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  1. Pharmacologic strategies to preserve renal function in acute decompensated heart failure.

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    Kumar, Sachin; Taylor, David O

    2015-02-01

    Over a million patients get hospitalized with the diagnosis of acute decompensated heart failure which poses an insurmountable financial burden on the health care system. Heart failure alone incurs over 30 billion dollars with half the cost spent towards acute hospitalizations. Majority of the treatment strategies have focused towards decongesting patients which often comes with the cost of worsening renal function. Renal dysfunction in the setting of acute decompensated heart failure portends worse morbidity and mortality. Recently, there has been a change in the focus with shift towards therapies attempting to conserve renal function. In the past decade, we have witnessed several large randomized controlled trials testing the established as well as emerging therapies in this subset of population with mixed results. This review intends to provide a comprehensive overview of the pharmacologic therapies commonly utilized in the management of acute decompensated heart failure and the body of evidence supporting these strategies.

  2. [Therapeutic strategies in acute decompensated heart failure and cardiogenic shock].

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    Buerke, M; Lemm, H; Russ, M; Schlitt, A; Werdan, K

    2010-08-01

    As the population of elderly people is increasing, the number of patients requiring hospitalization for acute exacerbations is rising. Traditionally, these episodes of hemodynamic instability were viewed as a transient event characterized by systolic dysfunction, low cardiac output, and fluid overload. Diuretics, along with vasodilator and inotropic therapy, eventually became elements of standard care. In a multicenter observational registry (ADHERE--Acute Decompensated Heart Failure National Registry) of more than 275 hospitals, patients with acute decompensated heart failure were analyzed for their characteristics and treatments options. These data have shown that this population consists of multiple types of heart failure, various forms of acute decompensation, combinations of comorbidities, and varying degrees of disease severity. The challenges in the treatment require multidisciplinary approaches since patients typically are elderly and have complex combinations of comorbidities. So far only a limited number of drugs is currently available to treat the different groups. Over the past years it was shown that even "standard drugs" might be deleterious by induction of myocardial injury, worsening of renal function or increasing mortality upon treatment. Therefore, based on pathophysiology, different types of acute decompensated heart failure require specialized treatment strategies.

  3. Rational use of diuretics in acute decompensated heart failure.

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    Goebel, Jason A; Van Bakel, Adrian B

    2008-09-01

    Chronic heart failure poses an enormous health care burden to the United States and other developed countries. Acute decompensated heart failure (ADHF) accounts for nearly half of the morbidity and expense of treating this disease. Most patients presenting with ADHF have symptomatic vascular congestion. Diuretics, especially loop diuretics, are the primary pharmacologic intervention used in this population. Despite their widespread use, scant data from randomized clinical trials are available to guide therapeutic choices. In addition, data from several large registries examining weight loss during hospitalization for ADHF suggest that efficacy with diuretic treatment is far from universal. Aggressive diuresis carries a significant risk of electrolyte and volume depletion, with subsequent arrhythmias, hypotension, and worsening renal function. These complications often translate into worse prognosis. Diuretic regimens used to treat ADHF must be individualized based on general knowledge of potency and pharmacokinetic and pharmacodynamic considerations. This article summarizes older and more recent literature to provide a framework for making rational treatment choices in this difficult patient population.

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

    Institute of Scientific and Technical Information of China (English)

    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.

  5. Effects of Nesiritide and Predictors of Urine Output in Acute Decompensated Heart Failure Results From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure)

    NARCIS (Netherlands)

    Gottlieb, Stephen S.; Stebbins, Amanda; Voors, Adriaan A.; Hasselblad, Vic; Ezekowitz, Justin A.; Califf, Robert M.; O'Connor, Christopher M.; Starling, Randall C.; Hernandez, Adrian F.

    2013-01-01

    Objectives This study sought to determine if nesiritide increases diuresis in congestive heart failure patients. Background In the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure), 7,141 patients hospitalized with acute decompensated heart failure (ADHF

  6. Nesiritide, Renal Function, and Associated Outcomes During Hospitalization for Acute Decompensated Heart Failure Results From the Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure (ASCEND-HF)

    NARCIS (Netherlands)

    van Deursen, Vincent M.; Hernandez, Adrian F.; Stebbins, Amanda; Hasselblad, Vic; Ezekowitz, Justin A.; Califf, Robert M.; Gottlieb, Stephen S.; O'Connor, Christopher M.; Starling, Randall C.; Tang, W. H. Wilson; McMurray, John J.; Dickstein, Kenneth; Voors, Adriaan A.

    2014-01-01

    Background-Contradictory results have been reported on the effects of nesiritide on renal function in patients with acute decompensated heart failure. We studied the effects of nesiritide on renal function during hospitalization for acute decompensated heart failure and associated outcomes. Methods

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

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    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

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

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    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

  9. Loop Diuretics in Acute Decompensated Heart Failure: Necessary? Evil? A Necessary Evil?

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    Felker, G. Michael; O’Connor, Christopher M.; Braunwald, Eugene

    2009-01-01

    Acute decompensated heart failure (ADHF) is a common and highly morbid cardiovascular disorder. Most hospitalizations for ADHF are related to symptoms of congestion, and the vast majority of ADHF patients are treated with intravenous loop diuretics. Despite this nearly ubiquitous use, data supporting the safety and efficacy of loop diuretics in ADHF are limited, and controversy exists about the best way to use loop diuretics with regard to both dosing and means of administration (continuous infusion vs. intermittent boluses). We reviewed the data supporting the safety and efficacy of loop diuretics in patients with ADHF. A large body of observational literature suggests that loop diuretics, especially at higher doses, may be associated with increased mortality in patients with heart failure even after detailed adjustment for other measures of disease severity. Additionally, multiple small underpowered trials suggest that continuous infusion may be equivalent or superior to intermittent bolus dosing. In summary, there is a critical need to develop more robust data on the use of loop diuretics in ADHF. In that context, the NIH Heart Failure Clinical Research Network has begun the Diuretics Optimization Strategies Evaluation (DOSE) study, a multi-center, double-blind, randomized controlled trial that will enroll 300 patients with ADHF. The DOSE study will randomize patients using a 2 × 2 factorial design to low dose vs. high dose furosemide, and intermittent bolus vs. continuous infusion. Successful completion of the DOSE study will provide important data on the optimal clinical use of loop diuretics in ADHF. PMID:19750134

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

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    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.)

  11. Triple Diuretics and Aquaretic Strategy for Acute Decompensated Heart Failure due to Volume Overload

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    Rita Jermyn

    2013-01-01

    Full Text Available Diuretics, including furosemide, metolazone, and spironolactone, have historically been the mainstay of therapy for acute decompensated heart failure patients. The addition of an aquaretic-like vasopressin antagonist may enhance diuresis further. However, clinical experience with this quadruple combination is lacking in the acute setting. We present two hospitalized patients with acute decompensated heart failure due to massive fluid overload treated with a combination strategy of triple diuretics in conjunction with the aquaretic tolvaptan. The first patient lost 72.1 lbs. (32.7 kg with an average urine output of 3.5 to 7.5 L/day over eight days on combined therapy with furosemide, metolazone, spironolactone, and tolvaptan. The second patient similarly achieved a weight loss of 28.2 lbs. (12.8 kg over 4 days on the same treatment. Both patients maintained stable serum sodium, potassium, and creatinine over this period and remained out of the hospital for more than 30 days. Thus, patients hospitalized with acute decompensated heart failure due to volume overload can achieve euvolemia rapidly and without electrolytes disturbances using this regimen, while being under the close supervision of a team of cardiologists and nephrologists. Additionally, this therapy can potentially decrease the need for ultrafiltration and the length of hospital stay.

  12. Triple Diuretics and Aquaretic Strategy for Acute Decompensated Heart Failure due to Volume Overload

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    Estrada, Chelsea; Patel, Sagar; Weisfelner Bloom, Michelle; Wadhwa, Nand K.

    2013-01-01

    Diuretics, including furosemide, metolazone, and spironolactone, have historically been the mainstay of therapy for acute decompensated heart failure patients. The addition of an aquaretic-like vasopressin antagonist may enhance diuresis further. However, clinical experience with this quadruple combination is lacking in the acute setting. We present two hospitalized patients with acute decompensated heart failure due to massive fluid overload treated with a combination strategy of triple diuretics in conjunction with the aquaretic tolvaptan. The first patient lost 72.1 lbs. (32.7 kg) with an average urine output of 3.5 to 7.5 L/day over eight days on combined therapy with furosemide, metolazone, spironolactone, and tolvaptan. The second patient similarly achieved a weight loss of 28.2 lbs. (12.8 kg) over 4 days on the same treatment. Both patients maintained stable serum sodium, potassium, and creatinine over this period and remained out of the hospital for more than 30 days. Thus, patients hospitalized with acute decompensated heart failure due to volume overload can achieve euvolemia rapidly and without electrolytes disturbances using this regimen, while being under the close supervision of a team of cardiologists and nephrologists. Additionally, this therapy can potentially decrease the need for ultrafiltration and the length of hospital stay. PMID:24829808

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

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    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.

  14. Hepatic encephalopathy in patients with acute decompensation of cirrhosis and acute-on-chronic liver failure.

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    Romero-Gómez, Manuel; Montagnese, Sara; Jalan, Rajiv

    2015-02-01

    Hepatic encephalopathy in a hospitalized cirrhotic patient is associated with a high mortality rate and its presence adds further to the mortality of patients with acute-on-chronic liver failure (ACLF). The exact pathophysiological mechanisms of HE in this group of patients are unclear but hyperammonemia, systemic inflammation (including sepsis, bacterial translocation, and insulin resistance) and oxidative stress, modulated by glutaminase gene alteration, remain as key factors. Moreover, alcohol misuse, hyponatremia, renal insufficiency, and microbiota are actively explored. HE diagnosis requires exclusion of other causes of neurological, metabolic and psychiatric dysfunction. Hospitalization in the ICU should be considered in every patient with overt HE, but particularly if this is associated with ACLF. Precipitating factors should be identified and treated as required. Evidence-based specific management options are limited to bowel cleansing and non-absorbable antibiotics. Ammonia lowering drugs, such as glycerol phenylbutyrate and ornithine phenylacetate show promise but are still in clinical trials. Albumin dialysis may be useful in refractory cases. Antibiotics, prebiotics, and treatment of diabetes reduce systemic inflammation. Where possible and not contraindicated, large portal-systemic shunts may be embolized but liver transplantation is the most definitive step in the management of HE in this setting. HE in patients with ACLF appears to be clinically and pathophysiologically distinct from that of acute decompensation and requires further studies and characterization.

  15. Intra-abdominal Hypertension: An Important Consideration for Diuretic Resistance in Acute Decompensated Heart Failure.

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    Nguyen, Vinh Q; Gadiraju, Taraka V; Patel, Hiren; Park, Minnsun; Le Jemtel, Thierry H; Jaiswal, Abhishek

    2016-01-01

    Fluid accumulation is the hallmark of heart failure decompensation. Fluid overload and congestion are associated with recurrent hospitalizations, poor quality of life, and increased mortality in heart failure. Despite the use of high-dose intravenous loop diuretic therapy, acutely decompensated heart failure patients may develop diuretic resistance. Diuretic refractoriness can be a result of elevated intra-abdominal pressure (IAP) in acutely decompensated heart failure. Increased renal venous and interstitial pressures in patients with elevated IAP may lead to renal impairment and diuretic resistance. Routine approaches such as sequential nephron blockade with a combination of loop and thiazide or thiazide-like diuretics, continuous diuretic infusion, and ultrafiltration may not be sufficient. Presented here is a case illustrating the importance of recognizing intra-abdominal hypertension in patients with diuretic resistance. Lowering IAP improves renal perfusion, renal filtration, and diuresis. When elevated, IAP is an easily reversible cause of diuretic resistance. Additionally, abdominal perfusion pressure can be used to guide therapy to reverse end-organ damage and avoid permanent renal replacement therapy.

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

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    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.

  17. Efficacy and safety of continuous hemodiafiltration for acute decompensated heart failure.

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    Shiomi, Hiroki; Matsubara, Kinya; Ariyoshi, Makoto; Iwamura, Yumi; Fukui, Kensuke; Sakamoto, Tomoko; Sawanishi, Takayoshi; Shima, Masami; Furukawa, Keizo

    2010-07-01

    The mortality of heart failure patients with renal insufficiency is high, and these patients tend to develop diuretic resistance. Under these conditions, continuous hemodiafiltration (CHDF) is a possible alternative volume reduction therapy to diuretics. However, its efficacy and safety are not clear. Between April 2005 and March 2008, 248 patients with acute decompensated heart failure were admitted to the CCU of Kyoto City Hospital. Of those patients, 31 (20 volume overloaded heart failure, 11 cardiogenic shock) received CHDF therapy, and their weight loss, acute hemodynamic changes, and clinical outcome were assessed to evaluate the efficacy and safety of CHDF therapy. CHDF was performed for 6.5 +/- 6.5 days. There was no significant change in acute hemodynamics after CHDF initiation. In the volume overloaded heart failure (VH) group, significant weight loss was observed at 24 hours and 48 hours after CHDF initiation (P shock (CS) group were 10.0% and 54.5%, respectively. CHDF for acute decompensated heart failure (ADHF) is a safe, effective, and reliable volume reduction therapy for volume overloaded heart failure. Further investigation is required to assess the effectiveness of CHDF for cardiogenic shock.

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

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    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.

  19. Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

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    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

  20. Effect of recombinant human brain natriuretic peptide combined with sodium nitroprusside therapy on hemodynamics and cardiac in patients with acute decompensated heart failure

    Institute of Scientific and Technical Information of China (English)

    Qiao-Li Xing; Xian-Hong Ma; Lu Wang

    2016-01-01

    Objective:To evaluate the effect of recombinant human brain natriuretic peptide combined with sodium nitroprusside therapy on hemodynamics and cardiac function levels in patients with acute decompensated heart failure.Methods:A total of 118 patients with acute decompensated heart failure were randomly divided into observation group and the control group (n=59). Control group received clinical conventional therapy for heart failure, observation group received recombinant human brain natriuretic peptide combined with sodium nitroprusside therapy, and the differences in hemodynamics, cardiac function and circulation factor levels were compared between two groups after 12 hours of treatment. Results: After 12 hours of treatment, central venous pressure, right atrial pressure and pulmonary capillary wedge pressure values as well as circulating blood IL-6, hsCRP, ST2, NT-proBNP and cTnⅠlevels of observation group were lower than those of control group, and left heart GLS, GCS, GSRs, GSRe, GSRa, ROT and ROTR levels were higher than those of control group (P<0.05).Conclusions:Recombinant human brain natriuretic peptide combined with sodium nitroprusside therapy for patients with acute decompensated heart failure has significant advantages in optimizing hemodynamics, cardiac function and other aspects.

  1. Citric acid as the last therapeutic approach in an acute life-threatening metabolic decompensation of propionic acidaemia.

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    Siekmeyer, Manuela; Petzold-Quinque, Stefanie; Terpe, Friederike; Beblo, Skadi; Gebhardt, Rolf; Schlensog-Schuster, Franziska; Kiess, Wieland; Siekmeyer, Werner

    2013-01-01

    The tricarboxylic acid (TCA) cycle represents the key enzymatic steps in cellular energy metabolism. Once the TCA cycle is impaired in case of inherited metabolic disorders, life-threatening episodes of metabolic decompensation and severe organ failure can arise. We present the case of a 6 ½-year-old girl with propionic acidaemia during an episode of acute life-threatening metabolic decompensation and severe lactic acidosis. Citric acid given as an oral formulation showed the potential to sustain the TCA cycle flux. This therapeutic approach may become a treatment option in a situation of acute metabolic crisis, possibly preventing severe disturbance of energy metabolism.

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

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    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.

  3. Plasma asymmetric dimethylarginine and cardiovascular events in patients with acute decompensated heart failure.

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    Dückelmann, Christina; Mittermayer, Friedrich; Haider, Dominik G; Altenberger, Johann; Wolzt, Michael

    2008-07-01

    This prospective study investigated whether plasma asymmetric dimethylarginine (ADMA) concentrations are related to cardiovascular events in patients with acute heart failure. It has been reported that increased plasma ADMA concentrations are associated with adverse cardiovascular outcome in chronic heart failure. In 118 patients with acute decompensated heart failure and impaired left ventricular function, ADMA and N-terminal pro-brain natriuretic peptide (NT-proBNP) were assessed by high-performance liquid chromatography and by an enzyme-linked immunosorbent assay, respectively. Venous blood was collected at admission and after 1 week, and clinical events were observed during follow-up. All patients (median age 73 years, 96 males) were followed up for a median of 10.7 months. A clinical endpoint (cardiac decompensation, major adverse cardiovascular event, or all-cause mortality) occurred in 66 patients. In 81 patients, changes (Delta) in ADMA or NT-proBNP between admission and a median of 7 days were available. ADMA, NT-proBNP at admission, and DeltaADMA or DeltaNT-proBNP were comparable in patients with and without a clinical endpoint. In contrast to ADMA, NT-proBNP concentrations above the median were associated with higher adjusted hazard ratio for occurrence of an endpoint (HR 2.1; 95% confidence interval 1.2-3.9; P = 0.013). An inverse relationship was observed between DeltaNT-proBNP and endpoints before (P = 0.010) and after (P = 0.015) adjustment for confounders. In patients with acute heart failure, ADMA did not detect patients at future cardiovascular risk.

  4. Effects of the Adenosine A(1) Receptor Antagonist Rolofylline on Renal Function in Patients With Acute Heart Failure and Renal Dysfunction Results From PROTECT (Placebo-Controlled Randomized Study of the Selective A(1) Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized With Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function)

    NARCIS (Netherlands)

    Voors, Adriaan A.; Dittrich, Howard C.; Massie, Barry M.; DeLucca, Paul; Mansoor, George A.; Metra, Marco; Cotter, Gad; Weatherley, Beth D.; Ponikowski, Piotr; Teerlink, John R.; Cleland, John G. F.; O'Connor, Christopher M.; Givertz, Michael M.

    2011-01-01

    Objectives This study sought to assess the effects of rolofylline on renal function in patients with acute heart failure (AHF) and renal dysfunction randomized in PROTECT (Placebo-Controlled Randomized Study of the Selective A(1) Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized Wi

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

    Science.gov (United States)

    Ferreira, João Pedro; Santos, Mário; Oliveira, José Carlos; Marques, Irene; Bettencourt, Paulo; Carvalho, Henrique

    2015-01-23

    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 enzimas importantes para a reabsorção da matriz extracelular e controle do remodelamento e da reparação vasculares. Demonstrou-se aumento da atividade de MMP2 na insuficiência cardíaca, e, na insuficiência cardíaca agudamente descompensada (ICAD), demonstrou-se uma diminuição nas MMPs circulantes juntamente com o tratamento bem-sucedido. Objetivos: Testar a influência da espironolactona nos níveis de MMP2. Métodos: Análise secundária de estudo prospectivo, intervencionista, incluindo 100 pacientes com ICAD, 50 designados não aleatoriamente para o uso de espironolactona (100 mg/dia) mais terapia padrão para ICAD (grupo espironolactona) e 50 para terapia padrão para ICAD apenas (grupo controle). Resultados: Os pacientes do grupo espironolactona eram mais jovens e tinham níveis mais baixos de creatinina e ureia (todos p < 0,05). Os valores basais de MMP2, NT-pro BNP e peso não diferiram entre os grupos espironolactona e controle. Observou-se tendência para uma redução mais pronunciada na MMP2 do basal para o dia 3 no grupo espironolactona (-21 [-50 a 19] vs 1,5 [-26 a 38] ng/ml, p = 0,06). Os valores de NT-pro BNP e peso tamb

  6. Decongestive treatment of acute decompensated heart failure: cardiorenal implications of ultrafiltration and diuretics.

    Science.gov (United States)

    Freda, Benjamin J; Slawsky, Mara; Mallidi, Jaya; Braden, Gregory L

    2011-12-01

    In patients with acute decompensated heart failure (ADHF), treatment aimed at adequate decongestion of the volume overloaded state is essential. Despite diuretic therapy, many patients remain volume overloaded and symptomatic. In addition, adverse effects related to diuretic treatment are common, including worsening kidney function and electrolyte disturbances. The development of decreased kidney function during treatment affects the response to diuretic therapy and is associated with important clinical outcomes, including mortality. The occurrence of diuretic resistance and the morbidity and mortality associated with diuretic therapy has stimulated interest to develop effective and safe treatment strategies that maximize decongestion and minimize decreased kidney function. During the last few decades, extracorporeal ultrafiltration has been used to remove fluid from diuretic-refractory hypervolemic patients. Recent clinical studies using user-friendly machines have suggested that ultrafiltration may be highly effective for decongesting patients with ADHF. Many questions remain regarding the comparative impact of diuretics and ultrafiltration on important clinical outcomes and adverse effects, including decreased kidney function. This article serves as a summary of key clinical studies addressing these points. The overall goal is to assist practicing clinicians who are contemplating the use of ultrafiltration for a patient with ADHF.

  7. Predictors of Postdischarge Outcomes From Information Acquired Shortly After Admission for Acute Heart Failure A Report From the Placebo-Controlled Randomized Study of the Selective A1 Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized With Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function (PROTECT) Study

    NARCIS (Netherlands)

    Cleland, John G.; Chiswell, Karen; Teerlink, John R.; Stevens, Susanna; Fiuzat, Mona; Givertz, Michael M.; Davison, Beth A.; Mansoor, George A.; Ponikowski, Piotr; Voors, Adriaan A.; Cotter, Gad; Metra, Marco; Massie, Barry M.; O'Connor, Christopher M.

    2014-01-01

    Background Acute heart failure is a common reason for admission, and outcome is often poor. Improved prognostic risk stratification may assist in the design of future trials and in patient management. Using data from a large randomized trial, we explored the prognostic value of clinical variables, m

  8. Impact of onset time of acute kidney injury on outcomes in patients with acute decompensated heart failure.

    Science.gov (United States)

    Takaya, Yoichi; Yoshihara, Fumiki; Yokoyama, Hiroyuki; Kanzaki, Hideaki; Kitakaze, Masafumi; Goto, Yoichi; Anzai, Toshihisa; Yasuda, Satoshi; Ogawa, Hisao; Kawano, Yuhei

    2016-01-01

    Since acute kidney injury (AKI) is not always related to mortality in patients with acute decompensated heart failure (ADHF), the aim of this study was to focus on onset time of AKI and its clinical importance. A total of 371 ADHF patients were included. The impact of AKI (≥ 0.3 mg/dl or 1.5-fold increase in serum creatinine level within 48 h) with early onset (≤ 4 days from admission) or late onset (≥ 5 days from admission) was assessed. AKI occurred in 99 patients, who were divided into two groups according to the median onset time of AKI: 50 with early onset of AKI and 49 with late onset of AKI. The maximum increase in serum creatinine level from admission was greater in patients with late onset of AKI than in patients with early onset of AKI (p = 0.012). Patients with late onset of AKI had a higher 12-month mortality rate than that in patients with early onset of AKI (log-rank test, p = 0.014). Late onset of AKI was an independent predictor of mortality (hazard ratio: 3.39, 95 % confidence interval: 1.84-6.18, p time of AKI may be useful for risk stratification of mortality in ADHF patients developing AKI.

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

    Directory of Open Access Journals (Sweden)

    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.

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

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    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

  11. Association between Severity of Anemia and 30-Day Readmission Rate: Archival Data of 847 Patients with Acute Decompensated Heart Failure

    Directory of Open Access Journals (Sweden)

    Jorge C. Busse

    2014-01-01

    Full Text Available Hospitals today are facing adjustments to reimbursements from excessive readmission rates. One of the most common and expensive causes of readmissions is exacerbation of a heart failure condition. The objective of this paper was to determine if there was an association between the presence of anemia in patients with acute decompensated heart failure and their readmission rate. Using archival data of 4 hospitals in the Miami area, a sample of 847 inpatients with a diagnostic related group (DRG of HF at discharge was considered. There was a significant association between low hemoglobin values and a high rate of readmissions at 14 days and at 30 days in subjects with normal sodium and creatinine values. For subjects with low sodium and high creatinine values, a higher readmission rate was seen in men with low hemoglobin but not in women. These results support a prospective effort to measure the impact of anemia and its treatment on readmission rates.

  12. Recurrent Acute Decompensated Heart Failure Owing to Severe Iron Deficiency Anemia Caused by Inappropriate Habitual Bloodletting

    Science.gov (United States)

    Lim, Woo-Hyun; Kim, Hack-Lyoung; Kim, Ki-Hwan; Na, Sang Hoon; Lee, Hyun-Jung; Kang, Eun Gyu; Seo, Jae-Bin; Chung, Woo-Young; Zo, Joo-Hee; Hong, Jung Ae; Kim, Kwangyoun; Kim, Myung-A

    2015-01-01

    A 68-year-old woman visited the emergency department twice with symptoms of acute heart failure including shortness of breath, general weakness, and abdominal distension. Laboratory findings showed extremely low level of serum hemoglobin at 1.4 g/dL. Echocardiographic examination demonstrated dilated left ventricular cavity with systolic dysfunction and moderate amount of pericardial effusion. In this patient, acute heart failure due to severe iron deficiency anemia was caused by inappropriate habitual bloodletting. PMID:26755934

  13. Modification in CSF specific gravity in acutely decompensated cirrhosis and acute on chronic liver failure independent of encephalopathy, evidences for an early blood-CSF barrier dysfunction in cirrhosis.

    Science.gov (United States)

    Weiss, Nicolas; Rosselli, Matteo; Mouri, Sarah; Galanaud, Damien; Puybasset, Louis; Agarwal, Banwari; Thabut, Dominique; Jalan, Rajiv

    2017-04-01

    Although hepatic encephalopathy (HE) on the background of acute on chronic liver failure (ACLF) is associated with high mortality rates, it is unknown whether this is due to increased blood-brain barrier permeability. Specific gravity of cerebrospinal fluid measured by CT is able to estimate blood-cerebrospinal fluid-barrier permeability. This study aimed to assess cerebrospinal fluid specific gravity in acutely decompensated cirrhosis and to compare it in patients with or without ACLF and with or without hepatic encephalopathy. We identified all the patients admitted for acute decompensation of cirrhosis who underwent a brain CT-scan. Those patients could present acute decompensation with or without ACLF. The presence of hepatic encephalopathy was noted. They were compared to a group of stable cirrhotic patients and healthy controls. Quantitative brain CT analysis used the Brainview software that gives the weight, the volume and the specific gravity of each determined brain regions. Results are given as median and interquartile ranges and as relative variation compared to the control/baseline group. 36 patients presented an acute decompensation of cirrhosis. Among them, 25 presented with ACLF and 11 without ACLF; 20 presented with hepatic encephalopathy grade ≥ 2. They were compared to 31 stable cirrhosis patients and 61 healthy controls. Cirrhotic patients had increased cerebrospinal fluid specific gravity (CSF-SG) compared to healthy controls (+0.4 %, p gravity did not differ between different brain regions according to the presence or absence of either ACLF or HE. In patients with acute decompensation of cirrhosis, and those with ACLF, CSF specific gravity is modified compared to both stable cirrhotic patients and healthy controls. This pattern is observed even in the absence of hepatic encephalopathy suggesting that blood-CSF barrier impairment is manifest even in absence of overt hepatic encephalopathy.

  14. Acute Heart Failure Registry: Risk Assessment Model in Decompensated Heart Failure

    Science.gov (United States)

    Delgado, Anne; Rodrigues, Bruno; Nunes, Sara; Baptista, Rui; Marmelo, Bruno; Moreira, Davide; Gama, Pedro; Nunes, Luís; Santos, Oliveira; Cabral, Costa

    2016-01-01

    Background Heart failure (HF) is a highly prevalent syndrome. Although the long-term prognostic factors have been identified in chronic HF, this information is scarcer with respect to patients with acute HF. despite available data in the literature on long-term prognostic factors in chronic HF, data on acute HF patients are more scarce. Objectives To develop a predictor of unfavorable prognostic events in patients hospitalized for acute HF syndromes, and to characterize a group at higher risk regarding their clinical characteristics, treatment and outcomes. Methods cohort study of 600 patients admitted for acute HF, defined according to the European Society of Cardiology criteria. Primary endpoint for score derivation was defined as all-cause mortality and / or rehospitalization for HF at 12 months. For score validation, the following endpoints were used: all-cause mortality and / or readmission for HF at 6, 12 and 24 months. The exclusion criteria were: high output HF; patients with acute myocardial infraction, acute myocarditis, infectious endocarditis, pulmonary infection, pulmonary artery hypertension and severe mitral stenosis. Results 505 patients were included, and prognostic predicting factors at 12 months were identified. One or two points were assigned according to the odds ratio (OR) obtained (p < 0.05). After the total score value was determined, a 4-point cut-off was determined for each ROC curve at 12 months. Two groups were formed according to the number of points, group A < 4 points, and group B = 4 points. Group B was composed of older patients, with higher number of comorbidities and predictors of the combined endpoint at 6, 12 and 24 months, as linearly represented in the survival curves (Log rank). Conclusions This risk score enabled the identification of a group with worse prognosis at 12 months.

  15. Acute-on-chronic and Decompensated Chronic Liver Failure: Definitions, Epidemiology, and Prognostication.

    Science.gov (United States)

    Olson, Jody C

    2016-07-01

    Chronic liver disease is the fifth leading cause of death worldwide and represents a major burden for the health care community. Cirrhosis is a progressive disease resulting in end-stage liver failure, which in the absence of liver transplantation is fatal. Acute-on-chronic liver failure carries high short-term mortality but is potentially reversible. Viral hepatitis, alcohol, and nonalcoholic fatty liver disease remain the principal causes of liver disease. Though treatments exist for hepatitis B and C, they remain unavailable to many with these diseases. This article reviews the epidemiology of advanced liver disease and the concept of acute-on-chronic liver failure.

  16. Ularitide for the treatment of acute decompensated heart failure: from preclinical to clinical studies

    OpenAIRE

    Anker, Stefan D.; Ponikowski, Piotr; Mitrovic, Veselin; Peacock, W. Frank; Filippatos, Gerasimos

    2015-01-01

    The short- and long-term morbidity and mortality in acute heart failure is still unacceptably high. There is an unmet need for new therapy options with new drugs with a new mode of action. One of the drugs currently in clinical testing in Phase III is ularitide, which is the chemically synthesized form of the human natriuretic peptide urodilatin. Urodilatin is produced in humans by differential processing of pro-atrial natriuretic peptide in distal renal tubule cells. Physiologically, urodila...

  17. Role of Neutrophil Gelatinase-Associated Lipocalin in the Diagnosis and Early Treatment of Acute Kidney Injury in a Case Series of Patients with Acute Decompensated Heart Failure: A Case Series

    Directory of Open Access Journals (Sweden)

    Silvia Angeletti

    2016-01-01

    Full Text Available Patients with acute decompensated heart failure (ADHF frequently develop worsening in renal function until Acute Kidney Injury (AKI. The use of kidney injury biomarkers could be useful in the early diagnosis of AKI. In the present study, the role of the neutrophil gelatinase-associated lipocalin (NGAL, compared to the standard creatinine, in ADHF patients, was analyzed to evaluate if an early treatment could affect the outcome. A case series of 24 ADHF patients was enrolled and patients randomly divided in two groups (Group A and Group B. In Group A, NGAL, creatinine, and eGFR were measured, while in Group B, creatinine and eGFR alone were measured. NGAL was measured by turbidimetric immunoassay and creatinine using an enzymatic spectrophotometric method. In presence of AKI, creatinine increase and eGFR decrease were significantly lower in Group A than in Group B, whereas in absence of AKI the difference between the two groups was not significant. Hospitalization stay was significantly lower in Group A (receiving early treatment based on NGAL than in Group B. In ADHF patients, plasma NGAL in combination with creatinine was superior to the standard creatinine in the diagnosis and early treatment of AKI with a better outcome and a decreased hospital stay.

  18. [Hepatorenal syndrome in decompensated cirrhosis : A special form of acute renal failure].

    Science.gov (United States)

    Lenz, K; Buder, R; Lohr, G; Piringer, P; Voglmayr, M

    2016-06-01

    Renal failure is a serious complication in patients with advanced cirrhosis. It occurs in about 20 % of patients hospitalized with cirrhosis. In about 70 % it is caused by prerenal failure, and in 30 % it is due to intrarenal causes. In about 70 % of patients with rperenal failure, renal function can be restored with fluid replacement, but the remaining 30 % are unresponsive to volume expansion. Minor increase in serum creatinine have been shown to be clinically relevant and can adversely affect survival. Therefore early efforts should be made to avoid precipitation of renal failure.Hepatorenal syndrome (HRS) is a  fully reversible impairment of renal function in patients with cirrhosis unresponsive to volume expansion characterized by an acute progressive decrease in kidney function (serumcreatinin > 1,5 mg/dl) - type 1 HRS, whereas type 2 HRS features a decrease in kidney function over a long time, mostly in patients with refractory ascites. Therapy with vasoconstrictors like terlipressin to reverse splanchnic vasodilation, together with albumin is effective in 30-50 % of patients with HRS 1 and improves survival. The only effective longterm therapy is livertransplantation. An improvement of kidney fuction before transplantation is associated with a better outcome and posttransplant kidney function.

  19. Impact of decreased serum albumin levels on acute kidney injury in patients with acute decompensated heart failure: a potential association of atrial natriuretic peptide.

    Science.gov (United States)

    Takaya, Yoichi; Yoshihara, Fumiki; Yokoyama, Hiroyuki; Kanzaki, Hideaki; Kitakaze, Masafumi; Goto, Yoichi; Anzai, Toshihisa; Yasuda, Satoshi; Ogawa, Hisao; Kawano, Yuhei; Kangawa, Kenji

    2017-02-07

    Although hypoalbuminemia at admission is a risk for acute kidney injury (AKI) and mortality in patients with acute decompensated heart failure (ADHF), the clinical significance of decreased serum albumin levels (DAL) during ADHF therapy has not been elucidated. This study aimed to evaluate whether DAL was associated with AKI, and whether intravenous atrial natriuretic peptide (ANP) administration, which provides an effective treatment for ADHF but promotes albumin extravasation, was associated with DAL and AKI. A total of 231 consecutive patients with ADHF were enrolled. AKI was defined as ≥0.3 mg/dl absolute or 1.5-fold increase in serum creatinine levels within 48 h. AKI occurred in 73 (32%) of the 231 patients during ADHF therapy. The median value of decreases in serum albumin levels was 0.3 g/dl at 7 days after admission. When DAL was defined as ≥0.3 g/dl decrease in serum albumin levels, DAL occurred in 113 patients, and was independently associated with AKI. Of the 231 patients, 73 (32%) were treated with intravenous ANP. DAL occurred more frequently in patients receiving ANP than in those not receiving ANP (77 vs. 36%, p < 0.001), and ANP was independently associated with DAL. The incidence of AKI was higher in patients receiving ANP than in those not receiving ANP (48 vs. 24%, p < 0.001). ANP was independently associated with AKI. In conclusion, DAL is associated with AKI. Intravenous ANP administration may be one of the promoting factors of DAL, which leads to AKI, indicating a possible novel mechanism of AKI.

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

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    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.

  1. Hyperkalemia after acute metabolic decompensation in two children with vitamin B12-unresponsive methylmalonic acidemia and normal renal function.

    Science.gov (United States)

    Pela, I; Gasperini, S; Pasquini, E; Donati, M A

    2006-07-01

    The patients affected by vitamin B12-unresponsive methylmalonic acidemia (MMA) on the long run develop chronic renal disease with interstitial nephropathy and progressive renal insufficiency. The mechanism of nephrotoxicity in vitamin B12-unresponsive MMA is not yet known. Chronic hyporeninemic hypoaldosteronism has been found in many cases of methylmalonic acidemia, hyperkalemia and renal tubular acidosis type 4. We report 2 patients affected by B12-unresponsive methylmalonic acidemia diagnosed at the age of 23 months and 5 years, respectively, with normal glomerular filtration and function. They showed hyporeninemic hypoaldosteronism and significant hyperkalemia requiring sodium potassium exchange resin (Kayexalate) therapy after an episode of metabolic decompensation leading to diagnosis of MMA. In both children, hyporeninemic hypoaldosteronism and hyperkalemia disappeared after 6 months of good metabolic control.

  2. A case of marked diuresis by combined dopamine and atrial natriuretic peptide administration without renal injury in acute decompensated heart failure.

    Science.gov (United States)

    Kamiya, Masataka; Sato, Naoki; Akiya, Mai; Okazaki, Hirotake; Takahashi, Yasuhiro; Mizuno, Kyoichi

    2013-01-01

    Renal injury is an important factor for worsening outcome in acute decompensated heart failure (ADHF). An 81-year-old woman was admitted due to ADHF with dyspnea and mild peripheral edema. The patient was managed with intravenous administration of atrial natriuretic peptide (ANP) at a dose of 0.0125 μg/kg/minute, which did not control volume overload even at an increased dose of 0.025 μg/kg/minute. After a low dose of dopamine (DA) of 1.0 μg/kg/ minute was added, urine output increased markedly to 120 from 30 mL/hour. Furthermore, her heart rate decreased to 80-100 from 120 bpm and the congestion improved with a reduced brain natriuretic peptide level. Interestingly, the combination of ANP and DA therapy reduced serum creatinine as well as the levels of urinary liver-type fatty acid binding protein, a novel reno-tubular stress marker, by 98.9%, and an oxidative stress marker, urinary 8-hydroxydeoxyguanosine, by 88.2% from baseline levels. Thus, this ADHF patient, a nonresponder to ANP alone, improved without renal injury when administered combination therapy consisting of low doses of ANP and DA, suggesting that this combined therapy might be useful for better management of ADHF in patients without diuretic responses with ANP alone. Further prospective studies are warranted.

  3. Clinical analysis of treating acute decompensated heart failure by recombinant human brain natriuretic peptide and nitroglycerin%重组人脑利钠肽和硝酸甘油治疗急性失代偿性心力衰竭的临床分析

    Institute of Scientific and Technical Information of China (English)

    孙晶

    2015-01-01

    Objective: research clinical effects of treating acute decompensated heart failure by recombinant human brain natriuretic peptide and nitroglycerin. Method: choose 86 cases patients with acute or chronic heart failure received in our hospital, and randomly divided them into control and treatment group, 43 cases in each. Apply nitroglycerin for control group patients and recombinant human brain natriuretic peptide and nitroglycerin for treatment group. Compare patients of two groups before and after treatment with index of improvement magnitude of respiration and heart rate level, treatment effect of acute decompensated heart failure, number of adverse reactions during treatment, heart failure symptoms remission time, ECG recovery time to normal level, total time of heart disease medication therapy treatment. Result:improvement magnitude of respiration and heart rate level of treatment group patients is signiifcantly bettern than that of control group, difference is signiifcant between groups (P0.05);and heart failure symptoms remission time, ECG recovery time to normal level, total time of heart disease medication therapy treatment is obviously shorter than that of control group, difference between groups is signiifcant (P0.05);心衰症状缓解时间、心电图表现恢复正常时间、心衰疾病用药治疗总时间明显短于对照组,组间差异显著(P<0.05)。结论应用硝酸甘油与重组人脑利钠肽联合对患有急性失代偿性心力衰竭疾病的患者实施治疗的临床效果非常明显。

  4. Renal neurohormonal regulation in heart failure decompensation.

    Science.gov (United States)

    Jönsson, Sofia; Agic, Mediha Becirovic; Narfström, Fredrik; Melville, Jacqueline M; Hultström, Michael

    2014-09-01

    Decompensation in heart failure occurs when the heart fails to balance venous return with cardiac output, leading to fluid congestion and contributing to mortality. Decompensated heart failure can cause acute kidney injury (AKI), which further increases mortality. Heart failure activates signaling systems that are deleterious to kidneys such as renal sympathetic nerve activity (RSNA), renin-angiotensin-aldosterone system, and vasopressin secretion. All three reduce renal blood flow (RBF) and increase tubular sodium reabsorption, which may increase renal oxygen consumption causing AKI through renal tissue hypoxia. Vasopressin contributes to venous congestion through aquaporin-mediated water retention. Additional water retention may be mediated through vasopressin-induced medullary urea transport and hyaluronan but needs further study. In addition, there are several systems that could protect the kidneys and reduce fluid retention such as natriuretic peptides, prostaglandins, and nitric oxide. However, the effect of natriuretic peptides and nitric oxide are blunted in decompensation, partly due to oxidative stress. This review considers how neurohormonal signaling in heart failure drives fluid retention by the kidneys and thus exacerbates decompensation. It further identifies areas where there is limited data, such as signaling systems 20-HETE, purines, endothelin, the role of renal water retention mechanisms for congestion, and renal hypoxia in AKI during heart failure.

  5. Pathogenesis of Cardiorenal Syndrome Type 1 in Acute Decompensated Heart Failure : Workgroup Statements from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI)

    NARCIS (Netherlands)

    Haase, Michael; Mueller, Christian; Damman, Kevin; Murray, Patrick T.; Kellum, John A.; Ronco, Claudio; McCullough, Peter A.; McCullough, PA; Kellum, JA; Mehta, RL; Murray, PT; Ronco, C

    2013-01-01

    Pathophysiological mechanisms of cardiorenal syndromes (CRS) types 1-5 are still sparsely characterized. In an attempt to address this issue, a consensus conference on CRS was held in Venice, Italy, in November 2012 under the auspices of the Acute Dialysis Quality Initiative (ADQI). Working group 1

  6. Effects of Hyponatremia Normalization on the Short-Term Mortality and Rehospitalizations in Patients with Recent Acute Decompensated Heart Failure: A Retrospective Study

    Directory of Open Access Journals (Sweden)

    Renato De Vecchis

    2016-10-01

    Full Text Available Background: Several studies have shown that hyponatremia is associated with increased risk of rehospitalization and death in patients with heart failure. In these studies, chronic heart failure (CHF patients with persistent hyponatremia were compared only with CHF patients with a normal sodium level at hospital admission. Aims: In the present retrospective study, conducted in a cohort of patients with recent acute decompensated heart failure (ADHF, all with hyponatremia ascertained at the time of hospital admission, we aimed to evaluate the effect of the normalization of serum sodium on the composite endpoint of short-term rehospitalization and mortality. Methods: A retrospective study centered on medical records of patients hospitalized for ADHF in the period April 2013 to April 2016 was performed. Data regarding serum sodium measurements had to be collected from medical records of cardiology wards of two hospitals, and were then processed for statistical analysis. As an inclusion criterion for enrollment, patients had to be suffering from heart failure that had required at least one hospitalization. Moreover, they had to be suffering from a state of hyponatremia (serum sodium < 135 mEq/L at admission on the occasion of the index hospitalization. Patients with hyponatremia at admission were divided into two groups, one comprising patients with hyponatremia that persisted at the time of discharge (persistent hyponatremia and a second including patients who had achieved normalization of their serum sodium levels (serum Na+ ≥ 135 mEq/L during hospitalization until discharge. For both groups, the risk of mortality and rehospitalization during a 30-day follow-up was assessed. Results: One hundred and sixty CHF patients with various degrees of functional impairment were enrolled in the study. Among them, 56 (35% had persistent hyponatremia over the course of hospitalization. At multivariable Cox proportional-hazards regression analysis, the risk of

  7. Effects of Hyponatremia Normalization on the Short-Term Mortality and Rehospitalizations in Patients with Recent Acute Decompensated Heart Failure: A Retrospective Study

    Science.gov (United States)

    De Vecchis, Renato; Di Maio, Marco; Di Biase, Giuseppina; Ariano, Carmelina

    2016-01-01

    Background: Several studies have shown that hyponatremia is associated with increased risk of rehospitalization and death in patients with heart failure. In these studies, chronic heart failure (CHF) patients with persistent hyponatremia were compared only with CHF patients with a normal sodium level at hospital admission. Aims: In the present retrospective study, conducted in a cohort of patients with recent acute decompensated heart failure (ADHF), all with hyponatremia ascertained at the time of hospital admission, we aimed to evaluate the effect of the normalization of serum sodium on the composite endpoint of short-term rehospitalization and mortality. Methods: A retrospective study centered on medical records of patients hospitalized for ADHF in the period April 2013 to April 2016 was performed. Data regarding serum sodium measurements had to be collected from medical records of cardiology wards of two hospitals, and were then processed for statistical analysis. As an inclusion criterion for enrollment, patients had to be suffering from heart failure that had required at least one hospitalization. Moreover, they had to be suffering from a state of hyponatremia (serum sodium < 135 mEq/L) at admission on the occasion of the index hospitalization. Patients with hyponatremia at admission were divided into two groups, one comprising patients with hyponatremia that persisted at the time of discharge (persistent hyponatremia) and a second including patients who had achieved normalization of their serum sodium levels (serum Na+ ≥ 135 mEq/L) during hospitalization until discharge. For both groups, the risk of mortality and rehospitalization during a 30-day follow-up was assessed. Results: One hundred and sixty CHF patients with various degrees of functional impairment were enrolled in the study. Among them, 56 (35%) had persistent hyponatremia over the course of hospitalization. At multivariable Cox proportional-hazards regression analysis, the risk of having a 30

  8. A Comparison of Traditional and Novel Definitions (RIFLE, AKIN, and KDIGO) of Acute Kidney Injury for the Prediction of Outcomes in Acute Decompensated Heart Failure

    Science.gov (United States)

    Roy, Andrew K.; Mc Gorrian, Catherine; Treacy, Cecelia; Kavanaugh, Edel; Brennan, Alice; Mahon, Niall G.; Murray, Patrick T.

    2013-01-01

    Aims To determine if newer criteria for diagnosing and staging acute kidney injury (AKI) during heart failure (HF) admission are more predictive of clinical outcomes at 30 days and 1 year than the traditional worsening renal function (WRF) definition. Methods We analyzed prospectively collected clinical data on 637 HF admissions with 30-day and 1-year follow-up. The incidence, stages, and outcomes of AKI were determined using the following four definitions: KDIGO, RIFLE, AKIN, and WRF (serum creatinine rise ≥0.3 mg/dl). Receiver operating curves were used to compare the predictive ability of each AKI definition for the occurrence of adverse outcomes (death, rehospitalization, dialysis). Results AKI by any definition occurred in 38.3% (244/637) of cases and was associated with an increased incidence of 30-day (32.3 vs. 6.9%, χ2 = 70.1; p < 0.001) and 1-year adverse outcomes (67.5 vs. 31.0%, χ2 = 81.4; p < 0.001). Most importantly, there was a stepwise increase in primary outcome with increasing stages of AKI severity using RIFLE, KDIGO, or AKIN (p < 0.001). In direct comparison, there were only small differences in predictive abilities between RIFLE and KDIGO and WRF concerning clinical outcomes at 30 days (AUC 0.76 and 0.74 vs. 0.72, χ2 = 5.6; p = 0.02) as well as for KDIGO and WRF at 1 year (AUC 0.67 vs. 0.65, χ2 = 4.8; p = 0.03). Conclusion During admission for HF, the benefits of using newer AKI classification systems (RIFLE, AKIN, KDIGO) lie with the ability to identify those patients with more severe degrees of AKI who will go on to experience adverse events at 30 days and 1 year. The differences in terms of predictive abilities were only marginal. PMID:23801998

  9. Improving Survival in Decompensated Cirrhosis

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    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.

  10. Management options in decompensated cirrhosis

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    Shah NL

    2015-07-01

    Full Text Available Neeral L Shah,1 Yasmin Pourkazemi Banaei,2 Kristen L Hojnowski,2 Scott L Cornella3 1Division of Gastroenterology and Hepatology, 2School of Medicine, 3Department of Medicine, University of Virginia, Charlottesville, VA, USA Abstract: Chronic injury to the liver from a variety of different sources can result in irreversible scarring of the liver, known as cirrhosis. Cirrhosis is a major cause of morbidity and mortality in the USA, and according to the Centers for Disease Control and Prevention was responsible for 31,903 deaths in 2010 alone. It is thus of the utmost importance to appropriately manage these patients in the inpatient and outpatient setting to improve morbidity and mortality. In this review, we address four major areas of cirrhosis management: outpatient management of portal hypertension with decompensation, hepatic encephalopathy, hepatorenal syndrome, and bleeding/coagulation issues. Outpatient management covers recommendations for health care maintenance and screening. Hepatic encephalopathy encompasses a brief review of pathophysiology, treatment in the acute setting, and long-term prevention. Hepatorenal syndrome is discussed in regards to pathophysiology and treatment in the hospital setting. Finally, a discussion of the assessment of coagulation profiles in cirrhosis and recommendations for bleeding and thrombosis complications is included. These topics are not all encompassing with regard to this complicated population, but rather an overview of a few medical problems that are commonly encountered in their care. Keywords: portal hypertension, hepatic encephalopathy, hepatorenal, coagulation

  11. preliminary study of prednisone applied in cardio-renal syndrome of acute decompensated heart failure%强的松在急性失代偿性心力衰竭伴心肾综合征中的应用

    Institute of Scientific and Technical Information of China (English)

    张天元; 王海洪

    2014-01-01

    Objective To investigate prednisone improving the heart function and renal function and potentiating diu-retic effects of patients with acute decompensated heart failure. Methods 45 cases of patients with acute decompensated heart failure took orally prednisone 40 ~ 60mg/ day besides conventional therapy,dose of prednisone decreased 5mg/ week. At the course of therapy,the renal function and body weight change were measured periodically,and changes of vital sign,edema,and side effects were observed as well. Results 14 days after the treatment with prednisone,the heart function and renal function of the patients with acute heart failure improved,the levels of serum creatinine and uric acid were lowered,the differences were statistically significant(P ﹤ 0. 05). There was a remarkable reduction(4. 2 ± 2. 5kg)in body weight,the differences were sta-tistically significant(P ﹤ 0. 01). Serum electrolyte level was no significant different compared with baseline(P ﹥ 0. 05). Con-clusion Prednisone can improve the heart function and renal function and potentiate diuretic effect in patients with acute de-compensated heart failure.%目的:探讨强的松对急性失代偿性心力衰竭患者心功能和肾功能的改善及其利尿作用。方法45例急性失代偿性心力衰竭患者在常规治疗的基础上加用糖皮质激素强的松40~60mg/ d,2周后强的松逐渐减量,每周减5mg。治疗过程中定期测肾功能、体质量变化、观察生命体征、水肿、尿量等变化及有无不良反应,并于治疗前后检查 X 线胸片和超声心动图评价心肾功能改善程度。结果强的松治疗14d 后,45例心力衰竭患者心功能改善,血肌酐和血尿酸水平治疗后较治疗前降低,差异有统计学意义(P ﹤0.05)。患者尿量连续增加,体质量明显下降(4.2±2.5)kg,差异有统计学意义(P ﹤0.01),而血电解质治疗前后比较无明显变化(P ﹥0.05)。结论强的松能改

  12. 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

    Institute of Scientific and Technical Information of China (English)

    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

  13. A Clinical Study of Recombinant Human Brain Natriuretic Peptide on Patients with Acute Decompensated Heart Failure%重组人脑利钠肽治疗急性心力衰竭的疗效观察

    Institute of Scientific and Technical Information of China (English)

    周秀金; 卢竟前

    2013-01-01

    Objective:To observe the clinic efficacy and safety of used recombinant human brain natriuretie peptide (rh-BNP)on patients with acute decompensated heart failure.Methods:48 patients who suffered from acute decompensated heart failure patients were divided into rh-BNP group(n=22)and control group(n=26).The rh-BNP group received rh-BNP made by China and traditional heart failure treatment; the control group was treated with traditional heart failure treatment.The changes of the clinical efficacy, left ventricular ejection fraction (LVEF)and brain natriuretie peptide test parameters were observed. Results:After 7 days treatment, clinical efficacy improvements were more significant in rh-BNP group compared control group (81.7% vs 61.6,P<0.05).LVEF were improved in rh-BNP group compared with control group((51±6)%vs(46±5)%,P<0.01).and BNP level were decreased obviously in rh-BNP group than control group((498±209)pg/ml vs(642±318)pg/ml,P<0.01),and there had positive relation in BNP decrease and LVEF increased(P<0.05).Conclusion:The use of rh-BNP is efficient and safe for acute decompensated heart failure patient.And BNP test can provide a dog marker for diagnosis and prognostic.%目的:探讨在监测血清脑钠肽水平下,短期使用注射用重组人脑利钠肽治疗急性心力衰竭或慢性心力衰竭急性发作的临床效果。方法:48例急性心力衰竭患者根据是否使用注射用重组人脑利钠肽分为常规组和注射用重组人脑利钠肽组,对比两组治疗的临床效果和超声心动图情况,并监测BNP水平。结果:治疗7 d后,注射用重组人脑利钠肽组临床有效率明显好于常规组(81.7%vs61.6%,P<0.05),左室射血分数明显高于常规组(51±6)%vs(46±5)%,(P<0.01),且血清脑钠肽水平明显降低(498±209)pg/mL vs(642±318)pg/mL,(P<0.01),血清脑钠肽下降水平和左室射血分数提高水平差异有统计学意义(P<0.05),有

  14. Clinical features of 100 patients with acute exacerbation of cirrhosis with liver function decompensation%失代偿期肝硬化患者肝损伤急性加重100例临床分析

    Institute of Scientific and Technical Information of China (English)

    周静; 苏菲

    2016-01-01

    目的:探讨失代偿期肝硬化肝损伤急性加重患者在肝衰竭分型中的合理定位,为临床诊治提供参考依据。方法采用回顾性分析法,纳入我院失代偿期肝硬化肝损伤急性加重患者100例和慢加急性肝衰竭(ACLF)患者200例,使用罗氏COBAS INTEGRA 800检测血生化指标;采用摆动磁珠凝固法检测凝血指标。应用SPSS16.0软件对两组患者临床资料进行分析。结果在300例患者中,由肝炎病毒活动性复制引起的急性肝损伤220例(73.3%),其他诱因引起者80例(26.7%);肝硬化组血清白蛋白和血钠分别为(27.2±4.2)g/l和130.5(90.1,143.8) mmol/l,显著低于肝衰竭组的(29.5±4.5)g/l和134.2(78.7,143.0)mmol/l(P<0.05);肝硬化组肝肾综合征、自发性腹膜炎、低钠血症发生率分别为26.0%、57.0%、75.0%,均显著高于肝衰竭组的13.0%、42.0%、53.0%(P<0.05);肝硬化组好转率为10.0%,显著低于肝衰竭组的25.5%(P<0.05)。结论在失代偿期肝硬化基础上因某种诱因导致肝损伤急性加重患者具有与ACLF患者相似的急性肝功能失代偿表现,同时也存在门脉高压为主的表现,其在肝衰竭分型中的合理定位尚需扩大病例数,进一步深入临床研究。%Objective To investigate the reasonable diagnosis of patients with acute exacerbated liver function in patients with decompensated liver cirrhosis. Methods 100 patients with acute exacerbated liver function with underlying decompensated cirrhosis and 200 patients with acute on chronic liver failure (ACLF) were retrospectively analyzed in our hospital. Blood biochemical parameters and blood coagulation function index were routinely detected. SPSS 16.0 software was used to analyze the clinical materials. Results Active replication of hepatitis B virus-induced acute liver injuries accounted for (73.3%),and other causes for (26.7%) in the 300 patients;serum levels of

  15. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  16. 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

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    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

  17. Nightmares and psychotic decompensation: a case study.

    Science.gov (United States)

    Levin, R; Daly, R S

    1998-01-01

    There have been numerous reports in the literature on the descriptive similarities between a severe nightmare and an acute psychotic episode. Nightmares may be a prelude to psychotic decompensation, and it has been suggested that frequent lifelong nightmares may even be diagnostic of an underlying vulnerability to psychosis. In this report, we present a case study of a 40-year old female experiencing chronic paranoid schizophrenia, whose two witnessed psychotic relapses in the hospital were immediately preceded by intense and vivid nightmare attacks. Significantly, the content of these nocturnal dreams was thematically consistent with her waking hallucinations, suggesting a direct continuity between these experiences. We propose that further systematic study of the dreams and nightmares of individuals diagnosed with schizophrenia may be particularly useful in understanding their phenomenological experience.

  18. Management of Coagulopathy in Patients with Decompensated Liver Cirrhosis

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    Pooja D. Amarapurkar

    2011-01-01

    Full Text Available Patients with decompensated liver cirrhosis have significantly impaired synthetic function. Many proteins involved in the coagulation process are synthesized in the liver. Routinely performed tests of the coagulation are abnormal in patients with decompensated liver cirrhosis. This has led to the widespread belief that decompensated liver cirrhosis is prototype of acquired hemorrhagic coagulopathy. If prothrombin time is prolonged more than 3 seconds over control, invasive procedures like liver biopsy, splenoportogram, percutaneous cholangiography, or surgery were associated with increased risk of bleeding, and coagulopathy should be corrected with infusion of fresh frozen plasma. These practices were without any scientific evidence and were associated with significant hazards of fresh frozen plasma transfusion. Now, it is realized that coagulation is a complex process involving the interaction of procoagulation and anticoagulation factors and the fibrinolytic system. As there is reduction in both anti and procoagulant factors, global tests of coagulation are normal in patients with acute and chronic liver disease indicating that coagulopathy in liver disease is more of a myth than a reality. In the last few years, surgical techniques have substantially improved, and complex procedures like liver transplantation can be done without the use of blood or blood products. Patients with liver cirrhosis may also be at increased risk of thrombosis. In this paper, we will discuss coagulopathy, increased risk of thrombosis, and their management in decompensated liver cirrhosis.

  19. Management of coagulopathy in patients with decompensated liver cirrhosis.

    Science.gov (United States)

    Amarapurkar, Pooja D; Amarapurkar, Deepak N

    2011-01-01

    Patients with decompensated liver cirrhosis have significantly impaired synthetic function. Many proteins involved in the coagulation process are synthesized in the liver. Routinely performed tests of the coagulation are abnormal in patients with decompensated liver cirrhosis. This has led to the widespread belief that decompensated liver cirrhosis is prototype of acquired hemorrhagic coagulopathy. If prothrombin time is prolonged more than 3 seconds over control, invasive procedures like liver biopsy, splenoportogram, percutaneous cholangiography, or surgery were associated with increased risk of bleeding, and coagulopathy should be corrected with infusion of fresh frozen plasma. These practices were without any scientific evidence and were associated with significant hazards of fresh frozen plasma transfusion. Now, it is realized that coagulation is a complex process involving the interaction of procoagulation and anticoagulation factors and the fibrinolytic system. As there is reduction in both anti and procoagulant factors, global tests of coagulation are normal in patients with acute and chronic liver disease indicating that coagulopathy in liver disease is more of a myth than a reality. In the last few years, surgical techniques have substantially improved, and complex procedures like liver transplantation can be done without the use of blood or blood products. Patients with liver cirrhosis may also be at increased risk of thrombosis. In this paper, we will discuss coagulopathy, increased risk of thrombosis, and their management in decompensated liver cirrhosis.

  20. The risk factors associated with intraoperative acute cardiac decompensation in patients undergoing off-pump coronary artery bypass grafting%非体外循环冠状动脉旁路移植术患者术中急性心功能失代偿的危险因素

    Institute of Scientific and Technical Information of China (English)

    董秀华; 卢家凯; 卿恩明; 王义军; 王学勇

    2010-01-01

    目的 筛选非体外循环冠状动脉旁路移植术(OPCABG)患者术中发生急性心功能失代偿的危险因素.方法 选择本院2007年11月至2009年2月行OPCABG的患者2379例,记录术前、术中与急性心功能失代偿可能有关的因素.根据是否发生急性心功能失代偿,分为2组:急性心功能失代偿组和非急性心功能失代偿组.采用1ogistic多元回归分析,筛选发生急性心功能失代偿的危险因素.结果 术中发生急性心功能失代偿368例(发生率15.5%),无一例患者死亡.logistic多元回归分析显示,室壁瘤、术中房颤、术中频发性室性期前收缩、术前射血分数<40%、术前室性期前收缩、合并瓣膜病、心肌梗死史、入室心动过速、急诊手术、左主干病变为术中发生急性心功能失代偿的危险因素.结论 术前合并室壁瘤、瓣膜病变、左主干病变、心肌梗死史、术前室性期前收缩、射血分数<40%,术中房颤、频发性室性期前收缩、入室心动过速和急诊手术为OPCABG患者术中发生急性心功能失代偿的危险因素.%Objective To identify the risk factors associated with intraoperative acute cardiac decompensation in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Methods From November 2007 to February 2009, 2379 OPCABGs were performed in our hospital. The possible risk factors associated with intraoperative cardiac decompensation were retrospectively analyzed. The preoperative patient demographics and intraoperative characteristics were correlated with intraoperative acute cardiac decompensation.The possible risk factors included sex, age, body weight, cardiac function (NYHA classification), the associated diseases (hypertension, diabetes mellitus, liver-kidney dysfunction), history of myocardial infarct, ventricular aneurysm, preoperative treatment with β-blocker and/or calcium channel blocking agent, ventricular extrasystole,atrial fibrillation, duration of

  1. 人重组B型利钠肽治疗高龄急性失代偿性心力衰竭患者的疗效和安全性%Efficacy and safety of recombinant human B-type natriuretic peptide in patients with advanced age and acute decompensated heart failure

    Institute of Scientific and Technical Information of China (English)

    付士辉; 朱兵; 王浩; 王亮; 刘源; 叶平; 骆雷鸣

    2011-01-01

    目的:探讨人重组B型利钠肽(rhBNP)治疗高龄急性失代偿性心力衰竭患者的疗效和安全性.方法:试验设计为随机对照试验,对象为2008年1月至2010年12月解放军总医院连续收住的高龄急性失代偿性心力衰竭患者80例,以抽签的方式随机分配到常规心力衰竭治疗组(常规组)和常规+rhBNP治疗组(rhBNP组),每组40例.2组患者均接受抗心力衰竭规范治疗,rhBNP组每天再给予rhBNP 0.5~1.0 mg(溶于50 ml生理盐水),以0.0075~0.0150 μg·kg-1·min-1速度经泵持续静脉输入10~15 h.疗程均为13 d.比较2组患者治疗前和治疗第4、8、14天的呼吸困难评分、水肿评分、净水分丢失情况、心率、血压和血肌酐水平.结果:常规组男性37例,女性3例,平均年龄(88±4)岁;rhBNP组男性38例,女性2例,平均年龄(86±5)岁.2组患者治疗前的基本临床特征和抗心力衰竭药物使用情况差异均无统计学意义.rhBNP组患者治疗第4天呼吸困难评分与常规组比较差异无统计学意义(P>0.05),第8和14天均明显低于常规组(均P<0.05).rhBNP组患者水肿评分第4、8和14天均明显低于常规组(均P<0.05).净水分丢失量第4、8和14天均明显多于常规组[中位数(最小值,最大值):263.5(-793,2184)ml比-129.0(-1249,3636)ml,239.5(-754,1370)ml比-29.5(-1364,2242)ml,386.5(-564,1490)m比71.0(-2274,1660)ml,均P<0.05].心率第4、8天均明显低于常规组[(73±13)次/min比(81±17)次/min,(70±10)次/min比(79±16)次/min,均P<0.05].2组治疗后不同时点血压和血肌酐差异均无统计学意义.结论:常规治疗加用rhBNP对高龄急性失代偿性心力衰竭患者具有较佳疗效和安全性.%Objective : To explore the efficacy and safety of recombjnant human brain natriuretic peptide ( thBNP) in patients with advanced age and acute decompensated heart failure.Methods : A randomized controlled trials was performed.From January 2008 to December 2010, 80 hospitalized patients with

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

    Energy Technology Data Exchange (ETDEWEB)

    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.)

  3. Change of Serum BNP Between Admission and Discharge After Acute Decompensated Heart Failure Is a Better Predictor of 6-Month All-Cause Mortality Than the Single BNP Value Determined at Admission

    Science.gov (United States)

    De Vecchis, Renato; Ariano, Carmelina; Giandomenico, Giuseppe; Di Maio, Marco; Baldi, Cesare

    2016-01-01

    Background B-type natriuretic peptide (BNP) is regarded as a reliable predictor of outcome in patients with acute decompensated heart failure (ADHF). However, according to some scholars, a single isolated measurement of serum BNP at the time of hospital admission would not be sufficient to provide reliable prognostic information. Methods A retrospective study was carried out on patients hospitalized for ADHF, who had then undergone follow-up of at least 6 months, in order to see if there was any difference in midterm mortality among patients with rising BNP at discharge as compared to those with decreasing BNP at discharge. Medical records had to be carefully examined to divide the case records into two groups, the former characterized by an increase in BNP during hospitalization, and the latter showing a decrease in BNP from the time of admission to the time of discharge. Results Ultimately, 177 patients were enrolled in a retrospective study. Among them, 53 patients (29.94%) had increased BNPs at the time of discharge relative to admission, whereas 124 (70.06%) exhibited decreases in serum BNP during their hospital stay. The group with patients who exhibited BNP increases at the time of discharge had higher degree of congestion evident in the higher frequency of persistent jugular venous distention (odds ratio: 3.72; P = 0.0001) and persistent orthopnea at discharge (odds ratio: 2.93; P = 0.0016). Moreover, patients with increased BNP at the time of discharge had a lower reduction in inferior vena cava maximum diameter (1.58 ± 2.2 mm vs. 6.32 ± 1.82 mm; P = 0.001 (one-way ANOVA)). In contrast, there was no significant difference in weight loss when patients with increased BNP at discharge were compared to those with no such increase. A total of 14 patients (7.9%) died during the 6-month follow-up period. Cox proportional hazard analysis revealed that BNP increase at the time of discharge was an independent predictor of 6-month all-cause mortality after

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

    Directory of Open Access Journals (Sweden)

    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

  5. N-carbamylglutamate protects patients with decompensated propionic aciduria from hyperammonaemia.

    Science.gov (United States)

    Gebhardt, B; Dittrich, S; Parbel, S; Vlaho, S; Matsika, O; Bohles, H

    2005-01-01

    In patients with propionic aciduria, the accumulating metabolite propionyl-CoA causes a disturbance of the urea cycle via the inhibition of N-acetylglutamate synthesis. Lack of this allosteric activator results in an inhibition of carbamoylphosphate synthase (CPS). This finally leads to hyperammonaemia. In two patients with decompensated propionic aciduria the CPS activator carbamylglutamate was tested for its ability to antagonize the propionyl-CoA associated hyperammonaemia. Oral carbamyl glutamate administration resulted in a significant increase in ammonia detoxification and could avoid further dialysis therapy. Safe, fast and easy to administer, carbamyl glutamate improves the acute therapy of decompensated propionic aciduria by increasing ammonia detoxification and avoiding hyperammonaemia.

  6. N-carbamylglutamate enhances ammonia detoxification in a patient with decompensated methylmalonic aciduria.

    Science.gov (United States)

    Gebhardt, Boris; Vlaho, Stefan; Fischer, Doris; Sewell, Adrian; Böhles, Hansjosef

    2003-08-01

    In patients with methylmalonic aciduria (MMA), the accumulating metabolite propiony-CoA results in an inhibition of the urea circle via the decreased synthesis of N-acetylglutamate, an essential activator of carbamylphosphat synthetase (CPS). This results in one of the major clinical problems which is hyperammonaemia. In a patient with decompensated MMA, the CPS activator carbamylglutamate was tested for its ability to antagonize the propionyl-CoA-induced hyperammonaemia. Oral carbamylgutamate administration resulted in an impressive increase in ammonia detoxification compared to peritoneal dialysis. Safe, fast and easy to administer, carbamylglutamate improves the acute therapy of decompensated MMA by increasing ammonia detoxification and avoiding hyperammonaemia.

  7. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    NARCIS (Netherlands)

    Venekamp, R.P.; Bonten, M.J.; Rovers, M.M.; Verheij, T.J.; Sachs, A.P.

    2012-01-01

    BACKGROUND: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic cort

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

    DEFF Research Database (Denmark)

    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...

  9. The role of B-type natriuretic peptide in the diagnosis and treatment of decompensated heart failure

    Institute of Scientific and Technical Information of China (English)

    Michael J. Gallagher; Peter A. McCullough

    2004-01-01

    Heart failure (HF) is a common disease associated with increasing age. B-type natriuretic peptide (BNP), is a cardiac neurohormone, and is released as prepro BNP and then enzyrnatically cleaved to the Ntenninal-proBNP (NT-proBNP) and BNP upon ventricular myocyte stretch. Blood measurements of BNP have been used to identify patients with I-IF. The BNP assay is currently used as a diagnostic and prognostic aid in HF. In general, a BNP level below 100 pg/mL excludes acutely decompensated HF and levels > 500 pg/ml indicate decompensation. Recombinant human BNP (hBNP, nesiritide) is an approved intravenous treatment for acute,decompensated -HF. Nesiritide given in supraphysiologic doses causes vasodilation, natriuresis, diuresis, and improved symptoms over the course of a 48-hour infusion. This paper will sort out the literature concerning the use of this peptide both as a diagnostic test and as an intravenous therapy.

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

    OpenAIRE

    Cătălin Pleșea Condratovici; Vladimir Bacarea; Núria Piqué

    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 xylo...

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

    DEFF Research Database (Denmark)

    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...... with a triptan plus a non-steroidal anti-inflammatory (NSAID), such as sumatriptan/naproxen sodium, is more effective in acute migraine treatment than monotherapy with either agent alone. (5) It is unclear whether triptans offer clinically relevant benefits over aspirin or NSAIDs in migraine patients. Thus...... NSAIDs, particularly effervescent aspirin, should be considered the first-line treatment of migraine attacks Udgivelsesdato: 2008/6...

  12. Rifaximin has no effect on hemodynamics in decompensated cirrhosis

    DEFF Research Database (Denmark)

    Kimer, Nina; Pedersen, Julie Steen; Busk, Troels Malte

    2017-01-01

    , P = 0.14, or vasoactive hormones were found. Subgroup analyses on patients with increased lipopolysaccharide binding protein and systemic vascular resistance below the mean (1,011 dynes × s/cm(5) ) revealed no effect of rifaximin. CONCLUSION: Four weeks of treatment with rifaximin did not reduce......Decompensated cirrhosis is characterized by disturbed systemic and splanchnic hemodynamics. Bacterial translocation from the gut is considered the key driver in this process. Intestinal decontamination with rifaximin may improve hemodynamics. This double-blind, randomized, controlled trial...... years (±8.4), average Child score 8.3 (±1.3), and Model for End-Stage Liver Disease score 11.7 (±3.9). Measurements of hepatic venous pressure gradient, cardiac output, and systemic vascular resistance were made at baseline and after 4 weeks. The glomerular filtration rate and plasma renin...

  13. 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

    Directory of Open Access Journals (Sweden)

    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

  14. 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

    Institute of Scientific and Technical Information of China (English)

    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

  15. Aerosolised hypertonic saline in hospitalized young children with acute bronchiolitis: a randomized controlled clinical trial.

    OpenAIRE

    Maheshkumar, K B; B.P. Karunakara; Nagalli, Manjunath Mallikarjuna; Mallikarjuna, H B

    2013-01-01

    ABSTRACT: Objectives: To determine the effectiveness of aerosolised 3% saline in hospitalised children with acute bronchiolitis. Design: Prospective, randomized, double blinded clinical study. Setting: Referral teaching hospital, from October 2007 to March 2009. Patients: 40 children [age less than 2 yrs] were enrolled sequentially and randomized into 2 groups [20 each; Group- A - 3% saline and Group-B [Normal saline]. Intervention: 4 nebulizations [3% saline or normal s...

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

    LENUS (Irish Health Repository)

    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.

  17. Mindfulness-based stress reduction and physiological activity during acute stress: a randomized controlled trial

    NARCIS (Netherlands)

    Nyklicek, I.; Mommersteeg, P.M.; Beugen, S. van; Ramakers, C.; Boxtel, G.J. Van

    2013-01-01

    OBJECTIVE: The aim was to examine the effects of a Mindfulness-Based Stress Reduction (MBSR) intervention on cardiovascular and cortisol activity during acute stress. METHOD: Eighty-eight healthy community-dwelling individuals reporting elevated stress levels were randomly assigned to the MBSR proto

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

    Institute of Scientific and Technical Information of China (English)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  20. A Prospective, Randomized Investigation of Plasma First Resuscitation for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma

    Science.gov (United States)

    2016-05-01

    Attenuation of Acute Coagulopathy of Trauma . PRINCIPAL INVESTIGATOR: Ernest E. Moore, MD CONTRACTING ORGANIZATION: University of Colorado Denver...Randomized Investigation of “Plasma First Resuscitation” for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma . 5b. GRANT NUMBER...NOTES 14. ABSTRACT The COMBAT (Control of Major Bleeding After Trauma ) study is a randomized clinical trial evaluating the early administration of

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

    DEFF Research Database (Denmark)

    Kjaer, Daniel W; Mortensen, Frank V; Møller, Jens K;

    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. Inflammasome activation in decompensated liver cirrhosis

    Institute of Scientific and Technical Information of China (English)

    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.

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

    Science.gov (United States)

    Kalkan Ucar, Sema; Coker, Mahmut; Habif, Sara; Saz, Eylem Ulas; Karapinar, Bulent; Ucar, Hakan; Kitis, Omer; Duran, Marinus

    2009-09-01

    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 hyperleucinaemia with hyperammonaemia. The oral administration of the N-acetylglutamate analogue, N-carbamylglutamate (NCG), 200 mg/kg/day as a loading dose, and 100 mg/kg/day as a maintenance dose, in combination with standard therapy resulted in a significant decrease of plasma ammonia levels. This observation suggests that NCG may be an important adjunct to standard therapy in the management of decompensated MSUD patients with high leucine and ammonia levels. Supportive evidence from either randomized controlled trials or a large prospective cohort study is needed to confirm this interesting finding.

  4. Correlation between tricuspid annular plane systolic excursion and glomerular filtration rate in patients with acute decompensated heart failure%急性失代偿型心力衰竭患者三尖瓣收缩期位移与肾小球滤过率的关系

    Institute of Scientific and Technical Information of China (English)

    李邵琳; 张菲斐

    2016-01-01

    目的:探讨急性失代偿型心力衰竭患者三尖瓣收缩期位移(TAPSE)变化及其与肾小球滤过率的关系。方法选取慢性收缩性心力衰竭急性失代偿入院患者102例,经胸超声心动图检测TASPE、左室射血分数(LVEF)及肺动脉收缩压(PASP),静脉采血测定B型氨基端利钠肽原(NT- proBNP)、电解质、血尿素氮(BUN)及血肌酐,采用改良的MDRD方程计算肾小球滤过率(eGFR),将eGFR0.05)。在肾功能不全组中肾小球滤过率分别与TASPE、NT- proBNP、PASP、LVEF进行相关性分析,显示只有TASPE与肾小球滤过率呈显著相关(=0.62,%Objective To explore the change of tricuspid annular plane systolic excursion (TAPSE) and its corre-lation with glomerular filtration rate (GFR) in patients with acute decompensated heart failure (ADHF). Methods One hundred and two consecutive patients with acute decompensated heart failure and left ventricular ejection fraction (LVEF) below 50% on echocardiogram were enrolled. The value of TASPE, LVEF and pulmonary arterial systolic pressure (PASP) were measured by the transthoracic echocardiography. Blood test was conducted to determine NT-proBNP, electrolytes, BUN and creatinine. The estimated GFR (eGFR) was calculated on the basis of simplified Modification of Diet in Renal Disease (MDRD). According to the eGFR, the patients were divided into preserved re-nal function (PRF) group [eGFR≥60 ml/(min·1.73m2), =54] and renal dysfunction (RDSF) group [eGFR﹤60 ml/(min·1.73m2), = 48]. The echocardiographic parameters and serum indexes were compared between the two groups. The correlations between TASPE and echocardiographic parameters, serum indexes in the RDSF group were analyzed. Results TASPE in the PRF group [(16.4 ± 4.0) mm] was significantly lower than that in the RDSF group [(18.9 ± 3.8) mm, ﹤ 0.001], but no significant difference in NT-proBNP, PASP or LVEF was observed between the two groups ( ﹥ 0

  5. A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.

    Science.gov (United States)

    Socié, Gérard; Vigouroux, Stéphane; Yakoub-Agha, Ibrahim; Bay, Jacques-Olivier; Fürst, Sabine; Bilger, Karin; Suarez, Felipe; Michallet, Mauricette; Bron, Dominique; Gard, Philippe; Medeghri, Zakaria; Lehert, Philippe; Lai, Chinglin; Corn, Tim; Vernant, Jean-Paul

    2017-02-02

    Treatment of steroid-resistant acute graft-versus-host disease (GVHD) remains an unmet clinical need. Inolimomab, a monoclonal antibody to CD25, has shown encouraging results in phase 2 trials. This phase 3 randomized, open-label, multicenter trial compared inolimomab vs usual care in adult patients with steroid-refractory acute GVHD. Patients were randomly selected to receive treatment with inolimomab or usual care (the control group was treated with antithymocyte globulin [ATG]). The primary objective was to evaluate overall survival at 1 year without changing baseline allocated therapy. A total of 100 patients were randomly placed: 49 patients in the inolimomab arm and 51 patients in the ATG arm. The primary criteria were reached by 14 patients (28.5%) in the inolimomab and 11 patients (21.5%) in the ATG arms, with a hazard ratio of 0.874 (P = .28). With a minimum follow-up of 1 year, 26 (53%) and 31 (60%) patients died in the inolimomab and ATG arms, respectively. Adverse events were similar in the 2 arms, with fewer viral infections in the inolimomab arm compared with the ATG arm. The primary end point of this randomized phase 3 trial was not achieved. The lack of a statistically significant effect confirms the need for development of more effective treatments for acute GVHD. This trial is registered to https://www.clinicaltrialsregister.eu/ctr-search/search as EUDRACT 2007-005009-24.

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

    DEFF Research Database (Denmark)

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

    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...... 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...

  7. Immunogenicity of hepatitis A vaccination in decompensated cirrhotic patients.

    Science.gov (United States)

    Arguedas, M R; Johnson, A; Eloubeidi, M A; Fallon, M B

    2001-07-01

    Hepatitis A virus (HAV) vaccination is recommended in chronic liver disease because of an increased morbidity and mortality associated with HAV superinfection. However, data regarding the efficacy of HAV vaccination in patients with advanced chronic liver disease is limited. We assessed the efficacy of a standard HAV vaccination schedule in decompensated chronic liver disease in comparison with compensated disease and defined clinical predictors associated with seroconversion. Eighty-four anti-HAV antibody-negative patients, 49 with compensated liver disease, and 35 with decompensated disease were enrolled. Seroconversion was measured by qualitative and quantitative anti-HAV antibody measurements 1 month after each vaccine dose, and univariate/multivariate analysis was performed to define clinical predictors associated with seroconversion. One month after the primary dose, 71.4% of patients with compensated liver disease had detectable anti-HAV antibody compared with 37.1% with decompensated liver disease (P decompensated disease (P decompensated disease. On multivariate analysis, Child-Pugh class was the only factor predicting response to vaccination. Seroconversion after HAV vaccination was significantly less common in decompensated liver disease and the presence of advanced disease (Child-Pugh class B/C) predicted a lower response rate. These findings indicate that the response to HAV vaccination in chronic liver disease is optimal when targeted to patients before the development of hepatic decompensation.

  8. Impact of Orthodontic Decompensation on Bone Insertion

    Directory of Open Access Journals (Sweden)

    Fabio Pinto Guedes

    2014-01-01

    Full Text Available There has always been concern in determining the relationship between orthodontic tooth movement and the consequent biological costs to the periodontium and tooth root. The possibility of evaluating the tooth and bone morphology by CBCT allows more accurate analysis of qualitative and quantitative aspects of these processes. This paper presents a case report of a 20-year-old male patient with Class III malocclusion and hyperdivergent facial pattern, who was surgically treated. A significant amount of labial movement of mandibular incisors was performed during orthodontic treatment before surgery. CBCT was used for evaluation of buccal and lingual bone plates before and after tooth decompensation. The changes in the bone insertion level of maxillary and mandibular incisors in the present case encourage a reflection on the treatment protocol in individuals with dentoskeletal discrepancies.

  9. Montelukast as an episodic modifier for acute viral bronchiolitis: a randomized trial.

    Science.gov (United States)

    Zedan, Magdy; Gamil, Nareman; El-Assmy, Mohamed; Fayez, Engy; Nasef, Nehad; Fouda, Ashraf; Settin, Ahmed

    2010-01-01

    This study was designed to evaluate the effect of once-daily montelukast therapy on the clinical progress and the cytokine profile of patients with acute viral bronchiolitis. A randomized, double-blind, placebo-controlled trial included 85 patients (mean age, 3.5 +/- 2.35 months), clinically diagnosed as first-episode acute bronchiolitis in addition to 10 healthy controls of matched age and sex. Patients were randomly assigned to receive either montelukast (4-mg sachets; n = 47) or placebo (n = 38) daily from the time of admission until discharge. The primary outcome measure was the length of hospital stay (LOS), and clinical severity scores (CSs) and changes in plasma levels of interferon gamma and interleukin-4 were secondary outcomes. LOS for the montelukast group was found to be significantly lower than that of the placebo group (p viral bronchiolitis.

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

    Science.gov (United States)

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

    2016-09-01

    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.

  11. Nitazoxanide in Acute Rotavirus Diarrhea: A Randomized Control Trial from a Developing Country

    Science.gov (United States)

    Mahapatro, Samarendra; Mahilary, Nijwm; Satapathy, Amit Kumar

    2017-01-01

    Background. Acute diarrhea is one of the leading causes of childhood mortality, with rotavirus being an important pathogen. Nitazoxanide, an antiparasitic agent, has been shown to inhibit rotavirus. Objective. This double-blind, randomized trial was designed to study the role of nitazoxanide in acute rotavirus diarrhea. Methods. Of 174 children (12 months to 5 years) with acute diarrhea, 50 rotavirus positive cases were randomized. The intervention group received syrup nitazoxanide twice daily (100 mg in 12–47 months, 200 mg in ≥4 yr) for 3 days along with standard treatment of diarrhea. Duration of diarrhea was the primary outcome measure. Results. The median duration (hrs) of diarrhea (54 versus 80; 95% CI: –26 [–13.2 to –38.8]) and hospitalization (68 versus 90; 95% CI: –22 [–12.98 to –31.02]) was significantly shorter in the nitazoxanide group. No significant difference was seen in the median duration (hrs) of fever or vomiting or the proportion of children requiring parenteral rehydration. There was no report of any adverse events. Conclusions. Oral nitazoxanide is effective and safe in the management of acute rotavirus diarrhea in Indian children (CTRI REF/2016/10/012507). PMID:28331496

  12. Nitazoxanide in Acute Rotavirus Diarrhea: A Randomized Control Trial from a Developing Country

    Directory of Open Access Journals (Sweden)

    Samarendra Mahapatro

    2017-01-01

    Full Text Available Background. Acute diarrhea is one of the leading causes of childhood mortality, with rotavirus being an important pathogen. Nitazoxanide, an antiparasitic agent, has been shown to inhibit rotavirus. Objective. This double-blind, randomized trial was designed to study the role of nitazoxanide in acute rotavirus diarrhea. Methods. Of 174 children (12 months to 5 years with acute diarrhea, 50 rotavirus positive cases were randomized. The intervention group received syrup nitazoxanide twice daily (100 mg in 12–47 months, 200 mg in ≥4 yr for 3 days along with standard treatment of diarrhea. Duration of diarrhea was the primary outcome measure. Results. The median duration (hrs of diarrhea (54 versus 80; 95% CI: –26 [–13.2 to –38.8] and hospitalization (68 versus 90; 95% CI: –22 [–12.98 to –31.02] was significantly shorter in the nitazoxanide group. No significant difference was seen in the median duration (hrs of fever or vomiting or the proportion of children requiring parenteral rehydration. There was no report of any adverse events. Conclusions. Oral nitazoxanide is effective and safe in the management of acute rotavirus diarrhea in Indian children (CTRI REF/2016/10/012507.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  14. Nesiritide for pulmonary arterial hypertension with decompensated cor pulmonale.

    Science.gov (United States)

    Kingman, Martha S; Thompson, Brenda S; Newkirk, Trixie; Torres, Fernando

    2005-01-01

    Pulmonary arterial hypertension complicated by decompensated cor pulmonale is a challenging clinical problem with few effective therapeutic options. B-type natriuretic peptide is a pluripotent hormone that promotes diuresis and natriuresis, vasodilates systemic and pulmonary vessels, and reduces circulating levels of endothelin and aldosterone. It may represent a possible therapeutic strategy for decompensated cor pulmonale in the same manner that it is used to treat decompensated left heart failure. The authors report their experience with B-type natriuretic peptide as adjunctive therapy for pulmonary arterial hypertension complicated by decompensated cor pulmonale. A detailed case report is presented followed by the evaluation of a series of 11 cases occurring in eight patients from December 2002 through April 2004.

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

    Directory of Open Access Journals (Sweden)

    Jeannette Painovich

    2012-01-01

    Full Text Available 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-reported anxiety, depression, health status, and patient satisfaction. Results. Of the 383 patients consented to the study, 253 were randomized to be offered acupuncture, and 130 were not offered acupuncture. Of those offered acupuncture, 173 (69% accepted and received daily acupuncture. On average, patients offered acupuncture had longer LOSs (4.9 versus 4.1 days than those not offered acupuncture (=.047. Adjustment for diagnosis and severity mix reduced this difference and its significance (=.108. No other significant differences in outcomes were found. Patients who were more anxious (=.000 or depressed (=.017 at admission tended to more often accept acupuncture when offered. Conclusion. Acupuncture is accepted by a majority of hospitalized acute care patients. However, it did not reduce LOS in this already short-stay population.

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

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    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.

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

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    Cătălin Pleșea Condratovici

    2016-01-01

    Full Text Available 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.

  18. Criteria for decompensation in binocular vision.

    Science.gov (United States)

    Jenkins, T C; Pickwell, L D; Yekta, A A

    1989-04-01

    Two groups of patients, one under 40 years of age and the other 40 years and over, were divided into subgroups according to whether they had symptoms associated with near vision. A method developed in 'signal detection theory' was used to determine whether a value could be found for heterophoria, or associated heterophoria, which would predict which patients had symptoms due to decompensated heterophoria in normal routine investigation. Receiver operator characteristic curves (ROC curves) were constructed to look for these cut-off values between patients with, and without, symptoms. No value for dissociated heterophoria was found that would discriminate between the symptomatic and asymptomatic patients. It is concluded that heterophoria measurement is not useful as a routine procedure. In the case of associated heterophoria, for the under 40 years age group, patients with a value of 1 prism dioptre or more are more likely to have symptoms than not, and one-third of patients with close work problems have a value of 2 prism dioptres or more. It was rare to find any asymptomatic patient with a value as high as this. In the 40 years and over age group those with an associated heterophoria of 2 prism dioptres or more are more likely to have symptoms than not. One-third of patients in the latter age group, with symptoms, have a value of 3 prism dioptres or more whilst it is rare to find an asymptomatic patient with a value as large as this.

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

    DEFF Research Database (Denmark)

    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...

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

    DEFF Research Database (Denmark)

    Jarden, Mary; Møller, Tom; Kjeldsen, Lars

    2013-01-01

    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 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...

  1. Intraarticular lidocaine versus intravenous analgesic for reduction of acute anterior shoulder dislocations. A prospective randomized study.

    Science.gov (United States)

    Matthews, D E; Roberts, T

    1995-01-01

    We performed a prospective, randomized study to evaluate the use of injected lidocaine as an anesthetic for closed reduction of acute anterior shoulder dislocations. Thirty consecutive patients who presented at the emergency department with acute anterior shoulder dislocations were randomly placed in one of two groups. One group received an intraarticular injection of 20 ml of 1% lidocaine and the other group, intravenous injections of morphine sulfate and midazolam. The groups were compared regarding time of reduction maneuver, difficulty of reduction, subjective pain, complications, and total time spent in the emergency department. The lidocaine provided adequate anesthesia and secondary relief of muscle spasm in 15 of 15 (100%) patients. When compared with the intravenous sedation group, the lidocaine group showed no statistically significant difference in time for reduction maneuver, difficulty of reduction, or subjective pain. The lidocaine group had no complications and had a statistically significant shorter emergency department visit when compared with the intravenous sedation group (mean, 78 minutes versus 186 minutes; P = 0.004). Lidocaine provides excellent anesthesia for patients with uncomplicated anterior shoulder dislocations and can be very beneficial when sedation is contraindicated. Lidocaine injections also proved to be cost effective in our institution, reducing total costs by as much as 62%.

  2. Efficacy and safety of 2-hour urokinase regime in acute pulmonary embolism: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Huang Kewu

    2009-12-01

    Full Text Available Abstract Backgrounds Urokinase (UK 2 200 U/kg·h for 12 hours infusion(UK-12 his an ACCP recommended regimen in treating acute pulmonary embolism (PE. It is unclear whether this dose and time can be reduced further. We compared the efficacy and safety of 20, 000 U/kg for 2 hours (UK-2 h with the UK-12 h regime in selected PE patients. Methods A randomized trial involving 129 patients was conducted. Patients with acute PE were randomly assigned to receive either UK-12 h (n = 70, or UK-2 h (n = 59. The efficacy was determined by the improvement of right heart dysfunction and perfusion defect at 24 h and 14 d post UK treatment. The bleeding incidence, death rate and PE recurrence were also evaluated. Results Similarly significant improvements in right heart dysfunction and lung perfusion defects were observed in both groups. Overall bleeding incidents were low in both groups. Major bleeding directly associated with UK infusion occurred in one patient in the UK-2 h group and one in the UK-12 h group. Mortality rates were low, with one reported fatal recurrent in the UK-12 h group and none in the UK-2 h group. When the rate of bleeding, death and PE recurrence were compared separately in the hemodynamic instability and the massive anatomic obstruction subgroups, no significant difference was found. Conclusions The UK-2 h regimen exhibits similar efficacy and safety as the UK-12 h regimen for acute PE. Trial Registration Clinical trial registered with http://clinicaltrials.gov/ct2/show/NCT00799968 (Identifier: NCT 00799968

  3. Treatment of Hepatitis B in Decompensated Liver Cirrhosis

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    Richard Guan

    2011-01-01

    Full Text Available Chronic hepatitis B infection progresses from an asymptomatic persistently infected state to chronic hepatitis, cirrhosis, decompensated liver disease, and/or hepatocellular carcinoma. About 3% of patients with chronic hepatitis develop cirrhosis yearly, and about 5% of individuals with hepatitis B cirrhosis become decompensated annually. The outcome for patients with decompensated cirrhosis is bleak. Lamivudine, the first oral antiviral agent available for hepatitis B treatment is safe and effective and can improve or stabilize liver disease in patients with advanced cirrhosis and viraemia. Viral resistance restricts its prolonged use. Entecavir and tenofovir are newer agents with excellent resistance profile to date. These and some other antiviral agents are being investigated for optimal use in this rather challenging patient group.

  4. The Decompensated Monofixation Syndrome (An American Ophthalmological Society Thesis)

    Science.gov (United States)

    Siatkowski, R. Michael

    2011-01-01

    Purpose To describe the clinical features and response to treatment of patients with decompensated monofixation syndrome (MFS) and to propose a hypothesis for a decompensation mechanism in such patients. Methods Fourteen adults with MFS who had been symptomatically stable for a mean duration of 25 years developed diplopia in the absence of neurologic or orbital disease. After retrospective chart review, they underwent detailed orthoptic testing. Results from this cross-sectional analysis were compared with similar data from 16 control subjects with stable MFS. Results Compared to stable MFS patients, decompensated subjects had significantly poorer horizontal fusional amplitudes but greater torsional fusional amplitudes; they were also more likely to have a small vertical strabismus and to have received initial treatment later. Stable subjects, however, also had subnormal horizontal as well as torsional fusional amplitudes. There was no difference between groups with respect to refractive error, amblyopia, type or prior treatment of strabismus, stereoacuity, or angle of deviation. After treatment, all patients regained monofixational alignment, but up to one-third had continued diplopia. Symptoms recurred in two patients whose treatment was initially successful. Conclusions Patients with MFS lose fusional amplitudes over time. In some cases this results in development of sensory torsion with secondary decompensation and diplopia. The rate of decompensation averages 7% per year from ages 20 to 70. Treatment for decompensation offers excellent motor results, but sensory symptoms may persist and recurrent symptoms may develop. Monitoring and maintenance of fusional vergence amplitudes should be part of the routine care for patients with MFS. PMID:22253490

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

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    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

  6. Mobile applications for handheld devices to screen and randomize acute stroke patients in clinical trials.

    Science.gov (United States)

    Qureshi, Ai; Connelly, B; Abbott, Ei; Maland, E; Kim, J; Blake, J

    2012-08-01

    The availability of internet connectivity and mobile application software used by low-power handheld devices makes smart phones of unique value in time-sensitive clinical trials. Trial-specific applications can be downloaded by investigators from various mobile software distribution platforms or web applications delivered over HTTP. The Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH) II investigators in collaboration with MentorMate released the ATACH-II Patient Recruitment mobile application available on iPhone, Android, and Blackberry in 2011. The mobile application provides tools for pre-screening, assessment of eligibility, and randomization of patients. Since the release of ATACH-II mobile application, the CLEAR-IVH (Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage) trial investigators have also adopted such a mobile application. The video-conferencing capabilities of the most recent mobile devices open up additional opportunities to involve central coordinating centers in the recruitment process in real time.

  7. A randomized controlled trial of intranasal-midazolam versus intravenous-diazepam for acute childhood seizures.

    Science.gov (United States)

    Thakker, Arpita; Shanbag, Preeti

    2013-02-01

    The objective of this study is to compare the safety and efficacy of midazolam given intranasally with diazepam given intravenously in the treatment of acute childhood seizures. A randomized controlled study was conducted in a pediatric emergency department in a tertiary general hospital. Fifty children aged from 1 month to 12 years presenting with acute seizures of at least 10 min duration were enrolled during a 12 month period. Intranasal midazolam (0.2 mg/kg) and intravenous diazepam (0.3 mg/kg) were administered. The main outcome measures were interval between arrival at hospital and starting treatment and interval between arrival at hospital and cessation of seizures. Intranasal midazolam and intravenous diazepam were equally effective. Overall 18 of 27 seizures were controlled with midazolam and 15 of 23 with diazepam. The mean interval between arrival at hospital and starting treatment was significantly shorter in the midazolam group [3.37 min (SD 2.46)] as compared to the diazepam group [14.13 min (SD 3.39)]. The mean interval between cessation of seizures and arrival at hospital was significantly shorter in the midazolam group [6.67 min (SD 3.12)] as compared to the diazepam group [17.18 min (SD 5.09)]. The mean interval between control of seizures and administration of the drug was shorter in the diazepam group [2.67 min (SD 2.31)] as compared to the midazolam group [3.01 min (SD 2.79)]. No significant side effects were observed in either group. Seizures were controlled more quickly with intravenous diazepam than with intranasal midazolam. Midazolam was as safe and effective as diazepam. The overall interval between arrival at hospital and cessation of seizures was shorter with intranasal midazolam than with intravenous diazepam. The intranasal route can be possibly used not only in medical centres, but with appropriate instruction by the parents of children with acute seizures at home.

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

    Institute of Scientific and Technical Information of China (English)

    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.

  9. Acute effects of massage or active exercise in relieving muscle soreness: randomized controlled trial.

    Science.gov (United States)

    Andersen, Lars L; Jay, Kenneth; Andersen, Christoffer H; Jakobsen, Markus D; Sundstrup, Emil; Topp, Robert; Behm, David G

    2013-12-01

    Massage is commonly believed to be the best modality for relieving muscle soreness. However, actively warming up the muscles with exercise may be an effective alternative. The purpose of this study was to compare the acute effect of massage with active exercise for relieving muscle soreness. Twenty healthy female volunteers (mean age 32 years) participated in this examiner-blind randomized controlled trial (ClinicalTrials.gov NCT01478451). The participants performed eccentric contractions for the upper trapezius muscle on a Biodex dynamometer. Delayed onset muscle soreness (DOMS) presented 48 hours later, at which the participants (a) received 10 minutes of massage of the trapezius muscle or (b) performed 10 minutes of active exercise (shoulder shrugs 10 × 10 reps) with increasing elastic resistance (Thera-Band). First, 1 treatment was randomly applied to 1 shoulder while the contralateral shoulder served as a passive control. Two hours later, the contralateral resting shoulder received the other treatment. The participants rated the intensity of soreness (scale 0-10), and a blinded examiner took measures of pressure pain threshold (PPT) of the upper trapezius immediately before treatment and 0, 10, 20, and 60 minutes after treatment 48 hours posteccentric exercise. Immediately before treatment, the intensity of soreness was 5.0 (SD 2.2) and PPT was 138 (SD 78) kPa. In response to treatment, a significant treatment by time interaction was found for the intensity of soreness (p < 0.001) and PPT (p < 0.05). Compared with control, both active exercise and massage significantly reduced the intensity of soreness and increased PPT (i.e., reduced pain sensitivity). For both types of treatment, the greatest effect on perceived soreness occurred immediately after treatment, whereas the effect on PPT peaked 20 minutes after treatment. In conclusion, active exercise using elastic resistance provides similar acute relief of muscle soreness as compared with that using massage

  10. Portal vein thrombosis, mortality and hepatic decompensation in patients with cirrhosis: A meta-analysis

    Institute of Scientific and Technical Information of China (English)

    Jonathan; G; Stine; Puja; M; Shah; Scott; L; Cornella; Sean; R; Rudnick; Marwan; S; Ghabril; George; J; Stukenborg; Patrick; G; Northup

    2015-01-01

    AIM: To determine the clinical impact of portal vein thrombosis in terms of both mortality and hepatic decompensations(variceal hemorrhage, ascites, portosystemic encephalopathy) in adult patients with cirrhosis.METHODS: We identified original articles reported through February 2015 in MEDLINE, Scopus, Science Citation Index, AMED, the Cochrane Library, and relevant examples available in the grey literature. Two independent reviewers screened all citations for inclusion criteria and extracted summary data. Random effects odds ratios were calculated to obtain aggregate estimates of effect size across included studies, with 95%CI.RESULTS: A total of 226 citations were identified and reviewed, and 3 studies with 2436 participants were included in the meta-analysis of summary effect. Patients with portal vein thrombosis had an increased risk of mortality(OR = 1.62, 95%CI: 1.11-2.36, P = 0.01). Portal vein thrombosis was associated with an increased risk of ascites(OR = 2.52, 95%CI: 1.63-3.89, P < 0.001). There was insufficient data available to determine the pooled effect on other markers of decompensation including gastroesophageal variceal bleeding or hepatic encephalopathy. CONCLUSION: Portal vein thrombosis appears to increase mortality and ascites, however, the relatively small number of included studies limits more generalizable conclusions. More trials with a direct comparison group are needed.

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

    Directory of Open Access Journals (Sweden)

    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.

    Science.gov (United States)

    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

    DEFF Research Database (Denmark)

    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. Organoprotective effects of serelaxin in patients with severe decompensated heart failure

    Directory of Open Access Journals (Sweden)

    Z. D. Kobalava

    2016-01-01

    Full Text Available Serelaxin (recombinant molecule of the human relaxin-2 is an innovative drug for the treatment of acute heart failure. Preclinical and clinical studies demonstrated the ability of serelaxin to relieve the symptoms of heart failure, provide a significant reduction in congestion and have a protective effect on the heart, kidneys, liver. 48-hour serelaxin infusion in patient with ischemic cardiomyopathy and severe decompensated heart failure with cardio-hepatic syndrome led to significant regression of systemic congestion (evaluated by physical signs and by bioimpedance vector analysis, the improvement of structural and functional state of the myocardium (evaluated by standard echocardiography and global systolic longitudinal deformation of the left ventricle with speckle tracking echocardiography, regression of cardio-hepatic syndrome, improvement of renal function. Serelaxin therapy was well tolerated and was safe. Presented case report demonstrates beneficial effects of serelaxin on the heart failure symptoms and the organoprotective effects.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.)

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

    Directory of Open Access Journals (Sweden)

    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.

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

    DEFF Research Database (Denmark)

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

    2012-01-01

    OBJECTIVE: The musculoskeletal system is a common but often overlooked cause of chest pain. The purpose of the present study is to evaluate the relative effectiveness of 2 treatment approaches for acute musculoskeletal chest pain: (1) chiropractic treatment that included spinal manipulation and (2......) 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...

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  20. Predictors of low cardiac output in decompensated severe heart failure

    Directory of Open Access Journals (Sweden)

    Marcelo Eidi Ochiai

    2011-01-01

    Full Text Available OBJECTIVE: To identify predictors of low cardiac output and mortality in decompensated heart failure. INTRODUCTION: Introduction: Patients with decompensated heart failure have a high mortality rate, especially those patients with low cardiac output. However, this clinical presentation is uncommon, and its management is controversial. METHODS: We studied a cohort of 452 patients hospitalized with decompensated heart failure with an ejection fraction of 60 years, and 64.6% were men. Low cardiac output was present in 281 (63% patients on admission. Chagas disease was the cause of heart failure in 92 (20.4% patients who had higher B type natriuretic peptide levels (1,978.38 vs. 1,697.64 pg/mL; P = 0.015. Predictors of low cardiac output were Chagas disease (RR: 3.655, P<0.001, lower ejection fraction (RR: 2.414, P<0.001, hyponatremia (RR: 1.618, P = 0.036, and renal dysfunction (RR: 1.916, P = 0.007. Elderly patients were inversely associated with low cardiac output (RR: 0.436, P = 0.001. Predictors of mortality were Chagas disease (RR: 2.286, P<0.001, ischemic etiology (RR: 1.449, P = 0.035, and low cardiac output (RR: 1.419, P = 0.047. CONCLUSIONS: In severe decompensated heart failure, predictors of low cardiac output are Chagas disease, lower ejection fraction, hyponatremia, and renal dysfunction. Additionally, Chagas disease patients have higher B type natriuretic peptide levels and a worse prognosis independent of lower ejection fraction.

  1. Spontaneous expulsive suprachoroidal hemorrhage caused by decompensated liver disease

    Directory of Open Access Journals (Sweden)

    Krishnagopal Srikanth

    2013-01-01

    Full Text Available Expulsive suprachoroidal hemorrhage can be surgical or spontaneous. Spontaneous expulsive suprachoroidal hemorrhage (SESCH is a rare entity. Most of the reported cases of SESCH were caused by a combination of corneal pathology and glaucoma. We are reporting a rare presentation of SESCH with no pre-existing glaucoma or corneal pathology and caused by massive intra- and peri-ocular hemorrhage due to decompensated liver disease.

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

    Directory of Open Access Journals (Sweden)

    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

    DEFF Research Database (Denmark)

    Connor, Kathryn M; Aurora, Sheena K; Loeys, Tom

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

    DEFF Research Database (Denmark)

    Connor, Kathryn M; Aurora, Sheena K; Loeys, Tom

    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.......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....

  5. Lamivudine treatment for decompensated cirrhosis resulting from chronic hepatitis B.

    Science.gov (United States)

    Villeneuve, J P; Condreay, L D; Willems, B; Pomier-Layrargues, G; Fenyves, D; Bilodeau, M; Leduc, R; Peltekian, K; Wong, F; Margulies, M; Heathcote, E J

    2000-01-01

    The prognosis of decompensated cirrhosis resulting from chronic hepatitis B is poor, and the benefits of treatment with interferon are outweighed by serious side effects and by the risk of fatal exacerbation of disease activity. Lamivudine rapidly reduces hepatitis B virus (HBV)-DNA in serum to undetectable levels. We have treated 35 patients with chronic hepatitis B and decompensated cirrhosis with lamivudine 100 mg or 150 mg orally once daily. Pretreatment, all were positive for HBV-DNA in serum. Ten had Child-Pugh class B and 25 had Child-Pugh class C liver disease. Seven patients underwent liver transplantation within 6 months of treatment initiation, 5 patients died within 6 months, and 23 patients were treated for at least 6 months (mean = 19 months). In a majority of these 23 cases, there was a slow but marked improvement in liver function, which was most apparent after 9 months of treatment, with a decrease in serum bilirubin from 67 +/- 13 to 30 +/- 4 micromol/L (P decompensated HBV cirrhosis, but the long-term benefits remain uncertain.

  6. A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine

    OpenAIRE

    Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D.; Zava, Dario; Pinessi, Lorenzo

    2010-01-01

    The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1–3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment pe...

  7. Predictors of fifty days in-hospital mortality in decompensated cirrhosis patients with spontaneous bacterial peritonitis

    Institute of Scientific and Technical Information of China (English)

    Chinmaya; Kumar; Bal; Ripu; Daman; Vikram; Bhatia

    2016-01-01

    AIM: To determine the predictors of 50 d in-hospital mortality in decompensated cirrhosis patients with spontaneous bacterial peritonitis(SBP).METHODS: Two hundred and eighteen patients admitted to an intensive care unit in a tertiary care hospital between June 2013 and June 2014 with the diagnosis of SBP(during hospitalization) and cirrhosis were retrospectively analysed. SBP was diagnosed by abdominal paracentesis in the presence of polymorphonuclear cell count ≥ 250 cells/mm3 in the peritoneal fluid. Student’s t test, multivariate logistic regression, cox proportional hazard ratio(HR), receiver operating characteristics(ROC) curves and Kaplan-Meier survival analysis were utilized for statistical analysis. Predictive abilities of several variables identified by multivariate analysis were compared using the area under ROC curve. P < 0.05 were considered statistical significant. RESULTS: The 50 d in-hospital mortality rate attributable to SBP is 43.11%(n = 94). Median survival duration for those who died was 9 d. In univariate analysis acute kidney injury(AKI), hepatic encephalopathy, septic shock, serum bilirubin, international normalized ratio, aspartate transaminase, and model for end-stage liver disease- sodium(MELD-Na) were significantly associated with in- hospital mortality in patients with SBP(P ≤ 0.001). Multivariate coxproportional regression analysis showed AKI(HR = 2.16, 95%CI: 1.36-3.42, P = 0.001) septic shock(HR = 1.73, 95%CI: 1.05-2.83, P = 0.029) MELD-Na(HR = 1.06, 95%CI: 1.02-1.09, P ≤ 0.001) was significantly associated with 50 d in-hospital mortality. The prognostic accuracy for AKI, MELD-Na and septic shock was 77%, 74% and 71% respectively associated with 50 d inhospital mortality in SBP patients.CONCLUSION: AKI, MELD-Na and septic shock were predictors of 50 d in-hospital mortality in decompensated cirrhosis patients with SBP.

  8. Safety and efficacy of vitamin-based antioxidant therapy in patients with severe acute pancreatitis: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dipika Bansal

    2011-01-01

    Full Text Available Background/Aim: Oxidative stress plays a major role in the pathogenesis of pancreatitis. Antioxidant therapy in the form of high-dose vitamin has been used for the treatment of severe acute pancreatitis with equivocal results. We wished to evaluate the efficacy and safety of antioxidant (vitamin A, vitamin C, vitamin E therapy in patients with severe acute pancreatitis. Setting and design: This was a single-center, prospective, randomized, open-label with blinded endpoint assessment study of antioxidant therapy, conducted in the emergency department attached to our hospital. Materials and Methods: Thirty-nine patients with severe acute pancreatitis were randomly assigned to antioxidant treatment group (n=19 or a control group (n=20 within 96 hours of developing symptoms. Patients in the antioxidant group received antioxidants (vitamin A, vitamin E, vitamin C in addition to the standard treatment provided to both the groups for a period of 14 days. The primary outcome variable was presence of organ dysfunction at day 7. The secondary outcome variables were length of hospital stay, multiorgan dysfunction (MODS at day 7, recovery at the end of 4 weeks, complications, and mortality. The change in markers of oxidative stress from baseline was also measured. Results: We demonstrated no significant difference in organ dysfunction (P=1.0, MODS (P=0.8, and length of hospital stay (P=0.29 between the two groups. All the patients survived in the antioxidant-treated group, whereas two patients died in the control group. The change in the levels of malondialdehyde, superoxide dismutase, and reduced glutathione were not significantly different in the two groups at day 7. Univariate analysis showed marginal benefit with antioxidant treatment (P=0.034 in patients with severe acute pancreatitis. Conclusions: This randomized study demonstrates that there is no significant benefit from antioxidant therapy in patients with established severe acute pancreatitis.

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

    Directory of Open Access Journals (Sweden)

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

    Directory of Open Access Journals (Sweden)

    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.

  11. Acute effects of aerosolized iloprost in COPD related pulmonary hypertension - a randomized controlled crossover trial.

    Directory of Open Access Journals (Sweden)

    Lucas Boeck

    Full Text Available BACKGROUND: Inhaled iloprost potentially improves hemodynamics and gas exchange in patients with chronic obstructive pulmonary disease (COPD and secondary pulmonary hypertension (PH. OBJECTIVES: To evaluate acute effects of aerosolized iloprost in patients with COPD-associated PH. METHODS: A randomized, double blind, crossover study was conducted in 16 COPD patients with invasively confirmed PH in a single tertiary care center. Each patient received a single dose of 10 µg iloprost (low dose, 20 µg iloprost (high dose and placebo during distinct study-visits. The primary end-point of the study was exercise capacity as assessed by the six minute walking distance. RESULTS: Both iloprost doses failed to improve six-minute walking distance (p = 0.36. Low dose iloprost (estimated difference of the means -1.0%, p = 0.035 as well as high dose iloprost (-2.2%, p<0.001 significantly impaired oxygenation at rest. Peak oxygen consumption and carbon dioxide production differed significantly over the three study days (p = 0.002 and p = 0.003, accordingly. As compared to placebo, low dose iloprost was associated with reduced peak oxygen consumption (-76 ml/min, p = 0.002, elevated partial pressure of carbon dioxide (0.27 kPa, p = 0.040 and impaired ventilation during exercise (-3.0l/min, p<0.001. CONCLUSIONS: Improvement of the exercise capacity after iloprost inhalation in patients with COPD-associated mild to moderate PH is very unlikely. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN61661881.

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

    LENUS (Irish Health Repository)

    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.

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

    NARCIS (Netherlands)

    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

  14. A randomized controlled trial on early physiotherapy intervention versus usual care in acute care unit for elderly: potential benefits in light of dietary intakes.

    NARCIS (Netherlands)

    Blanc-Bisson, C.; Dechamps, A.A.; Gouspillou, G.; Dehail, P.; Bourdel-Marchasson, I.

    2008-01-01

    OBJECTIVE: To evaluate effects of early intensive physiotherapy during acute illness on post hospitalization activity daily living autonomy (ADL). DESIGN: Prospective randomized controlled trial of intensive physiotherapy rehabilitation on day 1 to 2 after admission until clinical stability or usual

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

    Directory of Open Access Journals (Sweden)

    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

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

    DEFF Research Database (Denmark)

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

    2009-01-01

    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...

  17. Human umbilical cord mesenchymal stem cells improve liver function and ascites in decompensated liver cirrhosis patients.

    Science.gov (United States)

    Zhang, Zheng; Lin, Hu; Shi, Ming; Xu, Ruonan; Fu, Junliang; Lv, Jiyun; Chen, Liming; Lv, Sa; Li, Yuanyuan; Yu, Shuangjie; Geng, Hua; Jin, Lei; Lau, George K K; Wang, Fu-Sheng

    2012-03-01

    Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, mesenchymal stem cell (MSC) transfusion has been shown to lead to the regression of liver fibrosis in mice and humans. This study examined the safety and efficacy of umbilical cord-derived MSC (UC-MSC) in patients with decompensated LC. A total of 45 chronic hepatitis B patients with decompensated LC, including 30 patients receiving UC-MSC transfusion, and 15 patients receiving saline as the control, were recruited; clinical parameters were detected during a 1-year follow-up period. No significant side-effects and complications were observed in either group. There was a significant reduction in the volume of ascites in patients treated with UC-MSC transfusion compared with controls (P decompensated LC. UC-MSC transfusion, therefore, might present a novel therapeutic approach for patients with decompensated LC.

  18. Lumiracoxib for acute postoperative dental pain: a systematic review of randomized clinical trials

    OpenAIRE

    Ricardo Carvalho Lopes Silva; Rachel Riera; Humberto Saconato

    2011-01-01

    CONTEXT AND OBJECTIVE: Lumiracoxib is an anti-inflammatory drug that has been used to treat acute dental pain, mainly in postsurgical settings, in which the greatest levels of pain and discomfort are experienced during the first 24 hours. This study aimed to assess the efficacy and safety of lumiracoxib for treating acute postsurgical dental pain. DESIGN AND SETTING: Systematic review developed at the Brazilian Cochrane Centre, Universidade Federal de São Paulo (UNIFESP). METHODS: An electron...

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

    DEFF Research Database (Denmark)

    Kavli, M; Strøm, T; Carlsson, M;

    2012-01-01

    with the Child-Pugh score. METHODS: A single-centre retrospective cohort analysis was conducted in a university-affiliated ICU. Eighty-seven adult patients with decompensated liver alcoholic cirrhosis were admitted from January 2007 to January 2010. RESULTS: The patients were severely ill with median scores......: SAPS II 60, SOFA (day 1) 11, APACHE II 31, and Child-Pugh 12. Receiver operating characteristic curves area under curve was 0.79 for APACHE II, 0.83 for SAPS II, and 0.79 for SOFA (day1) compared with 0.59 for Child-Pugh. In patients only in need of mechanical ventilation, the 90-day mortality was 76......, SAPS II, and SOFA were better at predicting mortality than the Child-Pugh score. With three or more organ failures, the ICU mortality was > 90%. APACHE II > 30, SAPS II > 60, and SOFA at day 1 > 12 were all associated with a mortality of > 90%. Referral criteria of patients suffering from decompensated...

  20. Recovery of hand function with robot-assisted therapy in acute stroke patients: a randomized-controlled trial.

    Science.gov (United States)

    Sale, Patrizio; Mazzoleni, Stefano; Lombardi, Valentina; Galafate, Daniele; Massimiani, Maria P; Posteraro, Federico; Damiani, Carlo; Franceschini, Marco

    2014-09-01

    In the last few years, not many studies on the use of robot-assisted therapy to recover hand function in acute stroke patients have been carried out. This randomized-controlled observer trial is aimed at evaluating the effects of intensive robot-assisted hand therapy compared with intensive occupational therapy in the early recovery phases after stroke with a 3-month follow-up. Twenty acute stroke patients at their first-ever stroke were enrolled and randomized into two groups. The experimental treatment was performed using the Amadeo Robotic System. Control treatment, instead, was carried out using occupational therapy executed by a trained physiotherapist. All participants received 20 sessions of treatment for 4 consecutive weeks (5 days/week). The following clinical scales, Fugl-Meyer Scale (FM), Medical Research Council Scale for Muscle Strength (hand flexor and extensor muscles) (MRC), Motricity Index (MI) and modified Ashworth Scale for wrist and hand muscles (MAS), were performed at baseline (T0), after 20 sessions (end of treatment) (T1) and at the 3-month follow-up (T2). The Barthel Index was assessed only at T0 and T1. Evidence of a significant improvement was shown by the Friedman test for the FM [experimental group (EG): P=0.0039, control group (CG): Probot-assisted treatment on hand recovery functions in individuals with acute stroke. The robotic rehabilitation treatment may contribute toward the recovery of hand motor function in acute stroke patients. The positive results obtained through the safe and reliable robotic rehabilitation treatment reinforce the recommendation to extend it to a larger clinical practice.

  1. Randomized comparative study of moxalactam and cefazolin in the treatment of acute urinary tract infections in adults.

    OpenAIRE

    Lea, A.S.; Sudan, A W; Wood, B A; Gentry, L O

    1982-01-01

    Eighty-nine patients with clinical and laboratory evidence of acute urinary tract infection were randomized to therapy with either moxalactam (500 mg) or cefazolin (1 g) every 12 h. Escherichia coli was the predominant pathogen in both groups (92.6 versus 90.2%). Therapy was continued for 3 days after the patient defervesced. The minimum hospital stay was 5 days. Sequential urine cultures were obtained on day 3, at discharge, and 5 to 10 days after the cessation of therapy. THe average durati...

  2. Low-dose Ketamine Versus Morphine for Acute Pain In the ED: A Randomized Controlled Trial

    Science.gov (United States)

    2015-03-01

    reduction of pain as measured by provider and nurse satisfaction scores. 2. Methods 2.1. Study design Our studywas a prospective, randomized, controlled...intravenous ketamine in cancer patients on morphine therapy: a randomized, controlled, double-blind, crossover , double-dose study. J Pain Symptom Manag

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

    DEFF Research Database (Denmark)

    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. 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

    Directory of Open Access Journals (Sweden)

    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

  5. A multicentre randomized controlled trial of moderate hypothermia to prevent intracranial hypertension in acute liver failure

    DEFF Research Database (Denmark)

    Bernal, William; Murphy, Nicholas; Brown, Sarah

    2016-01-01

    . In a prospective randomized controlled trial we investigated if maintenance of MH prevented development of ICH in ALF patients at high risk of the complication. METHODS: Patients with ALF, high-grade encephalopathy and intracranial pressure (ICP) monitoring in specialist intensive care units were randomized...... or limit the development of brain swelling, a dangerous complication of the condition. There is limited data on its effects in humans. In a randomized controlled trial in severely ill patients with ALF we compared the effects of different temperatures and found no benefit on improving survival...

  6. Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke : A Randomized Clinical Trial

    NARCIS (Netherlands)

    Fransen, Puck S S; Berkhemer, Olvert A; Lingsma, Hester F; Beumer, Debbie; van den Berg, Lucie A; Yoo, Albert J; Schonewille, Wouter J; Vos, Jan Albert; Nederkoorn, Paul J; Wermer, Marieke J H; van Walderveen, Marianne A A; Staals, Julie; Hofmeijer, Jeannette; van Oostayen, Jacques A; Lycklama À Nijeholt, Geert J; Boiten, Jelis; Brouwer, Patrick A; Emmer, Bart J; de Bruijn, Sebastiaan F; van Dijk, Lukas C; Kappelle, L Jaap; Lo, Rob H; van Dijk, Ewoud J; de Vries, Joost; de Kort, Paul L M; van den Berg, J S Peter; van Hasselt, Boudewijn A A M; Aerden, Leo A M; Dallinga, René J; Visser, Marieke C; Bot, Joseph C J; Vroomen, Patrick C; Eshghi, Omid; Schreuder, Tobien H C M L; Heijboer, Roel J J; Keizer, Koos; Tielbeek, Alexander V; den Hertog, Heleen M; Gerrits, Dick G; van den Berg-Vos, Renske M; Karas, Giorgos B; Steyerberg, Ewout W; Flach, H Zwenneke; Marquering, Henk A; Sprengers, Marieke E S; Jenniskens, Sjoerd F M; Beenen, Ludo F M; van den Berg, René; Koudstaal, Peter J; van Zwam, Wim H; Roos, Yvo B W E M; van Oostenbrugge, Robert J; Majoie, Charles B L M; van der Lugt, Aad; Dippel, Diederik W J

    2016-01-01

    Importance: Intra-arterial treatment (IAT) for acute ischemic stroke caused by intracranial arterial occlusion leads to improved functional outcome in patients treated within 6 hours after onset. The influence of treatment delay on treatment effect is not yet known. Objective: To evaluate the influe

  7. Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke : A Randomized Clinical Trial

    NARCIS (Netherlands)

    Fransen, Puck S S; Berkhemer, Olvert A; Lingsma, Hester F; Beumer, Debbie; van den Berg, Lucie A; Yoo, Albert J; Schonewille, Wouter J; Vos, Jan Albert; Nederkoorn, Paul J; Wermer, Marieke J H; van Walderveen, Marianne A A; Staals, Julie; Hofmeijer, Jeannette; van Oostayen, Jacques A; Lycklama À Nijeholt, Geert J; Boiten, Jelis; Brouwer, Patrick A; Emmer, Bart J; de Bruijn, Sebastiaan F; van Dijk, Lukas C; Kappelle, L Jaap; Lo, Rob H; van Dijk, Ewoud J; de Vries, Joost; de Kort, Paul L M; van den Berg, J S Peter; van Hasselt, Boudewijn A A M; Aerden, Leo A M; Dallinga, René J; Visser, Marieke C; Bot, Joseph C J; Vroomen, Patrick C; Eshghi, Omid; Schreuder, Tobien H C M L; Heijboer, Roel J J; Keizer, Koos; Tielbeek, Alexander V; den Hertog, Heleen M; Gerrits, Dick G; van den Berg-Vos, Renske M; Karas, Giorgos B; Steyerberg, Ewout W; Flach, H Zwenneke; Marquering, Henk A; Sprengers, Marieke E S; Jenniskens, Sjoerd F M; Beenen, Ludo F M; van den Berg, René; Koudstaal, Peter J; van Zwam, Wim H; Roos, Yvo B W E M; van Oostenbrugge, Robert J; Majoie, Charles B L M; van der Lugt, Aad; Dippel, Diederik W J

    2016-01-01

    IMPORTANCE: Intra-arterial treatment (IAT) for acute ischemic stroke caused by intracranial arterial occlusion leads to improved functional outcome in patients treated within 6 hours after onset. The influence of treatment delay on treatment effect is not yet known. OBJECTIVE: To evaluate the influe

  8. Timing of laparoscopic cholecystectomy for acute cholecystitis: A prospective non randomized study

    Institute of Scientific and Technical Information of China (English)

    George Tzovaras; Dimitris Zacharoulis; Paraskevi Liakou; Theodoros Theodoropoulos; George Paroutoglou; Constantine Hatzitheofilou

    2006-01-01

    AIM: To study the timing of laparoscopic cholecystectomy for patients with acute cholecystitis.METHODS: Between January 2002 and December 2005,all American Society of Anesthesiologists classification (ASA) Ⅰ ,Ⅱand Ⅲ patients with acute cholecystitiswere treated laparoscopically during the urgent (index) admission. The patients were divided into three groups according to the timing of surgery: (1) within the first 3 d, (2) between 4 and 7 d and (3) beyond 7 d from the onset of symptoms. The impact of timing on the conversion rate, morbidity and postoperative hospital stay was studied.RESULTS: One hundred and twenty-nine patients underwent laparoscopic cholecystectomy for acute cholecystitis during the index admission. Thirty six were assigned to group 1, 58 to group 2, and 35 to group 3. The conversion rate and morbidity for the whole cohort of patients were 4.6% and 10.8%, respectively. There was no significant difference in the conversion rate, morbidity and postoperative hospital stay between the three groups.CONCLUSION: Laparoscopic cholecystectomy for acute cholecystitis during the index admission is safe, regardless of the time elapsed from the onset of symptoms. This policy can result in an overall shorter hospitalization.

  9. Tele-Interpersonal Psychotherapy Acutely Reduces Depressive Symptoms in Depressed HIV-Infected Rural Persons: A Randomized Clinical Trial.

    Science.gov (United States)

    Heckman, Timothy G; Heckman, Bernadette D; Anderson, Timothy; Lovejoy, Travis I; Markowitz, John C; Shen, Ye; Sutton, Mark

    2016-04-26

    Human immunodeficiency virus (HIV)-positive rural individuals carry a 1.3-times greater risk of a depressive diagnosis than their urban counterparts. This randomized clinical trial tested whether telephone-administered interpersonal psychotherapy (tele-IPT) acutely relieved depressive symptoms in 132 HIV-infected rural persons from 28 states diagnosed with Diagnostic and Statistical Manual of Mental Disorders-IV major depressive disorder (MDD), partially remitted MDD, or dysthymic disorder. Patients were randomized to either 9 sessions of one-on-one tele-IPT (n = 70) or standard care (SC; n = 62). A series of intent-to-treat (ITT), therapy completer, and sensitivity analyses assessed changes in depressive symptoms, interpersonal problems, and social support from pre- to postintervention. Across all analyses, tele-IPT patients reported significantly lower depressive symptoms and interpersonal problems than SC controls; 22% of tele-IPT patients were categorized as a priori "responders" who reported 50% or higher reductions in depressive symptoms compared to only 4% of SC controls in ITT analyses. Brief tele-IPT acutely decreased depressive symptoms and interpersonal problems in depressed rural people living with HIV.

  10. Role of glutamine versus placebo in prevention of acute gastrointestinal toxicity in pelvic radiotherapy: A randomized control study

    Directory of Open Access Journals (Sweden)

    Kazi Sazzad Manir

    2014-01-01

    Full Text Available Context: Nausea, vomiting, diarrhoea, abdominal cramping, ano-proctitis are common acute gastrointestinal (GI toxicities during pelvic radiotherapy (RT, having important impact on treatment outcome. Glutamine has a major role in mucosal growth and function. This phase III study is conducted to evaluate the role of prophylactic glutamine supplementation in prevention of acute GI toxicities during pelvic RT. Materials and Methods: Eighty five nonmetastatic patients with pelvic malignancy needing pelvic RT are included in this double blind randomized control trial. During RT 42 patients (Arm A received 10 g glutamine oral supplementation 1 h before every RT fraction. Forty three patients received glycine as placebo (Arm B in same schedule. Patients were assessed weekly for common acute RT induced GI toxicities. Toxicities were graded according to Common Terminology Criteria for Adverse Events version 4.02. Results: Two arms were well balanced with all baseline parameters. Median age was 57. 56.47% (n = 48 patients had cervical cancer. There was no significant difference between two arms in grade wise incidence of any of the GI toxicities. Trends of diarrhoea during weekly assessments also similar in both arms. Conclusion: There is no significant beneficial effect of glutamine during pelvic RT. As per our study data and our dose schedule glutamine should not be indicated in pelvic RT.

  11. Acute Effects of a Spinach Extract Rich in Thylakoids on Satiety: A Randomized Controlled Crossover Trial

    OpenAIRE

    Rebello, Candida J.; Chu, Jessica; Beyl, Robbie; Edwall, Dan; Erlanson-Albertsson, Charlotte; Frank L. Greenway

    2015-01-01

    Objective: By retarding fat digestion, thylakoids, the internal photosynthetic membrane system of green plants, promote the release of satiety hormones. This study examined the effect of consuming a single dose of concentrated extract of thylakoids from spinach on satiety, food intake, lipids, and glucose compared to a placebo. Design: Sixty overweight and obese individuals enrolled in a double-blind randomized crossover study consumed the spinach extract or placebo in random order at least a...

  12. Motion style acupuncture treatment (MSAT for acute low back pain with severe disability: a multicenter, randomized, controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Shin Joon-Shik

    2011-12-01

    Full Text Available Abstract Background Acupuncture is widely-used to treat patients with low back pain, despite insufficient evidence of the technique's efficacy for acute back pain. Motion style acupuncture treatment (MSAT is a non-traditional acupuncture treatment requiring a patient to exercise while receiving acupuncture. In Korea, MSAT is used to reduce musculoskeletal pain and improve functional status. The study aims to evaluate the effect of MSAT on acute low back pain with severe disability. Methods/Design This study is a multicenter, randomized, active-controlled trial with two parallel arms. Participants with acute low back pain and severe functional disability, defined as an Oswestry Disability Index (ODI value > 60%, will be randomly allocated to the acupuncture group and the nonsteroidal anti-inflammatory drug (NSAID injection group. The acupuncture group will receive MSAT and the NSAID injection group will receive an intramuscular injection of diclofenac. All procedures will be limited to one session and the symptoms before and after treatment will be measured by assessors blinded to treatment allocation. The primary outcome will be measured at 30 minutes after treatment using the numerical rating scale (NRS of low back pain while the patient is moving. Secondary outcomes will be measured at 30 minutes after treatment using the NRS of leg pain, ODI, patient global impression of change, range of motion (ROM of the lumbar spine, and degrees of straight leg raising (SLR. Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment. Discussion The results of this trial will be discussed. Trial Registration ClinicalTrial.gov NCT01315561

  13. Glycated Hemoglobin Levels in Patients with Decompensated Cirrhosis

    Directory of Open Access Journals (Sweden)

    Jeffrey Nadelson

    2016-01-01

    Full Text Available Introduction. Aim of this study is to determine if HbA1c levels are a reliable predictor of glycemic control in patients with decompensated cirrhosis. Methods. 200 unique patients referred for liver transplantation at University of Tennessee/Methodist University Transplant Institute with a HbA1c result were included. Three glucose levels prior to the “measured” A1c (MA1c were input into an HbA1c calculator from the American Diabetes Association website to determine the “calculated” A1c (CA1c. The differences between MA1c and CA1c levels were computed. Patients were divided into three groups: group A, difference of 1.5. Results. 97 (49% patients had hemoglobin A1c of less than 5%. Discordance between calculated and measured HbA1c of >0.5% was seen in 47% (n=94. Higher level of discordance of greater than >1.5 was in 12% of patients (n=24. Hemoglobin was an independent predictor for higher discordance (odds ratio 0.77 95%, CI 0.60–0.99, and p value 0.04. HbA1c was an independent predictor of occurrence of HCC (OR 2.69 955, CI 1.38–5.43, and p value 0.008. Conclusion. HbA1c is not a reliable predictor of glycemic control in patients with decompensated cirrhosis, especially in those with severe anemia.

  14. Does epicatechin contribute to the acute vascular function effects of dark chocolate? A randomized, crossover study

    NARCIS (Netherlands)

    Dower, James I.; Geleijnse, Marianne; Kroon, Paul A.; Philo, Mark; Mensink, Marco; Kromhout, Daan; Hollman, Peter C.H.

    2016-01-01

    Scope: Cocoa, rich in flavan-3-ols, improves vascular function, but the contribution of specific flavan-3-ols is unknown. We compared the effects of pure epicatechin, a major cocoa flavan-3-ol, and chocolate. Methods and results: In a randomized crossover study, twenty healthy men (40-80 years) w

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

    DEFF Research Database (Denmark)

    Frobell, Richard B; Roos, Ewa M; Roos, Harald P;

    2010-01-01

    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...... no significant differences between the two treatment groups with respect to secondary outcomes. Adverse events were common in both groups. The results were similar when the data were analyzed according to the treatment actually received. CONCLUSIONS: In young, active adults with acute ACL tears, a strategy...

  16. Further evidence for a non-random chromosomal abnormality in acute promyelocytic leukemia

    Energy Technology Data Exchange (ETDEWEB)

    Rowley, J.D.; Golomb, H.M.; Vardiman, J.; Fukahara, S.; Dougherty, C.; Potter, D.

    1977-01-01

    We have previously reported on two patients with acute promyelocytic leukemia (APL) who had what appeared to be a deletion of chromosome No. 17. We now describe a third patient with APL. All three patients had a structural rearrangement involving No. 15 and No. 17. Our current interpretation of the chromosomal abnormality is that it is a reciprocal translocation, t (15; 17) (q22; q21). Evidence that this is a consistent rearrangement associated with APL comes not only from our three patients, but also from two other published cases of APL, studied with banding, who also had an identical abnormality.

  17. Hepatic decompensation with sofosbuvir plus simeprevir in a patient with Child-Pugh B compensated cirrhosis.

    Science.gov (United States)

    Soriano, Vincent; Barreiro, Pablo; de Mendoza, Carmen; Peña, José M

    2016-01-01

    A 75-year-old male with compensated Child-Pugh B cirrhosis initiated sofosbuvir plus simeprevir, and developed hepatic decompensation and died a few days thereafter. High exposure to simeprevir leading to hepatotoxicity most likely explained this fatal outcome. This observation, along with similar cases recently reported in the literature, should raise awareness of the potential for decompensation in patients with advanced cirrhosis treated with simeprevir.

  18. Combined MELD and blood lipid level in evaluating the prognosis of decompensated cirrhosis

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    AIM: To evaluate the prognostic value of the combined model for end-stage liver disease (MELD) and blood lipid level in patients with decompensated cirrhosis. METHODS: A total of 198 patients with decompensated cirrhosis were enrolled into the study. The values of triglyceride (TG), cholesterol (TC), high density lipoproteins (HDL) and low density lipoprotein (LDL) of each patient on the fi rst day of admission were retrieved from the medical records, and MELD was calculated. All the patients were followed ...

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

    Institute of Scientific and Technical Information of China (English)

    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

  20. Intravenous iron supplementation may protect against acute mountain sickness: a randomized, double-blinded, placebo-controlled trial.

    Science.gov (United States)

    Talbot, Nick P; Smith, Thomas G; Privat, Catherine; Nickol, Annabel H; Rivera-Ch, Maria; León-Velarde, Fabiola; Dorrington, Keith L; Robbins, Peter A

    2011-01-01

    Acute mountain sickness (AMS) is a common and disabling condition that occurs in healthy individuals ascending to high altitude. Based on the ability of iron to influence cellular oxygen sensing pathways, we hypothesized that iron supplementation would protect against AMS. To examine this hypothesis, 24 healthy sea-level residents were randomized to receive either intravenous iron(III)-hydroxide sucrose (200 mg) or saline placebo, before ascending rapidly to Cerro de Pasco, Peru (4340 m). The Lake Louise scoring system was used to assess incidence and severity of AMS at sea level and on the first full day at altitude. No significant difference in absolute AMS score was detected between the two groups either at baseline or at high altitude. However, the mean increase in AMS score was 65% smaller in the iron group than in the saline group (pvolunteers.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    J.Z. Cui

    2016-03-01

    Full Text Available 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 (P<0.05, t-test. The mean increment in PSFS score of the ISWI group was 2.9±2.2 1 day after treatment, while that in the control group was 0.9±2.2. Our study showed that ISWI was effective for relieving pain 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  4. Randomized comparative study of moxalactam and cefazolin in the treatment of acute urinary tract infections in adults.

    Science.gov (United States)

    Lea, A S; Sudan, A W; Wood, B A; Gentry, L O

    1982-01-01

    Eighty-nine patients with clinical and laboratory evidence of acute urinary tract infection were randomized to therapy with either moxalactam (500 mg) or cefazolin (1 g) every 12 h. Escherichia coli was the predominant pathogen in both groups (92.6 versus 90.2%). Therapy was continued for 3 days after the patient defervesced. The minimum hospital stay was 5 days. Sequential urine cultures were obtained on day 3, at discharge, and 5 to 10 days after the cessation of therapy. THe average duration of hospital stay was 5.6 days for both groups of patients. THe incidence of recurrent infection was similar in uncomplicated patients (9.1 versus 10%) and in complicated patients with a condition predisposing them to urinary tract infections (43 versus 42%). Moxalactam-treated patients had a higher incidence of reversible hepatic enzyme elevation (36%) and Streptococcus faecalis superinfections (12.2%). Moxalactam is as effective as cefazolin for the elimination of gram-negative pathogens from the urine of patients with acute urinary tract infections, but it is associated with a higher incidence of reversible side effects. PMID:6214996

  5. A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine.

    Science.gov (United States)

    Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D; Zava, Dario; Pinessi, Lorenzo

    2011-04-01

    The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1-3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment periods lasting rizatriptan (3.2±1.1). The rates of pain-free (33% frovatriptan vs. 39% rizatriptan) and pain relief (55 vs. 62%) episodes at 2 h were not significantly different between the two treatments. The rate of recurrent episodes was significantly (prizatriptan). No significant differences were observed in sustained pain-free episodes (26% frovatriptan vs. 22% rizatriptan). The number of patients with adverse events was not significantly different between rizatriptan (34) and frovatriptan (25, p=NS). The results suggest that frovatriptan has a similar efficacy to rizatriptan, but a more prolonged duration of action.

  6. Randomized Trial of Two Dosages of Prophylactic Granulocyte Colony-Stimulating Factor after Induction Chemotherapy in Pediatric Acute Myeloid Leukemia

    Science.gov (United States)

    Inaba, Hiroto; Cao, Xueyuan; Pounds, Stanley; Pui, Ching-Hon; Rubnit, Jeffrey E.; Ribeiro, Raul C.; Razzouk, Bassem I.

    2010-01-01

    Background Granulocyte colony-stimulating factor (G-CSF) is effective in accelerating neutrophil recovery after intensive chemotherapy for acute myeloid leukemia (AML). However, the optimal G-CSF dosage for patients with AML has not been determined. To our knowledge, G-CSF dosages have not been compared in a randomized AML study. Methods Patients enrolled on the St. Jude AML97 protocol who remained on study after window therapy were eligible to participate. The effect of the dosage of G-CSF given after induction chemotherapy courses 1 and 2 was analyzed in 46 patients randomly assigned in a double-blinded manner to receive 5 or 10 μg/kg/day of G-CSF. The number of days of G-CSF treatment, neutropenia (absolute neutrophil count < 0.5 × 109/L), and hospitalization; the number of episodes of febrile neutropenia, grade 2-4 infection, and antimicrobial therapy; transfusion requirements; the cost of supportive care; and survival were compared between the two study arms. Results We found no statistically significant difference between the two arms in any of the endpoints measured. Conclusions The higher G-CSF dosage (10 μg/kg/day) offers no greater benefit than the lower dosage (5 μg/kg/day) in patients undergoing intensive chemotherapy for AML. PMID:21381017

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

    Institute of Scientific and Technical Information of China (English)

    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).

  8. 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

    Directory of Open Access Journals (Sweden)

    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

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

    Institute of Scientific and Technical Information of China (English)

    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.

  10. Superinfection of hepatitis E Virus as a cause of decompen-sation in liver cirrhosis due to hepatitis B virus

    Institute of Scientific and Technical Information of China (English)

    Manisha Jain; Anita Chakravarti; P Kar Mbbs Md

    2009-01-01

    Objevtive:Super infection with hepatitis A virus (HAV)and hepatitis E virus (HEV)in the presence of un-derlying hepatocellular injury can cause severe illness.In endemic areas such as India,however most patients already have been exposed to HAV but could still be susceptible to HEV infection.In our study we determined the seroprevalence of anti-HAV IgMand anti-HEV IgMto assess the incidence of superinfection with these vi-ruses in cirrhotic patients with the goal of defining the need for protection against these viruses and further cor-relate the presence of these viruses with the clinical course.Methods:We studied 53 patients of cirrhosis as a result of Hepatitis B virus.Apparent causes of decompensation were ruled out before their inclusion in the study group.Serum sample from these patients was tested for HBsAg,anti HBc IgG,anti HEV IgMand anti HAV IgG and IgMby commercially available ELISA kit.Liver function test was done on all the patients and correlated with various serological markers.Results:anti HBc IgG was present in all the cases of cirrhosis. Hepatitis B surface antigen was present in 20 out of 53 cases of cirrhosis.None of the patients demonstrated anti-HAV IgM,however one patient had anti-HEV IgM.Conclusion:Superinfection with HAV in adult pa-tient is uncommon in India.Prevalence of acute HEV infection in decompensated cirrhosis is low in the present study but presence of HEV superinfection in one patient corroborates the apprehension of liver function deterio-ration following superinfection with HEV virus.

  11. Effect of goal attainment theory based education program on cardiovascular risks, behavioral modification, and quality of life among patients with first episode of acute myocardial infarction: Randomized study.

    Science.gov (United States)

    Park, Moonkyoung; Song, Rhayun; Jeong, Jin-Ok

    2017-02-24

    Effect of goal-attainment-theory-based education program on cardiovascular risks, behavioral modification, and quality of life among patients with first episode of acute myocardial infarction: randomized study BACKGROUND: The behavioral modification strategies should be explored at the time of admission to lead the maximum effect of cardiovascular risk management.

  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

    Institute of Scientific and Technical Information of China (English)

    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. 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.

    NARCIS (Netherlands)

    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

  14. 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

    NARCIS (Netherlands)

    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

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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. Effect of Acute Noise Exposure on Salivary Cortisol: A Randomized Controlled Trial.

    Science.gov (United States)

    Pouryaghoub, Gholamreza; Mehrdad, Ramin; Valipouri, Alireza

    2016-10-01

    Cardiovascular adverse effects are interesting aspects of occupational noise exposure. One possible mechanism of these effects is an alternation in hypothalamic-pituitary-adrenal axis. Our aim was to measure salivary cortisol response to relatively high-intensity noise exposure in a controlled randomized trial study. We exposed 50 male volunteers to 90 dBA noise for 20 minutes and compared their level of salivary cortisol with 50 non-exposed controls. Salivary samples obtained before and after exposure. Before intervention means (SD) salivary cortisol level were 3.24 (0.47)ng/ml and 3.25 (0.41)ng/ml for exposed and non-exposed groups respectively. Mean salivary cortisol level increased to 4.17 ng/mlafter intervention in exposure group. This increment was statistically significant (P=0.00). Mean salivary cortisol level of the non-exposed group had statistically non-significant decrement after this period (0.2 ng/ml). The difference between salivary cortisol level of non-exposed and exposed groups after the intervention was statistically significant. Noise exposure may affect the hypothalamic-pituitary-adrenal axis activity, and this may be one of the mechanisms of noise exposure cardiovascular effects.

  18. Mechanical instability after acute ankle ligament injury: randomized prospective comparison of two forms of conservative treatment

    Directory of Open Access Journals (Sweden)

    Marcelo Pires Prado

    2013-08-01

    Full Text Available OBJECTIVE: This trial has the objective to investigate the incidence of mechanical ankle instability after the conservative treatment of first episode, severe ankle ligamentar lesions. This common lesion affects young, professional and physical active patients, causing important personal and economic consequences. There are difficulties related to adequate diagnosis and treatment for these lesions. METHOD: 186 patients with severe ankle ligament lesions were included in this trial. They were randomized in two treatment options. In group A patients were treated using ankle long orthoosis, weight bearing allowed as confortable, pain care, ice, elevation with restricted joint mobilization for three weeks. After that they were maintained in short, functional orthosis (air cast, starting the reabilitation program. In group B patients were immobilized using a functional orthosis (air cast, following the same other sequences that patients in group A. RESULTS: We did not find significant differences in relation to the residual mechanical ankle instability between both groups. We did not find differences in the intensity of pain, but the functional evaluation using AOFAS score system showed better results in the functional treatment group. CONCLUSION: The functional treatment (Group B had better AOFAS score and few days off their professional activities, comparing with patients treated with rigid orthosis (Group A, without increased chance in developing ankle mechanical instability.

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

    Directory of Open Access Journals (Sweden)

    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.

  20. Dark chocolate attenuates intracellular pro-inflammatory reactivity to acute psychosocial stress in men: A randomized controlled trial.

    Science.gov (United States)

    Kuebler, Ulrike; Arpagaus, Angela; Meister, Rebecca E; von Känel, Roland; Huber, Susanne; Ehlert, Ulrike; Wirtz, Petra H

    2016-10-01

    Flavanol-rich dark chocolate consumption relates to lower risk of cardiovascular mortality, but underlying mechanisms are elusive. We investigated the effect of acute dark chocolate consumption on inflammatory measures before and after stress. Healthy men, aged 20-50years, were randomly assigned to a single intake of either 50g of flavanol-rich dark chocolate (n=31) or 50g of optically identical flavanol-free placebo-chocolate (n=34). Two hours after chocolate intake, both groups underwent the 15-min Trier Social Stress Test. We measured DNA-binding-activity of the pro-inflammatory transcription factor NF-κB (NF-κB-BA) in peripheral blood mononuclear cells, as well as plasma and whole blood mRNA levels of the pro-inflammatory cytokines IL-1β and IL-6, and the anti-inflammatory cytokine IL-10, prior to chocolate intake as well as before and several times after stress. We also repeatedly measured the flavanol epicatechin and the stress hormones epinephrine and cortisol in plasma and saliva, respectively. Compared to the placebo-chocolate-group, the dark-chocolate-group revealed a marginal increase in IL-10 mRNA prior to stress (p=0.065), and a significantly blunted stress reactivity of NF-κB-BA, IL-1β mRNA, and IL-6 mRNA (p's⩽0.036) with higher epicatechin levels relating to lower pro-inflammatory stress reactivity (p's⩽0.033). Stress hormone changes to stress were controlled. None of the other measures showed a significant chocolate effect (p's⩾0.19). Our findings indicate that acute flavanol-rich dark chocolate exerts anti-inflammatory effects both by increasing mRNA expression of the anti-inflammatory cytokine IL-10 and by attenuating the intracellular pro-inflammatory stress response. This mechanism may add to beneficial effects of dark chocolate on cardiovascular health.

  1. Early application of citicoline in the treatment of acute stroke: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Shi, Pei-yu; Zhou, Xiao-cui; Yin, Xiao-xue; Xu, Liang-liang; Zhang, Xing-ming; Bai, Hong-ying

    2016-04-01

    This study was to evaluate the efficacy and safety of early application of citicoline in the treatment of patients with acute stroke by meta-analysis. Randomized controlled trials published until May 2015 were electronically searched in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, WHO International Clinical Trial Registration Platform, Clinical Trial.gov, and China Biology Medicine disc. Two reviewers independently screened the articles and extracted the data based on the inclusion and exclusion criteria. The quality of included articles was evaluated by using Revman5.0, and meta-analysis was performed. The results showed that 1027 articles were obtained in initial retrieval, and finally 7 articles, involving a total of 4039 cases, were included for analysis. The meta-analysis showed that no significant differences were found in the long-term mortality (OR=0.91, 95% CI 0.07 to 1.09, P=0.30), the rate of dependency (OR=1.02, 95% CI 0.87 to 1.24, P=0.85), and the effective rate (OR=0.98, 95% CI 0.84 to 1.14, P=0.82) between citicoline group and control group. The overall rate of adverse events in citicoline group was not significantly different from that in control group (P=0.30). The quality of included articles reached moderate-low level. In conclusion, citicolne cannot reduce long-term mortality and dependence rate in the treatment of acute stroke, and the effective rate of citivoline may be not better than that of controls but with reliable safety.

  2. The effect of antiemetics and reduced radiation fields on acute gastrointestinal morbidity of adjuvant radiotherapy in Stage I seminoma of the testis: a randomized pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Khoo, V.S.; Rainford, K.; Horwich, A.; Dearnaley, D.P. [Royal Marsden NHS Trust, Sutton (United Kingdom)

    1997-12-31

    The purpose of this pilot study was to evaluate the acute gastrointestinal morbidity of adjuvant radiotherapy (RT) for Stage I seminoma of the testis. Ten Stage I patients receiving para-aortic and ipsilateral pelvic nodal (dog-leg) RT provided a toxicity baseline (group A). Twenty Stage I patients randomized to dog-let RT or para-aortic RT (10 per group) were further randomized to received prophylactic ondansetron or expectant therapy with metoclopramide (group B). Daily patient-completed questionnaires evaluated acute toxicity. Dog-leg RT for Stage I seminomas is associated with readily demonstrable gastrointestinal tract (GIT) toxicity. The number of patients in this study is too small to produce definitive results, but there appears to be reduced GIT toxicity with prophylactic antiemetics. The effect of reduced RT fields has been assessed further in the MRC randomized tiral of field sizes (TE10). (Author).

  3. Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain – a randomized, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Blahova Z

    2016-12-01

    Full Text Available Zuzana Blahova,1 Janina Claudia Holm,1 Thomas Weiser,2 Erika Richter,2 Matthias Trampisch,2 Elena Akarachkova3 1Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria; 2Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany; 3I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation Background/objective: Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC of nonivamide (a capsaicinoid and nicoboxil (a nicotinic acid ester cream in the treatment of acute nonspecific low back pain.Materials and methods: This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon® cream in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score.Results: Patients (n=138, 21–65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0–10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points; p<0.0001. On the last treatment day, mean pain reduction by the FDC was stronger than with placebo (adjusted means: 5.132 vs. 2.174 points; p<0.0001. Mobility on Day 1 was in favor of the FDC when compared to placebo (odds ratio [95% confidence interval {CI}]: 7.200 [3.609, 14.363], p<0.0001. At the end of treatment, patients treated with the FDC rated efficacy significantly higher than placebo (odds ratio [95% CI]: 11.370 [5.342, 24.199], p<0.0001. Both treatments were tolerated well. No serious adverse events were reported.Conclusion: Nicoboxil

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

    Science.gov (United States)

    Magazine, Rahul; Shahul, Hameed Aboobackar; Chogtu, Bharti; Kamath, Asha

    2016-01-01

    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. PMID:27185992

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

    Directory of Open Access Journals (Sweden)

    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.

  6. Acute Effects of Contract-Relax Stretching vs. TENS in Young Subjects With Anterior Knee Pain: A Randomized Controlled Trial.

    Science.gov (United States)

    Valenza, Marie C; Torres-Sánchez, Irene; Cabrera-Martos, Irene; Valenza-Demet, Gerald; Cano-Cappellacci, Marcelo

    2016-08-01

    Valenza, MC, Torres-Sánchez, I, Cabrera-Martos, I, Valenza-Demet, G, and Cano-Cappellacci, M. Acute effects of contract-relax stretching vs. TENS in young subjects with anterior knee pain: A randomized controlled trial. J Strength Cond Res 30(8): 2271-2278, 2016-The aim of this study was to examine the immediate effects on pressure point tenderness, range of motion (ROM), and vertical jump (VJ) of contract-relax stretching vs. transcutaneous electrical nerve stimulation (TENS) therapy in individuals with anterior knee pain (AKP). Eighty-four subjects with AKP were randomly assigned to 1 of 3 different intervention groups: a contract-relax stretching group (n = 28), a TENS intervention group (n = 28), and a control group (n = 28). The participants included in the sample were both sex (37.5% men vs. 62.5% women) at a mean age of 21 years, with mean values of height and weight of 169 cm and 64 kg, respectively. The main outcome measures were knee ROM, pressure pain threshold (PPT), and VJ. The participants were assessed at baseline and immediately after treatment. In the case of VJ, at baseline, immediately after the intervention, at 3 and at 6 minutes posttreatment. The data analysis showed that PPT scores of participants in the stretching and TENS group significantly increased from pretest to posttest (p ≤ 0.05). A significant increase pre- to posttreatment in ROM (p stretching groups showed significant differences between preintervention and all postintervention values (p ≤ 0.05), whereas no significant differences were found in the control group. In conclusion, the results show significant pre-to-post-treatment effects in PPT, ROM, and VJ from both contract-relax stretching and TENS in young subjects with AKP.

  7. Does breastfeeding reduce acute procedural pain in preterm infants in the neonatal intensive care unit? A randomized clinical trial.

    Science.gov (United States)

    Holsti, Liisa; Oberlander, Timothy F; Brant, Rollin

    2011-11-01

    Managing acute procedural pain effectively in preterm infants in the neonatal intensive care unit remains a significant problem. The objectives of this study were to evaluate the efficacy of breastfeeding for reducing pain and to determine if breastfeeding skills were altered after this treatment. Fifty-seven infants born at 30-36 weeks gestational age were randomized to be breastfed (BF) or to be given a soother during blood collection. Changes in the Behavioral Indicators of Infant Pain (BIIP) and in mean heart rate (HR) across 3 phases of blood collection were measured. In the BF group, the Premature Infant Breastfeeding Behaviors (PIBBS) scale was scored before and 24 hours after blood collection. Longitudinal regression analysis was used to compare changes in Lance/squeeze and Recovery phases of blood collection between groups, with gestational age at birth, baseline BIIP scores, and mean HR included as covariates. Differences in PIBBS scores were assessed using a paired t-test. Relationships between PIBBS scores, BIIP scores, and HR were evaluated with Pearson correlations. No differences between treatment groups were found: BIIP (P=0.44, confidence interval [CI] -1.60-0.69); HR (P=0.73, CI -7.0-10.0). Infants in the BF group showed improved PIBBS scores after the treatment (Ppain indices or interfere with the acquisition of breastfeeding skills. Exploratory analyses indicate there may be benefit for infants with mature breastfeeding abilities.

  8. Orange Pomace Improves Postprandial Glycemic Responses: An Acute, Randomized, Placebo-Controlled, Double-Blind, Crossover Trial in Overweight Men

    Directory of Open Access Journals (Sweden)

    C.-Y. Oliver Chen

    2017-02-01

    Full Text Available Orange pomace (OP, a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-controlled, double blind, crossover trial with 34 overweight men who consumed either a 255 g placebo (PLA, a low (35% OP (LOP, or a high (77% (HOP dose OP beverage with breakfast. Blood was collected at 0, 10, 20, 30, and 45 min and at 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 8 h. Lunch was consumed after the 5.5-h blood draw. OP delayed the time (Tmax1 to the maximum concentration (Cmax1 of serum glucose during the 2-h period post breakfast by ≥36% from 33 (PLA to 45 (HOP and 47 (LOP min (p = 0.055 and 0.013, respectively. OP decreased post-breakfast insulin Cmax1 by ≥10% and LOP delayed the Tmax1 by 14 min, compared to PLA at 46 min (p ≤ 0.05. HOP reduced the first 2-h insulin area under concentration time curve (AUC by 23% compared to PLA. Thus, OP diminishes postprandial glycemic responses to a high carbohydrate/fat breakfast and the second meal in overweight men.

  9. 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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  10. Successful pregnancy outcome in decompensated chronic liver disease with portal vein thrombosis: case report and review of literature.

    Science.gov (United States)

    Kumar, Mukesh; Kamani, Lubna; Hussain, Riaz; Siddique, Shoaib

    2011-07-01

    Pregnancy is rare in women with decompensated chronic liver disease. In this case report, we describe a case of a young woman who presented with hepatitis B-related decompensated chronic liver disease with portal vein thrombosis having successful full-term uneventful pregnancy.

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

    Directory of Open Access Journals (Sweden)

    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.

  12. Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2 trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    McAuley Daniel F

    2012-09-01

    Full Text Available Abstract Background Acute lung injury (ALI is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2 trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI. Methods/Design Patients fulfilling the American-European Consensus Conference Definition of ALI will be randomized in a 1:1 ratio to receive enteral simvastatin 80 mg or placebo once daily for a maximum of 28 days. Allocation to randomized groups will be stratified with respect to hospital of recruitment and vasopressor requirement. Data will be recorded by participating ICUs until hospital discharge, and surviving patients will be followed up by post at 3, 6 and 12 months post randomization. The primary outcome is number of ventilator-free days to day 28. Secondary outcomes are: change in oxygenation index and sequential organ failure assessment score up to day 28, number of non pulmonary organ failure free days to day 28, critical care unit mortality; hospital mortality; 28 day post randomization mortality and 12 month post randomization mortality; health related quality of life at discharge, 3, 6 and 12 months post randomization; length of critical care unit and hospital stay; health service use up to 12 months post-randomization; and safety. A total of 540 patients will be recruited from approximately 35 ICUs in the UK and Ireland. An economic evaluation will be conducted alongside the trial. Plasma and urine samples will be taken up to day 28 to investigate potential mechanisms

  13. A phase 2/3 multicenter randomized clinical trial of ABX-CBL versus ATG as secondary therapy for steroid-resistant acute graft-versus-host disease.

    Science.gov (United States)

    Macmillan, Margaret L; Couriel, Daniel; Weisdorf, Daniel J; Schwab, Gisela; Havrilla, Nancy; Fleming, Thomas R; Huang, Saling; Roskos, Lorin; Slavin, Shimon; Shadduck, Richard K; Dipersio, John; Territo, Mary; Pavletic, Steve; Linker, Charles; Heslop, Helen E; Deeg, H Joachim; Blazar, Bruce R

    2007-03-15

    Treatment for steroid-resistant acute graft-versus-host disease (GVHD) has had limited success. ABX-CBL is a hybridoma-generated murine IgM monoclonal antibody against the CD147 antigen, weakly expressed on human leukocytes and up-regulated on activated lymphocytes. A prospective, multicenter, open-label, randomized clinical trial comparing ABX-CBL to antithymocyte globulin (ATG) for treatment of steroid-resistant acute GVHD was conducted in 95 patients at 21 centers. Forty-eight patients received ABX-CBL daily for 14 consecutive days followed by up to 6 weeks of ABX-CBL twice weekly. Forty-seven patients received equine ATG, 30 mg/kg every other day for a total of 6 doses with additional courses as needed. By day 180, overall improvement was similar in the patients receiving ABX-CBL and in those receiving ATG (56% versus 57%, P = .91). Patient survival at 18 months was less favorable on ABX-CBL than on ATG (35% versus 45%), with the 95% confidence interval ruling out that ABX-CBL provides at least a 10.4% improvement. Data from this trial suggest that ABX-CBL does not offer an improvement over ATG in the treatment of acute steroid-resistant GVHD. This prospective, multicenter, randomized clinical trial for steroid-resistant acute GVHD serves as a model for future evaluation of new agents.

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

    Directory of Open Access Journals (Sweden)

    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.

  15. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial.

    Science.gov (United States)

    Boonen, Steven; Van Meirhaeghe, Jan; Bastian, Leonard; Cummings, Steven R; Ranstam, Jonas; Tillman, John B; Eastell, Richard; Talmadge, Karen; Wardlaw, Douglas

    2011-07-01

    Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect -1.49 points, 95% CI -1.88 to -1.10, p kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred (~18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points.

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

    Institute of Scientific and Technical Information of China (English)

    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.

  17. 1H NMR-based serum metabolic profiling in compensated and decompensated cirrhosis

    Institute of Scientific and Technical Information of China (English)

    Su-Wen Qi; Zhi-Guang Tu; Wu-Jian Peng; Lin-Xian Wang; Xin Ou-Yang; An-Ji Cai; Yong Dai

    2012-01-01

    AIM: To study the metabolic profiling of serum samples from compensated and decompensated cirrhosis patients.METHODS: A pilot metabolic profiling study was conducted using three groups: compensated cirrhosis patients (n = 30), decompensated cirrhosis patients (n = 30) and healthy controls (n = 30). A 1H nuclear magnetic resonance (NMR)-based metabonomics approach was used to obtain the serum metabolic profiles of the samples. The acquired data were processed by multivariate principal component analysis and orthogonal partial least-squares discriminant analysis (OPLS-DA). RESULTS: The OPLS-DA model was capable of distinguishing between decompensated and compensated cirrhosis patients, with an R2Y of 0.784 and a Q2Y of 0.598. Twelve metabolites, such as pyruvate, phenylalanine and succinate, were identified as the most influential factors for the difference between the two groups. The validation of the diagnosis prediction showed that the accuracy of the OPLSDA model was 85% (17/20). CONCLUSION: 1H NMR spectra combined with pattern recognition analysis techniques offer a new way to diagnose compensated and decompensated cirrhosis in the future.

  18. Budd-Chiari like syndrome in decompensated alcoholic steatohepatitis and liver cirrhosis

    Institute of Scientific and Technical Information of China (English)

    Carlos Robles-Medranda; Hannah Lukashok; Beatriz Biccas; Vera L Pannain; Homero S Fogaca

    2006-01-01

    A rare case of pseudo-Budd-Chiari Syndrome in a patient with decompensated alcoholic liver disease is reported.Although clinical and radiological findings suggested Budd-Chiari Syndrome, the liver biopsy revealed micronodular cirrhosis and absence of histological signs of hepatic outflow obstruction.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    DEFF Research Database (Denmark)

    Henriksen, J H

    1985-01-01

    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 genesis...

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

    DEFF Research Database (Denmark)

    Henriksen, Jens Henrik Sahl

    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 ...... and perpetuation of ascites should be reconsidered in the light of these findings....

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

    Directory of Open Access Journals (Sweden)

    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

  3. Efficacy and feasibility of radiofrequency ablation for decompensated cirrhotic patients with hepatocellular carcinoma

    Institute of Scientific and Technical Information of China (English)

    WU Jin-yu; YANG Wei; CUI Ming; YIN Shan-shan; GAO Wen; WU Wei; YAN Kun; CHEN Min-hua

    2010-01-01

    Background Most HCC patients with decompensation of liver function lost the chance of surgical and/or interventional treatment. The aim of this study was to evaluate feasibility and outcome of radiofrequency ablation (RFA) in treating hepatocellular carcinoma (HCC) patients with poor liver function (Child-Pugh class C), who are not suitable for surgery or hepatic artery chemo-embolization.Methods Thirteen HCC patients (the number of tumors was 17) with liver function of Child-Pugh C (scores: 10.2±0.4)were included in the study. Among the patients, 8 were male and 5 were female with the average age of (61.6±10.9)years old. The average size of HCC was (3.8±1.0) cm. Two patients were recurrent HCC and 30.8% of the patients had multiple tumors (2-3 tumors). All the patients were treated with RFA.Results There were 22 RFA sessions (1-4 sessions per patient) in all, average ablations per tumor at first session was 3.1. One week after RFA, the liver enzymes elevated in 9 patients (69.2%), in 7 of them, the liver enzyme returned to pre-RFA level in 1-3 months. One month after RFA, the Child-Pugh grading was 10.3±0.8 (Child-Pugh C), while that of pre-RFA was 10.2±0.4 (Child-Pugh C), with no significant difference. Computer tomography (CT) one month after RFA showed that the tumor necrosis rate was 88.2% (15/17). Five patients had 2-4 repeated RFA due to HCC recurrence.During the follow-up of 2-69 months in this group, survival rate of one year was 53.8%, two years was 30.8%, and three year was 15.4%. The incidence of RFA-related complications was 13.6% (3/22 sessions), including 1 case of GI hemorrhage and 1 sub-capsular hemorrhage of the liver. One patient with HCC over 5 cm who had fever and liver abscess after RFA, and was dead 2 months later due to liver function failure.Conclusions Minimal invasive RFA provides possible treatment modality for HCC patients with poor liver function, who are not candidates for surgical and/or interventional therapy. For large HCC

  4. Short-term effect of levosimendan on free light chain kappa and lambda levels in patients with decompensated chronic heart failure.

    Science.gov (United States)

    Kurt, Ibrahim Halil; Yavuzer, Kemal; Batur, Mustafa Kemal

    2010-09-01

    To investigate the effects of levosimendan, a positive inotropic agent, on the new heart failure markers immunoglobulin free light chains kappa and lambda (FLC-kappa and FLC-lambda) in decompensated chronic heart failure (HF), 59 patients with New York Heart Association (NYHA) class III-IV HF were enrolled. Patients were randomized into levosimendan (n = 31) and standard HF treatment (n = 29) groups. Serum FLC-kappa and FLC-lambda, brain natriuretic peptide (BNP), and ejection fraction (EF) were measured before treatment and on the 5th day of treatment initiation. Forty-two percent of subjects were females (n = 25) and overall mean age was 64.1 +/- 10.7 years. FLC-kappa (P lambda (P kappa/FLC-lambda ratios in both groups were similar, whereas FLC-kappa and FLC-lambda levels and the FLC-kappa/FLC-lambda ratio showed no significant correlation with NYHA class, brain natriuretic peptide (BNP) and ejection fraction (EF) levels; and BNP and EF changes after the treatment. Symptomatic improvement in the levosimendan group according to the NYHA class was significantly better than in the standard treatment group (P = 0.044). While 55.2% of patients in the levosimendan group showed a 1-degree shift to lower NYHA classes, 10.3% showed a 2-degree decrease. In conclusion, levosimendan caused short-term hemodynamic and symptomatic improvements, with a more pronounced decrease in FLC levels in patients with advanced decompensated HF.

  5. Acute effects of single and multiple level thoracic manipulations on chronic mechanical neck pain: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Puntumetakul R

    2015-01-01

    Full Text Available Rungthip Puntumetakul,1,2 Thavatchai Suvarnnato,1,3 Phurichaya Werasirirat,1 Sureeporn Uthaikhup,2 Junichiro Yamauchi,4,5 Rose Boucaut6 1School of Physical Therapy, Faculty of Associated Medical Sciences, 2Research Center in Back, Neck, Other Joint Pain and Human Performance, 3Physical Therapy Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 4Graduate School of Human Health Sciences, Tokyo Metropolitan University, 5Future Institute for Sport Sciences, Tokyo, Japan; 6School of Health Sciences (Physiotherapy, University of South Australia, Adelaide, SA, Australia Background: Thoracic spine manipulation has become a popular alternative to local cervical manipulative therapy for mechanical neck pain. This study investigated the acute effects of single-level and multiple-level thoracic manipulations on chronic mechanical neck pain (CMNP.Methods: Forty-eight patients with CMNP were randomly allocated to single-level thoracic manipulation (STM at T6–T7 or multiple-level thoracic manipulation (MTM, or to a control group (prone lying. Cervical range of motion (CROM, visual analog scale (VAS, and the Thai version of the Neck Disability Index (NDI-TH scores were measured at baseline, and at 24-hour and at 1-week follow-up.Results: At 24-hour and 1-week follow-up, neck disability and pain levels were significantly (P<0.05 improved in the STM and MTM groups compared with the control group. CROM in flexion and left lateral flexion were increased significantly (P<0.05 in the STM group when compared with the control group at 1-week follow-up. The CROM in right rotation was increased significantly after MTM compared to the control group (P<0.05 at 24-hour follow-up. There were no statistically significant differences in neck disability, pain level at rest, and CROM between the STM and MTM groups.Conclusion: These results suggest that both single-level and multiple-level thoracic manipulation improve neck disability

  6. Enhanced Medical Rehabilitation increases therapy intensity and engagement and improves functional outcomes in post-acute rehabilitation of older adults: a randomized controlled trial

    Science.gov (United States)

    Lenze, Eric J.; Host, Helen H.; Hildebrand, Mary W.; Morrow-Howell, Nancy; Carpenter, Brian; Freedland, Kenneth E.; Baum, Carolyn A.; Dixon, David; Doré, Peter; Wendleton, Leah; Binder, Ellen F.

    2012-01-01

    Objectives For millions of disabled older adults each year, post-acute care in skilled nursing facilities (SNFs) is a brief window of opportunity to regain enough function to return home and live independently. Too often this goal is not achieved, possibly due to therapy that is inadequately intense or engaging. This study tested Enhanced Medical Rehabilitation, an intervention designed to increase patient engagement in, and intensity of, daily physical and occupational therapy sessions in post-acute care rehabilitation. Design Randomized controlled trial of Enhanced Medical Rehabilitation versus standard-of-care rehabilitation. Setting Post-acute care unit of a skilled nursing facility in St Louis, MO. Participants 26 older adults admitted from a hospital for post-acute rehabilitation. Intervention Based on models of motivation and behavior change, Enhanced Medical Rehabilitation is a set of behavioral skills for physical and occupational therapists (PT/OT) that increase patient engagement and intensity, with the goal of improving functional outcome, through: (1) a patient-directed, interactive approach, (2) increased rehabilitation intensity, and (3) frequent feedback to patients on their effort and progress. Measurements Therapy intensity: assessment of patient active time in therapy sessions. Therapy engagement: Rehabilitation Participation Scale. Functional and performance outcomes: Barthel Index, gait speed, and six-minute walk. Results Participants randomized to Enhanced Medical Rehabilitation had higher intensity therapy and were more engaged in their rehabilitation sessions; they had more improvement in gait speed (improving from 0.08 to 0.38 meter/sec vs. 0.08 to 0.22 in standard of care,p=0.003) and six-minute walk (from 73 to 266 feet vs. 40 to 94 feet in standard of care, p=0.026), with a trend for better improvement of Barthel Index (+43 points vs. 26 points in standard of care, p=0.087), compared to participants randomized to standard

  7. 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

    Directory of Open Access Journals (Sweden)

    Frederick Robert Carrick

    2016-01-01

    Full Text Available 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 qEEG and NIH Stroke Scales (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 stroke.Design:Double blind randomized controlled trial.Setting and Participants:34 subjects with acute MCA ischemic stroke at university affiliated hospital intensive care unit.Interventions:Subjects were randomized into a control group treated only with aspirin (125 mg/day and a treatment group treated with aspirin (125 mg/day and a subject specific EMT. Main Outcome measures: Delta-Alpha Ratio, Power Ratio Index and the Brain Symmetry Index calculated by quantitative electroencephalograms, and NIHSS. Results:There was strong statistical and substantive significant improvement in all outcome measures for the group of stroke patients undergoing EMT. Such improvement was not observed for the control group and there were no adverse effects.Conclusions:The addition of EMT to a MCA ischemic stroke treatment paradigm has demonstrated statistically significant changes in outcome measures and is a low cost, safe and effective complement to standard treatment.

  8. A randomized trial comparing hypofractionated and conventionally fractionated three-dimensional external-beam radiotherapy for localized prostate adenocarcinoma. A report on acute toxicity

    Energy Technology Data Exchange (ETDEWEB)

    Norkus, Darius; Miller, Albert; Kurtinaitis, Juozas; Valuckas, Konstantinas Povilas [Dept. of Radiotherapy, Inst. of Oncology, Vilnius Univ. (Lithuania); Haverkamp, Uwe [Dept. of Radiology, Clemenshospital, Muenster (Germany); Popov, Sergey [Dept. of Radiotherapy, Riga Eastern Hospital, Latvian Oncology Center, Riga (Latvia); Prott, Franz-Josef [Inst. of Radiology and Radiotherapy (RNS), St. Josefs Hospital, Wiesbaden (Germany)

    2009-11-15

    Purpose: to compare acute gastrointestinal (GI) and genitourinary (GU) toxicity between patient groups with localized prostate adenocarcinoma, treated with conventionally fractionated (CFRT) and hypofractionated (HFRT) three-dimensional conformal external-beam radiotherapy (3D-CRT). Patients and methods: 91 patients were enrolled into a randomized study with a minimum follow-up of 3 months. 44 men in the CFRT arm were irradiated with 74 Gy in 37 fractions at 2 Gy per fraction for 7.5 weeks. 47 men in the HFRT arm were treated with 57 Gy in 17 fractions for 3.5 weeks, given as 13 fractions of 3 Gy plus four fractions of 4.5 Gy. The clinical target volume (CTV) included the prostate and the base of seminal vesicles. The CTV-to-PTV (planning target volume) margin was 8-10 mm. Study patients had portal imaging and/or simulation performed on the first fractions and repeated at least weekly. Results: no acute grade 3 or 4 toxicities were observed. The grade 2 GU acute toxicity proportion was significantly lower in the HFRT arm: 19.1% versus 47.7% ({chi}{sup 2}-test, p = 0.003). The grade 2 GU acute toxicity-free survival was significantly better in the HFRT arm (log-rank test, p = 0.008). The median duration of overall GI acute toxicity was shorter with HFRT: 3 compared to 6 weeks with CFRT (median test, p = 0.017). Conclusion: in this first evaluation, the HFRT schedule is feasible and induces acceptable or even lower acute toxicity compared with the toxicities in the CFRT schedule. Extended follow-up is needed to justify this fractionation schedule's safety in the long term. (orig.)

  9. Loop diuretics in acute heart failure: beyond the decongestive relief for the kidney.

    Science.gov (United States)

    Palazzuoli, Alberto; Ruocco, Gaetano; Ronco, Claudio; McCullough, Peter A

    2015-09-03

    Current goals in the acute treatment of heart failure are focused on pulmonary and systemic decongestion with loop diuretics as the cornerstone of therapy. Despite rapid relief of symptoms in patients with acute decompensated heart failure, after intravenous use of loop diuretics, the use of these agents has been consistently associated with adverse events, including hypokalemia, azotemia, hypotension, and increased mortality. Two recent randomized trials have shown that continuous infusions of loop diuretics did not offer benefit but were associated with adverse events, including hyponatremia, prolonged hospital stay, and increased rate of readmissions. This is probably due to the limitations of congestion evaluation as well as to the deleterious effects linked to drug administration, particularly at higher dosage. The impaired renal function often associated with this treatment is not extensively explored and could deserve more specific studies. Several questions remain to be answered about the best diuretic modality administration, global clinical impact during acute and post-discharge period, and the role of renal function deterioration during treatment. Thus, if loop diuretics are a necessary part of the treatment for acute heart failure, then there must be an approach that allows personalization of therapy for optimal benefit and avoidance of adverse events.

  10. Results of a randomized trial in children with Acute Myeloid Leukaemia : Medical Research Council AML12 trial

    NARCIS (Netherlands)

    Gibson, Brenda E. S.; Webb, David K. H.; Howman, Andrew J.; De Graaf, Siebold S. N.; Harrison, Christine J.; Wheatley, Keith

    2011-01-01

    The Medical Research Council Acute Myeloid Leukaemia 12 (MRC AML12) trial (children) addressed the optimal anthracenedione/anthracycline in induction and the optimal number of courses of consolidation chemotherapy. 504 children (

  11. Admitting acute ischemic stroke patients to a stroke care monitoring unit versus a conventional stroke unit : a randomized pilot study

    NARCIS (Netherlands)

    Sulter, Geert; Elting, Jan Willem; Langedijk, Marc; Maurits, Natasha M; De Keyser, Jacques

    2003-01-01

    BACKGROUND AND PURPOSE: Pathophysiological considerations and observational studies indicate that elevated body temperature, hypoxia, hypotension, and cardiac arrhythmias in the acute phase of ischemic stroke may aggravate brain damage and worsen outcome. METHODS: Both units were organized with the

  12. Comprehensive Geriatric Assessment and Transitional Care in Acutely Hospitalized Patients The Transitional Care Bridge Randomized Clinical Trial

    NARCIS (Netherlands)

    Buurman, Bianca M.; Parlevliet, Juliette L.; Allore, Heather G.; Blok, Willem; van Deelen, Bob A. J.; van Charante, Eric P. Moll; de Haan, Rob J.; de Rooij, Sophia E.

    2016-01-01

    IMPORTANCE Older adults acutely hospitalized are at risk of disability. Trials on comprehensive geriatric assessment (CGA) and transitional care present inconsistent results. OBJECTIVE To test whether an intervention of systematic CGA, followed by the transitional care bridge program, improved activ

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

    Directory of Open Access Journals (Sweden)

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

    OpenAIRE

    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...

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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

  17. Clinical Efficacy Comparison of Saccharomyces boulardii and Yogurt Fluid in Acute Non-Bloody Diarrhea in Children: A Randomized, Controlled, Open Label Study

    OpenAIRE

    Makbule EREN; Dinleyici, Ener C; Vandenplas,Yvan

    2010-01-01

    The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 ± 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, a...

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

    DEFF Research Database (Denmark)

    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......-lumefantrine (AL). A comparison group of non-SCD children (HbAA genotype; n = 59) with uncomplicated malaria were also randomized to treatment with AA or AL. Recruited children were followed up and selected investigations were done on days 1, 2, 3, 7, 14, 28, 35, and 42. Selected clinical and laboratory parameters...

  19. 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

    DEFF Research Database (Denmark)

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

    2009-01-01

    8.0 to visual analogue scale 2.0, intragroup difference was significant (P = 0.00). Reduction in pain in the PVP group was immediate 12 to 24 hours after the procedure (P = 0.00). There was no significant difference in the other parameters when comparing the results at inclusion and after 3 months...... patients (41 females) were included from January 2001 until January 2008. Patients with acute (weeks) and subacute (between 2 and 8 weeks) osteoporotic fractures were included and randomized to either PVP or conservative treatment. Pain was assessed with a visual analogue scale and physical and mental...

  20. Comparison of Ertapenem and Ceftriaxone Therapy for Acute Pyelonephritis and Other Complicated Urinary Tract Infections in Korean Adults: A Randomized, Double-Blind, Multicenter Trial

    OpenAIRE

    PARK, DAE WON; Peck, Kyong Ran; Chung, Moon Hyun; Lee, Jin Seo; Park, Yoon Soo; Kim, Hyo Youl; Lee, Mi Suk; Kim, Jung Yeon; Yeom, Joon Sup; Kim, Min Ja

    2012-01-01

    The efficacy and safety of ertapenem, 1 g once daily, were compared with that of ceftriaxone, 2 g once daily, for the treatment of adults with acute pyelonephritis (APN) and complicated urinary tract infections (cUTIs) in a prospective, multicenter, double-blinded, randomized study. After ≥ 3 days of parenteral study therapy, patients could be switched to an oral agent. Of 271 patients who were initially stratified by APN (n = 210) or other cUTIs (n = 61), 66 (48.9%) in the ertapenem group an...

  1. Orthodontic decompensation in skeletal Class III malocclusion: redefining the amount of movement assessed by Cone-Beam Computed Tomography

    Directory of Open Access Journals (Sweden)

    José Antonio Zuega Cappellozza

    2015-10-01

    Full Text Available Introduction:Cone-Beam Computed Tomography (CBCT is essential for tridimensional planning of orthognathic surgery, as it allows visualization and evaluation of bone structures and mineralized tissues. Tomographic slices allow evaluation of tooth inclination and individualization of movement performed during preoperative decompensation. The aim of this paper was to assess maxillary and mandibular incisors inclination pre and post orthodontic decompensation in skeletal Class III malocclusion.Methods:The study was conducted on six individuals with skeletal Class III malocclusion, surgically treated, who had Cone-Beam Computed Tomographic scans obtained before and after orthodontic decompensation. On multiplanar reconstruction view, tomographic slices (axial, coronal and sagittal were obtained on the long axis of each incisor. The sagittal slice was used for measurement taking, whereas the references used to assess tooth inclination were the long axis of maxillary teeth in relation to the palatal plane and the long axis of mandibular teeth in relation to the mandibular plane.Results:There was significant variation in the inclination of incisors before and after orthodontic decompensation. This change was of greater magnitude in the mandibular arch, evidencing that natural compensation is more effective in this arch, thereby requiring more intensive decompensation.Conclusion:When routinely performed, the protocols of decompensation treatment in surgical individuals often result in intensive movements, which should be reevaluated, since the extent of movement predisposes to reduction in bone attachment levels and root length.

  2. Role of TIPS in Improving Survival of Patients with Decompensated Liver Disease

    Directory of Open Access Journals (Sweden)

    Sundeep J. Punamiya

    2011-01-01

    Full Text Available Liver cirrhosis is associated with higher morbidity and reduced survival with appearance of portal hypertension and resultant decompensation. Portal decompression plays a key role in improving survival in these patients. Transjugular intrahepatic portosystemic shunts are known to be efficacious in reducing portal venous pressure and control of complications such as variceal bleeding and ascites. However, they have been associated with significant problems such as poor shunt durability, increased encephalopathy, and unchanged survival when compared with conservative treatment options. The last decade has seen a significant improvement in these complications, with introduction of covered stents, better selection of patients, and clearer understanding of procedural end-points. Use of TIPS early in the period of decompensation also appears promising in further improvement of survival of cirrhotic patients.

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

    Directory of Open Access Journals (Sweden)

    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 

  4. Effectiveness of herbal acupuncture of Carthami semen(Honghwa vs its cotreatment with spiral taping for the treatment of acute low back pain : A randomized controlled trial

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    Jeong, Minsu

    2002-12-01

    Full Text Available Spiral taping shows great effectiveness in relieving musculoskeletal pains. The purpose of this research is to compare effectiveness of herbal acupuncture of Carthami semen(Honghwa vs its cotreatment with spiral taping for the treatment of acute low back pain. The target patients were those who satisfied with all of the following conditions. 1. Those who suffered from acute low back pain but without past history of the pain in the last six weeks. 2. The pain wasn't radiated to the lower limbs and were without any neurotic symptoms. A computerized randomization was used to set the patients in two groups. The control group was consisted of 41 patients and treated with herbal acupuncture. The experimental group was consisted of 49 patients and treated with spiral taping as well as herbal acupuncture. The treatment was given two times a week and the nurses measured the ROM and VAS evaluation before every treatment. The patients wrote ODI by themselves before the first treatment and after the 3rd treatment. After three months, an interview of the patients' condition through a follow up survey was done. In terms of acute low back pain in both the control group and experimental group, significant treatment effects were found by assessing VAS, ROM and ODI. By comparing the control group and the experimental group, there was more significant improvement in the experimental group than the control group of VAS and ROM, but no significant effect was found between the groups of ODI. This study shows that the herbal acupuncture of Carthami Semen plays a significant role in relieving acute low back pain. It also shows that spiral taping of the experimental group was more highly effective. As a result, spiral taping can be used with acupunture of Carthami Semen for a highly effective treatment for acute low back pain.

  5. Impact of physician specialty on quality care for patients hospitalized with decompensated cirrhosis.

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    Nicholas Lim

    Full Text Available Decompensated cirrhosis is a common precipitant for hospitalization, and there is limited information concerning factors that influence the delivery of quality care in cirrhotic inpatients. We sought to determine the relation between physician specialty and inpatient quality care for decompensated cirrhosis.We reviewed 247 hospital admissions for decompensated cirrhosis, managed by hospitalists or intensivists, between 2009 and 2013. The primary outcome was quality care delivery, defined as adherence to all evidence-based specialty society practice guidelines pertaining to each specific complication of cirrhosis. Secondary outcomes included new complications, length-of-stay, and in-hospital death.Overall, 147 admissions (59.5% received quality care. Quality care was given more commonly by intensivists, compared with hospitalists (71.7% vs. 53.1%, P = .006, and specifically for gastrointestinal bleeding (72% vs. 45.8%, P = .03 and hepatic encephalopathy (100% vs. 63%, P = .005. Involvement of gastroenterology consultation was also more common in admissions in which quality care was administered (68.7% vs. 54.0%, P = .023. Timely diagnostic paracentesis was associated with reduced new complications in admissions for refractory ascites (9.5% vs. 46.6%, P = .02, and reduced length-of-stay in admissions for spontaneous bacterial peritonitis (5 days vs. 13 days, P = .02.Adherence to quality indicators for decompensated cirrhosis is suboptimal among hospitalized patients. Although quality care adherence appears to be higher among cirrhotic patients managed by intensivists than by hospitalists, opportunities for improvement exist in both groups. Rational and cost-effective strategies should be sought to achieve this end.

  6. Endothelial keratoplasty for corneal decompensation leaded by a dexamethasone implant dislocation in anterior chamber

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    Fernanda Pacella

    2016-06-01

    Full Text Available Background: Dexamethasone intravitreal implant (DEX largely showed his safety and efficacy for the treatment of cases of macular edema. Even if uncommon, delivery dislocation in anterior chamber has been described in Literaure as complication of the injection procedure, leading to irreversible endothelial cell loss in the majority of cases. We report a case of a 66-year-old man with pain and vision loss in his left eye. The anamnesis revealed a recent intravitreal injection of DEX implant for a persistent cystoid macular edema related to central retinal vein occlusion. Anterior segment examination showed corneal edema and the rod implant adherent to corneal endothelium. A large peripheral iridectomy was evident with retroillumination and IOL appeared good centered in the bag. The implant was removed but corneal decompensation was irreversible. One month later, an endothelial keratoplasty was successfully performed restoring corneal transparency. DEX intravitreal implant can migrate from vitreous cavity to anterior chamber and lead to irreversible corneal decompensation by mechanical and chemical toxicity on corneal endothelium. Removeal of the implant is necessary to avoid total endothelial decompensation. Despite this, in some cases endothelial keratoplasty had to be performed.

  7. Direct antiviral agent treatment of decompensated hepatitis C virus-induced liver cirrhosis

    Institute of Scientific and Technical Information of China (English)

    Shogo; Ohkoshi; Haruka; Hirono; Satoshi; Yamagiwa

    2015-01-01

    Recently, direct antiviral agents(DAAs) have been increasingly used for the treatment of chronic hepatitis C virus(HCV) infections, replacing interferon-based regimens that have severe adverse effects and low tolerability. The constant supply of new DAAs makes shorter treatment periods with enhanced safety possible. The efficacy of DAAs for treatment of compensated liver cirrhosis(LC) is not less than that for treatment of non-cirrhotic conditions. These clinical advantages have been useful in pre- and post-liver transplantation(LT) settings. Moreover, DAAs can be used to treat decompensated HCV-induced LC in elderly patients or those with severe complications otherwise having poor prognosis. Although encouraging clinical data are beginning to appear, the actual efficacy of DAAs for suppressing disease progression, allowing delisting for LT and, most importantly, improving prognosis of patients with decompensated HCV-LC remains unknown. Casecontrol studies to examine the short- or long-term effects of DAAs for treatment of decompensated HCV-LC are urgently need.

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

    NARCIS (Netherlands)

    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

  9. A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with acute ischaemic stroke in Asia--CASTA.

    Science.gov (United States)

    Hong, Z; Moessler, H; Bornstein, N; Brainin, M; Heiss, W-D

    2009-10-01

    Cerebrolysin has exhibited neuroprotective as well as neurotrophic properties in various animal models of cerebral ischaemia and has shown clinical efficacy and good safety in several small controlled clinical studies in ischaemic stroke. Therefore, a large double-blind placebo-controlled randomized clinical trial was launched in Asia to prove the validity of this treatment strategy. In the more than 50 participating centres patients with acute ischemic hemispheric stroke are randomized within 12 hours of symptoms onset to treatment (30 ml Cerebrolysin diluted in physiologic saline) or placebo (saline) given as intravenous infusion once daily added to standard care for 10 days. The patients are followed with regular visits for 90 days. Efficacy is evaluated on day 90 by three outcome scales - modified Rankin Scale, Barthel Index and NIH Stroke Scale - combined to single global directional test. Additionally, adverse events are documented to prove safety. In this study a total of 1060 patients will be included and analysis of data will be completed in 2010. If positive, this trial will add an effective strategy to the treatment of acute ischaemic stroke.

  10. Intravenous dipyrone for the acute treatment of episodic tension-type headache: A randomized, placebo-controlled, double-blind study

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    M.E. Bigal

    2002-10-01

    Full Text Available Acute headaches are responsible for a significant percentage of the case load at primary care units and emergency rooms in Brazil. Dipyrone (metamizol is easily available in these settings, being the most frequently used drug. We conducted a randomized, placebo-controlled, double-blind study to assess the effect of dipyrone in the acute treatment of episodic tension-type headache. Sixty patients were randomized to receive placebo (intravenous injection of 10 ml saline or 1 g dipyrone in 10 ml saline. We used seven parameters of analgesic evaluation. The patients receiving dipyrone showed a statistically significant improvement (P<0.05 of pain compared to placebo up to 30 min after drug administration. The therapeutic gain was 30% in 30 min and 40% in 60 min. The number of patients needed to be treated for at least one to have benefit was 3.3 in 30 min and 2.2 in 60 min. There were statistically significant reductions in the recurrence (dipyrone = 25%, placebo = 50% and use of rescue medication (dipyrone = 20%, placebo = 47.6% for the dipyrone group. Intravenous dipyrone is an effective drug for the relief of pain in tension-type headache and its use is justified in the emergency room setting.

  11. 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

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    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

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

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    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

  13. A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia.

    Science.gov (United States)

    Kane, John M; Skuban, Aleksandar; Ouyang, John; Hobart, Mary; Pfister, Stephanie; McQuade, Robert D; Nyilas, Margaretta; Carson, William H; Sanchez, Raymond; Eriksson, Hans

    2015-05-01

    The objective of this study was to evaluate the efficacy, safety and tolerability of brexpiprazole versus placebo in adults with acute schizophrenia. This was a 6-week, multicenter, placebo-controlled double-blind phase 3 study. Patients with acute schizophrenia were randomized to brexpiprazole 1, 2 or 4 mg, or placebo (2:3:3:3) once daily. The primary endpoint was changed from baseline at week 6 in Positive and Negative Syndrome Scale (PANSS) total score; the key secondary endpoint was Clinical Global Impressions-Severity (CGI-S) at week 6. Brexpiprazole 4 mg showed statistically significant improvement versus placebo (treatment difference: -6.47, p=0.0022) for the primary endpoint. Improvement compared with placebo was also seen for the key secondary endpoint (treatment difference: -0.38, p=0.0015), and on multiple secondary efficacy outcomes. Brexpiprazole 1 and 2mg also showed numerical improvements versus placebo, although p>0.05. The most common treatment-emergent adverse events were headache, insomnia and agitation; incidences of akathisia were lower in the brexpiprazole treatment groups (4.2%-6.5%) versus placebo (7.1%). Brexpiprazole treatment was associated with moderate weight gain at week 6 (1.23-1.89 kg versus 0.35 kg for placebo); there were no clinically relevant changes in laboratory parameters and vital signs. In conclusion, brexpiprazole 4 mg is an efficacious and well-tolerated treatment for acute schizophrenia in adults. Clinical Trials.gov NCT01393613; BEACON trial.

  14. Effect of nebulized budesonide on respiratory mechanics and oxygenation in acute lung injury/acute respiratory distress syndrome: Randomized controlled study

    Science.gov (United States)

    Mohamed, Hatem Saber; Meguid, Mona Mohamed Abdel

    2017-01-01

    Background: We tested the hypothesis that nebulized budesonide would improve lung mechanics and oxygenation in patients with early acute lung injury (ALI) and/or acute respiratory distress syndrome (ARDS) during protective mechanical ventilation strategy without adversely affecting systemic hemodynamics. Methods: Patients with ALI/ARDS were included and assigned into two groups; budesonide group (30 cases) in whom 1 mg–2 ml budesonide suspension was nebulized through the endotracheal tube and control group (30 cases) in whom 2 ml saline (placebo) were nebulized instead of budesonide. This regimen was repeated every 12 h for three successive days alongside with constant ventilator settings in both groups. Hemodynamics, airway pressures, and PaO2/FiO2 were measured throughout the study period (72 h) with either nebulized budesonide or saline. Furthermore, tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6) were analyzed serologically as markers of inflammation at pre- and post-nebulization sessions. Results: We found a significant difference between the two groups regarding PaO2/FiO2 (P = 0.023), peak (P = 0.021), and plateau (P = 0.032) airway pressures. Furthermore, TNF-α, IL-1β, and IL-6 were significantly reduced after budesonide nebulizations. No significant difference was found between the two groups regarding hemodynamic variables. Conclusion: Nebulized budesonide improved oxygenation, peak, and plateau airway pressures and significantly reduced inflammatory markers (TNF-α, IL-1β and IL-6) without affecting hemodynamics. Trial Registry: Australian New Zealand Clinical Trial Registry (ANZCTR) at the number: ACTRN12615000373572. PMID:28217046

  15. A randomized, comparative study of dual therapy (doxycycline–rifampin versus triple therapy (doxycycline–rifampin–levofloxacin for treating acute/subacute brucellosis

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    Ahmad Hasanain

    Full Text Available Abstract Aim The aim of this study was to compare both the efficacy and safety profile of the WHO-recommended, dual therapy (doxycycline–rifampin to a quinolone-based, triple therapy (doxycycline–rifampin–levofloxacin for treating acute/subacute brucellosis. Patients and methods We studied 107 consecutive, naïve patients with acute/subacute brucellosis admitted to Assiut University Hospital. Patients were randomly allocated to receive the dual therapy of doxycycline–rifampin (group-A or to receive the triple therapy of doxycycline–rifampin–levofloxacin (group-B. Acute/subacute brucellosis was diagnosed based on the presence of: (1 contact with animals or fresh animal products, (2 suggestive clinical manifestations of less than one-year duration, and (3 positive antibody titer (1:160 by standard tube agglutination test. Results There was no significant difference between the two groups regarding their demographic data. Fever was the most frequent manifestation (96.3%. Epigastric pain was the most frequent adverse effect of treatment (12.1%. Group-A patients had a significantly higher relapse rate compared to group-B patients (22.6% versus 9.3%, p-value = 0.01. The rate of treatment adverse effects was higher among group-B patients, although not reaching statistical significance (20.4% versus 11.3%, p-value = 0.059. Conclusions Adding levofloxacin to the dual therapy for acute/subacute brucellosis (doxycycline–rifampin may increase its efficacy in terms of lowering the relapse rate of the disease. Further, larger scale studies are needed before considering modifying the standard, dual therapy for brucellosis.

  16. A single-blind, randomized comparison of olanzapine at a starting dose of 5 mg versus 20 mg in acute schizophrenia.

    Science.gov (United States)

    Mauri, Massimo Carlo; Colasanti, Alessandro; Rossattini, Matteo; Moliterno, Donatella; Baldi, Marialuisa L; Papa, Pietro

    2006-01-01

    Acute psychotic episodes represent critical situations during the course of schizophrenia. Olanzapine (OLZ), a second-generation antipsychotic, is efficacious in acute settings at dosages of 5 to 20 mg/d, and it can be considered a first-line treatment for patients with an acute episode of schizophrenia. The aim of this study was to evaluate the efficacy and tolerability of OLZ at a starting dose of 5 mg versus 20 mg in acute schizophrenic patients and to compare titration versus nontitration.Fifty-one schizophrenic inpatients were randomly assigned to receive OLZ at 5 mg/d (26 patients, group 1) or 20 mg/d (25 patients, group 2) as a starting dosage during an exacerbation phase. In group 1, the OLZ dosage was increased to a mean dosage of 10.55 (+/- 4.00) mg/d. Group 2 received OLZ at a fixed dose of 20 mg throughout the hospitalization period. Olanzapine was significantly and clinically effective on Brief Psychiatric Rating Scale (BPRS), Positive and Negative Syndrome Scale, PANSS positive symptoms, and Hamilton Rating Scale for Depression in both groups. There were no significant differences between groups 1 and 2 in the percent improvement in BPRS, Positive and Negative Syndrome Scale, PANSS positive symptoms, PANSS negative symptoms, or Hamilton Rating Scale for Depression; but group 2 was significantly superior in the mean percent improvement in the BPRS items of anxiety (P < 0.001) and suspiciousness (P < 0.05). In conclusion, the higher doses evidence more efficacy on anxiety and suspiciousness, so it seems to be useful to begin therapy with a full dose of the drug to obtain the maximum effect without any significant side effects.

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

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    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

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

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    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.

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

    Science.gov (United States)

    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.

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

    Institute of Scientific and Technical Information of China (English)

    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.

  1. Hiperpotassemia na vigência de espironolactona em pacientes com insuficiência cardíaca descompensada Hyperkalemia during spironolactone use in patients with decompensated heart failure

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    Marcelo Villaça Lima

    2008-09-01

    Full Text Available FUNDAMENTO: A incidência de hiperpotassemia relacionada à espironolactona é baixa na insuficiência cardíaca estável, entretanto não foi estudada durante a descompensação. OBJETIVO: Avaliar a influência da espironolactona na insuficiência cardíaca descompensada sobre o potássio sérico. MÉTODOS: Em um estudo de coorte, selecionamos pacientes hospitalizados por descompensação da insuficiência cardíaca, FEVE 6,0 mEq/l e uso de poliestireno de cálcio. Realizou-se a análise multivariada pela regressão logística, e p 60,5 mg/dl, durante a internação, apresenta risco relativo de 9,6 (IC 95% 8,03 - 11,20; p = 0,005 para a ocorrência de hiperpotassemia. CONCLUSÃO: A incidência de hiperpotassemia foi duas vezes maior com espironolactona, mas não estatisticamente significante. Elevação da uréia foi associada à hiperpotassemia. Estudos randomizados são necessários para esclarecer o assunto.BACKGROUND: The incidence of hyperkalemia related to spironolactone use is low in stable heart failure; however, it has not been studied during decompensation. OBJECTIVE: To evaluate the influence of spironolactone on serum potassium in decompensated heart failure (HF. METHODS: In a cohort study, patients that had been hospitalized due to decompensated HF, with left ventricular ejection fraction (LVEF 6.0 mEq/l and the use of calcium polystyrene. A multivariate analysis through logistic regression was carried out and values of p 60.5 mg/dl during the hospitalization presents a relative risk of 9.6 (95%CI 8.03 - 11.20; p = 0.005 for the occurrence of hyperkalemia. CONCLUSION: The incidence of hyperkalemia was two-fold higher with spironolactone use, but it was not statistically significant. The increase in urea levels was associated to the hyperkalemia. Randomized studies are necessary to clarify this issue.

  2. Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial

    Science.gov (United States)

    Sanchez Rodriguez, Yoan; Torres Gonzalez, Ana; Calzadilla Bertot, Luis; Arus Soler, Enrique; Martinez Perez, Yadina; Yasells Garcia, Ali; Abreu Vazquez, Maria del Rosario

    2011-01-01

    Objectives Viusid is a nutritional supplement with recognised antioxidant and immunomodulatory properties which could have beneficial effects on cirrhosis-related clinical outcomes such as survival, disease progression and development of hepatocellular carcinoma (HCC). This study evaluated the efficacy and safety of viusid in patients with HCV-related decompensated cirrhosis. Design A randomised double-blind and placebo-controlled study was conducted in a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). The authors randomly assigned 100 patients with HCV-related decompensated cirrhosis to receive viusid (three oral sachets daily, n=50) or placebo (n=50) during 96 weeks. The primary outcome of the study was overall survival at 96 weeks, and the secondary outcomes included time to disease progression, time to HCC diagnosis, time to worsening of the prognostic scoring systems Child–Pugh and Model for End-Stage Liver Disease, and time to a new occurrence or relapse for each one of the main clinical complications secondary to portal hypertension at 96 weeks. Results Viusid led to a significant improvement in overall survival (90%) versus placebo (74%) (HR 0.27, 95% CI 0.08 to 0.92; p=0.036). A similar improvement in disease progression was seen in viusid-treated patients (28%), compared with placebo-treated patients (48%) (HR 0.47, 95% CI 0.22 to 0.89; p=0.044). However, the beneficial effects of viusid were wholly observed among patients with Child–Pugh classes B or C, but not among patients with Child–Pugh class A. The cumulative incidence of HCC was significantly reduced in patients treated with viusid (2%) as compared with placebo (12%) (HR 0.15, 95% CI 0.019 to 0.90; p=0.046). Viusid was well tolerated. Conclusions The results indicate that treatment with viusid leads to a notable improvement in overall clinical outcomes such as survival, disease progression and development of HCC in patients with HCV

  3. 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

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    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.

  4. A prospective phase II randomized study of deferasirox to prevent iatrogenic iron overload in patients undertaking induction/consolidation chemotherapy for acute myeloid leukaemia.

    Science.gov (United States)

    Kennedy, Glen A; Morris, Kirk L; Subramonpillai, Elango; Curley, Cameron; Butler, Jason; Durrant, Simon

    2013-06-01

    This prospective randomized phase II study aimed to determine the safety and efficacy of deferasirox in preventing iatrogenic iron overload in patients receiving induction/consolidation chemotherapy for acute myeloid leukaemia (AML) ize. Serum ferritin, transferrin saturation and CRP were measured pre-, mid- and post- each chemotherapy cycle. Patients were randomized to receive either therapy with deferasirox vs. no deferasirox therapy once serum ferritin increased to >500 μg/l. The trial was stopped prematurely due to excess gastrointestinal (GI) and infectious toxicity demonstrable in the deferasirox arm, after 10 patients had been randomized to deferasirox and 6 patients to the control arm. Overall, deferasirox was poorly tolerated, with median maximum tolerated dose only 13·8 mg/kg/d and no patient able to tolerate doses >20 mg/kg/d. Median duration of deferasirox therapy was only 72 d (range 19-130 d), with 9/10 patients requiring unplanned dose interruptions and 4/10 patients unable to continue the drug predominantly due to GI effects. Although all 3 treatment-related deaths occurred in the deferasirox arm (P = 0·25), median overall survival was similar between treatment arms. Use of deferasirox to prevent iatrogenic iron overload in AML patients undertaking induction/consolidation is poorly tolerated and appears to be associated with excess GI and infectious toxicity.

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

    Science.gov (United States)

    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.

  6. Double-blind, randomized, double-dummy clinical trial comparing the efficacy of ketorolac trometamol and naproxen for acute low back pain

    Directory of Open Access Journals (Sweden)

    Plapler PG

    2016-06-01

    Full Text Available Pérola Grinberg Plapler,1 Morton Aaron Scheinberg,2 Christina da Cunha Ecclissato,3 Monalisa Fernanda Bocchi de Oliveira,3 Roberto Bleuel Amazonas31Orthopedic and Traumatology Institute of Clinical Hospital, University of São Paulo, 2Clinical Research Center Hospital AACD, São Paulo, 3NC Group Medical Affairs, Hortolândia, São Paulo, Brazil Background: Nonsteroidal anti-inflammatory drugs (NSAIDs are the most common type of medication used in the treatment of acute pain. Ketorolac trometamol (KT is a nonnarcotic, peripherally acting nonsteroidal anti-inflammatory drug with analgesic effects comparable to certain opioids.Objective: The aim of this study was to compare the efficacy of KT and naproxen (NA in the treatment of acute low back pain (LBP of moderate-to-severe intensity.Patients and methods: In this 10-day, Phase III, randomized, double-blind, double-dummy, noninferiority trial, participants with acute LBP of moderate-to-severe intensity as determined through a visual analog scale (VAS were randomly assigned in a 1:1 ratio to receive sublingual KT 10 mg three times daily or oral NA 250 mg three times daily. From the second to the fifth day of treatment, if patient had VAS >40 mm, increased dosage to four times per day was allowed. The primary end point was the reduction in LBP as measured by VAS. We also performed a post hoc superiority analysis.Results: KT was not inferior to NA for the reduction in LBP over 5 days of use as measured by VAS scores (P=0.608 for equality of variance; P=0.321 for equality of means and by the Roland–Morris Disability Questionnaire (P=0.180 for equality of variance test; P=0.446 for equality of means using 95% confidence intervals. The percentage of participants with improved pain relief 60 minutes after receiving the first dose was higher in the KT group (24.2% than in the NA group (6.5%; P=0.049. The most common adverse effects were heartburn, nausea, and vomiting.Conclusion: KT is not inferior

  7. CATCH: A randomized trial comparing tinzaparin versus warfarin for treatment of acute venous thromboembolism (VTE) in cancer patients

    NARCIS (Netherlands)

    Lee, Agnes Y.; Bauersachs, Rupert; Janas, Mette S.; Jarner, Mikala F.; Kamphuisen, Pieter W.; Meyer, Guy; Paz-Ares, Luis; Khorana, Alok A.

    2012-01-01

    Background: VTE is a major cause of morbidity and mortality in cancer patients. LMWHs have been shown to be superior to warfarin in one randomized study, but adequately powered confirmatory studies have not been conducted and warfarin continues to be widely used for treatment of cancer-associated VT

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

    Directory of Open Access Journals (Sweden)

    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.

  9. Dexamethasone compared to prednisolone for adults with acute lymphoblastic leukemia or lymphoblastic lymphoma: final results of the ALL-4 randomized, phase III trial of the EORTC Leukemia Group

    Science.gov (United States)

    Labar, Boris; Suciu, Stefan; Willemze, Roel; Muus, Petra; Marie, Jean-Pierre; Fillet, Georges; Berneman, Zwi; Jaksic, Branimir; Feremans, Walter; Bron, Dominique; Sinnige, Harm; Mistrik, Martin; Vreugdenhil, Gerard; De Bock, Robrecht; Nemet, Damir; Gilotay, Caroline; Amadori, Sergio; de Witte, Theo

    2010-01-01

    Background Corticosteroids are a standard component of the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma. Our aim was to determine whether dexamethasone results in a better outcome than prednisolone. Design and Methods Adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma were randomized to receive, as part of their induction therapy on days 1–8 and 15–22, either dexamethasone 8 mg/m2 or prednisolone 60 mg/m2. Those who reached complete remission were given two courses of consolidation therapy with high-dose cytarabine and mitoxantrone and methotrexate and asparaginase. Subsequently patients younger than 50 years, with a suitable donor, were to undergo allogeneic stem cell transplantation, whereas the others were planned to receive either an autologous stem cell transplant or high-dose maintenance chemotherapy with prophylactic central nervous system irradiation. Randomization was done with a minimization technique. The primary endpoint was event-free survival and the analyses was conducted on an intention-to-treat basis. Results Between August 1995 and October 2003, 325 patients between 15 to 72 years of age were randomized to receive either dexamethasone (163 patients) or prednisolone (162 patients). After induction and the course of first consolidation therapy, 131 (80.4%) patients in the dexamethasone group and 124 (76.5%) in the prednisolone group achieved complete remission. No significant difference was observed between the two treatment groups with regards to 6-year event-free survival rates (±SE) which were 25.9% (3.6%) and 28.7% (3.5%) in the dexamethasone and prednisolone groups, respectively (P=0.82, hazard ratio 0.97; 95% confidence interval, 0.75–1.25). Disease-free survival after complete remission was also similar in the dexamethasone and prednisolone groups, the 6-year rates being 32.3% and 37.5%, respectively (hazard ratio 1.03; 95% confidence interval 0.76–1.40). The 6-year cumulative

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

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    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.

  11. Simeprevir, daclatasvir and sofosbuvir for hepatitis C virus-infected patients with decompensated liver disease.

    Science.gov (United States)

    Lawitz, E; Poordad, F; Gutierrez, J A; Kakuda, T N; Picchio, G; Beets, G; Vandevoorde, A; Van Remoortere, P; Jacquemyn, B; Luo, D; Ouwerkerk-Mahadevan, S; Vijgen, L; Van Eygen, V; Beumont, M

    2016-11-23

    Approximately three million individuals in the United States are chronically infected with hepatitis C virus (HCV). Chronic HCV infection may lead to the development of compensated as well as decompensated liver cirrhosis. The Phase II IMPACT study was conducted in HCV genotype 1- or 4-infected cirrhotic patients with portal hypertension or decompensated liver disease and assessed for the first time the combination of the three direct-acting antivirals simeprevir, daclatasvir and sofosbuvir. Treatment-naïve or treatment-experienced adults with Child-Pugh (CP) score simeprevir 150 mg, daclatasvir 60 mg and sofosbuvir 400 mg, once daily. The primary efficacy endpoint was sustained virologic response 12 weeks after end of treatment (SVR12). Pharmacokinetics and safety were also assessed. Overall, 40 patients were enrolled (CP A: 19; CP B: 21). All 40 patients achieved SVR12. At week 8, the mean pharmacokinetic exposure to simeprevir, sofosbuvir, daclatasvir and GS-331007 (sofosbuvir metabolite) was 2.2-, 1.5-, 1.2- and 1.2-fold higher in patients with CP B than CP A, respectively. Grade 1/2 adverse events (AEs) occurred in 26 of 40 (65%) patients. One CP B patient had a Grade 3 AE (gastrointestinal haemorrhage), which was reported as a serious AE but not considered related to study drugs. Treatment for 12 weeks with simeprevir, daclatasvir and sofosbuvir was generally safe and well tolerated, and resulted in 100% of cirrhotic patients with portal hypertension or decompensated liver disease achieving SVR12.

  12. The effect of protein intake and resistance training on muscle mass in acutely ill old medical patients - A randomized controlled trial

    DEFF Research Database (Denmark)

    Buhl, Sussi F; Andersen, Aino L; Andersen, Jens Rikardt

    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...... standard care. Secondary outcomes were changes in muscle strength, functional ability and body weight. METHODS: 29 acutely admitted old (>65 years) patients were randomly assigned to the intervention (n = 14) or to standard care (n = 15). The Intervention Group received 1.7 g protein/kg/day during...... admission and a daily protein supplement (18.8 g protein) and resistance training 3 times per week the 12 weeks following discharge. Muscle mass was assessed by Dual-energy X-ray Absorptiometry. Muscle strength was assessed by Hand Grip Strength and Chair Stand Test. Functional ability was assessed...

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    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...

  14. 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.

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    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

  15. FACTORS EFFECTING THE DECOMPENSATION OF CHRONIC HEART FAILURE IN THE ELDERLY

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    V. N. Larina

    2013-01-01

    Full Text Available Aim. To identify risk factors of decompensation of chronic heart failure (CHF and related hospitalization in elderly outpatients.Material and methods. The total of 248 patients aged 60–85 years with CHF NYHA class II-IV were enrolled into the study. The first group consisted of 87 (35.1% patients who required hospitalization due to CHF decompensation during the follow-up, the second group of 161 patients without need for hospital admission. All the patients had undergone clinical and laboratory examination, estimation of CHF severity by the Scale of clinical state, assessment of quality of life and 6-minute walk test (6MWT, echocardiography.Results. Patients were matched for age, gender, disability occurrence, education level, body mass index, quality of life, hemodynamic parameters, incidence rates of anemia, diabetes mellitus and atrial fibrillation. CHF was more severe in patients who had required hospitalization (p<0.001, they were more often diagnosed with left ventricular aneurysm (p=0.001, chronic kidney disease (p=0.001, left ventricular ejection fraction (LVEF<35% (p<0.001, history of stroke (p<0.001, III-IV degree mitral regurgitation (p=0.007, hyperuricemia (p<0.001, lower exercise tolerance (p=0.007 compared with patients without hospitalization. Higher functional class of CHF (OR=0.29; 95% CI 0.13–0.69; p=0.003, LVEF<35% (OR 0.37; 95% CI 0.18–0.76; p=0.007, chronic kidney disease (OR=0.29; 95% CI 0.13–0.68; p=0.004 and hyperuricemia (OR=0.23; 95%CI 0.10–0.50; p<0.001 were shown to be independent risk factors of CHF decompensation that required hospital admission in elderly patients.Conclusuion. High FC of CHF, low LVEF, hyperuricemia and renal dysfunction play a key role in CHF decompensation and related hospitalization in elderly patients.

  16. Peripartum cardiomyopathy: postpartum decompensation and use of non-invasive cardiac output monitoring.

    Science.gov (United States)

    Lorello, G; Cubillos, J; McDonald, M; Balki, M

    2014-02-01

    The utility of a non-invasive cardiac output monitor (NICOM™) in guiding the peripartum management and identification of postpartum complications in a patient with severe peripartum cardiomyopathy is reported. A 31-year-old nulliparous woman at 35 weeks of gestation presented with a three-week history of worsening dyspnea and progressive functional deterioration. A transthoracic echocardiogram showed severe left ventricular systolic dysfunction with an ejection fraction peripartum cardiomyopathy. We suggest that use of NICOM™ be extended into the postpartum period to detect signs of cardiac decompensation in such patients.

  17. [Diuretic resistance and mechanical ventilation in decompensated cor pulmonale: successful treatment by slow continuous ultrafiltration].

    Science.gov (United States)

    Ries, W; Schenzer, A; Lüken, J; Ries, C; Machraoui, A

    2012-08-01

    We report on a 53-year-old male patient who presented with severe dyspnea at rest and massive volume overload because of decompensated cor pulmonale. Furthermore he suffered from stage 3 chronic kidney disease. As there was diuretics resistance and carbon dioxide narcosis, he had to be intubated and ventilated. The massive volume overload could be successfully treated with slow continuous ultrafiltration (SCUF) with removal of a volume of 27.5 l within 3 days. The SCUF therapy is an effective and gentle method to treat even an excessive volume overload based on diuretics resistance.

  18. 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

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    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

  19. Effects on muscle performance of NSAID treatment with Piroxicam versus placebo in geriatric patients with acute infection-induced inflammation. a double blind randomized controlled trial

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    Beyer Ingo

    2011-12-01

    Full Text Available Abstract Background Inflammation is the main cause of disease-associated muscle wasting. In a previous single blind study we have demonstrated improved recovery of muscle endurance following celecoxib treatment in hospitalized geriatric patients with acute infection. Here we further evaluate NSAID treatment with piroxicam in a double blind RCT and investigate the role of cytokines and heat shock proteins (Hsp with respect to muscle performance. We hypothesized that NSAID treatment would preserve muscle performance better than antibiotic treatment alone, by reducing infection-associated inflammation and by increasing expression of cytoprotective Hsp. Methods Consecutive admissions to the geriatric ward were screened. 30 Caucasian patients, median age 84.5 years, with acute infection-induced inflammation and serum levels of CRP > 10 mg/L were included and randomized to active treatment with 10 mg piroxicam daily or placebo. Assessment comprised general clinical and biochemical parameters, 25 cytokines in serum, intra-and extracellular Hsp27 and Hsp70, Elderly Mobility Scale (EMS scores, grip strength (GS, fatigue resistance (FR and lean body mass (LBM. Patients were evaluated until discharge with a maximum of 3 weeks after treatment allocation. Results EMS scores, FR and grip work (GW, a measure taking into account GS and FR, significantly improved with piroxicam, but not with placebo. Early decreases in IL-6 serum levels with piroxicam correlated with better muscle performance at week 2. Basal expression of Hsp27 in monocytes without heat challenge (WHC was positively correlated with FR at baseline and significantly increased by treatment with piroxicam compared to placebo. Profound modifications in the relationships between cytokines or Hsp and changes in muscle parameters were observed in the piroxicam group. Conclusions Piroxicam improves clinically relevant measures of muscle performance and mobility in geriatric patients hospitalized with

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

    Directory of Open Access Journals (Sweden)

    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.

  1. A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen®) in the Clinical Management of Acute Viral Diarrhea in Children

    Science.gov (United States)

    García-Menor, Emilia; García-Marín, Fátima; Vecino-López, Raquel; Horcajo-Martínez, Gloria; de Ibarrondo Guerrica-Echevarría, María-José; Gómez-González, Pedro; Velasco-Ortega, Syra; Suárez-Almarza, Javier; Nieto-Magro, Concepción

    2016-01-01

    This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p diarrhea (median and interquartile range) was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377). The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children. PMID:28229091

  2. Clinical efficacy comparison of Saccharomyces boulardii and yogurt fluid in acute non-bloody diarrhea in children: a randomized, controlled, open label study.

    Science.gov (United States)

    Eren, Makbule; Dinleyici, Ener C; Vandenplas, Yvan

    2010-03-01

    The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 +/- 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, although these differences were not significant. However, diarrhea had resolved in significantly more children on day 3 in the S. boulardii group (48.5% versus 25.5%; P yogurt treatment was cheaper than S. boulardii whereas in hospitalized patients, treatment cost was similar. In conclusion, the effect of daily freshly prepared YF was comparable to S. boulardii in the treatment of acute non-bloody diarrhea in children. The duration of diarrhea was shorter in the S. boulardii group, expressed as a significantly higher number of patients with normal stools on day 3.

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

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    Roberto De Icco

    2015-01-01

    Full Text Available 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 3 months later (T2. Regarding the acute effect, acoustic cues increased stride length and stride duration, while visual cues reduced the number of strides and normalized the stride/stance distribution but also reduced gait speed. As regards the chronic effect of cues, we recorded an improvement in some gait parameters in all 3 groups of patients: all 3 types of training improved gait speed; visual cues also normalized the stance/swing ratio, acoustic cues reduced the number of strides and increased stride length, and overground training improved stride length. The changes were not retained at T2 in any of the experimental groups. Our findings support and characterize the usefulness of cueing strategies in the rehabilitation of gait in PD.

  4. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study

    Science.gov (United States)

    Silverman, Michael J.

    2016-01-01

    Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recovery than patients in a control condition? Will there be differences in state hope for recovery as a result of hope-oriented songwriting or lyric analysis interventions? Method: Participants (N = 169) were cluster randomized to one of three single-session conditions: lyric analysis, songwriting, or wait-list control. Results: There was no significant between-group difference. However, both music therapy conditions tended to have slightly higher mean pathway, agency, and total state hope scores than the control condition even within the temporal parameters of a single music therapy session. There was no between-group difference in the songwriting and lyric analysis interventions. Conclusion: Although not significant, results support that educational music therapy may impact state hope for recovery within the temporal parameters of a single session. The specific type of educational music therapy intervention did not affect results. Implications for practice, limitations, and suggestions for future research are provided. PMID:27774084

  5. The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: A randomized, controlled trial

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    Laura Amy Massee

    2015-05-01

    Full Text Available Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa’s effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n=40, age M= 24.13 years, SD = 4.47 years was conducted to investigate the effects of both acute (same-day and sub-chronic (daily for four-weeks 250mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-minute cycles of the Cognitive Demand Battery (CDB encompassing two serial subtraction tasks (Serial Threes and Sevens, a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerised Cognitive Assessment Battery (SUCCAB was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763. Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN126130006 26763&ddlSearch=Registered

  6. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study

    Directory of Open Access Journals (Sweden)

    Michael J. Silverman

    2016-10-01

    Full Text Available Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: Will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recovery than patients in a control condition? Will there be differences in state hope for recovery as a result of hope-oriented songwriting or lyric analysis interventions?Method: Participants (N = 169 were cluster randomized to one of three single-session conditions: lyric analysis, songwriting, or wait-list control. Results: There was no significant between-group difference. However, both music therapy conditions tended to have slightly higher mean pathway, agency, and total state hope scores than the control condition even within the temporal parameters of a single music therapy session. There was no between-group difference in the songwriting and lyric analysis interventions. Conclusions: Although not significant, results support that educational music therapy may impact state hope for recovery within the temporal parameters of a single session. The specific type of educational music therapy intervention did not affect results. Implications for practice, limitations, and suggestions for future research are provided.

  7. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study.

    Science.gov (United States)

    Silverman, Michael J

    2016-01-01

    Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recovery than patients in a control condition? Will there be differences in state hope for recovery as a result of hope-oriented songwriting or lyric analysis interventions? Method: Participants (N = 169) were cluster randomized to one of three single-session conditions: lyric analysis, songwriting, or wait-list control. Results: There was no significant between-group difference. However, both music therapy conditions tended to have slightly higher mean pathway, agency, and total state hope scores than the control condition even within the temporal parameters of a single music therapy session. There was no between-group difference in the songwriting and lyric analysis interventions. Conclusion: Although not significant, results support that educational music therapy may impact state hope for recovery within the temporal parameters of a single session. The specific type of educational music therapy intervention did not affect results. Implications for practice, limitations, and suggestions for future research are provided.

  8. A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen® in the Clinical Management of Acute Viral Diarrhea in Children

    Directory of Open Access Journals (Sweden)

    Emilia García-Menor MD

    2016-11-01

    Full Text Available This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001. The duration of diarrhea (median and interquartile range was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377. The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children.

  9. Inclusion of thoracic spine thrust manipulation into an electro-therapy/thermal program for the management of patients with acute mechanical neck pain: a randomized clinical trial.

    Science.gov (United States)

    González-Iglesias, Javier; Fernández-de-las-Peñas, Cesar; Cleland, Joshua A; Alburquerque-Sendín, Francisco; Palomeque-del-Cerro, Luis; Méndez-Sánchez, Roberto

    2009-06-01

    Our aim was to examine the effects of a seated thoracic spine distraction thrust manipulation included in an electrotherapy/thermal program on pain, disability, and cervical range of motion in patients with acute neck pain. This randomized controlled trial included 45 patients (20 males, 25 females) between 23 and 44 years of age presenting with acute neck pain. Patients were randomly divided into 2 groups: an experimental group which received a thoracic manipulation, and a control group which did not receive the manipulative procedure. Both groups received an electrotherapy program consisting of 6 sessions of TENS (frequency 100Hz; 20min), superficial thermo-therapy (15min) and soft tissue massage. The experimental group also received a thoracic manipulation once a week for 3 consecutive weeks. Outcome measures included neck pain (numerical pain rate scale; NPRS), level of disability (Northwick Park Neck Pain Questionnaire; NPQ) and neck mobility. These outcomes were assessed at baseline and 1 week after discharge. A 2-way repeated-measures ANOVA with group as between-subject variable and time as within-subject variable was used. Patients receiving thoracic manipulation experienced greater reductions in both neck pain, with between-group difference of 2.3 (95% CI 2-2.7) points on a 11-NPRS, and perceived disability with between-group differences 8.5 (95% CI 7.2-9.8) points. Further, patients receiving thoracic manipulation experienced greater increases in all cervical motions with between-group differences of 10.6 degrees (95% CI 8.8-12.5 degrees) for flexion; 9.9 degrees (95% CI 8.1-11.7 degrees) for extension; 9.5 degrees (95% CI 7.6-11.4 degrees) for right lateral-flexion; 8 degrees (95% CI 6.2-9.8 degrees) for left lateral-flexion; 9.6 degrees (95% CI 7.7-11.6 degrees) for right rotation; and 8.4 degrees (95% CI 6.5-10.3 degrees) for left rotation. We found that the inclusion of a thoracic manipulation into an electrotherapy/thermal program was effective in

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

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    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

  11. A randomized controlled trial testing an adherence-optimized Vitamin D regimen to mitigate bone change in adolescents being treated for acute lymphoblastic leukemia.

    Science.gov (United States)

    Orgel, Etan; Mueske, Nicole M; Sposto, Richard; Gilsanz, Vicente; Wren, Tishya A L; Freyer, David R; Butturini, Anna M; Mittelman, Steven D

    2017-02-20

    Adolescents with acute lymphoblastic leukemia (ALL) develop osteopenia early in therapy, potentially exacerbated by high rates of concurrent Vitamin D deficiency. We conducted a randomized clinical trial testing a Vitamin D-based intervention to improve Vitamin D status and reduce bone density decline. Poor adherence to home supplementation necessitated a change to directly observed therapy (DOT) with intermittent, high-dose Vitamin D3 randomized versus standard of care (SOC). Compared to SOC, DOT Vitamin D3 successfully increased trough Vitamin 25(OH)D levels (p = .026) with no residual Vitamin D deficiency, 100% adherence to DOT Vitamin D3, and without associated toxicity. However, neither Vitamin D status nor supplementation impacted bone density. Thus, this adherence-optimized intervention is feasible and effective to correct Vitamin D deficiency in adolescents during ALL therapy. Repletion of Vitamin D and calcium alone did not mitigate osteopenia, however, and new, comprehensive approaches are needed to address treatment-associated osteopenia during ALL therapy.

  12. Use of the PiCCO system in critically ill patients with septic shock and acute respiratory distress syndrome: a study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zhang Zhongheng

    2013-02-01

    Full Text Available Abstract Background Hemodynamic monitoring is very important in critically ill patients with shock or acute respiratory distress syndrome(ARDS. The PiCCO (Pulse index Contour Continuous Cardiac Output, Pulsion Medical Systems, Germany system has been developed and used in critical care settings for several years. However, its impact on clinical outcomes remains unknown. Methods/design The study is a randomized controlled multi-center trial. A total of 708 patients with ARDS, septic shock or both will be included from January 2012 to January 2014. Subjects will be randomized to receive PiCCO monitoring or not. Our primary end point is 30-day mortality, and secondary outcome measures include ICU length of stay, days on mechanical ventilation, days of vasoactive agent support, ICU-free survival days during a 30-day period, mechanical-ventilation-free survival days during a 30-day period, and maximum SOFA score during the first 7 days. Discussion We investigate whether the use of PiCCO monitoring will improve patient outcomes in critically ill patients with ARDS or septic shock. This will provide additional data on hemodynamic monitoring and help clinicians to make decisions on the use of PiCCO. Trial registration http://www.clinicaltrials.gov NCT01526382

  13. A randomized, double-blind, placebo-controlled study of rapid-acting intramuscular olanzapine in Japanese patients for schizophrenia with acute agitation

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    Katagiri Hideaki

    2013-01-01

    Full Text Available Abstract Background Olanzapine rapid-acting intramuscular (IM injection is an atypical antipsychotic drug already used overseas and recently approved in Japan. The objective of this study was to confirm the efficacy of rapid-acting IM olanzapine 10 mg was greater than IM placebo in patients with exacerbation of schizophrenia with acute psychotic agitation by comparing changes from baseline to 2 hours after the first IM injection, as measured by the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC total score. Methods We conducted a placebo-controlled, randomized, double-blind, parallel-group study in Japanese patients diagnosed with schizophrenia according to the diagnostic criteria specified in the DSM-IV-TR. Patients were randomized to 2 treatment groups: IM olanzapine (10 mg or IM placebo. The primary efficacy outcome was the change in PANSS-EC from baseline to 2 hours after the first IM injection. Treatment groups were compared with an analysis of variance model which included treatment and site as factors. During the 24-hour treatment period, safety was assessed by clinical examination and laboratory investigations, electrocardiograms, extrapyramidal symptoms scales, and recording spontaneously reported adverse events. Results Of the 91 randomized patients, 90 patients (45 IM olanzapine-group; 45 IM placebo-group were in the full analysis set. The mean change of PANSS-EC total score from baseline to 2 hours after the first IM injection (mean±standard deviation was −9.2±4.5 for the IM olanzapine group and −2.8±5.6 for the IM placebo group. The difference between treatment groups was statistically significant (p Conclusion The efficacy of IM olanzapine 10 mg in patients with exacerbation of schizophrenia with acute psychotic agitation was greater than IM placebo in the primary efficacy measure, PANSS-EC. Intramuscular olanzapine 10 mg was shown to be generally safe and tolerable, and could be a new option for treatment

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

    Institute of Scientific and Technical Information of China (English)

    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.

  15. [Cerebral hemodynamic disorders in patients with chronic decompensated respiratory insufficiency. Physiopathogenetic considerations].

    Science.gov (United States)

    Ionescu, M

    1978-01-01

    The present paper reports on 12 patients (8 males, 4 females) suffering from chronic decompensated respiratory failure, who presented concomitant transient haemodynamic disturbances in the carotid and vertebrobasilary systems, manifested by hemisphere or brain stem symptoms. Owing to the adaptive capacity of these patients there exists a certain tolerance threshold to hypercapnic hypoxemia, but following accentuated or rapid aggravation of acid-base hypercapnic hypoxemia, the biological balance is abruptly perturbed leading to cerebral haemodynamic disturbances. The pathophysiological mechanism of production appears to be the accumulation of acid ions caused by pH acidification of the cerebrospinal fluid. Increase in the cerebral arterial output with decrease in the rate of circulation and vascular resistance take place especially in the vessels with atheromatous or hyaline lesions. Under conditions of severe acidosic hypercapnic hypoxemia this, nevertheless, insures a minimum of 10--20% oxygen required by the metabolism of the nerve cell, sufficient for maintaining the structure of the cell (vita minima). These vasculometabolic mechanisms explain why with improvement of haematosis, following remission of the decompensated disease and fall in acidotic hypercapnic hypoxemia values, the cerebral haemodynamic disturbances also show a more or less evident remission because the nerve cells having maintained their structure are able to take up their function again.

  16. Emerging therapies for the management of decompensated heart failure: from bench to bedside.

    Science.gov (United States)

    deGoma, Emil M; Vagelos, Randall H; Fowler, Michael B; Ashley, Euan A

    2006-12-19

    While pharmaceutical innovation has been highly successful in reducing mortality in chronic heart failure, this has not been matched by similar success in decompensated heart failure syndromes. Despite outstanding issues over definitions and end points, we argue in this paper that an unprecedented wealth of pharmacologic innovation may soon transform the management of these challenging patients. Agents that target contractility, such as cardiac myosin activators and novel adenosine triphosphate-dependent transmembrane sodium-potassium pump inhibitors, provide inotropic support without arrhythmogenic increases in cytosolic calcium or side effects of more traditional agents. Adenosine receptor blockade may improve glomerular filtration and diuresis by exerting a direct beneficial effect on glomerular blood flow while vasopressin antagonists promote free water excretion without compromising renal function and may simultaneously inhibit myocardial remodeling. Urodilatin, the renally synthesized isoform of atrial natriuretic peptide, may improve pulmonary congestion via vasodilation and enhanced diuresis. Finally, metabolic modulators such as perhexiline may optimize myocardial energy utilization by shifting adenosine triphosphate production from free fatty acids to glucose, a unique and conceptually appealing approach to the management of heart failure. These advances allow optimism not only for the advancement of our understanding and management of decompensated heart failure syndromes but for the translational research effort in heart failure biology in general.

  17. A descriptive study of the usage of spinal manipulative therapy techniques within a randomized clinical trial in acute low back pain.

    Science.gov (United States)

    Hurley, Deirdre A; McDonough, Suzanne M; Baxter, G David; Dempster, Martin; Moore, Ann P

    2005-02-01

    The majority of randomized clinical trials (RCTs) of spinal manipulative therapy have not adequately defined the terms 'mobilization' and 'manipulation', nor distinguished between these terms in reporting the trial interventions. The purpose of this study was to describe the spinal manipulative therapy techniques utilized within a RCT of manipulative therapy (MT; n = 80), interferential therapy (IFT; n = 80), and a combination of both (CT; n = 80) for people with acute low back pain (LBP). Spinal manipulative therapy was defined as any 'mobilization' (low velocity manual force without a thrust) or 'manipulation' (high velocity thrust) techniques of the spine described by Maitland and Cyriax. The 16 physiotherapists, all members of the Society of Orthopaedic Medicine, utilized three spinal manipulative therapy patterns in the RCT: Maitland Mobilization (40.4%, n = 59), Maitland Mobilization/Cyriax Manipulation (40.4%, n = 59) and Cyriax Manipulation (19.1%, n = 28). There was a significant difference between the MT and CT groups in their usage of spinal manipulative therapy techniques (chi2 = 9.178; df = 2; P = 0.01); subjects randomized to the CT group received three times more Cyriax Manipulation (29.2%, n = 21/72) than those randomized to the MT group (9.5%, n = 7/74; df = 1; P = 0.003). The use of mobilization techniques within the trial was comparable with their usage by the general population of physiotherapists in Britain and Ireland for LBP management. However, the usage of manipulation techniques was considerably higher than reported in physiotherapy surveys and may reflect the postgraduate training of trial therapists.

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

    Science.gov (United States)

    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.

  19. Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial

    Science.gov (United States)

    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-flavanol (n = 21) chocolate consumption for 12 weeks. At randomization (0, 60, 120 and 180 min after a single 40-g dose of chocolate), 6 and 12 weeks after daily 20-g chocolate intake, we evaluated plasma concentrations of flavanols and theobromine, as well as the FMD and BP. Results Plasma epicatechin was significantly increased (p < 0.001) 180 min after the consumption of 40-g high-flavanol chocolate compared to low-flavanol chocolate. Theobromine concentrations were significantly higher 180 min and 12 weeks after the intake of experimental chocolate or low-flavanol chocolate (p < 0.001). FMD was not different between the 2 groups at all pre-defined time periods. No other significant within-group or between-group changes were observed. Conclusion These results confirm the feasibility of a large-scale RCT comparing daily consumption of flavanol-rich chocolate to an equivalent placebo during pregnancy and demonstrate higher plasma epicatechin and theobromine concentration in the intervention group after acute ingestion Trial registration ClinicalTrials.gov Identifier: NCT01659060 PMID:23565841

  20. Chronic Hepatitis B with Spontaneous Severe Acute Exacerbation

    Directory of Open Access Journals (Sweden)

    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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  2. Acute postoperative digitalization of patients with arteriosclerotic heart disease after major surgery. A randomized haemodynamic study and proposal for therapy.

    Science.gov (United States)

    Bille-Brahe, N E; Engell, H C; Sørensen, M B

    1980-12-01

    Twenty patients with impaired left ventricular function during exercise, who underwent major vascular surgery for arteriosclerotic disease, were randomly digitalized in the immediate postoperative period. All patients had a smooth postoperative course. Haemodynamic measurements showed improved left ventricular function in those who received digitalis, since 60 min after full digitalization the digitalized patients had a highly significant decrease in pulmonary capillary wedge pressure (PCWP) with unchanged stroke volume index (SVI) and left ventricular stroke work index (LVSWI). The same improvement in cardiac function was present the next morning. The present study provides haemodynamic data in support of clinical studies showing a beneficial effect of prophylactic digitalization in surgical patients with clinical signs of arteriosclerotic heart disease, though not in overt failure.

  3. 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

    Institute of Scientific and Technical Information of China (English)

    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

  4. Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): Design and statistical analysis plan of the extended follow-up study

    NARCIS (Netherlands)

    L.A. Van Den Berg (Lucie A.); M.G.W. Dijkgraaf (Marcel); O.A. Berkhemer (Olvert); P.S.S. Fransen (Puck); D. Beumer (Debbie); H.F. Lingsma (Hester); C.B. Majoie (Charles B.); D.W.J. Dippel (Diederik); van der Lugt, A.J. (Aad J.); R.J. Van Oostenbrugge; W.H. van Zwam (Wim); Y.B.W.E.M. Roos (Y. B W E M); Lingsma, H.F. (Hester F.); A.J. Yoo (Albert J.); W.J. Schonewille (W.); Albert Vos, J. (Jan); P.J. Nederkoorn (Paul); M.J.H. Wermer (Marieke); M.A. van Walderveen (M.); J. Staals (Julie); J. Hofmeijer; J.A. van Oostayen (Jacques); à Nijeholt, G.J.L. (Geert J. Lycklama); J. Boiten (Jelis); P.A. Brouwer (Patrick A.); B.J. Emmer (Bart J.); S.F. de Bruijn (S.); L.C. van Dijk (Lukas); L. Jaap Kappelle; R.H. Lo (Rob H.); E.J. van Dijk (Ewoud); J. De Vries (Joost); P.L.M. de Kort (Paul); W.J. van Rooij (W.); J.S.P. van den Berg (Jan); B.A.A.M. Van Hasselt (Boudewijn A. A. M.); L.A.M. Aerden (Leo A.M.); R.J. Dallinga (René J.); M.C. Visser (Marieke); Bot, J.C.J. (Joseph C.J.); P.C. Vroomen (Patrick C.); O.S. Eshghi (Omid S.); T.H.C.M.L. Schreuder (Tobien H. C. M. L.); M.P. Heijboer (Rien); K. Keizer (Koos); A.V. Tielbeek (Alexander); H.M. den Hertog (Heleen); D.G. Gerrits (Dick G.); R.M. van den Berg-Vos (R.); Karas, G.B. (Giorgos B.); E.W. Steyerberg (Ewout); H. Zwenneke Flach; H. Marquering (Henk); M.E.S. Sprengers (Marieke E. S.); S. Jenniskens (Sjoerd); L.F.M. Beenen (Ludo); R. van den Berg (René); P.J. Koudstaal (Peter Jan); A. van der Lugt (Aad); C.B. Majoie (Charles)

    2016-01-01

    textabstractBackground: MR CLEAN was the first randomized trial to demonstrate the short-term clinical effectiveness of endovascular treatment in patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation. Several other trials confirmed that endovascular treatme

  5. Addition of bevacizumab to chemotherapy in acute myeloid leukemia at older age : a randomized phase 2 trial of the Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON) and the Swiss Group for Clinical Cancer Research (SAKK)

    NARCIS (Netherlands)

    Ossenkoppele, Gert J; Stussi, Georg; Maertens, Johan; van Montfort, Kees; Biemond, Bart J; Breems, Dimitri; Ferrant, August; Graux, Carlos; de Greef, Georgine E; Halkes, C J M; Hoogendoorn, Mels; Hollestein, Rene M; Jongen-Lavrencic, Mojca; Levin, Mark D; van de Loosdrecht, Arjan A; van Marwijk Kooij, Marinus; van Norden, Yvette; Pabst, Thomas; Schouten, Harry C; Vellenga, Edo; Verhoef, Gregor E G; de Weerdt, Okke; Wijermans, Pierre; Passweg, Jakob R; Löwenberg, Bob

    2012-01-01

    An urgent need for new treatment modalities is emerging in elderly patients with acute myeloid leukemia (AML). We hypothesized that targeting VEGF might furnish an effective treatment modality in this population. Elderly patients with AML were randomly assigned in this phase 2 study (n = 171) to rec

  6. Addition of bevacizumab to chemotherapy in acute myeloid leukemia at older age: A randomized phase 2 trial of the Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON) and the Swiss Group for Clinical Cancer Research (SAKK)

    NARCIS (Netherlands)

    G.J. Ossenkoppele (Gert); G. Stussi (Georg); J. Maertens (Johan); C.A.G.M. Montfort (Kees); B.J. Biemond (Bart); D.A. Breems (Dimitri); A. Ferrant (Augustin); C. Graux (Carlos); G.E. de Greef (Georgine); C.J.M. Halkes (Constantijn ); M. Hoogendoorn (Mels); L.M. Hollestein (Loes); M. Jongen-Lavrencic (Mojca); M.-D. Levin (Mark-David); A.A. van de Loosdrecht (Arjan); M. Van Marwijk Kooij (Marinus); Y. van Norden (Yvette); T. Pabst (Thomas); H. Schouten (Harry); E. Vellenga (Edo); G.E.G. Verhoef (Gregor); O. de Weerdt (O.); P.W. Wijermans (Pierre); J. Passweg (Jakob Robert); B. Löwenberg (Bob)

    2012-01-01

    textabstractAn urgent need for new treatment modalities is emerging in elderly patients with acute myeloid leukemia (AML). We hypothesized that targeting VEGF might furnish an effective treatment modality in this population. Elderly patients with AML were randomly assigned in this phase 2 study (n =

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

    Directory of Open Access Journals (Sweden)

    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..

  8. Ebrotidine versus ranitidine in the treatment of acute duodenal ulcer. A multicentre, randomized, double-blind, controlled clinical trial.

    Science.gov (United States)

    Matov, V; Metchkov, G; Krastev, Z; Tchernev, K; Mitova, R; Márquez, M; Torres, J; Herrero, E; Fillat, O; Ortiz, J A

    1997-04-01

    A total of 478 patients with endoscopically confirmed duodenal ulcer entered this randomized, parallel, double-blind trial. Patients were randomly assigned to receive ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]- 4-thiazolyl]methyl]thio]ethyl]amino]methylene]-4-bromo-benzenesulfona mid e, CAS 100981-43-9, FI-3542) 400 mg or ranitidine 300 mg tablets (4:1) respectively, administered in single evening doses. Endoscopy, clinical examination and symptom assessment were performed at baseline and at weeks 4 and 8. Safety evaluations including laboratory tests, treatment compliance and antacid consumption checks were conducted at the beginning and/or at the 4 and 8 week visits. Patients whose ulcer showed endoscopic healing at the 4-week control left the study. Both groups were matched in all parameters studied. The healing rates at 4 weeks were 76.4% and 75.3% for ebrotidine and ranitidine respectively, while at 8 weeks the final rates were 95% and 91.8% respectively. Accompanying symptoms disappeared rapidly and the patients returned to normal. Smoking proved to be a highly significant negative risk factor, since healing rates were 83.4% and 71.2% at 4 weeks and 97.4% and 92.3% at 8 weeks in non-smokers and smokers respectively (p = 0.0046). Smokers treated with ranitidine showed significantly lower final healing rates than non-smokers (86% vs 100%; p = 0.0358), while the healing rates among patients treated with ebrotidine were similar regardless of whether they were smokers or not (93.9% and 96.7% N.S.). Ebrotidine (94%) proved to be more effective than ranitidine (86%) in smokers with higher healing rates (p < 0.05). Alcohol intake showed no significant relationship with the healing rates. Both drugs demonstrated an excellent safety. There were no changes in blood parameters, and no significant adverse events were reported.

  9. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial.

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    Pierre-Marie Roy

    Full Text Available Misuse of thromboprophylaxis may increase preventable complications for hospitalized medical patients.To assess the net clinical benefit of a multifaceted intervention in emergency wards (educational lectures, posters, pocket cards, computerized clinical decision support systems and, where feasible, electronic reminders for the prevention of venous thromboembolism.Prospective cluster-randomized trial in 27 hospitals. After a pre-intervention period, centers were randomized as either intervention (n = 13 or control (n = 14. All patients over 40 years old, admitted to the emergency room, and hospitalized in a medical ward were included, totaling 1,402 (712 intervention and 690 control and 15,351 (8,359 intervention and 6,992 control in the pre-intervention and intervention periods, respectively.Symptomatic venous thromboembolism or major bleeding (primary outcome occurred at 3 months in 3.1% and 3.2% of patients in the intervention and control groups, respectively (adjusted odds ratio: 1.02 [95% confidence interval: 0.78-1.34]. The rates of thromboembolism (1.9% vs. 1.9%, major bleedings (1.2% vs. 1.3%, and mortality (11.3% vs. 11.1% did not differ between the groups. Between the pre-intervention and intervention periods, the proportion of patients who received prophylactic anticoagulant treatment more steeply increased in the intervention group (from 35.0% to 48.2%: +13.2% than the control (40.7% to 44.1%: +3.4%, while the rate of adequate thromboprophylaxis remained stable in both groups (52.4% to 50.9%: -1.5%; 49.1% to 48.8%: -0.3%.Our intervention neither improved adequate prophylaxis nor reduced the rates of clinical events. New strategies are required to improve thromboembolism prevention for hospitalized medical patients.ClinicalTrials.gov NCT01212393.

  10. Theophylline as an add-on to thrombolytic therapy in acute ischaemic stroke (TEA-Stroke): A randomized, double-blinded, placebo-controlled, two-centre phase II study

    DEFF Research Database (Denmark)

    Modrau, Boris; Hjort, Niels; Østergaard, Leif;

    2016-01-01

    the collateral supply in acute ischaemic brain tissue and thus facilitate reperfusion despite proximal vessel occlusion. The primary study objective is to evaluate whether theophylline is safe and efficient in acute ischaemic stroke patients as an add-on to thrombolytic therapy.MethodsThe TEA-Stroke Trial...... is a two-centre, proof of concept phase II clinical study with a randomized, double-blinded, placebo-controlled design. One hundred and twenty patients with acute ischaemic stroke and significant perfusion?diffusion mismatch, as determined by magnetic resonance imaging, are randomized 1:1 to either...... theophylline or placebo as an add-on to standard thrombolytic therapy.Study outcomeThe dual primary outcome measures include penumbra salvage (penumbral tissue not developing into infarcted tissue) and clinical improvement at the 24-h follow-up.DiscussionResults from studies of theophylline in stroke animal...

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

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    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

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

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    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

  13. Pathophysiology of the Cardiorenal Syndromes : Executive Summary from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI)

    NARCIS (Netherlands)

    McCullough, Peter A.; Kellum, John A.; Haase, Michael; Mueller, Christian; Damman, Kevin; Murray, Patrick T.; Cruz, Dinna; House, Andrew A.; Schmidt-Ott, Kai M.; Vescovo, Giorgio; Bagshaw, Sean M.; Hoste, Eric A.; Briguori, Carlos; Braam, Branko; Chawla, Lakhmir S.; Costanzo, Maria R.; Tumlin, James A.; Herzog, Charles A.; Mehta, Ravindra L.; Rabb, Hamid; Shaw, Andrew D.; Singbartl, Kai; Ronco, Claudio

    2014-01-01

    Cardiorenal syndromes (CRS) have been recently classified into five distinct entities, each with different major pathophysiologic mechanisms. CRS type 1 most commonly occurs in the setting of acutely decompensated heart failure where approximately 25% of patients develop a rise in serum creatinine a

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

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    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. Acute effects of mobile phone radiations on subtle energy levels of teenagers using electrophotonic imaging technique: A randomized controlled study

    Science.gov (United States)

    Bhargav, Hemant; Srinivasan, TM; Bista, Suman; Mooventhan, A; Suresh, Vandana; Hankey, Alex; Nagendra, HR

    2017-01-01

    Background: Mobile phones induce radio frequency electromagnetic field (RF-EMF) which has been found to affect subtle energy levels of adults through Electrophotonic Imaging (EPI) technique in a previous pilot study. Materials and Methods: We enrolled 61 healthy right-handed healthy teenagers (22 males and 39 females) in the age range of 17.40 ± 0.24 years from educational institutes in Bengaluru. Subjects were randomly divided into two groups: (1) (mobile phone in ON mode [MPON] at right ear) and (2) mobile phone in OFF mode (MPOF). Subtle energy levels of various organs of the subjects were measured using gas discharge visualization Camera Pro device, in double-blind conditions, at two points of time: (1) baseline and (2) after 15 min of MPON/MPOF exposure. As the data were found normally distributed, paired and independent samples t-test were applied to perform within and between group comparisons, respectively. Results: The subtle energy levels were significantly reduced after RF-EMF exposure in MPON group as compared to MPOF group for following areas: (a) Pancreas (P = 0.001), (b) thyroid gland (P = 0.002), (c) cerebral cortex (P exposure exerted quantifiable effects on subtle energy levels of endocrine glands, nervous system, liver, kidney, spleen, and immune system of healthy teenagers. Future studies should try to correlate these findings with respective biochemical markers and standard radio-imaging techniques. PMID:28149063

  16. Effectiveness of automated locomotor training in patients with acute incomplete spinal cord injury: A randomized controlled multicenter trial

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    Bastiaenen Carolien

    2011-05-01

    Full Text Available Abstract Background A large proportion of patients with spinal cord injury (SCI regain ambulatory function. However, during the first 3 months most of the patients are not able to walk unsupported. To enable ambulatory training at such an early stage the body weight is partially relieved and the leg movements are assisted by two therapists. A more recent approach is the application of robotic based assistance which allows for longer training duration. From motor learning science and studies including patients with stroke, it is known that training effects depend on the duration of the training. Longer trainings result in a better walking function. The aim of the present study is to evaluate if prolonged robot assisted walking training leads to a better walking outcome in patients with incomplete SCI and whether such training is feasible or has undesirable effects. Methods/Design Patients from multiple sites with a subacute incomplete SCI and who are not able to walk independently will be randomized to either standard training (3-5 sessions per week, session duration maximum 25 minutes or an intensive training (3-5 sessions per week, session duration minimum 50 minutes. After 8 weeks of training and 4 months later the walking ability, the occurrence of adverse events and the perceived rate of exertion as well as the patients' impression of change will be compared between groups. Trial registration This study is registered at clinicaltrials.gov, identifier: NCT01147185.

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

    Institute of Scientific and Technical Information of China (English)

    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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

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

    Science.gov (United States)

    Liao, Lin-Yu; Chen, Kuei-Min; Chung, Wei-Sheng; Chien, Jung-Yien

    2015-01-01

    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 day (all P<0.05). Conclusion Results of this study suggest that the respiratory rehabilitation exercise training package reduced symptoms and enhanced the effectiveness of the care of elderly inpatients with AECOPD. PMID:26345529

  20. Acute ingestion of beetroot bread increases endothelium-independent vasodilation and lowers diastolic blood pressure in healthy men: a randomized controlled trial.

    Science.gov (United States)

    Hobbs, Ditte A; Goulding, Marie G; Nguyen, Annie; Malaver, Thomas; Walker, Claire F; George, Trevor W; Methven, Lisa; Lovegrove, Julie A

    2013-09-01

    Dietary nitrate, from beetroot, has been reported to lower blood pressure (BP) by the sequential reduction of nitrate to nitrite and further to NO in the circulation. However, the impact of beetroot on microvascular vasodilation and arterial stiffness is unknown. In addition, beetroot is consumed by only 4.5% of the UK population, whereas bread is a staple component of the diet. Thus, we investigated the acute effects of beetroot bread (BB) on microvascular vasodilation, arterial stiffness, and BP in healthy participants. Twenty-three healthy men received 200 g bread containing 100 g beetroot (1.1 mmol nitrate) or 200 g control white bread (CB; 0 g beetroot, 0.01 mmol nitrate) in an acute, randomized, open-label, controlled crossover trial. The primary outcome was postprandial microvascular vasodilation measured by laser Doppler iontophoresis and the secondary outcomes were arterial stiffness measured by Pulse Wave Analysis and Velocity and ambulatory BP measured at regular intervals for a total period of 6 h. Plasma nitrate and nitrite were measured at regular intervals for a total period of 7 h. The incremental area under the curve (0-6 h after ingestion of bread) for endothelium-independent vasodilation was greater (P = 0.017) and lower for diastolic BP (DBP; P = 0.032) but not systolic (P = 0.99) BP after BB compared with CB. These effects occurred in conjunction with increases in plasma and urinary nitrate (P vasodilation and decreased DBP. Therefore, enriching bread with beetroot may be a suitable vehicle to increase intakes of cardioprotective beetroot in the diet and may provide new therapeutic perspectives in the management of hypertension.

  1. Effects of Intravenous and Catheter Directed Thrombolytic Therapy with Recombinant Tissue Plasminogen Activator (Alteplase in Non-Traumatic Acute Limb Ischemia; A Randomized Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Abbas Saroukhani

    2015-07-01

    Full Text Available Objective: To evaluate the efficacy and safety of intravenous and catheter directed thrombolysis by recombinant tissue plasminogen activator (Alteplase in the patients with non-traumatic acute limb ischemia (ALI. Methods: This was a randomized clinical trial being performed between 2009 and 2011 in Mashhad University of Medical Sciences. We included those patients who were<75 years, with symptoms of less than 14 days duration, ALI of grade IIa and IIb (according to Rutherford classification and absence of distal run off. Baseline assessment of peripheral circulation performed in all the patients. Patients were randomly assigned to undergo intravenous (n=18 or catheter directed thrombolysis (n=20 with Alteplase. The primary endpoint of the study was improvement of clinical status measured by Rutherford classification, ankle brachial index (ABI, visual analogue scale (VAS score measured at 1, 3 and 6 months. The secondary endpoint of the study was complete or near complete recanalization of the occluded artery. Results: A total number of 38 patients with mean age of 54.13±13.5 years were included in the study. There were 23 (60.5% men and 15 (39.5% women among the patients. Overall 3 (7.9% patients had upper and 35 (92.1% lower extremity ischemia. There was no significant difference between two study groups. None of the patients experienced major therapeutic side effects. Both ABI and VAS score improved in patients who have received first dose of t-PA within 24-hourof ALI. There was no significant difference between two study groups regarding the 6-month clinical grade ( p=0.088, VAS score ( p=0.316 and ABI ( p=0.360. The angiographic improvement was significantly higher in CDT group ( p<0.001. Conclusion: Intravenous and catheter directed thrombolysis with t-PA is a safe and effective method in treatment of acute arteriolar ischemia of extremities. However there both intravenous thrombolysis and CDT are comparable regarding the clinical outcome

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

    Institute of Scientific and Technical Information of China (English)

    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

  3. Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: A randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    A S Chandanwale

    2011-01-01

    Full Text Available Background : Eperisone hydrochloride is a centrally acting muscle relaxant inhibiting the pain reflex pathway, having a vasodilator effect. Aims : To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain. Settings and Design : Prospective, randomized, double-blind, placebo-controlled, multicentric trial conducted at five tertiary care orthopedic centers across India. Materials and Methods : It was planned to enroll 240 patients of either sex between 18-60 years with acute musculoskeletal spasm (AMSP with low back pain (LBP due to spondylosis deformans, prolapsed disc or muscle sprain. Patients with other associated unrelated spasm conditions were excluded. Assessments were done for finger-to-floor distance (FFD, lumbar pain, Lasegue′s sign, tenderness of vertebral muscles, need for rescue medication and response to therapy for efficacy and tolerability. Statistical Analysis : Parametric data were analyzed by ′t′ test and ANOVA, and non-parametric data were analyzed using Mann-Whitney ′U′ test and Kruskall-Wallis test. Proportions were compared using Fischer′s (Chi-square test. Results : Two hundred and forty patients were randomized to receive eperisone 150 mg/day in three divided doses (n=120 or placebo (n=120 for 14 days, of which 15 patients did not complete and 225 patients completed the study (eperisone, 112 and placebo, 113. Significantly greater improvement in FFD (P<0.001 from baseline on Day 14 was seen with eperisone (150.66 to 41.75 compared to placebo (138.51 to 101.60. Improvements in other parameters were greater with the eperisone group. For 89 (79.46% patients the therapy was rated as good-excellent with eperisone compared to 43 (38.05% patients with placebo. Nausea, abdominal pain, headache and dizziness were the common adverse events with both therapies. Rescue drug was needed by 40 (35.71% eperisone patients and 83 (73.45% placebo patients

  4. 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

    Directory of Open Access Journals (Sweden)

    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

  5. Effects of acupuncture therapy on plasma neuropeptide Y levels and resuscitation in patients with very early stage acute cerebral infarction A randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    Guozhong Zhang; Lina Ning; Sujuan Gao

    2009-01-01

    BACKGROUND: It is known that acupuncture therapy can decrease plasma neuropeptide Y (NPY) levels in patients with cerebral infarction, but different types of acupuncture therapy used in various stages of cerebral infarction have not been evaluated.OBJECTIVE: To explore the effect of acupuncture therapy on resuscitation (Xingnao Kaicliao) and plasma NPY levels in patients with very early stage acute cerebral infarction.DESIGN, TIME AND SETTING: This case-controlled study was performed at the Affiliated Hospital of the Medical College of the Chinese People's Armed Police Force between September 2004 and October 2005.PARTICIPANTS: Sixty patients with acute cerebral infarction of ≤ 6 hours were used in this study. Patients were randomly divided into an acupuncture therapy group (n = 30) and a routine treatment group (n = 30). Another 30 healthy subjects were used as the control group.METHODS: The acupuncture therapy of Xingnao Kaiqiao used in the acupuncture therapy group was based on routine western medical treatment and was performed at bilateral Neiguan (PC6) using the twirling, reinforcing-reducing method, Renzhong (DU26) using heavy bird-pecking needling, Sanyinjiao (SP6) using reinforcing and reducing by lifting and thrusting the needle, Jiquan (HT1), Weizhong (BL40) and Chize (LU5) using reinforcing and reducing by lifting and thrusting the needle. The acupuncture lasted for 14 days. Patients in the routine treatment group underwent routine medical treatment and no intervention was given to subjects in the control group.MAIN OUTCOME MEASURES: A 4 mL venous blood sample was obtained at different time points, I.e., immediately after hospitalization, the next morning, 7 and 14 days after treatment, to measure plasma NPY levels pre- and post-treatment using the radio-immunity method.RESULTS: The plasma NPY levels were significantly higher in both the routine treatment group and the acupuncture therapy group than in the control group pre- and post-treatment (P < 0

  6. LIVER TRANSPLANTATION IN A RANDOMIZED CONTROLLED TRIAL OF EMERGENCY TREATMENT OF ACUTELY BLEEDING ESOPHAGEAL VARICES IN CIRRHOSIS

    Science.gov (United States)

    Orloff, Marshall J.; Isenberg, Jon I.; Wheeler, Henry O.; Haynes, Kevin S.; Jinich-Brook, Horacio; Rapier, Roderick; Vaida, Florin; Hye, Robert J.; Orloff, Susan L.

    2010-01-01

    Background Bleeding esophageal varices (BEV) in cirrhosis has been considered an indication for liver transplantation (LT). This issue was examined in a randomized controlled trial (RCT) of unselected, consecutive patients with advanced cirrhosis and BEV that compared endoscopic sclerotherapy (EST) (n=106) to emergency direct portacaval shunt (EPCS) (n=105). Methods Diagnostic workup and treatment were initiated within 8 hours. Patients were evaluated for LT on admission and repeatedly thereafter. 96% underwent over 10 years of regular follow-up. The analysis was supplemented by 1300 unrandomized cirrhotic patients who previously underwent portacaval shunt (PCS) with 100% follow-up. Results In the RCT, long-term bleeding control was 100% following EPCS, only 20% following EST. 3, 5, 10, and 15-year survival rates were 75%, 73%, 46%, and 46% following EPCS, compared to 44%, 21%, 9%, and 9% following EST (p<0.001). Only 13 RCT patients (6%) were ultimately referred for LT mainly because of progressive liver failure; only 7 (3%) were approved for LT and only 4 (2%) underwent LT. 1- and 5-year LT survival rates were 0.68% and 0, compared to 81% and 73% after EPCS. In the 1300 unrandomized PCS patients. 50 (3.8%) were referred and 19 (1.5%) underwent LT. Five-year survival rate was 53% compared to 72% for all 1300 patients. Conclusions If bleeding is permanently controlled, as occurred invariably following EPCS, cirrhotic patients with BEV seldom require LT. PCS is effective first-line and long-term treatment. Should LT be required in patients with PCS, although technically more demanding, numerous studies have shown that PCS does not increase mortality or complications. EST is not effective emergency or long-term therapy. PMID:21168637

  7. Effects of motion style acupuncture treatment in acute low back pain patients with severe disability: a multicenter, randomized, controlled, comparative effectiveness trial.

    Science.gov (United States)

    Shin, Joon-Shik; Ha, In-Hyuk; Lee, Jinho; Choi, Youngkwon; Kim, Me-Riong; Park, Byoung-Yoon; Shin, Byung-Cheul; Lee, Myeong Soo

    2013-07-01

    Reviews of the efficacy of acupuncture as a treatment for acute low back pain (aLBP) have shown that there is insufficient evidence for its effect and that more research is needed. Motion style acupuncture treatment (MSAT) is novel in that it requires a part of the patient's body to move passively or actively while acupuncture needles are retained. A multicenter, randomized, comparative effectiveness trial was conducted to evaluate the effects of MSAT in aLBP with severe disability. A total of 58 aLBP patients with severe functional disability (defined per Oswestry Disability Index [ODI] ⩾60%) were recruited and assigned randomly to receive 1 session of either conventional diclofenac injection (n=29) or MSAT (n=29). The primary outcome measured improvement in LBP using the 10-point numerical rating scale of LBP, and the secondary outcome assessed disability using the Oswestry Disability Index at 30minutes and at 2, 4, and 24weeks after treatment. Analyses were by intention to treat. The numerical rating scale of the MSAT group decreased 3.12 (95% confidence interval=2.26, 3.98; P<.0001) more than that of the injection group and the Oswestry Disability Index of the MSAT group decreased 32.95% (95% confidence interval=26.88, 39.03; P<.0001) more than that of the injection group, respectively. The difference between the 2 groups maintained statistical significance at 2 and 4weeks after treatment. These results suggest that MSAT has positive effects on immediate pain relief and the functional recovery of aLBP patients with severe disability.

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

    Directory of Open Access Journals (Sweden)

    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

  9. All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study.

    Science.gov (United States)

    Schlenk, Richard F; Lübbert, Michael; Benner, Axel; Lamparter, Alexander; Krauter, Jürgen; Herr, Wolfgang; Martin, Hans; Salih, Helmut R; Kündgen, Andrea; Horst, Heinz-A; Brossart, Peter; Götze, Katharina; Nachbaur, David; Wattad, Mohammed; Köhne, Claus-Henning; Fiedler, Walter; Bentz, Martin; Wulf, Gerald; Held, Gerhard; Hertenstein, Bernd; Salwender, Hans; Gaidzik, Verena I; Schlegelberger, Brigitte; Weber, Daniela; Döhner, Konstanze; Ganser, Arnold; Döhner, Hartmut

    2016-12-01

    The aim of this clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with chemotherapy and to assess the NPM1 status as biomarker for ATRA therapy in younger adult patients (18-60 years) with acute myeloid leukemia (AML). Patients were randomized for intensive chemotherapy with or without open-label ATRA (45 mg/m(2), days 6-8; 15 mg/m(2), days 9-21). Two cycles of induction therapy were followed by risk-adapted consolidation with high-dose cytarabine or allogeneic hematopoietic cell transplantation. Due to the open label character of the study, analysis was performed on an intention-to-treat (ITT) and a per-protocol (PP) basis. One thousand one hundred patients were randomized (556, STANDARD; 544, ATRA) with 38 patients treated vice versa. Median follow-up for survival was 5.2 years. ITT analyses revealed no difference between ATRA and STANDARD for the total cohort and for the subset of NPM1-mutated AML with respect to event-free (EFS; p = 0.93, p = 0.17) and overall survival (OS; p = 0.24 and p = 0.32, respectively). Pre-specified PP analyses revealed better EFS in NPM1-mutated AML (p = 0.05) and better OS in the total cohort (p = 0.03). Explorative subgroup analyses on an ITT basis revealed better OS (p = 0.05) in ATRA for genetic low-risk patients according to ELN recommendations. The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).

  10. Clinical Effect of 58 Cases Entecavir Treatment of Liver Cirrhosis Decompensated%恩替卡韦治疗58例乙肝后肝硬化失代偿期临床效果观察

    Institute of Scientific and Technical Information of China (English)

    曾伟华

    2013-01-01

    Objective:to study the entecavir in patients with decompensated cirrhosis after hepatitis b period of treatment ef ect. Methods:58 patients with decompensated cirrhosis after hepatitis b period were randomly divided into two groups, control group of 29 patients with routine comprehensive treatment, the team in 29 cases in the control group treatment with oral entecavir, based on comparing two groups before and after the treatment of hepatic function index, after treatment, TBil, ALT, propagated and case fatality rate, HBVDNA turn rate. Results:the two groups before treatment there was no statistical y significant dif erence liver result index, (P> 0.05); The team TBil and ALT significantly lower than the control group after treatment, propagated is significantly higher than the control group, (P0.05);治疗后研究组TBil和ALT明显低于对照组,ALB明显高于对照组,(P<0.01)。研究组病死率明显低于对照组, HBVDNA转阴率明显高于对照组,(P<0.01)。结论恩替卡韦治疗乙肝后肝硬化失代偿期具有较好的临床效果,可加强抗病毒效果,迅速控制病情发展,延长患者生命。

  11. Simultaneous bilensectomy and endothelial keratoplasty for angle-supported phakic intraocular lens-induced corneal decompensation

    Directory of Open Access Journals (Sweden)

    Vikas Mittal

    2011-01-01

    Full Text Available A 40-year-old lady presented with severe endothelial cell loss in both eyes 14 years after angle-supported phakic intraocular lens (AS PIOL implantation. The left eye had severe corneal edema with bullous keratopathy. The right eye had markedly reduced endothelial cell count (655 cells/mm 2 although the cornea was clear. She underwent simultaneous bilensectomy (AS PIOL explantation and phacoemulsification and Descemet′s stripping and endothelial keratoplasty (DSEK in the left eye. Explanted AS PIOL was identified as ZSAL-4 (Morcher, Stuttgart, Germany model. Corneal edema cleared completely in 2 months with a best corrected visual acuity (-2.25 D sph of 20/60. No intervention was done in the right eye. The present case illustrates that AS PIOL-induced endothelial decompensation can be effectively managed by simultaneous bilensectomy and endothelial keratoplasty.

  12. Effectiveness of balance exercises in the acute post-operative phase following total hip and knee arthroplasty: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Pankaj Jogi

    2015-02-01

    Full Text Available Objectives: To determine the effectiveness of balance exercises in the acute post-operative phase following total hip arthroplasty or total knee arthroplasty. Methods: Patients who had total hip arthroplasty (n = 30 or total knee arthroplasty (n = 33 were seen in their residence 1–2 times per week for 5 weeks. At the first post-operative home visit, patients were randomly assigned to either typical (TE, n = 33 or typical plus balance (TE + B, n = 30 exercise groups. The TE group completed seven typical surgery-specific joint range-of-motion and muscle strengthening exercises, while the TE + B group completed the typical exercises plus three balance exercises. Patients were assessed before and 5 weeks after administering the rehabilitation program using four outcome measures: (1 the Berg Balance Scale, (2 the Timed Up and Go test, (3 the Western Ontario McMaster Universities Osteoarthritis Index, and (4 the Activities-specific Balance Confidence Scale. Results: Post-intervention scores for all four outcome measures were significantly improved (p < 0.01 over baseline scores. Patients who participated in the TE + B group demonstrated significantly greater improvement on the Berg Balance Scale and the Timed Up and Go tests (p < 0.01. Conclusion: Balance exercises added to a typical rehabilitation program resulted in significantly greater improvements in balance and functional mobility compared to typical exercises alone.

  13. Comparison of ertapenem and ceftriaxone therapy for acute pyelonephritis and other complicated urinary tract infections in Korean adults: a randomized, double-blind, multicenter trial.

    Science.gov (United States)

    Park, Dae Won; Peck, Kyong Ran; Chung, Moon Hyun; Lee, Jin Seo; Park, Yoon Soo; Kim, Hyo Youl; Lee, Mi Suk; Kim, Jung Yeon; Yeom, Joon Sup; Kim, Min Ja

    2012-05-01

    The efficacy and safety of ertapenem, 1 g once daily, were compared with that of ceftriaxone, 2 g once daily, for the treatment of adults with acute pyelonephritis (APN) and complicated urinary tract infections (cUTIs) in a prospective, multicenter, double-blinded, randomized study. After ≥ 3 days of parenteral study therapy, patients could be switched to an oral agent. Of 271 patients who were initially stratified by APN (n = 210) or other cUTIs (n = 61), 66 (48.9%) in the ertapenem group and 71 (52.2%) in the ceftriaxone group were microbiologically evaluable. The mean duration of parenteral and total therapy, respectively, was 5.6 and 13.8 days for ertapenem and 5.8 and 13.8 days for ceftriaxone. The most common pathogen was Escherichia coli. At the primary efficacy endpoint 5-9 days after treatment, 58 (87.9%) patients in the ertapenem group and 63 (88.7%) in the ceftriaxone had a favorable microbiological response. When compared by stratum and severity, the outcomes in the two groups were equivalent. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. The results indicate that ertapenem is highly effective and safe for the treatment of APN and cUTIs.

  14. Rizatriptan vs. rizatriptan plus trimebutine for the acute treatment of migraine: a double-blind, randomized, cross-over, placebo-controlled study.

    Science.gov (United States)

    Krymchantowski, A V; Filho, P F M; Bigal, M E

    2006-07-01

    Gastroparesis frequently happens during migraine attacks, postponing the onset of action of orally administered drugs. Furthermore, triptans seem to work better in the earlier phases of the migraine attacks. Therefore, associating a gastrokinetic drug with a triptan may translate into better efficacy and higher consistency of response. Trimebutine is an opioid derivative with exclusive action on receptors of the Meissner and Auerbach plexus throughout the digestive tube. It has no absorption or central penetration. Herein we contrast the combination of rizatriptan plus trimebutine with rizatriptan alone in the acute treatment of migraine. Forty patients with migraine consecutively seen in our clinic were randomized to treat two consecutive moderate or severe attacks with one tablet of 10 mg rizatriptan plus one capsule of 200 mg trimebutine and two attacks with the same triptan and placebo, in counterbalanced order. We collected information on the severity of the attack, as well as presence of nausea and photophobia at the time of drug intake, and after 1, 2 and 4 h. Recurrence and adverse events were also contrasted. Sixty-four attacks were treated with each drug regimen. At 1 h postdose, 30 (46.8%) of 64 attacks treated with the combination resolved completely, vs. eight (12.5%) of the rizatriptan-treated attacks, a difference of 34% (P rizatriptan alone resolved completely, a difference of 42% (95% confidence interval 26, 58, P rizatriptan and trimebutine is more effective than rizatriptan alone. The combination does not increase adverse events or recurrence of pain.

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

    Science.gov (United States)

    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.

  16. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial

    Directory of Open Access Journals (Sweden)

    Dock-Nascimento Diana B

    2011-06-01

    Full Text Available Abstract Background Prolonged preoperative fasting increases insulin resistance and current evidence recommends carbohydrate (CHO drinks 2 hours before surgery. Our hypothesis is that the addition of whey protein to a CHO-based drink not only reduces the inflammatory response but also diminish insulin resistance. Methods Seventeen patients scheduled to cholecystectomy or inguinal herniorraphy were randomized and given 474 ml and 237 ml of water (CO group or a drink containing CHO and milk whey protein (CHO-P group respectively, 6 and 3 hours before operation. Blood samples were collected before surgery and 24 hours afterwards for biochemical assays. The endpoints of the study were the insulin resistance (IR, the prognostic inflammatory and nutritional index (PINI and the C-reactive protein (CRP/albumin ratio. A 5% level for significance was established. Results There were no anesthetic or postoperative complications. The post-operative IR was lower in the CHO-P group when compared with the CO group (2.75 ± 0.72 vs 5.74 ± 1.16; p = 0.03. There was no difference between the two groups in relation to the PINI. The CHO-P group showed a decrease in the both CRP elevation and CRP/albumin ratio (p Conclusions Shortening the pre-operative fasting using CHO and whey protein is safe and reduces insulin resistance and postoperative acute phase response in elective moderate operations. Trial registration ClinicalTrail.gov NCT01354249

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  19. 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

    Directory of Open Access Journals (Sweden)

    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.

  20. Efficacy and Safety of Thrombolytic Therapy in Acute Submassive Pulmonary Embolism: Follow-Up Study

    Science.gov (United States)

    Sinha, Santosh Kumar; Sachan, Mohit; Goel, Amit; Singh, Karandeep; Mishra, Vikas; Jha, Mukesh Jitendra; Kumar, Ashutosh; Abdali, Nasar; Asif, Mohammad; Razi, Mahamdula; Pandey, Umeshwar; Thakur, Ramesh; Varma, Chandra Mohan; Krishna, Vinay

    2017-01-01

    Background Thrombolysis in acute submassive pulmonary embolism (PE) remains controversial. So we studied impact of thrombolytic therapy in acute submassive PE in terms of mortality, hemodynamic status, improvement in right ventricular function, and safety in terms of major and minor bleeding. Method A single-center, prospective, randomized study of 86 patients was conducted at LPS Institute of Cardiology, G.S.V.M. Medical College, Kanpur, India. Patients received thrombolysis (single bolus of tenecteplase) with unfractionated heparin (UFH, group I) or placebo with UFH (group II). Result Mean age of patients was 54.35 ± 12.8 years with male dominance (M:F = 70%:30%). Smoking was the most common risk factor seen in 29% of all patients, followed by recent history of immobilization (25%), history of surgery or major trauma within past 1 month (15%), dyslipidemia (10%) and diabetes mellitus (10%). Dyspnea was the most common symptom in 80% of all patients, followed by chest pain in 55% and syncope in 6%. Primary efficacy outcome occurred significantly better in group I vs. group II (4.5% vs. 20%; P = 0.04), and significant difference was also found in hemodynamic decompensation (4.5% vs. 20%; P = 0.04), the fall in mean pulmonary artery systolic pressure (PASP) (28.8% vs. 22.5%; P = 0.03), improvement in right ventricular (RV) function (70% vs. 40%; P = 0.001) and mean hospital stay (8.1 ± 2.5 vs. 11.1 ± 2.14 days; P = 0.001). There was no difference in mortality and major bleeding as safety outcome but increased minor bleeding occurred in group I patients (16% vs. 12%; P = 0.04). Conclusion Patients with acute submassive PE do not derive overall mortality benefit, recurrent PE and rehospitalization with thrombolytic therapy but had improved clinical outcome in form of decrease in hemodynamic decompensation, mean hospital stay, PASP and improvement of RV function with similar risk of major bleed but at cost of increased minor bleeding. PMID:28090232

  1. Antiviral therapy in hepatitis C virus cirrhotic patients in compensated and decompensated condition

    Institute of Scientific and Technical Information of China (English)

    Angelo Iacobellis; Antonio Ippolito; Angelo Andriulli

    2008-01-01

    The main goals of treating cirrhotic patients with antiviral therapy are to attain sustained viral clearance (SVR), halt disease progression, and prevent re-infection of the liver graft. However, while the medical need is great, the use of interferon and ribavirin might expose these patients to severe treated-related side effects as a large proportion of them have pre-existing hematological cytopenias. We have reviewed potential benefits and risks associated with antiviral drugs in patients with liver cirrhosis, due to hepatitis C virus (HCV) infection. In cases presenting with bridging fibrosis or cirrhosis, current regimens of antiviral therapy have attained a 44%-48% rate of SVR. In cirrhotic patients with portal hypertension, the SVR rate was 22% overall, 12.5% in patients with genotype 1, and 66.7% in those with genotypes 2 and 3 following therapy with low doses of either Peg-IFN alpha-2b and of ribavirin. In patients with decompensated cirrhosis, full dosages of Peg-IFN alpha-2b and of ribavirin produced a SVR rate of 35% overall, 16% in patients with genotype 1 and 4, and 59% in those with genotype 2 and 3. Use of hematological cytokines will either ensure full course of treatment to be accomplished with and prevent development of treatment-associated side effects. Major benefits after HCV eradication were partial recovery of liver metabolic activity, prevention of hepatitis C recurrence after transplantation, and removal of some patients from the waiting list for liver transplant. Several observations highlighted that therapy is inadvisable for individuals with poor hepatic reserve (ChUd-Pugh-Turcotte score ≥ 10). Although SVR rates are low in decompensated cirrhotics due to hepatitis C, these patients have the most to gain as successful antiviral therapy is potentially lifesaving. C 2008 The W.1G Press. All dghts reserved.

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

    DEFF Research Database (Denmark)

    Gurusamy, K; Samraj, K; Gluud, C

    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...

  3. Emergency Portacaval Shunt Versus Rescue Portacaval Shunt in a Randomized Controlled Trial of Emergency Treatment of Acutely Bleeding Esophageal Varices in Cirrhosis—Part 3

    Science.gov (United States)

    Isenberg, Jon I.; Wheeler, Henry O.; Haynes, Kevin S.; Jinich-Brook, Horacio; Rapier, Roderick; Vaida, Florin; Hye, Robert J.

    2010-01-01

    Background Emergency treatment of bleeding esophageal varices in cirrhosis is of singular importance because of the high mortality rate. Emergency portacaval shunt is rarely used today because of the belief, unsubstantiated by long-term randomized trials, that it causes frequent portal-systemic encephalopathy and liver failure. Consequently, portacaval shunt has been relegated solely to salvage therapy when endoscopic and pharmacologic therapies have failed. Question: Is the regimen of endoscopic sclerotherapy with rescue portacaval shunt for failure to control bleeding varices superior to emergency portacaval shunt? A unique opportunity to answer this question was provided by a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt conducted from 1988 to 2005. Methods Unselected consecutive cirrhotic patients with acute bleeding esophageal varices were randomized to endoscopic sclerotherapy (n = 106) or emergency portacaval shunt (n = 105). Diagnostic workup was completed and treatment was initiated within 8 h. Failure of endoscopic sclerotherapy was defined by strict criteria and treated by rescue portacaval shunt (n = 50) whenever possible. Ninety-six percent of patients had more than 10 years of follow-up or until death. Results Comparison of emergency portacaval shunt and endoscopic sclerotherapy followed by rescue portacaval shunt showed the following differences in measurements of outcomes: (1) survival after 5 years (72% versus 22%), 10 years (46% versus 16%), and 15 years (46% versus 0%); (2) median post-shunt survival (6.18 versus 1.99 years); (3) mean requirements of packed red blood cell units (17.85 versus 27.80); (4) incidence of recurrent portal-systemic encephalopathy (15% versus 43%); (5) 5-year change in Child’s class showing improvement (59% versus 19%) or worsening (8% versus 44%); (6) mean quality of life points in which lower is better (13.89 versus 27.89); and (7) mean cost of care per

  4. Pyronaridine-artesunate versus chloroquine in patients with acute Plasmodium vivax malaria: a randomized, double-blind, non-inferiority trial.

    Directory of Open Access Journals (Sweden)

    Yi Poravuth

    Full Text Available BACKGROUND: New antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safety of pyronaridine-artesunate with that of chloroquine for the treatment of uncomplicated P. vivax malaria. METHODS AND FINDINGS: This phase III randomized, double-blind, non-inferiority trial included five centers across Cambodia, Thailand, India, and Indonesia. In a double-dummy design, patients (aged >3-≤ 60 years with microscopically confirmed P. vivax mono-infection were randomized (1:1 to receive pyronaridine-artesunate (target dose 7.2:2.4 mg/kg to 13.8:4.6 mg/kg or chloroquine (standard dose once daily for three days. Each treatment group included 228 randomized patients. Outcomes for the primary endpoint, Day-14 cure rate in the per-protocol population, were 99.5%, (217/218; 95%CI 97.5, 100 with pyronaridine-artesunate and 100% (209/209; 95%CI 98.3, 100 with chloroquine. Pyronaridine was non-inferior to chloroquine: treatment difference -0.5% (95%CI -2.6, 1.4, i.e., the lower limit of the 2-sided 95%CI for the treatment difference was greater than -10%. Pyronaridine-artesunate cure rates were non-inferior to chloroquine for Days 21, 28, 35 and 42. Parasite clearance time was shorter with pyronaridine-artesunate (median 23.0 h versus chloroquine (32.0 h; p<0.0001, as was fever clearance time (median 15.9 h and 23.8 h, respectively; p = 0.0017. Kaplan-Meier estimates of post-baseline P. falciparum infection incidence until Day 42 were 2.5% with pyronaridine-artesunate, 6.1% with chloroquine (p = 0.048, log-rank test. Post-baseline P. vivax or P. falciparum infection incidence until Day 42 was 6.8% and 12.4%, respectively (p = 0.022, log rank test. There were no deaths. Adverse events occurred in 92/228 (40.4% patients with pyronaridine-artesunate and 72/228 (31.6% with chloroquine. Mild and transient increases in hepatic enzymes were observed for pyronaridine-artesunate. CONCLUSION: Pyronaridine-artesunate efficacy

  5. Pyronaridine-Artesunate versus Chloroquine in Patients with Acute Plasmodium vivax Malaria: A Randomized, Double-Blind, Non-Inferiority Trial

    Science.gov (United States)

    Poravuth, Yi; Socheat, Duong; Rueangweerayut, Ronnatrai; Uthaisin, Chirapong; Pyae Phyo, Aung; Valecha, Neena; Rao, B. H. Krishnamoorthy; Tjitra, Emiliana; Purnama, Asep; Borghini-Fuhrer, Isabelle; Duparc, Stephan; Shin, Chang-Sik; Fleckenstein, Lawrence

    2011-01-01

    Background New antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safety of pyronaridine-artesunate with that of chloroquine for the treatment of uncomplicated P. vivax malaria. Methods and Findings This phase III randomized, double-blind, non-inferiority trial included five centers across Cambodia, Thailand, India, and Indonesia. In a double-dummy design, patients (aged >3–≤60 years) with microscopically confirmed P. vivax mono-infection were randomized (1∶1) to receive pyronaridine-artesunate (target dose 7.2∶2.4 mg/kg to 13.8∶4.6 mg/kg) or chloroquine (standard dose) once daily for three days. Each treatment group included 228 randomized patients. Outcomes for the primary endpoint, Day-14 cure rate in the per-protocol population, were 99.5%, (217/218; 95%CI 97.5, 100) with pyronaridine-artesunate and 100% (209/209; 95%CI 98.3, 100) with chloroquine. Pyronaridine was non-inferior to chloroquine: treatment difference −0.5% (95%CI −2.6, 1.4), i.e., the lower limit of the 2-sided 95%CI for the treatment difference was greater than −10%. Pyronaridine-artesunate cure rates were non-inferior to chloroquine for Days 21, 28, 35 and 42. Parasite clearance time was shorter with pyronaridine-artesunate (median 23.0 h) versus chloroquine (32.0 h; pestimates of post-baseline P. falciparum infection incidence until Day 42 were 2.5% with pyronaridine-artesunate, 6.1% with chloroquine (p = 0.048, log-rank test). Post-baseline P. vivax or P. falciparum infection incidence until Day 42 was 6.8% and 12.4%, respectively (p = 0.022, log rank test). There were no deaths. Adverse events occurred in 92/228 (40.4%) patients with pyronaridine-artesunate and 72/228 (31.6%) with chloroquine. Mild and transient increases in hepatic enzymes were observed for pyronaridine-artesunate. Conclusion Pyronaridine-artesunate efficacy in acute uncomplicated P. vivax malaria was at least that of chloroquine. As pyronaridine

  6. Prospective multicenter randomized trial comparing physician versus patient transfer for primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    ZHANG Qi; YANG Zheng-kun; SHEN Wei-feng; ZHANG Rui-yan; QIU Jian-ping; ZHANG Jun-feng; WANG Xiao-long; JIANG Li; LIAO Min-lei; ZHANG Jian-sheng; HU Jian

    2008-01-01

    Background Primary percutaneous coronary intervention (PCI) has been identified as the first therapeutic option for patients with acute ST-segment elevation myocardial infarction (STEMI).The strategy of transferring patient to a PCI center was recently recommended for those with acute STEMI who were present to PCI incapable hospitals,which include lack of facilities or experienced operators.In China,some local hospitals have been equipped with PCI facilities,but they have no interventional physicians qualified for performing primary PCI.This study was conducted to assess the feasibility,safety and efficacy of the strategy of transferring physician to a PCI-equipped hospital to perform primary PCI for patients with acute STEMI.Methods Three hundred and thirty-four consecutive STEMI patients with symptom presentation ≤12 hours in five local hospitals from November 2005 to November 2007 were randomized to receive primary PCI by either physician transfer (physician transfer group,n=165)or patient transfer(patient transfer group,n=169)strategy.Door-to-balloon time,in-hospital and 30-day major adverse cardiac events(MACE,including death,non-fatal re-infarction,and target vessel revascularization)were compared between the two groups.Results Baseline characteristics between the two groups were comparable.Thrombolysis In myocardial infarction (TIMI) 3 flow was revealed in more patients in the physician transfer group at initial angiography(17.6% vs 10.1%,P<0.05).The success rate of primary PCI(96.3% vs 95.4%,P>0.05)and length of hospital stay were similar between the two groups ((15±4)days vs(14±3)days,P>0.05).In the physician transfer group,door-to-balloon time was significantly shortened ((95±20) minutes vs(147±29)minutes,P<0.0001)and more patients received primary PCI with door-to-balloon time less than 90 minutes(21.2% vs 7.7%,P<0.001).During hospitalization,MACE occurred in 6.7% and 11.2% of patients in the physician and patient transfer groups

  7. 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

    Institute of Scientific and Technical Information of China (English)

    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...

  8. Macrophage activation markers predict mortality in patients with liver cirrhosis without or with acute-on-chronic liver failure (ACLF)

    DEFF Research Database (Denmark)

    Grønbæk, Henning; Rødgaard-Hansen, Sidsel; Aagaard, Niels Kristian

    2016-01-01

    BACKGROUND & AIMS: Activation of liver macrophages plays a key role in liver and systemic inflammation and may be involved in development and prognosis of acute-on-chronic liver failure (ACLF). We therefore measured the circulating macrophage activation markers soluble sCD163 and mannose receptor......-III, respectively. The patients' clinical course was registered and their MELD, CLIF-C Acute Decompensation (AD), and CLIF-C ACLF-scores computed at inclusion. RESULTS: We found a stepwise increase (p

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

    Institute of Scientific and Technical Information of China (English)

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

    Directory of Open Access Journals (Sweden)

    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

  11. 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

    Institute of Scientific and Technical Information of China (English)

    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

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

    Directory of Open Access Journals (Sweden)

    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

  13. Palifermin and Chlorhexidine Mouthwashes in Prevention of Chemotherapy-Induced Mucositis in Children with Acute Lymphocytic Leukemia: a Randomized Controlled Trial

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    Narges Gholizadeh

    2016-12-01

    Full Text Available Statement of the Problem: Over the past three decades, significant improvements have been achieved in the survival of children with cancer. However, the considerable morbidity which occurs as a result of chemotherapy often restricts the treatment intensity. One of the important dose-limiting and costly adverse effects of cancer therapy is mucositis. Children with hematological malignancies are greatly at risk of developing mucositis. Purpose: This study aimed to assess the effectiveness of palifermin in preventing mucositis in children with acute lymphocytic leukemia (ALL who undergo chemotherapy. Materials and Method: In this clinical trial, 90 children with ALL were randomized to receive chlorhexidine (n=45 or palifermin (n=45. One group received 60 μg/ kg/ day palifermin as an intravenous bolus once daily for 3 days before and 3 days after the chemotherapy. Chlorhexidine mouthwash was administered once daily for 3 days before and 3 days after the chemotherapy. The world health organization (WHO oral toxicity scale was employed for grading the mucositis. The data were analyzed by using two-way ANOVA. Results: The two groups were matched for age and gender. The study groups were significantly different in terms of mucositis grading (P values after 1 and 2 week therapy were 0.00. Palifermin decreased the incidence and severity of chemotherapy-induced mucositis. Conclusion: Palifermin reduces the oral mucositis in children with ALL. Several mechanisms of action are suggested for keratinocyte growth factor (such as palifermin including promotion of cell proliferation and cytoprotection, restraining the apoptosis, and changing the cytokine profile. Keywords ● Oral Mucositis ● Palifermin ● Leukemia

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

    Directory of Open Access Journals (Sweden)

    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

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

    Institute of Scientific and Technical Information of China (English)

    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.

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

    Science.gov (United States)

    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 ( .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.

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

    DEFF Research Database (Denmark)

    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 betwee...... in 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....

  18. Thorombolytic therapy with rescue percutaneous coronary intervention versus primary percutaneous coronary intervention in patients with acute myocardial infarction: a multicenter randomized clinical trial

    Institute of Scientific and Technical Information of China (English)

    GAO Run-lin; L(U) Shu-zheng; WEI Meng; ZENG Ding-yin; CHEN Ji-lin; QIN Xue-wen; XU Bo; DU Chang-hui; HAN Ya-ling; YANG Xin-chun; MAO Jie-ming; FANG Wei-yi; WANG Lei; SHEN Wei-feng; LI Zhan-quan; JIA Guo-liang

    2010-01-01

    Background Although thrombolytic therapy with rescue percutaneous coronary intervention (PCI) is a common treatment strategy for ST-segment elevation acute myocardial infarction (STEMI), scant data are available on its efficacy relative to primary PCI, and comparison was therefore the aim of this study.Methods This multicenter, open-label, randomized, parallel trial was conducted in 12 hospitals on patients (age ≤70 years) with STEMI who presented within 12 hours of symptom onset (mean interval >3 hours). Patients were randomized to three groups: primary PCI group (n=101); recombinant staphylokinase (r-Sak) group (n=104); and recombinant tissue-type plasminogen activator (rt-PA) group (n=106). For all patients allocated to the thrombolytic therapy arm, coronary angiography was performed at 90 minutes after drug therapy to confirm infarct-related artery (IRA) patency; rescue PCI was performed in cases with TIMI flow grade ≤2. Bare-metal stent implantation was planned for all patients. Results After randomization it required an average of 113.4 minutes to start thrombolytic therapy (door-to-needle time)and 141.2 minutes to perform first balloon inflation in the IRA (door to balloon time).Rates of IRA patency (TIMI flow grade 2 or 3) and TIMI flow grade 3 were significantly lower in the thrombolysis group at 90 minutes after drug therapy than in the primary PCI group at the end of the procedure (70.5% vs. 98.0%, P <0.0001, and 53.0% vs. 85.9%, P <0.0001, respectively). Rescue PCI with stenting was performed in 117 patients (55.7%) in the thrombolytic therapy arm. Rates of patency and TIMI flow grade 3 were still significantly lower in the rescue PCI than in the primary PCI group (88.9% vs. 97.9%, P=0.0222, and 68.4% vs. 85.0%, P=0.0190, respectively). At 30 days post-therapy, mortality rate was significantly higher in the thrombolysis combined with rescue PCI group than in primary PCI group (7.1% vs. 0, P=0.0034). Rates of death/Ml and bleeding complications were

  19. Phase 1 human trial of autologous bone marrow-hematopoietic stem cell transplantation in patients with decompensated cirrhosis

    Institute of Scientific and Technical Information of China (English)

    Mehdi Mohamadnejad; Mehrnaz Namiri; Mohamad Bagheri; Seyed Masiha Hashemi; Hossein Ghanaati; Narges Zare Mehrjardi; Saeed Kazemi Ashtiani; Reza Malekzadeh; Hossein Baharvand

    2007-01-01

    AIM: To evaluate safety and feasibility of autologous bone marrow-enriched CD34+ hematopoietic stem cell Tx through the hepatic artery in patients with decompensated cirrhosis.METHODS: Four patients with decompensated cirrhosis were included. Approximately 200 mL of the bone marrow of the patients was aspirated, and CD34+ stem cells were selected. Between 3 to 10 million CD34+ cells were isolated. The cells were slowly infused through the hepatic artery of the patients.RESULTS: Patient 1 showed marginal improvement in serum albumin and no significant changes in other test results. In patient 2 prothrombin time was decreased;however, her total bilirubin, serum creatinine, and Model of End-Stage Liver Disease (MELD) score worsened at the end of follow up. In patient 3 there was improvement in serum albumin, porthrombin time (PT), and MELD score. Patient 4 developed radiocontrast nephropathy after the procedure, and progressed to type 1 hepatorenal syndrome and died of liver failure a few days later. Because of the major side effects seen in the last patient, the trial was prematurely stopped.CONCLUSION: Infusion of CD34+ stem cells through the hepatic artery is not safe in decompensated cirrhosis.Radiocontrast nephropathy and hepatorenal syndrome could be major side effects. However, this study does not preclude infusion of CD34+ stem cells through other routes.

  20. 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

    Energy Technology Data Exchange (ETDEWEB)

    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.)

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

    Directory of Open Access Journals (Sweden)

    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.

  2. Biostereometric Analysis Of Therapeutic Results In The Treatment Of Chronic, Progressive, Decompensating Postural Back Strain

    Science.gov (United States)

    Johnson, David M.

    1980-07-01

    A two year pilot program for biostereometric analysis of treatment effectiveness in five patients with chronic decompensating back strain has been completed. The patients came from the investigators family practice of osteopathic medicine. They all manifested objective signs of ligamentous and muscular strain of their postural biomechanics due to the combined effects of prior injury to the musculoskeletal system, gravity strain and the passage of time. Two of the patients were treated with osteopathic manipulative treatment plus a pelvic leverage treatment device developed by Martin Jungman, M.D. Two patients received osteopathic treatment alone and the fifth individual switched from control to full program status in the middle of the study after the second stereophotography recording. Signs and symptoms of all patients' gravity strain syndrome changed during the program. Those patients who had the full combination of treatment modalities showed the most positive and significant postural changes as demonstrated by the biostereometric technique developed and performed by the Department of Biostereometrics, Texas Institute of Rehabilitation and Research, Baylor College of Medicine, Houston, Texas. Improvement was clearly demonstrated more quickly than with the prior radiographic measuring methods. X-ray and other studies have also been done on this group. All of the data has not been processed yet in this program. The test patients have improved posture, muscle mass and tone, more stamina and reduced pain.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    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. 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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  9. 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

    Institute of Scientific and Technical Information of China (English)

    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.

  10. Repeated measurements of blood lactate concentration as a prognostic marker in horses with acute colitis evaluated with classification and regression trees (CART) and random forest analysis.

    Science.gov (United States)

    Petersen, M B; Tolver, A; Husted, L; Tølbøll, T H; Pihl, T H

    2016-07-01

    The objective of this study was to investigate the prognostic value of single and repeated measurements of blood l-lactate (Lac) and ionised calcium (iCa) concentrations, packed cell volume (PCV) and plasma total protein (TP) concentration in horses with acute colitis. A total of 66 adult horses admitted with acute colitis (2 mmol/L (sensitivity, 0.72; specificity, 0.8). In conclusion, blood lactate concentration measured at admission and repeated 6 h later aided the prognostic evaluation of horses with acute colitis in this population with a very high mortality rate. This should allow clinicians to give a more reliable prognosis for the horse.

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

    NARCIS (Netherlands)

    C.̧. Ünlü; N. de Korte (Niels); L. Daniels (Lidewine); E.C. Consten (Esther); M.A. Cuesta (Miguel); M.F. Gerhards (Michael); A.A. van Geloven (Anna); E.S. van der Zaag (Edwin); J.A.B. van der Hoeven (Joost); R. Klicks (Rutger); H.A. Cense (Huib); R.M. Roumen (Rudi); Q.A. Eijsbouts (Quirijn); J.F. Lange (Johan); P. Fockens (Paul); C.A. de Borgie (Corianne); W.A. Bemelman (Willem); J.B. Reitsma (Johannes); H.B.A.C. Stockmann; B.C. Vrouenraets (Bart); M.A. Boermeester (Marja)

    2010-01-01

    textabstractBackground. 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 co

  12. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study

    OpenAIRE

    Silverman, Michael J.

    2016-01-01

    Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: Will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recove...

  13. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study

    OpenAIRE

    Silverman, Michael J.

    2016-01-01

    Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recover...

  14. Randomized comparative study of amoxicillin-clavulanic acid and co-trimoxazole in the treatment of acute urinary tract infections in adults.

    OpenAIRE

    Karachalios, G N

    1985-01-01

    The efficacy and safety of amoxicillin-clavulanic acid were compared with those of co-trimoxazole in the treatment of acute urinary tract infections. A total of 104 patients (mean age, 52 years) with clinical and laboratory evidence of acute urinary tract infection were enrolled in the study. Characteristics and infecting organisms were equivalent in both groups of patients. Escherichia coli was the predominant bacteria pathogen in both groups. Both drugs resulted in clinical improvement in 1...

  15. Application of enteral nutrition intervention in patients with decompensated cirrhosis%肠道营养干预在失代偿期肝硬化患者的应用

    Institute of Scientific and Technical Information of China (English)

    马用江; 李静宇; 申利敏

    2015-01-01

    AIM:To investigate the influence of enteral nutrition intervention on the prognosis of patients with decompensated cir-rhosis.METHODS:A total of 100 patients with decompensated cirrhosis who were admitted to our hospital from January 2010 to January 2013 were randomly divided into observation group and control group,with 50 cases in each.The patients in control group received routine medical treatment,while those in the ob-servation group received enteral nutrition intervention combined with routine medical treatment.Curative effect of the two groups was compared.RESULTS:The Child-pugh classification and the incidence of complications of observation group were significantly superior,and the differences between two groups was statistically significant (P<0.05 ).CONCLUSION:The enteral nutrition intervention can effectively improve the condition of patients with decompensated cirrhosis and is worthy of clinical application.%目的:探讨肠道营养干预对失代偿期肝硬化患者预后的影响.方法:选取2010-01/2013-01我院收治的100例失代偿期肝硬化患者,随机分成观察组和对照组,每组各50例,对照组患者进行常规内科治疗,观察组患者在常规内科治疗基础上给予肠道营养干预,比较两组患者的治疗效果.结果:观察组患者Child-pugh分级、并发症发生情况明显优于对照组患者,组间比较差异具有统计学意义(P<0.05).结论:对失代偿期肝硬化患者进行肠道营养干预,能有效改善患者情况,值得推广应用.

  16. Curative effect observation of alprostadil in the treatment of pulmonary heart disease when the cardiac decompensa-tion period%前列地尔对心功能失代偿期肺心病的疗效观察

    Institute of Scientific and Technical Information of China (English)

    寇民生

    2015-01-01

    目的:探讨前列地尔在心功能失代偿期肺心病的疗效.方法:收治肺心病患者98例,随机分为对照组(48例)与治疗组(50例),对照组给予常规治疗.治疗组在常规治疗的基础上,给予脂微球前列地尔静脉滴注.结果:治疗组临床症状的改善、心功能的改善显著优于对照组(P<0.05);治疗组血氧分压、二氧化碳分压、肺动脉压、射血分数等指标与对照组比较,有明显改善(P<0.05).结论:前列地尔治疗心功能失代偿期肺心病有较好的效果.前列地尔是治疗慢性失代偿期肺心病的有效药物.%Objective:To investigate the effect of alprostadil in the treatment of pulmonary heart disease when the cardiac decompensation period.Methods:98 patients with pulmonary heart disease were selected,they were randomly divided into the control group(48 cases) and the treatment group(50 cases),the control group received the conventional treatment.The treatment group given the lipid microsphere alprostadil intravenous infusion on the basis of the conventional treatment.Results:The improvement of clinical symptoms and heart function of the treatment group were significantly better than those of the control group(P<0.05);the blood oxygen partial pressure,carbon dioxide partial pressure,pulmonary arterial pressure,ejection fraction and other indexes of the treatment group were significantly improved compared with the control group(P<0.05).Conclusion:Alprostadil in the treatment of pulmonary heart disease when the cardiac decompensation period has a better curative effect. Alprostadil is an effective drug for the treatment of chronic decompensated pulmonary heart disease.

  17. Body mass index and mortality in acutely decompensated heart failure across the world : a global obesity paradox

    NARCIS (Netherlands)

    Shah, Ravi; Gayat, Etienne; Januzzi, James L; Sato, Naoki; Cohen-Solal, Alain; diSomma, Salvatore; Fairman, Enrique; Harjola, Veli-Pekka; Ishihara, Shiro; Lassus, Johan; Maggioni, Aldo; Metra, Marco; Mueller, Christian; Mueller, Thomas; Parenica, Jiri; Pascual-Figal, Domingo; Peacock, William Frank; Spinar, Jindrich; van Kimmenade, Roland; Mebazaa, Alexandre

    2014-01-01

    OBJECTIVES: This study sought to define the relationship between body mass index (BMI) and mortality in heart failure (HF) across the world and to identify specific groups in whom BMI may differentially mediate risk. BACKGROUND: Obesity is associated with incident HF, but it is paradoxically associa

  18. Depression and Effect of Mortality in Hospitalized Patients with Decompensated Heart Failure

    Directory of Open Access Journals (Sweden)

    Osman Yıldırım

    2012-04-01

    Full Text Available Introduction: Hearth failure frequently seems with depression and increases the morbidity and mortality with worse prognosis. In this study, we aimed to investigate the psychological situation of decompensated syctolic heart failure (DSHF patients and applied medical and psychological therapy to them.Materials and Methods: Totally 71 patients enrolled to the study which entered to Cardiology Department of Abant Izzet Baysal University Medical School Hospital with diagnosis of functional class II-IV DSHF according to New York Cardiology Association classification and ejection fraction (EF of 40% or lower. These patients were divided into two groups (Group A: NHYA grade 2-3, Group B NYHA grade 4. The depression of patients were evaluated by geriatric depression scale (GDS.Results: Twenty one (29.6% of 71 patients had depression consisting of 8 (38% male and 13 (62% female. The depression in female patients were significantly different from male patients (p< 0.05. GDS scores were significantly higher in group B patients (p< 0.05. There was a positive corelation between GDS scores and age (r= 0.648, p= 0.023 and female patients have had significantly higher GDS scores (p< 0.05. The adaptation to the treatment was significantly better in non-depressive patients (p< 0.05. There was a positive corelation between the hospital entrance number due to NC-SHF and GDS scores in all DSHF (r= 0.415, p< 0.05. On the other hand, there was a negative corelation between the EF and GDS scores (r= -0.307, p= 0.019.Conclusion: Depression is frequently seen in patients with DSHF. These patients should be carefully followed against psychiatric symptoms to give adequate treatment.

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

    Science.gov (United States)

    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.

  20. Efficacy of Short-Term High-Dose Statin Pretreatment in Prevention of Contrast-Induced Acute Kidney Injury: Updated Study-Level Meta-Analysis of 13 Randomized Controlled Trials

    OpenAIRE

    Joo Myung Lee; Jonghanne Park; Ki-Hyun Jeon; Ji-Hyun Jung; Sang Eun Lee; Jung-Kyu Han; Hack-Lyoung Kim; Han-Mo Yang; Kyung Woo Park; Hyun-Jae Kang; Bon-Kwon Koo; Sang-Ho Jo; Hyo-Soo Kim

    2014-01-01

    BACKGROUND: There have been conflicting results across the trials that evaluated prophylactic efficacy of short-term high-dose statin pre-treatment for prevention of contrast-induced acute kidney injury (CIAKI) in patients undergoing coronary angiography (CAG). The aim of the study was to perform an up-to-date meta-analysis regarding the efficacy of high-dose statin pre-treatment in preventing CIAKI. METHODS AND RESULTS: Randomized-controlled trials comparing high-dose statin versus low-dose ...

  1. Early nursing intervention for decompensate hepatic cirrhosis patients with hepatic encephalopathy%早期护理干预在失代偿期肝硬化患者发生肝性脑病中的应用

    Institute of Scientific and Technical Information of China (English)

    孙兰珍

    2012-01-01

    Objective To explore the effect of early nursing intervention on decompensate hepatic cirrhosis patients with hepatic encephalopathy. Methods 60 patients with decompensate hepatic cirrhosis were randomly divided into two groups, the control group was conducted with conventional comprehensive treatment and nursing, while the observation group was conducted with additional nursing intervention on the basis of control group. Average duration of hospitalization and incidence rate of hepatic encephalopathy were compared between two groups. Results Incidence rate of hepatic encephalopathy in observation group was significantly lower than the control group, and the duration of hospitalization in observation was significantly shorter than the control group. Conclusion Hepatic encephalopathy can be caused by various factors. Early nursing intervention can reduce or avoid occurrence of hepatic encephalopathy.%目的 探讨早期护理干预对失代偿期肝硬化发生肝性脑病的影响.方法 将60例失代偿期肝硬化患者随机分为2组,对照组进行常规综合治疗及护理,观察组在此基础上采取护理干预,观察2组患者平均住院时间、肝性脑病的发生率即出现肝性脑病的病例数占本组总病例数的比率.结果 干预组肝性脑病发生率明显低于对照组,且住院时间明显少于对照组.结论 肝性脑病有多种诱发因素,通过早期护理干预可以减少或避免肝性脑病发生.

  2. Dialysis complications in acute kidney injury patients treated with prolonged intermittent renal replacement therapy sessions lasting 10 versus 6 hours: results of a randomized clinical trial.

    Science.gov (United States)

    Albino, Bianca Ballarin; Balbi, André Luis; Abrão, Juliana Maria Gera; Ponce, Daniela

    2015-05-01

    Prolonged intermittent renal replacement therapy (PIRRT) has emerged as an alternative to continuous renal replacement therapy in the management of acute kidney injury (AKI) patients. This trial aimed to compare the dialysis complications occurring during different durations of PIRRT sessions in critically ill AKI patients. We included patients older than 18 years with AKI associated with sepsis admitted to the intensive care unit and using noradrenaline doses ranging from 0.3 to 0.7 µg/kg/min. Patients were divided into two groups randomly: in G1, 6-h sessions were performed, and in G2, 10-h sessions were performed. Seventy-five patients were treated with 195 PIRRT sessions for 18 consecutive months. The prevalence of hypotension, filter clotting, hypokalemia, and hypophosphatemia was 82.6, 25.3, 20, and 10.6%, respectively. G1 was composed of 38 patients treated with 100 sessions, whereas G2 consisted of 37 patients treated with 95 sessions. G1 and G2 were similar in male predominance (65.7 vs. 75.6%, P = 0.34), age (63.6 ± 14 vs. 59.9 ± 15.5 years, P = 0.28) and Sequential Organ Failure Assessment score (SOFA; 13.1 ± 2.4 vs. 14.2 ± 3.0, P = 0.2). There was no significant difference between the two groups in hypotension (81.5 vs. 83.7%, P = 0.8), filter clotting (23.6 vs. 27%, P = 0.73), hypokalemia (13.1 vs. 8.1%, P = 0.71), and hypophosphatemia (18.4 vs. 21.6%, P = 0.72). However, the group treated with sessions of 10 h were refractory to clinical measures for hypotension, and dialysis sessions were interrupted more often (9.5 vs. 30.1%, P = 0.03). Metabolic control and fluid balance were similar between G1 and G2 (blood urea nitrogen [BUN]: 81 ± 30 vs. 73 ± 33 mg/dL, P = 1.0; delivered Kt/V: 1.09 ± 0.24 vs. 1.26 ± 0.26, P = 0.09; actual ultrafiltration: 1731 ± 818 vs. 2332 ± 947 mL, P = 0.13) and fluid balance (-731 ± 125 vs. -652 ± 141

  3. Rationale, design and organization of the Second Chinese Cardiac Study (CCS-2): a randomized trial of clopidogrel plus aspirin, and of metoprolol, among patients with suspected acute myocardial infarction. Second Chinese Cardiac Study (CCS-2) Collaborative Group.

    Science.gov (United States)

    2000-12-01

    Assessing combined anti-platelet therapy in suspected acute myocardial infarction Aspirin has been shown to be effective in the emergency treatment of acute myocardial infarction. It irreversibly inhibits platelet cyclo-oxygenase and thereby prevents the formation of the platelet aggregating agent thromboxane A2. Clopidogrel is an anti-platelet agent that acts by a different mechanism, inhibiting adenosine diphosphate-induced platelet aggregation. Simultaneous inhibition of both of these pathways might produce significantly greater anti-platelet effects than inhibition of either alone. The Second Chinese Cardiac Study (CCS-2) will reliably determine whether adding oral clopidogrel to aspirin for up to 4 weeks in hospital after suspected acute myocardial infarction can produce a greater reduction in the risk of major vascular events than can be achieved by giving aspirin alone. In order to be able to detect a further reduction of 10-15%, some 20,000-40,000 patients in over 1000 Chinese hospitals will be randomized. Assessing early beta-blocker therapy in suspected acute myocardial infarction Although over 27,000 patients have been studied previously in randomized trials of short-term beta-blocker therapy in acute myocardial infarction, the reduction in early mortality (513 (3.7%) for beta-blocker therapy deaths versus 586 (4.3%) for control deaths) was only just conventionally significant (P = 0.02) and, overall, the absolute benefits were small in the relatively low-risk patients studied. Although there might be worthwhile benefit in higher risk patients, there is currently little routine use of beta-blocker therapy in acute myocardial infarction. Hence, patients in CCS-2 will also be randomly allocated to receive metoprolol (intravenous then oral) or matching placebo for up to 4 weeks in hospital in a 2 x 2 factorial design. Such a design allows all patients to contribute fully to assessment of the separate effects of the anti-platelet regimen and the beta

  4. Randomized comparative study of amoxicillin-clavulanic acid and co-trimoxazole in the treatment of acute urinary tract infections in adults.

    Science.gov (United States)

    Karachalios, G N

    1985-01-01

    The efficacy and safety of amoxicillin-clavulanic acid were compared with those of co-trimoxazole in the treatment of acute urinary tract infections. A total of 104 patients (mean age, 52 years) with clinical and laboratory evidence of acute urinary tract infection were enrolled in the study. Characteristics and infecting organisms were equivalent in both groups of patients. Escherichia coli was the predominant bacteria pathogen in both groups. Both drugs resulted in clinical improvement in 100% of the patients; bacteriological cure after the termination of therapy was 95% with amoxicillin-clavulanic acid and 83% with co-trimoxazole (P less than 0.001). Side effects were not severe enough to necessitate discontinuation of the antimicrobial agents. Amoxicillin-clavulanic acid is effective and safe therapy for acute urinary tract infections caused by susceptible bacteria. PMID:3911880

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

    DEFF Research Database (Denmark)

    Henriksen, J H; Ring-Larsen, Helmer; 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...... (plasma minus ascitic fluid) oncotic pressure (rlin = 0.74, P less than 0.001) but significantly higher than that (P less than 0.005), indicating a 'non-equilibrium' in the splanchnic Starling forces. The results point to a multivariate genesis and perpetuation of cirrhotic ascites as laid down...

  6. 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.

    LENUS (Irish Health Repository)

    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.

  7. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial

    NARCIS (Netherlands)

    J. Oldgren; A. Budaj; C.B. Granger; Y. Khder; J. Roberts; A. Siegbahn; J.G.P. Tijssen; F. van der Werf; L. Wallentin

    2011-01-01

    After an acute coronary syndrome, patients remain at risk of recurrent ischaemic events, despite contemporary treatment, including aspirin and clopidogrel. We evaluated the safety and indicators of efficacy of the novel oral direct thrombin inhibitor dabigatran. In this double-blind, placebo-control

  8. A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction

    DEFF Research Database (Denmark)

    Choudry, Fizzah; Hamshere, Stephen; Saunders, Natalie

    2016-01-01

    AIMS: Clinical trials suggest that intracoronary delivery of autologous bone marrow-derived cells (BMCs) 1-7 days post-acute myocardial infarction (AMI) may improve left ventricular (LV) function. Earlier time points have not been evaluated. We sought to determine the effect of intracoronary auto...

  9. 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

    Science.gov (United States)

    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...

  10. Factors associated with acute and late dysphagia in the DAHANCA 6 & 7 randomized trial with accelerated radiotherapy for head and neck cancer

    DEFF Research Database (Denmark)

    Mortensen, Hanna Rahbek; Overgaard, Jens; Jensen, Kenneth;

    2013-01-01

    Dysphagia is a common and debilitating side effect in head and neck radiotherapy (RT). Prognostic factors are numerous and their interrelationship not well understood. The aim of this study was to establish a multivariate prognostic model for acute and late dysphagia after RT, based on informatio...

  11. Efficacy of paracetamol, diclofenac and advice for acute low back pain in general practice: design of a randomized controlled trial (PACE Plus)

    NARCIS (Netherlands)

    M. Schreijenberg; P.A.J. Luijsterburg (Pim); Y. van Trier (Yvonne); D. Rizopoulos (Dimitris); M.A. Koopmanschap (Marc); L. Voogt; C. Maher (Chris); B.W. Koes (Bart)

    2017-01-01

    textabstractBackground: Low back pain is common and associated with a considerable burden to patients and society. There is uncertainty regarding the relative benefit of paracetamol and diclofenac and regarding the additional effect of pain medication compared with advice only in patients with acute

  12. Safety and efficacy of enoxaparin vs unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes who receive tirofiban and aspirin: a randomized controlled trial

    NARCIS (Netherlands)

    Blazing, M.A.; Lemos, J.A. de; White, H.D.; Fox, K.; Verheugt, F.W.A.; Ardissino, D.; DiBattiste, P.M.; Palmisano, J.; Bilheimer, D.W.; Snapinn, S.M.; Ramsey, K.E.; Gardner, L.H.; Hasselblad, V.; Pfeffer, M.A.; Lewis, E.F.; Braunwald, E.; Califf, R.M.

    2004-01-01

    CONTEXT: Enoxaparin or the combination of glycoprotein IIb/IIIa inhibitor tirofiban with unfractionated heparin independently have shown superior efficacy over unfractionated heparin alone in patients with non-ST-elevation acute coronary syndromes (ACS). It is not clear if combining enoxaparin with

  13. A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'

    Directory of Open Access Journals (Sweden)

    Yoon Jung-Han

    2011-02-01

    Full Text Available Abstract Background Bone marrow derived stem/progenitor cell transplantation after acute myocardial infarction is safe and effective for improving left ventricular systolic function. However, the improvement of left ventricular systolic function is limited. This study will evaluate novel stem/progenitor cell therapy with combination cytokine treatment of the long-acting erythropoietin analogue, darbepoetin, and granulocyte colony-stimulating factor (G-CSF in patients with acute myocardial infarction. Methods The 'MAGIC Cell-5-Combination Cytokine Trial' is a multicenter, prospective, randomized, 3-arm, controlled trial with blind evaluation of the endpoints. A total of 116 patients will randomly receive one of the following three treatments: an intravenous darbepoetin infusion and intracoronary infusion of peripheral blood stem cells mobilized with G-CSF (n = 58, an intracoronary infusion of peripheral blood stem cells mobilized with G-CSF alone (n = 29, or conventional therapy (n = 29 at phase I. Patients with left ventricular ejection fraction Discussion This is the first study to evaluate the safety and efficacy of combination cytokine based progenitor/stem cell treatment. Trial registration http://www.ClinicalTrials.gov identifier: NCT00501917.

  14. 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

    Directory of Open Access Journals (Sweden)

    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.

  15. Decompensated liver cirrhosis and neural regulation of mesenteric vascular tone in rats: role of sympathetic, nitrergic and sensory innervations

    Science.gov (United States)

    Sastre, Esther; Caracuel, Laura; Prieto, Isabel; Llévenes, Pablo; Aller, M. Ángeles; Arias, Jaime; Balfagón, Gloria; Blanco-Rivero, Javier

    2016-01-01

    We evaluated the possible alterations produced by liver cholestasis (LC), a model of decompensated liver cirrhosis in sympathetic, sensory and nitrergic nerve function in rat superior mesenteric arteries (SMA). The vasoconstrictor response to electrical field stimulation (EFS) was greater in LC animals. Alpha-adrenoceptor antagonist phentolamine and P2 purinoceptor antagonist suramin decreased this response in LC animals more than in control animals. Both non-specific nitric oxide synthase (NOS) L-NAME and calcitonin gene related peptide (CGRP) (8-37) increased the vasoconstrictor response to EFS more strongly in LC than in control segments. Vasomotor responses to noradrenaline (NA) or CGRP were greater in LC segments, while NO analogue DEA-NO induced a similar vasodilation in both experimental groups. The release of NA was not modified, while those of ATP, nitrite and CGRP were increased in segments from LC. Alpha 1 adrenoceptor, Rho kinase (ROCK) 1 and 2 and total myosin phosphatase (MYPT) expressions were not modified, while alpha 2B adrenoceptor, nNOS expression and nNOS and MYPT phosphorylation were increased by LC. Together, these alterations might counteract the increased splanchnic vasodilation observed in the last phases of decompensated liver cirrhosis. PMID:27484028

  16. Occult Hepatitis B Virus Related Decompensated Cirrhosis of Liver in Young Males: First Report of Two Cases from Bangladesh

    Directory of Open Access Journals (Sweden)

    Mamun Al-Mahtab

    2008-05-01

    Full Text Available Cryptogenic cirrhosis is a diagnosis of exclusion. Polymerase chain reaction (PCR has demonstrated persistent hepatitis B virus (HBV infection in serum and liver tissue of HBsAg-negative chronic hepatitis, HBsAg-negative cirrhosis, and HBsAg-negative HCC patients. The entity of occult HBV infection is well established. We report two patients with occult HBV related decompensated cirrhosis of liver for the first time from Bangladesh. The first patient is a young male with jaundice and hepato-splenomegaly. The second patient is also a young male with ascites. Both had altered liver function tests. Diagnosis of decompensated cirrhosis of liver was established in both cases and in both the etiology was identified by PCR to be occult HBV infection. In areas with high prevalence of HBV, a diagnosis of "cryptogenic" cirrhosis based on HBsAg testing alone is not adequate. The so called "cryptogenic" but actually occult HBV cirrhotics are suitable candidates for antiviral treatment. Occult HBV infection must be considered in all patients with cryptogenic cirrhosis of liver in areas where HBV infection is prevalent.

  17. Rapid re-emergence of YMDD mutation of hepatitis B virus with hepatic decompensation after lamivudine retreatment

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    Lamivudine has a high rate of antiviral resistance. Sequential treatment of anti-hepatitis B virus (HBV) is commonly used for lamivudine resistance. We report 4 cases of patients with rapid redetection of HBV mutants during the lamivudine retreatment. The four patients received lamivudine as an initial treatment of HBV and adefovir and lamivudine as a rescue therapy consecutively. HBV-DNA level, YMDD mutations and adefovir -resistant mutations (RFMP) were tested every 3 mo during the sequential treatment. All the patients showed YMDD mutations during the initial lamivudine therapy. After adefovir therapy for lamivudineresistance, they showed viral breakthrough. Adefovir was switched to lamivudine, however, it did not induce viral suppression at all, rather increased HBV-DNA with rapid reemergence of the YMDD mutations. All the patients had ALT flares, and hepatic decompensation occurred in two patients. After switching to adefovir combined with entecavir or lamivudine for a rescue therapy, the patients had reduction in HBV-DNA and ALT improvement. These cases demonstrated that lamivudine retreatment of patients with preexposed lamivudine resistance leads to rapid reemergence of YMDD mutation with significant viral rebounds and subsequent hepatic decompensation. Sequential administration of lamivudine in patients with a prior history of YMDD mutation should be abandoned.

  18. Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial)

    OpenAIRE

    Telekes Peter; Holm Frantisek; Slaby Josef; Aschermann Ondrej; Wiendl Martin; Kettner Jiri; Kvapil Milan; Mates Martin; Hajek Petr; Macek Milan; Kukacka Jiri; Vejvoda Jiri; Alan David; Ostadal Petr; Horak David

    2010-01-01

    Abstract Background Statins have been proved to be effective in reduction of mortality and morbidity when started in the early secondary prevention in stabilized patients after acute coronary syndrome (ACS). The safety and efficacy of statin administration directly in the first-line therapy in unstable ACS patients is not clear. The aim of our study was, therefore, to assess the effect of statin treatment initiated immediately at hospital admission of patients with ACS. Methods The trial was ...

  19. 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.

    Science.gov (United States)

    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; Millot, Frederic; Philippet, Pierre; Baila, Liliana; Benoit, Yves; Otten, Jacques

    2010-07-08

    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 randomly assigned: 202 initially randomly assigned to PRED (60 mg/m(2)/d), 201 to DEX (6 mg/m(2)/d), and 8 nonrandomly assigned to PRED. At a median follow-up of 6.3 years, there were 19 versus 34 events for pulses versus no pulses; 6-year disease-free survival (DFS) rate was 90.6% (standard error [SE], 2.1%) and 82.8% (SE, 2.8%), respectively (hazard ratio [HR] = 0.54; 95% confidence interval, 0.31-0.94; P = .027). The effect of pulses was similar in the PRED (HR = 0.56) and DEX groups (HR = 0.59) but more pronounced in girls (HR = 0.24) than in boys (HR = 0.71). Grade 3 to 4 hepatic toxicity was 30% versus 40% in pulses versus no pulses group and grade 2 to 3 osteonecrosis was 4.4% versus 2%. For average-risk patients treated according to Berlin-Frankfurt-Muenster-based protocols, pulses should become a standard component of therapy.

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

    DEFF Research Database (Denmark)

    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....

  1. A prospective randomized controlled trial to study the role of sulfasalazine in prevention of acute gastrointestinal toxicity associated with concurrent chemoradiation in carcinoma cervix

    Directory of Open Access Journals (Sweden)

    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.

  2. Mobilisation of hematopoietic CD34+ precursor cells in patients with acute stroke is safe--results of an open-labeled non randomized phase I/II trial.

    Directory of Open Access Journals (Sweden)

    Sandra Boy

    Full Text Available BACKGROUND: Regenerative strategies in the treatment of acute stroke may have great potential. Hematopoietic growth factors mobilize hematopoietic stem cells and may convey neuroprotective effects. We examined the safety, potential functional and structural changes, and CD34(+ cell-mobilization characteristics of G-CSF treatment in patients with acute ischemic stroke. METHODS AND RESULTS: Three cohorts of patients (8, 6, and 6 patients per cohort were treated subcutaneously with 2.5, 5, or 10 µg/kg body weight rhG-CSF for 5 consecutive days within 12 hrs of onset of acute stroke. Standard treatment included i.v. thrombolysis. Safety monitoring consisted of obtaining standardized clinical assessment scores, monitoring of CD34(+ stem cells, blood chemistry, serial neuroradiology, and neuropsychology. Voxel-guided morphometry (VGM enabled an assessment of changes in the patients' structural parenchyma. 20 patients (mean age 55 yrs were enrolled in this study, 5 of whom received routine thrombolytic therapy with r-tPA. G-CSF treatment was discontinued in 4 patients because of unrelated adverse events. Mobilization of CD34(+ cells was observed with no concomitant changes in blood chemistry, except for an increase in the leukocyte count up to 75,500/µl. Neuroradiological and neuropsychological follow-up studies did not disclose any specific G-CSF toxicity. VGM findings indicated substantial atrophy of related hemispheres, a substantial increase in the CSF space, and a localized increase in parenchyma within the ischemic area in 2 patients. CONCLUSIONS: We demonstrate a good safety profile for daily administration of G-CSF when begun within 12 hours after onset of ischemic stroke and, in part in combination with routine i.v. thrombolysis. Additional analyses using VGM and a battery of neuropsychological tests indicated a positive functional and potentially structural effect of G-CSF treatment in some of our patients. TRIAL REGISTRATION: German

  3. Comparison of participants and non-participants in a randomized study of prevention of depression in patients with acute coronary syndrome

    DEFF Research Database (Denmark)

    Hansen, Baiba; Hanash, Jamal A.; Rasmussen, Alice;

    2011-01-01

    Background: The prevalence of depression and anxiety in patients after acute coronary syndrome (ACS) is higher than in the general population. In a study on prevention of post-ACS depression, more than half of eligible patients declined participation. Aims: The aim of this study was to evaluate...... but did not predict participation in the study of prevention of depression....... whether symptoms of depression and anxiety in participants and non-participants predicted participation in the study. Methods: This substudy was conducted between May 2005 and April 2007. Patients with ACS, eligible for the study (n=302) were asked four questions on depression and anxiety from the Primary...

  4. [Efficacy of lamivudine monotherapy and combination therapy with adefovir dipivoxil for patients with hepatitis B virus-related decompensated cirrhosis].

    Science.gov (United States)

    Jia, Hong-Yu; Lu, Wei; Zheng, Lin; Ying, Ling-Jun; Yang, Yi-da

    2011-02-01

    To compare the efficacy of Lamivudine (LAM) monotherapy and combination therapy with Adefovir Dipivoxil (ADV) for patients with hepatitis B virus (HBV) -related decompensated cirrhosis for 2 years. A total of 115 patients with HBV-related decompensated cirrhosis were erolled in this study, among 60 patients were treated with LAM combined with ADV and 55 were treated with LAM. The liver and kidney functions, HBV DNA, HBV-M, AFP, Ultrasond or CT scan of liver were tested every 1-3months. the treatment efficacy was evaluated by month 12 and 24. By month 12, the HBV DNA negative rates of combination therapy group and LAM monotherapy group were 51.1% (45 cases) and 47.5% (40 cases) respectively, by month 24 the rates were 86.7% and 60.0% respectively. By month 24 the HBeAg negative rates of combination therapy group and LAM monotherapy group were 43.5% and 30.0% respectively, with significant difference existed between the two therapy groups (P values is less than 0.05). By month 24, the ALT normalization rates of the two groups were 88.9% and 72.5% respectively. Viral breakthrough happened in 2 cases (4.4%) by month 12 and 3 cases (6.7%) by month 24 in LAM and ADV combination group, but no viral resistance observed. Viral breakthrough happened in 9 cases (22.5%) by month 12 and 15 cases (37.5%) by month 24 in LAM monotherapy group with viral resistance observed in 7 cases (17.5%) by month 12 and 13 cases (32.5) by month 24. Significant difference existed between the two groups (P is less than 0.05). Improvement of liver function was more obviously in the combination group. The accumulative total mortality or liver transplantation rate were 16.7% and 20.0% respectively in combination therapy group and LAM monotheapy group. No renal dysfunction observed in both groups. LAM combined with ADV is better choice for patients with HBV-related decompensated cirrhosis as compared to LAM monotherapy.

  5. 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

    Directory of Open Access Journals (Sweden)

    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

  6. Changes in pain, dysfunction, and grip strength of patients with acute lateral epicondylitis caused by frequency of physical therapy: a randomized controlled trial.

    Science.gov (United States)

    Lee, Soyoung; Ko, Youngjun; Lee, Wanhee

    2014-07-01

    [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 weeks. The outcome measurements were the visual analogue scale (VAS), Patient-Rated Tennis Elbow Evaluation (PRTEE), and grip strength. [Results] The results of this study were as follows: at 3 weeks, there were no significant differences in VAS and PRTEE in the 3 groups, but at 6 weeks, 6 days per week group significantly decreased these two outcomes. Grip strength was significantly increased in 3 and 6 days per week groups at 6 weeks. [Conclusion] In conclusion, physical therapy is needed 3 days per week for 3 weeks in patients with acute lateral epicondylitis. After 3 weeks, 6 days per week is the most effective treatment frequency.

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

    DEFF Research Database (Denmark)

    Friis-Møller, Alice; Agren, MS; Ostenfeld, U;

    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...... 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 zinc levels to 1,540 (1,035-2,265) microM and decreased (p zinc oxide (n = 3) than placebo......-treated patients (n = 12) were prescribed postoperative antibiotics (p = 0.005). Serum-zinc levels increased (p Zinc oxide was not associated with increased pain by the visual analog scale, cellular...

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

    DEFF Research Database (Denmark)

    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...... 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 wound fluid zinc levels to 1,540 (1,035-2,265) microM and decreased (p wounds. Fewer zinc oxide (n = 3) than placebo...... 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....

  9. Pyronaridine-Artesunate versus Chloroquine in Patients with Acute Plasmodium vivax Malaria: A Randomized, Double-Blind, Non-Inferiority Trial

    OpenAIRE

    Yi Poravuth; Duong Socheat; Ronnatrai Rueangweerayut; Chirapong Uthaisin; Aung Pyae Phyo; Neena Valecha; B. H. Krishnamoorthy Rao; Emiliana Tjitra; Asep Purnama; Isabelle Borghini-Fuhrer; Stephan Duparc; Chang-Sik Shin; Lawrence Fleckenstein

    2011-01-01

    BACKGROUND: New antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safety of pyronaridine-artesunate with that of chloroquine for the treatment of uncomplicated P. vivax malaria. METHODS AND FINDINGS: This phase III randomized, double-blind, non-inferiority trial included five centers across Cambodia, Thailand, India, and Indonesia. In a double-dummy design, patients (aged >3-≤ 60 years) with microscopically confirmed P. vivax mono-infection ...

  10. Evaluation of Talbot's Safety Zone of Infusion Volume and Osmolality in Infusion Therapy for Decompensated Liver Cirrhosis

    Directory of Open Access Journals (Sweden)

    Yuasa,Shiro

    1985-06-01

    Full Text Available Problems with infusion therapy for correcting fluid and sodium imbalance in decompensated liver cirrhosis (DLC were investigated by establishing the safety zone of Talbot et al. for parenteral fluid therapy in 4 DLC patients infused with over 900 ml of fluid each day for at least 9 days. The safety zone was different in each case. The safe infusion volume decreased and the safe electrolyte concentration shifted to a lower osmolality when there was ascites with renal failure than ascites without renal failure. Infusion therapy was performed without deterioration of the water and sodium balance in those patients whose infusion volume and fluid osmolality were in the safety zone. In contrast, ascites retention increased and peripheral edema appeared in patients whose infusion volume and osmolality were out of the safety zone. Therefore, the safety zone should be determined repeatedly during infusion therapy.

  11. Imatinib-induced decompensated heart failure in an elderly patient with chronic myeloid leukemia: case report and literature review

    Institute of Scientific and Technical Information of China (English)

    Hai-Hong Ran; Ran Zhang; Xue-Chun Lu; Bo Yang; Hui Fan; Hong-Li Zhu

    2012-01-01

    Because it is safe and well tolerated, imatinib is a standard first-line therapy for chronic myeloid leukemia (CML). Although there have been sporadic reports of imatinib-induced cardiotoxicity, including left ventricle (LV) dysfunction and heart failure, the evidence for it is contradictory. Here, we reported a case of an 88-year-old male patient with CML developed decompensated heart failure following imatinib therapy. Four days after the initiation of imatinib, the patient developed orthopnea, edema and a pleural effusion accompanied by abdominal distension, nausea and vomiting. The chest X-ray film showed an enlarged cardiac profile. The echocardiogram demonstrated a decreased LV ejection fraction and enlarged left-side cardiac chambers. B-type natriuretic peptide concentrations were markedly increased. The patient recovered soon after the withdrawal of imatinib and introduction of comprehensive therapy for heart failure. Imatinib-induced cardiotoxicity in elderly patients is a potentially serious complication that merits further evaluation.

  12. Orthodontic decompensation and correction of skeletal Class III malocclusion with gradual dentoalveolar remodeling in a growing patient.

    Science.gov (United States)

    Cai, Bin; Zhao, Xiao-Guang; Xiang, Lu-Sai

    2014-03-01

    An 8-year-old girl with a skeletal Class III malocclusion was treated in 2 phases. Maxillary expansion and protraction were carried out as the early intervention. However, her maxillary hypoplasia and mandibular hyperplasia deteriorated with age. The phase 2 comprehensive treatment began with proper mechanics when she was 12 years old with growth potential. In the maxillary arch, an auxiliary rectangular wire was used with a round main wire and an opening spring to create space for the impacted teeth and to bodily move the anterior teeth forward. Decompensation of mandibular incisors and correction of the Class III malocclusion were achieved by short Class III elastics with light forces and a gentle interaction between the rectangular wires and the lingual root-torque slots. The phase 2 active treatment period was 4 years 8 months. The 2-year follow-up indicated that our treatment results were quite stable.

  13. Immunomodulatory effect of NSAID in geriatric patients with acute infection: effects of piroxicam on chemokine/cytokine secretion patterns and levels of heat shock proteins. A double-blind randomized controlled trial. (ISRCTN58517443).

    Science.gov (United States)

    Beyer, Ingo; Njemini, Rose; Bautmans, Ivan; Demanet, Christian; Mets, Tony

    2012-03-01

    Inflammation in older persons is associated with frailty, cachexia, and disability. We hypothesized that NSAID treatment in addition to antibiotics in older patients with acute infection might rapidly reduce inflammatory cytokines and might be of therapeutic potential to improve outcomes. A double-blind controlled trial was conducted in geriatric patients admitted for acute infection. Patients were randomized to receive either 10 mg piroxicam or placebo. Patients ≥70 years with CRP levels >10 mg/L of acute infectious origin were eligible. Twenty-five cyto-/chemokines as well as heat shock proteins Hsp27 (HSPB1) and Hsp70 (HSPA1A) were measured the first 4 days and then weekly until discharge, with a maximum of 3 weeks. Thirty Caucasian patients were included (median age 84.5 years, 67% female, median CRP 87.5 mg/L). In the piroxicam group, IL-6 and IP-10/CXCL10 decreased significantly during the study period. Relationships between cytokines were disrupted in the piroxicam group: for 12 out of 20 cytokines the number of correlations between changes in serum levels was significantly lower compared to placebo. Serum Hsp70 levels decreased significantly in the piroxicam group, but not in the placebo group. Without heat challenge, intracellular levels of Hsp70 in monocytes decreased in both groups, whereas HsP27 in monocytes increased with piroxicam with a significant difference compared to placebo at 3 weeks. Piroxicam in this setting cannot be considered merely as an anti-inflammatory drug, but rather as an immunomodulator. Further studies are needed to establish whether these effects can change functional outcomes in geriatric patients.

  14. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: A randomized controlled trial [ISRCTN87413556

    Directory of Open Access Journals (Sweden)

    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.

  15. Randomization tests

    CERN Document Server

    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

  16. Long-term outcome of primary angioplasty compared with fibrinolysis across age groups: a Danish Multicenter Randomized Study on Fibrinolytic Therapy Versus Acute Coronary Angioplasty in Acute Myocardial Infarction (DANAMI-2) substudy

    DEFF Research Database (Denmark)

    Fosbøl, Emil Loldrup; Thune, Jens Jakob; Kelbaek, Henning;

    2008-01-01

    BACKGROUND: Primary angioplasty in patients with acute ST-elevation myocardial infarction has been shown to be superior to fibrinolysis. Whether elderly patients have the same long-term benefit from angioplasty, compared with fibrinolysis, as younger patients is unknown. METHODS: The effect...... of angioplasty versus fibrinolysis was investigated in 1,572 patients from the DANAMI-2 study across age groups. End points were total mortality and a composite end point of death, reinfarction, or disabling stroke. Follow-up was 3 years. RESULTS: Increasing age was associated with mortality (adjusted hazard...... ratio [HR] 2.45 per 10 year increment, 95% confidence interval [CI] 1.78-3.37, P angioplasty over fibrinolysis on the combined outcome was independent of age: patients aged

  17. Randomized comparison of the efficacies and tolerabilities of three artemisinin-based combination treatments for children with acute Plasmodium falciparum malaria in the Democratic Republic of the Congo.

    Science.gov (United States)

    Onyamboko, M A; Fanello, C I; Wongsaen, K; Tarning, J; Cheah, P Y; Tshefu, K A; Dondorp, A M; Nosten, F; White, N J; Day, N P J

    2014-09-01

    An open-label, randomized controlled trial was carried out in 2011-2012 in the Democratic Republic of the Congo to test the efficacy, safety, and tolerability of the artemisinin-based combination treatments dihydroartemisinin-piperaquine, amodiaquine-artesunate, and artemether-lumefantrine. Six hundred eighty-four children aged 3 to 59 months with uncomplicated Plasmodium falciparum malaria were randomly allocated to each study arm. Children were hospitalized for 3 days, given supervised treatment, and followed up weekly for 42 days. All regimens were well tolerated and rapidly effective. The median parasitemia clearance half-life was 2.2 h, and half-lives were similar between arms (P=0.19). The PCR-uncorrected cure rates by day 42 were 73.0% for amodiaquine-artesunate, 70.2% for artemether-lumefantrine, and 86.3% for dihydroartemisinin-piperaquine (P=0.001). Early treatment failure occurred in three patients (0.5%), one in each arm. The PCR-corrected cure rates were 93.4% for amodiaquine-artesunate, 92.7% for artemether-lumefantrine, and 94.3% for dihydroartemisinin-piperaquine (P=0.78). The last provided a longer posttreatment prophylactic effect than did the other two treatments. The day 7 plasma concentration of piperaquine was below 30 ng/ml in 47% of the children treated with dihydroartemisinin-piperaquine, and the day 7 lumefantrine concentration was below 280 ng/ml in 37.0% of children who received artemether-lumefantrine. Thus, although cure rates were all satisfactory, they could be improved by increasing the dose. (This study has been registered with the International Standard Randomized Controlled Trial Number Register [www.isrctn.org] under registration no. ISRCTN20984426.).

  18. Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study versus rizatriptan.

    Science.gov (United States)

    Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D; Zava, Dario; Pinessi, Lorenzo

    2011-12-01

    The objectives of this study are to assess the efficacy and safety of frovatriptan, and rizatriptan in the subgroup of women with menstrually related migraine of a multicenter, randomized, double blind, cross-over study. Each patient received frovatriptan 2.5 mg or rizatriptan 10 mg in a randomized sequence: after treating 3 episodes of migraine in not more than 3 months with the first treatment, the patient had to switch to the other treatment. Menstrually related migraine was defined according to the criteria listed in the Appendix of the last IHS Classification of Headache disorders. 99 out of the 125 patients included in the intention-to-treat analysis of the main study were of a female gender: 93 had regular menstrual cycles and were, thus, included in this analysis. A total of 49 attacks classified as menstrually related migraine were treated with frovatriptan and 59 with rizatriptan. Rate of pain relief at 2 h was 58% for frovatriptan and 64% for rizatriptan (p = NS), while rate of pain free at 2 h was 31 and 34% (p = NS), respectively. At 24 h, 67 and 81% of frovatriptan-treated, and 61 and 74% of rizatriptan-treated patients were pain free and had pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p rizatriptan). Frovatriptan was as effective as rizatriptan in the immediate treatment of menstrually related migraine attacks while showing a favorable sustained effect with a lower rate of migraine recurrence. These results need to be confirmed by randomized, double-blind, prospective, large clinical trials.

  19. Is high-frequency oscillatory ventilation more effective and safer than conventional protective ventilation in adult acute respiratory distress syndrome patients? A meta-analysis of randomized controlled trials

    Science.gov (United States)

    2014-01-01

    Introduction Comprehensively evaluating the efficacy and safety of high-frequency oscillatory ventilation (HFOV) is important to allow clinicians who are using or considering this intervention to make appropriate decisions. Methods To find randomized controlled trials (RCTs) comparing HFOV with conventional mechanical ventilation (CMV) as an initial treatment for adult ARDS patients, we searched electronic databases (including PubMed, MedLine, Springer Link, Elsevier Science Direct, ISI web of knowledge, and EMBASE) with the following terms: “acute respiratory distress syndrome”, “acute lung injury”, and “high frequency oscillation ventilation”. Additional sources included reference lists from the identified primary studies and relevant meta-analyses. Two investigators independently screened articles and extracted data. Meta-analysis was conducted using random-effects models. Results We included 6 RCTs with a total of 1,608 patients in this meta-analysis. Compared with CMV, HFOV did not significantly reduce the mortality at 30 or 28 days. The pooled relative risk (RR) was 1.051 (95% confidence interval (CI) 0.813 to 1.358). ICU mortality was also not significantly reduced in HFOV group, with a pooled RR of 1.218 (95% CI 0.925 to 1.604). The pooled effect sizes of HFOV for oxygenation failure, ventilation failure and duration of mechanical ventilation were 0.557 (95% CI 0.351 to 0.884), 0.892 (95% CI 0.435 to 1.829) and 0.079 (95% CI −0.045 to 0.203), respectively. The risk of barotrauma and hypotension were similar between the CMV group and HFOV group, with a RR of 1.205 (95% CI 0.834 to 1.742) and a RR of 1.326 (95% CI 0.271 to 6.476), respectively. Conclusions Although HFOV seems not to increase the risk of barotrauma or hypotension, and reduces the risk of oxygenation failure, it does not improve survival in adult acute respiratory distress syndrome patients. PMID:24887179

  20. Efficacy and safety of tonabersat, a gap-junction modulator, in the acute treatment of migraine: a double-blind, parallel-group, randomized study

    DEFF Research Database (Denmark)

    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...... tolerated and had no effect on vital signs, electrocardiogram recordings or laboratory values. The lack of efficacy may be a function of the slow absorption of tonabersat. As a consequence of slow absorption, daily administration of tonabersat as prophylaxis for migraine attacks is under investigation...

  1. Comparison of the acute-phase response after laparoscopic versus open aortobifemoral bypass surgery: a substudy of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Krog AH

    2016-09-01

    Full Text Available Anne H Krog,1,2 Mehdi Sahba,3 Erik M Pettersen,4 Irene Sandven,5 Per M Thorsby,1,6 Jørgen J Jørgensen,1,2 Jon O Sundhagen,2 Syed SS Kazmi2 1Institute of Clinical Medicine, University of Oslo, 2Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, 3Department of Vascular Surgery, Østfold Central Hospital, Fredrikstad, 4Department of Vascular Surgery, Sørlandet Hospital HF, Kristiansand, 5Oslo Center for Biostatistics and Epidemiology (OCBE, 6Hormone Laboratory, Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway Purpose: Minimally invasive surgical techniques have been shown to reduce the inflammatory response related to a surgical procedure. The main objective of our study was to measure the inflammatory response in patients undergoing a totally laparoscopic versus open aortobifemoral bypass surgery. This is the first randomized trial on subjects in this population.Patients and methods: This is a substudy of a larger randomized controlled multicenter trial (Norwegian Laparoscopic Aortic Surgery Trial. Thirty consecutive patients with severe aortoiliac occlusive disease eligible for aortobifemoral bypass surgery were randomized to either a totally laparoscopic (n=14 or an open surgical procedure (n=16. The inflammatory response was measured by perioperative monitoring of serum interleukin-6 (IL-6, IL-8, and C-reactive protein (CRP at six different time points.Results: The inflammatory reaction caused by the laparoscopic procedure was reduced compared with open surgery. IL-6 was significantly lower after the laparoscopic procedure, measured by comparing area under the curve (AUC, and after adjusting for the confounding effect of coronary heart disease (P=0.010. The differences in serum levels of IL-8 and CRP did not reach statistical significance.Conclusion: In this substudy of a randomized controlled trial comparing laparoscopic and open aortobifemoral bypass

  2. 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

    Directory of Open Access Journals (Sweden)

    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

  3. 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

    Science.gov (United States)

    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

  4. 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.

    Science.gov (United States)

    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

  5. Efficacy of Danlou Tablet in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Results from a Multicentre, Placebo-Controlled, Randomized Trial

    Directory of Open Access Journals (Sweden)

    Lei Wang

    2016-01-01

    Full Text Available This study seeks to investigate potential cardioprotection of Danlou Tablets in patients undergoing PCI with non-ST elevation acute coronary syndrome (NSTE-ACS. 219 patients with NSTE-ACS were randomised to Danlou Tablet pretreatment (n=109 or placebo (n=110. No patients received statins prior to PCI and all patients were given atorvastatin (10 mg/day after procedure. The main endpoint was the composite incidence of major adverse cardiac events (MACEs within 30 days after PCI. The proportion of patients with elevated levels of cTn I>5 × 99% of upper reference limit was significantly lower in the Danlou Tablet group at 8 h (22.0% versus 34.5%, p=0.04 and 24 h (23.9% versus 38.2%, p=0.02 after PCI. The 30-day MACEs occurred in 22.0% of the Danlou Tablet group and 33.6% in the placebo group (p=0.06. The incidence of MACE at 90-day follow-up was significantly decreased in the Danlou Tablet group compared to the placebo group (23.9% versus 37.3%, p=0.03. The difference between the groups at 90 days was the incidence of nonfatal myocardial infarction (22% versus 34.5%, p=0.04. These findings might support that treatment with Danlou Tablet could reduce the incidence of periprocedural myocardial infarction in patients with ACS undergoing PCI.

  6. Introduction of a prognostic biomarker to strengthen risk stratification of acutely admitted patients: rationale and design of the TRIAGE III cluster randomized interventional trial

    DEFF Research Database (Denmark)

    Sandø, Andreas; Schultz, Martin; Eugen-Olsen, Jesper

    2016-01-01

    patients at the ED. The main hypothesis is that the availability of suPAR can reduce all-cause mortality, assessed at least 10 months after admission, by drawing attention towards patients with an unrecognized high risk, leading to improved diagnostics and treatment. METHODS: The study is designed...... as a cross-over cluster randomized interventional trial. SuPAR is measured within 2 h after admission and immediately reported to the treating physicians in the ED. All ED physicians are educated in the prognostic capabilities of suPAR prior to the inclusion period. The inclusion period began January 11(th......) 2016 and ends June 6(th) 2016. The study aims to include 10.000 patients in both the interventional and control arm. The results will be presented in 2017. DISCUSSION: The present article aims to describe the design and rationale of the TRIAGE III study that will investigate whether the availability...

  7. Dynamics of adaptive and innate immunity in patients treated during primary human immunodeficiency virus infection: results from Maraviroc in HIV Acute Infection (MAIN) randomized clinical trial.

    Science.gov (United States)

    Ripa, M; Pogliaghi, M; Chiappetta, S; Galli, L; Pensieroso, S; Cavarelli, M; Scarlatti, G; De Biasi, S; Cossarizza, A; De Battista, D; Malnati, M; Lazzarin, A; Nozza, S; Tambussi, G

    2015-09-01

    We evaluated the dynamics of innate and adaptive immunity in patients treated with combined antiretroviral therapy (cART) during primary human immunodeficiency virus infection (PHI), enrolled in a prospective randomized trial (MAIN, EUDRACT 2008-007004-29). After 48 weeks of cART, we documented a reduction in activated B cells and CD8(+) T cells. Natural killer cell and dendritic cell frequencies were measured and a decrease in CD16(+) CD56(dim) with a reciprocal rise in CD56(high) natural killer cells and an increase in myeloid and plasmacytoid dendritic cells were recorded. In conclusion, 48 weeks of cART during PHI showed significant benefits for both innate and adaptive immunity.

  8. Randomized trial of two schedules of low-dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukaemia in older patients not considered candidates for intensive chemotherapy. A phase II study of the EORTC and GIMEMA leukaemia groups (AML-19).

    NARCIS (Netherlands)

    Amadori, S.; Suciu, S.; Selleslag, D.; Stasi, R.; Alimena, G.; Baila, L.; Rizzoli, V.; Borlenghi, E.; Gaidano, G.; Magro, D.; Torelli, G.; Muus, P.; Venditti, A.; Cacciola, E.; Lauria, F.; Vignetti, M.; Witte, T.J.M. de

    2010-01-01

    This study compared two schedules of low-dose gemtuzumab ozogamicin (GO) as induction monotherapy for untreated acute myeloid leukaemia in older patients unfit for intensive chemotherapy, to identify the more promising regimen for further study. Patients were randomized to receive either best suppor

  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

    Directory of Open Access Journals (Sweden)

    Pierre Thomas

    2008-06-01

    Full Text Available Pierre Thomas1, Eduard Vieta2 for the SOLMANIA study group1Department of Psychiatry, Fontan Hospital CHRU Lille, University of Lille 2, France; 2Bipolar Disorders Program, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, SpainAbstract: 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 of responders (defined by a decrease of ≥50% of the Y-MRS in patients completing the study. Safety was evaluated by adverse event reporting, determination of extrapyramidal function and clinical examination. Sixty-two patients were randomized to receive valproate-amisulpride, and 61 to receive valproate-haloperidol. At study end, responder rates were 72.6% in the amisulpride group and 65.5% in the haloperidol group. Remission rates were 83.9% and 89.7%, respectively. At study end, neither response rates nor remission rates differed significantly between groups. Treatment-emergent adverse events occurred significantly (p = 0.009 more frequently in the haloperidol group (86.4% than in the amisulpride group (66.1%. In conclusion, the valproate–amisulpride combination was as effective as the valproate – haloperidol combination in bipolar I patients, with a better safety profile.Keywords: amisulpride, valproate, haloperidol, clinical trial, mania, bipolar disorder

  10. 恩替卡韦治疗失代偿期乙型肝炎肝硬化的效果观察%Clinical observation of entecavir for the treatment of decompensation period of hepatitis B cirrhosis

    Institute of Scientific and Technical Information of China (English)

    葛亮; 林宾; 田瑞; 胡爱华

    2013-01-01

    目的探讨恩替卡韦治疗失代偿期乙型肝炎肝硬化的治疗效果及安全性。方法对失代偿期乙型肝炎肝硬化患者的临床资料进行回顾性分析和总结。将64例患者分为治疗组和对照组各32例,对照组进行一般治疗,如给予休息、合理饮食,利尿、保肝退黄、血浆蛋白支持、抗感染、止血等对症、支持以及预防并发症治疗;治疗组在对照组治疗的基础上,加用恩替卡韦进行治疗,观察两组患者治疗前、治疗后4周、12周及24周时患者的临床症状、肝功能以及HBV DNA转阴率、不良反应等情况。结果治疗组中,HBV DNA定量改善情况不仅优于治疗前(P<0.05),而且明显优于对照组(P<0.05),同时HBV DNA转阴率明显高于对照组(P<0.05);ALT、TBIL等指标改善情况明显优于对照组(P<0.05),ALB未见明显变化(P>0.05),未见明显不良反应发生。结论失代偿期乙型肝炎肝硬化患者应用恩替卡韦进行治疗,可明显改善患者的肝功能,延长患者的生存期,改善患者的生存质量,效果较为理想。%Objective To investigate the therapeutic effect and safety of entecavir for the treatment of decompensation period of hepatitis B cirrhosis. Methods The clinical data in patients with decompensation period of hepatitis B cirrhosis were retrospectively analyzed and summarized.64 patients were randomly divided into treatment group and control group,,each group had 32 cases,the control group with general treatment,such as rest,reasonable diet,diuresis,protect liver back yellow,plasma protein support,anti-infection,staunch the bleeding etc. symptomatic treatment,supported and prevented complications;The treatment group based on the control group,added entecavir. Observed two groups of patients before treatment,4 weeks,12 weeks and 24 weeks after treatment in patients with clinical symptoms,liver function and HBV DNA turn rate

  11. A randomized, prospective, two-center comparison of sirolimus-eluting stent and zotarolimus-eluting stent in acute ST-elevation myocardial infarction: The SEZE trial

    Institute of Scientific and Technical Information of China (English)

    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.

  12. Systematic Review and Pooled Analyses of Recent Neurointerventional Randomized Controlled Trials: Setting a New Standard of Care for Acute Ischemic Stroke Treatment after 20 Years

    Science.gov (United States)

    Hussain, Mohammed; Moussavi, Mohammad; Korya, Daniel; Mehta, Siddhart; Brar, Jaskiran; Chahal, Harina; Qureshi, Ihtesham; Mehta, Tapan; Ahmad, Javaad; Zaidat, Osama O.; Kirmani, Jawad F.

    2016-01-01

    Background Recent advances in the treatment of ischemic stroke have focused on revascularization and led to better clinical and functional outcomes. A systematic review and pooled analyses of 6 recent multicentered prospective randomized controlled trials (MPRCT) were performed to compare intravenous tissue plasminogen activator (IV tPA) and endovascular therapy (intervention) with IV tPA alone (control) for anterior circulation ischemic stroke (AIS) secondary to large vessel occlusion (LVO). Objectives Six MPRCTs (MR CLEAN, ESCAPE, EXTEND IA, SWIFT PRIME, REVASCAT and THERAPY) incorporating image-based LVO AIS were selected for assessing the following: (1) prespecified primary clinical outcomes of AIS patients in intervention and control arms: good outcomes were defined by a modified Rankin Scale score of 0-2 at 90 days; (2) secondary clinical outcomes were: (a) revascularization rates [favorable outcomes defined as modified Thrombolysis in Cerebral Infarction scale (mTICI) score of 2b/3]; (b) symptomatic intracranial hemorrhage (sICH) rates and mortality; (c) derivation of number needed to harm (NNH), number needed to treat (NNT), and relative percent difference (RPD) between intervention and control groups, and (d) random effects model to determine overall significance (forest and funnel plots). Results A total of 1,386 patients were included. Good outcomes at 90 days were seen in 46% of patients in the intervention (p < 0.00001) and in 27% of patients in the control groups (p < 0.00002). An mTICI score of 2b/3 was achieved in 70.2% of patients in the intervention arm. The sICH and mortality in the intervention arm compared with the control arm were 4.7 and 14.3% versus 7.9 and 17.8%, respectively. The NNT and NNH in the intervention and control groups were 5.3 and 9.1, respectively. Patients in the intervention arm had a 50.1% (RPD) better chance of achieving a good 90-day outcome as compared to controls. Conclusions Endovascular therapy combined with IV t

  13. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies.

    Science.gov (United States)

    Mannix, L K; Loder, E; Nett, R; Mueller, L; Rodgers, A; Hustad, C M; Ramsey, K E; Skobieranda, F

    2007-05-01

    These are the first prospective studies to use criteria for menstrual migraine proposed in the 2004 revision of the International Classification of Headache Disorders (ICHD-II) to examine the efficacy of rizatriptan for treatment of a menstrual attack. Two identical protocols (MM1 and MM2) were randomized, parallel, placebo-controlled, double-blind studies. Adult women with ICHD-II menstrual migraine were assigned to either rizatriptan 10-mg tablet or placebo in a 2 : 1 ratio. Patients treated a single menstrual migraine attack of moderate or severe pain intensity. The primary end-point was 2-h pain relief and the secondary end-point was 24-h sustained pain relief. A total of 707 patients (MM1 357, MM2 350) treated a menstrual migraine attack. The percentage of patients reporting 2-h pain relief was significantly greater for rizatriptan than for placebo (MM1 70% vs. 53%, MM2 73% vs. 50%), as was the percentage of patients reporting 24-h sustained pain relief (MM1 46% vs. 33%; MM2 46% vs. 33%). Rizatriptan 10 mg was effective for the treatment of ICHD-II menstrual migraine, as measured by 2-h pain relief and 24-h sustained pain relief.

  14. A single serving of blueberry (V. corymbosum) modulates peripheral arterial dysfunction induced by acute cigarette smoking in young volunteers: a randomized-controlled trial.

    Science.gov (United States)

    Del Bo', Cristian; Porrini, Marisa; Fracassetti, Daniela; Campolo, Jonica; Klimis-Zacas, Dorothy; Riso, Patrizia

    2014-12-01

    Cigarette smoking causes oxidative stress, hypertension and endothelial dysfunction. Polyphenol-rich foods may prevent these conditions. We investigated the effect of a single serving of fresh-frozen blueberry intake on peripheral arterial function and arterial stiffness in young smokers. Sixteen male smokers were recruited for a 3-armed randomized-controlled study with the following experimental conditions: smoking treatment (one cigarette); blueberry treatment (300 g of blueberry) + smoking; control treatment (300 mL of water with sugar) + smoking. Each treatment was separated by one week of wash-out period. The blood pressure, heart rate, peripheral arterial function (reactive hyperemia and Framingham reactive hyperemia), and arterial stiffness (digital augmentation index, digital augmentation index normalized for a heart rate of 75 bpm) were measured before and 20 min after smoking with Endo-PAT2000. Smoking impaired the blood pressure, heart rate and peripheral arterial function, but did not affect the arterial stiffness. Blueberry consumption counteracted the impairment of the reactive hyperemia index induced by smoking (-4.4 ± 0.8% blueberry treatment vs. -22.0 ± 1.1% smoking treatment, p smoking treatment, p smoking treatment, mmHg, p smoking. No effect was observed for arterial stiffness and other vital signs. In conclusion, data obtained suggest a protective role of blueberry on reactive hyperemia, Framingham reactive hyperemia, and systolic blood pressure in subjects exposed to smoke of one cigarette. Future studies are necessary to elucidate the mechanisms involved.

  15. 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.

    Science.gov (United States)

    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 peas led to lower BG compared with fibre (p pea components as value-added ingredients in foods designed to improve glycemic control.

  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

    Directory of Open Access Journals (Sweden)

    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. Acute-on-chronic Liver Failure.

    Science.gov (United States)

    Sarin, Shiv Kumar; Choudhury, Ashok

    2016-12-01

    Acute-on-chronic liver failure (ACLF) is a distinct entity that differs from acute liver failure and decompensated cirrhosis in timing, presence of treatable acute precipitant, and course of disease, with a potential for self-recovery. The core concept is acute deterioration of existing liver function in a patient of chronic liver disease with or without cirrhosis in response to an acute insult. The insult should be a hepatic one and presentation in the form of liver failure (jaundice, encephalopathy, coagulopathy, ascites) with or without extrahepatic organ failure in a defined time frame. ACLF is characterized by a state of deregulated inflammation. Initial cytokine burst presenting as SIRS, progression to CARS and associated immunoparalysis leads to sepsis and multi-organ failure. Early identification of the acute insult and mitigation of the same, use of nucleoside analogue in HBV-ACLF, steroid in severe alcoholic hepatitis, steroid in severe autoimmune hepatitis and/or bridging therapy lead to recovery, with a 90-day transplant-free survival rate of up to 50 %. First-week presentation is crucial concerning SIRS/sepsis, development, multiorgan failure and consideration of transplant. A protocol-based multi-disciplinary approach including critical care hepatology, early liver transplant before multi-organ involvement, or priority for organ allocation may improve the outcome. Presentation with extrahepatic organ involvement or inclusion of sepsis as an acute insult in definition restricts the therapy, i.e., liver transplant or bridging therapy, and needs serious consideration. Augmentation of regeneration, cell-based therapy, immunotherapy, and gut microbiota modulation are the emerging areas and need further research.

  18. MELD vs Child-Pugh and creatinine-modified Child-Pugh score for predicting survival in patients with decompensated cirrhosis

    Institute of Scientific and Technical Information of China (English)

    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.

  19. 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

    Directory of Open Access Journals (Sweden)

    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

  20. Effects of recombinant human brain natriuretic peptide on the prognosis of patients with acute anterior myocardial infarction undergoing primary percutaneous coronary intervention: a prospective, multi-center, randomized clinical trial

    Science.gov (United States)

    Hou, Ai-Jie; Zang, Hong-Yun; Huang, Ru-Gang; Zheng, Xiao-Qun; Lin, Hai-Long; Wang, Wei; Hou, Ping; Xia, Fei; Li, Zhan-Quan

    2017-01-01

    Background This study aims to investigate the effects of recombinant human brain natriuretic peptide (rhBNP) on serum enzyme data, cardiac function parameters and cardiovascular events in patients with acute anterior myocardial infarction (MI). Methods A total of 421 patients with acute anterior or extensive anterior MI were collected from 20 hospitals. These patients were randomly divided into two groups: rhBNP and control groups. Both groups of patients received primary percutaneous coronary intervention (PCI) within the effective time window. In the rhBNP group, rhBNP administration (0.01 µg/kg/min, 48–72 successive hours) was performed as early as possible after hospital admission. Prior to and one or seven days after PCI, serum concentrations of cardiac troponin (cTnT), creatine kinase-MB (CK-MB) and N-terminal pro-brain natriuretic peptide (NT-proBNP) were measured. At seven days and 6 months after PCI, left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDd) and stroke volume (SV) were measured using 2D Doppler echocardiography. MACEs that occurred during hospitalization and within 6 months after PCI were recorded. Results At postoperative days one and seven, serum concentrations of cTnT were significantly lower in the rhBNP group than in the control group. At postoperative day one, serum concentrations of CK-MB were significantly lower in the rhBNP group than in the control group. At postoperative day seven, serum concentrations of NT-proBNP were significantly lower in the rhBNP group than in the control group, and LVEF was significantly greater in the rhBNP group than in the control group. At postoperative 6 months, LVEDd was significantly lower in the rhBNP group compared with the control group. In addition, SV and LVEF were significantly greater in the rhBNP group than in the control group. By postoperative month 6, the incidence of composite cardiovascular events (16.0% vs. 26.0%, P=0.012), cardiac death (7.0% vs.13

  1. Acute ingestion of a novel whey-derived peptide improves vascular endothelial responses in healthy individuals: a randomized, placebo controlled trial

    Directory of Open Access Journals (Sweden)

    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.

  2. [Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study)].

    Science.gov (United States)

    Pujet, J C; Keddad, K; Sévenier, F; Jolivet-Landreau, I

    2002-01-01

    The objective was to compare, during a 5-day therapy, the efficacy and tolerability of an antihistaminic antitussive syrup, oxomemazine, combining a small quantity of guaifenesine (T), with a centrally acting antitussive, clobutinol (S), in adult patients aged from 18 to 70 years and presenting with a dry cough of infectious origin. This study was performed by 22 general practitioners and 130 ambulatory patients were enrolled. The primary criterion of this multicenter, randomized, single blind study was to compare the evolution of cough intensity using a Visual Analog Squale (VAS) graduated from 0 to 10 cm. Nine secondary criteria including tolerability were also assessed. With regard to cough intensity, the treatments were not equivalent. A greater reduction was observed with T (-5.2 +/- 2.3 versus -4.3 +/- 2.3). This result was confirmed by a further reduction in cough intensity at days: 2 (p = 0.04), 4 (p = 0.05), and 5 (p = 0.02). The frequency of cough disappearance before the end of the study was significantly greater for T than for S: 46% versus 29% (p = 0.05). The time before disappearance of the cough was 4.0 + 1.1 days for both medicines. Induction of sleep and the frequency of nocturnal wakening were significantly better for T from day 4 (p = 0.02). The drowsiness induced by T meant that diurnal quality of life was better with S on days 1 (p = 0.002) and 2 (p = 0.01). Tolerability was similar for both medicines. In conclusion, as a symptomatic treatment of dry cough, T is efficient and well tolerated. Moreover, we have observed a tendency towards superior efficacy of T than S. T is therefore a useful alternative in the therapeutic armamentarium available to the general practitioner.

  3. Acute Effects of Caffeine on Heart Rate Variability, Blood Pressure and Tidal Volume in Paraplegic and Tetraplegic Compared to Able-Bodied Individuals: A Randomized, Blinded Trial

    Science.gov (United States)

    Flueck, Joelle Leonie; Schaufelberger, Fabienne; Lienert, Martina; Schäfer Olstad, Daniela; Wilhelm, Matthias; Perret, Claudio

    2016-01-01

    Caffeine increases sympathetic nerve activity in healthy individuals. Such modulation of nervous system activity can be tracked by assessing the heart rate variability. This study aimed to investigate the influence of caffeine on time- and frequency-domain heart rate variability parameters, blood pressure and tidal volume in paraplegic and tetraplegic compared to able-bodied participants. Heart rate variability was measured in supine and sitting position pre and post ingestion of either placebo or 6 mg caffeine in 12 able-bodied, 9 paraplegic and 7 tetraplegic participants in a placebo-controlled, randomized and double-blind study design. Metronomic breathing was applied (0.25 Hz) and tidal volume was recorded during heart rate variability assessment. Blood pressure, plasma caffeine and epinephrine concentrations were analyzed pre and post ingestion. Most parameters of heart rate variability did not significantly change post caffeine ingestion compared to placebo. Tidal volume significantly increased post caffeine ingestion in able-bodied (p = 0.021) and paraplegic (p = 0.036) but not in tetraplegic participants (p = 0.34). Systolic and diastolic blood pressure increased significantly post caffeine in able-bodied (systolic: p = 0.003; diastolic: p = 0.021) and tetraplegic (systolic: p = 0.043; diastolic: p = 0.042) but not in paraplegic participants (systolic: p = 0.09; diastolic: p = 0.33). Plasma caffeine concentrations were significantly increased post caffeine ingestion in all three groups of participants (p<0.05). Plasma epinephrine concentrations increased significantly in able-bodied (p = 0.002) and paraplegic (p = 0.032) but not in tetraplegic participants (p = 0.63). The influence of caffeine on the autonomic nervous system seems to depend on the level of lesion and the extent of the impairment. Therefore, tetraplegic participants may be less influenced by caffeine ingestion. Trial Registration ClinicalTrials.gov NCT02083328 PMID:27776149

  4. [Acute rheumatic fever in children, a diagnostic problem].

    Science.gov (United States)

    Wieringa, J W; Ramaker, C; Wolf, B H M

    2006-05-20

    Three girls of Moroccan descent, aged 9, 10 and 7 years, presented with fever, joint pain and other symptoms. After Streptococcus infection and carditis were confirmed and the Jones criteria for acute rheumatic fever were met, the patients were treated with penicillin and acetylsalicylic acid. All 3 patients recovered. However, the second girl presented 2 months later with cardiac decompensation caused by valve disorders, after which aortic and mitral valvuloplasty was performed. The third girl developed joint pain again after 3 weeks and was diagnosed with juvenile idiopathic arthritis; treatment was adjusted accordingly. The prevalence of rheumatic heart diseases is 10-20 times higher in developing countries than in industrialised nations. The diagnosis 'acute rheumatic fever' should be considered in children of school age with unexplained fever, also when the Jones criteria have not yet been met. This may apply to migrant children in particular.

  5. Small Acute Benefits of 4 Weeks Processing Speed Training Games on Processing Speed and Inhibition Performance and Depressive Mood in the Healthy Elderly People: Evidence from a Randomized Control Trial.

    Science.gov (United States)

    Nouchi, Rui; Saito, Toshiki; Nouchi, Haruka; Kawashima, Ryuta

    2016-01-01

    Background: Processing speed training using a 1-year intervention period improves cognitive functions and emotional states of elderly people. Nevertheless, it remains unclear whether short-term processing speed training such as 4 weeks can benefit elderly people. This study was designed to investigate effects of 4 weeks of processing speed training on cognitive functions and emotional states of elderly people. Methods: We used a single-blinded randomized control trial (RCT). Seventy-two older adults were assigned randomly to two groups: a processing speed training game (PSTG) group and knowledge quiz training game (KQTG) group, an active control group. In PSTG, participants were asked to play PSTG (12 processing speed games) for 15 min, during five sessions per week, for 4 weeks. In the KQTG group, participants were asked to play KQTG (four knowledge quizzes) for 15 min, during five sessions per week, for 4 weeks. We measured several cognitive functions and emotional states before and after the 4 week intervention period. Results: Our results revealed that PSTG improved performances in processing speed and inhibition compared to KQTG, but did not improve performance in reasoning, shifting, short term/working memory, and episodic memory. Moreover, PSTG reduced the depressive mood score as measured by the Profile of Mood State compared to KQTG during the 4 week intervention period, but did not change other emotional measures. Discussion: This RCT first provided scientific evidence related to small acute benefits of 4 week PSTG on processing speed, inhibition, and depressive mood in healthy elderly people. We discuss possible mechanisms for improvements in processing speed and inhibition and reduction of the depressive mood. Trial registration: This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry (UMIN000022250).

  6. The Vitamin D Assessment (ViDA) Study: design of a randomized controlled trial of vitamin D supplementation for the prevention of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures.

    Science.gov (United States)

    Scragg, Robert; Waayer, Debbie; Stewart, Alistair W; Lawes, Carlene M M; Toop, Les; Murphy, Judy; Khaw, Kay-Tee; Camargo, Carlos A

    2016-11-01

    Observational studies have shown that low vitamin D status is associated with an increased risk of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures. We recruited 5110 Auckland adults, aged 50-84 years, into a randomized, double-blind, placebo-controlled trial to test whether vitamin D supplementation protects against these four major outcomes. The intervention is a monthly cholecalciferol dose of 100,000IU (2.5mg) for an estimated median 3.3 years (range 2.5-4.2) during 2011-2015. Participants were recruited primarily from family practices, plus community groups with a high proportion of Maori, Pacific, or South Asian individuals. The baseline evaluation included medical history, lifestyle, physical measurements (e.g. blood pressure, arterial waveform, lung function, muscle function), and a blood sample (stored at -80°C for later testing). Capsules are being mailed to home addresses with a questionnaire to collect data on non-hospitalized outcomes and to monitor adherence and potential adverse effects. Other data sources include New Zealand Ministry of Health data on mortality, hospitalization, cancer registrations and dispensed pharmaceuticals. A random sample of 438 participants returned for annual collection of blood samples to monitor adherence and safety (hypercalcemia), including repeat physical measurements at 12 months follow-up. The trial will allow testing of a priori hypotheses on several other endpoints including: weight, blood pressure, arterial waveform parameters, heart rate variability, lung function, muscle strength, gait and balance, mood, psoriasis, bone density, and chronic pain.

  7. Rationale and Design of a Randomized, Double-Blind, Placebo Controlled Multicenter Trial to Study Efficacy, Security, and Long Term Effects of Intermittent Repeated Levosimendan Administration in Patients with Advanced Heart Failure: LAICA study

    OpenAIRE

    García-González, Martín J.; de Mora-Martín, Manuel; López-Fernández, Silvia; López-Díaz, Javier; Martínez Sellés Oliveria Soares, Manuel; Romero-García, José; Cordero, Marco; Lara-Padrón, Antonio; Marrero-Rodríguez, Francisco; García-Saiz, María del Mar

    2013-01-01

    Background Advanced heart failure (HF) is associated with high morbidity and mortality; it represents a major burden for the health system. Episodes of acute decompensation requiring frequent and prolonged hospitalizations account for most HF-related expenditure. Inotropic drugs are frequently used during hospitalization, but rarely in out-patients. The LAICA clinical trial aims to evaluate the effectiveness and safety of monthly levosimendan infusion in patients with advanced HF to reduce th...

  8. Effect of acute hyperglycemia on left ventricular contractile function in diabetic patients with and without heart failure: two randomized cross-over studies.

    Directory of Open Access Journals (Sweden)

    Roni Nielsen

    Full Text Available It is unknown whether changes in circulating glucose levels due to short-term insulin discontinuation affect left ventricular contractile function in type 2 diabetic patients with (T2D-HF and without (T2D-nonHF heart failure.In two randomized cross-over-designed trials, 18 insulin-treated type 2 diabetic patients with (Ejection Fraction (EF 36 ± 6%, n = 10 (trial 2 and without systolic heart failure (EF 60 ± 3%, n = 8 (trial 1 were subjected to hyper- and normoglycemia for 9-12 hours on two different occasions. Advanced echocardiography, bicycle exercise tests and 6-minute hall walk distance were applied.Plasma glucose levels differed between study arms (6.5 ± 0.8 mM vs 14.1 ± 2.6 mM (T2D-HF, 5.8 ± 0.4 mM vs 9.9 ± 2.1 mM (T2D-nonHF, p<0.001. Hyperglycemia was associated with an increase in several parameters: maximal global systolic tissue velocity (Vmax (p<0.001, maximal mitral annulus velocity (S'max (p<0.001, strain rate (p = 0.02 and strain (p = 0.05. Indices of increased myocardial systolic contractile function were significant in both T2D-HF (Vmax: 14%, p = 0.02; S'max: 10%, p = 0.04, T2D-nonHF (Vmax: 12%, p<0.01; S'max: 9%, p<0.001 and in post exercise S'max (7%, p = 0.049 during hyperglycemia as opposed to normoglycemia. LVEF did not differ between normo- and hyperglycemia (p = 0.17, and neither did peak exercise capacity nor catecholamine levels. Type 2 diabetic heart failure patients' 6-minute hall walk distance improved by 7% (p = 0.02 during hyperglycemia as compared with normoglycemia.Short-term hyperglycemia by insulin discontinuation is associated with an increase in myocardial systolic contractile function in type 2 diabetic patients with and without heart failure and with a slightly prolonged walking distance in type 2 diabetic heart failure patients. (Clinicaltrials.gov identifier NCT00653510.

  9. Prognosis of emergency room stabilization of decompensated congestive heart failure with high dose lasix

    Directory of Open Access Journals (Sweden)

    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.

  10. Acute pancreatitis

    Science.gov (United States)

    ... its blood vessels. This problem is called acute pancreatitis. Acute pancreatitis affects men more often than women. Certain ... pancreatitis; Pancreas - inflammation Images Digestive system Endocrine glands Pancreatitis, acute - CT scan Pancreatitis - series References Forsmark CE. Pancreatitis. ...

  11. Cystitis - acute

    Science.gov (United States)

    Uncomplicated urinary tract infection; UTI - acute cystitis; Acute bladder infection; Acute bacterial cystitis ... cause. Menopause also increases the risk for a urinary tract infection. The following also increase your chances of having ...

  12. Random duality

    Institute of Scientific and Technical Information of China (English)

    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.

  13. Random duality

    Institute of Scientific and Technical Information of China (English)

    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.

  14. Serum C-reactive protein predicts early mortality in hospitalized patients with HBV-related decompensated cirrhosis.

    Science.gov (United States)

    Zhu, ShaoMing; Waili, Yulituzi; Qi, XiaoTing; Chen, YueMei; Lou, YuFeng; Chen, Bo

    2017-01-01

    The serum C-reactive protein (CRP) is an inflammatory marker. The aim of the present study was to elucidate whether CRP could serve as a potential surrogate marker for 30-day mortality in hospitalized patients with HBV-related decompensated cirrhosis (HBV-DeCi).This was a retrospective cohort study that included 140 patients with HBV-DeCi. All patients were followed up for 1-month. A panel of clinical and biochemical variables were analyzed for potential associations with outcomes using multiple regression models.The serum CRP was significantly higher in nonsurviving patients than in surviving patients. Multivariate analysis demonstrated that CRP levels (odds ratio: 1.047, P = 0.002) and the model for end-stage liver disease score (odds ratio: 1.370, P = 0.001) were independent predictors for mortality.Serum CRP is a simple marker that may serve as an additional predictor of 1-month mortality in hospitalized patients with HBV-DeCi.

  15. Coordinated series of studies to evaluate characteristics and mechanisms of acute coronary syndromes in high-risk patients randomly assigned to enoxaparin or unfractionated heparin: design and rationale of the SYNERGY Library.

    Science.gov (United States)

    Petersen, John L; Mahaffey, Kenneth W; Becker, Richard C; Goodman, Shaun G; Kleiman, Neal S; Marian, A J; Stone, Gregg W; Lansky, Alexandra J; Lincoff, A Michael; Hazen, Stanley L; Nessel, Christopher C; Toro-Figueroa, Luis; Tate, Lynn; Reist, Craig J; Cohen, Marc; Califf, Robert M; Ferguson, James J

    2004-08-01

    Clinical trials and accompanying substudies in patients with acute coronary syndromes (ACS) have over the last several years yielded a wealth of knowledge about the pathophysiology and management of this high-risk condition. The Superior Yield of the New strategy of Enoxaparin, Revascularization, and GlYcoprotein IIb/IIIa inhibitors (SYNERGY) trial is a large-scale, randomized, controlled trial evaluating the effect of enoxaparin and unfractionated heparin on death and myocardial infarction in high-risk patients presenting with non-ST-segment elevation ACS. The SYNERGY Library has been designed as a coordinated series of investigations with simultaneous data acquisition on the same cohort of approximately 500 SYNERGY patients at 60 centers in North America. Specifically, electrocardiograms, coronary arteriograms, inflammatory markers, coagulation studies, and genetic samples will be collected and processed at core laboratory facilities, and the results will be stored in a central repository. This novel strategy for substudy investigation is unprecedented in cardiovascular clinical trials. The goal is to gain significant understanding about this patient population, discover new principles of pathophysiology, identify novel pharmacologic targets, and streamline further drug development. It is hoped that the SYNERGY Library will serve as a model for future substudy design to maximize academic insight within the framework of a large-scale, multicenter trial.

  16. Addition of cladribine to the standard induction treatment improves outcomes in a subset of elderly acute myeloid leukemia patients. Results of a randomized Polish Adult Leukemia Group (PALG) phase II trial.

    Science.gov (United States)

    Pluta, Agnieszka; Robak, Tadeusz; Wrzesien-Kus, Agata; Katarzyna Budziszewska, Bozena; Sulek, Kazimierz; Wawrzyniak, Ewa; Czemerska, Magdalena; Zwolinska, Malgorzata; Golos, Aleksandra; Holowiecka-Goral, Aleksandra; Kyrcz-Krzemien, Slawomira; Piszcz, Jaroslaw; Kloczko, Janusz; Mordak-Domagala, Monika; Lange, Andrzej; Razny, Małgorzata; Madry, Krzysztof; Wiktor-Jedrzejczak, Wieslaw; Grosicki, Sebastian; Butrym, Aleksandra; Kuliczkowski, Kazimierz; Warzocha, Krzysztof; Holowiecki, Jerzy; Giebel, Sebastian; Szydlo, Richard; Wierzbowska, Agnieszka

    2017-04-01

    Intensive induction chemotherapy using anthracycline and cytarabine backbone is considered the most effective upfront therapy in physically fit older patients with acute myeloid leukemia (AML). However, outcomes of the standard induction in elderly AML are inferior to those observed in younger patients, and they are still unsatisfactory. As addition of cladribine to the standard induction therapy is known to improve outcome in younger AML patients. The present randomized phase II study compares efficacy and toxicity of the DAC (daunorubicin plus cytarabine plus cladribine) regimen with the standard DA (daunorubicin plus cytarabine) regimen in the newly diagnosed AML patients over 60 years of age. A total of 171 patients were enrolled in the study (DA, 86; DAC, 85). A trend toward higher complete remission (CR) was observed in the DAC arm compared to the DA arm (44% vs. 34%; P = .19), which did not lead to improved median overall survival, which in the case of the DAC group was 8.6 months compared to in 9.1 months in the DA group (P = .64). However, DAC appeared to be superior in the group of patients aged 60-65 (CR rate: DAC 51% vs. DA 29%; P = .02). What is more, a subgroup of patients, with good and intermediate karyotypes, benefited from addition of cladribine also in terms of overall survival (P = .02). No differences in hematological and nonhematological toxicity between the DA and DAC regimens were observed.

  17. 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

    Directory of Open Access Journals (Sweden)

    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.

  18. 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

    Directory of Open Access Journals (Sweden)

    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.

  19. Ketogenic diet: rapid onset of selenium deficiency-induced cardiac decompensation.

    Science.gov (United States)

    Sirikonda, Naga S; Patten, William D; Phillips, John R; Mullett, Charles J

    2012-06-01

    Selenium-deficiency cardiomyopathy is a known secondary complication from long-term treatment with a ketogenic diet for medical refractory epilepsy. Our patient, a 5-year-old boy on a ketogenic diet for intractable seizures, had a normal selenium level before starting the diet, but he shortly thereafter developed acute reversible cardiomyopathy and ventricular tachycardia, which was unmasked during a hospitalization for an elective operative procedure. His cardiomyopathy was suspected to be secondary to a selenium-deficient state and was confirmed by way of a markedly low serum selenium level and supported by rapid improvement with the initiation of selenium supplementation and cessation of the ketogenic diet. For patients being initiated on a ketogenic diet, current screening guidelines call for baseline and follow-up selenium levels every 3 months during the first year along with RDA selenium supplementation, which is 30 mcg/day. Most of the new ketogenic diet formulas meet this requirement. Our patient underwent elective surgery before his planned 3-month selenium level check and had potentially preventable complications. Secondary to this experience, we suggest that all patients initiated on a ketogenic diet should have a preoperative electrocardiogram (EKG), an echocardiogram, and selenium level determined before any elective surgery. These steps would prevent unnecessary perioperative morbidity and mortality.

  20. Safety of intravenous ivabradine in acute ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention: a randomized, placebo-controlled, double-blind, pilot study

    Science.gov (United States)

    Lopez-de-Sà, E; Schiele, F; Hamon, M; Meinertz, T; Goicolea, J; Werdan, K; Lopez-Sendon, JL

    2013-01-01

    Aims: Rapid heart rate lowering may be attractive in acute ST-segment elevation myocardial infarction (STEMI). Accordingly we studied the effect of intravenous ivabradine on heart rate in this setting. Methods and results: This was a multicenter randomized double-blind placebo-controlled trial: patients aged 40–80 years were randomized after successful primary percutaneous coronary intervention (PCI) performed within 6 h of STEMI symptom onset. Patients were in sinus rhythm and with heart rate >80 bpm and systolic blood pressure >90 mm Hg. They were randomly assigned (2:1 ratio) to intravenous ivabradine (n=82) (5 mg bolus over 30 s, followed by 5 mg infusion over 8 h) or matching placebo (n=42). The primary outcome measure was heart rate and blood pressure. In both groups, heart rate was reduced over 8 h, with a faster and more marked decrease on ivabradine than placebo (22.2±1.3 vs 8.9±1.8 bpm, p<0.0001). After treatment discontinuation, heart rate was similar in both groups. Throughout the study, there was no difference in blood pressure between groups. There was no difference in cardiac biomarkers (creatine kinase (CK-MB), troponin T and troponin I). On echocardiography performed at baseline and post treatment (median 1.16 days), final left ventricular volumes were lower in the ivabradine group both for left ventricular end-diastolic volume (LVEDV) (87.1±28.2 vs 117.8±21.4 ml, p=0.01) and left ventricular end-systolic volume (LVESV) (42.5±19.0 versus 59.1±11.3 ml, p=0.03) without differences in volume change or left ventricular ejection fraction. Conclusion: This pilot study shows that intravenous ivabradine may be used safely to slow the heart rate in STEMI. Further studies are needed to characterize its effect on infarct size, left ventricular function and clinical outcomes in this population. PMID:24222839

  1. 失代偿期肝硬化患者大肠埃希菌血流感染临床及预后分析%Clinical and prognostic analysis of decompensated cirrhosis patients Escherichia coil bloodstream infections

    Institute of Scientific and Technical Information of China (English)

    何卫平; 杨柳; 鲍春梅; 张文瑾; 崔恩博; 蔡少平; 范振平; 曲芬

    2015-01-01

    Objective To investigate the clinical characteristic and drug resistance of decompensated cirrhosis patients bloodstream infections causing by Escherichia coli,and determine risk factors for mortality among patients with bloodstream infections.Methods The clinical data and drug susceptibility of decompensated cirrhosis patients Escherichia coli bloodstream infections from 2009 to 2012 in 302 hospital of PLA were retrospectively analyzed.Univariable and multivariable Logistic regression was used to identify independent risk factors for all-cause mortality.Results A total 211 strains of E.coli were isolated from decompensated cirrhosis inpatients,80 strains ESBLs detecting were positive,positive rate was 37.9%.Most of infection source were uncertain.The drug resistance of ESBLs positive strains was higher than ESBLs negative strains,but no statistical difference existed in age,sex,basic disease,infection source,peak temperature,white blood cell count,the percentage of neutrophils between ESBLs positive strains and negative strains.154 patients were survived and 57 patients were died after treatment,with a mortality of 27.01%.On multivariate analysis,independent risk factors for in-hospital mortality were old age [odds ratio (OR) =2.429],abnormal pulse (OR =2.977),liver failure (OR =11.159),hepatic encephalopathy(OR =2.524),septic shock (OR =8.837),acute kidney injury (OR =3.758),gastrointestinal bleeding(OR =4.118).Body temperature of > 39 ℃ (OR =0.301) had protective effect to lower mortality.A Logistic probobility model was created by adding points for each independent risk factor,and had a c-statistic of 0.898.Conclusions Due to decompensated cirrhosis patients Escherichia coli bloodstream infection severity and bad prognosis,early effective antimicrobial therapy and severe complication prevention should be taken to reduce mortality.%目的 分析失代偿期肝硬化患者大肠埃希菌血流感染的临床特点及耐药性,探讨影响疾

  2. 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

    Directory of Open Access Journals (Sweden)

    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

  3. Acute Bronchitis

    Science.gov (United States)

    ... Smoking also slows down the healing process. Acute bronchitis treatment Most cases of acute bronchitis can be treated at home.Drink fluids, but ... bronchial tree. Your doctor will decide if this treatment is right for you. Living with acute bronchitis Most cases of acute bronchitis go away on ...

  4. Observation on Short-Term Intermittent Administration Dopamine at Low Doses on Patients With Severe Decompensated Heart Failure%小剂量多巴胺间歇短程应用治疗重度失代偿性心力衰竭观察

    Institute of Scientific and Technical Information of China (English)

    陈永成

    2016-01-01

    Objective To explore the short-term intermittent administration dopamine at low doses on patients with severe decompensated heart failure. Methods 84 cases of severe patients with severe decompensated heart failure in our hospital were selected, random grouping, each of 42 cases. The routine group was treated with neuroendocrine antagonist, digitalis, diureticsand and other conventional treatmen. The study group was given a small dose of dopamine on the basis of the conventional group. The clinical effect and adverse reaction rate of the two groups were statistically analyzed. Results The clinical total effective rate of the study group was 88.1% better than that of the conventional group 66.7%,the difference between the two groups was significant (P0.05). Conclusion Usingshort-term intermittent administration dopamine at low doses on patients with severe decompensated heart failure, can significantly improve the clinical effect, and does not increase the incidence of adverse reactions.%目的:探究小剂量多巴胺间歇短程应用治疗重度失代偿性心力衰竭。方法选取我院收治的84例重度失代偿性心力衰竭患者,随机分组,各42例。常规组给予神经内分泌拮抗剂、洋地黄制剂及利尿剂等常规治疗。研究组于此基础上予小剂量以多巴胺治疗。统计两组患者临床效果及不良反应发生率。结果研究组临床总有效率88.1%,优于常规组66.7%,两组差异有统计学意义(P <0.05);两组患者不良反应发生率对比,差异无统计学意义(P >0.05)。结论采用小剂量多巴胺间歇短程治疗重度失代偿性心力衰竭患者,可提高其临床效果,且不会增加不良反应发生率,在临床研究中具有重要意义。

  5. Polymorphisms in the IL-1 gene cluster influence systemic inflammation in patients at risk for acute-on-chronic liver failure.

    Science.gov (United States)

    Alcaraz-Quiles, José; Titos, Esther; Casulleras, Mireia; Pavesi, Marco; López-Vicario, Cristina; Rius, Bibiana; Lopategi, Aritz; de Gottardi, Andrea; Graziadei, Ivo; Gronbaek, Henning; Ginès, Pere; Bernardi, Mauro; Arroyo, Vicente; Clària, Joan

    2017-01-01

    Acute-on-chronic liver failure (ACLF) in cirrhosis is an increasingly recognized syndrome characterized by acute decompensation, organ failure(s) and high short-term mortality. Recent findings suggest that an overexuberant systemic inflammation plays a primary role in ACLF progression. In this study, we examined whether genetic factors shape systemic immune responses in patients with decompensated cirrhosis. Six single-nucleotide polymorphisms (SNPs) in inflammation-related genes (interleukin [IL]-1 beta [IL-1β], rs1143623; IL-1 receptor antagonist [IL-1ra], rs4251961; IL-10, rs1800871; suppressor of cytokine signaling-3, rs4969170; nucleotide-binding oligomerization domain-containing protein 2, rs3135500; and chemerin chemokine-like receptor 1, rs1878022) were genotyped in 279 patients with cirrhosis with (n = 178) and without (n = 101) ACLF from the CANONIC study of the CLIF consortium. Among these SNPs, we identified two polymorphisms belonging to the IL-1 gene cluster (IL-1β and IL-1ra) in strong association with ACLF. Both SNPs were protective against ACLF; IL-1β (odds ratio [OR], 0.34, 95% confidence interval [CI], 0.13-0.89; P decompensated cirrhosis carrying the protective SNP genotypes. Notably, a higher frequency of the protective genotypes was observed in patients without (80%) than in those with (20%) ACLF. Consistently, patients carrying the combined protective genotypes showed a lower 28-day mortality rate.

  6. Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial.

    Science.gov (United States)

    Platzbecker, Uwe; Avvisati, Giuseppe; Cicconi, Laura; Thiede, Christian; Paoloni, Francesca; Vignetti, Marco; Ferrara, Felicetto; Divona, Mariadomenica; Albano, Francesco; Efficace, Fabio; Fazi, Paola; Sborgia, Marco; Di Bona, Eros; Breccia, Massimo; Borlenghi, Erika; Cairoli, Roberto; Rambaldi, Alessandro; Melillo, Lorella; La Nasa, Giorgio; Fiedler, Walter; Brossart, Peter; Hertenstein, Bernd; Salih, Helmut R; Wattad, Mohammed; Lübbert, Michael; Brandts, Christian H; Hänel, Mathias; Röllig, Christoph; Schmitz, Norbert; Link, Hartmut; Frairia, Chiara; Pogliani, Enrico Maria; Fozza, Claudio; D'Arco, Alfonso Maria; Di Renzo, Nicola; Cortelezzi, Agostino; Fabbiano, Francesco; Döhner, Konstanze; Ganser, Arnold; Döhner, Hartmut; Amadori, Sergio; Mandelli, Franco; Ehninger, Gerhard; Schlenk, Richard F; Lo-Coco, Francesco

    2017-02-20

    Purpose The initial results of the APL0406 trial showed that the combination of all- trans-retinoic acid (ATRA) and arsenic trioxide (ATO) is at least not inferior to standard ATRA and chemotherapy (CHT) in first-line therapy of low- or intermediate-risk acute promyelocytic leukemia (APL). We herein report the final analysis on the complete series of patients enrolled onto this trial. Patients and Methods The APL0406 study was a prospective, randomized, multicenter, open-label, phase III noninferiority trial. Eligible patients were adults between 18 and 71 years of age with newly diagnosed, low- or intermediate-risk APL (WBC at diagnosis ≤ 10 × 10(9)/L). Overall, 276 patients were randomly assigned to receive ATRA-ATO or ATRA-CHT between October 2007 and January 2013. Results Of 263 patients evaluable for response to induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients achieved complete remission (CR) in the ATRA-ATO and ATRA-CHT arms, respectively ( P = .12). After a median follow-up of 40.6 months, the event-free survival, cumulative incidence of relapse, and overall survival at 50 months for patients in the ATRA-ATO versus ATRA-CHT arms were 97.3% v 80%, 1.9% v 13.9%, and 99.2% v 92.6%, respectively ( P < .001, P = .0013, and P = .0073, respectively). Postinduction events included two relapses and one death in CR in the ATRA-ATO arm and two instances of molecular resistance after third consolidation, 15 relapses, and five deaths in CR in the ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a therapy-related myeloid neoplasm. Conclusion These results show that the advantages of ATRA-ATO over ATRA-CHT increase over time and that there is significantly greater and more sustained antileukemic efficacy of ATO-ATRA compared with ATRA-CHT in low- and intermediate-risk APL.

  7. A Randomized Double-blind Placebo-controlled Trial of Fibrinolysin for Acute Cerebral Infarction%纤溶酶治疗急性期脑梗死的随机双盲对照研究

    Institute of Scientific and Technical Information of China (English)

    尹俊雄; 曾宪容; 程远; 程媛媛; 万鹏程; 任泗昌; 王普; 代红源; 郭富强

    2013-01-01

    目的:评价纤溶酶治疗急性期脑梗死的疗效及安全性.方法:采用随机、双盲、安慰剂对照的前瞻性研究,纳入非溶栓治疗的急性期脑梗死患者115 例,随机分为纤溶酶组55 例和对照组60 例;在脑梗死基本治疗的基础上,纤溶酶组给予纤溶酶200~300U,静脉滴注7d,对照组给予生理盐水(安慰剂)250 mL,静脉滴注7d.比较2 组发病后90d 的死亡率及生活依赖率,住院期间神经功能缺损评分及发生出血性转化(HT)情况.结果:2 组发病后90d 死亡率差异无统计学意义,但纤溶酶组生活依赖率低于对照组(P<0.05);住院期间纤溶酶组神经功能缺损恢复程度优于对照组(P<0.05);2 组HT 发生率差异无统计学意义;伴HT 患者的预后不劣于不伴HT 的患者.结论:纤溶酶治疗急性期脑梗安全、有效.%Objective: To investigate the efficacy and safety of fibrinolysin on treatment of acute cerebral infarction. Methods: A randomized, double-blind, placebo-controlled study was carried out. One hundred and fifty-one patients with acute cerebral infarction have been recruited for the study and divided into fibrinolysin group (55 cases) and the control group (60 cases) by random number created by computer. The patients in the fibrinolysin group were treated with fibrinolysin 200 ~ 300 U for 7 days after the skin test was negative, plus the basic treatment of cerebral infarction. The cases in the control group were treated with 0.9% saline (placebo) 250 mL for 7 days, plus the basic treatment of cerebral infarction. The mortality and life dependent rate at day 90 after onset were compared between the two groups. The neurological deficit scores and the incidence of hemorrhagic transformation (HT) during hospitalization were compared between the two groups. Results: No significant difference was found in mortality rate at day 90 between two groups. The life dependent rate of fibrinolysin group at day 90 was lower than that in the

  8. ω-3多不饱和脂肪酸治疗急性肺损伤的Meta分析%Impact of omega-3 fatty acids supplementation in acute lung injury patients: a Meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    田宏亮; 田红岩; 韦丽娜; 段磊; 孔玉科; 曾嵘

    2012-01-01

    To evaluate the impact of omega-3 fatty acids intervention on clinical outcomes in acute lung injury patients. Methods: Literatures relating to the evaluation of the omega-3 fatty acids in acute lung injury patients were searched in databases including PubMed, EMBASE, Cochrane Library, Web of Science, Chinese Biomedical Databases , China National Knowledge Infrastructure, and Wanfang Database etc. All the eligible studies were randomized controlled trials and their results were published up to October 2012. The quality of the included studies was evaluated by Jadad evaluation standard. The data were analyzed with RevMan 5. 1 from the Cochrane Collaboration. Results: Totally 6 randomized controlled trials entered final meta analysis study and the baseline data of each trial were comparable. The results showed a significant effectiveness in the PaO2, PaO2/FiO2,Total Protein,LOS. However, the length of LOV stay and adverse effects showed no significant difference between two group. Conclusion: Omega-3 fatty acids interventions can benefit patients by reducing the morbidity of postoperative infectious complications and shortening the length of hospital stay.%目的:探讨ω-3多不饱和脂肪酸(ω-3PUFA)治疗急性肺损伤(ALI)病人的临床效果及其应用价值.方法:计算机检索PubMed、EMBASE、SCI、Cochrane Library、中国生物医学文献数据库、中文科技期刊全文数据库、中国期刊全文数据库和中华医学会数字化期刊,并辅助手工检索,收集采用ω-3PUFA治疗ALI的随机对照试验(RCT),检索至2012年10月截止.采用Jadad评分评价纳入研究质量,用RevMan 5.1软件进行Meta分析.结果:共纳入6个RCT,各试验间资料均有可比性.经Meta分析结果显示,试验组(ω-3PUFA治疗组)与对照组(常规治疗组)在ALI病人的动脉氧分压(PaO2)、氧合指数(PaO2/FiO2)、入住ICU时间(LOS)和总蛋白(TP)等方面均有显著性差异,而撤离呼吸机时间(LOV)和不良反应则

  9. 脑蛋白水解物治疗急性特发性面神经麻痹随机对照研究%Cerebrolysin injection in the treatment of acute idiopathic facial paralysis: a randomized controled trial

    Institute of Scientific and Technical Information of China (English)

    付睿; 戴威; 孟然; 赵星辉; 黄栋

    2011-01-01

    Objective To evaluate the efficacy of Cerebrolysin injection on the acute idiopathic facial paralysis.Methods Seventy-two patients with acute idiopathic facial paralysis were randomly assigned to Cerebrolysin injection ( n =36 ) and control groups ( n = 36 ). Patients in Cerehrolysin injection group received cerehrolysin 20 ml per day for ten consecutive days. Both Cerebrolysin and control groups received prednisone, vitamin B and Adenosine Disodiu. House-Brack-mann facial nerve grading system was used to evaluate the outcomes at 4 weeks and 3 months after Cerebrolysin administration. Results Complete recover rate ( 61. 1% vS. 33. 3% and 75% vs. 44. 4% )and the overall effective rate ( 80. 5%vs.50%and 94. 4%vs. 72. 2% ) were significantly higher in Cerebrolysin group than in control group at either 4 weeks or 3months after treatment. The difference hetween Cerehrolysin group and control group was statistically significant. The overall effective rate for grade Ⅴand Ⅵ of House-Brackmann were significantly higher in Cerehrolysin group than in control group ( 82. 4% vs 44. 4% )(ρ = 0. 035 ). Conclusions Cerebrolysin is more effective than conventional treatment in treating acute idiopathic: facial paralysis.%目的 评价脑蛋白水解物(施普善)治疗急性特发性面神经麻痹的疗效.方法 72例急性特发性面神经麻痹患者随机分为施普善组和对照组各36例,两组同时使用相同剂量的激素、B族维生素和能量合剂治疗,施普善组在常规治疗基础上加用施普善治疗.治疗后4周和3个月采用House-Brackmann面神经功能分级系统评分评价疗效.结果 治疗后4周和3个月施普善组与对照组患者的痊愈率分别为61.1%×33.3%和75%×44.4%,总有效率分别为80.5% vs.50%和94.4% vs.72.2%,二组差异均有统计学意义(P<0.05).对于House-Brackmann分级Ⅴ~Ⅵ级的重症患者施普善组的总有效率较对照组更高为82.4%和44.4%(P=0.035),差

  10. 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.

    Science.gov (United States)

    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.

  11. Effects of priming with recombinant human granulocyte colony-stimulating factor on conditioning regimen for high-risk acute myeloid leukemia patients undergoing human leukocyte antigen-haploidentical hematopoietic stem cell transplantation: a multicenter randomized controlled study in southwest China.

    Science.gov (United States)

    Gao, Lei; Wen, Qin; Chen, Xinghua; Liu, Yao; Zhang, Cheng; Gao, Li; Kong, Peiyan; Zhang, Yanqi; Li, Yunlong; Liu, Jia; Wang, Qingyu; Su, Yi; Wang, Chunsen; Wang, Sanbin; Zeng, Yun; Sun, Aihua; Du, Xin; Zeng, Dongfeng; Liu, Hong; Peng, Xiangui; Zhang, Xi

    2014-12-01

    HLA-haploidentical hematopoietic stem cell transplantation (haplo-HSCT) is an effective and immediate treatment for high-risk acute myeloid leukemia (HR-AML) patients lacking matched donors. Relapse remains the leading cause of death for HR-AML patients after haplo-HSCT. Accordingly, the prevention of relapse remains a challenge in the treatment of HR-AML. In a multicenter randomized controlled trial in southwestern China, 178 HR-AML patients received haplo-HSCT with conditioning regimens involving recombinant human granulocyte colony-stimulating factor (rhG-CSF) or non-rhG-CSF. The cumulative incidences of relapse and graft-versus-host disease (GVHD), 2-year leukemia-free survival (LFS), and overall survival (OS) were evaluated. HR-AML patients who underwent the priming conditioning regimen with rhG-CSF had a lower relapse rate than those who were treated with non-rhG-CSF (38.2%; 95% confidence interval [CI], 28.1% to 48.3% versus 60.7%, 95% CI, 50.5% to 70.8%; P priming group and 31 patients in the non-rhG-CSF-priming group were still alive at the median follow-up time of 42 months (range, 24 to 80 months). The 2-year probabilities of LFS and OS in the rhG-CSF-priming and non-rhG-CSF-priming groups were 55.1% (95% CI, 44.7% to 65.4%) versus 32.6% (95% CI, 22.8% to 42.3%) (P priming group (67.4%; 95% CI, 53.8% to 80.9% versus 41.9%; 95% CI, 27.1% to 56.6%; P priming conditioning regimen is an acceptable choice for HR-AML patients, especially for the patients with no M4/M5/M6 subtype who achieved CR before transplantation.

  12. Acute myopathy associated with liver cirrhosis

    Institute of Scientific and Technical Information of China (English)

    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.

  13. Role of Soluble ST2 as a Prognostic Marker in Patients with Acute Heart Failure and Renal Insufficiency.

    Science.gov (United States)

    Kim, Min-Seok; Jeong, Tae-Dong; Han, Seung-Bong; Min, Won-Ki; Kim, Jae-Joong

    2015-05-01

    This study sought to assess the relationship between serum concentrations of the soluble ST2 (sST2) and B-type natriuretic peptide (BNP) and investigate the role of sST2 as a prognosticator in patients hospitalized with acute heart failure (HF) and renal insufficiency. sST2 was measured at admission and discharge in 66 patients hospitalized with acute decompensated HF and renal insufficiency (estimated glomerular filtration rate [eGFR] renal insufficiency (eGFR renal function, even though BNP level was much higher in patients with severe renal insufficiency. During 3 month follow-up, 9 (13.6%) died and 16 (24.2%) were readmitted due to HF aggravation.On multivariate analysis, sST2 at discharge was independently associated with death or HF readmission during 3 months after discharge (hazard ratio, 1.038; 95% confidence interval, 1.011-1.066, P = 0.006). In conclusion, sST2 is not affected by renal function compared with BNP in acute HF patients. The measurement of predischarge sST2 can be helpful in predicting short-term outcomes in acute decompensated HF patients with renal insufficiency.

  14. Random Matrices

    CERN Document Server

    Stephanov, M A; Wettig, T

    2005-01-01

    We review elementary properties of random matrices and discuss widely used mathematical methods for both hermitian and nonhermitian random matrix ensembles. Applications to a wide range of physics problems are summarized. This paper originally appeared as an article in the Wiley Encyclopedia of Electrical and Electronics Engineering.

  15. [Severe acute liver failure: a case study].

    Science.gov (United States)

    Moreno Arroyo, M Carmen; Puig Llobet, Montserrat; Cuervo Lavado, Luis

    2012-01-01

    Fulminant hepatic failure (FHF), also known as fulminant hepatitis, is a rare and extremely serious condition with a high mortality rate. Its rapid evolution and complexity in managing the treatment, creates the need to provide some immediate care by a team that specialises in intensive care. This acute decompensation is usually associated with other disorders, such as coagulopathy and hepatic encephalopathy, being responsible for major complications that can lead to organ failure. In our region the most common origin is unknown, followed by acute infection with hepatitis B. The treatment of this syndrome is based on the general measures applicable to any critically ill patient: treat the cause and early detection of extrahepatic complications, urgent liver transplantation being one of the alternatives with a better prognosis. This article presents a case report describing the monitoring of an Irish woman of 20 years who was transferred from a hospital in Ibiza to a hospital in Barcelona, with a suspected diagnosis of FHF. Following the conceptual model of Virginia Henderson, the collaborative problems and nursing diagnoses are described, presenting a care plan according to NANDA (North American Nursing Association), NIC (Nursing Intervention Classification), NOC (Nursing Outcomes Classification). This case helps to establish an individualised care plan that provides guidance to nurse professionals in critical patient care by increasing the knowledge of FHF.

  16. 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

    Directory of Open Access Journals (Sweden)

    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

  17. Inhaled vs nebulized salbutamol in the management of acute asthma exacerbation in preschool children: a randomized comparative trial Salbutamol inhalado o nebulizado en el tratamiento de la exacerbación aguda del asma en el preescolar: estudio comparativo aleatorizado.

    Directory of Open Access Journals (Sweden)

    Rafael J. Manotas Cabarcas

    1999-03-01

    Full Text Available In order to evaluate the effectiveness and safety of inhaled vs nebulized salbutamol, in children between one and six years, a randomized trial was performed in 70 patients during a six month period, in Medellín, Colombia. Patients were included because of acute asthma exacerbation. In 32 children two 100 mg doses of salbutamol were administered in three opportunities by means of an inhaling chamber with intervals of twenty minutes. In 38 children, on the other hand, 0.15 mg/k, diluted in 4 ml of saline solution, were administered three times by nebulization, during twenty minutes, with similar intervals. Respiratory frequency and oxygen saturation were measured before and after treatment, and the clinical response and secondary effects were registered. Children in both groups were similar regarding age, seriousness of the crisis, previous evolution and clinical and paraclinical criteria used in the evaluation. Improvement was similar in both groups (p>0.05; also similar was the number of good, fair and poor responses to treatment. Secondary reactions, particularly tachycardia, occurred in 36.8% of nebulized children and in 21.9% of those treated by inhalation (p=0.27. It is concluded that, in the studied population, results of treatment of acute asthma crises were similar regardless of the system of administration of salbutamol, either inhaled of nebulized. Con el objetivo de evaluar la eficacia y seguridad del salbutamol inhalado en comparación con el nebulizado, en niños de uno a seis años de edad, se diseñó un ensayo clínico aleatorizado en 70 casos que consultaron en un período de seis meses al Hospital Infantil Arzobispo Caycedo de la ciudad de Medellín, Colombia, por presentar una exacerbación aguda de asma. Se suministraron al grupo inhalado compuesto por 32 niños, dos disparos de 100 mg de salbutamol, mediante una inhalocámara de polietileno de fabricación casera y de 500 ml de capacidad, por tres oportunidades separadas

  18. Serum 1H-NMR metabolomic fingerprints of acute-on-chronic liver failure in intensive care unit patients with alcoholic cirrhosis.

    Directory of Open Access Journals (Sweden)

    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.

  19. Effects on Pharmacokinetics of Propranolol and Other Factors in Rats After Acute Exposure to High Altitude at 4,010 m.

    Science.gov (United States)

    Wenbin, Li; Rong, Wang; Hua, Xie; Juanhong, Zhang; Xiaoyu, Wu; Zhengping, Jia

    2015-05-01

    A series of pathological, physiological, and biochemical changes, even anatomical histological changes happen while humans arrive at the high plateau region from plain area. There is a certain relationship between the body's compensatory or decompensated adjustments to the environment and the changes of absorption, distribution, metabolism, and excretion of drugs. The objective of the study is to observe the effects of acute exposure to high altitude at 4,010 m on pharmacokinetics of propranolol in rats, and to provide basis and new ideas to adjust drug dosage and administration, so as to promote rational drug use in high altitude. 28 healthy male wistar rats were randomly divided into four groups, group A and B which were in plain area; group C and D which were acutely exposed to high altitude by aviation; group A and C were used for pharmacokinetics determination of propranolol, while group B and D had no drug administration for physiological and pathological changes research at high altitude. The pharmacokinetics of propranolol significantly changed; area under curve, C max (the peak concentration), mean residence time, and t 1/2 (the biological half-life) increased significantly by 481.72, 398.94, 44.87, and 58.77 %, respectively; clearance and V (apparent volume of distribution) decreased by 81.50 and 70.56 %, respectively, after acute exposure to high altitude at 4,010 m; Analytic results show that pH, buffer base, base excess, ctCO2 (content of total carbon dioxide), sO2 (oxygen saturation of arterial blood), pO2 (oxygen tension of arterial blood), and cNa(+) severely decreased by 2.43, 630.00, 311.00, 11.48, 91.38, 76.22, and 2.82 %, respectively, while pCO2 (carbon dioxide tension of arterial blood) and cCl(-) significantly increased by 47.40 and 6.76 %. Lactate dehydrogenase and total protein significantly decreased by 58.44 and 26.82 %, while total bilirubin and alkaline phosphatase severely increased by 338 and 24.94 % after acute exposure to high

  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.

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    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. Determinants of noninvasive ventilation success or failure in morbidly obese patients in acute respiratory failure.

    Directory of Open Access Journals (Sweden)

    Malcolm Lemyze

    Full Text Available PURPOSE: Acute respiratory failure (ARF is a common life-threatening complication in morbidly obese patients with obesity hypoventilation syndrome (OHS. We aimed to identify the determinants of noninvasive ventilation (NIV success or failure for this indication. METHODS: We prospectively included 76 consecutive patients with BMI>40 kg/m2 diagnosed with OHS and treated by NIV for ARF in a 15-bed ICU of a tertiary hospital. RESULTS: NIV failed to reverse ARF in only 13 patients. Factors associated with NIV failure included pneumonia (n = 12/13, 92% vs n = 9/63, 14%; p<0.0001, high SOFA (10 vs 5; p<0.0001 and SAPS2 score (63 vs 39; p<0.0001 at admission. These patients often experienced poor outcome despite early resort to endotracheal intubation (in-hospital mortality, 92.3% vs 17.5%; p<0.001. The only factor significantly associated with successful response to NIV was idiopathic decompensation of OHS (n = 30, 48% vs n = 0, 0%; p = 0.001. In the NIV success group (n = 63, 33 patients (53% experienced a delayed response to NIV (with persistent hypercapnic acidosis during the first 6 hours. CONCLUSIONS: Multiple organ failure and pneumonia were the main factors associated with NIV failure and death in morbidly obese patients in hypoxemic ARF. On the opposite, NIV was constantly successful and could be safely pushed further in case of severe hypercapnic acute respiratory decompensation of OHS.

  2. Random thoughts

    Science.gov (United States)

    ajansen; kwhitefoot; panteltje1; edprochak; sudhakar, the

    2014-07-01

    In reply to the physicsworld.com news story “How to make a quantum random-number generator from a mobile phone” (16 May, http://ow.ly/xFiYc, see also p5), which describes a way of delivering random numbers by counting the number of photons that impinge on each of the individual pixels in the camera of a Nokia N9 smartphone.

  3. Acute pancreatitis

    Directory of Open Access Journals (Sweden)

    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.

  4. Acute pancreatitis

    Directory of Open Access Journals (Sweden)

    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.

  5. Acute-on-chronic liver failure: terminology, mechanisms and management.

    Science.gov (United States)

    Sarin, Shiv K; Choudhury, Ashok

    2016-03-01

    Acute-on-chronic liver failure (ACLF) is a distinct clinical entity and differs from acute liver failure and decompensated cirrhosis in timing, presence of acute precipitant, course of disease and potential for unaided recovery. The definition involves outlining the acute and chronic insults to include a homogenous patient group with liver failure and an expected outcome in a specific timeframe. The pathophysiology of ACLF relates to persistent inflammation, immune dysregulation with initial wide-spread immune activation, a state of systematic inflammatory response syndrome and subsequent sepsis due to immune paresis. The disease severity and outcome can be predicted by both hepatic and extrahepatic organ failure(s). Clinical recovery is expected with the use of nucleoside analogues for hepatitis B, and steroids for severe alcoholic hepatitis and, possibly, severe autoimmune hepatitis. Artificial liver support systems help remove toxins and metabolites and serve as a bridge therapy before liver transplantation. Hepatic regeneration during ongoing liver failure, although challenging, is possible through the use of growth factors. Liver transplantation remains the definitive treatment with a good outcome. Pre-emptive antiviral agents for hepatitis B before chemotherapy to prevent viral reactivation and caution in using potentially hepatotoxic drugs can prevent the development of ACLF.

  6. What Is Decompensated Cirrhosis?

    Science.gov (United States)

    ... Algorithms, Screens, Toolkits Provider Education Provider Education Home Conferences and Events Online Courses (CME) Journal Articles Browse by Topic Publications and Products Web Resources About ...

  7. What Is Decompensated Cirrhosis?

    Science.gov (United States)

    ... Education Home Conferences and Events Online Courses (CME) Journal Articles Browse by Topic Publications and Products Web Resources About Us More Health Care Veterans Health Administration Health Benefits Health Benefits Home Apply for VA Care Apply ...

  8. 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

    DEFF Research Database (Denmark)

    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)....

  9. In Heart Failure Patients with Left Bundle Branch Block Single Lead MultiSpot Left Ventricular Pacing Does Not Improve Acute Hemodynamic Response To Conventional Biventricular Pacing. A Multicenter Prospective, Interventional, Non-Randomized Study

    OpenAIRE

    Maciej Sterliński; Adam Sokal; Radosław Lenarczyk; Frederic Van Heuverswyn; Aldo Rinaldi, C.; Marc Vanderheyden; Vladimir Khalameizer; Darrel Francis; Joeri Heynens; Berthold Stegemann; Richard Cornelussen

    2016-01-01

    Introduction Recent efforts to increase CRT response by multiSPOT pacing (MSP) from multiple bipols on the same left ventricular lead are still inconclusive. Aim The Left Ventricular (LV) MultiSPOTpacing for CRT (iSPOT) study compared the acute hemodynamic response of MSP pacing by using 3 electrodes on a quadripolar lead compared with conventional biventricular pacing (BiV). Methods Patients with left bundle branch block (LBBB) underwent an acute hemodynamic study to determine the %change in...

  10. 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

    Institute of Scientific and Technical Information of China (English)

    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

  11. Acute cholecystitis

    OpenAIRE

    Halpin, Valerie

    2014-01-01

    Acute cholecystitis causes unremitting right upper quadrant pain, anorexia, nausea, vomiting, and fever, and if untreated can lead to perforations, abscess formation, or fistulae. About 95% of people with acute cholecystitis have gallstones.It is thought that blockage of the cystic duct by a gallstone or local inflammation can lead to acute cholecystitis, but we don't know whether bacterial infection is also necessary.

  12. Noninvasive mechanical ventilation in chronic obstructive pulmonary disease and in acute cardiogenic pulmonary edema.

    Science.gov (United States)

    Rialp Cervera, G; del Castillo Blanco, A; Pérez Aizcorreta, O; Parra Morais, L

    2014-03-01

    Noninvasive ventilation (NIV) with conventional therapy improves the outcome of patients with acute respiratory failure due to hypercapnic decompensation of chronic obstructive pulmonary disease (COPD) or acute cardiogenic pulmonary edema (ACPE). This review summarizes the main effects of NIV in these pathologies. In COPD, NIV improves gas exchange and symptoms, reducing the need for endotracheal intubation, hospital mortality and hospital stay compared with conventional oxygen therapy. NIV may also avoid reintubation and may decrease the length of invasive mechanical ventilation. In ACPE, NIV accelerates the remission of symptoms and the normalization of blood gas parameters, reduces the need for endotracheal intubation, and is associated with a trend towards lesser mortality, without increasing the incidence of myocardial infarction. The ventilation modality used in ACPE does not affect the patient prognosis.

  13. Randomized metarounding

    Energy Technology Data Exchange (ETDEWEB)

    CARR,ROBERT D.; VEMPALA,SANTOSH

    2000-01-25

    The authors present a new technique for the design of approximation algorithms that can be viewed as a generalization of randomized rounding. They derive new or improved approximation guarantees for a class of generalized congestion problems such as multicast congestion, multiple TSP etc. Their main mathematical tool is a structural decomposition theorem related to the integrality gap of a relaxation.

  14. Acute Ischemic Stroke and Transient Ischemic Attack

    OpenAIRE

    Staykov, Dimitre; Schwab, Stefan

    2014-01-01

    This short review focuses on recent practically relevant studies in stroke treatment and prevention and discusses their implications on clinical practice and future research, including 3 shortly published randomized controlled trials investigating interventional treatment in acute ischemic stroke (The Interventional Management of Stroke phase III trial [IMS III], Synthesis Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke, and ...

  15. 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

    Directory of Open Access Journals (Sweden)

    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

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

    DEFF Research Database (Denmark)

    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...

  17. 性激素对失代偿期肝硬化患者的影响探讨%Relationships between decompensated cirrhosis and sex hormones

    Institute of Scientific and Technical Information of China (English)

    王慧; 刘雄昌; 张月荣; 陈晓琴; 吴德明; 杨俊杰

    2015-01-01

    探讨性激素与失代偿期肝硬化患者关系的研究状况,性激素是肝硬化临床无创性诊断筛选出较敏感、特异的诊断标志,近年内国内外学者不断地研究,现就性激素与肝硬化的相关性作一综述讨论。%To investigate research status of the sex hormones and decompensated cirrhosis, sex hormones is non-invasive diagnosis of liver cirrhosis in clinical screening, is more sensitive and specific diagnostic markers. Many scholars continue to research on sex hormones and correlation.

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

    DEFF Research Database (Denmark)

    Fattovich, G; Giustina, G; Schalm, S W

    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......% at 5 years. Cox's regression analysis identified three variables that independently correlated with HCC: age, serum levels of platelets, and liver firmness on physical examination. HBV (HBeAg or HBV-DNA) and HDV (anti-HDV) markers at presentation had no prognostic value for the development of HCC....... In conclusion, a high proportion of patients with HBsAg-positive compensated cirrhosis do not experience worsening of their condition for several years, but once decompensation occurs life expectancy is poor. European, white patients with compensated cirrhosis type B are at consistent risk for HCC. Prognostic...

  19. Prediction of True Circulatory Decompensation in Chronic Heart Failure for Optimal Timing of Mechanical Circulatory Support: Non-Invasive Arterial-Ventricular Coupling

    Directory of Open Access Journals (Sweden)

    Roland Hetzer

    2012-02-01

    Full Text Available Background: Prospective comparative studies to predict the risk of hemodynamic deterioration in patients referred for transplantation were performed on the basis of standard invasive and non-invasive data and new wave intensity (WI parameters. Methods and results: Study Group 1 consisted of 151 consecutive outpatients (age 48.7 ± 12 years; 110 men with end-stage dilative cardiomyopathy. Group 2, consisting of 11 consecutive patients (age 50 ± 11 years; 6 men with sinus rhythm and “true” decompensation, was used to create “critical values” of WI. There were no demographic or somatic (weight and height differences between the groups. The follow-up period of ambulatory patients was 31 ± 8 months. Non-invasive WI was studied in the common carotid artery. Complete invasive and non-invasive data were also recorded on the day of investigation. During follow-up 44 pts were lost; there were 15 cardiac deaths (10%, life-saving ventricular assist device implantation in 10 (6.6% and transplantation in 19 (12.7%. For statistical purposes this group was named the “events” Group B (n = 44. A predisposing factor for events (death, “true” decompensation and “urgent” transplantation in ambulatory patients was low first peak (“cut-off value” assessed in Group 2 < 410