In both arms of the trial slight or moderate mucosal erythema was the most frequent acute side effect, which did not completely subside within 8 weeks after irradiation

  10. Effectiveness of interferon alfa on incidence of hepatocellular carcinoma and decompensation in cirrhosis type C. European Concerted Action on Viral Hepatitis (EUROHEP)

    Fattovich, G; Giustina, G; Degos, F;

    1997-01-01

    The role of interferon alfa treatment in improving morbidity endpoints in patients with chronic hepatitis C infection is currently under debate. The aim of this study was to evaluate the effectiveness of interferon in preventing hepatocellular carcinoma and decompensation in cirrhosis type C....

  11. An Organic Khorasan Wheat-Based Replacement Diet Improves Risk Profile of Patients with Acute Coronary Syndrome: A Randomized Crossover Trial

    Anne Whittaker; Francesco Sofi; Maria Luisa Eliana Luisi; Elena Rafanelli; Claudia Fiorillo; Matteo Becatti; Rosanna Abbate; Alessandro Casini; Gian Franco Gensini; Stefano Benedettelli

    2015-01-01

    Khorasan wheat is an ancient grain with previously reported health benefits in clinically healthy subjects. The aim of this study was to examine whether a replacement diet, thereby substituting all other cereal grains, with products made with organic khorasan wheat could provide additive protective effects in reducing lipid, oxidative and inflammatory risk factors, in patients with Acute Coronary Syndromes (ACS) in comparison to a similar replacement diet using products made from organic mod...

  12. Changes in Pain, Dysfunction, and Grip Strength of Patients with Acute Lateral Epicondylitis Caused by Frequency of Physical Therapy: A Randomized Controlled Trial

    Lee, Soyoung; Ko, YoungJun; Lee, Wanhee

    2014-01-01

    [Purpose] The purpose of this study was to investigate the changes in pain, dysfunction, and grip strength of patients with acute lateral epicondylitis and to suggest the appropriate treatment frequency and period. [Subjects] The subjects were divided into three: 2 days per week group (n=12), 3 days per week group (n=15), and 6 days per week group (n=13). [Methods] All groups received conventional physical therapy for 40 minutes and therapeutic exercises for 20 minutes per session during 6 we...

  13. The acute effects of exercise on cortical excitation and psychosocial outcomes in men treated for prostate cancer: a randomized controlled trial

    Daniel Santa Mina; Crissa Leanne Guglietti; Danilo Rocha de Jesus; Shabbir Muhammad Husayn Alibhai; Paul Ritvo

    2014-01-01

    Purpose: Regular exercise improves psychological wellbeing in men treated for prostate cancer. For this population and among cancer survivors in general, the effect of a single bout of exercise on self-report or objective measures of psychological wellbeing has not been examined. We examined the acute effect of a single bout of exercise on the cortical silent period (CSP) and on self-reported mood in men that have received treatment for prostate cancer. Methods: Thirty-six prostate canc...

  14. Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial

    Arun Jenish J; Lodha Rakesh; Kabra Sushil K

    2012-01-01

    Abstract Background There are no published studies that have compared bronchodilatory effect of inhaled budesonide/formoterol combination with budesonide/salbutamol delivered by metered dose inhaler with a spacer in acute exacerbation of asthma in children. We, therefore, compared the bronchodilatory effects of inhaled budesonide/formoterol (dose: 200 μg and 12 μg respectively) combination with budesonide (200 μg)/salbutamol (200 μg) administered by metered dose inhaler and spacer in children...

  15. Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial

    Mogollon, Jaime Andres; Bujold, Emmanuel; Lemieux, Simone; Bourdages, Mélodie; Blanchet, Claudine; Bazinet, Laurent; Couillard, Charles; Noël, Martin; Dodin, Sylvie

    2013-01-01

    Background Several randomized clinical trials (RCTs) indicate that flavanol-rich chocolate has beneficial effects on flow-mediated dilation (FMD) and blood pressure (BP). However, no RCTs have evaluated these outcomes in pregnant women. The objective of this 2-group, parallel, double-blind RCT was to examine the effects of flavanol-rich chocolate on FMD and BP in pregnant women with normal BP. Methods Forty-four healthy, pregnant women were randomized to the high-flavanol (n = 23) or low-flav...

  16. A randomized phase II/III study of adverse events between sequential (SEQ) versus simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) in nasopharyngeal carcinoma; preliminary result on acute adverse events

    To investigate acute and late toxicities comparing sequential (SEQ-IMRT) versus simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT) in nasopharyngeal carcinoma (NPC) patients. Newly diagnosed stage I-IVB NPC patients were randomized to receive SEQ-IMRT or SIB-IMRT, with or without chemotherapy. SEQ-IMRT consisted of two sequential radiation treatment plans: 2Gy x 25 fractions to low-risk planning target volume (PTV-LR) followed by 2Gy x 10 fractions to high-risk planning target volume (PTV-HR). In contrast, SIB-IMRT consisted of only one treatment plan: 2.12Gy and 1.7Gy x 33 fractions to PTV-HR and PTV-LR, respectively. Toxicities were evaluated according to CTCAE version 4.0. Between October 2010 and November 2013, 122 eligible patients were randomized between SEQ-IMRT (54 patients) and SIB-IMRT (68 patients). With median follow-up time of 16.8 months, there was no significant difference in toxicities between the two IMRT techniques. During chemoradiation, the most common grade 3–5 acute toxicities were mucositis (15.4 % vs 13.6 %, SEQ vs SIB, p = 0.788) followed by dysphagia (9.6 % vs 9.1 %, p = 1.000) and xerostomia (9.6 % vs 7.6 %, p = 0.748). During the adjuvant chemotherapy period, 25.6 % and 32.7 % experienced grade 3 weight loss in SEQ-IMRT and SIB-IMRT (p = 0.459). One-year overall survival (OS) and progression-free survival (PFS) were 95.8 % and 95.5 % in SEQ-IMRT and 98 % and 90.2 % in SIB-IMRT, respectively (p = 0.472 for OS and 0.069 for PFS). This randomized, phase II/III trial comparing SIB-IMRT versus SEQ-IMRT in NPC showed no statistically significant difference between both IMRT techniques in terms of acute adverse events. Short-term tumor control and survival outcome were promising

  17. Plasma-to-ascitic fluid transport rate of albumin in patients with decompensated cirrhosis. Relation to intraperitoneal albumin

    Henriksen, J H; Ring-Larsen, Helmer; Lassen, N A; Parving, H H; Winkler, K

    1983-01-01

    Albumin-kinetics and haemodynamic studies were performed in 20 patients with decompensated liver cirrhosis in order to improve the knowledge on genesis and perpetuation of hepatic ascites, especially with respect to determinants of intraperitoneal protein. A positive relationship was found betwee...... the 'lymph-imbalance' theory of ascites formation, whereas a 'fluid equilibrium' theory seems to be too simple, especially with respect to explain protein sequestration in the peritoneal cavity....... the plasma-to-peritoneal transport rate of albumin (index of 'lymph-imbalance') and the mass of intraperitoneal albumin (rlog = 0.82, P less than 0.001), indicating a significant role of 'lymph-imbalance' to sequestration of protein in the peritoneal cavity. Ascitic fluid albumin concentration was on...

  18. Clinical significance of peritoneal and retroperitoneal edema in patients with de-compensated cirrhosis as demonstrated by CT scan

    Objective: To investigate the clinical significance of peritoneal and retroperitoneal edema in patients with de-compensated cirrhosis (DCC). Methods: Forty-four patients, were identified with DCC on the basis of clinic and laboratory examinations, except the cases with mesenteric, omental and retroperitoneal edema caused by inflammatory and malignant diseases. The diagnosis of edema depended upon hyper-density in peritoneal and retroperitoneal. The degree of edema was divided into minor, middle, and sever types based on the extent of edema. Ascites, varices, serum albumin (ALB) levels, and hyaluronic acid (HA) levels were also documented. Correlations between the laboratory and CT findings were analyzed. Results: The severity of peritoneal edema was correlated with decreasing serum ALB (rs = 0.7088, P s = 0.5294, P s = 0.5440, P s = 0.1335, P > 0.05). Conclusion: CT findings of the edema in peritoneal and retroperitoneal may indicate the severity of the liver cirrhosis

  19. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication: A randomized controlled trial

    Wurdak, M.; Wolstein, J.; Kuntsche, E.N.

    2016-01-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized contro

  20. A prospective randomized controlled trial to study the role of sulfasalazine in prevention of acute gastrointestinal toxicity associated with concurrent chemoradiation in carcinoma cervix

    Santanu Pal

    2013-01-01

    Full Text Available Background: The primary aim of the study was to evaluate the effectiveness of sulfasalazine in reducing the incidence of acute radiation-induced enteritis in carcinoma cervix patients receiving pelvic external beam radiotherapy along with concurrent cisplatin-based chemotherapy. Materials and Methods: Between November 2011 and July 2012 a total of 98 patients of locoregionally advanced carcinoma of cervix (49 each in study and control arms were enrolled in this study. Patients in both the arms were treated with whole pelvis external beam radiotherapy with total dose of 50 Gy in conventional fractionation. Along with this inj. cisplatin was given concurrently at the dose of 40 mg/m 2 of body surface area every week during radiation for 5 weeks. Concurrent chemoradiation was followed by brachytherapy after a gap of 2 weeks. Patients in the study arm also received tablet sulfasalazine 1,000 mg orally twice daily from the day of starting of radiotherapy to 1 week after completion of treatment. Weekly follow-up of all patients to assess acute toxicities was done using common toxicity criteria version 4.0 (CTC v4.0 toxicity scores. Data analysis was carried out by SPSS version 20.0 software. Results: Incidence of grade II or higher grade, lower gastrointestinal toxicity was 19.14% (09/47 in study arm and 41.66% (20/48 in control arm which was statistically significant (P = 0.017. Conclusion: The study shows that sulfasalazine can significantly reduce the acute radiation-induced diarrhea (ARID in patients undergoing whole pelvis external beam radiotherapy for carcinoma cervix. The drug is safe, cheap, and readily available.

  1. The acute effects of exercise on cortical excitation and psychosocial outcomes in men treated for prostate cancer: a randomized controlled trial

    Santa Mina, Daniel; Guglietti, Crissa L; de Jesus, Danilo R.; Azargive, Saam; Matthew, Andrew G; Alibhai, Shabbir M. H; Trachtenberg, John; Daskalakis, Jeffrey Z.; Ritvo, Paul

    2014-01-01

    Purpose: Regular exercise improves psychological well-being in men treated for prostate cancer (PCa). For this population and among cancer survivors in general, the effect of a single bout of exercise on self-report or objective measures of psychological well-being has not been examined. We examined the acute effect of a single bout of exercise on the cortical silent period (CSP) and on self-reported mood in men that have received treatment for PCa. Methods: Thirty-six PCa survivors were r...

  2. The effect of protein intake and resistance training on muscle mass in acutely ill old medical patients - A randomized controlled trial

    Buhl, Sussi F; Andersen, Aino L; Andersen, Jens Rikardt; Andersen, Ove; Jensen, Jens-Erik B; Rasmussen, Anne Mette L; Pedersen, Mette M; Damkjær, Lars; Gilkes, Hanne; Petersen, Janne

    2016-01-01

    BACKGROUND & AIM: Stress metabolism is associated with accelerated loss of muscle that has large consequences for the old medical patient. The aim of this study was to investigate if an intervention combining protein and resistance training was more effective in counteracting loss of muscle than ...... differences were found. CONCLUSION: No significant effect on muscle mass was observed in this group of acutely ill old medical patients. High compliance was achieved with the dietary intervention, but resistance training was challenging. Clinical trials identifier NCT02077491....

  3. A three-group study, internet-based, face-to-face based and standard- management after acute whiplash associated disorders (WAD – choosing the most efficient and cost-effective treatment: study protocol of a randomized controlled trial

    Bring Annika

    2009-07-01

    Full Text Available Abstract Background The management of Whiplash Associated Disorders is one of the most complicated challenges with high expenses for the health care system and society. There are still no general guidelines or scientific documentation to unequivocally support any single treatment for acute care following whiplash injury. The main purpose of this study is to try a new behavioural medicine intervention strategy at acute phase aimed to reduce the number of patients who have persistent problems after the whiplash injury. The goal is also to identify which of three different interventions that is most cost-effective for patients with Whiplash Associated Disorders. In this study we are controlling for two factors. First, the effect of behavioural medicine approach is compared with standard care. Second, the manner in which the behavioural medicine treatment is administered, Internet or face-to-face, is evaluated in it's effectiveness and cost-effectiveness. Methods/Design The study is a randomized, prospective, experimental three-group study with analyses of cost-effectiveness up to two-years follow-up. Internet – based programme and face-to-face group treatment programme are compared to standard-treatment only. Patient follow-ups take place three, six, twelve and 24 months, that is, short-term as well as long-term effects are evaluated. Patients will be enrolled via the emergency ward during the first week after the accident. Discussion This new self-help management will concentrate to those psychosocial factors that are shown to be predictive in long-term problems in Whiplash Associated Disorders, i.e. the importance of self-efficacy, fear of movement, and the significance of catastrophizing as a coping strategy for restoring and sustaining activities of daily life. Within the framework of this project, we will develop, broaden and evaluate current physical therapy treatment methods for acute Whiplash Associated Disorders. The project will

  4. Comparison of the Anti-Adhesion Activity of Three Different Cranberry Extracts on Uropathogenic P-fimbriated Escherichia coli: a Randomized, Double-blind, Placebo Controlled, Ex Vivo, Acute Study.

    Howell, Amy; Souza, Dan; Roller, Marc; Fromentin, Emilie

    2015-07-01

    Research suggests that cranberry (Vaccinium macrocarpon) helps maintain urinary tract health. Bacterial adhesion to the uroepithelium is the initial step in the progression to development of a urinary tract infection. The bacterial anti-adhesion activity of cranberry proanthocyanidins (PACs) has been demonstrated in vitro. Three different cranberry extracts were developed containing a standardized level of 36 mg of PACs. This randomized, double-blind, placebo controlled, ex vivo, acute study was designed to compare the anti-adhesion activity exhibited by human urine following consumption of three different cranberry extracts on uropathogenic P-fimbriated Escherichia coli in healthy men and women. All three cranberry extracts significantly increased anti-adhesion activity in urine. from 6 to 12 hours after intake of a single dose standardized to deliver 36 mg of PACs (as measured by the BL-DMAC method), versus placebo. PMID:26411014

  5. Scintigraphic evaluation of routine filterwire distal protection in percutaneous coronary intervention for acute ST-segment elevation myocardial infarction: a randomized controlled trial

    Kaltoft, Anne; Nielsen, Søren Steen; Terkelsen, Christian Juhl;

    2009-01-01

    AIM: Distal embolization during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) may result in reduced myocardial perfusion, infarct extension and impaired prognosis. In a prospective randomized trial, we assessed the effect of routine filterwire...... distal protection on scintigraphic estimated infarct size. METHODS AND RESULTS: The effect of routine filterwire distal protection was evaluated in 344 patients with STEMI <12 hours undergoing primary PCI. Patients were randomized to distal protection with a filterwire or standard PCI. The primary...... endpoint was myocardial infarct size measured by Sestamibi SPECT after 30 days (%). Secondary endpoints included myocardial salvage, ST-segment resolution (STR), myocardial biomarker release and major adverse cardiac and cerebral events. Baseline characteristics including area at risk (estimated by...

  6. A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision

    Agren, Magnus S; Ostenfeld, Ulla; Kallehave, Finn;

    2006-01-01

    The purpose of this randomized, double-blind, placebo-controlled multicenter trial was to compare topical zinc oxide with placebo mesh on secondary healing pilonidal wounds. Sixty-four (53 men) consecutive patients, aged 17-60 years, were centrally randomized to either treatment with 3% zinc oxide...... (n = 33) or placebo (n = 31) by concealed allocation. Patients were followed with strict recording of beneficial and harmful effects including masked assessment of time to complete wound closure. Analysis was carried out on an intention-to-treat basis. Median healing times were 54 days (interquartile...... range 42-71 days) for the zinc and 62 days (55-82 days) for the placebo group (p = 0.32). Topical zinc oxide increased (p < 0.001) wound fluid zinc levels to 1,540 (1,035-2,265) microM and decreased (p < 0.05) the occurrence of Staphylococcus aureus in wounds. Fewer zinc oxide (n = 3) than placebo...

  7. A Randomized Controlled Trial of Glucose versus Amylase Resistant Starch Hypo-Osmolar Oral Rehydration Solution for Adult Acute Dehydrating Diarrhea

    Ramakrishna, Balakrishnan S.; Subramanian, Venkataraman; Mohan, Vivek; Sebastian, Bendon K; Young, Graeme P.; Farthing, Michael J; Binder, Henry J.

    2008-01-01

    Background Reduction of gross diarrhea rate in excess of that seen over time with intravenous therapy and appropriate antibiotics is not usually achieved by oral glucose-electrolyte rehydration therapy for cholera and cholera-like diarrheas. Methodology and Principal Findings This prospective randomized clinical trial at a tertiary referral hospital in southern India was undertaken to determine whether amylase resistant starch, substituting for glucose in hypo-osmolar oral rehydration solutio...

  8. Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: A randomized trial

    Tardif, Jean-claude; Ballantyne, Christie M.; Barter, Philip; Dasseux, Jean-Louis; Fayad, Zahi A; Guertin, Marie-Claude; Kastelein, John J. P.; Keyserling, Constance; Klepp, Heather; Koenig, Wolfgang; L'Allier, Philippe L.; Lespérance, Jacques; Lüscher, Thomas F.; Paolini, John F.; Tawakol, Ahmed

    2014-01-01

    Aim High-density lipoproteins (HDLs) have several potentially protective vascular effects. Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo. Objective: To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography (IVUS) and quantitative coronary angiography (QCA). Design and setting A prospective, double-blinded, randomized trial was conducted at 51 centres in the USA, the Netherlands, Canada, and France. Intra...

  9. Amisulpride plus valproate vs haloperidol plus valproate in the treatment of acute mania of bipolar I patients: a multicenter, open-label, randomized, comparative trial

    Thomas, Pierre; Vieta, Eduard; ,

    2008-01-01

    The primary objective of this study was to compare the effectiveness of combination treatment of valproate and amisulpride with that of valproate and haloperidol in bipolar I disorder. Adult inpatients with a current manic episode fulfilling DSM-IV-TR diagnostic criteria for bipolar type I disorder were included. Patients were randomized to amisulpride (400–800 mg/day) or haloperidol (5–15 mg/day) for 3 months and all received valproate. The primary effectiveness criterion was the percentage ...

  10. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication — A randomized controlled trial

    Wurdak, M.; Wolstein, J; Kuntsche, E.N.

    2015-01-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized controlled trial, 254 adolescents received a psychosocial intervention plus motive-tailored (intervention group; IG) or general exercises (control group; CG). Adolescents in the IG received exercises in ...

  11. Cyanoacrylate Injection Compared with Band Ligation for Acute Gastric Variceal Hemorrhage: A Meta-Analysis of Randomized Controlled Trials and Observational Studies

    2014-01-01

    Background. Cyanoacrylate injection (GVO) and band ligation (GVL) are effective treatments for gastric variceal hemorrhage. However, data on the optimal treatment are still controversial. Methods. For our overall analysis, relevant studies were identified from several databases. For each outcome, data were pooled using a fixed-effect or random-effects model according to the result of a heterogeneity test. Results. Seven studies were included. Compared with GVL, GVO was associated with increas...

  12. Mometasone Furoate Effect on Acute Skin Toxicity in Breast Cancer Patients Receiving Radiotherapy: A Phase III Double-Blind, Randomized Trial From the North Central Cancer Treatment Group N06C4

    Purpose: A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy. Methods and Materials: Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy. Results: A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002). Conclusion: Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.

  13. Mometasone Furoate Effect on Acute Skin Toxicity in Breast Cancer Patients Receiving Radiotherapy: A Phase 3 Double-Blind, Randomized Trial from the North Central Cancer Treatment Group N06C4

    Miller, Robert C.; Schwartz, David J.; Sloan, Jeff A.; Griffin, Patricia C.; Deming, Richard L.; Anders, Jon C.; Stoffel, Thomas J.; Haselow, Robert E.; Schaefer, Paul L.; Bearden, James D.; Atherton, Pamela J.; Loprinzi, Charles L.; Martenson, James A.

    2010-01-01

    Purpose A 2-arm, double-blinded, randomized trial to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy. Methods and Materials Patients with ductal carcinoma in situ or invasive breast carcinoma receiving external beam radiotherapy to breast or chest wall were randomly assigned to daily apply 0.1% MMF or placebo cream. Primary study end point was provider-assessed maximum grade of Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation dermatitis. Secondary end points included provider-assessed CTCAE grade 3 or greater radiation dermatitis and adverse-event monitoring. Patient-reported outcome (PRO) measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and quality of life self-assessment. Assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy. Results In total, 176 patients were enrolled from September 21, 2007 through December 7, 2007. The provider-assessed primary end point showed no difference in mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs 1.3 for placebo; P=.18). CTCAE toxicity was greater in placebo group (P=.04), primarily from pruritus. For PRO measures, the maximum Skindex-16 score for MMF group showed less itching (P=.008), less irritation (P=.01), less symptom persistence or recurrence (P=.02), and less annoyance with skin problems (P=.04); the group's maximum Skin Toxicity Assessment Tool score showed less burning sensation (P=.02) and less itching (P=.002). Conclusion Patients receiving daily MMF during radiotherapy may experience reduced acute skin toxicity in comparison to placebo. PMID:20800381

  14. Comparative study on the ACE inhibitors Quinapril and Captopril for the (Angiotensin converting enzyme) treatment of the decompensated cardiac insufficiency in dog

    In a randomized study of 52 dogs the efficacy and safety of captopril and quinapril in the treatment of canine heart failure is studied. The drugs were found to be comparably effective. The recommended dosage schedule for the short acting captopril is three times daily 0.5 mg/kg body weight. Quinapril belongs to a newer generation of ACE inhibitors with a longer half life than captopril and the treatment was started with a single dose of 0.5 mg/kg body weight. This dosage schedule was sufficient for the successful therapy of most of the dogs with heart failure phase II (12 of 13), but in 4 of 7 dogs with heart failure phase III and in all of the patients with phase IV the single dose had to be increased and/or the dosing interval of quinapril had to be shortened, because they still showed complaints due to heart failure. We recommend to adjust the dosage schedule of quinapril individually to the severity of heart failure. Therapy should be started once daily with an application of 0,5 mg/kg body weight and the dog should be controlled about one week later. If there are still symptoms of decompensated heart failure, the dosage may be increased gradually until a maximum dosage of 0.5 mg/kg three times daily. Especially for patients with severe heart failure we recommend at least when treatment is started a concomitant diuretic therapy. Echocardiographic evaluation of cardiac function shows if there is an indication for positive inotropic support witha digitalis glycoside. Quinapril, a novel inhibitor of the angiotensin-converting enzyme can ease the management of canine heart failure, because at least in dogs with mild to moderate heart failure dosing interval is longer compared with captopril. Moreover, quinapril is available as 5 mg tablets whereas the smallest captopril tablets contain 12.5 mg agent. It has to be mentioned that expenses for a treatment with ACE inhibitors are significantly higher than for a therapy with digitalis, so frequently above all the

  15. Economic evaluation of the artificial liver support system MARS in patients with acute-on-chronic liver failure

    Hessel Franz P

    2006-10-01

    Full Text Available Abstract Background Acute-on-chronic liver failure (ACLF is a life threatening acute decompensation of a pre-existing chronic liver disease. The artificial liver support system MARS is a new emerging therapeutic option possible to be implemented in routine care of these patients. The medical efficacy of MARS has been demonstrated in first clinical studies, but economic aspects have so far not been investigated. Objective of this study was to estimate the cost-effectiveness of MARS. Methods In a clinical cohort trial with a prospective follow-up of 3 years 33 ACLF-patients treated with MARS were compared to 46 controls. Survival, health-related quality of life as well as direct medical costs for in- and outpatient treatment from a health care system perspective were determined. Based on the differences in outcome and indirect costs the cost-effectiveness of MARS expressed as incremental costs per life year gained and incremental costs per QALY gained was estimated. Results The average initial intervention costs for MARS were 14600 EUR per patient treated. Direct medical costs over 3 years follow up were overall 40000 EUR per patient treated with MARS respectively 12700 EUR in controls. The 3 year survival rate after MARS was 52% compared to 17% in controls. Kaplan-Meier analysis of cumulated survival probability showed a highly significant difference in favour of MARS. Incremental costs per life-year gained were 31400 EUR; incremental costs per QALY gained were 47200 EUR. Conclusion The results after 3 years follow-up of the first economic evaluation study of MARS based on empirical patient data are presented. Although high initial treatment costs for MARS occur the significantly better survival seen in this study led to reasonable costs per live year gained. Further randomized controlled trials investigating the medical efficacy and the cost-effectiveness are recommended.

  16. Analysis of Workflow and Time to Treatment and the Effects on Outcome in Endovascular Treatment of Acute Ischemic Stroke: Results from the SWIFT PRIME Randomized Controlled Trial.

    Goyal, Mayank; Jadhav, Ashutosh P; Bonafe, Alain; Diener, Hans; Mendes Pereira, Vitor; Levy, Elad; Baxter, Blaise; Jovin, Tudor; Jahan, Reza; Menon, Bijoy K; Saver, Jeffrey L

    2016-06-01

    Purpose To study the relationship between functional independence and time to reperfusion in the Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial in patients with disabling acute ischemic stroke who underwent endovascular therapy plus intravenous tissue plasminogen activator (tPA) administration versus tPA administration alone and to investigate variables that affect time spent during discrete steps. Materials and Methods Data were analyzed from the SWIFT PRIME trial, a global, multicenter, prospective study in which outcomes were compared in patients treated with intravenous tPA alone or in combination with the Solitaire device (Covidien, Irvine, Calif). Between December 2012 and November 2014, 196 patients were enrolled. The relation between time from (a) symptom onset to reperfusion and (b) imaging to reperfusion and clinical outcome was analyzed, along with patient and health system characteristics that affect discrete steps in patient workflow. Multivariable logistic regression was used to assess relationships between time and outcome; negative binomial regression was used to evaluate effects on workflow. The institutional review board at each site approved the trial. Patients provided written informed consent, or, at select sites, there was an exception from having to acquire explicit informed consent in emergency circumstances. Results In the stent retriever arm of the study, symptom onset to reperfusion time of 150 minutes led to 91% estimated probability of functional independence, which decreased by 10% over the next hour and by 20% with every subsequent hour of delay. Time from arrival at the emergency department to arterial access was 90 minutes (interquartile range, 69-120 minutes), and time to reperfusion was 129 minutes (interquartile range, 108-169 minutes). Patients who initially arrived at a referring facility had longer symptom onset to groin puncture times compared with

  17. Effect of a Simple Information Booklet on Pain Persistence after an Acute Episode of Low Back Pain: A Non-Randomized Trial in a Primary Care Setting

    Coudeyre, Emmanuel; Baron, Gabriel; Coriat, Fernand; Brin, Sylvie; Revel, Michel; Poiraudeau, Serge

    2007-01-01

    Objective Mass-media campaigns have been known to modify the outcome of low back pain (LBP). We assessed the impact on outcome of standardized written information on LBP given to patients with acute LBP. Methods Design: A 3-month pragmatic, multicenter controlled trial with geographic stratification. Setting: Primary care practice in France. Participants: 2752 patients with acute LBP. Intervention: An advice book on LBP (the “back book”). Main outcome measures: The main outcome measure was persistence of LBP three months after baseline evaluation. Results 2337 (85%) patients were assessed at follow-up and 12.4% of participants reported persistent LBP. The absolute risk reduction of reporting persistent back pain in the intervention group was 3.6% lower than in the control group (10.5% vs. 14.1%; 95% confidence interval [−6.3% ; −1.0%]; p value adjusted for cluster effect = 0.01). Patients in the intervention group were more satisfied than those in the control group with the information they received about physical activities, when to consult their physician, and how to prevent a new episode of LBP. However, the number of patients who had taken sick leave was similar, as was the mean sick-leave duration, in both arms, and, among patients with persistent pain at follow-up, the intervention and control groups did not differ in disability or fear-avoidance beliefs. Conclusions The level of improvement of an information booklet is modest, but the cost and complexity of the intervention is minimal. Therefore, the implications and generalizability of this intervention are substantial. Trial Registration ClinicalTrials.gov NCT00343057 PMID:17684553

  18. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting.

    Emmanuel Coudeyre

    Full Text Available Mass-media campaigns have been known to modify the outcome of low back pain (LBP. We assessed the impact on outcome of standardized written information on LBP given to patients with acute LBP.A 3-month pragmatic, multicenter controlled trial with geographic stratification.Primary care practice in France.2752 patients with acute LBP.An advice book on LBP (the "back book".The main outcome measure was persistence of LBP three months after baseline evaluation.2337 (85% patients were assessed at follow-up and 12.4% of participants reported persistent LBP. The absolute risk reduction of reporting persistent back pain in the intervention group was 3.6% lower than in the control group (10.5% vs. 14.1%; 95% confidence interval [-6.3% ; -1.0%]; p value adjusted for cluster effect = 0.01. Patients in the intervention group were more satisfied than those in the control group with the information they received about physical activities, when to consult their physician, and how to prevent a new episode of LBP. However, the number of patients who had taken sick leave was similar, as was the mean sick-leave duration, in both arms, and, among patients with persistent pain at follow-up, the intervention and control groups did not differ in disability or fear-avoidance beliefs.The level of improvement of an information booklet is modest, but the cost and complexity of the intervention is minimal. Therefore, the implications and generalizability of this intervention are substantial.ClinicalTrials.gov NCT00343057.

  19. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: A randomized controlled trial [ISRCTN87413556

    McRae Sarah E

    2005-03-01

    Full Text Available Abstract Background The management of burn injuries is reported as painful, distressing and a cause of anxiety in children and their parents. Child's and parents' pain and anxiety, often contributes to extended time required for burns management procedures, in particular the process of changing dressings. The traditional method of pharmacologic analgesia is often insufficient to cover the burnt child's pain, and it can have deleterious side effects 12. Intervention with Virtual Reality (VR games is based on distraction or interruption in the way current thoughts, including pain, are processed by the brain. Research on adults supports the hypothesis that virtual reality has a positive influence on burns pain modulation. Methods This study investigates whether playing a virtual reality game, decreases procedural pain in children aged 5–18 years with acute burn injuries. The paper reports on the findings of a pilot study, a randomised trial, in which seven children acted as their own controls though a series of 11 trials. Outcomes were pain measured using the self-report Faces Scale and findings of interviews with parent/carer and nurses. Results The average pain scores (from the Faces Scale for pharmacological analgesia only was, 4.1 (SD 2.9, while VR coupled with pharmacological analgesia, the average pain score was 1.3 (SD 1.8 Conclusion The study provides strong evidence supporting VR based games in providing analgesia with minimal side effects and little impact on the physical hospital environment, as well as its reusability and versatility, suggesting another option in the management of children's acute pain.

  20. Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial

    2013-01-01

    Background Posttraumatic Stress Disorder (PTSD) may occur in patients after exposure to a life-threatening illness. About one out of six patients develop clinically relevant levels of PTSD symptoms after acute myocardial infarction (MI). Symptoms of PTSD are associated with impaired quality of life and increase the risk of recurrent cardiovascular events. The main hypothesis of the MI-SPRINT study is that trauma-focused psychological counseling is more effective than non-trauma focused counseling in preventing posttraumatic stress after acute MI. Methods/Design The study is a single-center, randomized controlled psychological trial with two active intervention arms. The sample consists of 426 patients aged 18 years or older who are at 'high risk’ to develop clinically relevant posttraumatic stress symptoms. 'High risk’ patients are identified with three single-item questions with a numeric rating scale (0 to 10) asking about 'pain during MI’, 'fear of dying until admission’ and/or 'worrying and feeling helpless when being told about having MI’. Exclusion criteria are emergency heart surgery, severe comorbidities, current severe depression, disorientation, cognitive impairment and suicidal ideation. Patients will be randomly allocated to a single 45-minute counseling session targeting either specific MI-triggered traumatic reactions (that is, the verum intervention) or the general role of psychosocial stress in coronary heart disease (that is, the control intervention). The session will take place in the coronary care unit within 48 hours, by the bedside, after patients have reached stable circulatory conditions. Each patient will additionally receive an illustrated information booklet as study material. Sociodemographic factors, psychosocial and medical data, and cardiometabolic risk factors will be assessed during hospitalization. The primary outcome is the interviewer-rated posttraumatic stress level at three-month follow-up, which is hypothesized to be

  1. Efficacy of sorghum peanut blend and corn soy blend plus in the treatment of moderate acute malnutrition in children aged 6–59 months in Karamoja, Uganda: a cluster randomized trial

    Amegovu AK

    2014-08-01

    Full Text Available Andrew Kiri Amegovu,1 Sophie Ochola,1 Patrick Ogwok,2 Peter Yiga,2 Juliet Musalima,2 Mandha Juliana2 1Department of Food, Nutrition and Dietetics, Kenyatta University, Nairobi, Kenya; 2Department of Food Technology, Kyambogo University, Kampala, Uganda Abstract: More than half of the world's deaths in children below 5 years of age are caused by under nutrition. Early management of moderate acute malnutrition (MAM is necessary to avoid deterioration to severe acute malnutrition. Corn soy blend plus (CSB+ mixed with vegetable oil and sugar is the traditional treatment for MAM but is too expensive for poor countries. The effectiveness of affordable and available local food materials are currently being studied as alternative food supplements to treat malnutrition. In this trial, the efficacy of sorghum peanut blend (SPB mixed with ghee and honey for the treatment of MAM was compared to that of CSB+ among children 6–59 months old in Karamoja, Uganda. This was a single-blind randomized parallel trial in which two health centers were assigned on a 1:1 ratio to the two study groups. The participants (mothers and their moderately malnourished children were recruited at the health centers and assigned to the groups depending on the health facility attended. Each child received a daily ration of either CSB+ or SPB for a maximum period of 3 months. Anthropometric measurements of the children were taken on a bi-weekly basis. The primary outcomes were the recovery rate and duration on the program before recovery. Of the recruited 440 participants, 392 completed the study and were included in the analysis (SPB group 194; CSB+ group 198. Analysis was by intention to treat. The recovery rates were not significantly different for the SPB group and the CSB+ group (82.3% and 76.8%, respectively; chi-square test P=0.093. Duration of recovery was significantly shorter for the SPB+ group, with a median of 43 days compared to 57 days for the SPB group (Kaplan

  2. The acute effect of exercise modality and nutrition manipulations on post-exercise resting energy expenditure and respiratory exchange ratio in women: a randomized trial

    Wingfield, Hailee L; Smith-Ryan, Abbie E; Melvin, Malia N; Roelofs, Erica J.; Trexler, Eric T; Hackney, Anthony C; Mark A. Weaver; Ryan, Eric D

    2015-01-01

    Background The purpose of this study was to examine the effect of exercise modality and pre-exercise carbohydrate (CHO) or protein (PRO) ingestion on post-exercise resting energy expenditure (REE) and respiratory exchange ratio (RER) in women. Methods Twenty recreationally active women (mean ± SD; age 24.6 ± 3.9 years; height 164.4 ± 6.6 cm; weight 62.7 ± 6.6 kg) participated in this randomized, crossover, double-blind study. Each participant completed six exercise sessions, consisting of thr...

  3. Efficacy and safety of tonabersat, a gap-junction modulator, in the acute treatment of migraine: a double-blind, parallel-group, randomized study

    Hauge, A W; Olesen, J; Dahlöf, C G H;

    2009-01-01

    The ability of tonabersat to relieve the symptoms of migraine attacks with or without aura was evaluated in a randomized, double-blind, placebo-controlled, multicentre, parallel-group study. Patients received 20 or 40 mg of tonabersat, or 50 mg of sumatriptan (positive control), or placebo at the...... onset of a moderate or severe attack. Headache intensity, relief and recurrence were recorded for 24 h after dosing. On the basis of primary or secondary efficacy measures, tonabersat did not provide a clinically or statistically significant advantage over placebo. Tonabersat generally was well...

  4. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT

    van Assen Luite

    2010-01-01

    Full Text Available Abstract Background Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. Methods/Design This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum till one year (maximum will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands. The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy, also for a period of six weeks. Primary outcomes are Global Perceived Effect (GPE and functional status (Neck Disability Index (NDI-DV. Secondary outcomes are neck pain (Numeric Rating Scale (NRS, Eurocol, costs and quality of life (SF36. Discussion This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. Trial registration ClinicalTrials.gov Identifier: NCT00713843

  5. Randomization tests

    Edgington, Eugene

    2007-01-01

    Statistical Tests That Do Not Require Random Sampling Randomization Tests Numerical Examples Randomization Tests and Nonrandom Samples The Prevalence of Nonrandom Samples in Experiments The Irrelevance of Random Samples for the Typical Experiment Generalizing from Nonrandom Samples Intelligibility Respect for the Validity of Randomization Tests Versatility Practicality Precursors of Randomization Tests Other Applications of Permutation Tests Questions and Exercises Notes References Randomized Experiments Unique Benefits of Experiments Experimentation without Mani

  6. Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01] - study protocol and baseline practice and provider characteristics

    2013-01-01

    Background Inappropriate antibiotic prescribing for nonbacterial infections leads to increases in the costs of care, antibiotic resistance among bacteria, and adverse drug events. Acute respiratory infections (ARIs) are the most common reason for inappropriate antibiotic use. Most prior efforts to decrease inappropriate antibiotic prescribing for ARIs (e.g., educational or informational interventions) have relied on the implicit assumption that clinicians inappropriately prescribe antibiotics because they are unaware of guideline recommendations for ARIs. If lack of guideline awareness is not the reason for inappropriate prescribing, educational interventions may have limited impact on prescribing rates. Instead, interventions that apply social psychological and behavioral economic principles may be more effective in deterring inappropriate antibiotic prescribing for ARIs by well-informed clinicians. Methods/design The Application of Behavioral Economics to Improve the Treatment of Acute Respiratory Infections (BEARI) Trial is a multisite, cluster-randomized controlled trial with practice as the unit of randomization. The primary aim is to test the ability of three interventions based on behavioral economic principles to reduce the rate of inappropriate antibiotic prescribing for ARIs. We randomized practices in a 2 × 2 × 2 factorial design to receive up to three interventions for non-antibiotic-appropriate diagnoses: 1) Accountable Justifications: When prescribing an antibiotic for an ARI, clinicians are prompted to record an explicit justification that appears in the patient electronic health record; 2) Suggested Alternatives: Through computerized clinical decision support, clinicians prescribing an antibiotic for an ARI receive a list of non-antibiotic treatment choices (including prescription options) prior to completing the antibiotic prescription; and 3) Peer Comparison: Each provider’s rate of inappropriate antibiotic prescribing relative to top

  7. Intraoperative Low-Dose Ketamine Infusion Reduces Acute Postoperative Pain Following Total Knee Replacement Surgery: A Prospective, Randomized Double-Blind Placebo-Controlled Trial

    Objective: To evaluate the effect of intraoperative low-dose ketamine with general anesthesia on postoperative pain after total knee replacement surgery. Study Design: A randomized, double-blind comparative study. Place and Duration of Study: Ankara Numune Training and Research Hospital, Turkey, from January and June 2011. Methodology: Sixty adults undergoing total knee arthroplasty were enrolled in this study. The patients were randomly allocated into two groups of equal size to receive either racemic ketamine infusion (6.25 g/kg/minute) or the same volume of saline. A visual analogue scale (VAS) was used to measure each patient's level of pain at 1, 3, 6, 12, and 24 hours after surgery. Time to first analgesic request, postoperative morphine consumption and the incidence of side effects were also recorded. Results: Low-dose ketamine infusion prolonged the time to first analgesic request. It also reduced postoperative cumulative morphine consumption at 1, 3, 6, 12, and 24 hours postsurgery (p < 0.001). Postoperative VAS scores were also significantly lower in the ketamine group than placebo, at all observation times. Incidences of side effects were similar in both study groups. Conclusion: Intraoperative continuous low-dose ketamine infusion reduced pain and postoperative analgesic consumption without affecting the incidence of side effects. (author)

  8. 重组人生长激素和人血白蛋白对肝硬化失代偿的疗效比较%Therapeutic Effect Comparison of Recombinant Human Growth Hormone and Human Serum Albumin in Decompensative Liver Cirrhosis

    刘慧; 邱小文

    2011-01-01

    目的 考察重组人生长激素与人血白蛋白对失代偿期肝硬化的治疗效果.方法 将42例白蛋白低于35g/L的失代偿期肝硬化患者随机分为两组,生长激素治疗组:20例,予重组人生长激素4IU,肌注,1次/2 d,疗程30天;白蛋白治疗组:22例,予20%人血白蛋白50 ml,静滴,2次/周,疗程30天.两组患者同时予相同保肝、对症治疗.于治疗第15天、30天、60天、90天测定各项指标.结果 15天时,白蛋白组血清白蛋白含量上升(P<0.05);30天时,两组患者血清白蛋白含量均上升(P<0.05);60天后,生长激素治疗组血清白蛋白水平升至最高点,白蛋白治疗组较前降低,两组间差异有统计学意义(P<0.01);90天后生长激素治疗组血清白蛋白含量仍维持较高,且肝功能好转,而白蛋白治疗组降至治疗前水平.结论 重组人生长激素与人血白蛋白均可明显提高失代偿期肝硬化血清白蛋白水平,但重组人生长激素,对肝硬化失代偿的治疗作用,中远期疗效更好.%Objective To compare the therapeutic effects of recombinant human growth hormone and human serum albumin on decompensative liver cirrhosis.Methods Forty-two patients diagnosed as decompensative liver cirrhosis with sera albumin below 35 g/L, were randomly divided into two groups.Besides conventional liver-protecting treatment, 20 were treated by recombinant human growth hormone 4 IU, intramuscular injection, once every two days, 30 days as a period of treatment; 22 cases were treated by 20% human serum albumin 50 ml, intravenous injection, twice a week, 30 days as a period of treatment.On 15, 30, 60 and 90 days of the treatment, albumin, alanine aminotransferase (ALT) and others indexes were tested.Results On the 15th day, the serum albumin was increased only in albumin group (P<0.05).On the 30th day, the serum albumin was increased in both groups (P<0.05).But on the 60th day, the serum albumin remained to increase and reached to peak in growth

  9. The impact of therapy for childhood acute lymphoblastic leukaemia on intelligence quotients; results of the risk-stratified randomized central nervous system treatment trial MRC UKALL XI

    Vargha-Khadem Faraneh

    2011-10-01

    Full Text Available Abstract Background The MRC UKALLXI trial tested the efficacy of different central nervous system (CNS directed therapies in childhood acute lymphoblastic leukaemia (ALL. To evaluate morbidity 555/1826 randomised children underwent prospective psychological evaluations. Full Scale, verbal and performance IQs were measured at 5 months, 3 years and 5 years. Scores were compared in; (1 all patients (n = 555 versus related controls (n = 311, (2 low-risk children (presenting white cell count (WCC 9/l randomised to intrathecal methotrexate (n = 197 versus intrathecal and high-dose intravenous methotrexate (HDM (n = 202, and (3 high-risk children (WCC ≥ 50 × 109/l, age ≥ 2 years randomised to HDM (n = 79 versus cranial irradiation (n = 77. Results There were no significant differences in IQ scores between the treatment arms in either low- or high-risk groups. Despite similar scores at baseline, results at 3 and 5 years showed a significant reduction of between 3.6 and 7.3 points in all three IQ scores in all patient groups compared to controls (P Conclusion Children with ALL are at risk of CNS morbidity, regardless of the mode of CNS-directed therapy. Further work needs to identify individuals at high-risk of adverse CNS outcomes. Trial registration ISRCTN: ISRCTN16757172

  10. MELD vs Child-Pugh and creatinine-modified Child-Pugh score for predicting survival in patients with decompensated cirrhosis

    George V. Papatheodoridis; Evangelos Cholongitas; Eleni Dimitriadou; Giota Touloumi; Vassilios Sevastianos; Athanasios J. Archimandritis

    2005-01-01

    AIM: Model of End-stage Liver Disease (MELD) score has recently gained wide acceptance over the old Child-Pugh score in predicting survival in patients with decompensated cirrhosis, although it is more sophisticated. We compared the predictive values of MELD, Child-Pugh and creatinine modified Child-Pugh scores in decompensated cirrhosis. METHODS: A cohort of 102 patients with decompensated cirrhosis followed-up for a median of 6 mo was studied.Two types of modified Child-Pugh scores estimated by adding 0-4 points to the original score using creatinine levels as a sixth categorical variable were evaluated.RESULTS: The areas under the receiver operating characteristic curves did not differ significantly among the four scores, but none had excellent diagnostic accuracy (areas:0.71-0.79). Child-Pugh score appeared to be the worst, while the accuracy of MELD was almost identical with that of modified Child-Pugh in predicting short-term and slightly better in predicting medium-term survival. In Cox regression analysis, all four scores were significantly associated with survival, while MELD and creatinine-modified Child-Pugh scores had better predictive values (c-statistics: 0.73 and 0.69-0.70) than Child-Pugh score (c-statistics: 0.65). Adjustment for gamma-glutamate transpeptidase levels increased the predictive values of all systems (c-statistics: 0.77-0.81). Analysis of the expected and observed survival curves in patients subgroups according to their prognosis showed that all models fit the data reasonably well with MELD probably discriminating better the subgroups with worse prognosis. CONCLUSION: MELD compared to the old Child-Pugh and particularly to creatinine-modified Child-Pugh scores does not appear to offer a clear advantage in predicting survival in patients with decompensated cirrhosis in daily clinical practice.

  11. Early Indication of Decompensated Heart Failure in Patients on Home-Telemonitoring: A Comparison of Prediction Algorithms Based on Daily Weight and Noninvasive Transthoracic Bio-impedance

    Cuba Gyllensten, Illapha; Alberto G Bonomi; Goode, Kevin M.; Reiter, Harald; Habetha, Joerg; Amft, Oliver; Cleland, John GF

    2016-01-01

    Background Heart Failure (HF) is a common reason for hospitalization. Admissions might be prevented by early detection of and intervention for decompensation. Conventionally, changes in weight, a possible measure of fluid accumulation, have been used to detect deterioration. Transthoracic impedance may be a more sensitive and accurate measure of fluid accumulation. Objective In this study, we review previously proposed predictive algorithms using body weight and noninvasive transthoracic bio-...

  12. AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR HIGH-RISK ACUTE LYMPHOBLASTIC LEUKEMIA: NON-RANDOMIZED STUDY WITH A MAXIMUM FOLLOW-UP OF MORE THAN 22 YEARS

    Grzegorz Helbig

    2014-06-01

    Full Text Available Objective. To evaluate the efficacy and toxicity of autologous hematopoietic stem cell transplantation (AHSCT for high-risk acute lymphoblastic leukemia (ALL. Material and methods. Overall, 128 high-risk ALL patients at a median age of 26 years (range 18-56 years at diagnosis received AHSCT between 1991-2008. Induction treatment was anthracycline-based in all patients. Conditioning regimen consisted of CAV (cyclophosphamide, cytarabine, etoposide in 125 patients whereas 3 subjects received cyclophosphamide and TBI (total body irridation. Bone marrow was stored for 72 hours in 4oC and re-infused 24 hours after conditioning completion. Bone marrow was a source of stem cells in 119 patients, peripheral blood in 2 and 7 subjects received both bone marrow and peripheral blood. Results. With a median follow-up after AHSCT of 1.6 years (range 0.1-22.3 years, the probability of leukemia-free survival (LFS for the whole group at 10 years was 27% and 23% at 20 years. Transplant-related mortality at 100 days after AHSCT was 3.2%.. There was a strong tendency for better LFS for MRD-negative patients if compared with patients who had positive or unknown MRD status at AHSCT (32% vs 23% and 25%, respectively; p=0.06. There was no difference in LFS between B- and T-lineage ALL as well as between patients transplanted in first complete remission (CR1 and CR2. LFS at 10 years for patients with detectable BCR-ABL at transplant was 20% and this was comparable with subjects with negative and missing BCR-ABL status (26% and 28%; p=0.97. Conclusions. The results of AHSCT for high-risk ALL remains unsatisfactory with low probability of long-term LFS.

  13. Prognosis of emergency room stabilization of decompensated congestive heart failure with high dose lasix

    Mahboob Pouraghaei

    2015-06-01

    Full Text Available Objective: Congestive heart failure (CHF has become one of the most important health care problems in western countries. This article focuses on the outpatient diagnosis and management of heart failure. We want to compare the outcome of patients who were treated with high dose diuretics in the emergency department (ED without admission with patients who were admitted to hospital for standard treatment. Methods: This was a randomized prospective clinical trial study. The patients who came to the ED from March 20, 2008 up to August 20, 2008 were divided into two groups randomly. The length of ED stay in the experimental group was documented. Also, readmission and mortality in 6 months and satisfaction in both groups were taken into consideration. All data were analyzed using SPSS 15.0. Results: In experimental group, the rate of recurrent admission, expiration, discharge, clinic visit, and clinic admission was 8%, 4%, 29%, 18%, and 0% respectively. On the other hand, in control group it was 16%, 40%, 18%, 22%, and 2% respectively. Additionally, there was a significant difference between these groups (P = 0.00. Conclusion: This study is the first regional prospective trial to comprehensively examine the therapeutic management in patients with CHF. This study, comparing the high dose diuretic efficacy in the decreasing of hospital stay and readmission; and decreasing mortality rate with routine therapy, showed that there was a significant difference between these two strategies in the mortality rate, readmission, and length of hospital stay (P = 0.00.

  14. A randomized, prospective, two-center comparison of sirolimus-eluting stent and zotarolimus-eluting stent in acute ST-elevation myocardial infarction: The SEZE trial

    Woo-Young Chung; Sang-Hyun Kim; In-Ho Chae; Joo-Hee Zo; Myung-A Kim; Dong-Ju Choi; Jeehoon Kang; Young-Seok Cho; Hae-Jun Park; Han-Mo Yang; Jae-Bin Seo; Jung-Won Suh; Kwang-Il Kim; Tae-Jin Youn

    2012-01-01

    Background The zotarolimus-eluting stent has shown larger in-stent late lumen loss compared to sirolimus-eluting stents in previous studies.However,this has not been thoroughly evaluated in ST elevation myocardial infarction.Methods This was a prospective,randomized,controlled trial evaluating angiographic outcomes in patients presenting with ST elevation myocardial infarction,treated with zotarolimus-eluting stents or sirolimus-eluting stents.From March 2007 to February 2009,122 patients were randomized to zotarolimus-eluting stents or sirolimus-eluting stents in a 1:1 fashion.The primary endpoint was 9-month in-stent late lumen loss confirmed by coronary angiography,and secondary endpoints were percent diameter stenosis,binary restenosis rate,major adverse cardiac events (a composite of cardiac death,non-fatal myocardial infarction,and target vessel revascularization),and late-acquired incomplete stent apposition.Results Angiographic in-stent late lumen loss was significantly higher in the zotarolimus-eluting stent group compared to the sirolimus-eluting stent group ((0.49±0.65) mm vs.(0.10±0.46) mm,P=0.001).Percent diameter stenosis at 9-month follow-up was also larger in the zotarolimus-eluting stent group ((30.0±17.9)% vs.(17.6±14.0)%,P <0.001).In-segment analysis showed similar findings.There were no significant differences in binary restenosis rate,major adverse cardiac events,and late-acquired incomplete stent apposition.Conclusions Compared to sirolimus-eluting stents,the zotarolimus-eluting stent is associated with significantly higher in-stent late lumen loss at 9-month angiographic follow-up in the treatment of ST elevation myocardial infarction.Although there was no significant difference in 1-year clinical outcomes,the clinical implication of increased late lumen loss should be further studied.

  15. Prevention and treatment of acute radiation-induced skin reactions: a systematic review and meta-analysis of randomized controlled trials

    Radiation-induced skin reaction (RISR) is a common side effect that affects the majority of cancer patients receiving radiation treatment. RISR is often characterised by swelling, redness, pigmentation, fibrosis, and ulceration, pain, warmth, burning, and itching of the skin. The aim of this systematic review was to assess the effects of interventions which aim to prevent or manage RISR in people with cancer. We searched the following databases up to November 2012: Cochrane Skin Group Specialised Register, CENTRAL (2012, Issue 11), MEDLINE (from 1946), EMBASE (from 1974), PsycINFO (from 1806), CINAHL (from 1981) and LILACS (from 1982). Randomized controlled trials evaluating interventions for preventing or managing RISR in cancer patients were included. The primary outcomes were development of RISR, and levels of RISR and symptom severity. Secondary outcomes were time taken to develop erythema or dry desquamation; quality of life; time taken to heal, a number of skin reaction and symptom severity measures; cost, participant satisfaction; ease of use and adverse effects. Where appropriate, we pooled results of randomized controlled trials using mean differences (MD) or odd ratios (OR) with 95% confidence intervals (CI). Forty-seven studies were included in this review. These evaluated six types of interventions (oral systemic medications; skin care practices; steroidal topical therapies; non-steroidal topical therapies; dressings and other). Findings from two meta-analyses demonstrated significant benefits of oral Wobe-Mugos E for preventing RISR (OR 0.13 (95% CI 0.05 to 0.38)) and limiting the maximal level of RISR (MD -0.92 (95% CI -1.36 to -0.48)). Another meta-analysis reported that wearing deodorant does not influence the development of RISR (OR 0.80 (95% CI 0.47 to 1.37)). Despite the high number of trials in this area, there is limited good, comparative research that provides definitive results suggesting the effectiveness of any single intervention for

  16. Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial

    Ma Yi-Wen

    2011-04-01

    Full Text Available Abstract Background This post hoc analysis (trial registration: ClinicalTrials.gov NCT00590577 assessed onset of efficacy and tolerability of acute treatment with once-monthly paliperidone palmitate (PP, a long-acting atypical antipsychotic initiated by day 1 and day 8 injections, in a markedly to severely ill schizophrenia population. Methods Subjects entering the 13-week, double-blind trial were randomized to PP (39, 156, or 234 mg [25, 100, and 150 mg eq of paliperidone, respectively] or placebo. This subgroup analysis included those with a baseline Clinical Global Impressions-Severity (CGI-S score indicating marked to severe illness. PP subjects received a 234-mg day 1 injection (deltoid, followed by their assigned dose on day 8 and monthly thereafter (deltoid or gluteal. Thus, data for PP groups were pooled for days 4 and 8. Measures included Positive and Negative Syndrome Scale (PANSS, CGI-S, Personal and Social Performance (PSP, and adverse events (AEs. Analysis of covariance (ANCOVA and last-observation-carried-forward (LOCF methodologies, without multiplicity adjustments, were used to assess changes in continuous measures. Onset of efficacy was defined as the first time point a treatment group showed significant PANSS improvement (assessed days 4, 8, 22, 36, 64, and 92 versus placebo, which was maintained through end point. Results A total of 312 subjects met inclusion criterion for this subgroup analysis. After the day 1 injection, mean PANSS total scores improved significantly with PP (all received 234 mg versus placebo at day 4 (P = 0.012 and day 8 (P = 0.007. After the day 8 injection, a significant PANSS improvement persisted at all subsequent time points in the 234-mg group versus placebo (P P P P Conclusions In this markedly to severely ill population, acute treatment with 234 mg PP improved psychotic symptoms compared with placebo by day 4. After subsequent injections, observed improvements are suggestive of a dose

  17. Cyanoacrylate Injection Compared with Band Ligation for Acute Gastric Variceal Hemorrhage: A Meta-Analysis of Randomized Controlled Trials and Observational Studies

    Xiaohua Ye

    2014-01-01

    Full Text Available Background. Cyanoacrylate injection (GVO and band ligation (GVL are effective treatments for gastric variceal hemorrhage. However, data on the optimal treatment are still controversial. Methods. For our overall analysis, relevant studies were identified from several databases. For each outcome, data were pooled using a fixed-effect or random-effects model according to the result of a heterogeneity test. Results. Seven studies were included. Compared with GVL, GVO was associated with increased likelihood of hemostasis of active bleeding (odds ratio [OR] = 2.32; 95% confidence interval [CI] = 1.19–4.51 and a longer gastric variceal rebleeding-free period (hazard ratio = 0.37; 95% CI = 0.24–0.56. No significant differences were observed between GVL and GVO for mortality (hazard ratio = 0.66; 95% CI = 0.43–1.02, likelihood of variceal obliteration (OR = 0.89; 95% CI = 0.52–1.54, number of treatment sessions required for complete variceal eradication (weighted mean difference = −0.45; 95% CI = −1.14–0.23, or complications (OR = 1.02; 95% CI = 0.48–2.19. Conclusion. GVO may be superior to GVL for achieving hemostasis and preventing recurrence of gastric variceal rebleeding but has no advantage over GVL for mortality and complications. Additional studies are warranted to enable definitive conclusions.

  18. The analgesic efficacy of etoricoxib compared with oxycodone/acetaminophen in an acute postoperative pain model: a randomized, double-blind clinical trial.

    Chang, David J; Desjardins, Paul J; King, Thomas R; Erb, Tara; Geba, Gregory P

    2004-09-01

    Our objective in this study was to compare the analgesic effects of etoricoxib and oxycodone/acetaminophen in a postoperative dental pain model. Patients experiencing moderate to severe pain after extraction of two or more third molars were randomized to single doses of etoricoxib 120 mg (n = 100), oxycodone/acetaminophen 10/650 mg (n = 100), or placebo (n = 25). The primary end-point was total pain relief over 6 h. Other end-points included patient global assessment of response to therapy; onset, peak, and duration of effect; and rescue opioid analgesic use. Active treatments were statistically significantly superior to placebo for all efficacy measures. Total pain relief over 6 h for etoricoxib was significantly more than for oxycodone/acetaminophen (P acetaminophen by 5 min. The peak effect was similar for both drugs. Compared with oxycodone/acetaminophen patients, etoricoxib patients experienced a longer analgesic duration, had a smaller percentage requiring rescue opioids during 6 and 24 h, and required less rescue analgesia during 6 and 24 h. Oxycodone/acetaminophen treatment resulted in more frequent adverse events (AEs), drug-related AEs, nausea, and vomiting compared with etoricoxib treatment. In conclusion, etoricoxib 120 mg provided superior overall efficacy compared with oxycodone/acetaminophen 10/650 mg and was associated with significantly fewer AEs. PMID:15333415

  19. Acute effects of pea protein and hull fibre alone and combined on blood glucose, appetite, and food intake in healthy young men--a randomized crossover trial.

    Mollard, Rebecca C; Luhovyy, Bohdan L; Smith, Christopher; Anderson, G Harvey

    2014-12-01

    Whether pulse components can be used as value-added ingredients in foods formulated for blood glucose (BG) and food intake (FI) control requires investigation. The objective of this study was to examine of the effects of pea components on FI at an ad libitum meal, as well as appetite and BG responses before and after the meal. In a repeated-measures crossover trial, men (n = 15) randomly consumed (i) pea hull fibre (7 g), (ii) pea protein (10 g), (iii) pea protein (10 g) plus hull fibre (7 g), (iv) yellow peas (406 g), and (v) control. Pea hull fibre and protein were served with tomato sauce and noodles, while yellow peas were served with tomato sauce. Control was noodles and tomato sauce. FI was measured at a pizza meal (135 min). Appetite and BG were measured pre-pizza (0-135 min) and post-pizza (155-215 min). Protein plus fibre and yellow peas led to lower pre-pizza BG area under the curve compared with fibre and control. At 30 min, BG was lower after protein plus fibre and yellow peas compared with fibre and control, whereas at 45 and 75 min, protein plus fibre and yellow peas led to lower BG compared with fibre (p yellow peas led to lower BG compared with fibre (p pea components as value-added ingredients in foods designed to improve glycemic control. PMID:25302637

  20. Hepatitis C in Special Patient Cohorts: New Opportunities in Decompensated Liver Cirrhosis, End-Stage Renal Disease and Transplant Medicine

    Anna Hüsing

    2015-08-01

    Full Text Available Worldwide, hepatitis C virus (HCV is a common infection. Due to new antiviral approaches and the approval of direct-acting antiviral agents (DAA, HCV therapy has become more comfortable. Nevertheless, there are special patient groups, in whom treatment of HCV is still challenging. Due to only few data available, tolerability and efficacy of DAAs in special patient cohorts still remain unclear. Such special patient cohorts comprise HCV in patients with decompensated liver disease (Child-Pugh Class B or C, patients with chronic kidney disease, and patients on waiting lists to renal/liver transplantation or those with HCV recurrence after liver transplantation. HCV infection in these patient cohorts has been shown to be associated with increased morbidity and mortality and may lead to reduced graft survival after transplantation. Successful eradication of HCV results in a better outcome concerning liver-related complications and in a better clinical outcome of these patients. In this review, we analyze available data and results from recently published literature and provide an overview of current recommendations of HCV-therapy regimen in these special patient cohorts.

  1. Hepatitis C in Special Patient Cohorts: New Opportunities in Decompensated Liver Cirrhosis, End-Stage Renal Disease and Transplant Medicine.

    Hüsing, Anna; Kabar, Iyad; Schmidt, Hartmut H; Heinzow, Hauke S

    2015-01-01

    Worldwide, hepatitis C virus (HCV) is a common infection. Due to new antiviral approaches and the approval of direct-acting antiviral agents (DAA), HCV therapy has become more comfortable. Nevertheless, there are special patient groups, in whom treatment of HCV is still challenging. Due to only few data available, tolerability and efficacy of DAAs in special patient cohorts still remain unclear. Such special patient cohorts comprise HCV in patients with decompensated liver disease (Child-Pugh Class B or C), patients with chronic kidney disease, and patients on waiting lists to renal/liver transplantation or those with HCV recurrence after liver transplantation. HCV infection in these patient cohorts has been shown to be associated with increased morbidity and mortality and may lead to reduced graft survival after transplantation. Successful eradication of HCV results in a better outcome concerning liver-related complications and in a better clinical outcome of these patients. In this review, we analyze available data and results from recently published literature and provide an overview of current recommendations of HCV-therapy regimen in these special patient cohorts. PMID:26251895

  2. Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial

    Cronin John

    2012-08-01

    Full Text Available Abstract Background Asthma is a major cause of pediatric morbidity and mortality. In acute exacerbations of asthma, corticosteroids reduce relapses, subsequent hospital admission and the need for ß2-agonist therapy. Prednisolone is relatively short-acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Prolonged treatment course, vomiting and a bitter taste may reduce patient compliance with prednisolone. Dexamethasone is a long-acting corticosteroid with a half-life of 36 to 72 hours. It is used frequently in children with croup and bacterial meningitis, and is well absorbed orally. The purpose of this trial is to examine whether a single dose of oral dexamethasone (0.3 mg/kg is clinically non-inferior to prednisolone (1 mg/kg/day for three days in the treatment of exacerbations of asthma in children who attend the Emergency Department. Methods/design This is a randomized, non-inferiority, open-label clinical trial. After informed consent with or without assent, patients will be randomized to either oral dexamethasone 0.3 mg/kg stat or prednisolone 1 mg/kg/day for three days. The primary outcome measure is the comparison between the Pediatric Respiratory Assessment Measure (PRAM across both groups on Day 4. The PRAM score, a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16 years, will be performed by a clinician blinded to treatment allocation. Secondary outcomes include relapse, hospital admission and requirement for further steroid therapy. Data will be analyzed on an intention-to-treat and a per protocol basis. With a sample size of 232 subjects (105 in each group with an estimated 10% loss to follow-up, we will be able to reject the null hypothesis - that the population means of the experimental and control groups are equal with a probability (power of 0.9. The Type I error probability associated with this test (of the null hypothesis is 0.05. Discussion This

  3. Early detection and intervention using neutrophil gelatinase-associated lipocalin (NGAL may improve renal outcome of acute contrast media induced nephropathy: A randomized controlled trial in patients undergoing intra-arterial angiography (ANTI-CIN Study

    Stiegler Philipp

    2011-08-01

    Full Text Available Abstract Background Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN. Neutrophil gelatinase-associated lipocalin (NGAL, a new biomarker predictive for acute kidney injury (AKI, has been shown to be useful for earlier diagnosis of CIN; however, urinary NGAL values may be markedly increased in chronic renal failure at baseline. Results from those studies suggested that urinary NGAL values may not be helpful for the clinician. An intravenous volume load is a widely accepted prophylactic measure and possibly a reasonable intervention to prevent deterioration of renal function. The aim of our study is to evaluate NGAL as an early predictor of CIN and to investigate the clinical benefit of early post-procedural i.v. hydration. Methods/Design The study will follow a prospective, open-label, randomized controlled design. Patients requiring intra-arterial contrast media (CM application will be included and receive standardized, weight-based, intravenous hydration before investigation. Subjects with markedly increased urinary NGAL values after CM application will be randomized into one of two study groups. Group A will receive 3-4 ml/kg BW/h 0.9% saline intravenously for 6 hours. Group B will undergo only standard treatment consisting of unrestricted oral fluid intake. The primary outcome measure will be CIN defined by an increase greater than 25% of baseline serum creatinine. Secondary outcomes will include urinary NGAL values, cystatin C values, contrast media associated changes in cardiac parameters such as NT-pro-BNP/troponin T, changes in urinary cytology, need for renal replacement treatment, length of stay in hospital and death. We assume that 20% of the included patients will show a definite rise in urinary NGAL. Prospective statistical power calculations indicate that the study will have 80% statistical power to detect a clinically significant decrease of CIN of 40% in the

  4. Acute Bronchitis

    ... of bronchitis: acute and chronic. Most cases of acute bronchitis get better within several days. But your cough ... that cause colds and the flu often cause acute bronchitis. These viruses spread through the air when people ...

  5. Study Design for the IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care) Trial: A Double-blind Randomized Controlled Trial of Intravenous Glucose, Insulin, and Potassium (GIK) for Acute Coronary Syndromes in Emergency Medical Services

    Selker, Harry P.; Beshansky, Joni R.; Griffith, John L.; D’Agostino, Ralph B.; Massaro, Joseph M.; Udelson, James E.; Rashba, Eric J.; Ruthazer, Robin; Sheehan, Patricia R.; Desvigne-Nickens, Patrice; Rosenberg, Yves D.; Atkins, James M.; Sayah, Assaad J.; Aufderheide, Tom P.; Rackley, Charles E.; Opie, Lionel H.; Lambrew, Costas T.; Cobb, Leonard A.; MacLeod, Bruce A.; Ingwall, Joanne S.; Zalenski, Robert J.; Apstein, Carl S.

    2014-01-01

    Background Experimental studies suggest that metabolic myocardial support by intravenous (IV) glucose, insulin, and potassium (GIK) reduces ischemia-induced arrhythmias, cardiac arrest, mortality, progression from unstable angina pectoris (UAP) to acute myocardial infarction (AMI), and MI size. However, trials of hospital administration of IV GIK to patients with ST elevation MI (STEMI) have generally not shown favorable effects, possibly due to the GIK intervention taking place many hours after ischemic symptom onset. A trial of GIK used in the very first hours of ischemia has been needed, consistent with the timing of benefit seen in experimental studies. Objective The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care (IMMEDIATE) Trial tested whether, if given very early, GIK could have the impact seen in experimental studies. Accordingly, distinct from prior trials, IMMEDIATE tested the impact of GIK 1) in patients with acute coronary syndromes (ACS), rather than only AMI or STEMI, and 2) administered in prehospital emergency medical service (EMS) settings, rather than later, in hospitals, following emergency department evaluation. Design IMMEDIATE was an EMS-based randomized placebo-controlled clinical effectiveness trial conducted in 13 cities across the US which enrolled 911 participants. Eligible were patients age 30 or older for whom a paramedic performed a 12-lead electrocardiogram (ECG)to evaluate chest pain or other symptoms suggestive of ACS for whom electrocardiograph-based ACI-TIPI (acute cardiac ischemia time-insensitive predictive instrument) indicated a > 75% probability of ACS, and/or the TPI (thrombolytic predictive instrument) indicated presence of a STEMI, or if local criteria for STEMI notification of receiving hospitals were met. Prehospital IV GIK or placebo was started immediately. Pre-specified were the primary endpoint of progression of ACS to infarction, and as major secondary endpoints

  6. Randomized clinical trial on seven-day-per-week continuous accelerated irradiation for patients with esophageal carcinoma:Preliminary report on tumor response and acute toxicity

    Su-Ping Sun; Ya-Zhou Liu; Tao Ye; Wen Zhang; Wen-Bin Shen; Jing-Lei Shi; Hai-Ting Xu; Wei-Dong Wang

    2006-01-01

    AIM: Tumor response and normal tissue toxicity of seven-day-per-week continuous accelerated irradiation (CAIR) for patients with esophageal carcinoma were evaluated and compared to conventional irradiation (CR).METHODS: Sixty patients with squamous cell carcinoma of the esophagus were randomized into two groups:the CAIR group (30 patients) and the CR group (30 pa(RT) with 2 Gy/fraction per day at 7 d/wk with a total dose of 50-70 Gy (average dose 64.2 Gy). The overall time of irradiation was 3.6-5.0 wk (average 4.6 wk). RT in the CR group was 2 Gy/fraction per day at 5 d/wk with a total dose of 40-70 Gy (average dose 61.7 Gy).The overall time of irradiation was 4.0-7.0 wk (average 6.4wk).RESULTS: The data showed that the immediate tumor response to RT was better in the CAIR group than in the CR group. Efficiency rates (CR plus PR) were 82.8%(24/29) and 58.6% (17/29), respectively (P = 0.047). In both groups the incidences of esophagitis and tracheitis were insignificant (P = 0.376, 0.959), and no patient received toxicity that could not be tolerated.CONCLUSION: CAIR shortens overall treatment time and is well tolerated by patients. It may be superior to CR in enhancing the local response of tumor, but its remote effect for esophageal carcinoma awaits further follow-up.

  7. Acute ingestion of a novel whey-derived peptide improves vascular endothelial responses in healthy individuals: a randomized, placebo controlled trial

    Kupchak Brian R

    2009-07-01

    Full Text Available Abstract Background Whey protein is a potential source of bioactive peptides. Based on findings from in vitro experiments indicating a novel whey derived peptide (NOP-47 increased endothelial nitric oxide synthesis, we tested its effects on vascular function in humans. Methods A randomized, placebo-controlled, crossover study design was used. Healthy men (n = 10 and women (n = 10 (25 ± 5 y, BMI = 24.3 ± 2.3 kg/m2 participated in two vascular testing days each preceded by 2 wk of supplementation with a single dose of 5 g/day of a novel whey-derived peptide (NOP-47 or placebo. There was a 2 wk washout period between trials. After 2 wk of supplementation, vascular function in the forearm and circulating oxidative stress and inflammatory related biomarkers were measured serially for 2 h after ingestion of 5 g of NOP-47 or placebo. Macrovascular and microvascular function were assessed using brachial artery flow mediated dilation (FMD and venous occlusion strain gauge plethysmography. Results Baseline peak FMD was not different for Placebo (7.7% and NOP-47 (7.8%. Placebo had no effect on FMD at 30, 60, and 90 min post-ingestion (7.5%, 7.2%, and 7.6%, respectively whereas NOP-47 significantly improved FMD responses at these respective postprandial time points compared to baseline (8.9%, 9.9%, and 9.0%; P P = 0.008 for time × trial interaction. Plasma myeloperoxidase was increased transiently by both NOP-47 and placebo, but there were no changes in markers inflammation. Plasma total nitrites/nitrates significantly decreased over the 2 hr post-ingestion period and were lower at 120 min after placebo (-25% compared to NOP-47 (-18%. Conclusion These findings indicate that supplementation with a novel whey-derived peptide in healthy individuals improves vascular function.

  8. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication - A randomized controlled trial.

    Wurdak, Mara; Wolstein, Jörg; Kuntsche, Emmanuel

    2016-06-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized controlled trial, 254 adolescents received a psychosocial intervention plus motive-tailored (intervention group; IG) or general exercises (control group; CG). Adolescents in the IG received exercises in accordance with their drinking motives as indicated at baseline (e.g. alternative ways of spending leisure time or dealing with stress). Exercises for the CG contained alcohol-related information in general (e.g. legal issues). The data of 81 adolescents (age: M = 15.6, SD = 1.0; 42.0% female) who participated in both the baseline and the follow-up were compared using ANOVA with repeated measurements and effect sizes (available case analyses). Adolescents reported lower alcohol use at the four-week follow-up independently of the kind of intervention. Significant interaction effects between time and IG were found for girls in terms of drinking frequency (F = 7.770, p effect sizes of drinking frequency (d = - 1.18), binge drinking (d = - 1.61) and drunkenness (d = - 2.87) were much higher than the .8 threshold for large effects. Conducting psychosocial interventions in a motive-tailored way appears more effective for girls admitted to hospital due to alcohol intoxication than without motive-tailoring. Further research is required to address the specific needs of boys in such interventions. (German Clinical Trials Register, DRKS ID: DRKS00005588). PMID:26844193

  9. Effects of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life: A randomized controlled trial in prostate cancer patients undergoing radiotherapy

    Purpose: To study the effect of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life (HRQOL) in prostate cancer patients referred to radiotherapy. Materials and methods: A total of 130 patients were randomly assigned to one of two groups: an intervention group (IG, n = 64), instructed to reduce their intake of insoluble dietary fibres and lactose, a standard care group (SC, n = 66), instructed to continue their normal diet. Gastrointestinal side effects and other aspects of HRQOL were evaluated from baseline up to 2 months after completed radiotherapy, using the EORTC QLQ-C30 and QLQ-PR25 and the study-specific Gastrointestinal Side Effects Questionnaire (GISEQ). A scale indicating adherence to dietary instructions was developed from a Food Frequency Questionnaire (FFQ), with lower scores representing better compliance. Descriptive and inferential statistical analyses were conducted. Results: There was an interaction effect between randomization and time in the FFQ Scores (p < 0.001), indicating that both groups followed their assigned dietary instructions. The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. During radiotherapy, the percentage of patients with bowel symptoms and bloated abdomen was lower in IG compared to SC, but the between-group differences were not statistically significant. During radiotherapy, the percentage of patients with bowel symptoms, urinary symptoms, pain, fatigue and diminished physical and role functioning increased in both groups. Conclusions: The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. The tendency towards lower prevalence of bowel symptoms in IG may indicate some positive effect of the dietary intervention, but methodological refinements, clearer results and longer follow-up are needed before the value of diet change can be established with certainty.

  10. Design of a randomized controlled trial of comprehensive rehabilitation in patients with myocardial infarction, stabilized acute coronary syndrome, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting: Akershus Comprehensive Cardiac Rehabilitation Trial (the CORE Study

    Karin Kogstad Else

    2000-11-01

    Full Text Available Abstract Objectives 1. To assess the long-term effectiveness of a comprehensive cardiac rehabilitation programme on quality of life and survival in patients with a large spectrum of cardiovascular diseases (myocardial infarction, acute coronary syndrome, percutaneous transluminal coronary angioplasty and coronary artery bypass grafting. 2. To establish the degree of correlation between expected improvement of health-related quality of life and improvement in physical function attributable to rehabilitation in the intervention group, in comparison with similar changes in the conventional care group. Design Randomized, controlled, parallel-group design (intervention/conventional care. Setting Akershus County, southeast of Oslo City, Norway. Participants 500 patients, men and women, aged 40-85 years, who have sustained at least one of the above-mentioned cardiovascular diseases. Interventions 8 weeks of supervised, structured physical training of three periods of 20 min per week, targeting a heart rate of 60-70% of the individual's maximum; home-based physical exercise training with the same basic schedule as in the supervised period; quantification of patients' compliance with the exercise programme by the use of wristwatches, information stored in the watch memory being retrieved once a month during the 3-year follow-up period; and life-style modification with an emphasis on the cessation of smoking and on healthy nutrition and weight control.

  11. Combination of Chinese Herbal Medicines and Conventional Treatment versus Conventional Treatment Alone in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention (5C Trial: An Open-Label Randomized Controlled, Multicenter Study

    Shao-Li Wang

    2013-01-01

    Full Text Available Aims. To evaluate the efficacy of Chinese herbal medicines (CHMs plus conventional treatment in patients with acute coronary syndrome (ACS after percutaneous coronary intervention (PCI. Methods and Results. Participants (n=808 with ACS who underwent PCI from thirteen hospitals of mainland China were randomized into two groups: CHMs plus conventional treatment group (treatment group or conventional treatment alone group (control group. All participants received conventional treatment, and participants in treatment group additionally received CHMs for six months. The primary endpoint was the composite of cardiac death, nonfatal recurrent MI, and ischemia-driven revascularization. Secondary endpoint was the composite of readmission for ACS, stroke, or congestive heart failure. The safety endpoint involved occurrence of major bleeding events. The incidence of primary endpoint was 2.7% in treatment group versus 6.2% in control group (HR, 0.43; 95% CI, 0.21 to 0.87; P=0.015. The incidence of secondary endpoint was 3.5% in treatment group versus 8.7% in control group (HR, 0.39; 95% CI, 0.21 to 0.72; P=0.002. No major bleeding events were observed in any participant. Conclusion. Treatment with CHMs plus conventional treatment further reduced the occurrence of cardiovascular events in patients with ACS after PCI without increasing risk of major bleeding.

  12. Random Walks on Random Graphs

    Cooper, Colin; Frieze, Alan

    The aim of this article is to discuss some of the notions and applications of random walks on finite graphs, especially as they apply to random graphs. In this section we give some basic definitions, in Section 2 we review applications of random walks in computer science, and in Section 3 we focus on walks in random graphs.

  13. Random duality

    GUO TieXin; CHEN XinXiang

    2009-01-01

    The purpose of this paper is to provide a random duality theory for the further development of the theory of random conjugate spaces for random normed modules.First,the complicated stratification structure of a module over the algebra L(μ,K) frequently makes our investigations into random duality theory considerably different from the corresponding ones into classical duality theory,thus in this paper we have to first begin in overcoming several substantial obstacles to the study of stratification structure on random locally convex modules.Then,we give the representation theorem of weakly continuous canonical module homomorphisms,the theorem of existence of random Mackey structure,and the random bipolar theorem with respect to a regular random duality pair together with some important random compatible invariants.

  14. Random duality

    2009-01-01

    The purpose of this paper is to provide a random duality theory for the further development of the theory of random conjugate spaces for random normed modules. First, the complicated stratification structure of a module over the algebra L(μ, K) frequently makes our investigations into random duality theory considerably difierent from the corresponding ones into classical duality theory, thus in this paper we have to first begin in overcoming several substantial obstacles to the study of stratification structure on random locally convex modules. Then, we give the representation theorem of weakly continuous canonical module homomorphisms, the theorem of existence of random Mackey structure, and the random bipolar theorem with respect to a regular random duality pair together with some important random compatible invariants.

  15. Effectiveness evaluation of an integrated automatic termomechanic massage system (SMATH® system in non-specific sub-acute and chronic low back pain - a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial

    Mazzolari Rita

    2011-10-01

    Full Text Available Abstract Background Low back pain (LBP is a major health problem in modern society, with 70-85% of the population experiencing LBP at some time in their lives. Each year, 5-10% of the workforce misses work due to LBP, most for less than 7 days. Almost 10% of all patients are at risk of developing chronic pain and disability. Little clinical evidence is available for the majority of treatments used in LBP therapy. However, moderate evidence exists for interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation, and cognitive behavioral therapy for subacute and chronic LBP. The SMATH® system (system for automatic thermomechanic massage in health is a new medical device (MD that combines basic principles of mechanical massage, thermotherapy, acupressure, infrared therapy, and moxibustion. SMATH® is suitable for automatic multidisciplinary treatment on patients with non-specific sub-acute and chronic LBP. Methods/design This paper describes the protocol for a double-blinded, sham-controlled, randomized, single-center short term clinical trial in patients with non-specific sub-acute and chronic LBP aged 18 to 70 years. The primary outcome will be the effectiveness of SMATH® versus sham therapy (medical device without active principles determined by evaluating self perceived physical function with Roland Morris Disability Questionnaire (RMDQ scores after 4 weeks of treatment (end of treatment. Major secondary outcome will be effectiveness of SMATH® determined by evaluating self perceived physical function comparing RMDQ scores between end of treatment and baseline. The trial part of the study will take 7 months while observational follow-up will take 11 months. The sample size will be 72 participants (36 for each arm. The project has been approved by the Ethical Committee of Cremona Hospital, Italy on 29 November 2010. Discussion Compared to other medical specialties, physical and rehabilitation medicine (PRM has not yet received

  16. Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial

    2011-01-01

    Background This post hoc analysis (trial registration: ClinicalTrials.gov NCT00590577) assessed onset of efficacy and tolerability of acute treatment with once-monthly paliperidone palmitate (PP), a long-acting atypical antipsychotic initiated by day 1 and day 8 injections, in a markedly to severely ill schizophrenia population. Methods Subjects entering the 13-week, double-blind trial were randomized to PP (39, 156, or 234 mg [25, 100, and 150 mg eq of paliperidone, respectively]) or placebo. This subgroup analysis included those with a baseline Clinical Global Impressions-Severity (CGI-S) score indicating marked to severe illness. PP subjects received a 234-mg day 1 injection (deltoid), followed by their assigned dose on day 8 and monthly thereafter (deltoid or gluteal). Thus, data for PP groups were pooled for days 4 and 8. Measures included Positive and Negative Syndrome Scale (PANSS), CGI-S, Personal and Social Performance (PSP), and adverse events (AEs). Analysis of covariance (ANCOVA) and last-observation-carried-forward (LOCF) methodologies, without multiplicity adjustments, were used to assess changes in continuous measures. Onset of efficacy was defined as the first time point a treatment group showed significant PANSS improvement (assessed days 4, 8, 22, 36, 64, and 92) versus placebo, which was maintained through end point. Results A total of 312 subjects met inclusion criterion for this subgroup analysis. After the day 1 injection, mean PANSS total scores improved significantly with PP (all received 234 mg) versus placebo at day 4 (P = 0.012) and day 8 (P = 0.007). After the day 8 injection, a significant PANSS improvement persisted at all subsequent time points in the 234-mg group versus placebo (P < 0.05). PANSS improvements were greater from day 36 through end point in the 156-mg group (P < 0.05) and only at end point in the 39-mg group (P < 0.05). CGI-S and PSP scores improved significantly in the 234-mg and 156-mg PP groups versus placebo at end

  17. Acute myopathy associated with liver cirrhosis

    Ok-Jae Lee; Jee-Hyang Yoon; Eun-Jeong Lee; Hyun-Jin Kim; Tae-Hyo Kim

    2006-01-01

    AIM: Many cirrhotic patients have muscular symptoms and rhabdomyolysis. However, myopathy associated with liver cirrhosis has not been established as a disease entity. We evaluated the clinical significance of acute myopathy associated with liver cirrhosis.METHODS: We retrospectively reviewed the medical records of 5440 cirrhotic patients who had been admitted to Gyeongsang National University Hospital from August 1997 to January 2003. Among these, 99 developed acute myopathies, and they were analyzed with respect to clinical and laboratory parameters, and outcomes.RESULTS: The Child-Pugh classification at the time of myopathy onset was A in 3(3.1%) cases, B in 33(33.3%), and C in 63 (63.6%). Infection was identified as the most predisposing factor to myopathy. Fifty percent of 18 idiopathic cases who were tested for influenza antibody were positive. Forty-two of the 99 cases were complicated by acute renal failure, and 25 (59.5%) of these expired. Apart from 6 cases lost to follow-up, 64 of 93 recovered, giving a mortality rate of 31.2%. Mortality was higher in Child-Pugh class C than in B or A.CONCLUSION: Acute myopathy can develop as a serious complication in liver cirrhosis. Its frequency, severity and mortality depend on underlying liver function, and are higher in decompensated liver cirrhosis. Influenza should be considered as an etiologic factor in idiopathic cases. It is proposed that acute myopathy associated with liver cirrhosis be called 'hepatic myopathy', and that careful monitoring for hepatic myopathy is necessary in the patients with advanced liver cirrhosis.

  18. Treat chronic hepatitis C virus infection in decompensated cirrhosis - pre- or post-liver transplantation? the ironic conundrum in the era of effective and well-tolerated therapy.

    Bunchorntavakul, C; Reddy, K Rajender

    2016-06-01

    The management of hepatitis C virus (HCV) infection in patients with decompensated cirrhosis has evolved dramatically over the past few years mainly due to the availability of all-oral antiviral regimens. The currently approved all-oral direct-acting antivirals (DAA) containing sofosbuvir, ledipasvir, daclatasvir and ribavirin, in various combinations, have shown to be safe and effective in patients with decompensated cirrhosis with sustained virological response (SVR) rates nearly comparable to those with well-compensated liver disease. Unique issues yet remain such as the challenges with renal insufficiency, tolerability of ribavirin and risk of further hepatic decompensation with a protease inhibitor-based regimen. While most patients who achieve SVR have demonstrated improvement in hepatic synthetic function over the short course of follow, the long-term beneficial effects are unknown. Further, the baseline predictors of improvement in hepatic function have not been well delineated and thus have left us in a quandary as to what we might expect with successful therapy and thus we are at a loss to well educate our patients. The major concern, in potential liver transplant candidates, is of unintended 'harm' by achieving SVR but without improvement in hepatic function to an extent where the patients might function well. As HCV therapies are as effective in liver transplant recipients, there is a growing sentiment in some of the transplant quarters that those with decompensated liver disease and awaiting liver transplant be treated for HCV after liver transplant. This strategy would thus eliminate any concern of leaving a patient in 'no person's' land by treating HCV successfully pretransplant but not to the point of functional normalcy, while also would maintain the risk of HCC. Yet a contrarian view would be that not all patients have access to liver transplantation (LT), cannot bear the cost, have comorbidities or contraindications to LT. While the debate

  19. Cost-effectiveness of entecavir versus adefovir for the treatment of chronic hepatitis B in patients with decompensated cirrhosis from a third-party US payer perspective

    Juday, Timothy

    2012-01-01

    Naoky Tsai,1 Lennox Jeffers,2 Lael Cragin,3 Sonja Sorensen,3 Wenqing Su,3 Lisa Rosenblatt,4 Hong Tang,4 Tony Hebden,4 Timothy Juday41John A Burns School of Medicine, University of Hawaii, Honolulu, HI, USA; 2University of Miami School of Medicine, Miami, FL, USA; 3United BioSource Corporation, Bethesda, MD, USA; 4Bristol-Myers Squibb Company, Plainsboro, NJ, USABackground: Decompensated cirrhosis is a serious clinical complication of chronic hepatitis B (CHB) that places a large economic burd...

  20. [The significance of morphologic changes in acute occlusive cholecystitis for determining the surgical approach].

    Iukhtin, V I; Khripun, A I; Raksha, A P; Zhukotskiĭ, A V; Sergeeva, N A; Dorofeeva, I M; Belous, G G

    1996-01-01

    Specific morphological and functional changes in the liver in acute obturative cholecystitis have been experimentally studied in 30 dogs and clinically examined in 21 patients. No morphological substrate of liver insufficiency were found in early period of acute obturative cholecystitis. Early changes in the liver are of reactive nature and have the features of active nonspecific hepatitis. The reactions of compensation and decompensation are changing each other periodically. The intensive reactions of compensation take place in the first 2 or 3 days of disease. The reactions of compensation weaken gradually. There is no correlation between changes in the liver and in blood serum. The early surgery and laparoscopic procedures in acute obturative cholecystitis are advocated. PMID:8965448

  1. Energy randomness

    Miller, Joseph S.; Rute, Jason

    2015-01-01

    Energy randomness is a notion of partial randomness introduced by Diamondstone and Kjos-Hanssen to characterize the sequences that can be elements of a Martin-L\\"of random closed set (in the sense of Barmpalias, Brodhead, Cenzer, Dashti, and Weber). It has also been applied by Allen, Bienvenu, and Slaman to the characterization of the possible zero times of a Martin-L\\"of random Brownian motion. In this paper, we show that $X \\in 2^\\omega$ is $s$-energy random if and only if $\\sum_{n\\in\\omega...

  2. Training family physicians and residents in family medicine in shared decision making to improve clinical decisions regarding the use of antibiotics for acute respiratory infections: protocol for a clustered randomized controlled trial

    Frémont Pierre

    2011-01-01

    Full Text Available Abstract Background To explore ways to reduce the overuse of antibiotics for acute respiratory infections (ARIs, we conducted a pilot clustered randomized controlled trial (RCT to evaluate DECISION+, a training program in shared decision making (SDM for family physicians (FPs. This pilot project demonstrated the feasibility of conducting a large clustered RCT and showed that DECISION+ reduced the proportion of patients who decided to use antibiotics immediately after consulting their physician. Consequently, the objective of this study is to evaluate, in patients consulting for ARIs, if exposure of physicians to a modified version of DECISION+, DECISION+2, would reduce the proportion of patients who decide to use antibiotics immediately after consulting their physician. Methods/design The study is a multi-center, two-arm, parallel clustered RCT. The 12 family practice teaching units (FPTUs in the network of the Department of Family Medicine and Emergency Medicine of Université Laval will be randomized to a DECISION+2 intervention group (experimental group or to a no-intervention control group. These FPTUs will recruit patients consulting family physicians and residents in family medicine enrolled in the study. There will be two data collection periods: pre-intervention (baseline including 175 patients with ARIs in each study arm, and post-intervention including 175 patients with ARIs in each study arm (total n = 700. The primary outcome will be the proportion of patients reporting a decision to use antibiotics immediately after consulting their physician. Secondary outcome measures include: 1 physicians and patients' decisional conflict; 2 the agreement between the parties' decisional conflict scores; and 3 perception of patients and physicians that SDM occurred. Also in patients, at 2 weeks follow-up, adherence to the decision, consultation for the same reason, decisional regret, and quality of life will be assessed. Finally, in both patients

  3. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study.

    Povsic, Thomas J; Roe, Matthew T; Ohman, Erik Magnus; Steg, Philippe Gabriel; James, Stefan; Plotnikov, Alexei; Mundl, Hardi; Welsh, Robert; Bode, Christoph; Gibson, Charles Michael

    2016-04-01

    Dual antiplatelet therapy (DAPT), the combination of aspirin and a P2Y12 inhibitor, given for 12 months remains the standard of care after presentation with acute coronary syndrome (ACS) because it has been shown to be associated with a significant reduction in ischemic events compared with aspirin monotherapy. The factor Xa inhibitor rivaroxaban was shown to be associated with a significant reduction in the composite of cardiovascular death, myocardial infarction, and stroke, and resulted in a nominal reduction in cardiovascular death, when added to background DAPT in the ATLAS ACS 2-TIMI 51 trial; however, there was excessive bleeding with this "triple-therapy" approach. The combination of rivaroxaban with P2Y12 inhibition in a "dual-pathway" approach may be an effective therapeutic regimen for the treatment of ACS, given the known importance of P2Y12 inhibition after stenting and intriguing data that the combination of an anticoagulant with clopidogrel after stenting in patients with atrial fibrillation appears an attractive option to this patient population. GEMINI-ACS-1 is a prospective, randomized, double-dummy, double-blind, active-controlled trial that will assess the safety of dual antithrombotic therapy (rivaroxaban [2.5 mg twice daily] + P2Y12 inhibitor) as compared with DAPT (aspirin [100 mg] + P2Y12 inhibitor) within 10 days of an ACS event in 3,000 patients. Patients will be randomized in a 1:1 ratio stratified by intended P2Y12 inhibitor use (clopidogrel 75 mg daily or ticagrelor 90 mg twice daily), with 1500 patients expected in each P2Y12 inhibitor strata. The primary end point is Thrombolysis in Myocardial Infarction clinically significant bleeding (major, minor, or requiring medical attention). The exploratory efficacy determination will be a composite of cardiovascular death, myocardial infarction, ischemic stroke, and stent thrombosis. GEMINI-ACS-1 will assess the safety and feasibility of dual antithrombotic therapy with rivaroxaban and a P2Y

  4. Impact of aerobic exercise training during chemotherapy on cancer related cognitive impairments in patients suffering from acute myeloid leukemia or myelodysplastic syndrome - Study protocol of a randomized placebo-controlled trial.

    Zimmer, P; Oberste, M; Bloch, W; Schenk, A; Joisten, N; Hartig, P; Wolf, F; Baumann, F T; Garthe, A; Hallek, M; Elter, T

    2016-07-01

    Cancer related cognitive impairments (CRCI) are frequently reported by patients prior to, during and after medical treatment. Although this cognitive decline severely affects patients' quality of life, little is known about effective treatments. Exercise programs represent a promising supportive strategy in this field. However, evidence is sparse and existing studies display methodological limitations. In the planned study, 83 men and women newly diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) will be randomized into one of three treatment groups. During 4weeks of induction chemotherapy with Anthracycline and Cytarabin patients allocated to exercise group will cycle 3×/week for 30min at moderate to vigorous intensity on an ergometer. Patients allocated to placebo group will receive a supervised myofascial release training (3×/week, approx. 30min) and patients at control group will get usual care. As primary endpoints a cognitive test battery will be conducted measuring performances depending on verbal/spatial memory and executive functioning. Secondary endpoints will be self-perceived cognitive functioning, as well as neurotrophic and inflammatory serum markers. All assessments will be conducted immediately after hospitalization and before chemotherapy is commenced, immediately before discharge of hospital after 4-5weeks as well as before continuing medical treatment 3-4weeks after discharge. This will be the first study investigating the impact of an aerobic exercise training on CRCI in AML/MDS patients. We hope that the study design and the state-of-the-art assessments will help to increase knowledge about CRCI in general and exercise as potential treatment option in this under investigated population. PMID:27261170

  5. Acute Pancreatitis and Pregnancy

    ... Acute Pancreatitis > Acute Pancreatitis and Pregnancy test Acute Pancreatitis and Pregnancy Timothy Gardner, MD Acute pancreatitis is ... of acute pancreatitis in pregnancy. Reasons for Acute Pancreatitis and Pregnancy While acute pancreatitis is responsible for ...

  6. Randomized random walk on a random walk

    This paper discusses generalizations of the model introduced by Kehr and Kunter of the random walk of a particle on a one-dimensional chain which in turn has been constructed by a random walk procedure. The superimposed random walk is randomised in time according to the occurrences of a stochastic point process. The probability of finding the particle in a particular position at a certain instant is obtained explicitly in the transform domain. It is found that the asymptotic behaviour for large time of the mean-square displacement of the particle depends critically on the assumed structure of the basic random walk, giving a diffusion-like term for an asymmetric walk or a square root law if the walk is symmetric. Many results are obtained in closed form for the Poisson process case, and these agree with those given previously by Kehr and Kunter. (author)

  7. Bronchitis - acute

    ... sharing features on this page, please enable JavaScript. Acute bronchitis is swelling and inflammation in the main passages ... present only for a short time. Causes When acute bronchitis occurs, it almost always comes after having a ...

  8. Bronchitis - acute

    Acute bronchitis is swelling and inflammation in the main passages that carry air to the lungs. The swelling narrows ... makes it harder to breathe. Another symptom of bronchitis is a cough. Acute means the symptoms have ...

  9. Acute Bronchitis

    Bronchitis is an inflammation of the bronchial tubes, the airways that carry air to your lungs. It ... chest tightness. There are two main types of bronchitis: acute and chronic. Most cases of acute bronchitis ...

  10. Acute fatal metabolic complications in alkaptonuria.

    Davison, A S; Milan, A M; Gallagher, J A; Ranganath, L R

    2016-03-01

    Alkaptonuria (AKU) is a rare inherited metabolic disorder of tyrosine metabolism that results from a defect in an enzyme called homogentisate 1,2-dioxygenase. The result of this is that homogentisic acid (HGA) accumulates in the body. HGA is central to the pathophysiology of this disease and the consequences observed; these include spondyloarthropathy, rupture of ligaments/muscle/tendons, valvular heart disease including aortic stenosis and renal stones. While AKU is considered to be a chronic progressive disorder, it is clear from published case reports that fatal acute metabolic complications can also occur. These include oxidative haemolysis and methaemoglobinaemia. The exact mechanisms underlying the latter are not clear, but it is proposed that disordered metabolism within the red blood cell is responsible for favouring a pro-oxidant environment that leads to the life threatening complications observed. Herein the role of red blood cell in maintaining the redox state of the body is reviewed in the context of AKU. In addition previously reported therapeutic strategies are discussed, specifically with respect to why reported treatments had little therapeutic effect. The potential use of nitisinone for the management of patients suffering from the acute metabolic decompensation in AKU is proposed as an alternative strategy. PMID:26596578

  11. Acute pancreatitis

    Bo-Guang Fan; Åke Andrén-Sandberg

    2010-01-01

    Background : Acute pancreatitis continues to be a serious illness, and the patients with acute pancreatitis are at risk to develop different complications from ongoing pancreatic inflammation. Aims : The present review is to highlight the classification, treatment and prognosis of acute pancreatitis. Material & Methods : We reviewed the English-language literature (Medline) addressing pancreatitis. Results : Acute pancreatitis is frequently caused by gallstone disease or excess alcohol ingest...

  12. Acute pancreatitis

    Bo-Guang Fan; Åke Andrén-Sandberg

    2010-01-01

    Background: Acute pancreatitis continues to be a serious illness, and the patients with acute pancreatitis are at risk to develop different complications from ongoing pancreatic inflammation. Aims: The present review is to highlight the classification, treatment and prognosis of acute pancreatitis. Material & Methods: We reviewed the English-language literature (Medline) addressing pancreatitis. Results: Acute pancreatitis is frequently caused by gallstone disease or excess alcohol ingestion....

  13. Geographic Differences in Patients in a Global Acute Heart Failure Clinical Trial (from the ASCEND-HF Trial).

    Metra, Marco; Mentz, Robert J; Hernandez, Adrian F; Heizer, Gretchen M; Armstrong, Paul W; Clausell, Nadine; Corbalan, Ramon; Costanzo, Maria Rosa; Dickstein, Kenneth; Dunlap, Mark E; Ezekowitz, Justin A; Howlett, Jonathan G; Komajda, Michel; Krum, Henry; Lombardi, Carlo; Fonarow, Gregg C; McMurray, John J V; Nieminen, Markku S; Swedberg, Karl; Voors, Adriaan A; Starling, Randall C; Teerlink, John R; O'Connor, Christopher M

    2016-06-01

    A growing number of countries and geographical regions are involved in major clinical trials. Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure is the largest trial in acutely decompensated heart failure (HF) with patients from 5 geographical regions: North America (NA), Latin America (LA), Western Europe (WE), Central Europe (CE), and Asia-Pacific (AP). Data from the 5 geographical areas were compared including baseline characteristics, medications, 30-day outcomes (mortality and mortality or HF hospitalization), and 180-day mortality. Of the 7,141 study patients, 3,243 (45.4%) were from NA (average of 15.2 patients/site), 1,762 (24.7%) from AP (28.4 patients/site), 967 (13.5%) from CE (20.2 patients/site), 665 (9.3%) from LA (17.1 patients/site), and 504 (7.1%) from WE (14.4 patients/site). There were marked differences in co-morbidities, clinical profile, medication use, length of stay, 30-day event rates, and 180-day mortality by region. Compared with NA, the adjusted risk for death or HF hospitalization at 30 days was significantly lower in CE (odds ratio [OR] 0.46, 95% CI 0.33 to 0.64), WE (OR 0.52 95% CI 0.35 to 0.75), and AP (OR 0.62 95% CI 0.48 to 0.79) and numerically lower in LA (OR 0.77, 95% CI 0.57 to 1.04) with similar results for 180-day mortality. In conclusion, in patients with acutely decompensated HF, major differences in baseline characteristics, treatments, length of the hospital stay, and 30-day HF rehospitalization rates, and 180-day mortality were found in patients enrolled from different geographical areas. PMID:27108685

  14. Serum 1H-NMR metabolomic fingerprints of acute-on-chronic liver failure in intensive care unit patients with alcoholic cirrhosis.

    Roland Amathieu

    Full Text Available INTRODUCTION: Acute-on-chronic liver failure is characterized by acute deterioration of liver function in patients with compensated or decompensated, but stable, cirrhosis. However, there is no accurate definition of acute-on-chronic liver failure and physicians often use this term to describe different clinical entities. Metabolomics investigates metabolic changes in biological systems and identifies the biomarkers or metabolic profiles. Our study assessed the metabolomic profile of serum using proton nuclear magnetic resonance ((1H-NMR spectroscopy to identify metabolic changes related to acute-on-chronic liver failure. PATIENTS: Ninety-three patients with compensated or decompensated cirrhosis (CLF group but stable liver function and 30 patients with cirrhosis and hospitalized for the management of an acute event who may be responsible of acute-on-chronic liver failure (ACLF group, were fully analyzed. Blood samples were drawn at admission, and sera were separated and stored at -80°C until (1H-NMR spectral analysis. Using orthogonal projection to latent-structure discriminant analyses, various metabolites contribute to the complete separation between these both groups. RESULTS: The predictability of the model was 0.73 (Q(2 Y and the explained variance was 0.63 (R(2 Y. The main metabolites that had increased signals related to acute-on-chronic liver failure were lactate, pyruvate, ketone bodies, glutamine, phenylalanine, tyrosine, and creatinine. High-density lipids were lower in the ALCF group than in CLF group. CONCLUSION: A serum metabolite fingerprint for acute-on-chronic liver failure, obtained with (1H-NMR, was identified. Metabolomic profiling may aid clinical evaluation of patients with cirrhosis admitted into intensive care units with acute-on-chronic liver failure, and provide new insights into the metabolic processes involved in acute impairment of hepatic function.

  15. RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome

    Steg, Ph Gabriel; Mehta, Shamir R; Jukema, J Wouter;

    2011-01-01

    To establish the safety, tolerability and most promising regimen of darexaban (YM150), a novel, oral, direct factor Xa inhibitor, for prevention of ischaemic events in acute coronary syndrome (ACS).......To establish the safety, tolerability and most promising regimen of darexaban (YM150), a novel, oral, direct factor Xa inhibitor, for prevention of ischaemic events in acute coronary syndrome (ACS)....

  16. Acute pancreatitis

    Bo-Guang Fan

    2010-05-01

    Full Text Available Background: Acute pancreatitis continues to be a serious illness, and the patients with acute pancreatitis are at risk to develop different complications from ongoing pancreatic inflammation. Aims: The present review is to highlight the classification, treatment and prognosis of acute pancreatitis. Material & Methods: We reviewed the English-language literature (Medline addressing pancreatitis. Results: Acute pancreatitis is frequently caused by gallstone disease or excess alcohol ingestion. There are a number of important issues regarding clinical highlights in the classification, treatment and prognosis of acute pancreatitis, and treatment options for complications of acute pancreatitis including pancreatic pseudocysts. Conclusions: Multidisciplinary approach should be used for the management of the patient with acute pancreatitis.

  17. Acute pancreatitis

    Bo-Guang Fan

    2010-01-01

    Full Text Available Background : Acute pancreatitis continues to be a serious illness, and the patients with acute pancreatitis are at risk to develop different complications from ongoing pancreatic inflammation. Aims : The present review is to highlight the classification, treatment and prognosis of acute pancreatitis. Material & Methods : We reviewed the English-language literature (Medline addressing pancreatitis. Results : Acute pancreatitis is frequently caused by gallstone disease or excess alcohol ingestion. There are a number of important issues regarding clinical highlights in the classification, treatment and prognosis of acute pancreatitis, and treatment options for complications of acute pancreatitis including pancreatic pseudocysts. Conclusions : Multidisciplinary approach should be used for the management of the patient with acute pancreatitis.

  18. What Is Decompensated Cirrhosis?

    ... Z) Hepatitis HIV Mental Health Mental Health Home Suicide Prevention Substance Abuse Military Sexual Trauma PTSD Research (MIRECC) Military Exposures Polytrauma Rehabilitation Spinal Cord Injury Telehealth Womens Health Issues Wellness Programs MyHealtheVet Nutrition Quitting Smoking ...

  19. Consumption of red-hot chili pepper increases symptoms in patients with acute anal fissures. A prospective, randomized, placebo-controlled, double blind, crossover trial Efeito da pimenta vermelha nos sintomas de pacientes com fissuras anais agudas

    Pravin J. Gupta

    2008-06-01

    Full Text Available BACKGROUND: Red-hot chili pepper and other spices have been blamed for causing or exacerbating symptoms of anal pathologies like anal fissure and hemorrhoids. AIM: To determine if consumption of chilies increases symptoms of acute anal fissures. METHODS: Individual patients were randomized to receive capsules containing chili or placebo for one week in addition to analgesics and fiber supplement. Patients were asked to note score for symptoms like pain, anal burning, and pruritus during the study period. After 1 week, cross over treatment was administered to the same group of patients with the same methodology and results were noted at the end of 2 weeks. RESULTS: Fifty subjects were recruited for this study. Forty three of them completed the trial (22 in the chili group and 21 in the placebo group. The daily mean pain score was significantly lower in the placebo group in the study period. Score 2.05 in chili group and 0.97 in placebo group. There was a significant burning sensation experienced by the patients in the chili group (score 1.85 for the chili group vs 0.71 for the placebo group. Patient’s mean recorded improvement score was significantly higher after taking placebo. Eighty one point three percent patients preferred placebo while 13.9% preferred chilies. Two patients had no preference. CONCLUSION: Consumption of chili does increase the symptoms of acute anal fissure and reduces patient compliance.RACIONAL: A pimenta vermelha e outras especiarias têm sido responsabilizadas por agravar a sintomatologia das doenças anais, tais como fissuras e hemorróidas. OBJETIVO: Determinar se o consumo de pimentas vermelhas aumentaria os sintomas em fissuras anais agudas. MÉTODOS: Pacientes foram recrutados e randomizados para receber cápsulas contendo pimenta ou placebos por 1 semana, somadas a analgésicos e suplementos de fibras. Foi solicitado que anotassem um escore de sintomas, tais como dor, queimação anal, prurido durante o per

  20. Differential acute postprandial effects of processed meat and isocaloric vegan meals on the gastrointestinal hormone response in subjects suffering from type 2 diabetes and healthy controls: a randomized crossover study.

    Lenka Belinova

    Full Text Available The intake of meat, particularly processed meat, is a dietary risk factor for diabetes. Meat intake impairs insulin sensitivity and leads to increased oxidative stress. However, its effect on postprandial gastrointestinal hormone (GIH secretion is unclear. We aimed to investigate the acute effects of two standardized isocaloric meals: a processed hamburger meat meal rich in protein and saturated fat (M-meal and a vegan meal rich in carbohydrates (V-meal. We hypothesized that the meat meal would lead to abnormal postprandial increases in plasma lipids and oxidative stress markers and impaired GIH responses.In a randomized crossover study, 50 patients suffering from type 2 diabetes (T2D and 50 healthy subjects underwent two 3-h meal tolerance tests. For statistical analyses, repeated-measures ANOVA was performed.The M-meal resulted in a higher postprandial increase in lipids in both groups (p<0.001 and persistent postprandial hyperinsulinemia in patients with diabetes (p<0.001. The plasma glucose levels were significantly higher after the V-meal only at the peak level. The plasma concentrations of glucose-dependent insulinotropic peptide (GIP, peptide tyrosine-tyrosine (PYY and pancreatic polypeptide (PP were higher (p<0.05, p<0.001, p<0.001, respectively and the ghrelin concentration was lower (p<0.001 after the M-meal in healthy subjects. In contrast, the concentrations of GIP, PYY and PP were significantly lower after the M-meal in T2D patients (p<0.001. Compared with the V-meal, the M-meal was associated with a larger increase in lipoperoxidation in T2D patients (p<0.05.Our results suggest that the diet composition and the energy content, rather than the carbohydrate count, should be important considerations for dietary management and demonstrate that processed meat consumption is accompanied by impaired GIH responses and increased oxidative stress marker levels in diabetic patients.ClinicalTrials.gov NCT01572402.

  1. 急性失代偿性心力衰竭的现代观点(六)%Modern Concepts of Acute Decompensated Heart Failure(ADHF)(6)

    钱方毅

    2009-01-01

    @@ 6.4.2 血管加压素拮抗剂血 管加压素拮抗剂(vasopressin antagonist,AVP拮抗剂)AVP(或抗利尿激素)由垂体后叶所释放,是对一些刺激因素的反应,包括血浆渗透压的增高,严重低血容量、低血压及Ang Ⅱ.已经鉴定出有两型AVP受体:V1(V1a,V1b)及V2受体.V1a受体存在于血管壁,介导血管收缩.V2受体则位于肾脏,可促进水的重吸收.在急性及慢性HF时,AVP的水平均不正常.

  2. Clinical characteristics of decompensated primary biliary cirrhosis%原发性胆汁性肝硬化失代偿期的临床特征

    王蕊; 尤红; 马红; 张福奎; 马佳丽; 贾继东; 欧晓娟; 张涛; 王宇; 段维佳; 赵新颜

    2012-01-01

    Objective To study the clinical characteristics of decompensated primary biliary cirrhosis (PBC). Methods The clinical characteristics including demographics, laboratory tests, clinical manifestations, complications as well as scores of several prognostic models of 204 patients with PBC (113 patients with compensated cirrhosis and 91 patients with decompensated cirrhosis) were retrospectively studied. Then compared the clinical characteristics with 51 patients from decompensated hepatitis B (HBV group), 20 patients from hepatitis C (HCV group) and 51 patients from decompensated alcoholic liver disease(ALD group). Results (1) The patients with decompensated PBC were older than those with compensated PBC and had significantly decreased blood cell counts, serum lipids, albumin and cholinesterase levels while increased international normalized ratio (INR), total bilirubin level and direct bilirubin level. The model integration of Child-Pugh grading, model of end-stage liver disease (MELD) and Mayo significantly increased (P< 0.05). (2) The patients with decompensated PBC were in mostly middle aged to elderly women and had higher serum alkaline phosphatase while the prothrombin time was shortened compared with those in HBV, HCV and ALD group. They had higher incidence of pruritus (compared with those in HCV and ALD group, P-<0. 05), upper gastrointestinal bleeding (compared with those in HBV and HCV group, P<0. 05), more frequent complications with Sjogren's syndrome and osteoporosis and lower incidence of hepatocellular carcinoma. Conclusion PBC primarily affected middle aged to elderly women and the decompensated cirrhotic patients had significantly special clinical characteristics compared with those from other etiologies.%目的 了解原发性胆汁性肝硬化( PBC)失代偿期的临床特征.方法 回顾性分析204例PBC患者(包括代偿期113例,失代偿期91例)的人口统计学、实验室检查、临床表现及预后模型积分等,研究失代偿

  3. A Randomized Study of Clofarabine Versus Clofarabine Plus Low-Dose Cytarabine us Front-Line Therapy for Older Patients with Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome%氯法拉滨与氯法拉滨联合小剂量阿糖胞苷对老年急性髓性白血病及高危骨髓增生异常综合征随机对照研究

    肖志坚; 陆泽生

    2009-01-01

    @@ 1 文献来源 Faded S, Ravandi F, Huang X, et al. A randomized study of Clofarabine versus Clofarabine plus low-dose Cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome [J]. Blood, 2008,112(5) : 1638-1645.

  4. Eye-Movement Training Results in Changes in qEEG and NIH Stroke Scale in Subjects Suffering from Acute Middle Cerebral Artery Ischemic Stroke: A Randomized Control Trial

    Carrick, Frederick Robert; Oggero, Elena; Pagnacco, Guido; Wright, Cameron H. G.; Machado, Calixto; Estrada, Genco; Pando, Alejandro; Cossio, Juan C.; Beltrán, Carlos

    2016-01-01

    Context Eye-movement training (EMT) can induce altered brain activation and change the functionality of saccades with changes of the brain in general. Objective To determine if EMT would result in changes in quantitative electroencephalogram (qEEG) and NIH Stroke Scale (NIHSS) in patients suffering from acute middle cerebral artery (MCA) infarction. Our hypothesis is that there would be positive changes in qEEG and NIHSS after EMT in patients suffering from acute MCA ischemic strok...

  5. Comparison of the ability of the PDD-ICG clearance test, CTP, MELD, and MELD-Na to predict short-term and medium-term mortality in patients with decompensated hepatitis B cirrhosis

    Cheng, Xiang-Pu; Zhao, Jing; Chen, Yu; Meng, Fan-Kun; Xu, Bin; Yu, Hong-Wei; Meng, Qing-Hua; Liu, Yan-Min; Zhang, Shi-Bin; Meng, Sha; Zhang, Jing-Yun; Zhang, Jin-Yan; Duan, Zhong-Ping

    2016-01-01

    Objective Various methods, including the indocyanine green (ICG) clearance test, the Child–Turcotte–Pugh score (CTP), model for end-stage liver disease (MELD), and MELD combined with serum sodium concentration (MELD-Na), have been used widely in liver function evaluation in patients with end-stage liver disease. In this study, we compared the ability of these methods to predict mortality in patients with decompensated hepatitis B cirrhosis. Methods A total of 98 patients with decompensated hepatitis B cirrhosis were included in this study and followed up for 12 months. The ICG-derived measurements (ICG-PDR, ICG-R15, EHBF), CTP, MELD, and MELD-Na were obtained within 2 days after patients’ admission and patients’ survival at 1, 3, 6, and 12 months was recorded. Receiver operating curve was used to evaluate the ability of these methods to predict mortality in these patients with decompensated hepatitis B cirrhosis. Results At 1 month, 3 months, 6 months and 12 months, the cumulative number of deaths and liver transplant recipients was 12 (12.2%), 17 (17.3%), 21 (21.4%) and 25 (25.5%), respectively. The ICG-derived measurements, CTP, MELD, and MELD-Na of nonsurvivors were significantly different compared with that in survivors. All methods yielded viable values in predicting short-term and medium-term prognosis for patients with decompensated hepatitis B cirrhosis, with most area under the curve exceeding 0.8. Moreover, the ICG-derived measurements showed a significant correlation with that of CTP, MELD, and MELD-Na. Conclusion All four methods, ICG clearance test, CTP, MELD, and MELD-Na, provided reliable prediction of mortality in patients with decompensated hepatitis B cirrhosis for both short-term and medium-term prognosis. PMID:26649802

  6. Treatment disparities in acute coronary syndromes, heart failure, and kidney disease.

    McCullough, Peter A; Maynard, Robert C

    2011-01-01

    It has been consistently observed that patients with renal dysfunction have more premature, severe, complicated, and fatal cardiovascular disease than age- and sex-matched individuals with normal renal function. There have been 4 major explanations for this finding: (1) positive confounding by third variables associated with chronic kidney disease (CKD), including diabetes mellitus and hypertension; (2) therapeutic nihilism or lesser use of beneficial therapies in CKD; (3) greater toxicities of therapies, such as bleeding from anticoagulants or contrast-induced kidney injury; (4) biological factors which result directly from CKD that work to promote and accelerate cardiovascular disease. In this paper, we focus on the issue of treatment disparities or therapeutic nihilism and its contribution to poor outcomes in the setting of acute coronary syndromes and acutely decompensated heart failure. This issue is important because if we can overcome barriers to the utilization of beneficial treatments, then clinical outcomes should improve over time. PMID:21625092

  7. Splanchnic and renal elimination and release of catecholamines in cirrhosis. Evidence of enhanced sympathetic nervous activity in patients with decompensated cirrhosis

    Ring-Larsen, H; Kanstrup, I L; Christensen, N J;

    1984-01-01

    Plasma noradrenaline (NA) and adrenaline (A) concentrations were determined in different vascular areas in 32 patients with cirrhosis and in nine controls during a right sided heart, liver, and renal vein catheterisation. The patients were divided into four groups: (I) Compensated (without ascites......, respectively, the three last mentioned values being significantly raised (p less than 0.01). Median arterial adrenaline concentrations were not significantly increased. In patients arterial-hepatic venous extraction ratios of noradrenaline and adrenaline were on the average 25% (p less than 0.01) and 20% (p...... differences were significantly increased in groups II, III and IV (0.47, 0.53 and 0.68 nmol/l, p less than 0.01), indicating a significant net release of noradrenaline from the kidneys in recompensated and decompensated patients. Renal extraction of adrenaline was normal. In conclusion, increased arterial...

  8. Lysine clonixinate versus dipyrone (metamizole for the acute treatment of severe migraine attacks: a single-blind, randomized study Clonixinato de lisina versus dipirona (metamizol para o tratamento agudo de uma crise intensa de enxaqueca: estudo monocego e randomizado

    Abouch Valenty Krymchantowski

    2008-06-01

    Full Text Available BACKGROUND AND OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAID are effective to treat migraine attacks. Lysine clonixinate (LC and dipyrone (metamizol have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. METHOD: Thirty patients (28 women, 2 men, aged 18 to 48 years with migraine according the International Headache Society (IHS (2004 were studied. The patients were randomized into 2 groups when presenting to an emergency department with a severe migraine attack. The study was single-blind. Headache intensity, nausea, photophobia and side effects were evaluated at 0, 30, 60 and 90 minutes after the drug administration. Rectal indomethacin as rescue medication (RM was available after 2 hours and its use compared between groups. RESULTS: All patients completed the study. At 30 minutes, 0% of the dipyrone group 13% of the LC group were pain free (p=0.46. At 60 and 90 minutes, 2 (13% and 5 (33% patients from the dipyrone group and 11 (73% and 13 (86.7% patients from the LC group were pain free (pCONTEXTO E OBJETIVO: Antiinflamatórios não esteroidais (AINE são eficazes no tratamento de crises de enxaqueca. O objetivo deste estudo foi comparar a eficácia e a tolerabilidade das apresentações injetáveis do clonixinato de lisina (CL e da dipirona no tratamento de crises intensas de enxaqueca. MÉTODO: Trinta pacientes (28 mulheres, 2 homens, com idades entre 18 e 48 anos e enxaqueca de acordo com a Classificação Internacional de Cefaléias (2004 foram estudados. Os pacientes foram randomizados em 2 grupos ao se apresentarem em uma unidade de emergência, com uma crise intensa de enxaqueca. O desenho do estudo foi monocego. A intensidade da cefaléia, a presença de náusea e fotofobia e os efeitos colaterais foram avaliados e comparados na administração das drogas e após 30

  9. Random magnetism

    The 'ingredients' which control a phase transition in well defined systems as well as in random ones (e.q. random magnetic systems) are listed and discussed within a somehow unifying perspective. Among these 'ingredients' the couplings and elements responsible for the cooperative phenomenon, the topological connectivity as well as possible topological incompatibilities, the influence of new degrees of freedom, the order parameter dimensionality, the ground state degeneracy and finally the 'quanticity' of the system are found. The general trends, though illustrated in magnetic systems, essentially hold for all phase transitions, and give a basis for connection of this area with Field theory, Theory of dynamical systems, etc. (Author)

  10. Random matrices

    Eynard, Bertrand; Ribault, Sylvain

    2015-01-01

    We provide a self-contained introduction to random matrices. While some applications are mentioned, our main emphasis is on three different approaches to random matrix models: the Coulomb gas method and its interpretation in terms of algebraic geometry, loop equations and their solution using topological recursion, orthogonal polynomials and their relation with integrable systems. Each approach provides its own definition of the spectral curve, a geometric object which encodes all the properties of a model. We also introduce the two peripheral subjects of counting polygonal surfaces, and computing angular integrals.

  11. [Pharmacological treatment of acute cough].

    Småbrekke, Lars; Melbye, Hasse

    2009-05-14

    Acute cough may cause considerable distress for patients with upper airway infections, and is a symptom commonly presented to doctors. We wanted to assess the evidence basis for pharmacological treatment of this condition. Predefined terms (MeSH and Emtree) and free text were used to search PubMed and Embase for double-blind randomized trials, reviews and guidelines. Little evidence supports the use of guaifenesine, bromhexine and acetylcysteine for acute cough associated with upper airway infections. Likewise, there is insufficient evidence to decide whether noscapine, codeine and ehylmorphine are beneficial for acute cough on this indication. Well-designed randomized controlled trials with valid outcomes are needed to document possible benefits of treatment. Treatment with codeine or ethylmorphine may be at the expense of adverse effects, abuse or dependence. PMID:19448753

  12. Acute-on-chronic liver failure: a review

    Zamora Nava LE

    2014-04-01

    Full Text Available Luis Eduardo Zamora Nava,1 Jonathan Aguirre Valadez,2 Norberto C Chávez-Tapia,3 Aldo Torre21Department of Endoscopy, 2Department of Gastroenterology, National Institute of Medical Sciences and Nutrition Salvador Zubirán, 3Obesity and Digestive Diseases Unit, Medica Sur Clinic and Foundation, Mexico City, MexicoAbstract: There is no universally accepted definition of acute-on-chronic liver failure; however, it is recognized as an entity characterized by decompensation from an underlying chronic liver disease associated with organ failure that conveys high short-term mortality, with alcoholism and infection being the most frequent precipitating events. The pathophysiology involves inflammatory processes associated with a trigger factor in susceptible individuals (related to altered immunity in the cirrhotic population. This review addresses the different definitions developed by leading research groups, epidemiological and pathophysiological aspects, and the latest treatments for this entity.Keywords: acute-on-chronic liver failure, cirrhosis, organ failure, acute kidney injury, infection

  13. Random Decrement

    Asmussen, J.C.; Ibrahim, S.R.; Brincker, Rune

    Abstraet Thispaper demansirates how to use the Random Decrement (RD) technique for identification o flinear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a...

  14. Random Decrement

    Asmussen, J. C.; Ibrahim, S. R.; Brincker, Rune

    This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

  15. Random Decrement

    Asmussen, J. C.; Ibrahim, R.; Brincker, Rune

    1998-01-01

    This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

  16. Random dynamics

    The goal of random dynamics is the derivation of the laws of Nature as we know them (standard model) from inessential assumptions. The inessential assumptions made here are expressed as sets of general models at extremely high energies: gauge glass and spacetime foam. Both sets of models lead tentatively to the standard model. (orig.)

  17. Random Vibrations

    Messaro. Semma; Harrison, Phillip

    2010-01-01

    Ares I Zonal Random vibration environments due to acoustic impingement and combustion processes are develop for liftoff, ascent and reentry. Random Vibration test criteria for Ares I Upper Stage pyrotechnic components are developed by enveloping the applicable zonal environments where each component is located. Random vibration tests will be conducted to assure that these components will survive and function appropriately after exposure to the expected vibration environments. Methodology: Random Vibration test criteria for Ares I Upper Stage pyrotechnic components were desired that would envelope all the applicable environments where each component was located. Applicable Ares I Vehicle drawings and design information needed to be assessed to determine the location(s) for each component on the Ares I Upper Stage. Design and test criteria needed to be developed by plotting and enveloping the applicable environments using Microsoft Excel Spreadsheet Software and documenting them in a report Using Microsoft Word Processing Software. Conclusion: Random vibration liftoff, ascent, and green run design & test criteria for the Upper Stage Pyrotechnic Components were developed by using Microsoft Excel to envelope zonal environments applicable to each component. Results were transferred from Excel into a report using Microsoft Word. After the report is reviewed and edited by my mentor it will be submitted for publication as an attachment to a memorandum. Pyrotechnic component designers will extract criteria from my report for incorporation into the design and test specifications for components. Eventually the hardware will be tested to the environments I developed to assure that the components will survive and function appropriately after exposure to the expected vibration environments.

  18. Characteristics, Diagnosis and Prognosis of Acute-on-Chronic Liver Failure in Cirrhosis Associated to Hepatitis B.

    Li, Hai; Chen, Liu-Ying; Zhang, Nan-Nan; Li, Shu-Ting; Zeng, Bo; Pavesi, Marco; Amorós, Àlex; Mookerjee, Rajeshwar P; Xia, Qian; Xue, Feng; Ma, Xiong; Hua, Jing; Sheng, Li; Qiu, De-Kai; Xie, Qing; Foster, Graham R; Dusheiko, Geoffrey; Moreau, Richard; Gines, Pere; Arroyo, Vicente; Jalan, Rajiv

    2016-01-01

    The diagnostic and prognostic criteria of acute-on-chronic liver failure (ACLF) were developed in patients with no Hepatitis B virus (HBV) cirrhosis (CANONIC study). The aims of this study were to evaluate whether the diagnostic (CLIF-C organ failure score; CLIF-C OFs) criteria can be used to classify patients; and the prognostic score (CLIF-C ACLF score) could be used to provide prognostic information in HBV cirrhotic patients with ACLF. 890 HBV associated cirrhotic patients with acute decompensation (AD) were enrolled. Using the CLIF-C OFs, 33.7% (300 patients) were diagnosed as ACLF. ACLF was more common in the younger patients and in those with no previous history of decompensation. The most common organ failures were 'hepatic' and 'coagulation'. As in the CANONIC study, 90-day mortality was extremely low in the non-ACLF patients compared with ACLF patients (4.6% vs 50%, p < 0.0001). ACLF grade and white cell count, were independent predictors of mortality. CLIF-C ACLFs accurately predicted short-term mortality, significantly better than the MELDs and a disease specific score generated for the HBV patients. Current study indicates that ACLF is a clinically and pathophysiology distinct even in HBV patients. Consequently, diagnostic criteria, prognostic scores and probably the management of ACLF should base on similar principles. PMID:27146801

  19. Including whey protein and whey permeate in ready-to-use supplementary food improves recovery rates in children with moderate acute malnutrition: A randomized, double-blind clinical trial

    The utility of dairy ingredients in the supplementary foods used in the treatment of childhood moderate acute malnutrition (MAM) remains unsettled. We evaluated the effectiveness of a peanut-based ready-to-use supplementary food (RUSF) with soy protein compared with a novel RUSF containing dairy in...

  20. Acute pancreatitis

    ... page: //medlineplus.gov/ency/article/000287.htm Acute pancreatitis To use the sharing features on this page, ... fatty foods after the attack has improved. Outlook (Prognosis) Most cases go away in a week. However, ...

  1. Acute Pericarditis

    ... Sugar Control Helps Fight Diabetic Eye Disease Are 'Workaholics' Prone to OCD, Anxiety? ALL NEWS > Resources First ... cancer, or heart surgery, the fluid is blood. Causes Acute pericarditis usually results from infection or other ...

  2. Acute dyspnea

    Radiodiagnosis is applied to determine the causes of acute dyspnea. Acute dyspnea is shown to aggravate the course of pulmonary diseases (bronchial asthma, obstructive bronchitis, pulmonary edema, throboembolism of pulmonary arteries etc) and cardiovascular diseases (desiseas of myocardium). The main tasks of radiodiagnosis are to determine volume and state of the lungs, localization and type of pulmonary injuries, to verify heart disease and to reveal concomitant complications

  3. Bronchitis (acute)

    Wark, Peter

    2008-01-01

    Acute bronchitis, with transient inflammation of the trachea and major bronchi, affects over 40/1000 adults a year in the UK. The causes are usually considered to be infective, but only around half of people have identifiable pathogens.The role of smoking or environmental tobacco smoke inhalation in predisposing to acute bronchitis is unclear.A third of people may have longer-term symptoms or recurrence.

  4. To Observe the Effect of Low-dose Peginterferon α-2a and Ribavirin Treatment of Decompensated Hepatitis C Cirrhosis%小剂量聚乙二醇干扰素α-2a联合利巴韦林抗病毒治疗失代偿期丙型肝炎肝硬化的临床效果观察

    王琳; 王智敏

    2015-01-01

    Objective To study the patients with cirrhosis of the liver decompensation period of hepatitis c, observe choice interferon alpha 2 a small dose of polyethylene glycol (Peg-interferons alpha 2 a) and ribavirin completed after treatment for clinical treatment. Methods 70 patients with hepatitis c cirrhosis of the liver decompensation period from January 2013 to January 2015. Through the stochastic indicator method complete hepatitis cirrhosis patients randomized, C2 group of 35 cases (control group) : clinical choose the method of conventional treatment, C1 group (observation group of 35 cases):clinical choose Peg-interferons alpha-2 a plus ribavirin treatment method. Compared to two kinds of hepatitis, liver cirrhosis patients in such aspects as clinically relevant indicators show the difference. Results Two groups of patients with cirrhosis of the liver decompensation period of hepatitis c after completion of clinical treatment in ALT, propagated and AST, C1 group is obviously better than the group of C2 hepatitis cirrhosis patients (P<0.05). In terms of liver ifbrosis indexes, C1 group is obviously better than the group of C2 hepatitis cirrhosis patients (P<0.05). Conclusion For patients with cirrhosis of the liver decompensation period of hepatitis c, clinical choose Peg-interferons alpha 2 a and method of ribavirin treatment, can effectively improve liver ifbrosis indexes such as, in patients with signiifcantly alleviate the clinical symptoms of patients with hepatitis cirrhosis of the liver, will eventually decompensation period of hepatitis c effective to improve the quality of life of patients with cirrhosis.%目的:探讨针对失代偿期丙型肝炎肝硬化患者,观察选择小剂量聚乙二醇干扰素α-2a(Peg-IFNα-2a)+利巴韦林完成治疗后获得的临床治疗。方法选择我院2013年1月~2015年1月失代偿期丙型肝炎肝硬化患者70例。通过随机数表法完成肝炎肝硬化患者的随机分组,C1组(观察组35

  5. RANDOM LASSO.

    Wang, Sijian; Nan, Bin; Rosset, Saharon; Zhu, Ji

    2011-03-01

    We propose a computationally intensive method, the random lasso method, for variable selection in linear models. The method consists of two major steps. In step 1, the lasso method is applied to many bootstrap samples, each using a set of randomly selected covariates. A measure of importance is yielded from this step for each covariate. In step 2, a similar procedure to the first step is implemented with the exception that for each bootstrap sample, a subset of covariates is randomly selected with unequal selection probabilities determined by the covariates' importance. Adaptive lasso may be used in the second step with weights determined by the importance measures. The final set of covariates and their coefficients are determined by averaging bootstrap results obtained from step 2. The proposed method alleviates some of the limitations of lasso, elastic-net and related methods noted especially in the context of microarray data analysis: it tends to remove highly correlated variables altogether or select them all, and maintains maximal flexibility in estimating their coefficients, particularly with different signs; the number of selected variables is no longer limited by the sample size; and the resulting prediction accuracy is competitive or superior compared to the alternatives. We illustrate the proposed method by extensive simulation studies. The proposed method is also applied to a Glioblastoma microarray data analysis. PMID:22997542

  6. Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

    2012-01-01

    Background Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However, there is increasing evidence that intragraft B-cells are also important in the T-cell-mediated rejections. First, a significant proportion of patients with acute T-cell-mediated rejection have B-cells present in the infiltrates. Second, the outcome of these patients is inferior, which has been related to an inferior response to the conventional anti-rejection therapy. Third, treatment of these patients with an anti-CD20 antibody (rituximab) improves the allograft outcome as reported in single case observations and in one small study. Despite the promise of these observations, solid evidence is required before incorporating this treatment option into a general treatment recommendation. Methods/Design The RIACT study is designed as a randomized, double-blind, placebo-controlled, parallel group multicenter Phase III study. The study examines whether rituximab, in addition to the standard treatment with steroid-boli, leads to an improved one-year kidney allograft function, compared to the standard treatment alone in patients with acute T-cell mediated tubulointerstitial rejection and significant B-cell infiltrates in their biopsies. A total of 180 patients will be recruited. Discussion It is important to clarify the relevance of anti-B cell targeting in T-cell mediated rejection and answer the question whether this novel concept should be incorporated in the conventional anti-rejection therapy. Trial registration Clinical trials gov. number: NCT01117662 PMID:23101480

  7. Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

    Schiffer Lena

    2012-10-01

    Full Text Available Abstract Background Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90% of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However, there is increasing evidence that intragraft B-cells are also important in the T-cell-mediated rejections. First, a significant proportion of patients with acute T-cell-mediated rejection have B-cells present in the infiltrates. Second, the outcome of these patients is inferior, which has been related to an inferior response to the conventional anti-rejection therapy. Third, treatment of these patients with an anti-CD20 antibody (rituximab improves the allograft outcome as reported in single case observations and in one small study. Despite the promise of these observations, solid evidence is required before incorporating this treatment option into a general treatment recommendation. Methods/Design The RIACT study is designed as a randomized, double-blind, placebo-controlled, parallel group multicenter Phase III study. The study examines whether rituximab, in addition to the standard treatment with steroid-boli, leads to an improved one-year kidney allograft function, compared to the standard treatment alone in patients with acute T-cell mediated tubulointerstitial rejection and significant B-cell infiltrates in their biopsies. A total of 180 patients will be recruited. Discussion It is important to clarify the relevance of anti-B cell targeting in T-cell mediated rejection and answer the question whether this novel concept should be incorporated in the conventional anti-rejection therapy. Trial registration Clinical trials gov. number: NCT01117662

  8. Acute myelogenous leukemia (AML) - children

    Acute myelogenous leukemia - children; AML; Acute myeloid leukemia - children; Acute granulocytic leukemia - children; Acute myeloblastic leukemia - children; Acute non-lymphocytic leukemia (ANLL) - children

  9. Differential Acute Postprandial Effects of Processed Meat and Isocaloric Vegan Meals on the Gastrointestinal Hormone Response in Subjects Suffering from Type 2 Diabetes and Healthy Controls: A Randomized Crossover Study

    Lenka Belinova; Hana Kahleova; Hana Malinska; Ondrej Topolcan; Jindra Vrzalova; Olena Oliyarnyk; Ludmila Kazdova; Martin Hill; Terezie Pelikanova

    2014-01-01

    Background The intake of meat, particularly processed meat, is a dietary risk factor for diabetes. Meat intake impairs insulin sensitivity and leads to increased oxidative stress. However, its effect on postprandial gastrointestinal hormone (GIH) secretion is unclear. We aimed to investigate the acute effects of two standardized isocaloric meals: a processed hamburger meat meal rich in protein and saturated fat (M-meal) and a vegan meal rich in carbohydrates (V-meal). We hypothesized that the...

  10. Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial

    Meister, Rebecca; Princip, Mary; Schmid, Jean-Paul; Schnyder, Ulrich; Barth, Jürgen; Znoj, Hansjörg; Herbert, Claudia; von Känel, Roland

    2013-01-01

    BACKGROUND Posttraumatic Stress Disorder (PTSD) may occur in patients after exposure to a life-threatening illness. About one out of six patients develop clinically relevant levels of PTSD symptoms after acute myocardial infarction (MI). Symptoms of PTSD are associated with impaired quality of life and increase the risk of recurrent cardiovascular events. The main hypothesis of the MI-SPRINT study is that trauma-focused psychological counseling is more effective than non-trauma focused co...

  11. Lysine clonixinate versus dipyrone (metamizole) for the acute treatment of severe migraine attacks: a single-blind, randomized study Clonixinato de lisina versus dipirona (metamizol) para o tratamento agudo de uma crise intensa de enxaqueca: estudo monocego e randomizado

    Abouch Valenty Krymchantowski; Henrique Carneiro; Jackeline Barbosa; Carla Jevoux

    2008-01-01

    BACKGROUND AND OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Lysine clonixinate (LC) and dipyrone (metamizol) have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. METHOD: Thirty patients (28 women, 2 men), aged 18 to 48 years with migraine according the International Headache Societ...

  12. Improving the treatment of severe acute malnutrition in childhood: a randomized controlled trial of synbiotic-enhanced therapeutic food with long term follow-up of post-treatment mortality and morbidity

    Kerac, M

    2011-01-01

    BACKGROUND: Tackling severe acute malnutrition (SAM) is a global public health priority. This thesis explores two major influences on treatment outcomes: -Treatment efficacy -Patient-related risk factors OBJECTIVES: 1. To explore whether a pre/probiotic mixture (Synbiotic2000 Forte™) improves treatment outcomes (nutritional and clinical) in children affected by SAM. 2. To describe long term outcomes from SAM and identify key mortality risk factors. METHODS: All 1024 malno...

  13. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome : The design of the GEMINI-ACS-1 phase II study

    Povsic, Thomas J.; Roe, Matthew T.; Ohman, Erik Magnus; Steg, Philippe Gabriel; James, Stefan; Plotnikov, Alexei; Mundl, Hardi; Welsh, Robert; Bode, Christoph; Gibson, Charles Michael

    2016-01-01

    Dual antiplatelet therapy (DAPT), the combination of aspirin and a P2Y12 inhibitor, given for 12 months remains the standard of care after presentation with acute coronary syndrome (ACS) because it has been shown to be associated with a significant reduction in ischemic events compared with aspirin monotherapy. The factor Xa inhibitor rivaroxaban was shown to be associated with a significant reduction in the composite of cardiovascular death, myocardial infarction, and stroke, and resulted in...

  14. Randomized clinical trial of laparoscopic versus open appendicectomy

    Pedersen, Allan Gorm; Petersen, O B; Wara, P;

    2001-01-01

    BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...

  15. Permselectivity of the liver blood-lymph (ascitic fluid) barrier to macromolecules in decompensated cirrhosis: relation to calculated pore-size

    Henriksen, Jens Henrik Sahl

    1983-01-01

    This study was undertaken to investigate permselectivity of the liver blood-lymph (ascitic fluid) barrier to endogeneous marcomolecules in patients with decompensated cirrhosis. Albumin (mol wt 69,000), immunoglobulin-G (mol wt 160,000) and immunoglobulin-M (mol wt 900,000) were determined in...... plasma and ascitic fluid from 13 cirrhotic patients. As previously substantiated in patients with cirrhosis, the ascitic fluid/plasma concentration ratio (R) of a protein is proportional to the transport rate from blood to lymph (ascitic fluid). Mean Ralb = 0.28 and RIgG = 0.29 were identical, but...... significantly higher than, RIgM = 0.18 (P less than 0.01). Ralb was directly correlated to RIgG (r = 0.97, P less than 0.001) and to RIgM (r = 0.78, P less than 0.005). Mean RIgG/Ralb = 1.03, which expresses the relative flux rates between IgG and albumin, was significantly above the ratio between the free...

  16. Pizotifen relieves acute migraine symptoms

    A.S.M. Kamrul Huda

    2008-01-01

    Full Text Available To The Editor: Various pharmacological agents are used for the treatment of migraine. In the last five years, various drug companies in Bangladesh have been marketing pizotifen as a preventive treatment of all types of migraine. Pizotifen is a serotonin antagonist acting mainly at the 5-HT1, 5-HT2A and 5HT2C receptors. It also has some activity as an antihistamine (1. Pizotifen is a well-established preventative therapy of migraine. I would like to report my own experience in using pizotifen in treating the acute attacks of migraine. Pizotifen was prescribed as acute therapy in 11 patients, 6 females (4 had migraine without aura and 2 had migraine with aura and 5 males (all had migraine without aura. Three female and 5 male patients, who had migraine without aura, reported no beneficial effect of pizotifen as treatment for the acute attacks. Three female patients (two with migraine with aura and one with migraine without aura had their headache relieved by use of pizotifen as treatment for the acute attacks. This is an initial observation about the effectiveness of pizotifen as acute therapy in migraine. However, this could be simply a placebo affect. Nevertheless, it will be worth exploring the role of pizotifen as a therapeutic agent for acute attacks of migraine by conducting well-designed randomized, controlled studies.

  17. Analysis of prognostic factors and establishment of prognostic index for patients with decompensated cirhosis%失代偿期肝硬化患者预后因素分析及预后指数建立

    张玉; 刘志坚; 周贤斌

    2011-01-01

    Objective To analyze prognostic factors and to establish prognostic index for the patients with decompensated cirrhosis.Methods The clinical data were collected from 196 patients with decompensated cirrhosis admitted to hospital from January 2004 to December 2006.Prognostic factors of decompensated cirrhosis were selected by Cox's proportional hazard regression model and prognostic index (PI) was established.The accuracy of PI, the Child- Turcotte- Pugh (CTP) score and model for end stage liver disease (MELD) in prognosis of decompensated cirrhosis was evaluated by ROC curve.Results Six prognostic factors were extracted by Cox's proportional hazard regression model: ascites levels, grading of hepatic encephalopathy, upper gastrointestinal bleeding, A/G, INR and serum creatinine.The area under ROC curve of PI, CTP and MELD was 0.840,0.745,0.780 respectively in predicting 1 year prognosis of decompensated cirrhosis.Conclusion Six risk factors are associated with prognosis of decompensated cirrhosis.The prognostic index established in this study is superior to CTP and MELD in short and medium term prognosis for decompensated cirrhosis.%目的 分析失代偿期肝硬化患者预后的影响因素,尝试建立预后判断指数(PI指数),以判断肝功能衰竭的预后. 方法应用Cox比例风险回归模型筛选196例失代偿期肝硬化患者预后的危险因素;应用ROC曲线下面积来评估PI指数、CTP分级、MELD模型对失代偿期肝硬化患者预后预测的准确性和精确性. 结果⑴筛选出6个影响失代偿期肝硬化患者1年预后的独立危险因素:腹水程度、肝性脑病分期、上消化道出血、A/G比值、INR、肌酐.⑵预测失代偿期肝硬化患者1年预后时,PI指数、CTP分级及MELD模型的ROC曲线下面积分别为分别为0.840、0.745、0.780. 结论腹水程度、肝性脑病分期、上消化道出血、A/G比值、INR、肌酐是影响失代偿期肝硬化患者预后的6个独立危险因素;PI指

  18. Orange juice–derived flavanone and phenolic metabolites do not acutely affect cardiovascular risk biomarkers: a randomized, placebo-controlled, crossover trial in men at moderate risk of cardiovascular disease

    Schar, Manuel; Curtis, Peter; Hazim, Sara; Ostertag, Luisa; Kay, Colin; Potter, John; Cassidy, Aedin

    2015-01-01

    Background: Epidemiologic data suggest inverse associations between citrus flavanone intake and cardiovascular disease (CVD) risk. However, insufficient randomized controlled trial data limit our understanding of the mechanisms by which flavanones and their metabolites potentially reduce cardiovascular risk factors. Objective: We examined the effects of orange juice or a dose-matched hesperidin supplement on plasma concentrations of established and novel flavanone metabolites and their effect...

  19. A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome

    Faderl, Stefan; Ravandi, Farhad; Huang, Xuelin; Garcia-Manero, Guillermo; Ferrajoli, Alessandra; Estrov, Zeev; Borthakur, Gautam; Verstovsek, Srdan; Thomas, Deborah A.; Kwari, Monica; Kantarjian, Hagop M.

    2008-01-01

    We previously reported the feasibility of clofarabine and cytarabine combinations in AML. Questions remain as to (1) the therapeutic advantage of this combination and (2) the role of lower doses of clofarabine and cytarabine in older patients. We have conducted an adaptively randomized study of lower-dose clofarabine with or without low-dose cytarabine in previously untreated patients with AML aged 60 years and older. Patients received 30 mg/m2 clofarabine intravenously daily for 5 days with ...

  20. Development of an obstetric vital sign alert to improve outcomes in acute care obstetrics.

    Behling, Diana J; Renaud, Michelle

    2015-01-01

    Maternal morbidity and mortality is a national health problem. Causal analysis of near-miss and actual serious patient safety events, including those resulting in maternal death, within obstetric units often highlights a failure to promptly recognize and treat women who were exhibiting signs of decompensation/deterioration. The Obstetric Vital Sign Alert (OBVSA) is an early warning tool that leverages discrete data points in the electronic health record, calculating a risk score that is displayed as a visual cue for acute care obstetric staff. When studied in a cohort of women with postpartum hemorrhage, use of the OBVSA reduced symptom-to-response time and intervention time, as well as key process and outcome measures. PMID:25900584

  1. Antibiotics for acute maxillary sinusitis

    Ahovuo-Saloranta, Anneli; Borisenko, Oleg V; Kovanen, Niina;

    2008-01-01

    antibiotics from different classes for acute maxillary sinusitis in adults. We included trials with clinically diagnosed acute sinusitis, whether or not confirmed by radiography or bacterial culture. DATA COLLECTION AND ANALYSIS: At least two review authors independently screened search results, extracted......BACKGROUND: Expert opinions vary on the appropriate role of antibiotics for sinusitis, one of the most commonly diagnosed conditions among adults in ambulatory care. OBJECTIVES: We examined whether antibiotics are effective in treating acute sinusitis, and if so, which antibiotic classes are the...... most effective. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2007, Issue 3); MEDLINE (1950 to May 2007) and EMBASE (1974 to June 2007). SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing antibiotics with placebo or...

  2. Risk Preferences under Acute Stress

    Cingl, Lubomír; Cahlíková, Jana

    2013-01-01

    Many important decisions are made under stress and they often involve risky alternatives. There has been ample evidence that stress influences decision making in cognitive as well as in affective domains, but still very little is known about whether individual attitudes to risk change with exposure to acute stress. To directly evaluate the causal effect of stress on risk attitudes, we adopt an experimental approach in which we randomly expose participants to a psychosocial stressor in the for...

  3. Effect of Prometheus liver assist system on systemic hemodynamics in patients with cirrhosis: a randomized controlled study

    Dethloff, T.; Tofteng, F.; Frederiksen, H.J.; Hojskov, M.; Hansen, B.A.; Larsen, F.S.

    2008-01-01

    Adsorption and Dialysis, Prometheus system (Study group; n = 8); Molecular Adsorbent Recirculation System (MARS) (Control group 1, n = 8); or hemodialysis (Control group 2; n = 8). All patients included in the study had decompensated cirrhosis at the time of the inclusion into the study. Circulatory changes......AIM: To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the Prometheus liver assist system in a randomized, controlled study. METHODS: Twenty-four patients were randomized to either the study group or to one of two control groups: Fractionated Plasma Separation...... were monitored with a Swan-Ganz catheter and bilirubin and creatinine were monitored as measures of protein-bound and water-soluble toxins. RESULTS: Systemic hemodynamics did not differ between treatment and control groups apart from an increase in arterial pressure in the MARS group (P = 0.008). No...

  4. Predicting Functional Recovery after Acute Ankle Sprain

    Sean R O'Connor; Bleakley, Chris M; Tully, Mark A; McDonough, Suzanne M

    2013-01-01

    INTRODUCTION:Ankle sprains are among the most common acute musculoskeletal conditions presenting to primary care. Their clinical course is variable but there are limited recommendations on prognostic factors. Our primary aim was to identify clinical predictors of short and medium term functional recovery after ankle sprain.METHODS:A secondary analysis of data from adult participants (N = 85) with an acute ankle sprain, enrolled in a randomized controlled trial was undertaken. The predictive v...

  5. Acute pancreatitis

    Al Mofleh Ibrahim

    1997-01-01

    Full Text Available The past few years have witnessed a tremendous progress in our knowledge regarding the pathogenesis, diagnosis, prognostic evaluation and classification of acute pancreatitis. The role of ischemia, lysosomal enzymes, oxygen free radicals, polymorphnuclear cells-byproducts and inflammatory mediators in the pathogenesis of pancreatic necrosis and multiple organ failure has been emphasized. Furthermore, the recent knowledge about agents infecting pancreatic necrosis, routes of infection, bacteriological examination of fine needle aspirate and appropriate antibiotics have changed the concept of acute pancreatitis. New diagnostic tests such as rapid urinary trypsinogen-2 test and inflammatory mediators including polymorphnuclear elastase, C-reactive protein and interleukin-6 contribute to early diagnosis, prognostic evaluation and initiation of an appropriate therapy.

  6. Mental stress in atopic dermatitis--neuronal plasticity and the cholinergic system are affected in atopic dermatitis and in response to acute experimental mental stress in a randomized controlled pilot study.

    Eva Milena Johanne Peters

    Full Text Available RATIONALE: In mouse models for atopic dermatitis (AD hypothalamus pituitary adrenal axis (HPA dysfunction and neuropeptide-dependent neurogenic inflammation explain stress-aggravated flares to some extent. Lately, cholinergic signaling has emerged as a link between innate and adaptive immunity as well as stress responses in chronic inflammatory diseases. Here we aim to determine in humans the impact of acute stress on neuro-immune interaction as well as on the non-neuronal cholinergic system (NNCS. METHODS: Skin biopsies were obtained from 22 individuals (AD patients and matched healthy control subjects before and after the Trier social stress test (TSST. To assess neuro-immune interaction, nerve fiber (NF-density, NF-mast cell contacts and mast cell activation were determined by immunohistomorphometry. To evaluate NNCS effects, expression of secreted mammal Ly-6/urokinase-type plasminogen activator receptor-related protein (SLURP 1 and 2 (endogenous nicotinic acetylcholine receptor ligands and their main corresponding receptors were assessed by quantitative RT-PCR. RESULTS: With respect to neuro-immune interaction we found higher numbers of NGF+ dermal NF in lesional compared to non-lesional AD but lower numbers of Gap43+ growing NF at baseline. Mast cell-NF contacts correlated with SCORAD and itch in lesional skin. With respect to the NNCS, nicotinic acetylcholine receptor α7 (α7nAChR mRNA was significantly lower in lesional AD skin at baseline. After TSST, PGP 9.5+ NF numbers dropped in lesional AD as did their contacts with mast cells. NGF+ NF now correlated with SCORAD and mast cell-NF contacts with itch in non-lesional skin. At the same time, SLURP-2 levels increased in lesional AD skin. CONCLUSIONS: In humans chronic inflammatory and highly acute psycho-emotional stress interact to modulate cutaneous neuro-immune communication and NNCS marker expression. These findings may have consequences for understanding and treatment of chronic

  7. Risk-adapted management of acute pulmonary embolism: recent evidence, new guidelines.

    Käberich, Anja; Wärntges, Simone; Konstantinides, Stavros

    2014-10-01

    Venous thromboembolism (VTE), the third most frequent acute cardiovascular syndrome, may cause life-threatening complications and imposes a substantial socio-economic burden. During the past years, several landmark trials paved the way towards novel strategies in acute and long-term management of patients with acute pulmonary embolism (PE). Risk stratification is increasingly recognized as a cornerstone for an adequate diagnostic and therapeutic management of the highly heterogeneous population of patients with acute PE. Recently published European Guidelines emphasize the importance of clinical prediction rules in combination with imaging procedures (assessment of right ventricular function) and laboratory biomarkers (indicative of myocardial stress or injury) for identification of normotensive PE patients at intermediate risk for an adverse short-term outcome. In this patient group, systemic full-dose thrombolysis was associated with a significantly increased risk of intracranial bleeding, a complication which discourages its clinical application unless hemodynamic decompensation occurs. A large-scale clinical trial program evaluating new oral anticoagulants in the initial and long-term treatment of venous thromboembolism showed at least comparable efficacy and presumably increased safety of these drugs compared to the current standard treatment. Research is continuing on catheter-directed, ultrasound-assisted, local, low-dose thrombolysis in the management of intermediate-risk PE. PMID:25386356

  8. Risk-Adapted Management of Acute Pulmonary Embolism: Recent Evidence, New Guidelines

    Anja Käberich

    2014-10-01

    Full Text Available Venous thromboembolism (VTE, the third most frequent acute cardiovascular syndrome, may cause life-threatening complications and imposes a substantial socio-economic burden. During the past years, several landmark trials paved the way towards novel strategies in acute and long-term management of patients with acute pulmonary embolism (PE. Risk stratification is increasingly recognized as a cornerstone for an adequate diagnostic and therapeutic management of the highly heterogeneous population of patients with acute PE. Recently published European Guidelines emphasize the importance of clinical prediction rules in combination with imaging procedures (assessment of right ventricular function and laboratory biomarkers (indicative of myocardial stress or injury for identification of normotensive PE patients at intermediate risk for an adverse short-term outcome. In this patient group, systemic full-dose thrombolysis was associated with a significantly increased risk of intracranial bleeding, a complication which discourages its clinical application unless hemodynamic decompensation occurs. A large-scale clinical trial program evaluating new oral anticoagulants in the initial and long-term treatment of venous thromboembolism showed at least comparable efficacy and presumably increased safety of these drugs compared to the current standard treatment. Research is continuing on catheter-directed, ultrasound-assisted, local, low-dose thrombolysis in the management of intermediate-risk PE.

  9. Rationale and design of EXPLORE: a randomized, prospective, multicenter trial investigating the impact of recanalization of a chronic total occlusion on left ventricular function in patients after primary percutaneous coronary intervention for acute ST-elevation myocardial infarction

    Tuseth Vegard

    2010-09-01

    Full Text Available Abstract Background In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events. Methods/Design The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years. Discussion The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume

  10. Acute and subacute idiopathic interstitial pneumonias.

    Taniguchi, Hiroyuki; Kondoh, Yasuhiro

    2016-07-01

    Idiopathic interstitial pneumonias (IIPs) may have an acute or subacute presentation, or acute exacerbation may occur in a previously subclinical or unrecognized chronic IIP. Acute or subacute IIPs include acute interstitial pneumonia (AIP), cryptogenic organizing pneumonia (COP), nonspecific interstitial pneumonia (NSIP), acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) and AE-NSIP. Interstitial lung diseases (ILDs) including connective tissue disease (CTD) associated ILD, hypersensitivity pneumonitis, acute eosinophilic pneumonia, drug-induced lung disease and diffuse alveolar haemorrhage need to be differentiated from acute and subacute IIPs. Despite the severe lack of randomized controlled trials for the treatment of acute and subacute IIPs, the mainstream treatment remains corticosteroid therapy. Other potential therapies reported in the literature include corticosteroids and immunosuppression, antibiotics, anticoagulants, neutrophil elastase inhibitor, autoantibody-targeted treatment, antifibrotics and hemoperfusion therapy. With regard to mechanical ventilation, patients in recent studies with acute and subacute IIPs have shown better survival than those in previous studies. Therefore, a careful value-laden decision about the indications for endotracheal intubation should be made for each patient. Noninvasive ventilation may be beneficial to reduce ventilator associated pneumonia. PMID:27123874

  11. Zinc deficiency in pakistani children with decompensated chronic liver disease; a cross-sectional survey at a hospital in lahore, pakistan

    This study aimed to objectively assess mean serum zinc levels and influence of age, gender and primary etiology of chronic liver disease (CLD) on these levels in a sample of Pakistani pediatric patients with decompensated CLD (DCLD). Methodology: It was a cross-sectional survey carried out at Combined Military Hospital, Lahore, from August 2013 to February 2014. Through non-probability consecutive sampling we included 100 cases belonging to both genders, fitting in the age-range of 1 - 12 years and having DCLD based on Child-Pugh classification score = 6. Patients with diarrhea, respiratory or urinary tract infection, liver tumors or receiving treatments with immune suppressants, antifungals, antivirals and zinc supplementation were excluded. Results After exclusion, off 74 cases, 58.1% were male. Majority belonged to the age group of 6 - 12 years (54.1%). Idiopathic DCLD was the most prevalent primary etiology (40.5%). Mean serum zinc levels (44.5 ± 4.7 mu g/dL) were significantly lower (p< 0.001) than the minimum normal serum zinc levels (65 micro g/dL). The mean serum zinc levels were lower significantly in children with idiopathic CLD as the primary etiology (p=0.012) and insignificantly in females and children belonging to the age group of 1- < 6 years (p= 0.08 and p= 0.59 respectively) Conclusion Mean serum zinc levels in our sample of pediatric patients with DCLD were significantly lower than the reference values for normal children, were lowest in children suffering from idiopathic CLD and were not dependent on gender and age. (author)

  12. 自体骨髓干细胞移植联合恩替卡韦治疗乙型肝炎肝硬化失代偿期的临床研究%Clinical study of transplantation of autologous bone marrow stem cells combined with entecavir for hepatitis B patients with decompensated cirrhosis

    崔永辉

    2015-01-01

    目的:观察自体骨髓干细胞移植联合恩替卡韦治疗乙型肝炎肝硬化失代偿期的临床疗效。方法选取河南省商丘市第一人民医院40例初诊的乙型肝炎肝硬化失代偿期患者,随机分为2组:对照组22例予以常规保肝治疗及恩替卡韦抗病毒治疗。治疗组18例在对照组治疗的基础上,行经肝动脉途径自体骨髓干细胞移植治疗。观察两组患者2、4、8、12周的临床症状体征,谷丙转氨酶、血清白蛋白、总胆红素、凝血酶原活动度、肝纤维化四项、HBV-DNA等指标变化,比较两组患者第12周的临床症状体征及化验室指标。结果经治疗后两组患者纳差、乏力、腹胀、腹水及双下肢水肿等临床症状体征均有不同程度的改善,以治疗组明显。术后第12周两组HBV-DNA检测均低于最低检出值。经治疗后两组谷丙转氨酶、总胆红素及肝纤维化四项等指标均有不同程度下降,血清白蛋白、凝血酶原活动度等均有所改善,以治疗组明显。两组患者Child-Pugh评分及终末期肝病模型评分均较治疗前有所下降,以治疗组明显。结论自体干细胞移植联合恩替卡韦治疗失代偿期乙型肝炎肝硬化患者,能够明显改善患者的临床症状及肝脏功能。自体骨髓干细胞移植是治疗乙型肝炎肝硬化失代偿期的新的有效手段。%Objective To observe the clinical efficacy of transplantation of autologous bone marrow stem cells combined with entecavir treating hepatitis B patients with decompensated cirrhosis.Methods Forty newly diagnosed hepatitis B patients with decompensated cirrhosis in the First People′s Hospital of Shangqiu of Henan Province were randomly divided into control group and observation group.The 22 patients in control group were treated with conventional liver protected treatment and entecavir antiviral therapy.On the basis of the control group,the 18 patients in observation group

  13. Topics in random walks in random environment

    Over the last twenty-five years random motions in random media have been intensively investigated and some new general methods and paradigms have by now emerged. Random walks in random environment constitute one of the canonical models of the field. However in dimension bigger than one they are still poorly understood and many of the basic issues remain to this day unresolved. The present series of lectures attempt to give an account of the progresses which have been made over the last few years, especially in the study of multi-dimensional random walks in random environment with ballistic behavior. (author)

  14. Effects on hemodynamics and gas exchange of omega-3 fatty acid-enriched lipid emulsion in acute respiratory distress syndrome (ARDS: a prospective, randomized, double-blind, parallel group study

    Sacanell Judit

    2008-10-01

    Full Text Available Abstract Introduction We investigated the effects on hemodynamics and gas exchange of a lipid emulsion enriched with omega-3 fatty acids in patients with ARDS. Methods The design was a prospective, randomized, double-blind, parallel group study in our Intensive Medicine Department of Vall d'Hebron University Hospital (Barcelona-Spain. We studied 16 consecutive patients with ARDS and intolerance to enteral nutrition (14 men and 2 women; mean age: 58 ± 13 years; APACHE II score: 17.8 ± 2.3; Lung Injury Score: 3.1 ± 0.5; baseline PaO2/FiO2 ratio: 149 ± 40. Patients were randomized into 2 groups: Group A (n = 8 received the study emulsion Lipoplus® 20%, B.Braun Medical (50% MCT, 40% LCT, 10% ω-3; Group B (n = 8 received the control emulsion Intralipid® Fresenius Kabi (100% LCT. Lipid emulsions were administered during 12 h at a dose of 0.12 g/kg/h. Measurements of the main hemodynamic and gas exchange parameters were made at baseline (immediately before administration of the lipid emulsions, every hour during the lipid infusion, at the end of administration, and six hours after the end of administration lipid infusion. Results No statistically significant changes were observed in the different hemodynamic values analyzed. Likewise, the gas exchange parameters did not show statistically significant differences during the study. No adverse effect attributable to the lipid emulsions was seen in the patients analyzed. Conclusion The lipid emulsion enriched with omega-3 fatty acids was safe and well tolerated in short-term administration to patients with ARDS. It did not cause any significant changes in hemodynamic and gas exchange parameters. Trial registration ISRCTN63673813

  15. Acute abdomen

    Acute abdomen may be connected with the injury of one of the internal organs, injury of large blood vessels, with the spreading of pains from some other area. It may also be a manifestation of systemic disease or poisoning. The main purposes of radiodiagnosis are: determination of the cause of clinical syndrome; determination of the localization and spreading of pathological changes in abdominal organs; finding out the character of complications. If the data of the ordinary roentgenological investiagtion and isn't complete, the computer tomography of abdominal and pelvic cavities is needed

  16. Antibiotics as part of the management of severe acute malnutrition

    Severe acute malnutrition contributes to 1 million deaths among children annually. Adding routine antibiotic agents to nutritional therapy may increase recovery rates and decrease mortality among children with severe acute malnutrition treated in the community. In this randomized, double-blind, plac...

  17. [Acute myocarditis].

    Combes, Alain

    2013-05-01

    Myocarditis is defined as inflammation of the myocardium accompanied by myocellular necrosis. Acute myocarditis must be considered in patients who present with recent onset of cardiac failure or arrhythmia. Fulminant myocarditis is a distinct entity characterized by sudden onset of severe congestive heart failure or cardiogenic shock, usually following a flu-like illness, parvovirus B19, human herpesvirus 6, coxsackievirus and adenovirus being the most frequently viruses responsible for the disease. Treatment of myocarditis remains largely supportive, since immunosuppression has not been proven to be beneficial for acute lymphocytic myocarditis. Trials of antiviral therapies, or immunostimulants such as interferons, suggest a potential therapeutic role but require further investigation. Lastly, early recognition of patients rapidly progressing to refractory cardiac failure and their immediate transfer to a medical-surgical center experienced in mechanical circulatory support is warranted. In this setting, ECMO should be the first-line mechanical assistance. For highly unstable patients, a Mobile Cardiac Assistance Unit, that rapidly travels to primary care hospitals with a portable ECMO system and hooks it up before refractory multiorgan failure takes hold, is the preferred option. PMID:23789482

  18. RECURRENT SEASONAL ACUTE PSYCHOSIS

    Agarwal, Vivek

    1999-01-01

    Acute psychoses have been reported to occur more frequently in summer. This is a report of seasonal recurrence of acute psychosis in a patient. This case report emphasizes towards the biological etiology of acute psychoses.

  19. Acute cerebellar ataxia

    Cerebellar ataxia; Ataxia - acute cerebellar; Cerebellitis; Post-varicella acute cerebellar ataxia; PVACA ... Acute cerebellar ataxia in children, especially younger than age 3, may occur several weeks after an illness caused by a virus. ...

  20. Effects of an omega-3 fatty acid-enriched lipid emulsion on eicosanoid synthesis in acute respiratory distress syndrome (ARDS: A prospective, randomized, double-blind, parallel group study

    Chacon Pilar

    2011-04-01

    Full Text Available Abstract Background The use of lipid emulsions has been associated with changes in lung function and gas exchange which may be mediated by biologically active metabolites derived from arachidonic acid. The type and quantity of the lipid emulsions used could modulate this response, which is mediated by the eicosanoids. This study investigates the use of omega-3 fatty acid-enriched lipid emulsions in ARDS patients and their effects on eicosanoid values. Methods Prospective, randomized, double-blind, parallel group study carried out at the Intensive Medicine Department of Vall d'Hebron University Hospital (Barcelona-Spain. We studied 16 consecutive patients with ARDS and intolerance to enteral nutrition (14 men; age: 58 ± 13 years; APACHE II score 17.8 ± 2.3; Lung Injury Score: 3.1 ± 0.5; baseline PaO2/FiO2 ratio: 149 ± 40. Patients were randomized into two groups: Group A (n = 8 received the study emulsion Lipoplus® 20%, B. Braun Medical (50% MCT, 40% LCT, 10% fish oil (FO; Group B (n = 8 received the control emulsion Intralipid® Fresenius Kabi (100% LCT. Lipid emulsions were administered for 12 h at a dose of 0.12 g/kg/h. We measured LTB4, TXB2, and 6-keto prostaglandin F1α values at baseline [immediately before the administration of the lipid emulsions (T-0], at the end of the administration (T-12 and 24 hours after the beginning of the infusion (T 24 in arterial and mixed venous blood samples. Results In group A (FO LTB4, TXB2, 6-keto prostaglandin F1α levels fell during omega-3 administration (T12. After discontinuation (T24, levels of inflammatory markers (both systemic and pulmonary behaved erratically. In group B (LCT all systemic and pulmonary mediators increased during lipid administration and returned to baseline levels after discontinuation, but the differences did not reach statistical significance. There was a clear interaction between the treatment in group A (fish oil and changes in LTB4 over time. Conclusions Infusion of

  1. Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study.

    Wolf, Dörte; Otto, Joachim

    2015-01-01

    Lidocaine is a well-accepted topical anaesthetic, also used in minors to treat painful conditions on mucosal membranes. This randomized, double-blind, placebo-controlled study (registered prospectively as EudraCT number 2011-005336-25) was designed to generate efficacy and safety data for a lidocaine gel (2%) in younger children with painful conditions in the oral cavity. One hundred sixty-one children were included in two subgroups: 4-8 years, average age 6.4 years, treated with verum or placebo and 6 months-verum. Pain reduction was measured from the time prior to administration to 10 or 30 minutes after. In addition, adverse events and local tolerability were evaluated. In group I, pain was reduced significantly after treatment with verum compared to placebo at both time points. In group II, the individual pain rating shift showed statistically significant lower pain after treatment. Only seven out of 161 patients reported an adverse event but none were classified as being related to the study medication. The local tolerability was assessed as very good in over 97% of cases. For painful sites in the oral cavity, a 2% lidocaine gel is a meaningful tool for short-term treatment in the paediatric population. PMID:26693229

  2. Acute Myopericarditis Mimicking Acute Myocardial Infarction

    Seval İzdeş; Neriman Defne Altıntaş; Gülin Karaaslan; Recep Uygun; Abdulkadir But

    2011-01-01

    Acute coronary syndromes among young adults are relatively low when compared with older population in the intensive care unit. Electrocardiographic abnormalities mimicking acute coronary syndromes may be caused by non-coronary syndromes and the differential diagnosis requires a detailed evaluation. We are reporting a case of myopericarditis presenting with acute ST elevation and elevated cardiac enzymes simulating acute coronary syndrome. In this case report, the literature is reviewed to dis...

  3. Development of a positive psychology intervention for patients with acute cardiovascular disease

    Julia K. Boehm

    2011-09-01

    Full Text Available The management of depression and other negative psychological states in cardiac patients has been a focus of multiple treatment trials, though such trials have not led to substantial improvements in cardiac outcomes. In contrast, there has been minimal focus on interventions to increase positive psychological states in cardiac patients, despite the fact that optimism and other positive states have been associated with superior cardiovascular outcomes. Our objective was to develop an 8-week, phone-based positive psychology intervention for patients hospitalized with acute cardiac disease (acute coronary syndrome or decompensated heart failure. Such an intervention would consist of positive psychology exercises adapted for this specific population, and it would need to be feasible for practitioners and patients in real-world settings. By adapting exercises that were previously validated in healthy individuals, we were able to generate a positive psychology telemedicine intervention for cardiac patients that focused on optimism, kindness, and gratitude. In addition, we successfully created a companion treatment manual for subjects to enhance the educational aspects of the intervention and facilitate completion of exercises. Finally, we successfully performed a small pilot trial of this intervention, and found that the positive psychology intervention appeared to be feasible and well-accepted in a cohort of patients with acute cardiac illness. Future studies should further develop this promising intervention and examine its impact on psychological and medical outcomes in this vulnerable population of cardiac patients.

  4. 干细胞移植治疗失代偿期肝硬化临床评估%The therapeutic effect of stem cell transplantation on decompensated cirrhosis

    黄丽雯; 刘黎; 周健

    2012-01-01

    目的 观察干细胞移植治疗失代偿期肝硬化的疗效.方法 选择110例失代偿期肝硬化患者在常规治疗基础上行干细胞移植,移植后第4周复查肝功能、凝血酶原时间、胆碱酯酶和甲胎蛋白等实验室指标及观察临床症状和体征的变化.结果 移植后第4周,血浆白蛋白(ALB)、胆碱酯酶(CHE)显著升高(P0.05);干细胞移植可明显改善失代偿期肝硬化患者临床症状和体征(P0. 05 ) before and after stem cell transplant. The clinical symptoms, signs and life quality of patients with decompensated cirrhosis were significantly improved after stem cell transplantation ( P < 0. 05 ). No adverse reactions and serious intraoperative complications were found in the near future. Conclusion The stem cell transplantation has better short-term therapeutic effect on decompensated cirrhosis.

  5. Peritonitis bacteriana espontánea: estudio en pacientes cirróticos descompensados con ascitis Spontaneous bacterial peritonitis in decompensated cirrhotic patients with ascites

    Fernando Montoya Maya

    1995-02-01

    . coli y estreptococos del grupo viridans debe tenerse en cuenta para la adecuada selección de la terapia empírica antibacteriana.

    Between February 1993 and March 1994 a prospective descriptive study was carried out in 25 cirrhotic patients (three of them on two occasions with clinical or ultrasonographic ascites; they were hospitalized in the Internal Medicine ward of San Vicente de Paúl Hospital, in Medellín, Colombia, because of decompensation. All of them went through diagnostic paracentesis with cytologic, bacteriologic and chemical studies. Average age was 43.9 years (13 to 77 years, 13 were women (52% and 12 men (48%. Infection of the ascitic fluid was found in 11 cases (39.3%, namely: Bacterascites 6 cases (monomicrobial 3 cases (27.3%, polymicrobial 3 cases (27.3%», spontaneous bacterial peritonitis 3 cases (polymicrobial 2 cases (18.2% and monomicrobial1 case (9.1 %» and neutrocytic ascites 2 cases (18.2%. Seventy two percent of the infectious episodes caused fever (p < 0.01 and in 46% there was abdominal pain (p < 0.1. AII patients with infected ascites belonged to Child's classification C. Serum albumin levellower than 2 g/dl was a risk factor for developing infection. Escherichia coli was cultivated on 5 occasions (45.5%, viridans group of Streptococci in 5 (45.5%, anaerobes in 3 (27.3% and other bacteria in 3 (27.3%. Mortality due to infected ascites was 27.3% (3 cases, comparable to that produced by other causes that was 29.4% (5/17. We conclude that ascitic fluid infection is a common complication in decompensated cirrhotic patients. Thecardinal clinical signs are fever and abdominal pain. The frequent isolation of E. coli and viridans group Streptococci has to be taken into account for the initiation of antibiotic therapy in cases with clinical suspicion.

  6. Blood glucose in acute stroke

    Olsen, Tom Skyhøj

    2009-01-01

    Blood glucose is often elevated in acute stroke, and higher admission glucose levels are associated with larger lesions, greater mortality and poorer functional outcome. In patients treated with thrombolysis, hyperglycemia is associated with an increased risk of hemorrhagic transformation of...... infarcts. For a number of years, tight glycemic control has been regarded as beneficial in critically illness, but recent research has been unable to support this notion. The only completed randomized study on glucose-lowering therapy in stroke has failed to demonstrate effect, and concerns relating to the...... risk of inducing potentially harmful hypoglycemia has been raised. Still, basic and observational research is overwhelmingly in support of a causal relationship between blood glucose and stroke outcome and further research on glucose-lowering therapy in acute stroke is highly warranted....

  7. Completely random signed measures

    Hellmund, Gunnar

    Completely random signed measures are defined, characterized and related to Lévy random measures and Lévy bases.......Completely random signed measures are defined, characterized and related to Lévy random measures and Lévy bases....

  8. Acute abdomen

    The book first presents the anatomy and physiology of the abdomen and continues with chapters discussing clinical and laboratory aspects and a suitable order of diagnostic examinations with reference to the acute processes, explaining the diagnostic tools: ultrasonography, radiography including angiography and CT, tapping techniques and endoscopy together with their basic principles, examination techniques, and diagnosis. One chapter presents a complete survey of the processes involving the entire abdomen - as e.g. peritonitis, ileus, abdominal trauma, intraperitoneal hemorrage. This chapter profoundly discusses the diagnostics and therapies including emergency measures and surgery. Problems requiring consultation among varous specialists, in internal medicine, gynecology, urology, or pediatrics, are discussed in great detail. Information for the anesthetist is given for cases of emergency. More than one third of the book is devoted to organ-specific information, dicussing the pathogenesis, diagnostics, and therapy of the oesophagus, stomach, large and small intestine, bile ducts, pankreas, liver, spleen, and the abdominal vessels and the abdominal wall. (orig.) With 153 figs., 90 tabs

  9. Acute pancreatitis

    A prospective study was performed on the relationship of CT findings to the clinical course of 148 patients with acute pancreatitis. The type of pancreatic inflammation seen on CT was classified into six categories based on an overall assessment of size, contour and density of the gland, and peripancreatic abnormalities. The majority (94%) of patients in whom CT showed mild pancreatic changes (grades A, B and C) had two or less positive clinical indicaters of severe pancreatitis (Ranson's signs). In contrast, 92% of patients in whom CT showed more severe changes of pancreatitis (grades D, E or F) had three or more positive signs. The nine patients who died with pancreatitis-related complications were in grades D, E or F. We wish to draw attention to a CT appearance which we have called 'fat islets' (low density intrapancreatic or peripancreatic areas, the contents of which approach fat in attenuation values); there was a strong correlation between this appearance and subsequent infection. (author). 24 refs.; 7 figs.; 4 tabs

  10. Randomized LU Decomposition

    Shabat, Gil; Shmueli, Yaniv; Aizenbud, Yariv; Averbuch, Amir

    2013-01-01

    We present a fast randomized algorithm that computes a low rank LU decomposition. Our algorithm uses random projections type techniques to efficiently compute a low rank approximation of large matrices. The randomized LU algorithm can be parallelized and further accelerated by using sparse random matrices in its projection step. Several different error bounds are proven for the algorithm approximations. To prove these bounds, recent results from random matrix theory related to subgaussian mat...

  11. Transfusion related acute lung injury

    Sharma Ratti; Bhattacharya Prasun; Thakral Beenu; Saluja Karan; Marwaha Neelam

    2009-01-01

    Transfusion related acute lung injury (TRALI) is an uncommon but potentially fatal adverse reaction to transfusion of plasma containing blood components. We describe a case of 10-year-old male child with aplastic anemia, platelet count of 7800/΅l, B positive blood group who developed fever (39.2΀C), difficulty in breathing and cyanosis within 2 hrs after transfusion of a random platelet concentrate. Despite the best resuscitative efforts, the child died within next 24 hrs. The prese...

  12. Comparing MTI randomization procedures to blocked randomization.

    Berger, Vance W; Bejleri, Klejda; Agnor, Rebecca

    2016-02-28

    Randomization is one of the cornerstones of the randomized clinical trial, and there is no shortage of methods one can use to randomize patients to treatment groups. When deciding which one to use, researchers must bear in mind that not all randomization procedures are equally adept at achieving the objective of randomization, namely, balanced treatment groups. One threat is chronological bias, and permuted blocks randomization does such a good job at controlling chronological bias that it has become the standard randomization procedure in clinical trials. But permuted blocks randomization is especially vulnerable to selection bias, so as a result, the maximum tolerated imbalance (MTI) procedures were proposed as better alternatives. In comparing the procedures, we have somewhat of a false controversy, in that actual practice goes uniformly one way (permuted blocks), whereas scientific arguments go uniformly the other way (MTI procedures). There is no argument in the literature to suggest that the permuted block design is better than or even as good as the MTI procedures, but this dearth is matched by an equivalent one regarding actual trials using the MTI procedures. So the 'controversy', if we are to call it that, pits misguided precedent against sound advice that tends to be ignored in practice. We shall review the issues to determine scientifically which of the procedures is better and, therefore, should be used. PMID:26337607

  13. Demographics, Clinical Characteristics, Management, and Outcomes of Acute Heart Failure Patients: Observations from the Oman Acute Heart Failure Registry

    Prashanth Panduranga

    2016-05-01

    Full Text Available Objectives: We sought to describe the demographics, clinical characteristics, management and outcomes of patients in Oman with acute heart failure (AHF as part of the Gulf aCute heArt failuRe rEgistry (CARE project. Methods: Data were analyzed from 988 consecutive patients admitted with AHF to 12 hospitals in Oman between 14 February and 14 November 2012. Results: The mean age of our patients was 63±12 years. Over half (57% were male and 95% were Omani citizens. Fifty-seven percent of patients presented with acute decompensated chronic heart failure (ADCHF while 43% had new-onset AHF. The primary comorbid conditions were hypertension (72%, coronary artery disease (55%, and diabetes mellitus (53%. Ischemic heart disease (IHD, hypertensive heart disease, and idiopathic cardiomyopathy were the most common etiologies of AHF in Oman. The median left ventricular ejection fraction of the cohort was 36% (27–45% with 56% of the patients having heart failure with reduced ejection fraction (< 40%. Atrial fibrillation was seen in 15% of patients. Acute coronary syndrome (ACS and non-compliance with medications were the most common precipitating factors. At discharge, angiotensin converting enzyme inhibitors and beta-blockers were prescribed adequately, but aldosterone antagonists were under prescribed. Within 12-months follow-up, one in two patients were rehospitalized for AHF. In-hospital mortality was 7.1%, which doubled to 15.7% at three months and reached 26.4% at one-year post discharge. Conclusions: Oman CARE was the first prospective multicenter registry of AHF in Oman and showed that heart failure (HF patients present at a younger age with recurrent ADCHF and HF with reduced ejection fraction. IHD was the most common etiology of HF with a low prevalence of AHF, but a high prevalence of acute coronary syndrome and non-compliance with medications precipitating HF. A quarter of patients died at one-year follow-up even though at discharge medical

  14. Random walks on combs

    Durhuus, B; Wheater, J; Durhuus, Bergfinnur; Jonsson, Thordur; Wheater, John

    2006-01-01

    We develop techniques to obtain rigorous bounds on the behaviour of random walks on combs. Using these bounds we calculate exactly the spectral dimension of random combs with infinite teeth at random positions or teeth with random but finite length. We also calculate exactly the spectral dimension of some fixed non-translationally invariant combs. We relate the spectral dimension to the critical exponent of the mass of the two-point function for random walks on random combs, and compute mean displacements as a function of walk duration. We prove that the mean first passage time is generally infinite for combs with anomalous spectral dimension.

  15. Matricially free random variables

    Lenczewski, Romuald

    2008-01-01

    We show that the operatorial framework developed by Voiculescu for free random variables can be extended to arrays of random variables whose multiplication imitates matricial multiplication. The associated notion of independence, called matricial freeness, can be viewed as a generalization of both freeness and monotone independence. At the same time, the sums of matricially free random variables, called random pseudomatrices, are closely related to Gaussian random matrices. The main results presented in this paper concern the standard and tracial central limit theorems for random pseudomatrices and the corresponding limit distributions which can be viewed as matricial generalizations of semicirle laws.

  16. Acute chylous peritonitis due to acute pancreatitis

    2012-01-01

    We report a case of acute chylous ascites formation presenting as peritonitis (acute chylous peritonitis) in a patient suffering from acute pancreatitis due to hypertriglyceridemia and alcohol abuse. The development of chylous ascites is usually a chronic process mostly involving malignancy, trauma or surgery, and symptoms arise as a result of progressive abdominal distention. However, when accumulation of “chyle” occurs rapidly, the patient may present with signs of peritonitis. Preoperative...

  17. The observation of clinical effectiveness of adefovir combined with Anfate in treatment of patients with decompensated cirrhosis%阿德福韦酯联合复方牛胎肝提取物治疗失代偿期肝硬化疗效观察

    余永胜; 王丽莉; 刘燕萍; 张春燕

    2011-01-01

    Objective To observe the effects and safety of adefovir combined with anfate(compound fetal cow liver extract tablets)in treament of patients with decompensated cirrhosis caused by chronic hepatitis B.Methods 45 decompensated cirrhosis patients with HBsAg, HBeAb-Positive HBcAb-Positive( 103Copies/ml < HBV-DNA Level <10^6 Copies/ml)were randomly divided into conventional therapy group and with adefovie Combined Anfate Aapsule treatment. The clinical effectiveness after 6months was observed. Results The rates of serum ALT normalization,HBV-DNA levels undetectable( < 103copies/ml) ,were 75.0% (18/24) ,45.8% (11/24). in adefovie combined Anfate treatment group and 76.1% ( 16/21 ) ,42.8 % (9/21 )in control group, there was no statistically significant difference between the two groups after 6months( P > 0.05 ). Hepatic fibrosis index as HA, LN,PC3 were decreased in two groups. There was respectively between the two groups, ,in the therapy group the rate patients got distinct improvement about the clinical symptoms was 87.5% ( 21/24 ), which was remarkably higher than placebo group's 52.4%( 11/21 ). ( P < 0.05). There was no ebidence of renal toxicity. Conclusion The effect of adefovir combined with anfate in treatment of decompensated cirhosis was stable and safe for.%目的 观察阿德福韦酯联合复方牛胎肝提取物治疗慢性乙型肝炎肝硬化失代偿期患者的疗效和安全性。方法 选择HBsAg 、HBeAb和HBcAb阳性(103 copies/ml< HBV-DNA< 106 copies/ml)的肝硬化失代偿期患者45例。随机分为两组,一组采用普通保肝对症治疗加用阿德福韦酯抗病毒治疗,另一组在保肝对症治疗的基础上加用阿德福韦酯联合复方牛胎肝提取物抗病毒抗纤维化治疗。结果 治疗前两组各项指标差异无统计学意义,而治疗6个月后与治疗前比较,差异均有统计学意义,其中,ALT复常率、HBV-DNA转阴率(< 103 copies/ml)治疗组分别为75.0% (18

  18. Pharmacological approach to acute pancreatitis

    Ulrich Christian Bang; Synne Semb; Camilla Nφjgaard; Flemming Bendtsen

    2008-01-01

    The aim of the present review is to summarize the current knowledge regarding pharmacological prevention and treatment of acute pancreatitis (AP)based on experimental animal models and clinical trials.Somatostatin (SS) and octreotide inhibit the exocrine production of pancreatic enzymes and may be useful as prophylaxis against Post Endoscopic retrograde cholangiopancreatography Pancreatitis (PEP). The protease inhibitor Gabexate mesilate (GM) is used routinely as treatment to AP in some countries, but randomized clinical trials and a meta-analysis do not support this practice. Nitroglycerin (NGL) is a nitrogen oxide (NO) donor, which relaxes the sphincter of Oddi.Studies show conflicting results when applied prior to ERCP and a large multicenter randomized study is warranted. Steroids administered as prophylaxis against PEP has been validated without effect in several randomized trials. The non-steroidal anti-inflammatory drugs (NSAID) indomethacin and diclofenac have in randomized studies showed potential as prophylaxis against PEP. Interleukin 10 (IL-10) is a cytokine with anti-inflammatory properties but two trials testing IL-10 as prophylaxis to PEP have returned conflicting results.Antibodies against tumor necrosis factor-alpha (TNF-α)have a potential as rescue therapy but no clinical trials are currently being conducted. The antibiotics betalactams and quinolones reduce mortality when necrosis is present in pancreas and may also reduce incidence of infected necrosis. Evidence based pharmacological treatment of AP is limited and studies on the effect of potent anti-inflammatory drugs are warranted.

  19. On Gaussian random supergravity

    We study the distribution of metastable vacua and the likelihood of slow roll inflation in high dimensional random landscapes. We consider two examples of landscapes: a Gaussian random potential and an effective supergravity potential defined via a Gaussian random superpotential and a trivial Kähler potential. To examine these landscapes we introduce a random matrix model that describes the correlations between various derivatives and we propose an efficient algorithm that allows for a numerical study of high dimensional random fields. Using these novel tools, we find that the vast majority of metastable critical points in N dimensional random supergravities are either approximately supersymmetric with |F|≪Msusy or supersymmetric. Such approximately supersymmetric points are dynamical attractors in the landscape and the probability that a randomly chosen critical point is metastable scales as log (P)∝−N. We argue that random supergravities lead to potentially interesting inflationary dynamics

  20. Quantum Random Number Generators

    Herrero-Collantes, Miguel; Garcia-Escartin, Juan Carlos

    2016-01-01

    Random numbers are a fundamental resource in science and engineering with important applications in simulation and cryptography. The inherent randomness at the core of quantum mechanics makes quantum systems a perfect source of entropy. Quantum random number generation is one of the most mature quantum technologies with many alternative generation methods. We discuss the different technologies in quantum random number generation from the early devices based on radioactive decay to the multipl...